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Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 1 of 23 MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation(EU)2017/746 April 2024 This document has been endorsed by the Medical Device Coordination Group(MDCG)established by Article 103 of Regulation(EU)2017/745.The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission.Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 2 of 23 Table of contents 1 INTRODUCTION.4 2 SCOPE.5 2.1 PERFORMANCE STUDIES OF IN VITRO DIAGNOSTIC MEDICAL DEVICES.5 3 ABBREVIATIONS.5 4 DEFINITIONS.6 4.1 ADVERSE DEVICE EFFECT(ADE).6 4.2 ADVERSE EVENT(AE).6 4.3 ANTICIPATED SERIOUS ADVERSE DEVICE EFFECT(ASADE).6 4.4 COMPANION DIAGNOSTIC(CDX).6 4.5 DEVICE FOR PERFORMANCE STUDY.6 4.6 DEVICE DEFICIENCY(DD).6 4.7 INCIDENT.7 4.8 IN-HOUSE IVD.7 4.9 INTERVENTIONAL CLINICAL PERFORMANCE STUDY.7 4.10 INVESTIGATOR.7 4.11 LEFT-OVER SAMPLE.7 4.12 MALFUNCTION.7 4.13 MANUFACTURER.7 4.14 NEW FINDING.7 4.15 PERFORMANCE STUDY(PS).7 4.16 PERFORMANCE STUDY PLAN(PSP).7 4.17 SERIOUS ADVERSE DEVICE EFFECT(SADE).7 4.18 SERIOUS ADVERSE EVENT(SAE).8 4.19 SPECIMEN.8 4.20 SPONSOR.8 4.21 STUDY PROCEDURE.8 4.22 SUBJECT.8 4.23 UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT(USADE).8 5 REPORTING METHOD.8 5.1 REPORTABLE EVENTS IN PRE-MARKET PS INITIATED UNDER DIRECTIVES LEGISLATION.9 5.2 TRANSITION TO REPORTING VIA EUDAMED.9 5.3 OVERVIEW OF FORMATS TO BE USED BY SPONSORS WHEN REPORTING TO NCAS.9 5.4 COLLECTING REPORTS FROM INVESTIGATORS.9 6 REPORTABLE EVENTS.9 6.1 EXCEPTIONS FOR PMPF STUDIES FALLING UNDER IVDR ARTICLE 70(1).11 6.2 REPORTABLE EVENTS OCCURRING IN OTHER MSS/THIRD COUNTRIES.11 7 REPORT BY WHOM.12 8 REPORT TO WHOM.12 Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 3 of 23 9 REPORTING TIMELINES.12 9.1 REPORT BY SPONSOR TO NCAS.12 9.2 REPORT BY THE INVESTIGATOR TO THE SPONSOR.12 10 CAUSALITY ASSESSMENT.13 11 REPORTING FORM.14 11.1 COMPLETION GUIDELINES:FORM HEADER.15 11.2 COMPLETION GUIDELINES:EVENT DETAILS.16 12 REFERENCES.20 13 APPENDIX PERFORMANCE STUDY SUMMARY SAFETY REPORTING FORM.20 Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 4 of 23 1 Introduction Safety reporting in performance studies of in vitro diagnostic medical devices(IVDs)shall be performed in line with the requirements of Article 76(2)of Regulation(EU)2017/746 In Vitro Diagnostic Medical Device Regulation(IVDR):The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in IVDR Article 69:a)any serious adverse event that has a causal relationship with the device,the comparator or the study procedure or where such causal relationship is reasonably possible;b)any device deficiency that might have led to a serious adverse event if appropriate action had not been taken,intervention had not occurred,or circumstances had been less fortunate;c)any new findings in relation to any event referred to in points a)and b).The period for reporting shall take account of the severity of the event.Where necessary to ensure timely reporting,the sponsor may submit an initial report that is incomplete followed up by a complete report.Upon request by any Member State in which the performance study is being conducted,the sponsor shall provide all information referred to in paragraph 1 of IVDR Article 76(1).For post-market performance follow-up(PMPF)studies of CE marked devices1 used within the intended purpose covered by the CE marking,reporting requirements of IVDR Articles 76(5-6)apply.This means that the vigilance provisions laid down in IVDR Articles 82 to 85 and in the acts adopted pursuant to IVDR Article 86 apply to PMPF studies.However,this guidance document is still relevant for PMPF studies as the reporting of serious adverse events(SAEs)where a causal relationship to the preceding PMPF study has been established follow the reporting procedures of performance studies as outlined in IVDR Article 76.Since the electronic system referred to in IVDR Article 69(Eudamed and its module for clinical investigations and performance studies)is not yet available and fully functional from the date of application of the IVDR,this guidance outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional(see also sections 5.1 and 5.2 in this guidance).This document defines SAE reporting modalities and includes a summary tabulation reporting format.1 The PMPF studies referred to in IVDR Article 70(1).Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 5 of 23 2 Scope 2.1 Performance studies of in vitro diagnostic medical devices The reporting modalities and format set out in this guidance apply to:Performance studies covered by IVDR Article 58(1):in which surgically invasive sample-taking is done only for the purpose of the performance study;that is an interventional clinical performance study as defined in IVDR Article 2(46);where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies;performance studies covered by IVDR Article 58(2)involving companion diagnostics(except when only using left-over samples);PMPF studies covered by IVDR Article 70(1)that involve procedures additional to those performed under the normal conditions of use of the IVD and where those additional procedures are invasive or burdensome,in case a causal relationship between a SAE and the preceding performance study has been established;performance studies covered by IVDR Article 70(2)that are conducted to assess,outside the scope of its intended purpose,an IVD that already bears the CE marking.2 combined studies of medicinal products and IVDs.When the study satisfies the definition of a performance study of an IVD,regardless of whether it is conducted in the context of a clinical trial of a medicinal product,the requirements of the IVDR and including its safety reporting obligations apply to the study.This guidance document is then relevant for compliance with the IVDR regarding safety reporting.MDCG 2022-10 provides further guidance on the interface between Regulation(EU)536/2014 on clinical trials for medicinal products for human use(CTR)and the IVDR.3 Abbreviations ADE Adverse Device Effect AE Adverse Event ASADE Anticipated Serious Adverse Device Effect CDx Companion diagnostic 2 The performance study sponsor is responsible for reporting per IVDR Article 76.However,the device manufacturer remains responsible for postmarket surveillance and vigilance obligations for the CE Mark device per IVDR Articles 82-83.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 6 of 23 DD Device deficiency IVD In Vitro diagnostic medical device IVDR Regulation(EU)2017/746 on in vitro diagnostic medical devices MDR Regulation(EU)2017/745 on medical devices MS Member State NCA national competent authority PS Performance study PSP Performance study plan SADE Serious Adverse Device Effect SAE Serious Adverse Event USADE Unanticipated serious adverse device effect 4 Definitions 4.1 Adverse Device Effect(ADE)Any adverse event related to the use of a device for performance study or a comparator3.See ISO 20916 section 3.1.4.2 Adverse Event(AE)Any untoward medical occurrence,inappropriate patient management decision,unintended disease or injury or any untoward clinical signs,including an abnormal laboratory finding,in subjects,users or other persons,in the context of a performance study,whether or not related to the device for performance study.See IVDR Article 2(60).4.3 Anticipated Serious Adverse Device Effect(ASADE)Any serious adverse device effect which by its nature,incidence,severity or outcome has been identified in the risk assessment.See ISO 20916 section 3.5.4.4 Companion diagnostic(CDx)A device which is essential for the safe and effective use of a corresponding medicinal product to:(a)identify,before and/or during treatment,subjects who are most likely to benefit from the corresponding medicinal product;or 3 A comparator might be:other CE-marked IVD,reference method,gold standard,Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 7 of 23(b)identify,before and/or during treatment,subjects likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.See IVDR Article 2(7).4.5 Device for performance study A device intended by the manufacturer to be used in a performance study.A device intended to be used for research purposes,without any medical objective,shall not be deemed to be a device for performance study.See IVDR Article 2(45).4.6 Device deficiency(DD)Any inadequacy in the identity,quality,durability,reliability,usability,safety or performance of a device for performance study,including malfunction,use errors or inadequacy in information supplied by the manufacturer.See IVDR Article 2(62).4.7 Incident Any malfunction or deterioration in the characteristics or performance of a device made available on the market,including use-error due to ergonomic features,as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision,action taken or not taken on the basis of information or result(s)provided by the device.See IVDR Article 2(67).4.8 In-house IVD An IVD manufactured and used within the same health institution as outlined in IVDR Article 5(5).Health institution is defined in IVDR Article 2(29).4.9 Interventional clinical performance study A clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment.See IVDR Article 2(46).4.10 Investigator An individual responsible for the conduct of a performance study at a performance study site.See IVDR Article 2(48).4.11 Left-over sample Unadulterated remainder of human derived samples collected as part of routine clinical practice and after all standard analysis has been performed.Such specimens/samples would be otherwise discarded as there is no remaining clinical need for them.This can include specimens collected for research or other purposes not connected to the clinical performance study in question.Left-over samples include“specimen or sample that are collected in the past and obtained from repositories(e.g.tissue banks,commercial vendor collections).See ISO 20916 section 3.25.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 8 of 23 4.12 Malfunction Any failure of an device for performance study to perform in accordance with its intended use when used in accordance with the instructions for use or performance study plan.See ISO 20916 section 3.27.4.13 Manufacturer A natural or legal person who manufactures or fully refurbishes a device or has a device designed,manufactured or fully refurbished,and markets that device under its name or trade mark.See IVDR Article 2(23).4.14 New Finding New information discovered as the result of an inquiry/investigation/test based on the occurrence of the event.Follow-up from the event.See MDCG 2020-10/1.4.15 Performance study(PS)A study undertaken to establish or confirm the analytical or clinical performance of a device.See IVDR Article 2(42).4.16 Performance study plan(PSP)A document that describes the rationale,objectives,design methodology,monitoring,statistical considerations,organisation and conduct of a PS.See IVDR Article 2(43).4.17 Serious Adverse Device Effect(SADE)Any ADE that has resulted in any of the consequences characteristic of a serious adverse event.See ISO 20916 section 3.43.4.18 Serious Adverse Event(SAE)Any AE that led to any of the following:a)a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested,or in the death of the individuals offspring,b)death,c)serious deterioration in the health of the individual being tested or the recipient of tested donations or materials,that resulted in any of the following:i.life-threatening illness or injury,ii.permanent impairment of a body structure or a body function,iii.hospitalisation or prolongation of subject hospitalisation,iv.medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,v.chronic disease,d)foetal distress,foetal death or a congenital physical or mental impairment or birth defect.See IVDR Article 2(61).Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 9 of 23 4.19 Specimen Any discrete portion of a body fluid or tissue taken for examination,study,or analysis of one or more quantities or characteristics to determine the character of the whole body fluid or tissue.See ISO 20916 section 3.47.4.20 Sponsor Any individual,company,institution or organisation which takes responsibility for the initiation,for the management and setting up of the financing of the PS.See IVDR Article 2(57).4.21 Study procedure Any procedure foreseen in the PS(e.g.specimen collection)with the aim of investigating the device.4.22 Subject An individual who participates in a PS and whose specimen(s)undergo in vitro examination by a device for PS and/or by a device used for control purposes.See IVDR Article 2(47).4.23 Unanticipated serious adverse device effect(USADE)Any SADE,the nature,severity or outcome of which is not consistent with the reference safety information.See ISO 20916 section 3.52.5 Reporting method The template of the Summary Reporting Form4 in the appendix should be used for all studies from 26 May 2022.The tabular form in the appendix needs to be filled in/updated for each reportable event or for new findings/updates to already reported events.It shall be transmitted to all national competent authorities(NCAs)where the PS is being performed.For a new finding or update,the line of the SAE needs to be updated and the first column set to“m”.Write the new findings in the free description of event column and highlight the additions.When applicable,update the others columns as well.For more details on how to complete the form,see section 11.Reporting form.5.1 Reportable events in pre-market PS initiated under directives legislation Any SAE or DD that may(have)lead to a SAE occurring in a PS after 26 May 2022,regardless of when the PS started,should be reported in accordance with Article 76 of the IVDR.5 5.2 Transition to reporting via Eudamed Once Eudamed is fully functional,the obligations and requirements that relate to safety reporting via Eudamed shall apply.Full functionality of Eudamed shall start from six months after the date of publication of the notice referred to in IVDR Article 34(3)of the MDR.4 National provisions can apply 5 National requirements may apply to PS that commenced under the IVDD.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 10 of 23 5.2.1 Ongoing events at time of transition to Eudamed It is acknowledged that at the time of transition to reporting via Eudamed,there will be ongoing events for which initial reports have been made according to the procedures described in this document.For these reportable events,follow-up and final reports will be submitted to the NCAs by the same procedure,but all new reportable events shall be entered in Eudamed.Whether retrospective uploading of previous event reports to Eudamed will be possible is not clear at the time this guidance is issued.5.3 Overview of formats to be used by sponsors when reporting to NCAs From 26 May 2022 and until Eudamed is available.The tabular format of this guidance(Appendix-Summary Reporting Form)should be used.When Eudamed is available but not yet mandatory and until the timepoint when Eudamed becomes mandatory.Either the tabular format of this guidance(Appendix-Summary Reporting Form)or the Eudamed web form can be used.Note:Once the shift to Eudamed reporting has been made for a specific PS,Eudamed should continue to be used for reporting all new events and updates to those events throughout the remainder of the study.When Eudamed is mandatory,i.e.from the date corresponding to six months after the date of publication of the notice referred to in MDR Article 34(3).Web form via Eudamed shall be used for all new events,and updates to those events.The tabular format of this guidance(Appendix-Summary Reporting Form)can be used only to transmit follow-up reports/final reports to the NCAs on events which were initially reported in this format.5.4 Collecting reports from investigators The format in which sponsors wish to receive single event reports from investigators will be up to the sponsor to design and they may be adapted to an individual PS.When sponsors design such reporting forms,they should consult this guidance document to ensure all relevant details are captured in the reports from the investigator,so that the sponsors can fulfil their reporting obligations.6 Reportable events For the purpose of this guidance and based on the definitions above,the following events are considered reportable events in accordance with IVDR Article 76(2):a)any SAE that has a causal relationship with the device6,the comparator7 or the study procedure or where such causal relationship is reasonably possible;6 Device=device for performance study.7 A comparator might be:other CE-marked IVD,reference method,gold standard,Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 11 of 23 b)any DD that might have led to a SAE if appropriate action had not been taken,intervention had not occurred,or circumstances had been less fortunate;c)any new findings in relation to any event referred to in points a)and b).From the definition above,it also follows that SAEs related to a CE marked IVD which is part of a PS with an IVD for PS(for example a CE marked comparator IVD or a CE marked IVD that is used during the study procedure)are reportable if there is a causal(or reasonably possible)relationship to that IVD.The reporting procedures described in this guide should then be followed by the PS sponsor,in addition to the normal vigilance reporting for CE marked devices by the manufacturer(double reporting is certainly possible).All causality assessments should be made using section 10 of this guidance.Only causality level 1(i.e.“not related”)is excluded from reporting.If either the sponsor or the investigator has assigned a higher causality level than not related,the event should be reported.As not all safety provisions in the IVDR are applicable to all types of IVD PS,the following table depicts the safety provisions laid out in the IVDR that are applicable per type of IVD PS.Type of PS IVDR safety reporting provisions PS referred to in IVDR Article 58(1-2):Any PS or any combined IVD study(a clinical study of a medicinal product,medical device,in which an IVD is also studied):a.in which surgically invasive sample-taking is done only for the purpose of the PS;b.that is an interventional clinical PS as defined in IVDR Article 2(46);c.where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies;d.involving CDx(except when only using left-over samples).IVDR Article 76(2-3)PMPF study referred to in IVDR Article 70(1)with additional burdensome and/or invasive procedures.IVDR Article 76(5)AND IVDR Article 76(6)For more information,see section 6.1:Exceptions for PMPF studies falling under IVDR Article 70(1)and Section 10:causality Assessment.PS referred to IVDR Article 70(2)conducted to assess,outside the scope of its intended purpose,a device which already bears the CE marking.IVDR Article 76(2-3)Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 12 of 23 PS with an in-house IVD referred to in IVDR Article 5(5).No provisions on safety reporting according to the IVDR.However,safety reporting may be regulated by national legislation.6.1 Exceptions for PMPF studies falling under IVDR Article 70(1)SAE reporting for PMPF studies falling under Article 70(1)is governed by Articles 76(5)and 76(6).This means that the provisions on vigilance apply and need to by the manufacturer of the CE marked device(s).However,when a causal relationship between the SAE and the preceding PS has been established,reporting procedures for PS should be followed by the PS sponsor.This means that:For the purpose of this guidance(safety reporting in PS),reportable events in PMPF studies are those SAEs where a causal relationship between the SAE and the preceding PS has been established.The other relationship categories i.e.not related,possible and probable do not need to be reported.In the context of vigilance,IVDR Articles 82-85 need to be taken into account and this concerns the serious incidents where a relationship between the incident and the device is at least reasonably possible.It is thus possible that events occurring in such PS need to be reported to both the competent authorities in charge of PS AND to the competent authorities in charge of vigilance.6.2 Reportable events occurring in other MSs/Third Countries 6.2.1 Reportable events occurring in other MSs(MS)The sponsor shall report the reportable SAEs per PS.If several PS are conducted(e.g.specimen collection in multiple sites)with the same device,only those SAEs that happen in PS that have the same PSP code should be reported for those PS,and only to those MS where a PS with that specific PSP code is being conducted8.It is acknowledged that the same PS can be conducted under different versions of the same PSP code in different MS,e.g.with country specific adaptations,and in those cases the SAE reporting can normally be combined for all the versions of the PSP for the same PS.Reportable events occurring before the PS is authorised to start in a MS will be reported to this MS upon authorization in this MS.8“Is being conducted”has to be interpreted as“has been approved or have been notified to the NCA”.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 13 of 23 6.2.2 Reportable events occurring in third countries Reportable events occurring in third countries9 in which a PS is conducted(e.g.specimen collection in that country)under the same PSP(see section 6.2.1 for what is meant with same PSP)have to be reported in accordance with this guidance to the NCA(s)of the European MS(s)in which the PS is being conducted.The NCA will start receiving the reportable events occurring in third countries as soon as the PS is authorised to start in that MS.Reportable events occurring in third countries after the participating European sites have closed,shall continue to be reported to the MSs in which the PS was conducted.Reportable events occurring before the PS is authorized to start in a MS will be reported to this MS upon authorization in this MS.7 Report by whom Reportable events have to be reported by the sponsor of the PS(or the PS sponsors delegate),which could be the manufacturer,the legal representative or another person10 or entity.8 Report to whom Reportable events must be reported at the same time to all NCAs where the PS has commenced,using the summary table featured in the appendix.A list of PS contact points within the NCAs is published at the European Commissions webpage.For the purpose of this guidance,a PS is considered to have commenced in an individual MS when the sponsor is authorised to start the study in that MS in accordance with the provisions laid down in the IVDR.MSs may also require separate reporting to the Ethics Committee(s).9 Reporting timelines 9.1 Report by sponsor to NCAs.The sponsor must report to all NCAs where the PS is authorised to start:For all reportable events as described in section 6 which indicate an imminent risk of death,serious injury,or serious illness and that requires prompt remedial action for other patients/subjects,users or other persons or a new finding to it:immediately,but 9 Countries other than Switzerland,Turkey and those belonging to the EEA.10 Contact person established by the sponsor in line with IVDR Article 58(4)if accepted by MS.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 14 of 23 not later than 2 calendar days after awareness by sponsor of a new reportable event or of new information in relation with an already reported event.This includes events that are of significant and unexpected nature such that they become alarming as a potential public health hazard.It also includes the possibility of multiple deaths occurring at short intervals.These concerns may be identified by either the NCA or the sponsor.Any other reportable events as described in section 6 or a new finding/update to it:immediately,but not later than 7 calendar days following the date of awareness by the sponsor of the new reportable event or of new information in relation with an already reported event.In some cases,a different periodicity or different modalities may be agreed between the participating NCAs and the sponsor according to the studys design and to the pathology studied in the PS.This would allow implementation of adequate provision for PS in which SAE frequency is expected to be high due to the natural progression of the disease(e.g.palliative oncology).9.2 Report by the investigator to the sponsor The sponsor must implement and maintain a system to ensure that the reporting of the reportable events as defined under section 6 will be provided by the investigator to the sponsor immediately,but not later than 3 calendar days after awareness of the event.10 Causality assessment The relationship between the use of the in vitro diagnostic medical device11(including the study procedure)and the occurrence of each SAE must be assessed and categorized.During causality assessment activity,clinical judgement must be used and the relevant documents,such as the Investigators Brochure,the PSP or the Risk Analysis Report must be consulted,as all the foreseeable SAEs and the potential risks are listed and assessed there12.The presence of confounding factors,such as concomitant medication/treatment,the natural history of the underlying disease,other concurrent illness or risk factors must also be considered.The above considerations also apply to the SAEs occurring in the comparison group.For the purpose of harmonizing reports,each SAE will be classified according to four different levels of causality:1.Not related 2.Possible 3.Probable 11 Intended as both device for PS and comparator.12 For a comparator device,the instructions for use could be a relevant document.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 15 of 23 4.Causal relationship The sponsor and the investigators will use the following definitions to assess the relationship of the SAE to the device for PS,the comparator or the study procedure.1.Not related:the relationship to the device for PS,the comparator or to study procedures can be excluded when:-the event has no temporal relationship with the use of the device for PS,or the procedures related to use of the device for PS;-the relationship between the SAE and the device for PS is biologically implausible;-the discontinuation of device use or the reduction of the level of activation/exposure-when clinically feasible-and reintroduction of its use(or increase of the level of activation/exposure),do not impact on the SAE;-the event involves a body-site or an organ that cannot be affected by the device for PS or procedure;-the SAE can clearly be attributed to another cause(e.g.an underlying or concurrent illness/clinical condition,an effect of another device,drug,treatment or other risk factors);-the SAE does not depend on a false result given by the device for PS;In order to establish the non-relatedness,not all the criteria listed above might be met at the same time,depending on the type of device/procedures and the SAE.2.Possible:the relationship with the use of the device for PS or the comparator,or the relationship with study procedures,is weak but cannot be ruled out completely.Alternative causes are also possible(e.g.an underlying or concurrent illness/clinical condition or/and an effect of another device,drug or treatment).Cases where relatedness cannot be assessed,or no information has been obtained,should also be classified as possible.3.Probable:the relationship with the use of the device for PS or the comparator,or the relationship with study procedures,seems relevant and/or the event cannot be reasonably explained by another cause.4.Causal relationship:the SAE is associated with the device for PS,comparator or with study procedures beyond reasonable doubt when:-the product category the device for PS belongs to or similar IVDs and study procedures are known to have this event;-the event has a temporal relationship with the device for PS or study procedures;-other possible causes(e.g.an underlying or concurrent illness/clinical condition or/and an effect of another device,drug or treatment)have been adequately ruled out;-harm to the subject is due to error in use;Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 16 of 23-the event depends on a false result given by the device for PS used for diagnosis13,when applicable;In order to establish the relatedness,not all the criteria listed above might be met at the same time,depending on the type of device/procedures and the SAE.The sponsor and the investigators will distinguish between the SAEs related to the device for PS and those related to the procedures(any procedure specific to the PSP).Complications caused by concomitant treatments not imposed by the PSP are considered not related.Similarly,several routine diagnostic or patient management procedures are applied to subjects regardless of the PSP.If routine procedures are not imposed by the PSP,complications caused by them are also considered not related.The relationship between a SAE and the procedure or the device needs to be assessed separately.This does however not mean that they are mutually exclusive;a SAE can be related to both the procedure and the device,or it can be related only to the procedure or only to the device.When it is unclear whether an event is related to the device or to the procedure,the investigator should:set the relationship to device to possible(or higher)AND set the relationship to procedure to possible(or higher)When the healthcare provider performs the procedures and uses the device(s)for PS,the causality assessment of this healthcare provider should prevail.In case of self-tests,the assessment by the sponsor and the one by the user are equally weighted.In some particular cases the event may not be adequately assessed because information is insufficient or contradictory and/or the data cannot be verified or supplemented.The sponsor and the investigators will make the maximum effort to define and categorize the event and avoid these situations.Where an investigator assessment is not available and/or the sponsor remains uncertain about classifying the SAE,the sponsor should not exclude the relatedness;the event should be classified as“possible”,and the reporting is not to be delayed.Particular attention shall be given to the causality evaluation of unanticipated SAEs.The occurrence of unanticipated events could suggest that the PS places subjects at increased risk of harm than was to be expected beforehand.11 Reporting form The reporting form template for the summary SAE tabulation is given in the Appendix of this document.13 If a device for performance study gives an incorrect diagnosis,the subject might,for example,receive an unnecessary treatment and incur all the risks that accompany that treatment,or might be incorrectly diagnosed with a serious disease.In other cases,the subject might not receive an effective treatment(thereby missing out on the benefits that treatment would confer),or might not be diagnosed with the correct disease or condition.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 17 of 23 The reporting form is study specific and covers only a given PS,defined by a distinct PSP.English is the recommended language for the reporting form.The reporting form can be modified in any applicable software(not only Microsoft Excel),but the file needs to be compatible with Microsoft Excel when sent to the participating NCAs.Sponsors who generate the excel report file by automated processes may implement other technical features in their systems for excel file generation to ensure the preferred terms listed in metadata are used.The template form contains inserted filters and functionalities to facilitate the use of preferred terminology in the reporting.These are important for the analysis and should be maintained.The table gives a cumulative overview of the reportable events per PS and will be updated and transmitted to participating NCAs each time a new reportable event or a new finding to an already reported event is to be reported.If more detailed information has to be provided on request of an NCA,the individual study specific reporting form should be used.11.1 Completion guidelines:Form header 11.1.1 EUDAMED/CIV-ID It will not be possible to generate the Union-wide unique single identification number mentioned in IVDR Article 66(1)before Eudamed is fully functional.Until Eudamed is fully functional,PS will get tracking numbers(CIV-ID)upon registration in the Eudamed2 database which is performed by the NCA upon receipt of an application.This CIV-ID is provided to the sponsor during the NCAs handling of the initial application for the PS and should be entered on the safety reporting form.11.1.2 Title of PS The identifying title of the PS.The title indicated here should be consistent with other title entries(such as in PS application form,PSP cover page etc).11.1.3 PSP number/code The unique identification code or short name assigned to the specific PSP by the sponsor(numeric,alphanumeric or acronym)should be indicated.11.1.4 Contact person Name,address,e-mail and telephone number should be provided for the person who is the sponsors point of contact in case the NCA has follow-up questions regarding submitted safety report forms.11.1.5 MS NCA Reference numbers For each participating MS,indicate the country code14 and the NCAs national reference number for the PS.Example:SE 5.1-20YY-XXXXXX 14 Use ISO-3166-1 alpha-2 codes,i.e.two-letter country codes as defined in ISO 3166-1 Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 18 of 23 DK 20YYXXXXXX 11.1.6 No.of subjects enrolled to date total&No.of specimens tested with the IVD to date total Indicate the total number of subjects who have been enrolled and number of specimens that have been tested with the IVD(per date of report)in the PS globally.11.1.7 No.of subjects enrolled to date per country&No.of specimens collected to date per country List all countries where the PS has been authorised by the report date and indicate the number of enrolled subjects and number of obtained specimens in the PS(per date of report)in each country.11.1.8 Device type Indicate the type of device(s)assessed in the PS according to EMDN categories(use the level as specialised as possible).The EMDN can be accessed and downloaded in pdf and excel format at webgate.ec.europa.eu/dyna2/emdn and the European Commissions website page for MDCG documents.11.1.9 Reference MS Indicate the name of the MS which drew the unique EUDAMED ID(normally the first MS receiving an application for the PS).Once the coordinated assessment procedure(per IVDR Article 74)is up and running,the coordinating MS should be indicated here.11.1.10 No.of devices for PS used to date total Indicate the total number of devices for PS(e.g.reagent kits)which have been used(per date of report)in the PS globally.The number of devices used could be indicative of a quality issue.Therefore,if not applicable to the device used,please provide justification and add another parameter to assess quality issues with the IVD.11.1.11 No.of devices for PS used to date per country List all countries where the PS has been authorised by the report date and indicate the number of devices for PS(e.g.reagent kits)which have been used in the PS(per date of report)in each country.The number of devices used could be indicative of a quality issue.Therefore,if not applicable to the device used,please provide justification and add another parameter to assess quality issues with the IVD.11.1.12 Date of report Indicate the date when the report is compiled for transmission to NCAs.Format DD/MM/YYYY.11.2 Completion guidelines:Event details Each unique reportable event is presented in a separate line.Updates to a previously reported event should be made by changing the information in the same line,and clearly identified according to the principles described below.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 19 of 23 Any new information added in the form should be highlighted in bold and/or colour.This includes any new lines added and any changes made to the information in an already existing line.In the initial report,in any given line,no fields shall be left intentionally blank.To meet this requirement,preliminary information should be filled in,despite the need of further updating.11.2.1 Status The sponsor shall identify the new/updated information in the status column as:A=added=new reportable event;D=deleted=already reported event that has been deleted due to downgrading to non-serious,due to integration in another event,or Add the reason for deletion in the corresponding cell in column“Free description of event”.M=modified=new finding/update to an already reported event;U=unchanged.Do not add other options.11.2.2 Date Sponsor received report of SAE/DD Indicate the date when the sponsor was first notified by the study site about the event.This date is checked for compliance with reporting timelines as outlined in section 9 Reporting timelines.Format DD/MM/YYYY.11.2.3 Country code Indicate the country code14 for the country in which the subject associated with the event has been enrolled.Choose from dropdown menu or enter manually if code is not available.11.2.4 Study site 11.2.4.1 Specimen collection Name identifying the institution or site where the specimen was collected.11.2.4.2 Specimen analysis Name identifying the institution or site where the specimen was analysed.11.2.5 Subject ID code The study specific subject ID code,i.e.the link between study data and the actual subject identity(which is not to be provided in this form).11.2.6 SAE or DD ID code The investigator,sponsor or manufacturer should assign a unique ID to each SAE or DD that has occurred.This number shall remain unchanged throughout all other alterations of the particular SAE reporting due to ongoing assessment.11.2.7 Date of specimen collection Indicate the date of the relevant collection of the specimen.Format DD/MM/YYYY.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 20 of 23 11.2.8 Date of event onset The date when the first signs of an event were noticed may be different(earlier)than the date when the event fulfilled the seriousness criteria(see further the definition in section 4.15).The date when the event became an SAE should be reported as Date of event onset.In case of DDs which did not lead to an SAE,the date the DD was discovered should be indicated.Format DD/MM/YYYY.11.2.9 SAE or DD Choose one option from SAE or DD.When a DD lead to a SAE,both need to be reported on separate lines.In the line of the DD/SAE,refer to the associated SAE/DD.Complete all possible information in both lines.This might mean double reporting of some information,but it is necessary that both the DD and the SAE have all information and can be analysed separately.Do not add other options.11.2.10 Subject gender Choose one option from the following list(do not add other options):Female Male Other Unknown 11.2.11 Classification of event Choose one option from the following list of consequence characteristics(do not add other options):Patient management decision resulting in death or an imminent life-threatening situation for the individual being tested or in the death of the individuals offspring Death Life-threatening illness or injury Permanent impairment of body structure or body function Hospitalization or prolongation of hospitalization Medical or surgical intervention Chronic disease Foetal distress,foetal death or congenital physical or mental or birth defect Not applicable(Note that this option is only to be selected in case of reportable DDs that did not lead to an SAE)11.2.12 SAE connected to specimen collection or to specimen analysis Choose one option from the following list(do not add other options):Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 21 of 23 Specimen collection Specimen analysis(including pre-analytical,analytical and post-analytical phase)11.2.13 Free description of event Provide a description of the event in free text.Please provide other relevant information not already captured in this report.Below is a non-exhaustive list of items that could be relevant to cover:Nature of the observed symptoms Duration and severity of the symptoms Date of onset of first signs of the event(before it became a SAE)Medical background of the subject Medical care of the subject Comments on the event in relation to already known safety data 11.2.14 Device issue(if applicable)The IMDRF codes applicable to device issues can be found in annex A on the IMDRF webpage related to AE terminology.You can use this worksheet to look up the appropriate codes.Please report all the appropriate codes applicable for the SAE or DD reported.Please separate each code only by“;”.Please do not use the terminology,but only the codes.11.2.15 Clinical signs/symptoms The IMDRF codes applicable to clinical signs/symptoms can be found in annex E on the IMDRF webpage related to AE terminology.Please report all the appropriate codes applicable for the SAE or DD reported.Please separate each code only by“;”.Please do not use the terminology,but only the codes.11.2.16 Clinical impact The IMDRF codes applicable to clinical impact of the SAE or DD can be found in annex F on the IMDRF webpage related to AE terminology.Please report all the appropriate codes applicable for the SAE or DD reported.Please separate each code only by“;”.Please do not use the terminology,but only the codes.11.2.17 Action/treatment/outcome Provide information in free text on actions taken,treatment(s)administered and the outcome.“Outcome”is a broader term then“event status”and the value to be entered here is considered to be more specific than the options given for“event status”(see 11.4.13).11.2.18 Relationship to procedure Choose one option from the following list of causality levels(for explanatory texts see section 10 Causality assessment)(do not add other options):Not related Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 22 of 23 Possible Probable Causal Not applicable(please justify)Please report the assessments by sponsor and investigator in the respective columns.The investigator could mean the specimen collection site investigator or the specimen analysis site investigator.11.2.19 Relationship to device Choose one option from the following list of causality levels(for explanatory texts see section 10 Causality assessment)(do not add other options):Not related Possible Probable Causal Not applicable(please justify)Please report the assessments by sponsor and investigator in the respective columns.The investigator could mean the specimen collection site investigator or the specimen analysis site investigator.11.2.20 Study arm Choose one option from the following list:Test group(described in the PSP)Comparison group(described in the PSP)Blinded Not applicable Note:For some study designs it might be more relevant to add name of device;i.e.in a PS with several test groups it might be useful to differentiate which study device was used for testing the subject.11.2.21 Event status(only applicable for SAE)Choose one option from the following list(do not add other options):Resolved Resolved with Sequelae Ongoing Death Doesnt need to be completed for DD.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 23 of 23 11.2.22 Date of event resolution(only applicable for SAE)Add date in format DD/MM/YYYY.If event status is“Ongoing”enter Not Applicable.12 References 1.Regulation(EU)2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.2.Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices.3.Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices(Eudamed).4.Codes for the representation of names of countries and their subdivisions Part 1:Country codes(ISO 3166-1)published by International Organisation for Standardization(ISO).5.In vitro diagnostic medical devices Clinical performance studies using specimens from human subjects Good study practice(ISO 20916)published by International Organisation for Standardization(ISO).6.Documents by the International Medical Device Regulators Forum(IMDRF)to support regulatory harmonization:https:/www.imdrf.org/documents.7.MDCG 2022-10:Q&A on the interface between Regulation(EU)536/2014 on clinical trials for medicinal products for human use(CTR)and Regulation(EU)2017/746 on in vitro diagnostic medical devices(IVDR).13 Appendix Performance Study Summary Safety Reporting Form
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futurehealthindex2022Healthcare hits resetPriorities shift as healthcare leaders navigate a changed worldGlobal reportThe Future Health Index is commissioned by PhilipsContentsForewordResearch premiseConclusionGlossary of termsResearch methodologyEmerging from the pandemic,healthcare leaders reassess their needsUnlocking the power of dataHow predictive analytics can supercharge care0304051017212325Future Health Index 2022 Healthcare hits reset2Across15countriesThe Future Health Index 2022 report now in its seventh year is based on proprietary research conducted in 15 countries.In 2022,the Future Health Index focuses on how data and advanced analytics are giving healthcare providers new tools which enhance their ability to deliver care to all sectors of their communities,both in and out of a traditional hospital setting.Research premiseAustralia Brazil China France GermanyIndia IndonesiaItalyNetherlands PolandRussia Saudi Arabia Singapore South Africa United StatesCountries included in the researchThis is the largest global survey analyzing the top priorities and concerns of healthcare leaders*.*HealthcareleaderisdefinedasaC-suiteorseniorexecutivedecisionmaker/influencerworkinginahospital,medicalpractice,imagingcenter/office-basedlab,ambulatorycenterorurgentcarefacility3,000healthcare leadersResponses from almost Future Health Index 2022 Healthcare hits reset3Over the past two years,pressure on the healthcare industry has been unrelenting.The pandemic has continued to challenge resources,systems and the provision of care at every turn and in every country around the world.Today,as we emerge from the pandemic,we see healthcare leaders embarking on a reset refocusing on a number of new and existing priorities,from addressingstaffshortages,toextendingcaredelivery,to leveraging big data and predictive analytics,as they navigate new realities in medical management.The Future Health Index 2022 report provides a detailed picture of the most pressing priorities for todays healthcare leaders and reveals what they plan to do about them.Top ofthelistarestaffsatisfactionandretention,whichhavebecomeincreasinglydifficulttomaintain in a sector facing widescale labor shortages.Next is the drive to extend care delivery beyond hospital walls,which has been accelerated by the pandemic,and continues to fuel investments in digital health technologies and capabilities.Meanwhile,as we highlighted in last years report,a sharp focus on social responsibility hashadapositiveeffectinpromotinggreenerhealthcare systems.However,for some,the change has not been fast enough,with our latest research revealing that many leaders are now accelerating their sustainability plans,in line with the evolving expectations of patients.Finally,unlocking the power of big data and predictive analytics has presented some ofthemostsignificantopportunitiesforhealthcare leaders to improve the quality,cost and speed of care.But the pace of development is slow,and leaders recognize the need to strengthen their investments withstrongstrategicpartnerships,stafftraining and governance in order to maximize their returns.Insummary,this2022reportreflectsaresetting of priorities and of care delivery itself,as healthcare leaders navigate a fundamentally changed world.ForewordAs we emerge from the pandemic,we see healthcare leaders embarking on a reset.Jan Kimpen PhilipsChiefMedicalOfficerFuture Health Index 2022 Healthcare hits reset4Emerging from the pandemic,healthcare leaders reassess their needsA much-needed refocus on staff Thepandemichasexacerbatedthedifficultiesfaced by healthcare leaders before the crisis.Today,healthcare leaders face a human capital crisis:the great resignation has serious consequences for the industry,leading to the closure of facilities,in some cases.This is an issuethatmustbeaddressedinordertofix other challenges.Evolving the approach to care deliveryThe pandemic has led healthcare leaders to act with agility,build resilience and adopt smarter waysofworkingtohelpfuture-proofcare.Ithas also pushed them to rethink how care is delivered.In many cases,healthcare leaders have continued to use care practices that were adopted more widely during the pandemic,including virtual care.1In the hospital sector,the COVID situation hit us hard.future investments fell behind a bit.we are now clearly looking to the future again.Operation Room Department Head Urban hospital,GermanyThe following chapter explores the current priorities for healthcare leaders and how their planned investments in digital technology can support these priorities.Chapter 1 Emerging from the pandemic,healthcare leaders reassess their needsHealthcare leaders refocus on staffsatisfactionandretentionTackling the human capital crisis is top of mindEmployee retention is a serious issue in healthcare systems across the world:global demand for healthcare workers is predicted to riseto80millionstaffby2030*.Withsupplyofhealthcareworkersexpected to reach just 65 million over the same period,this leaves asignificant*15millionshortfall.Drivenbyagingpopulationsandeconomic and population growth,this demand is anticipated to be highestinmiddle-incomecountries.Coupledwiththisisthedepartureofstaff:morethanhalfofallhealthcare workers worldwide are experiencing burnout that,ifnotaddressed,couldcausemanytoleavetheirfields*.Theconsequencesofpoorstaffretentionaresevereandincludehighcostsassociatedwithreplacingstaff,whichaffectpatientcareandstaffmorale.Staff satisfaction and retention ranks as the highest priority for healthcare leadersExtending care delivery beyond the hospital/healthcare facilityStaff satisfaction and retentionFacilitating a shift to remote/virtual care(e.g.,telehealth)*https:/human-resources- countries stand out as prioritizing staff satisfaction and retention the most three years from nowA job that takes two people to complete is being given to only one person to do.It must be hard for our staff.Department Head of Neurology Urban hospital,ChinaThismayexplainwhystaffsatisfactionandretentionare,together,top of healthcare leaders priority lists,both today and three yearsfromnow(30%today,28%inthreeyears).However,theunderlying reasons behind this vary from country to country.In the United States,for example,it is driven by the great resignation andcompetingsalariesfromothersectors.InIndia,itistheever-increasing demand for more healthcare professionals that is the driver,whileinChinathepriorityisfocusedaroundthespecificneed for doctors and nurses.Investing in technology can help alleviate the burdens faced by healthcare professionals The Future Health Index 2020*report found that younger healthcare professionals who work in smart facilities are more likely thantheirpeersinbothdigitalandanalogfacilitiestobesatisfiedin their work.By placing such an emphasis on technology in their facilities,leadersarelikelytobesimultaneouslyimprovingstaffexperience and satisfaction.Future Health Index 2022 Healthcare hits reset6Chapter 1 Emerging from the pandemic,healthcare leaders reassess their needsExpanding care beyond hospital walls gains momentum Extending care is another top priority for leaders The value of delivering care beyond hospital walls was in evidence during the pandemic*,with digital tools such as contact tracing apps and telehealth consultations helping to keep communities safe while ensuring continuity of care.Today,healthcare leaders view extending care deliveryastheirhighestpriorityafterstaffsatisfactionandretention.ThisreflectstheFutureHealthIndex2021report,whichfoundthat24%ofhealthcareleaders would prioritize extended care in the following three years.Notably,there is also a continuing acceleration in the riseinambulatorycare,oneofthefastest-growingsegments of the healthcare industry*.This focus is also closely aligned with the Quadruple Aim as it meetstheneedsofbothpatientsandstaff,whileimproving outcomes and considerably reducing costs.Digital health recordsArticial intelligenceDigital health records and AI are the leading digital technology investments todayHCP-to-HCP telehealthVoice recognition toolsHCP-to-patient telehealth609)$%Extending care delivery has grown to be a priority today and three years from nowThree years from now26 21 priorityCurrent priority*https:/ see an increasing shift in care outside of the big box hospital model and into the home setting.Chief Operating Officer Urban hospital,AustraliaTo deliver this care,leaders continue to invest in enabling technologies These technologies include digital health records,telehealthandartificialintelligence(AI)toolsthatcanenhanceefficiency,improvecareandconnectremote communities.Such technologies remain a top investment for healthcare leaders,highlighting how leaders are building on advances made during the pandemic when telehealth played a key role.The pandemic spurred a huge surge in investment in telehealth.A 2020 analysis*by Frost&Sullivan found that the telehealth market in the US alone was predictedtodisplayseven-foldgrowthby2025.In2021,64%ofhealthcareleaderswereinvestinginit.Now,with the technology already in place,healthcare leaders are looking to secure the right technology infrastructure to ensure they get maximum value from telehealth.Future Health Index 2022 Healthcare hits reset7Social responsibility is a growing priority for healthcare leaders2021 priority12%Current priorityChapter 1 Emerging from the pandemic,healthcare leaders reassess their needsTackling health inequalities within the communityHealthcare leaders are prioritizing social responsibilityHealthinequalitiesarecomplexandfar-reaching,andaffectabroadrangeofcommunities.Keyfactors include socioeconomic status,geographic location,race and ethnicity,and gender and sexual identity.The pandemic highlighted health inequalities across society,leadingtoacallfromtheWorldHealthOrganization for global action to address such issues*.This years research found that social responsibility,including addressing health inequalities,has become one of healthcare leaders top priorities both now and in thefuture.One-quarter(25%)ofhealthcareleaderssaythat being a socially responsible healthcare provider is one of their primary responsibilities and,in many cases,are already acting on this sense of responsibility.Over half(58%)saytheyeitherhaveinitiativesinplacetohelp tackle health inequity or are currently developing such initiatives.A recent snapshot*of the ways US hospitals are working to limit health disparities showed community outreach programs,healthy food access schemes,volunteering,and diversity and inclusion planning.These activities are mirrored in private sector hospitals around the world.*https:/www.who.int/campaigns/world-health-day/2021*https:/ adopters in technology are ahead in dealing with health inequality57!%017F(A%We currently have initiativesWe are currently developing initiativesWe intend to develop initiatives in next 3 yearsGlobal averageEarly adopters of digital health technology and predictive analyticsLate adopters of digital health technology and predictive analyticsWhy addressing health inequalities is on the agendaHealth inequalities have been sharply magnifiedinthepasttwoyears.Those from minority communities experienced disproportionate rates ofillnessanddeathduetoCOVID-19.This is attributed*to increased risk of exposure to the virus due to living,working and transportation situations.They also faced greater risk of experiencing serious illness if infected due to higher rates of underlying health conditions.The socialandeconomiceffectsofthepandemic also threaten to reverse progress toward gender equality,with a recent global study reporting increased disruptions in reproductive healthservices,aswellasfindingthatwomen have experienced negative social and economic*impacts to a greater extent than men.At a global level,acute issues such as poor supply and limited infrastructure are now under greater scrutiny,with healthcare leaders and governments under increasing pressure to respond.Technology plays a part in tackling such disparitiesOvertwo-thirds(68%)ofhealthcareleaderssaythattheuse of predictive analytics can have a positive impact on health inequality.For example,predictive analytics can provide fast and accurate insights around risk scores and collective health issues.These insights help to proactively identify groups of people at risk,particularly among poorer and more vulnerable groups.Hospitals are then able to incorporate this information into planning for community health issues such as disease outbreaks and cancer incidence,improving the healthcare delivered to these underserved groups.Underlining this link,healthcare leaders who say they are early adopters of technology and predictive analytics are more likely than those who are late adopters to have initiatives to deal with health inequalities in place,highlighting how technology adoption can address health inequality.Withtwo-thirdsoftheworldspopulationlackingaccessto basic medical imaging technology*,one initiative that ismakingadifferencebybringingqualitycaretopatientsinneedisPURE,anon-profitorganizationdedicatedtoenhancing ultrasound education and use in the developing world.Participating physicians in the US and Europe use tele-ultrasoundtosupportemergencymedicineresidentsinKigali,Rwanda,whointurnsharetheirlearningwithhealthcare professionals in rural areas,boosting the countrys emergency medicine facilities.Future Health Index 2022 Healthcare hits reset8Chapter 1 Emerging from the pandemic,healthcare leaders reassess their needsEmbarking on a fast track to sustainability Healthcare leaders are prioritizing environmental sustainability The Future Health Index 2021 report found that just4%ofhealthcareleaderssawimplementingsustainability practices as a priority,although many(58%)agreeditwouldbecomeapriorityby2024.Today,thepictureisverydifferent.Thisyearsfindingssuggestthathealthcareleadershavefast-trackedtheirsustainabilityplans.Almostone-quarter(24%)are prioritizing sustainability,and the same number plan to do so three years from now.This shift may be explained by both the public commitment of50countriestodevelopclimate-resilientandlow-carbonhealthsystemsaspartoftheCOP26Health Programme*in late 2021,and a resetting of expectations as leaders embark upon implementing their sustainability plans.Healthcare leaders in urban facilities are more likely than their peers in rural facilities to prioritize sustainability(26%vs19%),demonstratingtherole of patients and healthcare workers in driving sustainability.In urban areas where there is a wider choice of facilities,healthcare leaders are more likely to feel pressure to meet patient demands for The role of sustainability in healthcareWiththehealthcareindustrybeingoneofthemostcarbon-intensive industries,leaders have long faced calls to adopt more sustainable practices.The supply chain is one of the most important areas on which to focus.Other common initiatives include increased use of renewable energy,expanding the circularity of products and materials,efficientconstructionpractices,and replacing harmful chemicals with safer alternatives.Organizations such as Health Care WithoutHarm*areleadingthegrowing demand for sustainability with a range of initiatives,including tools for facilities to control their waste management and education programs on the health impacts of climate change.Operational leaders taking the lead in addressing sustainabilityClinicalOperational22%!%Current priorityThree years from nowSustainability as a priorityin 2021 and 20224$X$ 212022Current priorityThree years from now*https:/ leaders in Australia and Poland are ahead of most other countries in prioritizing sustainability241%Global averageAustralia30%Polandsustainable practices in order to attract and keep patients*.Equally,sustainability is increasingly playing a key part in recruiting talent in areas where thereissignificantcompetition.However,whileleaders in rural facilities are currently behind those in urban facilities in prioritizing sustainability,they are set to surpass them in terms of the issue three years fromnow(29%vs25%).There are also differences in attitudes towards sustainability between operational and clinical healthcare leaders Clinical leaders are less likely to prioritize sustainability than their operational colleagues today and this differenceisevengreaterinthefuture.However,theycan also have an impact on emissions reductions,for example by prescribing medications that are manufactured with a lower carbon footprint or advocatingforequipmentthathaszerolandfillatthe end of its life.For hospitals and healthcare facilities to achieve their sustainability goals,both clinical and operational leaders must play an equal part in carbon reduction.Future Health Index 2022 Healthcare hits reset9Unlocking the power of dataConfidence is highHealthcare leaders are increasingly using data in bothoperationalandclinicalworkflows.Doingsohelpsimproveefficienciesandguidesswifter,moreinformeddecision-makingtohelptreatpatientsfaster.Theeffectiveuseofdatahasbecomeakeycomponent for healthcare leaders as they look to tackle the organizational crises within their facilities,helping to extend and improve care.Healthcareleadersareconfidentthatthewealthofcritical,high-qualitydatatheyhaveattheirfingertipscanunlockenormouspotential.Analyzing this information allows them to create robust healthcare strategies and unlock actionable insights that can enable new ways of predicting,diagnosing and treating diseases.These insights in turn can help to fuel greater efficiencieswhilereducingtreatmentcostsandimproving the quality of care.Navigating the remaining frustrations Yet,while they acknowledge the value of data,healthcare leaders continue to experience frustrations,such as siloed data and limited infrastructure,in capturing and deploying that dataeffectively.Keenlyawarethattheylacktheinternal resources to unlock the true potential of the information they have,they are looking to their peers and other partners for support,training,and knowledge sharing.The following chapter explores what healthcare leaders value in data and their current challenges to data utilization,proposes solutions to those challenges and looks at how partnerships can help.2Its better to prevent than to cure.there will be greater possibilities for prevention using advancements in digital health technology.Chief Medical Information Officer Urban hospital,the NetherlandsChapter 2 Unlocking the power of dataHealthcare data proves its worthHealthcare leaders are confident in the value that data can bring to their workDataplaysacrucialroleindeliveringhealthcare,helpingtodrive smarter clinical decisions and encourage greater operational efficiency.Actionable insights provide healthcare leaders with operational forecasting and clinical predictions,and enhance both the patientandstaffexperience.Nearlytwo-thirds(65%)ofhealthcareleaders believe the value data brings in areas such as digital health records,patient monitoring and medical devices makes the time and resource investments required worthwhile.Trust in the insights provided by data is also strong across both clinicalandoperationalsettings,whileconfidenceindatautilizationis particularly high among clinical leaders,who are more likely to have a positive outlook on data than their peers who work on the operational side.My hospital/healthcare facility is able to extract actionable insights from the data we have availableCondence in data utilization71%The data available to my hospital/healthcare facility is accurate69%The value that data brings to my hospital/healthcare facility is worth the time and resources invested65%Lack of trust is among the lowest barriers to using data17%Lack of trust in insights provided by dataClinical leaders are more likely to show condence in data utilization than operational leadersClinical leadersOperational leaders73iqdqfgc%The value data brings is worth the time and resources investedThe data available to my hospital/healthcare facility is accurateMy hospital has the digital health technology needed to fully utilize dataMy hospital can extract actionable insights from dataMixed views from patients on data sharingThe Lancets 2020 study,Public perceptions on data sharing:key insights from the UK and the USA,examined public attitudes towards data sharing*,data access and the use of AI in healthcare.Most of those questioned were happy to share their data with their doctor.However,there was a suggestion that patients were concerned that data might not be protected from commercialend-use.Respondentswereless probable to be willing to share their details with an institution that was likely to use the data for commercial purposes(e.g.insurancecompany)thanapublicbody(e.g.government,researchinstitution).Theimplication is that more needs to be done to educate,inform and reassure the public on how their health data is used.*https:/ Health Index 2022 Healthcare hits reset 11Chapter 2 Unlocking the power of dataRegardless of their rate of technology adoption,healthcare leaders still encounter data challenges Despite their confidence,many leaders are frustrated about the lack of progress in embedding data throughout care pathwaysLimited technology infrastructure;staff reluctance or data illiteracy;the sheer amount of data to be processed:most of these barriers have been a constant presence for healthcare leaders since the Future Health Index research began in 2016.Technology infrastructure limitations Almostone-quarter(23%)ofhealthcareleaderssay this is the top impediment.However,with technologies like digital health records close to the top of leaders investment priority lists,it is also clear that they are trying to address this.Siloed data Justoverhalf(51%)ofhealthcareleaderssaythatdatasiloshindertheirabilitytoutilizedataeffectively.Thisiscloselylinkedtothefactthat20%ofhealthcareleadershavedifficultiesmanagingahighvolumeofdataand19%havedifficultiesobtainingdata.Grouped with frustrations surrounding technology infrastructureandstaffknowledge,leadersmaystruggle to resolve data access and management challenges.Siloed data is a greater issue for healthcareleadersinsmall-(56%)andmedium-sized(51%)hospitals(basedonthenumberoflocations),thanfortheirpeersinlargerhospitals(39%).Thissuggeststhatmulti-sitefacilitiesare,bynecessity,taking more action to address the issue of data silos.Data security and policy Oneinfive(21%)leaderssaythatdatapolicyand/or regulations impede their ability to use data to its full potential,with the same number citing concerns about data privacy and security.This is not surprising considering the volume and scale of reported healthcare data breaches.Staff knowledge and mindset Todayshealthcareleadersreportinadequatestaffunderstandingofhowtousedata(20%)andstafffeelingoverwhelmedbythevolumeofdata(55%).Staffresistancetousingmoreadvancedtechnologiescan present challenges too.Healthcare leaders see staffdevelopmentasvital,withaboutone-fifth(22%)sayingthattrainingandeducatingstaffwouldmostsupport them in using data.Withdataconsideredthebedrockofsomanydigitaltechnologiesthatunderpinefficiencies,careoutcomesandpatientandstaffexperiences,theseobstacles can impact leaders ability to deliver on key priorities,like expanding care and improving staffmorale.Staffs lack of knowledge about dataData policy/regulationsConcerns related to data privacy/securityTechnology infrastructure limitationsResistance among staff to upgrade technologyTop barriers to effective use of data23#! %Ransomware:an invisible yet growing threat for healthcare systemsA type of malicious software designed to block access to computer systems until a sum of money is paid,ransomware attacks representasignificantrisktohealthcareorganizations.The Federal Bureau of Investigations(FBI)2021InternetCrimeReport*found that the healthcare sector faced the most ransomware attacks in 2021 compared to any other critical infrastructure sector.A heavy reliance on technology to treat patients,coupled with the high volume of data typically held by hospitals and healthcare facilities,means they are especially vulnerable to being targeted by hackers.Such attacks create delays in medical procedures,can lead to longer patient stays and increase patient mortality rates,as well as requiring extensive funds to resolve the impacts of the attack a ransomware attack on the Irish healthcare system in May 2021 resulted in costs of more than 100 million*.46%of leaders view data as more of a burden than an asset*https:/www.ic3.gov/Media/PDF/AnnualReport/2021_IC3Report.pdf*https:/ Health Index 2022 Healthcare hits reset 12Chapter 2 Unlocking the power of dataDrivingdataadoptionacross care settingsLeaders pinpoint key measures to improve adoption of data technologiesHealthcare leaders are considering several initiatives tohelpdriveuptakeofdata-centrichealthcaretechnologies,includingstafftraining,improvedtracking,and the addition of data specialists to manage and analyze data.Justoverone-fifth(21%)ofallhealthcareleaderssurveyed say that implementing data security and privacy systems would be most helpful,a need that also ranked highly in the Future Health Index 2021 report.Interestingly,despite data privacy and security being concerns for these leaders,this isnt asignificantpriorityforthem,eithertodayorthreeyears from now.HealthcareleadersinEurope(32%)aremorelikelyto want more clarity on how data is being used comparedtothoseinAsia(24%)ortheAmericas(23%),reflectingstricterdataprivacyregulationsin the European Union.This is observed in the fact that healthcare leaders in the Netherlands are more likely to want clarity than their peers in most of the countries surveyed.Integrating health/IT informatics as a core operating functionInvesting in cloud-computing tools and servicesTraining/educating staff on usageInvesting in technology infrastructure within my hospital/healthcare facilityTracking performance metrics/KPIs to measure impactAvailability of data specialists to manage and analyze dataMore clarity how data is being used within my hospital/healthcare facilityTop factors that would support healthcare leaders in fully utilizing dataAddressing interoperability/data standards 27$#2%Europe24%Asia23%AmericasHealthcare leaders in Europe are most likely to seek clarity on how their data is being usedEurope France,Germany,Italy,Netherlands,Poland,RussiaAsia China,India,Indonesia,SingaporeAmericas Brazil,the USFuture Health Index 2022 Healthcare hits reset 13Chapter 2 Unlocking the power of dataThe divide between early and late technology adoptersThere is a gap between early-and late-adopting hospitals and healthcare facilities when it comes to data technologyUnlike early adopters,late adopters feel that in order to succeed with new data strategies,they need:more clarity around how data is being used,greater access to data specialists and better tracking of performancemetricsandKPIs.Onewayofaddressingthese concerns could be through forging mentoring partnerships with early adopters in other hospitals and healthcare facilities.Late adopters are more likely to report having issues amongstaffwhenitcomestoupgradingtechnology(32%vs.21%),suggestingearlyadoptersmayhavemoresystemsinplacetohelptheirstaffadjusttochanges in technology.Late adopters are also more likely to experience a lack of data interoperability acrosstechnologyplatforms(25%vs.18%).Whenit isdifficultforlateadopterstoupgradetechnologyduetochallengeswithtrainingstaff,theyarealso less likely to resolve interoperability issues.These hospitalscouldbenefitfrommultifacetedsolutionsthathelptrainstaffforaneasiertransitiontoadvanced technology,enabling them to use data moreeffectively.Investment priorities differ tooLate adopters are more likely to be investing in voicerecognitiontools(35%vs.20%),perhapsbecause many are still catching up when it comes to digital health records.Many hospitals that are still in the process of adopting digital health records relyonmanualrecord-keeping,andthereforehavea greater need to invest in voice recognition to help save time.Indeed,late adopters are more likely to prioritize improving the technology infrastructure in their hospital(26%vs.18%)anddrivingefficienciesinthehospital(27%vs.20%).Ontheotherhand,earlyadopters have moved on to prioritize more recent needsinhealthcare,liketelehealth(27%vs.20%)andstaffsatisfactionandretention(31%vs.23%).Differences in current priorities between early and late adopters of digital health technologyEarly adopters of digital health technologyLate adopters of digital health technologyImproving technology infrastructure in my hospitalStaff satisfaction and retention18&1#%Differences in barriers to using data between early and late adopters of digital health technology212%Resistance among staff to upgrade technologyLack of data interoperability across tech platformsFuture Health Index 2022 Healthcare hits reset 14Chapter 2 Unlocking the power of dataA growing need for collaboration with peersHealthcare leaders know they cant do it alone In the Future Health Index 2021 report,more than one-third(41%)ofhealthcareleaderssaidtheybelieved strategic partnerships were the best way to successfully implement digital health technologies.Suchpartnershipsofferrichopportunitiestoaccessskills,knowledge and expertise from technology companies.They also enable a more bespoke approach for each hospital or healthcare system and present less risk.Today,research shows the need for partnerships is even more pressing,regardless of where leaders areontheiradoptionjourneys.Fewerthanone-fifth(19%)saytheyhavealltheexpertisetheyneedinternally to make full use of the available data.And,therearestill69%ofearlyadopterswhodonotyethave all of the expertise they need to fully utilize data.Global averageEarly adopters of digital health technologyLate adopters of digital health technologyEarly adopters of technology are investing heavily in the right expertise todayWe have all of the expertise neededWe have some of the expertise neededWe have a minimal amount of the expertise needed31%2I%90t%Learning from peersItisclearthathealthcareleadersplacesignificantvalue in what they can learn from their peers,particularlyinrelationtodata.Overone-third(37%)today say that other hospitals and healthcare facilities would be the external partner of preference to help themfullyutilizedata,andmorethanone-quarterofhealthcare leaders say that success stories from other hospitals or healthcare facilities would strengthen their trust in predictive analytics.TheCOVID-19pandemicresultedinmanystronghealthcare partnerships that improved the agility of and access to the healthcare sector.Collaboration with hospitals and healthcare systems,once considered competitors*,demonstrated the power of partnerships in advancing patient care.50%Singapore43%United States19%Global averageHealthcare leaders in Singapore and the United States are most likely to say they have all the internal expertise they need*https:/ Health Index 2022 Healthcare hits reset 15Chapter 2 Unlocking the power of dataLeaders are keen to partner with healthcare technology companiesPartnering with healthcare technology companies is seen to offer numerous benefitsLastyearsresearchfoundthat36%ofhealthcareleaderswantedtocollaborate with health IT or informatics companies to help drive digital transformation.Thistrendcontinuesin2022,withone-third(33%)ofhealthcare leaders citing health technology companies as a partner of preference.There are particular areas of knowledge that leaders want to tap into with these partnerships.They seek extensive support from strategic partnerships with health technology companies,in areas including:strategic vision,specialized healthcare management consulting services,guidance/services for data analysis,access to innovative technology,and flexible payment models.The varied range of areas that leaders are looking for support with implies that partnering with companieswithbroadhealthcareexpertisewouldbemostbeneficial in order to collaborate in all of these priority areas.Unsurprisingly,they also look to health technology companies to supporttheirstaff,withoverone-quarter(26%)citingstafftraining andeducationasthemostimportantbenefitfromsuchapartnership.Partnership requirements also vary depending on the maturity of technology adoption.For example,healthcare leaders who are early adopters of predictive analytics are more likely to seek guidance on regulatoryissuesfromapartnershipthantheirlate-adoptingpeers,who express greater preference for healthcare management consulting.Differences between what early and late adopters of predictive analytics want from a partnership24rly adopters of predictive analyticsGlobal averageLate adopters of predictive analytics250%Guidance on regulatory issuesSpecialized healthcare management consultingThe support healthcare leaders seek from health technology companies Flexible payment modelsAccess to innovative technologyGuidance/services for data analysisIntegration of technology systems within my hospitalStrategic visionSpecialized healthcare management consulting services27&%Future Health Index 2022 Healthcare hits reset 16How predictive analytics can supercharge careHuge potential across healthcare Healthcare leaders recognize the potential of predictive analytics to drive a step change in their ability to achieve their key priorities.At a clinical level,predictive analytics can help healthcare providers deliver the right care,to the right patient,at the right time.Operationally,it equips healthcare systems with the ability to identify trends,enhancing care and reducing costs.But our study suggests that,regardless of their stage of adoption,healthcare leaders are still struggling to unlock its full value.Without support,implementation lags behindBuilding trust around data capture,storage and governance,while encouraging more widespread and consistent adoption of predictive analytics,are some of the key concerns of healthcare leadershighlightedintheresearchfindings.Thegapbetweenthesignificantimprovementsto healthcare that data analytics can provide,and the reality of how it is used today,suggests that more technological support is needed to turn predictive analytics into a platform to supercharge care.3A physician using AI will be a much better physician than one without AI.Department Head of Radiology Urban hospital,the NetherlandsChapter 3 How predictive analytics can supercharge careLeadersfocusonthebenefitsof predictive analyticsPredictive technologies are seen to improve care and lessen the administrative burdenA broad term used to describe advanced analytics that makes predictions about future events,behaviors and outcomes,predictive analytics increasingly plays a key role in advancing care,improving patient outcomes and the staff experience.Offeringbothreal-timeandfutureclinicaldecisionsupport,fromdiagnosis to prognosis and treatment,predictive technologies are avaluabletoolacrosshealthcaresettings.ThiswasreflectedintheFuture Health Index 2021 report,where healthcare leaders cited predictive technologies as an important way of preparing for the future,and something they planned to invest in during the next threeyears(40%).Today,many leaders have already embarked on this journey,with56%reportingtheyhavealreadyadopted,orareintheprocess of adopting,predictive analytics in some form,in their hospital or healthcare facility.Healthcare leaders are generally united in their recognition of the potential of predictive analytics to improve care outcomes and deliver on their other priorities.The areas they feel predictive analyticscouldmostbenefittheirhospitalorhealthcarefacilityare broad and span both clinical and operational spheres.They include expanding access to healthcare and driving healthcare transformation more generally,for example through improving scheduling and remote patient monitoring.Healthcare leaders believe predictive analytics will have a positive impact across operational workows tooPredicting healthcare professional variabilityScheduling and utilizationMaintenance predictionRemote patient monitoringTreatment planning and assessment25#!%Health outcomesPatient experienceHealthcare leaders believe patients will see the biggest positive impact from predictive analytics in clinical settingsStaff experiencePopulation health managementCost of careValue-based careHealth inequality72rpiihg%Future Health Index 2022 Healthcare hits reset 18Chapter 3 How predictive analytics can supercharge careThe promise of predictive analytics is still out of reach for many healthcare leadersUptake of predictive analytics remains uneven Predictive analytics promises to transform healthcare.But,while healthcare leaders acknowledge the benefitsofthetechnology,itsuptakeremainsuneven,with Singapore,the US and Brazil far ahead of most Europeancountries.Thereisalsoamarkeddifferencein adoption rates between developed and emerging countries(28%vs20%).Those healthcare leaders who are furthest along in their adoption of predictive analytics do not think they are making the most of its potential.For example,aboutone-fifth(21%)offirst-to-innovateleaders see predictive analytics as delivering the most impactinremotepatientmonitoring,yetjust12%areusing it in this area.It is likely that the barriers to data adoption,highlighted in the previous chapter,are fueling this gap between current and potential use of predictive analytics.Unless leaders are able to address them,their adoption journeys are likely to stall.Stage of adoption of predictive analytics by country type 24( %Global averageDeveloped countriesEmerging countriesAlready adopted predictive analyticsIn the process of adopting predictive analyticsPlan to adopt predictive analytics within the next 1-3 years327(!%Predictive analytics adoption by operational vs.clinical leaders24!%Global averageClinical professionsOperational professionsAlready adopted predictive analyticsIn the process of adopting predictive analyticsPlan to adopt predictive analytics within the next 1-3 years3204# %Rates of predictive analytics adoption by countryThose who have already adopted or are currently in the process of adopting predictive analytics56yffeedYYUTH73%9%Global averageSingaporeChinaBrazilUnited StatesItalyIndonesiaFranceIndiaNetherlandsAustraliaGermanySaudi ArabiaRussiaSouth AfricaPolandFor us,predictive analytics is part of our roadmap.When we talk about analytics,we want it to be predictive.We want it to be proactive in its ability to provide real time data that we can action.Chief Information Officer,suburban hospital,United StatesHowever,there are pockets of experience that leaders can draw on for guidance as they look to drive adoption of predictive analytics in their own facilities.Healthcare leaders in Asia report the highest rates of adoption.At a global level,healthcare leaders in clinical positions have higher rates of adoption than their peers in operational roles,particularly those working inradiology(31%),wherepredictiveanalyticsis being used as one of several tools to help clinicians analyze and diagnose images more quickly.Given the preference of many healthcare leaders to learn from their peers,such leaders are well placed to share learnings and best practice with those in the earlier stages of adoption.Future Health Index 2022 Healthcare hits reset 19Security and privacy concerns remain as roadblocks to progressData security and privacy are critical factors for healthcare leaders as they seek to foster trust in predictive analytics among staff and patientsAround the world,healthcare data breaches are on therise.Over90%ofglobalhealthcareorganizationshave reported at least one security breach within the last three years*.It is against this global backdrop that healthcare leaders are citing greater data security and privacy systems and protocols as the top way to strengthen trust in predictive analytics in both operational and clinical settings.Thoseindevelopedcountries(29%)aremorelikelythanthoseinemergingmarkets(25%)tocite increased transparency in how insights are determined on the operational side.This is likely due to the European countries in our research where stringentEuropeandataregulationslikeGDPRplace a lot of responsibility for data protection and responsible data use on healthcare providers.Developedcountriesarealsomorelikelythanemergingcountries(28%vs23%)towantimproved regulations related to data security and privacy.InitiativesliketheEuropeanHealthDataSpace*aEuropeanCommission-ledprojecttopromotehealth data exchange across Europe improve Healthcare leaders cite improved data security/privacy as one of their top means to increase trust in predictive analytics in clinical settingsAsia-PacicMiddle Eastand AfricaEuropeAmericas*41728%Globalaverage*https:/ and Brazil onlyTrust in predictive analytics by region across clinical settingsGlobalaverageAsia-PacicMiddle Eastand AfricaEuropeAmericas*87qiq%Chapter 3 How predictive analytics can supercharge careData security is key to unlocking trust in predictive analytics in both clinical and operational settings385%ClinicalOperationalhealthcare,policy-makingandresearch,whileensuring strict protection of the privacy of citizens.Such programs can help to address these concerns and hopefully improve the safe adoption of technologies like predictive analytics.It is clear that while there is a desire to invest in predictive analytics,healthcare leaders are still keen to ensurethehumantouchisnotlost.Overone-quarter(29%)saythatincreasedhumaninvolvement,whereahumanalwaysmakesthefinaldecision,isoneofthetop factors that could potentially enhance their trust in predictive analytics.In healthcare,I dont think theres any data thats worth protecting more than patient health data.Chief Operating Officer Urban hospital,GermanyFuture Health Index 2022 Healthcare hits reset 20ConclusionConclusionThe Future Health Index 2022 paints a picture of a sector that has seen dramatic transformation in recent years,which has accelerated rapidly over the past 12 months.Rather than continuing to focus solely on the pandemic,we see todays healthcare leaders radically shifting their priorities to meet new realities in medical management.Specifically,leadershaveindicated three key priorities for 2022 and beyond:Jan Kimpen,PhilipsChiefMedicalOfficerImproving the staff experienceWiththesectorfacingasignificant15millionlaborshortfallby2030,improvingthestaffexperiencehasbecome a top priority for todays leaders.This years report has shown that leaders believe increased training in digital health technologies will be key toprogress,helpingstafffeellessoverwhelmedbydata-centricprocessesandmorereadytoembracenewworkflows.However,increasedtrainingisjustonepieceofthepuzzlefixingthelaborcrisisinthelong term will ultimately depend on the successful coordination of governments,regulators and the industry as a whole to improve working conditions across the board.Addressing threats to healthcare data securityWiththeindustryexperiencingrecordsurgesindatabreaches,oneinfiveleadersnowcitedataprivacyand security as top concerns.This years report has shownhoweffectiveinitiativesliketheEuropeanHealthDataSpacecanbeinaddressingsuchconcerns.However,the future of healthcare data security will depend as much on educational initiatives for leaders asitwillonvendorsfollowingsecurity-by-designprinciples infusing security from product design and development through testing and deployment,with robust policies and procedures for monitoring,updates and incident response management,as has long been standard practice in other industries like financialservices.Bridging the gap between the promise of predictive analytics and current usageFrom data silos and interoperability concerns to technology infrastructure limitations,many factors are to blame for the uneven uptake of predictive analytics to date.The good news is,were now seeing a number of leaders pioneering this technology and inspiring others to drive adoption in their own facilities.As moreorganizationsreaptherewardsofmachine-generated insights in both clinical and operational settings,suchasenhanceddecision-makingandlowered administrative burdens,we expect to see increaseddemandforpeer-to-peermentorshipsbetween early and late adopters,as well as strategic partnerships with health technology companies,bringing the whole sector up to speed.All things considered,our sector has taken stock and reprioritized in the wake of another year of transformations,and against a growing backdropofcomplexchallengesthatwillendurefarbeyondthepandemic,fromstaffshortagesandsecuritythreatstotherapidriseofchronic diseases.Ultimately,we see healthcare leaders embarking on a reset to meet the demands of a fundamentally changed world a world they hope to shape and improve with the help of data and predictive analytics.Future Health Index 2022 Healthcare hits reset 22Glossary of termsGlossary of termsAmbulatory primary care center Outpatientcarecenters(e.g.,urgentcare,walk-inclinics,etc.)Analog facilities Mostorallpatientdataishandledinapaper-basedformat or using traditional communications,e.g.,phone,fax,etc.Artificial intelligence(AI)AI refers to the use of machine learning and other methods that may mimic intelligent human behaviors,resulting in a machine or program that can sense,reason,actandadapttoassistwithdifferenttasks.B2B health technology companies Companies that sell products,equipment,or solutions to hospitals and healthcare facilities.Data privacy The culture expectations,organizational regulations and legislation that protect personal information from unauthorized use and dissemination.Data security Protecting data against unauthorized access.Digital facilities Simple/basictechnologiesareused,withmostorallpatient data and communications being handled electronically.Digital health records Technology that can store a variety of health information,including medical history,test results,healthindicators,etc.Digitalhealthrecordscanbeusedwithinacertainhealthcarefacility,acrossdifferenthealthcare facilities,by only the patients themselves,by one healthcare professional or across all healthcare professionals involved in a patients care.Electronic medicalrecords(EMRs)andelectronichealthrecords(EHRs)fallwithinthetermdigitalhealthrecords.Digital health technology A variety of technology that transmits or shares health data.The technology can take a variety of forms,including but not limited to home health monitors,digital health records,equipment in hospitals and healthorfitnesstrackerdevices.Digital transformation The integration of digital technology into all aspects of how a healthcare business interacts with patients,healthcare providers and regulators.Early adopters of digital health technology Earlyadoptersaredefinedasleaderswhoindicatedthat,compared to other hospitals or facilities,they are amongthefirsttoadoptaninnovationortheyadoptinnovations before most others.Early adopters of digital health technology and predictive analytics Theseleadersaredefinedasthosewhoarethefirsttoadopt innovations in digital health technology and who have already adopted predictive analytics.Early adopters of predictive analytics Earlyadoptersaredefinedasleaderswhoindicatedthattheir hospital has already adopted predictive analytics or is in the process of adopting predictive analytics.Global non-governmental organizations Anonprofitorganizationthatoperatesindependentlyof any government.Health equity or equality The absence of unfair,avoidable or remediable differencesamonggroupsofpeople,whetherthosegroupsaredefinedsocially,economically,demographically,or geographically or by other dimensions of inequality.Health IT/Informatics companies Companies that build communications protocols within healthcaresystems(e.g.,Cerner,Epic,etc.)Health technology companies Companies that sell or provide wearables,health apps and other technology to the general public.Healthcare leader AC-suiteorseniorexecutiveworkinginahospital,medicalpractice,imagingcenter/office-basedlab,orurgentcarefacilitywhoisafinaldecision-makerorhasinfluenceinmakingdecisions.Healthcare professional Allmedicalstaff(includingdoctors,nurses,surgeons,specialists,etc.),andexcludesadministrativestaff.Healthcare professional-to-healthcare professional telehealth Virtual communication between healthcare professionals through sharing images,recommending treatment plans,etc.Healthcare professional-to-patient telehealth Communication between healthcare professionals and their patients via video calls,patient portals,etc.Interoperability The ability of health information systems to work together within and across organizational boundaries,regardless of brand,operating system or hardware.Late adopters of digital health technology Lateadoptersaredefinedasleaderswhoindicatedthat,compared to other hospitals or facilities,they adopt innovations later than most others.Late adopters of digital health technology and predictive analytics Theseleadersaredefinedasthosewhoareamongthelast to adopt innovations in digital health technology and have no plans to adopt predictive analytics.Late adopters of predictive analytics Lateadoptersaredefinedasleaderswhohavenotyetadopted predictive analytics but they are planning to in the future.Machine learning A process of AI that provides systems with the ability to automatically learn and improve from experience withoutbeingexplicitly(re)programed.Out-of-hospital procedural environments Carecenterssuchasambulatorysurgicalcenters,office-based labs,etc.Predictive analytics A branch of advanced analytics that makes predictions about future events,behaviors,and outcomes.Predictive technologies A body of tools capable of discovering and analyzing patterns in data so that past behavior can be used to forecast likely future behavior.Quadruple Aim:Philips makes value-based care principles actionable by addressing the Quadruple Aim:Improved patient experience improving the patient experienceofcare(includingqualityandsatisfaction)Better health outcomes improving the health of individuals and populations Improvedstaffexperienceimprovingthework-lifebalance of healthcare professionals Lower cost of care reducing the per capita cost of healthcareRemote patient monitoring Technology that provides care teams with the tools they need to remotely track the health of their patients outside of conventional clinical settings(e.g.,at home),collaboratewiththepatientsotherhealthcareprofessional(s)andhelpdetectproblemsbeforetheylead to readmissions.Examples of this include cardiac implantsurveillance,vital-signsensorsathome,etc.Resilience The capacity of hospitals or healthcare systems to quickly recover from challenges.Smart facilities Advanced connected care technologies are used,in addition to patient data and communications being handled electronically.Social responsibility Individuals and companies have a duty to act in the best interests of their environment and society as a whole.Staff Thisreferstoallstaff,includingphysicians,nurses,administrative employees,etc.Sustainability Meeting the environmental needs of the present without compromising the ability of future generations to meet their own needs.Technology infrastructure Foundational technology services,software,equipment,facilities and structures upon which the capabilities of nations,cities and organizations are built.This includes both IT infrastructure and traditional infrastructure that issufficientlyadvancedsuchthatitcanbeconsideredmodern technology.Telehealth/virtual care Thedistributionofhealth-relatedservicesandinformation via electronic information and telecommunication technologies.Value-based care The concept of healthcare professionals receiving reimbursement based on patient health outcomes rather than on the volume of tests or procedures completed.Voice recognition tools/software A tool used to convert spoken language into text by using speech recognition algorithms.Future Health Index 2022 Healthcare hits reset 24Research methodologyResearch methodologyResearch overview and objectives Commencing in 2016,Royal Philips has conducted original research every year with the goal of understanding the ways various countries around the world are addressing global health challenges and how they are improving and expandingtheirabilitytocarefortheircommunities.Withagrowing list of competing needs facing healthcare leaders,the Future Health Index 2022 focuses on the expanding role digital tools and connected care technology is playing in the abilitytodelivermoreaccessible,affordableandcustomizedhealthcare.ThefirstFutureHealthIndexreleasedin2016,measuredperceptions of how healthcare was experienced on both sidesofthepatient-professionaldivide.Thefollowingyear,the research compared perceptions to the reality of health systems in each country that was studied.In 2018,theFutureHealthIndexidentifiedkeychallengestothelarge-scaleadoptionofvalue-basedhealthcareandoverall improved access,evaluating where connected care technology could speed up the transformation process.In2019,theFutureHealthIndexexploredthehealthcareexperience for both patients and healthcare professionals and how technology was moving us to a new era of healthcare delivery transformation.In 2020,the Future Health Index examined the expectations and experiences ofhealthcareprofessionalsagedunder40.Lastyear,theFuture Health Index 2021 considered how healthcare leaders*were meeting the continuing demands of the pandemicandwhatthenewrealityofhealthcarepost-crisismight look like.In 2022,the Future Health Index concentrates on how healthcare leaders are now refocusing on the priorities and initiatives which were paused during the pandemic.They are increasingly incorporating data,advanced analytics toolsandartificialintelligencetomitigateoperationalandclinical challenges and to enhance their ability to deliver care to communities both in and out of traditional hospital settings.Withthepandemicintheirrear-viewmirror,theyare now looking to leverage their growing technology capabilities in a variety of directions.From rethinking how much care needs to occur in a hospital or healthcare facility to expanding social responsibility and sustainability initiatives,technology is giving healthcare leaders the ability toexecutecustomizedstrategiestofittheexactneedsoftheir communities.To provide a holistic understanding of the current healthcare systems around the world,the study upon which the Future Health Index 2022 is based incorporates insights derived from a quantitative survey and a series of qualitative interviews.*HealthcareleaderisdefinedasaC-suiteorseniorexecutiveworkinginahospital,medicalpractice,imagingcenter/office-basedlab,orurgentcarefacilitywhoisafinaldecision-makerorhasinfluenceinmakingdecisions.Future Health Index 2022 Healthcare hits reset 26Research methodology Unweighted sample size(N=)Estimated margin of error(percentage points)Interview methodologyAustralia200 /-7.0Online and telephone Brazil200 /-6.5Online and telephone China200 /-7.5Online and telephone France200 /-7.0Online and telephone Germany200 /-6.5Online and telephone India200 /-6.0Online and telephone Indonesia100 /-6.5Online and telephone Italy200 /-7.0Online and telephone Netherlands200 /-6.5Online and telephone Poland200 /-7.0Online and telephone Russia200 /-6.0Online and telephone Saudi Arabia200 /-6.5Online and telephone Singapore200 /-8.0Online and telephone South Africa200 /-7.0Online and telephone United States200 /-7.5Online and telephoneTotal2,900 /-3.5Question localizations In some instances,certain questions needed to be adjusted slightlyforrelevancewithinspecificcountries.Carewastaken to ensure the meaning of the question remained as close to the original,English version,as possible.2022 qualitative interviews methodology The qualitative portion of the Future Health Index 2022 wasconductedbytheKJTGroup,amarketresearchandconsultingfirmwhichspecializesinthehealthcareindustry.To provide context and additional depth to the quantitative data,the quantitative survey results were supplemented withfindingsfromaseriesof45-minuteinterviewswithhealthcare leaders in their native language.These interviews were conducted during the month of March 2022.There were30participants,sixfromeachofthefollowingmarkets:Australia,China,Germany,the Netherlands and the United States.Belowshowsthespecificsamplesize,estimatedmarginoferror*atthe95%confidencelevel,andinterviewingmethodology used for each country.2022 quantitative survey methodology The quantitative portion of the study was executed by iResearch,a global business and consumer research servicesfirmemployingamixedmethodologyofonlineand telephone surveying.2,900healthcareleadersin15countries(Australia,Brazil,China*,France,Germany,India,Indonesia,Italy,the Netherlands,Poland,Russia,Saudi Arabia,Singapore,SouthAfricaandtheUnitedStates)participatedina 15-20minutesurveyintheirnativelanguagefromDecember2021February2022.200healthcareleadersin each of the 15 countries completed the survey,except in Indonesia where the total sample was 100.*SurveydataisrepresentativeofMainlandChinaonlyanddoesnotincludeTaiwanorHongKong.*Estimated margin of error is the margin of error that would be associated with a sample of this size for the full healthcare leader population in each country.However,this is estimated since robust data is not available on the number of healthcare leaders in each country surveyed.Future Health Index 2022 Healthcare hits reset Future Health Index is commissioned by Philips.To see the full report visit Future Health Index 2022 report examines the experiencesofalmost3,000healthcareleadersandtheirexpectations for the future.The research for the Future Health Index 2022 report was conducted in 15 countries(Australia,Brazil,China,France,Germany,India,Indonesia,Italy,the Netherlands,Poland,Russia,Saudi Arabia,Singapore,SouthAfrica,andtheUnitedStates).Thestudycombines a quantitative survey and qualitative interviews conductedfromDecember2021March2022.
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Future Health Index 2023 Taking healthcare everywhere 1Taking healthcare everywhereAddressing staff shortages and patient needs with new care delivery modelsGlobal reportThe Future Health Index is commissioned by Philipsfuturehealthindex2023ContentsResearch premise 3Foreword 4Key findings at a glance 5Chapter 1 6 Tackling staff shortages through digital innovation Chapter 2 11 Bringing healthcare closer to the patient Chapter 3 16 Partnering across the healthcare ecosystem Conclusion 22AppendicesMethodology 25Glossary of terms 27Sources 28Future Health Index 2023 Taking healthcare everywhere 2Healthcare leaders are C-suite or senior executive decision makers/influencers working in a hospital,medical practice,imaging center/office-based lab,ambulatory center or urgent care facility.Younger healthcare professionals are defined as those aged between 18 and 40 who have completed their first medical/nursing degree and are working as a healthcare professional in a clinician role (all specializations,except psychiatry/dental care).The Future Health Index analyzes the priorities and perspectives of healthcare leaders and younger healthcare professionals.Now in its eighth year,it is the largest global survey of its kind,based on proprietary research conducted in 14 countries.This years report explores how healthcare leaders and younger healthcare professionals view the role of new care delivery models,which integrate in-person and virtual care within and beyond hospital walls.Research premiseCountries included in the research Australia Brazil China Germany India Indonesia Italy Japan Netherlands Poland Saudi Arabia Singapore South Africa United States14countries3,000healthcare leaders and younger healthcare professionalsResponses from almost AcrossFuture Health Index 2023 Taking healthcare everywhere 3Fast-tracked by the pandemic,the past three years have given us a glimpse of the future of healthcare delivery:one that extends beyond hospital walls into the home and the community,with digital technology connecting care across settings.There is no going back now.This years Future Health Index shows how healthcare leaders and younger healthcare professionals are aligned in their vision to innovate new care delivery models that meet patients where they are.Healthcare leaders around the world are challenged with maintaining quality care through staff shortages,while financial pressures add to the strain.Meanwhile,patient expectations are also different from what they were pre-pandemic.As digital transformation has continued to accelerate in every aspect of our lives,from how we buy to how we work and learn,our best and most convenient experience anywhere is now what we expect everywhere including in healthcare.Healthcare leaders recognize that optimizing current ways of working will only get them so far.A new paradigm of care delivery is needed.The 2023 Future Health Index report offers clues to what that will look like.Investments in AI and virtual care continue to be on the rise,showing commitment from healthcare leaders to lean into the potential of digital technology to improve efficiencies,experiences,and outcomes.At the same time,they are looking to expand care delivery into lower-cost settings outside the hospital.Or,as I like to say,we are moving to a future of“your care,your way”,where patients will benefit from a wider range of virtual and in-person access points.Younger healthcare professionals welcome this shift.In fact,as this years survey findings show,they are asking for it.Younger healthcare professionals are keen to be at the forefront of digital innovation.Just like healthcare leaders,they envision a more personalized and connected approach to healthcare,orchestrated around the patients needs,and with digital technologies such as AI supporting them in their day-to-day work.But both groups also realize they cannot get there alone.Even more so than in previous Future Health Index reports,partnerships emerged as a key theme this year.Both healthcare leaders and younger healthcare professionals say that closer collaboration between providers is needed to deliver integrated patient care across settings.They also see a key role for data/IT providers and health technology companies,to help liberate data and turn it into meaningful insights when and where they are needed.And finally,they are turning to partners for help in improving environmental sustainability an area where healthcare has much to gain.I invite you to explore the survey findings in more detail in this report and reflect on what they mean for your organization.Where will you take healthcare next?I hope that,as you set out on that journey,you find inspiration from both current and future healthcare leaders.ForewordWhen I think of the future of healthcare delivery,I think of your care,your way.Shez Partovi Chief Innovation&Strategy Officer and Business Leader of Enterprise Informatics at PhilipsFuture Health Index 2023 Taking healthcare everywhere 4Key findings at a glanceThree main themes emerge from the 2023 Future Health Index,showing how healthcare systems are innovating care delivery to meet evolving patient needs with increasingly strained resources.Each of these themes is explored in more detail in the following chapters.Chapter 1 Tackling staff shortages through digital innovation Faced with acute workforce shortages and growing financial pressures,healthcare leaders are seeking to streamline processes for improved efficiencies.They are ramping up their investments in automation and AI to alleviate pressure on staff and to ultimately empower them with more predictive insights for clinical decision support.This is welcomed by younger healthcare professionals,who are also eager to embrace new digital technology and consider it a key factor in choosing where to work.Chapter 2Bringing healthcare closer to the patientHealthcare leaders and younger healthcare professionals share a common vision for a more distributed healthcare system that meets patients where they are.Virtual care continues to be on the rise,expanding the reach of intensive and critical care beyond hospital walls.At the same time,both surveyed groups also envision further growth of ambulatory and community-based care services to help improve patient access,convenience and health outcomes.Chapter 3Partnering across the healthcare ecosystemAs payers are expecting more cost-effective care that delivers better outcomes,healthcare leaders are partnering across the healthcare ecosystem to overcome technology barriers,break down data silos,and deliver more integrated care that improves patient outcomes.In addition,they see a role for partnerships in furthering environmental sustainability in healthcare a topic that is also top of mind for an eco-conscious generation of younger healthcare professionals.Future Health Index 2023 Taking healthcare everywhere 5Tackling staff shortages through digital innovation1Chapter 1 Tackling staff shortages through digital innovationAlleviating pressure on staffAs workforce shortages continue to strain hospital capacity around the world,healthcare leaders are rethinking how and where they deliver care.This years survey revealed that more than half of them(56%)are either using or planning to use digital health technology solutions to reduce the impact of workforce shortages(see Figure 1).Top of their list are digital health technology solutions that connect with out-of-hospital settings(selected by 43%of healthcare leaders),closely followed by cloud-based technology to support access to information from any location(42%)(see Figure 2).Their vision for the future is clear:healthcare systems will no longer be bound to hospital facilities,but leverage resources when and where they are needed the most.To reduce the impact of workforce shortages,healthcare leaders are also using or planning to use critical decision support technology(39%).This was a top choice especially among cardiology leaders(50%)and radiology leaders(48%),indicating that these specialists in particular recognize the potential of predictive analytics and AI to augment the capabilities of healthcare professionals.In addition,healthcare leaders are seeking to mitigate staff shortages through communications technology(38%),workflow technology(38%),and mobile check-in or registration for patients(38%)all pointing to an opportunity for digital innovation to alleviate pressure on staff while improving the patient experience.Figure 1:Figure 2:Technologies that healthcare leaders are using or planning to use to reduce the impact of workforce shortagesHealthcare leaders seek new efficiencies56%of healthcare leaders are using or planning to use digital health technology solutions to help reduce the impact of workforce shortagesTechnology solutions that connect with out-of-hospital settings43%Cloud-based technology to support access to information from any location42%Critical decision support technology(e.g.,predictive analytics and articial intelligence(AI)in clinical settings)39%Communications technology 38%Workow technology 38%Mobile check-in/registration for patients38%Future Health Index 2023 Taking healthcare everywhere 7Chapter 1 Tackling staff shortages through digital innovationStreamlining workflowsAlmost all healthcare leaders(96%)surveyed are facing financial pressures a situation that is unlikely to improve soon in the current inflationary environment.This is giving a further impetus to workflow automation as healthcare leaders seek to do more with less.Unsurprisingly,86%of surveyed leaders are taking actions to reduce the impact of financial pressures.Their most common solution(selected by 36%)is to streamline patient processes,for example through automated appointment bookings.Also ranking high on their list is streamlining internal processes,for example by automating administrative tasks(33%)(see Figure 3).Beyond technology,healthcare leaders are also looking at other solutions to mitigate financial pressures.These include exploring new purchasing models to lower costs(34%),sharing functions with other facilities(34%)and refocusing their hospital or facility on the most profitable services(33%).Resuming“business as usual”in a post-pandemic era is no longer an option healthcare leaders are forced to reimagine their role in the wider ecosystem;a theme we will return to in Chapter 3.Figure 3:Solutions used by healthcare leaders who are taking action to mitigate financial pressureStreamlining patient processes36%Exploring new purchasing models to lower costs34%Sharing functions with other facilities34%Refocusing on the most protable services33%Streamlining internal processes33%Merging with other hospitals/health systems32%Shifting spend away from new investments31%Future Health Index 2023 Taking healthcare everywhere 8Chapter 1 Tackling staff shortages through digital innovationFollowing its explosive growth in recent years,artificial intelligence(AI)continues to be a key area of future investment for healthcare leaders.83%of healthcare leaders are planning to invest in AI in the next three years,up from 74%in 2021.AI for clinical decision support Compared to the findings from the Future Health Index 2021 report,planned investments in AI over the next three years show the biggest increase for clinical decision support(from 24%in 2021 to 39%in 2023)(see Figure 4).This includes AI used for diagnosis or treatment recommendations,early warning scores,and automatic disease detection.Radiology leaders in particular plan to ramp up their future investments in AI for clinical decision support,from 27%in 2021 to 50%in 2023;followed by informatics leaders(from 24%to 39%)and cardiology leaders(from 29%to 38%).To a lesser extent,planned investments in AI for predicting outcomes also increased(from 30%in 2021 to 39%in 2023,across all healthcare leaders).One such application is to compare a patient to similar patients to better predict how they will respond to certain treatment plans.Figure 4:How planned investments in AI three years from now have evolved between 2021 and 2023,according to healthcare leadersInvestments in AI continue to ramp upAI for operational and clinical efficienciesThe percentage of healthcare leaders planning to invest in AI for operational efficiency(37%)remains steady from 2021 to 2023.Examples range from AI used for automating required documentation to AI that can help schedule patients,staff and tasks.These applications will continue to play a vital role in enabling more efficient use of resources to mitigate the impact of workforce shortages.717px%to optimize operational efficiency 377%to integrate diagnostics 322%to predict outcomes309%for clinical decision support 249 212023Articial Intelligence(AI)used.Planned investments in AI for integrating diagnostic information(such as imaging,pathology,and a patients clinical history)also remain constant,at 32%.Recent clinical studies have shown its potential to save valuable time in diagnostic decision-making,while supporting the clinician experience,for example in cancer care1.Future Health Index 2023 Taking healthcare everywhere 9Chapter 1 Tackling staff shortages through digital innovationDigital innovation essential for younger healthcare professionalsAttracting and retaining talentYounger healthcare professionals surveyed in this years research welcome the increased investments in AI and other digital innovations.In fact,they are explicitly asking for it.Being at the forefront of AI in healthcare emerged as top selected consideration for younger healthcare professionals in choosing a hospital or practice to work in(selected by 49%)(see Figure 5).Leading the way in connected care delivery is also important to them(44%)indicating a receptivity to new care delivery models that connect different care settings.On a more basic level,they evaluate potential employers on the availability of technology for everyday tasks,such as tablets for notetaking or secure patient portals(41%).Taken together,these findings paint a picture of a generation that is eager to embrace smart and connected technologies to help deliver better patient care.This suggests that digital innovation can be a powerful tool in attracting and retaining younger talent as healthcare leaders increasingly compete for scarce talent with other sectors,and thereby accelerate digital transformation.Figure 5:Top selected factors in the choice of workplace for younger healthcare professionalsbetter training on new technologies(38%)illustrating the need for continuous education to help them get the most out of digital innovation.They would also like more opportunity to have their voice heard(39%).This underlines the importance of involving healthcare professionals in the design and optimization of new ways of working.As other studies have highlighted,successful digital transformation requires that healthcare leaders make effective change management as much a priority as the technological aspects of digital transformation2.A culture of collaborationAlso important to younger healthcare professionals in choosing where to work is having a culture of collaboration(44%),with different specialties working together,and professional autonomy(42%),giving them flexibility in developing care plans for patients.This calls on healthcare leaders to create a culture where younger healthcare professionals feel empowered and connected.When asked what would make them feel most empowered to improve patient care,younger healthcare professionals cited,amongst others,717pxing at the forefront of articial intelligence in healthcareBeing at the forefront of connected care deliveryA culture of collaborationProfessional autonomyAvailability of technology for everyday tasks4934544DBA%Future Health Index 2023 Taking healthcare everywhere 10Bringing healthcare closer to the patient2Chapter 2 Bringing healthcare closer to the patientExtending care beyond hospital walls Accelerated by the pandemic,new care delivery models that blend the physical and the virtual have redefined patients expectations of how and where care is delivered.Last year,the Future Health Index revealed that healthcare leaders viewed extending care delivery beyond the hospital as their highest priority,after staff satisfaction and retention.In 2023,we see that trend continue.Virtual care is here to stayVirtual care is quickly turning into a mainstay of medicine.68%of healthcare leaders(see Figure 6)say it is among the technologies that have already had or will have the biggest impact on improving patient care in the next three years.This is reflected in how they are allocating their budgets.54%of healthcare leaders say their hospital or facility is investing heavily in virtual care today,compared to 47%in 2022.This includes both professional-to-professional virtual care,which enables more distributed access to expertise across locations,as well as professional-to-patient virtual care,which is bringing specialist care into patients homes.Figure 6:of healthcare leaders say virtual care is a technology that has had or will have the biggest impact on improving care68%Future Health Index 2023 Taking healthcare everywhere 12Chapter 2 Bringing healthcare closer to the patientWhen asked more broadly where they are providing or planning to provide care in the next three years,healthcare leaders show the same appetite for virtual care.For example,41%of healthcare leaders already provide intensive or critical care supported virtually,and another 41%plan to do so in the next three years(see Figure 7).This signals the continued adoption of tele-ICU models,which can extend critical care resources to the bedside independent of a health facilitys location through centralized,remote surveillance by skilled professionals.Expanding access to careIn conjunction with increased investments in virtual care,healthcare leaders also intend to make care available through a wider array of in-person access points.This includes surgery centers,emergency care provided outside main hospitals,and walk-in centers(all three were cited as expansion areas in the next three years by 36%of healthcare leaders).In addition,nutritional services(37%),patient education programs(36%),community healthcare workers or nurses(35%)and mental health services(35%)are part of their plans for the next three years.This indicates that healthcare leaders are not only offering more access points closer to the patient they are also taking a more holistic approach that considers different aspects of a patients health.Diagnostic imaging/screening centersAmbulatory care centersCommunity healthcare workers/nursesOffice-based lab(OBL)Walk-in centersSurgery centerEmergency care outside main/core hospitalsHealth literacy/patient education programsPhysical rehabilit-ationAcute care at home(virtually/in-person)Intensive or critical care supported virtuallyMental health servicesLong-term careNutritionistCurrently providePlan to provide in 3 yearsNot currently providing this,and I would not like to provide thisWould like to provide this,but there are no plans to59(%2S0%3P5%2I3%4H6%2F6%3E6%3C6%3B3%3B%3AA%385%383%277#%3%Younger healthcare professionals share the same vision for more distributed and holistic healthcare delivery.Of those whose facility doesnt currently offer them,younger healthcare professionals are most likely to want ambulatory care centers(68%),walk-in centers(67%)and acute care at home,provided virtually or in person(65%).Patient education programs(63%),community healthcare workers(62%),nutritional services(57%),and mental health services(56%)also feature on their wish list,among other services.Figure 7:Healthcare services that leaders are currently providing or planning to provide 3 years from nowFuture Health Index 2023 Taking healthcare everywhere 13Chapter 2 Bringing healthcare closer to the patientMore effective,accessible and convenient care Figure 8:Healthcare leaders and younger healthcare professionals agree on the benefits of new ways to deliver care,besides patient outcomesIncreased treatment adherenceNew care delivery models that integrate physical and virtual services within and beyond hospital walls have numerous benefits,according to both healthcare leaders and younger healthcare professionals(see Figure 8).Their top pick(selected by 42%of healthcare leaders and younger healthcare professionals):increased patient compliance and treatment adherence.This dovetails with the second-highest ranking benefit for both groups:improved patient education and awareness.Meeting patients where they areHealthcare leaders and younger healthcare professionals see other patient benefits of new care delivery models as well.Both groups(34%of healthcare leaders and 32%of younger professionals)cite increased efficiency as an additional advantage of new care delivery models,for example because of reduced waiting times.This holds even more true in countries with geographically dispersed populations such as Australia,China and the US.In those countries,new care delivery models that connect the hospital to the home could go a long way towards improving access to care for remote communities,while alleviating some of the burden on overstretched hospital staff.In addition,almost one-third(32%)of all surveyed healthcare leaders and younger healthcare professionals call out increased convenience for the patient as a benefit of new care delivery models.This is congruent with studies showing how patients have come to appreciate the convenience of telehealth after having grown accustomed to it during the pandemic3.%Increased patient compliance/adherence to treatmentImproved patient education and awareness/understandingIncreased efficiency Collaboration with local communities to improve population healthMore technologically advanced healthcareMore convenient locations for patients(near and in patients homes)Healthcare leaders Younger healthcare professionals42B9724132322%The role of remote patient monitoring in treatment adherenceNew care delivery models such as virtual care and remote patient monitoring can make it significantly easier for patients to follow their treatment plans.Studies show that lack of treatment adherence in patients with chronic diseases is very common,affecting as many as 40%to 50%of patients who are prescribed medications for management of chronic conditions such as diabetes or hypertension4.Adherence to exercise and care plans can be equally challenging for patients.AI-enabled remote patient monitoring can offer insight into health trends over time,allowing for earlier interventions while giving patients greater health awareness in between hospital visits.Research has shown this can result in measurable improvements to patient health outcomes,including reductions in blood pressure,blood glucose,and weight5.Future Health Index 2023 Taking healthcare everywhere 14Chapter 2 Bringing healthcare closer to the patientNew care delivery models can also benefit environmental sustainabilityReducing carbon footprint Besides improving outcomes and experiences for patients,healthcare leaders think that the evolution towards more distributed and virtual care is also good news for the planet.More than half of them(57%)agree that new ways to deliver care are more environmentally friendly/sustainable(see Figure 9).This percentage is even higher in countries with geographically dispersed populations such as India(78%of healthcare leaders),Japan(74%)and Australia(67%),where patients in rural communities often need to travel long distances to the nearest healthcare facility.It is also higher among early adopters of new technology(62%),indicating that these early adopters are ahead in seeing sustainability-related benefits from new care delivery models.Indeed,the reduced need for travel and physical paperwork could help offset some of the healthcare sectors carbon footprint which accounts for over 4%of global CO2 emissions6.A recent study evidenced the link between distributed care models,particularly those involving telehealth,and reduced impact on the environment.Examining European data from 2020 and 2021,it found an average of 3.057 kg of net CO2 emissions avoided for every digital appointment and 1.5 kg avoided for every medical report downloaded instead of being physically collected in the clinic7.Figure 9:of healthcare leaders believe new models of care delivery are more environmentally sustainable57%Future Health Index 2023 Taking healthcare everywhere 15Partnering across the healthcare ecosystem3Chapter 3 Partnering across the healthcare ecosystemRelationships with payers are evolvingAs a result of the emergence of new care delivery models,healthcare leaders see their relationships with payers change.Payers are expecting more cost-effective,high-quality care delivered in partnership with others across care settings.A push for more cost-effective,integrated care deliveryMost strikingly,42%of healthcare leaders say that payers are reducing the services they seek from them,while at the same time 34%indicate that payers are increasing the types of services they seek from them(see Figure 10).This dual pressure to ramp up certain services,while cutting down on others,comes against the backdrop of escalating healthcare costs that are making payers prioritize where they put their funding to achieve the greatest gain in health and economic outcomes.Increasingly,payers are incentivizing a shift from expensive hospital services to care provided in lower-cost settings such as ambulatory facilities or the home8.Healthcare leaders feel the need to adapt.No longer can they think of their hospital or health system in isolation.34%of them say that payers have become more demanding of them and 33%are asked to work with new partners.This is creating a burning platform for increased collaboration across the healthcare ecosystem for example between hospitals and diagnostic,ambulatory,primary,and community care centers9 to deliver more integrated care,orchestrated around the patients needs.The importance of better regional and national coordination of care,which came into sharp focus during the pandemic in many parts of the world,ties in with this.Payers are asking for evidence of outcomesPayers are also looking for more evidence data,say 31%of healthcare leaders.This indicates that the shift Figure 10:How healthcare leaders see their relationship with payers change as a result of new care delivery models%reducing the services they seek from us42%trying to reshape the nancial models for our agreements36%increasing the types of services they seek from us34%more selective/demanding of their partners34%asking us to work with new partners3331%also becoming service aggregatorslooking for more evidence datademanding different payment models to drive sustainability31%looking for more synergistic partnerships30%is becoming the payer6%2%1%is trying to serve a more favorable payer mixN/A-I do not see the relationship with payers changingThe hospital/healthcare facility I work in.Payers are.towards high-value care,a focus area in previous editions of the Future Health Index,continues to place demands on leaders to demonstrate that the care they are delivering is having the desired outcomes for patients.This need is felt most strongly in the US,where 49%of healthcare leaders say payers are asking for more evidence data.It adds a strong incentive to focus on providing high-quality outcomes at lower cost,in collaboration with stakeholders across the entire ecosystem.Future Health Index 2023 Taking healthcare everywhere 17Chapter 3 Partnering across the healthcare ecosystemProviders are partnering across care settings Expanding the reach of care The contours of wider collaboration across the healthcare ecosystem are already apparent.Building partnerships outside their healthcare system is one of the most selected actions which one-third(34%)of healthcare leaders are taking to ensure that new ways of delivering care improve patient outcomes(see Figure 11).When asked which organizations they are partnering with today,healthcare leaders answered diagnostic imaging or screening centers(28%),ambulatory care centers(23%),emergency medical centers(23%),and retailers or pharmacies(22%)all of which can bring care closer to the patient.However,there is substantial variation between countries in the extent to which they are partnering with other healthcare providers.Healthcare leaders in Japan(69%)and India(63%)are most likely to partner with diagnostic imaging or screening centers,while healthcare leaders in the US(53%)and Singapore(43%)lead the way in partnering with ambulatory care centers.Younger healthcare professionals want new partnershipsYounger healthcare professionals share the same desire to partner with other healthcare providers.In fact,it is the top-ranking action(chosen by 36%)that they would like healthcare leaders to take to ensure that new care delivery models improve patient outcomes.In addition to the partnerships mentioned above,they also express a wish for collaborating with community centers(19%),residential care homes(18%),and wellness providers(18%)three years from now again pointing to a desire to work more collaboratively within the broader healthcare ecosystem.When asked what would empower them most in improving patient care,closer collaboration with other organizations involved in care delivery also emerged as their top choice,selected by more than two-fifths(43%)of younger healthcare professionals(see Figure 12).Figure 12:43%of younger healthcare professionals would feel more empowered to improve patient care based on closer collaboration with other organizations involved in care deliveryFigure 11:34%of healthcare leaders are building partnerships outside their healthcare system to ensure that new ways of delivering care improve patient outcomesFuture Health Index 2023 Taking healthcare everywhere 18Chapter 3 Partnering across the healthcare ecosystemUnlocking the value of data through technology partnershipsFigure 13:Success factors for providing new ways to deliver care,among both healthcare leaders and younger healthcare professionals combinedSufficient evidence of improved outcomes or cost effectiveness30ta interpretation skills within your hospital/healthcare facility29%Staffs willingness to adopt new technologies29%Availability of appropriate technology and technological infrastructure28%Timely and smart data sharing28%Patients willingness to adopt new technologies27%Examples or case studies of new types of care delivery in action27dressing interoperability/data standards across technological systems and platformsWays to spread costs over time27%Ongoing and continuous staff education26%To realize their vision of delivering integrated care across a wider range of settings,healthcare leaders and younger healthcare professionals recognize the need to be able to share and interpret data in a meaningful way.That is why both groups continue to see an important role for partnering with health technology companies and data/IT providers,alongside other healthcare organizations.Improving data sharingMore specifically,when asked which factors will determine the success of new care delivery models,healthcare leaders and younger healthcare professionals were united in calling out interoperability across systems and platforms(28ross both groups combined),availability of appropriate technology and technology infrastructure(28%),and timely and smart data sharing(27%)(see Figure 13).Echoing the importance of educating and empowering staff,as discussed in Chapter 1,healthcare leaders and younger healthcare professionals also believe that new care delivery models will require the right data interpretation skills within their hospital or healthcare facility(29%),supported by ongoing staff education(26%).Providers want evidence and financial flexibilityUltimately,though,when it comes to the impact and adoption of new care delivery models,evidence is needed to convince both payers and providers.Edging out all other considerations,30%of healthcare leaders and younger healthcare professionals want proof of improved outcomes or cost effectiveness.In addition,27%of them see examples or case studies of new types of care delivery in action as a success factor.From a financial perspective,having ways to spread costs over time was also cited as a success factor for new care delivery models(27%).The growing shift from traditional,transactional purchase models to as-a-service business models in healthcare could help offer this financial flexibility,while creating a shared focus on improving outcomes between healthcare providers and their technology partners.Future Health Index 2023 Taking healthcare everywhere 19Chapter 3 Partnering across the healthcare ecosystemThe power of partnerships in greening healthcareCompeting priorities hinder green initiativesThe 2021 and 2022 editions of the Future Health Index saw a sharp increase in the prioritization of environmental sustainability by healthcare leaders surveyed.This years findings indicate that,while almost all healthcare leaders(more than 99%)are taking some form of initiative to address environmental sustainabilility,many struggle to balance it with other priorities.When asked what challenges healthcare leaders are facing in implementing environmental sustainability initiatives,lower priority compared to other goals was their most often cited answer(selected by 36%)(see Figure 14).Other factors that are holding healthcare leaders back in implementing environmental sustainability initiatives include lack of standardization across the healthcare industry(34%),lack of specific regulation(33%),no means of measuring improvements or success(33%)and lack of an implementation strategy(32%).Next generation seeks out green employersFor many younger healthcare professionals,however,investing in environmental sustainability is increasingly top of mind.In fact,it has become an important consideration in where to work.More than one-third(35%)of them are looking for employers who have strong sustainability policies in place(see Figure 15).For healthcare leaders seeking to attract and retain young talent in a fiercely competitive market,this means that making a concerted effort to reduce their environmental impact is not just the right thing to do.It is also key in appealing to an eco-conscious workforce.Figure 14:Barriers to implementing environmental sustainability initatives according to healthcare leaders Lower priority compared to other goalsLack of standardization across the industryLack of specic regulationNo means of measuring improvements/successLack of an implementation strategy364332%Figure 15:35%of younger healthcare professionals consider it important that a future workplace has strong sustainability policies in placeFuture Health Index 2023 Taking healthcare everywhere 20Chapter 3 Partnering across the healthcare ecosystemPartnering to overcome barriersTo overcome challenges in implementing environmental sustainability initiatives,healthcare leaders believe it is important to create a business case(38%)and set ambitious targets that allow for measurable progress(36%).They also see value in best practice sharing with peers(37%)as well as working with a third party(35%)and/or recruiting more staff with specialist skills(34%)(see Figure 16).Who,then,should take the lead in developing sustainability standards in healthcare?Both healthcare leaders and younger healthcare professionals are most likely to rank governments as those who should be primarily responsible(see Figure 17).They also see a role to play for individual hospitals or health systems,medical technology companies,industry associations,and medical NGOs or charities pointing to an opportunity for wider ecosystem collaboration in protecting the health of our planet as well.Figure 17:Leaders and younger healthcare professionals think governments should be most responsible for creating sustainability standards(ranked 1st)GovernmentIndividual hospitals or health systemsMedical technology companiesIndustry associationsMedical NGOs/charitiesHealthcare leaders Younger healthcare professionals25(#!%Figure 16:Ways in which healthcare leaders plan to overcome these barriersCreate a business case for implementing initiativesShare best practice examples/learn from peersSet clear/ambitious targets and measure progressWork with or consult a third party to deliver or support sustainability programsRecruit more staff with specialist skills387654osystem collaboration key to reducing environmental impactWith the established link between human health and environmental health,many in the healthcare industry agree that it is time to extend the principle of First,do no harm the very foundation of healthcare to the planet.Fully decarbonizing healthcare includes taking an end-to-end view of the entire value chain.This means actors across the healthcare ecosystem care providers,health tech companies,pharma,suppliers,and others collaborating to drive sustainable ways of working.Supply chains drive over half of healthcare emissions10.One way health systems can magnify their impact is to select suppliers who have committed to science-based targets for carbon reduction.By supporting and incentivizing suppliers to adopt such targets,organizations can achieve even greater impact than by simply lowering emissions from their own operations.Some hospitals are already engaged in innovative collaborations to find less carbon-intensive solutions.Together with its suppliers,Stanford University Medical Center eliminated 1,200 tons of greenhouse gas emissions by replacing the anesthesia drug desflurane with much more climate-friendly alternatives such as sevoflurane11.Future Health Index 2023 Taking healthcare everywhere 21ConclusionBuilding a collaborative healthcare ecosystem Healthcare leaders and younger healthcare professionals share the same vision for the future:one in which healthcare is delivered in more connected,convenient,and sustainable ways across care settings,enabled by digital technology.Yet to fully realize this vision,both groups recognize that greater collaboration is essential,both within and beyond their organization.As this years Future Health Index shows,collaboration is taking many different forms.Healthcare providers are partnering with other organizations across the healthcare value chain to offer more personalized and integrated care.They are turning to health technology companies and data/IT providers to alleviate pressure on staff with automation,AI,and data-driven insights at the point of care.And they are also looking to share best practices with other providers and specialized partners to make healthcare more environmentally sustainable.Other stakeholders such as governments and payers have an equally crucial role to play in advancing new care delivery models.In partnership with all involved,they can help develop and implement the common standards and incentives that are needed to reduce variation and promote harmonization across the healthcare ecosystem whether it is to increase interoperability and facilitate the secure flow of data across care settings,or to support sustainable innovations and accelerate the decarbonization of healthcare.Going forward,clinical and economic evidence of the benefits of new care delivery models will be an essential driver for further adoption by providers and payers.Small-scale pilots conducted in partnership can help generate that evidence,showing how digital innovations can improve patient health outcomes as well as the patient and staff experience.Similarly,being able to measure progress on environmental sustainability goals will help propel green initiatives in healthcare.Ultimately,thats how both patients and the planet will benefit from new care delivery models which serve everyone,everywhere.Future Health Index 2023 Taking healthcare everywhere 23AppendicesResearch methodologyResearch overview and objectives Commencing in 2016,Royal Philips has conducted original research every year with the goal of understanding the ways various countries around the world are addressing global health challenges and how they are improving and expanding their ability to care for their communities.Building and expanding on previous years,the Future Health Index 2023 focuses on addressing staff shortages and meeting patient needs with new care delivery models,speaking to both healthcare leaders and younger healthcare professionals*globally.The first Future Health Index,released in 2016,measured perceptions of how healthcare was experienced on both sides of the patient-professional divide.The following year,the research compared perceptions to the reality of health systems in each country that was studied.In 2018,the Future Health Index identified key challenges to the large-scale adoption of value-based healthcare and overall improved access,evaluating where connected care technology could speed up the transformation process.In 2019,the research explored the healthcare experience for both patients and healthcare professionals and how technology was moving us to a new era of healthcare delivery transformation.In 2020,the Future Health Index examined the expectations and experiences of healthcare professionals aged under 40.In 2021,the Future Health Index report considered how healthcare leaders were meeting the continuing demands of the pandemic and what the new reality of healthcare post-crisis might look like.Last years report,concentrated on the role of digital tools and connected care technology in meeting the complex needs of healthcare leaders.In 2023,the Future Health Index looks to both healthcare leaders and younger healthcare professionals those aged 40 and under in 14 countries to quantify the experience and expectations of those in different roles and at various stages of their healthcare careers.It focuses on their perception of new care delivery models,which integrate physical and virtual care within and beyond hospital walls.*Healthcare leaders are C-suite or senior executive decision makers/influencers working in a hospital,medical practice,imaging center/office-based lab,ambulatory center or urgent care facility.Younger healthcare professionals are defined as those aged between 18 and 40 who have completed their first medical/nursing degree and are working as a healthcare professional in a clinician role(all specializations,except psychiatry/dental care).Future Health Index 2023 Taking healthcare everywhere 25*Survey data is representative of Mainland China only and does not include Taiwan or Hong Kong.*Estimated margin of error is the margin of error that would be associated with a sample of this size for the full healthcare leader or younger healthcare professional population in each country.However,this is estimated since robust data is not available on the number of healthcare leaders or younger healthcare professionals in each country surveyed.Research methodology Unweighted sample size(N=)Estimated margin of error(percentage points)Healthcare leadersEstimated margin of error(percentage points)Younger healthcare professionalsInterview methodologyAustralia200 /-6.0 /-6.0Online and telephone Brazil200 /-5.5 /-6.5Online and telephone China200 /-6.5 /-7.2Online and telephone Germany200 /-6.0 /-6.8Online and telephone India200 /-5.2 /-6.0Online and telephone Indonesia200 /-6.5 /-6.5Online and telephone Italy200 /-6.5 /-6.5Online and telephone Japan200 /-5.5 /-6.0Online and telephoneNetherlands200 /-6.2 /-6.4Online and telephone Poland200 /-5.5 /-6.0Online and telephone Saudi Arabia200 /-6.0 /-6.5Online and telephone Singapore200 /-5.5 /-7.0Online and telephone South Africa200 /-6.5 /-6.8Online and telephone United States200 /-6.0 /-7.0Online and telephoneTotal2,800 /-6.23Question localizations In some instances,certain questions needed to be adjusted slightly for relevance within specific countries.Care was taken to ensure the meaning of the question remained as close to the original,English version,as possible.Below shows the specific sample size,estimated margin of error*at the 95%confidence level,and interviewing methodology used for each country.2023 quantitative survey methodology The quantitative study was executed by iResearch,a global business and consumer research services firm employing a mixed methodology of online and telephone surveying.1,400 healthcare leaders and 1,400 younger healthcare professionals in 14 countries(Australia,Brazil,China*,Germany,India,Indonesia,Italy,Japan,the Netherlands,Poland,Saudi Arabia,Singapore,South Africa and the United States)participated in a 15-20 minute survey in their native language from November 2022 February 2023.100 healthcare leaders and 100 younger healthcare professionals in each of the 14 countries completed the survey.Future Health Index 2023 Taking healthcare everywhere 26Glossary of termsAmbulatory care center Outpatient care centers(e.g.,urgent care,walk-in clinics,etc.).Artificial intelligence(AI)AI refers to the use of machine learning and other methods that may mimic intelligent human behaviors,resulting in a machine or program that can sense,reason,act and adapt to assist with different tasks.As-a-service modelsMethods of delivering hardware,software and/or services on a subscription basis.Automation The application of technology,programs,robotics or processes to support people in achieving outcomes more efficiently.Data Used here to refer to a variety of clinical and/or operational information amassed from numerous sources including but not limited to digital health records(DHRs),medical imaging,payer records,wearables,medical devices,staff schedule and workflow management tools,etc.Digital health technology A variety of technology that transmits or shares health data.The technology can take a variety of forms,including but not limited to home health monitors,digital health records,equipment in hospitals/healthcare facilities,and health or fitness tracker devices.Distributed careInstead of having patients come into a central location,distributed care brings care to the patient.Increasingly,healthcare could be delivered through a decentralized network of ambulatory clinics,retail settings,and home-based monitoring,coaching,and treatment.Early adopters of digital health technology Early adopters are defined as those who indicated that,compared to other hospitals or facilities,they are among the first to adopt an innovation or they adopt innovations before most others.Global non-governmental organizations A nonprofit organization that operates independently of any government.Healthcare ecosystem Describes people involved in care delivery(including patients,family members and caregivers),the locations of care and services provided,and how they work together to improve efficiencies and optimize experiences.Health technology companies Companies that sell or provide medical equipment,wearables,health apps and other technology to healthcare organizations,patients,and the general public.Healthcare leader A C-suite or senior executive working in a hospital,medical practice,imaging center/office-based lab,or urgent care facility who is a final decision-maker or has influence in making decisions.Healthcare professional All medical staff(including doctors,nurses,surgeons,specialists,etc.),and excludes administrative staff.Healthcare professional-to-healthcare professional virtual care Virtual communication between healthcare professionals through sharing images,recommending treatment plans,etc.Healthcare professional-to-patient virtual care Communication between healthcare professionals and their patients via video calls,patient portals,etc.Integrated careCollaboration between the health and care services required by individuals to deliver care that meets patient needs in an efficient way.Interoperability The ability of health information systems to work together within and across organizational boundaries,regardless of brand,operating system or hardware.Late adopters of digital health technology Late adopters are defined as those who indicated that,compared to other hospitals or facilities,they adopt innovations later than most others.New ways to deliver care This defines the way in which health services are provided.New ways to deliver care combine the needs of patients,caregivers and providers,to achieve the best possible care through integrated services within and beyond hospital walls.Out-of-hospital services/settings Care centers such as ambulatory surgical centers,office-based labs,etc.Payer A payer is a person,organization,or entity that pays for the care services administered by a healthcare provider.Payers are usually,but not always,commercial organizations like insurance companies;government or public sector bodies;or individuals.Predictive analytics A branch of advanced analytics that makes predictions about future events,behaviors,and outcomes.Remote patient monitoring Technology that provides care teams with the tools they need to remotely track the health of their patients outside of conventional clinical settings(e.g.,at home),collaborate with the patients other healthcare professional(s)and help detect problems before they lead to readmissions.Examples of this include cardiac implant surveillance,vital-sign sensors at home,etc.Staff This refers to all staff,including physicians,nurses,administrative employees,etc.Sustainability Meeting the environmental needs of the present without compromising the ability of future generations to meet their own needs.Technology infrastructure Foundational technology services,software,equipment,facilities and structures upon which the capabilities of nations,cities and organizations are built.This includes both IT infrastructure and traditional infrastructure that is sufficiently advanced such that it can be considered modern technology.Telehealth/virtual care The distribution of health-related services and information via electronic information and telecommunication technologies.WorkflowsA process involving a series of tasks performed by various people within and between work environments to deliver care.Accomplishing each task may require actions by one person,between people,or across organizations and can occur sequentially or simultaneously.Younger healthcare professionalA healthcare professional working in a clinician role(all specializations,except psychiatry/dental care),under the age of 40.Future Health Index 2023 Taking healthcare everywhere 27Sources1.Ronmark,E.,Hoffmann,R.,Skokic,V.,et al.Effect of digital-enabled multidisciplinary therapy conferences on efficiency and quality of the decision making in prostate cancer care.BMJ Health Care Inform.2022 Aug;29(1):e100588.https:/ Smarter Way for Healthcare Providers to go Digital(2020).http:/ Love Telehealth Physicians Are Not So Sure(2022).https:/ Unmet Challenge of Medication Nonadherence.Perm J.2018;22:18-033.https:/pubmed.ncbi.nlm.nih.gov/30005722/5.How AI-Enabled Remote Patient Monitoring is Improving Patient Adherence and Outcomes(2022).https:/ Care Without Harm(2019).Healthcares climate footprint:How the health sector contributes to the global climate crisis and opportunities for action(p.22).https:/noharm-global.org/documents/health-care-climate-footprint-report7.Morcillo Serra,C.,Aroca Tanarro,A.,Cummings,C.M.et al.Impact on the reduction of CO2 emissions due to the use of telemedicine.Sci Rep 12,12507(2022).https:/doi.org/10.1038/s41598-022-16864-28.Value-Based Care Challenges,Opportunities for Payers in 2021(2021).https:/ Moment of Truth for Healthcare Spending(2023).https:/www3.weforum.org/docs/WEF_The_Moment_of_Truth_for_Healthcare_Spending_2023.pdf10.The eight levers to cut healthcare supply chain emissions(2022).https:/www.cips.org/supply-management/news/2022/november/the-eight-levers-to-cut-healthcare-supply-chain-emissions/11.Hospitals take creative steps to reduce carbon footprint(2022).https:/www.aamc.org/news-insights/hospitals-take-creative-steps-reduce-carbon-footprintFuture Health Index 2023 Taking healthcare everywhere Future Health Index is commissioned by Philips.To see the full report,visit Future Health Index 2023 report examines the experiences of almost 3,000 healthcare leaders and younger healthcare professionals and their expectations for the future.The research for the Future Health Index 2023 report was conducted in 14 countries(Australia,Brazil,China,Germany,India,Indonesia,Italy,Japan,Netherlands,Poland,Saudi Arabia,Singapore,South Africa and the United States).The study comprises a quantitative survey conducted from November 2022 February 2023.
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g ContentsThe Biggest Interest Among Fitness EnthusiastsGlobal Body Composition Trends Over TimeImpact of COVID-on Body CompositionBody Composition Trends Across Gender and Age GroupsTrends in Health Care for S E EW H A TY O U R EM A D EO FReport2023InBody Co.,Ltd.started in 1996 in a small underground laboratory of a young sci-entist in Korea.InBody introduced the worlds first body composition analyzer that implemented direct measurement by body part and multi-frequency measure-ment,and established awareness that the balance of body composition,such as body fat and muscle mass,is more important to health in an era when only weight and BMI were indices of health.It created a new market that did not exist before.InBody,which has expanded beyond Korea to overseas markets,currently exports to over 110 countries through its nine subsidiaries,solidifying its position as a glob-al healthcare company.InBody has been actively introduced in various research and medical fields and has established itself as a reliable device for researchers,having been used in more than 5,000 papers around the world.The small fruit that five young people started bearing in an underground laboratory in Seoul has now become a dream and a source of pride for the 1,000 employees who work together to grow the company,and it has also become the basis for healthy habits for people around the world.InBodys next step is creating a world where it is easier for everyone to know their body composition and understand their body.By following the flow of body com-position,the balance of our entire body can reveal why we are sick or what we can do to become healthier.The 2023 InBody Report was prepared in the hope that by analyzing and sharing the numerous body composition data that InBody has accumulated,it will be the beginning of a meaningful journey for everyone to know their body composition and lead a healthy life.*The data used in this report were used solely for statistical purposes,to provide information,limited to the data for which personal information was agreed upon,and no information that can identify individuals is included in the data.InBody ReportIntroductionContentsINTRO05 TheInBodyReportof2023:MethodsforProcessingData07 WhatistheBiggestInterestAmongFitnessEnthusiasts?08 AListofBodyCompositionTerminologiesMAIN.GlobalBodyCompositionTrendsOverTime13 AverageMuscleMassforMenandWomenbyCountry(2017-2021)14 GlobaltrendsinInBodyMeasurement15 HealthCareSeasonbyCountryExaminedbyInBodyMeasurementPeriod17 TrendsinChangesinBodyFatPercentageofPeoplebyCountryonaYearlyBasis18 SeasonalWeightFluctuations:GaininginWinterandLosinginSummerTemperature-RelatedTrendsinBodyFatPercentage:AComparisonbetweentheNorthernandSouthernHemispheres.ImpactofCOVID-19onBodyComposition19 GlobalInBodyMeasurementTrendsFollowingtheCOVID-19Pandemic21 GlobalVariationsinMuscleMassChangesDuringCOVID-19Pandemic23 ImpactofProlongedCOVID-19onMuscleMassandBodyFatMass:ACoun-try-WideAnalysisbyGender.BodyCompositionTrendsAcrossGenderandAgeGroups25 ComparingAge-RelatedMuscleLossinAsianandWesternMalePopulations27 DifferencesinBodyFatPercentageChangebetweenAsianandWesternWomenOUTRO31 InBodyforHomevs.InBodyforProfessionals:TheDifferencesbetweentheDataMeasuredbyEachDeviceandtheUser33 ChangesinHealthandWellnessTrendsafterCOVID-1934 APreviewoftheHealthCareTrendin2023,ECWRatio(ExtracellularWater/TotalBodyWater)InBody Report Body Composition Index of 12 CountriesThe contents of this report were prepared based on InBody measure-ment data accumulated from around the world,and they cover body composition trends in various countries,gender,and age groups.We would like to help all readers around the world who read this re-port check and compare where their body composition is currently positioned,and lead a healthy life through more systematic body composition management.01INTROU.K.GermanyNetherlandsKoreaChinaMalaysiaAustraliaJapan,India,Currently,InBodyProfessionalBCAdevicesareusedtocollectbodycompositiondatainrealtimeandstoreitinthecloud.AsofJanuary2023,over83milliondatahavebeenaccumulated.Forthe2023InBodyReport,weanalyzed5yearsworthofdatacollectedworldwidefrom2017to2021.Weprocessedthedatatominimizeinputandmeasurementerrorsandprovidegeneralinformation.Thereportisbasedondatafrom12countries,includingKorea,Japan,China,Canada,theU.S.,andAustralia,andfocusesonadultsovertheageof20whohavetakenInBodytestsandshownahighlevelofinterestintheirhealth.The InBody Report of 2023:Methods for Processing Data*The data used in this report were used solely for statistical purposes,to provide information,limited to the data for which personal infor-mation was agreed upon,and no information that can identify indi-viduals is included in the data.05INTROMAINOUTROU.S.MexicoChinaMalaysiaAustraliaJapanCanada,India,NetherlandsGermanyMalaysiaMexicoU.S.U.K.India JapanChinaCanadaKoreaAustraliaMen40,54089,85510,45636,5281,130,99359,649182,35394,68681,85554,0282,409,881158,088Women55,366113,66115,82863,4631,644,89972,809128,852152,740102,68352,4744,343,186308,897Total95,906203,51626,28499,9912,775,892132,458311,205247,426184,538106,5026,753,067466,985-Amountofdatafrom12countriesthathaveundergonedatapre-processing*Data from China is the data after 2019.*We selected the 12 countries based on the amount of accumulated body composition data collected by InBody Professional BCA devic-es in each country.2023 InBody Report06TheCOVID-19Pandemicbeganin2020,causingasig-nificantchangeinpeoplesdailylives.Socialdistanc-ingmeasureshavebroughtmostindoorandoutdooractivitiestoahalt.Activitieslikeexercising,diningout,andwatchingmovieswithothershavesignificantlyde-creased.ThosewhowereinfectedwithCOVID-19orhadclosecontactwithaninfectedpersonhadtogothroughquarantinelife,makingoutdooractivitiesimpossible.Aspeopleslifestyleschange,theirbehaviorsandinterestshavealsoshifted.Sincetheoutbreak,manypeoplehavegraduallystartedtostayindoorsandfocusonself-care.Withvaccinesandtreatmentsyettobefullydeveloped,peoplearenowmorefocusedonmaintainingahealthylifestylethroughdietandexercisethaneverbefore.Indailylife,weoftendiscussourhealthstatusthroughphrasessuchasYoulookhealthythesedaysorImnotfeelingwellthesedays.”However,aswebecomemoreattentivetoourhealth,westarttoquestionwhatexactlyconstitutesgoodhealth.Definingapersonshealthystatusischallengingbe-causebeingunderweightdoesnotnecessarilyequatetogoodhealth.However,ifweconsiderthebodycon-ditionofapersonwiththerightweightandtherightamountofmusclemass,wecansaythatsuchapersonhasahealthybodycomposition.Peopleinterestedinmaintainingtheirhealthrecognizethatacertainlevelofmusclemasscorrelateswithphysicalstrength,endur-ance,andvitality,andtheymakeaconsciousefforttoincreasemusclemassbyexercisinginoutdoorparks,fitnesscenters,andhomegyms.DespitetheCOVID-19pandemic,participationinsportsandexercisefordailylifehasreturnedtopre-pandemiclevels.Furthermore,havingasufficientamountofmusclemasshasbecomeincreasinglyimportantforrecoveryfromillness,makingitacrucialaspectofmaintaininggoodhealth.Thus,theterm“muscle”hasbecomeanessentialkeywordforachievingahealthylifestyle.Inthe2023InBodyReport,“musclemassofpeoplearoundtheworld”wasselectedasthemainkeyword.Thisreportaimstoexaminetrendsinmusclemassacrossdifferentcountries,agegroups,andgenders,aswellaschangesinmusclemassvaluesduetoCOVID-19.UsingdatameasuredwithInBody,weaimtoidentifythecurrenthealthtrendsandpredictfuturedevelopmentsfor2023.What is the Biggest Interest Among Fitness Enthusiasts?Since the outbreak of COVID-19,interest in health,particularly in re-lation to muscle mass has grown.The amount of muscle mass one possesses often plays a crucial role in determining their ability to recover from diseases.This is because mus-cle mass is vital for leading a more active daily life.The 2023 InBody Report has identi-fied muscle mass of people around the world as the main focus,and highlights the trends,changes,and shifts in health based on the meas-urements of muscle mass taken by InBody across the globe.07INTROMAINOUTROA List of Body Composition TerminologiesThehumanbodyiscomposedofvariouscomponentssuchasfat,protein,andminerals,collectivelyreferredtoasbodycomposition.Inthisreport,weuseseveraltermsrelatedtobodycomposition.Tohelpreadersunderstandthesetermsmoreeasily,wehaveorganizedthemintorelatedcategories.1.BMIBMIstandsforBodyMassIndexandisameasureofbodyweightrelativetoheight.Itiscalculatedbydividingonesweightinkilogramsbythesquareoftheirheightinmeters(kg/).BMIiscommonlyusedinnutritionalscienceandsportsmedicinetoassessthedegreeofapparentobesity.2.PBFPBF(%)=(BodyFatMass(kg)/Weight(kg)100PBFstandsforPercentageBodyFat.Itmeasurestheamountoffatmassinthebodybydividingbodyfatmassbyweightandmultiplyingby100.WhiletheBodyMassIndex(BMI)isdeterminedonlybyweightandheight,itcannotaccuratelydiagnoseobesitybecauseitfailstoreflectchangesinbothmuscleandbodyfatmass.Therefore,inthecaseofbodybuilders,obesitycanbediagnosedifthereisahighamountofmusclemassandlowbodyfat.However,PBFisanindexthatisoftenusedtodeterminewhethersomeoneisoverweightasitindicatestheamountofbodyfatpresent.PBFhasdifferentstandardsformenandwomenduetodifferentbodystructures.ThestandardrangeofPBFformenis10to20%,andforwomen,itis18to28%.3.FFMFFM(kg)=Weight(kg)BodyFatMass(kg)FFMstandsforFatFreeMass,whichisalsoknownasleanmass.Althoughpeoplemayhavethesameweight,someappearthinnerwhileothersappearheavier.Ourbodycomponentscanbedividedintotwocategories:fatandnon-fat.Thefatstoredinourbodyisreferredtoasbodyfat,whiletheremainingweightaftersubtractingbodyfatisknownasleanmass.Leanmassconsistsofelementsthatmakeupthehumanbody,suchasmuscles,bones,or-gans,brain,andwater,excludingbodyfat.Muscleisthemostimportantcomponentofleanmass,asitcontributestoahigherbasalmetabolicrate.Therefore,havingahigherproportionofleanmassinthebodycanbebeneficialformetabolismandoverallhealth.4.BFMBFM(kg)=Weight(kg)FatFreeMass(kg)BFMstandsforBodyFatMass.Asmentionedearlier,bodyweightisthesumofbodyfatmassandleanmass(FFM).Havingahighamountofbodyfatincreasestheriskofcardiovasculardiseasessuchasdiabetes,highbloodpres-sure,andhyperlipidemia.5.SMMSMMstandsforSkeletalMuscleMass.Therearethreetypesofmusclesthatmakeupourbody:myocardium,smoothmuscle,andskeletalmuscle.Myocardiumreferstothemusclesoftheheart,andsmoothmusclereferstothemus-clespresentinorgans.Myocardiumandsmoothmuscleareinvoluntarymusclesthatwecannotcontrolonourown,butskeletalmuscleisattachedtobonesortendonsandcontractsvoluntarilytocreatemovement.Whenwetalkaboutbuildingmusclewithexercise,weareusuallyreferringtobuildingskeletalmuscle.6.SMISMI(kg/)=AppendicularSkeletalMuscleMass(kg)/Height()SMIstandsforSkeletalMuscleMassIndex.SMIiscalculatedbydividingthemusclemassofthelimbsexcludingthetrunkbythesquareoftheheight(),andisanimportantdiagnosticindex.In2016,theWorldHealthOrganization(WHO)classifiedsarcopeniaasadisease,makingSMIakeytoolindiagnosingthecondition.Sarcopeniareferstothegraduallossofmusclemassandstrengththatoccurswithaging.IfSMIislessthan7.0kg/mformalesorlessthan5.7kg/mforfemales,itisconsideredassarcopenia.2023 InBody Report081)Global Body Composition Trends Over Time2)Impact of COVID-19 on Body Composition3)Body Composition Trends Across Gender and Age Groups02MAIN11.Impact of COVID-19 on Body CompositionAsourlifestyleshavechangedduetoCOVID-19,sotoohaveourweight,musclemass,andbodyfat.TheimpactofCOVID-19onbodycompositionhasvarieddependingoneachcountrysresponse,thenumberofInBodytestsadministered,andthenumberofpeopletested.Inthischapter,wewillexaminetheeff ectsofCOVID-19onbodycomposition.Body Composition Trends Across Gender and Age GroupsWehaveconfirmedthatbodycompositionvariesacrosscountries,influencedbyheredityandculture.However,evenwithinthesameraceandculture,diff erencesinbodycompositioncanoccurbasedongen-derandage.Inthischapter,wewillexaminethetrendsinbodycompositionbygenderandage.Global Body Composition Trends Over TimeEvenifthebodyweightisthesame,thedistributionofbodycompositionamongindividualsdiffers.Thismeansthatpeo-plewiththesameweightcanhavevaryingamountsofmusclemassandfatmass.Yourheredityandlivingenvironmentcandeterminewhetheryouarepronetogainingmoremuscleorfat.Inthischapter,wewillexaminethemusclemassandbodyfatmassofindividualsacross12countries,confirmedusingInBodybigdata.12Data source:InBody cloud server(global big data)Target:Adult males between the ages of 20 and 0 by countryPeriod:January 201-December 2021SMI(kg/m)=Appendicular Skeletal Muscle Mass(kg)/Height(m)Sarcopenia was classifi ed as a disease by WHO in 2016.In the case of men,when SMI is less than kg/m,it is classifi ed as sarcopenia.Data source:InBody cloud server(global big data)Target:Adult females between the ages of 20 and 0 by countryPeriod:January 201-December 2021In the case of women,when SMI is less than.kg/m,it is classifi ed as sarcopenia.BeforedelvingintothecontentsoftheInBodyReport,letsfi rstexaminethedataonaveragemusclemassandaver-agebodyfatpercentageforeachcountry,asmeasuredbyInBody.Thisinformationispresentedinthegraphbelow.Ofthevariousmeasuresusedtoevaluatemusclemass,theskeletalmusclemassindex(SMI)isobtainedbydividingmusclemassbythesquareofheight().Thisvalueprovidesanobjectiveassessmentofmusclemassbyaccount-ingfortheproportionalincreaseinmusclemasswithheight.AhigherSMIvalueindicatesgreatermusclemass.Asshowninthegraphbelow,theU.S.,Australia,Netherlands,Germany,Canada,andtheU.K.rankamongthetopsixcountrieswiththehighestmusclemassacrossgenders.Overall,WesterncountriesexhibitslightlymoredevelopedskeletalmusclemasscomparedtoAsiancountries.ThegoodnewsisthattheSMIaveragesforeachcountryfarex-ceedthesarcopeniathresholddepictedinthegraph.Diff erencesinmusclemassbetweencountriesaretheresultofgeneticandenvironmentalfactors.Interestingly,thereexistssignifi cantvariationinmusclemassvaluesevenwithinasinglecountry,withnotablediff erencesob-servedacrossgenderandagegroups.SMI(Kg/m)CountryIndiaJapanMalaysiaChinaKoreaMexicoU.K.CanadaNetherlands GermanyAustraliaU.S.Ranking according to average SMI values of adult males in countriesSMI(K g/m)JapanChinaMalaysiaKoreaIndiaMexicoCanadaU.K.Germany NetherlandsU.S.Australia.Ranking according to average SMI values of adult females in countries.CountryAverage Muscle Mass for Men and Women by Country(2017-2021)13INTROMAINOUTROGlobal trends in InBody MeasurementData source:InBody cloud server(Korea)Target:Korean adult males and females between the ages of 20 and 0Period:January 201-December 2021COVID-19 outbreak in March 2020Data source:InBody cloud server(Asia)Target:Australian adult males and females between the ages of 20 and 0Period:January 201-December 2021COVID-19 outbreak in March 2020 KoreaNo.of peopleTime(Year and month).AustraliaNo.of peopleTime(Year and month).Number of InBody measurements per month,26136,25216,009302,23COVID196,221,0951,3016,631,35302,23302,23COVID19COVID1916,631,351,35Whendopeopletypicallymeasuretheirbodycomposition?ThemostcommontimeisinJanuary,asweoftensetnewgoalsforourNewYearsresolutions,whichoftenincludesweightmanagement.Aswenaturallyaccumulatemorebodyfatasweage,diettendstotakeprecedenceinourNewYearsresolutions.YoucantracktheprogressofNewYearsresolutionsbyexaminingtheInBodymeasurementdata.ThegraphbelowindicatesthatthenumberofInBodymeasurementsgenerallydeclinesduringthewinterseason,whentheweatherturnscolder.However,onceJanuaryarrives,thenumberofInBodytestrisessharply.ThistrendiscommonnotonlyinKoreabutalsoinmanyothercountries.HealthisaprimaryfocusformanypeoplewhensettingtheirNewYearsresolutions,withsevenoutoftenKoreansselectinghealthastheirgoalfor2022.Lookingatthegraphbelow,inSeptemberinAustralia,thenumberofInBodytestsincreasedby2to2.5timescom-paredtotheaveragenumberofmeasurementsinthesameyear.WhathappenedinAustralia,unlikeothercoun-tries?BesidesNewYearsresolutions,whatotherfactorshadanimpact?.BodyCompositionofPeoplearoundtheWorldbyYear14Health Care Season by Country Examined by InBody Measurement PeriodInBodymeasurementdataistypicallycollectedinbulkduringaspecificseasoneveryyear,varyingbycountry.Beforeem-barkingonhealthcareroutines,suchasdieting,peopleoftenmeasuretheirbodycompositionandassesstheirphysicalcon-ditionwithInBody.ThefactthatInBodydataiscollectedduringaspecificseasoneachyearforeachcountrysuggeststhatpeo-pleinthesamecountrytendtostarttakingcareoftheirhealtharoundthesameseason.First,fromJanuary2017toDecember2021,welookedatthenumberofmonthlyInBodymeasurementdataofKoreanwomen,andthreewasthehighestnumberofInBodymeas-urementdatainJanuaryofeachyearfrom2017to2020.Jan-uaryisthemonthtomakeplansforandresolutionsonhowtospendtheyearforthenewyear.Infact,asaresultofasurveyofKoreanspersonalgoalsforthenewyearin2022byHankookResearch,“healthmaintenanceandrecovery”rankedfirstand“dietandweightloss”rankedsecond.AsaresultofasurveybyStatista,aGermanmarketresearchinstitute,theNewYearsresolutionsofAmericansin2022alsoshowedthat“maintaininghealthrankedfirst.”Ofcourse,thereweresomechangesduetotheimpactofCOV-ID-19.LookingatthenumberofInBodymeasurementdatafromKoreanwomen,sinceJanuary2021wasatimewhentheCOVID-19wasinfullswing,thenumberofInBodymeasure-mentdatadecreasedby96%comparedtoJanuary2019andbymorethan97%comparedtoJanuary2020.FromApril2021,whenthefirstvaccinationoftheCOVID-19vaccinebegan,thenumberofInBodymeasurementdatasoaredduetoexpecta-tionsforback-to-normal,hittingtheall-timehighoftheyearinMay,withawhopping4690%increasecomparedtoJanuaryofthesameyear.IncomparisontoKorea,weselectedIndiaandAustralia,whoseseasonalpatternsareeasytocomparewithKorea.Next,welookedatthenumberofInBodymeasurementdataofIndianwomen.InIndia,asomewhatunusualpatternemerged.Lookingatthedatafrom2017to2020,theInBodymeasure-mentdatasurgedinFebruaryandOctobereveryyear.Thein-creaseinthenumberofInBodymeasurementdatainFebruaryseemstobeduetotheNewYearsresolutionssuchashealthcareanddiet,andOctobercanbeinterpretedastheinfluenceoftheclimate.Generally,Indiahasthreeseasons.OctobertoFebruaryistherelativelywarmwinter,ApriltoJuneisthehotseason,andJunetoSeptemberistherainyseason.Duringthehotseasonandrainyseason,itisnoteasytomovethebodyforoutdooractivitiesandexercise,sohealthcareisalittlene-glected,butfromOctoberwhenactivitiesbecomeeasier,morepeoplestarthealthcareinearnest.Anothercountry,likeIndia,wherethenumberofInBodymeas-urementdataisincreasingduetoclimateisAustralia.InAustral-ia,thenumberofInBodymeasurementdatasurgeseveryyearinOctober,notJanuary.Lookingatthedatafrom2017to2020,theInBodymeasurementdatainOctobereachyearincreasedbyanaverageof2.3timescomparedtoJanuary.Australiaisasouthernhemispherecountrythatshowstheoppositesea-sonaltrendtoKorea,anorthernhemispherecountry.WhenitiswinterinKorea,itissummerinAustralia,andwhenitissum-merinKorea,itiswinterinAustralia.OctoberinKoreaistheseasonwhenthetemperaturedropsasautumnbegins.Ontheotherhand,inAustralia,thewarmsummerbeginsinOctober,thetemperaturerises,soitiseasytomanagehealththroughactiveactivities.ThroughthemonthlyInBodymeasurementdata,itwaspossi-bletodeterminewheneachcountrybegantotakehealthcareseriously.Weconductedanin-depthanalysisbasedonseveralvariablestoidentifythesourcesofthedifferences.Asacountryinthesouthernhemisphere,AustraliaexhibitstheexactoppositeseasonalpatterntoKorea.In Australia,the number of InBody measurement data increases in October when the warm season begins.In order to determine the differences in the number of InBody tests according to seasonal changes,we additionally looked at India,which has a different seasonal pattern from Korea.15INTROMAINOUTROData source:InBody cloud server(Asia)Target:Australian adult females between the ages of 20 and 0Period:January 201-December 2021COVID-19 outbreak in March 2020Data source:InBody cloud server(Asia)Target:Indian adult females between the ages of 20 and 0 Period:January 201-December 2021COVID-19 outbreak in March 2020Data source:InBody cloud server(Korea)Target:Korean adult females between the ages of 20 and 0Period:January 201-December 2021COVID-19 outbreak in March 2020KoreaNo.of peopleNo.of peopleTime(Year and month).IndiaNo.of peopleNo.of peopleTime(Year and month).AustraliaTime(Year and month)No.of peopleNo.of people.Number of InBody measurements per month of adult females53,515,913,60333,61611,93012,0259,69111,5331,53,62,031,29-9%.BodyCompositionofPeoplearoundtheWorldbyYear16Itisinterestingtolookatthetrendofbodyfatchangeofpeoplearoundtheworldwhomeasuredtheirbodycompo-sitionwithInBody.Therearedistinctpatternsinbodycompositionchangesthatvaryaccordingtogenderandage,withnotablediff erencesinbodyfattrendsbycountry.UnliketheaveragebodyfatpercentagediscussedinthepreviouschapterthatwereanalyzedfromtheresultsoftheInBodydatameasuredin12countries,thetrendofchangesinbodyfatbyperiodwasdiff erentforeachcountry,al-thoughsimilarpatternofgraphswasshowneveryyearwhenbodyfatwasanalyzedonayearlybasis.LetstakealookatKoreandata.InKorea,bodyfatdecreasesfromthebeginningoftheyeartothemiddleoftheyear,andincreasestowardtheendoftheyear.Basedononeyear,thegraph,whichlookslikeabowlwithaslightindentationinthemiddle,isrepeatedeveryyear.WefoundthattheyearlybodyfatgraphsinvariouscountriessuchastheU.S.,India,Germany,theU.K.,andAustral-iaalsorepeatthesamepatterneveryyearwithdiff erentshapesforeachcountry.So,whydobodyfatpatternsvaryfromcountrytocountry,andwhydocyclesrepeatonanannualbasis?Trends in Changes in Body Fat Percentage of People by Country on a Yearly BasisL)Data source:InBody cloud server(Korea)Target:Korean adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Average change in PBF by monthL)Data source:InBody cloud server(Europe)Target:German adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Average change in PBF by monthL)Data source:InBody cloud server(U.S.)Target:American adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Average change in PBF by monthR)Data source:InBody cloud server(Korea)Target:Korean adult females between the ages of 20 and 0 Period:January 201-December 2021Main index:Average change in PBF by monthR)Data source:InBody cloud server(Europe)Target:German adult females between the ages of 20 and 0Period:January 201-December 2021Main index:Average change in PBF by monthR)Data source:InBody cloud server(U.S.)Target:American adult females between the ages of 20 and 0 Period:January 201-December 2021Main index:Average change in PBF by monthMen(Germany)PBF(%)Time(Year and month).Men(U.S.)PBF(%)Time(Year and month).Men(Korea)Time(Year and month)PBF(%).Women(Korea)Time(Year and month)PBF(%).Women(Germany)PBF(%)Time(Year and month).Women(U.S.)PBF(%)Time(Year and month).Changes in body fat percentage by month17INTROMAINOUTRO“Igainedweightinwinter.”Thisisastatementweoftenhearpeoplemake.Butwhydopeoplesaythattheygainweightandloseweightwiththechangeofseasons?Toanswerthisquestion,from2017to2021,welookedatthechangesinaveragebodyfatpercentagebymonthforpeoplewhosebodycompositionwasmeasuredwithInBody.Whenweanalyzedchangesinaveragebodyfatpercent-agebymonthinKoreanmen,wefoundthatthesamepatternoccurredonayearlybasis.BodyfatpercentagedecreasedfromDecembertoJune,reacheditslowestpointinmidsummer(June-July),increasedfromJulytoNovember,andpeakedinNovember.Thispatternshowsthatbodyfatpercentagetendstodecreaseinthesummerandincreaseinthewinter.Thereasonwhybodyfatpercentagechangesinthesamepatternbyseason,asyoumayhaveguessed,islargelyduetotheinfluenceofactivitymetabolism.Infact,thebasalmetabolicrateishigherinwinterthaninsummer,makingitabetterseasonforreducingbodyfatthroughexercise.However,duringwinter,theamountofexercisenaturallydecreasesduetothecoldweather,andfatigueincreasesduetothedecreaseinsunlight.Asaresult,ifpeopledonotmovetheirbodiesasmuch,calorieconsumptiondecreasesaswell.Onthecontrary,duringsummer,outdooractivitiesincreaseandthereismoresunlight,resultinginfewerdayswherepeoplefeellethargic.Asaresult,theamountofactivityandcalorieconsumptionincrease,andbodyfatpercentagedecreases.ThisresultwasderivedonlyfromdataonKoreanmen,sofurtherdatawasneededtoreinforcethefactthatbodyfatpercentageislowerinsummerandhigherinwinter.Therefore,weexaminedthechangesinaveragebodyfatpercentagebymonthinAustralia,acountryinthesouthernhemispherewithoppositeseasonstothoseinKorea.Interestingly,overthesameperiod,bodyfatpercentagesinAustraliaexhibitedacompletelyop-positepatterntothoseinKorea.InJune,forexample,bodyfatpercentagedecreasedinthenorthernhem-isphereduringthesummer,whileitincreasedinthesouthernhemisphereduringthewinter.However,wenoticedapeculiarityinthedata.InJan-uary,whenthereisnosignificantdifferenceintem-peraturefromDecember,bodyfatpercentagebeginstograduallydecrease.FromFebruarytoNovember,bodyfatpercentageshowsadecreasingtrenddespitebeinginthemiddleofwinter.Thistrendappearstobeinfluencedbythesocialclimateinwhichthenumberofpeoplewhostartexercisingbyregisteringatfacilitiessuchasfi tnesscentersfortheNewYearRapidlyincreas-es.Infact,everyJanuary,comparedtothepreviousDecember,thebodycompositiondataaccumulatedbyInBodysurges,indicatinganincreaseinthenumberofpeoplemeasuringtheirbodycompositionwithInBodytoachievetheirNewYearsexercisegoals.Data source:InBody cloud server(Korea)Target:Korean adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Average change in PBF by monthData source:InBody cloud server(Korea,Asia)Target:Adult males between the ages of 20 and 0(Korea and Australia)Period:January 201-December 2021Main index:Average change in PBF by monthChanges in body fat percentage by month in men(Korea)PBF(%)No.of peopleTime(Year and month).PBF(%)No.of peopleNo.of peopleTime(Year and month)AustraliaKorea.Changes in body fat percentage by month in Korean and Australian menJuneAugustSummerKoreaAustraliaSeasonal Weight Fluctuations:Gaining in Winter and Losing in Summer Temperature-Related Trends in Body Fat Percentage:A Comparison between the Northern and Southern Hemispheres.BodyCompositionofPeoplearoundtheWorldbyYear18DuetotheoutbreakofCOVID-19in2020,thenumberofInBodytestsworldwidedecreasedbyapproximately79%inAprilcomparedtoJanuary.ThisphenomenonappearedasoutdooractivitiesdecreaseddrasticallyfollowingtheoutbreakofCOVID-19.ThetimetakenforthenumberofInBodyteststorecovervariesfromcountrytocountry,butittypicallytookabout3to4months.However,sincetheimplementationofmeasuressuchassocialdistancing,shutdowns,andrestrictionsonthenum-berofpeopleindoors,peoplesbehaviorpatternshavebeenaff ected.InthecaseofKorea,thenumberofInBodytestsrapidlydecreasedasthesecondstageofsocialdistancingwasimplementedfrommid-august2020,andthistrendcontinued.Associaldistancingmeasureswereeased,thenumberoftestsincreasedsignifi cantly.Whilena-tionalpolicieshadcausedasharpdecreaseinthenumberoftests,peoplecontinuedtoengageinoutdoorandin-doorsportsactivitiestostayhealthy,andthenumberofInBodyTestseventuallyrecoveredtopre-COVID-19levels.Inthefollowingsections,wewillexaminetheshortandlongtermeff ectsofCOVID-19onpeoplesbodycomposition.Global InBody Measurement Trends Following the COVID-19 PandemicData source:InBody cloud server(Korea)Target:Korean adult males and females between the ages of 20 and 0 Period:January 201-December 2021Data source:InBody cloud server(Europe)Target:German adult males and females between the ages of 20 and 0 Period:January 201-December 2021.KoreaNo.of peopleTime(Year and month)GermanyNo.of peopleTime(Year and month).Number of InBody measurements per month19INTROMAINOUTROCanadaTime(Year and month)No.of people.JapanNo.of peopleTime(Year and month).MexicoNo.of peopleTime(Year and month)U.S.No.of peopleTime(Year and month).Data source:InBody cloud server(United States)Target:American adult males and females between the ages of 20 and 0 Period:January 201-December 2021Data source:InBody cloud server(Canada)Target:Canadian adult males and females between the ages of 20 and 0 Period:January 201-December 2021Data source:InBody cloud server(Latin)Target:Mexican adult males and females between the ages of 20 and 0 Period:January 201-December 2021Data source:InBody cloud server(Asia)Target:Japanese adult males and females between the ages of 20 and 0 Period:January 201-December 2021 II.TheEff ectofCOVID-19onBodyComposition20DespiteexperiencingthesameCOVID-19pandemic,theInBodymeasurementresultsrevealeddiversereactionsamongcountries.Asaconsequenceofthepandemic,thenumberofInBodymeasurementsdecreased,andweex-aminedthedemographicsofindividualswhounderwentthetestduringthistime.Ifwelookatmostcountries,includingKorea,U.S.,andGermany,wecaninferthatpeoplewithabove-averagemus-clemassusuallyvisitedsportsfacilitiesandunderwentInBodytests,asthenumberofInBodytestssignifi cantlyreducedduetoCOVID-19.Thereweretimeswhenthemusclemasswasmeasuredmuchhigherthantheaveragevalue,indicatingthatthebodycompositionmeasurementwasconductedforthesakeoftheirhealthdespitetherestrictionsduetothenationalpolicies.Global Variations in Muscle Mass Changes During COVID-19 PandemicData source:InBody cloud server(Korea)Target:Korean adult males and females between the ages of 20 and 0 Period:January 201-December 2021Main index:Monthly average change in SMMData source:InBody cloud server(United States)Target:American adult males and females between the ages of 20 and 0 Period:January 201-December 2021Main index:Monthly average change in SMMData source:InBody cloud server(Europe)Target:German adult males and females between the ages of 20 and 0 Period:January 201-December 2021Main index:Monthly average change in SMMMuscle mass change by monthKoreaSMM(kg)No.of peopleTime(Year and month).U.S.SMM(kg)No.of peopleTime(Year and month).GermanySMM(kg)No.of peopleTime(Year and month).NetherlandsKorea,Germany,and the United States were selected as representa-tive countries in Asia,Europe,and the Americas.We also added a graph for Canada,which 21INTROMAINOUTROData source:InBody cloud server(Canada)Target:Canadian adult males and females between the ages of 20 and 0 Period:January 201-December 2021Main index:Monthly average change in SMMInApril2020,Canadadiff eredfromothercountriesasmanypeoplewithlessmusclemassthantheaverageforthesamemonthoverthepastfi veyearsconductedInBodymeasurements.Thisindicatesthateachcountryhasadiff er-entpatternofvisitingindoorsportsfacilitieswhenoutdooractivitiesbecomediffi cultduetoCOVID-19.Unlikebodyfat,changesinmusclemassarenotaff ectedinashortperiodoftime,soitisdiffi culttoidentifythatmusclemasshasincreasedordecreasedduetoCOVID-19.However,asCOVID-19isprolonged,checkingthechangeinmusclemass/fatbeforeandafterCOVID-19outbreakwillbeofsignifi canthelpforhealthcareinthefuture.WhatwerethechangesinmusclemassandfatmassbeforeandaftertheCOVID-19outbreakineachcountry?Time(Year and month).NetherlandsTime(Year and month).CanadaSMM(kg)No.of peopleTime(Year and month).II.TheEff ectofCOVID-19onBodyComposition22AftertheCOVID-19outbreak,therewasasignificantdecreaseinthenumberofInBodymeasurementsandchangesinbodyfatmassandmusclemasswereobserved.Aspeoplebegantoregaintheirdailylives,thenumberofvisitorstoindoorsportsfacilitiesstartedtoincreasegradually.Similarly,thenumberofInBodymeasurementsalsobegantorecover,andbodyfatmassandmusclemassreturnedtopre-COVID-19levelsinmostcountries.However,fouroutofthetwelvecountriesshoweduniquechangesinbodycompositionfollowingthepandemic.Amongmen,theU.K.showedanincreaseinbodyfatmasswhilemaintainingmusclemass,whilemeninKoreaandtheNetherlandsshowedanidealbodycompositionwithanincreaseinmusclemassandmaintenanceofbodyfatmass.Meninothercountriesreturnedtotheirpre-COVID-19bodycomposition.Inthecaseofwomen,onlytheU.S.showedanincreaseinbodyfatmasswhilemaintainingmusclemass.Inothercountries,bodycompositionwassimilartothatbeforeCOVID-19.Thesefindingsreflecttheglobaleffortsofpeopletoprioritizetheirhealththroughexerciseanddiet,evenamidsttheuncertaintyofthepandemic.Impact of Prolonged COVID-19 on Muscle Mass and Body Fat Mass:A Country-Wide Analysis by GenderMaleBFM/FFMKoreaU.S.ChinaJapanCanadaU.K.GermanyNetherlandsBFMFFM:Increase:MaintainFemaleBFM/FFMKoreaU.S.ChinaJapanCanadaU.K.GermanyNetherlandsBFMFFM:Increase:MaintainBody Fat Mass(BFM):Body fat mass means fat mass.Fat Free Mass(FFM):Lean mass means muscle mass.The data was divided based on COVID-19 in March 2020.23INTROMAINOUTROBFM(kg)No.of peopleTime(Year and month).FFM(kg)No.of peopleTime(Year and month).Men(U.K.)BFM(kg)No.of peopleTime(Year and month).FFM(kg)No.of peopleTime(Year and month).Men(Korea)BFM(kg)No.of peopleTime(Year and month).FFM(kg)No.of peopleTime(Year and month).Men(Netherlands)BFM(kg)No.of peopleTime(Year and month).FFM(kg)No.of peopleTime(Year and month).Women(U.S.)Changes in BFM(body fat mass)and FFM(fat free mass)by monthData source:InBody cloud server(Europe)Target:English adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Monthly average change of BFM and FFMBFM increased/FFM maintainedData source:InBody cloud server(Korea)Target:Korean adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Monthly average change of BFM and FFMBFM maintained/FFM increasedData source:InBody cloud server(Europe)Target:Dutch adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Monthly average change of BFM and FFMBFM maintained/FFM increasedData source:InBody cloud server(United States)Target:American adult females between the ages of 20 and 0 Period:January 201-December 2021Main index:Monthly average change of BFM and FFMBFM increased/FFM increasedII.TheEff ectofCOVID-19onBodyComposition24Menundergorapidagingfromtheirmid-30sonward,whichismainlycharacterizedbythelossofmusclemass.Thisage-relateddeclineinmuscleislargelyattributedtoadecreaseintestosterone,themalehormonethatplaysacrucialroleinmaintainingmusclemassandregulatingfatmetabolism.Testosteronelevelsbegintoincreaseduringpubertyandreachtheirpeakinthe20s,butstarttodeclinegraduallyfromtheagesof35to44inmen.Theagingprocessinmenintheir30sisinfl uencednotonlybyhormonesbutalsobytheirlifestylechoices.Menaroundtheworldoftenstartdrinkingandsmokingintheir20sand30s.AccordingtotheWorldHealthOrganization(WHO),theaveragesmokingrateforadultmalesinhigh-incomecountrieswas27.4%in2020,muchhigherthanthe7.0%foradultfemales.Thesametrendscanbeobservedinalcoholconsumptionrates.Forexample,inKorea,1)thehigh-riskdrinkingrateamongadultmaleswas21.6%in2020,comparedtojust6.3%forfemales.Itiswell-knownthatdrinkingandsmokingcanacceleratetheagingprocess.In2017,aDanishresearchteampublishedthe“Copen-hagenHeartStudy”inthe“JournalofEpidemiologyandCommunityHealth,”whichrevealedthatalcoholdrinkersandsmokersshowedremarkableaginginvariousindicatorssuchasearlobewrinkles,cornealring,xanthomas,andhairloss.Evenifwelookattheabdominalobesityratebyagebasedonadultwaistcircumference,menintheir20sand30shavethehighestincreaseinabdominalobesity.Thiscanbeattributedtodecreasedmusclemasscausedbydeclin-ingtestosteronelevels,aswellaschangesinlifestyleduetodrinkingandsmoking,whichaccelerateaginginmenworldwide.Ifso,aretherenationalorracialdiff erencesinthetimingoftheaginginmen?WedecidedtoinvestigatethetimingofmusclemasslossbetweenAsianandWesternmenbyexaminingchangesinskeletalmusclemassbyagegroupinKoreanandAmericanmen,forwhomwehavethemostbodycompositiondataamongAsianandWesterncoun-tries.ItcanbeobservedthattheskeletalmusclemassofKoreanmenstartstodeclineintheirmid-30s,whilethatofAmericanmenbeginstodeclineintheirmid-40s.Thus,itcanbeseenthatAsianmentendtolosemusclemassapproximately10yearsearlierthanWesternmen.Kaufman,M.J.&Vermeulen A.(200),The Decline of Androgen Levels in Elderly Men and Its Clinical and Therapeutic Implications,Endocrine Reviews 26:336 1)Based on the average amount of drinking per time,or more drinks for men and or more drinks for women,and 2 or more drinks per weekMenlosingmuscleintheir3sandmenlosingmuscleintheir4sComparing Age-Related Muscle Loss in Asian and Western Male PopulationsMale hormonal changes with ageMale hormoneAge(Year)Time of declineAs men approach their late 30s,they experience aging due to decreased testosterone level and reduced muscle mass.Looking at InBody big data,Korean men show a decline in muscle mass from their mid-30s,and American men show a decline in muscle mass from their mid-40s.25INTROMAINOUTROThereareknowndiff erencesinmusclefi bersandhormonelevelsamongpeopleofdiff erentracesthatcanaff ectathleticperformance.Forexample,researchsuggeststhatAsianmentendtohavefewerandrogenreceptorsthanWesternmen.Asianmenalsomayhavemoreslow-twitchmusclesthatareassociatedwithendurance,andWesternmenmayhavemorefast-twitchmusclesthatprovidequickburstsofpower.Additionally,factorssuchaschildhoodparticipationinoutdooractivitiescanalsoimpactathleticabilities.Data source:InBody cloud server(Korea)Target:Korean adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Changes in SMM with ageData source:InBody cloud server(United States)Target:American adult males between the ages of 20 and 0 Period:January 201-December 2021Main index:Changes in SMM with ageKoreaSMM(kg)No.of peopleAgeU.S.SMM(kg)No.of peopleAgeChanges in muscle mass in men with ageTime of declineTime of decline.BodyCompositionTrendsbyGender/Age26WhenaWesternwomanandanAsianwomanofthesameagestandsidebyside,weoftengettheimpressionthattheAsianwomanlooksyounger.Butwhyisthisthecase?Whiletheremaybevariousfactorsatplay,webelievethatthetimingofbodyfataccumulationmaybeonepossibleexplanation.Excessivebodyfatpercentagecanleadtovar-ioushealthissues,includingdiabetesandprematureaging.Therefore,weexaminedchangesinbodyfatpercentageinrepresentativecountriestounderstandanydifferencesbetweenAsianandWesternwomen.Weexaminedbodyfatpercentagesbyagein12countriesandfoundthatwhilebodyfatpercentagegenerallyin-creaseswithage,thetimingofthemostsignificantincreasevariesbycountry.Ingeneral,weobservedthatAsianwomenexperienceamorerapidincreaseinbodyfatpercentagelaterinlifethanWesternwomen.AsforWesterncountries,letstakealookattheU.S.andGermany,whichrankatthetopforthenumberofwomensbodycompositiondata.ThesteepestincreaseinbodyfatpercentageforAmericanWomenoccursbetweentheagesof20and30.Similarly,Germanwomenalsoshowthesteepestincreaseinbodyfatpercentagebetweentheagesof20and30,althoughnotasmuchasAmericanwomen.Bothcountriesshowasignificantincreaseinbodyfatper-centagebetweentheagesof20and40.Thistime,wewilltakeacloserlookatKoreaandIndia,twocountrieswithahighnumberoffemalebodycompo-sitiondatainAsia.Koreanwomenshowarapiddecreaseinbodyfatpercentagefromtheir20stolate20s.Fromtheir30stolate40s,theincreaseanddecreaseinbodyfatpercentagefluctuateinsmallwidths,butthemarginofincreasesharplyrisesintheir50sand60s.Indianwomenexperienceacontinuousincreaseinbodyfatpercentagefromtheir20sto70s.However,fromtheir40sto60s,themarginofincreaseinbodyfatpercentagesignificantlyin-creasescomparedtobefore.AlthoughtherearesomedifferencesbetweenKoreaandIndiaintheagegroupwherebodyfatpercentageincreasesrapidly,bothcountriesshowaslowerincreaseinbodyfatpercentagecomparedtoWesternwomensuchasthoseintheU.S.andGermany.Differences in Body Fat Percentage Change between Asian and Western WomenAsian women experience a rapid increase in body fat percentage later than Western women.Asian women usually have a rapid increase in body fat percentage between their 40s and 60s,and Western women between their 20s and 30s.27INTROMAINOUTROData source:InBody cloud server(United States)Target:American adult females between the ages of 20 and 0 Period:January 201-December 2021Main index:Change in PBF with ageData source:InBody cloud server(Europe)Target:German adult females between the ages of 20 and 0 Period:January 201-December 2021Main index:Change in PBF with ageData source:InBody cloud server(Korea)Target:Korean adult females between the ages of 20 and 0 Period:January 201-December 2021Main index:Change in PBF with ageData source:InBody cloud server(Asia)Target:Indian adult females between the ages of 20 and 0 Period:January 201-December 2021Main index:Change in PBF with ageGermanyPBF(%)AgeKoreaPBF(%)No.of peopleAgeIndiaPBF(%)No.of peopleAgeAgeU.S.PBF(%)No.of peopleNo.of peopleChanges in body fat percentage in women with ageIncreaseIncreaseDecreaseMaintain.BodyCompositionTrendsbyGender/Age28The availability of body composition analyzers has signifi cantly al-tered the way people worldwide view health indicators.Prior to their widespread use,weight and BMI(Body Mass Index)were the primary measures used to assess health.Peoples awareness of body composition has increased,and body composition analyzers are becoming more accessible.The changes in our lifestyles require us to explore this fi eld,which is now readily available.03OUTROInrecentyears,theworldhasunder-gonesignificantchangesindailylifeduetotheunexpectedCOVID-19pan-demic.Manybusinesseshaveexperi-encedsetbacksinoperations,includingfitnesscenters.Duetothepandemic,thespaceavailableforexercisehasde-creased,andforthosewhohavebeenunabletogooutside,thetimespentmovingtheirbodiesnaturallyhasalsodecreased.Additionally,increasedde-mandfordeliveryfoodhascontributedtochangesinourbodycomposition.Atthesametime,thetrendfor“at-hometraining”begantotakeoff.Variouspopularonlinefi tnesstrainersemergedonYoutube,andat-homeworkoutsbecameoneofthemostpopularcategoriesonremoteeduca-tionplatforms.Asmorepeoplestartedexercisingathome,thedemandforreliablebodyscalesincreased.InBodysathomebodycompositionanalyzergainedattentionprimarilybecauseofitsabilitytoprovideprecisereadingsofallbodycompositionmetrics,espe-ciallybecauseofinconsistentmeasure-mentsinotherscalesWewanttoinvestigatewhethertherearedifferencesinbodycompositiondatacollectedbyInBodydevicesforat-homeuseversusthoseusedbyprofes-sionalsinsettingslikefitnesscenters.DuringourexplorationofvariousconditionsandaspectsrelatedtotheimpactofCOVID-19,wecameacrossaninterestingfi nding.First,letsexaminethebodycomposi-tiondataofKoreanwomen.PriortotheCOVID-19pandemic,womenwhousedInBodyat-homedevice,itexhibitedlowerbodyfatpercentagesthanthosewhousedInBodyProfessionaldevice.However,followingthepandemic,KoreanwomenwhousedInBodyProfes-sionaldevicesexperiencedadecreaseinbodyfatpercentagecomparedtopre-pandemicmeasurements.Koreanmenshowedadiff erentgraphcomparedtowomen.BothbeforeandafterCOVID-19,menwhohadtheirbodycompositionmeasuredusingInBodyat-homedeviceconsistentlyhadahigherbodyfatpercentagethanmenwhohadtheirbodycompositionmeasuredusingInBodyProfessionaldeviceatafi tnesscenter.BeforeandaftertheoutbreakofCOVID-19,thediff erencesinbodycompositionmeasuredbyInBodyat-homedeviceandProfessionaldevicebasedongenderareinterestingfactorsforpredictinganindividualslifestyleandexercisepatterns.InBody for Home vs.InBody for Professionals:The Diff erences between the Data Measured by Each Device and the UserINTROMAINOUTRO31Data source:InBody cloud server(Korea)Target:Korean adult females between the ages of 20 and 0 Period:January 201-December 2021Equipment:In-Body for home(In-Body Dial)Main index:Monthly average change in PBFData source:InBody cloud server(Korea)Target:Korean adult females between the ages of 20 and 0 Period:January 201-December 2021Equipment:InBody20(3.1%),InBody0(12.9%),InBody30(.9%),and other equipmentInBody for professionals:InBody equipment installed in hospitals,public health centers,fi tness centers,etc.Main index:Monthly average change in PBFData source:InBody cloud server(Korea)Target:Korean adult males between the ages of 20 and 0 Period:January 201-December 2021Equipment:InBody for home(In-Body Dial)Main index:Monthly average change in PBFData source:InBody cloud server(Korea)Target:Korean adult males between the ages of 20 and 0 Period:January 201-December 2021Equipment:InBody20(.6%),InBody0(12.2%),InBody30(.03%),and other equipmentInBody for professionals:InBody equipment installed in hospitals,public health centers,fi tness centers,etc.Main index:Monthly average change in PBF.Changes in body fat percentage by month in Korean adult females as seen by InBody at-home devicesPBF(%)No.of peopleTime(Year and month).Changes in body fat percentage by month in Korean adult females as seen by InBody for professionalsPBF(%)No.of peopleTime(Year and month).Changes in body fat percentage by month in Korean adult females as seen by InBody at-home devicePBF(%)No.of peopleTime(Year and month).Changes in body fat percentage by month in Korean adult females as seen by InBody for professionalsPBF(%)No.of peopleTime(Year and month).COVID19COVID19COVID19COVID192023 InBody Report32AftertheoutbreakofCOVID-19,therehasbeenasharpincreaseinthenumberofpeopleinterestedinhealthandwellness.Whilemanyindustrieshavebeennega-tivelyaffectedbythestrengtheningofsocialdistancingmeasures,athleisurecompanieshavebeenabletore-mainprofitable.Thebiggestchangeistheincreaseinthenumberofpeopledoing“at-hometraining.”Variouspopularwork-outtrainershavestartedtoappearonYoutube,andcommunitypostsintroducingthebestat-homeworkouttrainingcourses.Atthesametime,demandhasin-creasedforhouseholdscalesthatcanpreciselymeasureweightandbodycomposition.Abodycompositionana-lyzerlinkedtoanappcontinuouslychecksyourbodyconditionandhelpsplanforworkouts.Variousplat-formsofferhealthyexercisemethodsanddietsolutionsaccordingtochangesinyourbodycompositionthroughanapplinkedtothebodycompositionanalyzer,whichhasalsogainedattention.Atthesametime,peoplewhoprioritizecost-effective-nessforhomeappliancesstartedtopaymoreattentiontodeviceswithsuperiortechnologythatcanbeusedathomeforalongtimeeveniftheycostalittlemore.AfterCOVID-19,thenumberofpeoplestartingfull-fledgedexerciseathomehasincreasedsignificantly.Eventhosewithnopreviousexerciseexperiencehavebecomeinterestedinhealthandwellnessandarefind-ingexerciseenjoyable.Associaldistancingwaseased,morepeopleweregoingtogymsandpersonaltrainersmanagingmembersmoreactivelytomakeupforthelosscausedbyCOVID-19.Healthandwellnesstrendsaroundtheworldarecon-stantlyevolving,butonethingisclear:caringaboutoneshealthandtakingcareofoneselfisbecominganessentialelementofdailyliferatherthanjustatempo-rarytrend.Changes in Health and Wellness Trends after COVID-19INTROMAINOUTRO33Measuringbodyfatandmusclemassandexaminingtheconditionofonesbodythroughabodycompositionanalyzerhasalreadybecomeanessentialelementineveryoneslife.Beyondtheeraoffocusingsolelyonfatandmusclefordiet,theeraoffocusingontheimportanceofbodywater,whichaccountsformorethan70%ofyourbody,hasarrived.Sincewateraccountsforthelargestportionofthebody,monitoringthewaterbalanceinthebodycanrevealtheprogressofmanydiseases.Waterinthehumanbodyislargelydividedintointracellularwater(ICW)andextracellularwater(ECW).Healthypeoplemain-tainaconstantbodywaterratio.Monitoringbodywaterisveryimportantforpatientssufferingfromdiseases,thosewithtoxicsub-stancesandinflammationinthebody,orthosewithpoornutritionalstatusbecausethebalanceofbodywaterratioappearsdifferentfromthatofthegeneralpublic.ThisisexpressedasECW/TBW(ExtracellularWater/TotalBodyWater),anditissaidtobeidealwhentheratioisfrom0.36to0.39.Inparticular,monitoringbodywaterinhemodialysispatientshasagreatimpactontreatmentasitcanmeanthedifferencebetweenlifeanddeath.Forhemodialysispatients,whetherthefluidinthebodyisproperlydialyzed,thatis,whetherornotitisdrained,isanimportantfactorinthetreatmentprocess.Whenmeasuringbodywater,theprogressoftreatmentforpatientswithkidneydiseaseisindicatedbysettingadryweight(theweightwhenthebodyisnotswollen,bloodpressureiswellmaintained,andenergylevelsareattheirpeak)andconfirmingthatthewaterisbeingproperlydialyzed.Bodywatermeasurementisalsousedtoevaluateobesityandanti-aging.Fundamentally,musclesaremadeupofwater,sopeoplewhoaredehydratedaremorelikelytolackmuscle,leadingtoobesity.Theeraofsimplymeasuringthedegreeofobesitybybodyfathaspassed,andnowwecanevaluateourbodycondition,obesity,andanti-agingmoreaccuratelythroughbodywatermeasure-ment.Forthosewhoareexperiencinghealthmanagementthroughmusclemassandbodyfatpercentagebeyondbodyweight,ifweweretochooseahigher-levelhealthcarefactorforthosemanagingtheirhealththroughmusclemassandbodyfatpercentagebeyondbodyweight,bodywaterwouldcertainlybetheidealchoice.A Preview of the Health Care Trend in 2023,ECW Ratio(Extracellular Water/Total Body Water)2023 InBody Report34Based on insights derived from InBody big data,we have examine the body composition by country.The 2023 InBody Report includes av-erage body composition index for men and women in 12 countries,which are provided in the appendix.AppendixInBodyReportBodyCompositionIndexof12CountriesAppendix_InBody Report Body Composition Index of 12 CountriesMen CountryWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)40,54021.518.79Netherlands55,36632.287.1289,85522.38.8Germany113,66131.497.0210,45624.938.21Malaysia15,82833.736.2636,52826.428.55Mexico63,46336.116.751,130,99323.259.13U.S.1,644,89935.117.1959,64921.828.73U.K.72,80932.696.97182,353 27.038.13India128,852 36.616.6994,68621.18.11Japan152,74029.476.1681,85521.948.31China102,68328.746.2654,02823.798.7Canada52,47432.76.882,409,88122.618.38Korea4,343,18631.526.31158,08823.639.01Australia308,89733.027.21Men NetherlandsWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)12,44717.438.7220s14,58529.496.988,759218.8230s11,45431.597.197,32922.848.9240s11,76832.687.276,92224.528.8950s11,51234.517.173,80726.078.6760s4,67435.271,27627.298.3370s1,37335.616.79Men GermanyWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)23,82918.298.7520s26,72029.056.918,97921.488.8630s21,94830.517.0914,13023.368.9640s20,78631.477.216,70424.328.9150s25,20332.747.0610,89225.838.6660s13,86734.46.895,32126.78.3270s5,13734.496.73Men MalaysiaWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)3,62023.078.1720s4,95432.556.123,78525.58.330s5,66433.886.351,82026.138.2940s3,29034.346.3779926.78.0950s1,44234.956.1835526.97.860s39736.316.077727.657.2270s8137.155.8337Men MexicoWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)23,82918.298.7520s26,72029.056.918,97921.488.8630s21,94830.517.0914,13023.368.9640s20,78631.477.216,70424.328.9150s25,20332.747.0610,89225.838.6660s13,86734.46.895,32126.78.3270s5,13734.496.73Men U.S.WomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)394,20820.129.0420s444,67733.37.13305,67523.49.2330s448,34234.677.31212,09525.099.3140s359,76335.57.31132,33226.179.1750s249,93236.867.1362,35527.598.8660s108,405386.8824,32828.778.4170s33,78038.46.59Men U.K.WomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)20,44219.438.620s21,63230.546.8220,24421.658.7730s23,11631.887.0111,13423.618.8840s14,55433.797.135,49825.498.8450s9,58736.277.051,74527.038.5760s3,00636.686.7858627.058.2470s91436.336.57Men IndiaWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)85,879 25.198.0420s55,290 35.586.5359,065 27.918.2630s40,577 36.566.8324,211 29.248.2540s20,876 37.536.888,941 30.468.0550s8,673 39.66.723,079 32.347.760s2,562 41.416.41,178 31.417.6570s874 38.176.57Men JapanWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)30,43118.838.2420s44,17028.726.0726,01621.268.1930s40,17729.416.2218,48522.28.240s32,69629.76.3210,45522.688.1150s20,34130.26.214,90123.297.8160s7,87330.186.064,39825.057.2370s7,48330.45.742023 InBody Report38Appendix_InBody Report Body Composition Index of 12 CountriesMen ChinaWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)42,95920.678.3120s46,81828.256.1726,41723.128.3330s38,29428.86.38,12123.618.3240s12,04129.356.452,93124.258.1950s4,02431.096.4188524.39860s1,02732.16.3954223.248.0470s47930.266.28Men CanadaWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)8,71119.578.7120s11,55130.946.99,47522.838.7930s10,57832.176.9912,67623.918.840s12,27832.7712,92725.058.7550s10,83533.796.837,29225.978.5260s5,47634.466.642,94727.888.1870s1,75635.476.33Men KoreaWomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)1,087,00121.178.3620s1,678,07231.076.16707,05623.728.4930s1,249,36931.426.34325,32523.838.4540s762,27931.416.5177,93423.648.2550s446,02932.66.4582,20824.027.9960s162,78433.66.3530,35725.357.6470s44,65334.776.14Men Australia WomenNumber of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)Number of dataMean value of body fat percentage(%)Mean value of skeletal muscle index(kg/)50,10320.51920s113,49331.427.1753,25823.279.0630s95,17432.637.2931,83625.299.140s59,85633.657.2914,89327.678.9550s28,30936.537.15,73030.828.6360s9,32539.346.872,26832.898.2370s2,74041.36.58*The data used in this report were used solely for statistical purposes,to provide information,limited to the data for which personal information was agreed upon,and no information that can identify individuals is included in the data.392023 InBody Report40Thecopyrightofthe2023InBodyReportisownedbyInBodyCo.,Ltd.Commercialuseofthisreportisprohibited,andwhenciting,besuretoindicatethesource.Forinquiriesaboutthisreport,pleasecontactusbelow.InBodyPublicRelationsTeamTeamLeaderLeeKyung-wooTelephone:( 82)2-300-2226E-mail:2023 InBody Co.,Ltd.retains all rights to this publication.IB-ENG-00-A-230310Date of publication:March10,2023Publisher:InBodyCo.,Ltd.Directing:Kyungwoo LeeandBohye Choi Editorial:Suyeon YangDesign:WuyongChoi andSubin LeeInBodyBuilding,625,Eonju-ro,Gangnam-gu,Seoul g Report2023
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Lnderdossier Wandlungsprozesse,Herausforderungen und Politikanstze im Altenpflegesystem in Deutschland aus einer Gerechtigkeitsperspektive Hildegard Theobald Universitt Vechta August 2023 Hervorgegangen aus dem deutsch-chinesischen Projekt Sorgearbeit und Geschlechtergerechtigkeit.Altenpflege in China und Deutschland“zwischen der Friedrich-Ebert-Stiftung Shanghai und dem Ginling Womens College der Nanjing Normal University(NNU)FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 1 Inhaltsverzeichnis 1.Einfhrung:Herausforderungen in der Pflege in Deutschland.2 2.Zur Situation der Pflegekrfte.6 2.1 Vernderungsanstze in der Pflegeausbildung.6 2.2 Arbeits-,und Beschftigungsbedingungen.7 3.Versorgungsstrukturen im Welfare Mix.9 3.1 Zusammenspiel familirer und professioneller Versorgung.9 3.2 Entwicklung professioneller Infrastruktur.12 3.3 Die kommunale Ebene.14 4.Herausforderungen und Vernderungsanstze aus einer Perspektive der Gerechtigkeit.15 Literatur.17 FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 2 1.Einfhrung:Herausforderungen in der Pflege in Deutschland1 Demografische und soziale Wandlungsprozesse haben die Versorgung lterer in Deutschland seit den 1990er Jahren vor Herausforderungen gestellt.Als Reaktion darauf wurde 1995 die universelle Pflegeversicherung eingefhrt,welche die verfgbaren Sozialleistungen in einer Pflegesituation definiert,und die Untersttzung familirer Versorgung sowie die Etablierung der professionellen Infrastruktur grundlegend beeinflusst hat.Vor dem Hintergrund dieser Entwicklungen werden in diesem Lnderdossier die Herausforderungen in der Pflege analysiert und Lsungsanstze diskutiert.Gefragt wird nach Voraussetzungen fr eine nachhaltige Entwicklung der Versorgung,die den steigenden quantitativen und qualitativen Anforderungen entspricht und diese mit einer angemessenen Situation fr professionell und informell Pflegende verknpft.Zentral fr die Analyse ist eine Gerechtigkeitsperspektive,die die Dimensionen Geschlecht,soziokonomischer Status und Migration bercksichtigt.In diesem Abschnitt werden die zentralen gesellschaftlichen Wandlungsprozesse erlutert,die das vorhandene Pflegesystem herausfordern und die fr die Entwicklung von Politikanstzen relevanten zivilgesellschaftlichen Akteure vorgestellt.Im zweiten Teil werden Gegebenheiten,Herausforderungen und Lsungsanstze aus der Perspektive der Pflegekrfte und anschlieend bezglich der(Weiter)entwicklung der Versorgungsstrukturen errtert.Abschlieend werden die Ergebnisse resmiert,mit einer Gerechtigkeitsperspektive verbunden und weiterfhrende Handlungsanstze vorgestellt.Seit den 1990er Jahren zeigt sich in Deutschland ein erheblicher Anstieg des Anteils lterer ab 65 Jahren in der Bevlkerung von 1590 auf prognostiziert 27 35.Gleichzeitig erhhte sich auch der Anteil der ber Achtzigjhrigen in der Bevlkerung von 490 auf 7 20 bzw.auf 8 35 gem der Prognose.Ausgangspunkt und Anstieg unterscheiden sich in beiden Altersgruppen deutlich zwischen den Geschlechtern,mit einem hheren Anteil der Frauen in beiden Altersgruppen.Der Geschlechterunterschied verringert sich im Zeitverlauf(vgl.Tabelle 1).Fr die aktuellen Entwicklungen,das Jahr 2020 und die Prognose fr das Jahr 2035,spielen zustzlich die erheblichen regionalen Unterschiede eine Rolle(vgl.Tabelle 1).Generell zeigt sich der hchste Anteil lterer in beiden Altersgruppen in den Flchenlndern Ost,gefolgt von den Flchenlndern West.Die gnstigste Situation hinsichtlich der Verteilung und des Anstiegs der lteren Bevlkerung findet sich in den Stadtstaaten.Der deutschlandweit und regional verhltnismig niedrige Anstieg des Anteils der lteren ab 80 Jahren zwischen 2020 und 2035 wird durch den Einfluss der Corona-Pandemie auf die Sterblichkeit der lteren mitbestimmt,die in dieser Datengrundlage bercksichtigt wird.Die ist die einzige Datengrundlage in dem Lnderdossier,die diesen Einfluss bereits einbezieht.1 Ich bedanke mich fr die ausgezeichnete Recherchearbeit der wissenschaftlichen Hilfskrfte Paulina Essig und Bianca Maria Mers.FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 3 Tabelle 1:Demographischer Wandel Anteil der Altersgruppen an der Gesamtbevlkerung Jahr/Region Altersgruppen Mnner Frauen Gesamt 1990 Deutschland 65 80 10,44%2,18,13%5,27,94%3,78 20 Deutschland 65 80 19,55%5,56$,33%8,68!,98%7,14 20 Flchenlnder West 65 80 19,13%5,47#,58%8,39!,39%6,96 20 Flchenlnder Ost 65 80 23,19%6,51),56,65&,42%8,61 20 Stadtstaaten 65 80 16,75%4,73!,61%7,58,22%6,16 35 Deutschland 65 80 24,84%6,06),39%8,99,15%7,54 35 Flchenlnder West 65 80 24,73%5,93),04%8,68&,91%7,32 35 Flchenlnder Ost 65 80 28,26%7,464,27,391,32%9,45 35 Stadtstaaten 65 80 19,67%4,94#,88%7,64!,71%6,18%Eigene Berechnungen auf der Basis der Datenquellen:Statistischen Bundesamt(2021a)fr 1990 und(2021b)fr 2020,2035 Legende:Flchenlnder Ost:Neue Bundeslnder;Flchenlnder West:Alte Bundeslnder mit Ausnahme der Stadtstaaten:Hamburg,Bremen,Berlin.Der demographische Wandel ist eine zentrale Einflussvariable auf die Entwicklung der Pflegebedrftigkeit.Seit der Einfhrung der Pflegeversicherung 1995 stieg die Anzahl Pflegebedrftiger von 1,55 Millionen 1996,auf 2,29 Millionen 2010,und 3,83 Millionen 2019.Der markante Anstieg nach 2010 kann neben dem demographischen Wandel auch auf die Pflegereformen zurckgefhrt werden(Rothgang/Mller 2021).Rothgang und Mller(2021)rechnen aufgrund der Demographie bis 2030 mit einem Anstieg auf insgesamt 5,86 bis 6,04 Millionen Pflegebedrftige.Regionale Differenzierungen der Entwicklung der Pflegebedrftigkeit besttigen fr 2017,die in den obengenannten Daten zum demographischen Wandel hervortretenden regionalen Unterschiede(Schwinger et al.2019).Die genannten Prognosen knnen den Anstieg aufgrund der Demographie berschtzen,da der Anteil der ber 80-jhrigen an der Bevlkerung,der quantitativ dominanten Gruppe der Pflegebedrftigen,in den Berechnungen aufgrund der Nicht-Bercksichtigung des Einflusses der Corona-Pandemie berschtzt werden kann.Die regionalen Differenzierungen bleiben gem der demographischen Prognose erhalten(siehe Tabelle 1).Die Zunahme lterer betrifft auch die Bevlkerung mit Migrationshintergrund,d.h.von Personen,die entweder selbst migriert sind oder zumindest ein Elternanteil besitzen,das migriert ist FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 4 bzw.die deutsche Staatsbrgerschaft nicht durch Geburt besitzt(vgl.Khnert/Ignatzi 2019).Im Jahr 2019 hatten 21,2 Millionen Menschen(26%)der Bevlkerung einen Migrationshintergrund(Statistisches Bundesamt 2021c).Auch hier sind regionale Unterschiede erkennbar.In Stadtstaaten,sowie einigen alten Bundeslndern haben 26-29r Bevlkerung einen Migrationshintergrund im Vergleich zu lediglich fnf Prozent in den neuen Bundeslndern(Khnert/Ignatzi 2019).Vor dem Hintergrund der gesellschaftlichen Alterungsprozesse berechneten Thum und Kolleg*innen(2015)einen Anstieg des Anteils von Personen mit Migrationshintergrund an allen Pflegebedrftigen von 9,8 13 auf 13,6 30.Aufgrund des Alterungsprozesses reduziert sich auch der Anteil der Bevlkerung im erwerbsfhigen Alter mit negativen Konsequenzen fr das Arbeitskrfteangebot und die Finanzierung der fr den deutschen Wohlfahrtsstaat zentralen Sozialversicherungen.Die Erhhung der Erwerbsttigkeit der Frauen wurde als ein zentraler Ansatzpunkt ausgewhlt,diesem Prozess entgegenzuwirken.Diese Politiken haben zu einem erheblichen Anstieg der Frauenerwerbsttigenquote gefhrt,auch fr Frauen im Alter von 45-65 Jahren.Deren vernderte Erwerbsintegration wird aufgrund der zentralen Bedeutung fr die familire Sorgearbeit im Folgenden dargelegt(vgl.Abbildung 1).Abbildung 1:Wandel der Frauenerwerbsttigkeit 1991-2019 FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 5 Whrend sich die Erwerbsttigkeit der Frauen von 45-65 Jahren zwischen 1991 bis 2000 nur leicht erhhte,werden ab 2000 erhebliche Anstiege auf 76 19 erkennbar(vgl.Abbildung 1).Das umfasst Vollzeit-,und Teilzeitttigkeiten,wobei Teilzeitarbeit lediglich einen moderaten Zuwachs von 45%im Jahr 2000 auf 54%im Jahr 2019 aufweist.In dem Anstieg werden unterschiedliche Muster abhngig vom Qualifikationsniveau erkennbar.So stieg der Anteil unter Frauen mit einem Studienabschluss von einer bereits hohen Quote von 74%im Jahr 2000 auf 86%im Jahr 2019.Aufgrund des niedrigeren Ausgangsniveaus erlebten Frauen auf den anderen Qualifikationsebenen hhere Anstiege der Erwerbsttigenquote von 19-26%in dem Zeitraum.Die Erwerbsttigenquoten 2019 liegen dann vergleichbar mit den Studienabsolventinnen bei 84%fr die Fachschulabsolvent*innen,bei 77%fr Frauen mit einem Lehrabschluss,jedoch deutlich niedriger bei 57%fr Frauen ohne Berufsabschluss.Zur Bewltigung der Herausforderungen in der pflegerischen Versorgung wurden unter Einbeziehung relevanter gesellschaftlicher Akteure verschiedene Politikanstze entwickelt.Die Akteure und ihre grundlegenden Positionen werden hier vorgestellt und anschlieend in der Diskussion zentraler Reformanstze in zentralen Fragen pflegerischer Versorgung dieses Dossiers spezifiziert.2 Zentrale kontroverse Themen in der Debatte betreffen die Rolle und Verantwortung des Staats in der ffentlichen Finanzierung sowie der Regulierung und Ausgestaltung der Sozialleistungen,die Rolle der Familie und der Freiwilligenarbeit und die Weiterentwicklung professioneller Pflegearbeit.Dabei lassen sich grundlegende Positionen unterscheiden.Die zentrale Gewerkschaft Ver.di und die dem linken Spektrum zugerechneten Wohlfahrtsverbnde,wie die Arbeiterwohlfahrt(AWO)oder der Deutsche Parittische Wohlfahrtsverband(DPWV)betonen strker staatliche Verantwortung.Die kirchlich orientierten Wohlfahrtsverbnde(Diakonie und Caritas)verknpfen staatliche Verantwortung mit einer strkeren Betonung auf Freiwilligen-,und Familienarbeit.Die Berufsverbnde in der Pflege fokussieren auf die Professionalisierung der Pflegefacharbeit.Die Verbnde der privaten Anbieter wiederum zielen auf einen mglichst wenig regulierten,marktorientierten Modus der Erbringung der Pflegedienstleistungen.2 Die Grundlage der Ausfhrungen ist eine Recherche der zentralen Aussagen auf der Website der Akteure im November/Dezember 2021.FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 6 2.Zur Situation der Pflegekrfte Der Aufbau einer professionellen Versorgung erfordert die Gewinnung und Bindung einer entsprechenden Anzahl angemessen ausgebildeter Pflegekrfte.Eingebettet in den demographischen Wandel hat die Einfhrung der Pflegeversicherung 1995 zu einem deutlichen Ausbau der professionellen Pflegeinfrastruktur und damit nahezu zu einer Verdoppelung der Beschftigtenzahl von 623 900 im Jahr 1999(Vollzeitquivalente(VZ)470 500)auf 1,187 Millionen Beschftigte im Jahr 2019(VZ 865.600)gefhrt(Rothgang/Mller 2021).Seit 2010 wird in diesem Sektor bundesweit ein ausgeprgter Mangel an Pflegefachkrften erkennbar,whrend sich unter den Helfer*innen,ca.50r Pflegekrfte,ein berangebot zeigt(Bundesagentur fr Arbeit 2021).Es liegen verschiedene Schtzungen zur zuknftigen Entwicklung des Pflegekrftebedarfs vor,die den Einfluss der Corona-Pandemie auf die demographische Entwicklung nicht bercksichtigen.Eine Schtzung von Rothgang und Mller(2021)kommt aufgrund des angenommenen demographischen Wandels auf einen zustzlichen Bedarf von 144 000 Pflegekrften(VZ)zwischen 2020 und 2030.Die Prognose von Schwinger und Kolleg*innen(2020)besttigt diese Annahme,wobei die von ihnen berechneten regionalen Pflegekrftebedarfe den Statistiken zum regionspezifischen demographischen Wandel im ersten Kapitel folgen.Auch wenn aufgrund des weniger stark verlaufenden demographischen Wandels ein niedrigerer Anstieg des Pflegekrftebedarfs anzunehmen ist,fhren die vermutete Steigerung der Inanspruchnahme professioneller(ambulanter)Dienstleistungen und die Verrentungen der Pflegekrfte aufgrund des demographischen Wandels zu einem hheren Bedarf(vgl.Kapitel 1).Fr den derzeitigen und zuknftig angenommenen ausgeprgten Mangel an Pflegefachkrften werden die geringe Attraktivitt der Ausbildung zur(Alten)pflegefachkraft,die Hrden in der Weiterbildung der Helfer*innen zur Fachkraft sowie die schwierigen Arbeits-,und Beschftigungsbedingungen verantwortlich gemacht.In jngerer Zeit wurden verschiedene politische Initiativen zur Bewltigung der Herausforderungen ergriffen.2.1 Vernderungsanstze in der Pflegeausbildung Reformen im Bereich der Pflegeausbildung bilden einen zentralen Ansatzpunkt,dem Pflegefachkrftemangel zu begegnen.Mit der Erhhung der Anzahl der Auszubildenden in der Altenpflege um ca.30%zwischen 2011 und 2019 konnte eine Zielsetzung erreicht werden(Slotala 2019,Bundesministerium fr Gesundheit 2020).Relevant fr den Anstieg der Ausbildungen waren die Verbesserung der Ausbildungsbedingungen,wie die Erhhung der Ausbildungsvergtung oder auch die Abschaffung des Schulgelds.Ein weiterer Erfolgsfaktor war der deutliche Anstieg der Weiterbildungen zur Pflegefachkraft basierend auf dem Programm zur dreijhrigen Nachqualifizierung in der Altenpflege durch die Bundesagentur fr Arbeit seit Dezember 2012.Eine wichtige Zielgruppe dieser Weiterqualifizierungsmanahmen stellen bereits in der Pflege ttige bzw.erwerbslose Pflegehelfer*innen dar(Geschftsstelle,2015;Bundesagentur fr Arbeit 2021;BMFSFJ 2022).Flchtlinge bilden eine weitere Zielgruppe fr die Ttigkeit in der Pflege.Im Jahr 2020 waren 13.000 Flchtlinge als Pflegekrfte ttig im Vergleich zu 2.000 im Jahr 2015(Bundesagentur fr Arbeit 2021).Relevant wird dabei der Zugang zu einer Pflegeausbildung.FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 7 Ergebnisse des Modellprojekts Care for Integration“fr Flchtlinge zeigen,dass 80r Teilnehmenden erfolgreich die Altenpflegehelferausbildung abgeschlossen haben.86%unter ihnen mchte eine Fachkraftausbildung anschlieen und langfristig im Feld ttig werden.Durch den hohen Mnneranteil 62r Teilnehmer*innen kann dies positiv zu den Geschlechterproportionen beitragen(Isfort/Hylla 2020).Mit der Reform der Ausbildung der Pflegeberufe von 2020 soll die Pflegeausbildung generell attraktiver und damit die Anzahl der Auszubildenden weiter gesteigert werden.Kernstcke bilden dabei die Zusammenfhrung der bisherigen bereichsspezifischen Pflegefachkraftausbildungen(Kranken-,Alten-,Kinderkrankenpflege)in eine generalistische Pflegefachausbildung.Darber hinaus wird ein regelhaftes primrqualifizierendes BA-Studium eingefhrt.Trotz der Hrden durch die Corona-Pandemie konnte bei den ersten beiden Ausbildungskohorten 2020 und 2021 ein Anstieg der Ausbildungszahlen von 56.118 vor der Reform 2019 auf 57.294 2020 und auf 61.329 im Jahr 2021 erzielt werden.Wie fr die Vorluferausbildungen,entschieden sich vor allem Frauen mit einem Anteil von 76%fr die neue generalistische Pflegefachausbildung.Der Zahlen der Erstimmatrikulationen im BA-Studiengang blieben mit einem Anstieg von 100 vor der Reform 2019 auf 500 2021 hinter den Erwartungen zurck.Untersuchungen fanden,dass trotz einer positiven Bewertung der Studiengnge die unklaren Ttigkeitsprofile nach dem Studium und die nicht-vorhandene Vergtung des Studiums im Vergleich zur Ausbildung dazu beitrugen(BMFSFJ 2022)2.2 Arbeits-,und Beschftigungsbedingungen Die markante Erhhung der Anzahl der Beschftigten in der professionellen Pflege seit der Einfhrung der Pflegeversicherung geht mit einer schwierigen Arbeits-,und Beschftigungssituation in dem frauendominierten Ttigkeitsfeld Frauenanteil 84 19 einher(vgl.Statistisches Bundesamt 2021d).Seit der Einfhrung der Pflegeversicherung hat sich der Anteil der Beschftigten in Teilzeitttigkeiten auf ca.70%im ambulanten und stationren Bereich im Jahr 2019 erhht.Circa 16,9r Beschftigten im ambulanten Bereich und 8,0%im stationren Bereich gehen einer geringfgigen Beschftigung nach,d.h.einer Teilzeitbeschftigung mit einem niedrigen Stundenumfang und einem reduzierten Umfang sozialer Sicherung.Hinzu kommen unangemessene Lhne und insbesondere erhebliche Lohnunterschiede.Laut Bundesagentur fr Arbeit(2022)betrug der durchschnittliche Bruttolohn pro Monat bundesweit fr Altenpflegefachkrfte im Dezember 2021 3.344 Euro und fr Altenpflegehelfer*innen 2.352 Euro.Die Lhne liegen deutlich niedriger in den neuen im Vergleich zu den alten Bundeslndern,und bei gewinnorientierten im Vergleich zu den freigemeinntzigen bzw.ffentlichen Trgern(Gre/Stegmller 2019;Bundesagentur fr Arbeit 2022).Forschungsergebnisse zur Arbeitssituation verweisen ebenfalls auf schwierige Bedingungen.Dazu zhlen insbesondere die niedrige Personalausstattung,der hohe Zeitdruck,die hohe physische und psychische Belastung oder auch die geringen Entwicklungsmglichkeiten,dabei sind die Bedingungen in der Pflege deutlicher schlechter als in anderen Berufsgruppen(vgl.Theobald et.al.2013;Schmucker 2019).Derzeit werden in der Politik zwei Anstze der Vernderung verfolgt.Die Einfhrung eines evidenzbasierten Standardverfahrens zur Festlegung der Personalausstattung in Altenpflegeheimen soll die hohe Arbeitsbelastung reduzieren.Die Begleitforschung erbrachte,dass ein deutlicher Anstieg insbesondere von Assistenzkrften und dabei eine mgliche Reduktion FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 8 des Fachkraftanteils hierbei zielfhrend sind(vgl.Rothgang et al.2019).Die gesetzlich vorgeschriebene Fachkraftquote mit einem Anteil von 50chkrften im Ttigkeitsfeld Pflege und Betreuung soll durch eine anhand des Pflegebedarfs der Bewohner*innen einrichtungsspezifisch bestimmten Quote ersetzt werden.Zur Entlastung sollen darber hinaus Pflegehelfer*innen eingestellt werden,was mit einem Rckgang des Fachkrfteanteils einhergeht.Mit dem Reformgesetz zur Weiterentwicklung der Gesundheitsversorgung von 2021 wurde diese grundlegende Herangehensweise bernommen.Whrend die Zielsetzung der Erhhung der Personalzahlen einhellig begrt wird,ist um den Fachkrfteanteil eine Kontroverse entstanden.Hier sprechen sich die Gewerkschaft Ver.di,die AWO und der Deutsche Berufsverband fr Altenpflege(DBVA)gegen die Reduktion des Fachkraftanteils aus.Weitere Berufsverbnde fokussieren auf die Strkung der Position der Pflegefacharbeit und weniger auf das Ttigkeitsfeld insgesamt.Eine entgegengesetzte Position nimmt der Bundesverband privater Anbieter sozialer Dienste(bpa)ein,der auch die reduzierte Fachkraftvorgabe kritisch sieht und als Mastab fr Qualitt die Messung der Ergebnisqualitt vorschlgt.Mit der Einfhrung eines bundesweiten allgemeingltigen Tarifvertrags sollen die unangemessenen,sehr unterschiedlichen Lhne berwunden werden.Die Etablierung eines allgemeingltigen Tarifvertrags durch die Bundesregierung erfordert,dass ein quantitativ relevanter Anteil der Arbeitgeber in dem Sektor dem Tarifvertrag zustimmt.Der von der Gewerkschaft Ver.di mit ausgewhlten Arbeitgeberverbnden ausgehandelte vorlufige allgemeingltige Tarifvertrag erhielt jedoch nicht ausreichend Zustimmung.Die privaten Arbeitgeber sprachen sich prinzipiell gegen diese Zielsetzung aus.Die beiden kirchlichen Wohlfahrtsverbnde erklrten sich als verhandlungsbereit,stimmten jedoch dem Tarifvertrag nicht zu.Als Alternative wurde das Tariftreuegesetz im Rahmen des Gesetzes zur Weiterentwicklung der Gesundheitsversorgung 2021 formuliert.Dieses schreibt vor,dass ab September 2022 alle Einrichtungen,die im Rahmen der Pflegeversicherung Dienstleistungen anbieten wollen,ihren Mitarbeiter*innen Lhne auf der Basis eines von ihnen ausgewhlten regionalen Tarifvertrags bzw.des von den regionalen Pflegekassen berechneten regionalen Durchschnittslohns bezahlen mssen.Dieses Gesetz wird von vielen Akteuren,wie beispielsweise Ver.di als nicht ausreichend fr eine Verbesserung der Lohnsituation kritisiert.Eine gegenteilige Position nimmt der bpa ein,der die bisherige positive Lohnentwicklung ohne Tarifvertrag hervorhebt und die Vorgaben im Tariftreuegesetz als unzulssigen Eingriff in die Handlungs-,und Entscheidungsspielrume der Unternehmer*innen bewertet.Der bpa untersttzte mit weiteren Verbnden im privatwirtschaftlichen Spektrum die Einreichung einer Beschwerde gegen das Tariftreuegesetz gewinnorientierter Pflegeeinrichtungen beim Bundesverfassungsgericht.Die Entscheidung des Bundesverfassungsgerichts steht noch aus.Whrend die genannten Reformgesetze grundlegende Facetten der Beschftigungssituation verndern wollen,sollen mit dem Modellprojekt Gute Arbeitsbedingungen in der Pflege“(2019-2023)Arbeitsbedingungen in den Einrichtungen verbessert und damit die Bindung der Pflegekrfte an die Einrichtung bzw.das Berufsfeld verstrkt werden.Das Projekt besteht aus einer Pilotphase im Jahr 2019 und einem Rollout von 2021 bis 2023,mit dem das in dem Pilotprojekt erprobte Vorgehen bundesweit in ca.1.000 ambulanten und stationren Einrichtungen umgesetzt werden soll(Appel/Schein 2019;Behrens et al.(2020).FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 9 Im Rahmen des Pilotprojekts wurden zunchst zentrale Handlungsfelder z.B.Arbeitszeitregelungen,Arbeitsorganisation,Fhrungskompetenz-fr eine Verbesserung definiert,darauf bezogene Instrumentenkoffer mit Leitfden zu konkreten Vernderungsmanahmen und Methoden der Erhebung einrichtungsspezifischer Handlungsfelder entwickelt.Anschlieend wurden nach einer Erhebung der einrichtungs-spezifischen Handlungsfelder die 25 ausgewhlten Einrichtungen in der Implementation mit Beratungs-,und Schulungsangeboten begleitet.Innerhalb weniger Monate konnte mit dieser Herangehensweise in den beteiligten Einrichtungen Verbesserungen erzielt werden.Zentrale Elemente fr den Erfolg waren die Ausbildung der Berater*innen und der leitenden Pflegekrfte in den Einrichtungen sowie ihre zeitlichen Kapazitten.Als Hrde in der Umsetzung erwiesen sich der begrenzte zeitliche Umfang des Projekts,der fr den Rollout erweitert wurde.Fr den bundesweiten Rollout wurden zeitlich begrenzte regionale Kompetenzzentren gegrndet,die fr die Anwerbung der Einrichtungen,die Organisation und Durchfhrung der Schulungen und den Austausch zwischen den Einrichtungen verantwortlich sind.3.Versorgungsstrukturen im Welfare Mix In Deutschland wird die pflegerische Versorgung als eine gesamtgesellschaftliche Aufgabe mit dem Staat als Regulator und Finanzier betrachtet.Eine zentrale Rolle fr die Definition der staatlichen Sozialleistungen,der ffentlichen Finanzierung und Regulierung der Dienstleistungserbringung nimmt die gesetzliche Pflegeversicherung ein.Die Ausfhrung pflegerischer Versorgung wird im Sinne eines Welfare Mix an Familie,Wohlfahrtsorganisationen,zivilgesellschaftliche Akteure und gewinnorientierte Anbieter delegiert.Die Pflegeversicherung bietet der Bevlkerung ein weites Spektrum an Sozialleistungen in gesetzlich definierten Pflegesituationen.Seit der Einfhrung der Pflegeversicherung hat sich der Anteil unter den lteren ab 65 Jahren,die Leistungen erhalten von 12,099 auf 17,4%im Jahr 2019 deutlich erhht(Statistisches Bundesamt 2001;2021d).In den folgenden Ausfhrungen werden nach dem Zusammenspiel professioneller und familirer Versorgung zentrale Facetten der Entwicklung professioneller Dienste und Anstze der kommunalen Versorgung errtert.3.1 Zusammenspiel familirer und professioneller Versorgung Wie bereits angefhrt hat die Erhhung der Frauenerwerbsttigkeit seit 2000 das traditionelle familienbasierte Pflegesystem infrage gestellt.Als neuer Ansatz wird das Konzept eines Pflegemix diskutiert,in dem die familire Versorgung in ein breites Spektrum von Untersttzungsleistungen eingebettet wird.Erste Hinweise auf die Realitten familirer Versorgung liefern die Ergebnisse einer Reprsentativbefragung von Hielscher und Kolleg*innen(2017)aus dem Jahr 2015 sowie Ergebnisse der Pflegestatistik.Nach Angaben der Pflegestatistik nutzten im Jahr 2019 36r ab 65-jhrigen Leistungsempfnger*innen der Pflegeversicherung,die zuhause lebten,ambulante Dienstleistungen(Statistisches Bundesamt 2021d).Hielscher und Kolleg*innen(2017)fanden in ihrer Reprsentativbefragung,dass in knapp 50r privaten Pflegehaushalte verschiedene Dienstleistungen einbezogen werden.Dies betraf neben den ambulanten Dienstleistungen die Beschftigung einer Haushaltshilfe(35r Haushalte)oder die Anstellung einer Betreuungskraft auf einer live-in Basis im Privathaushalt(8%FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 10 der Haushalte)(vgl.Abschnitt 3.2).Generell nehmen alleinlebende Frauen,Angehrige der Mittelschichten und ltere ohne Migrationshintergrund hufiger Dienstleistungen in Anspruch.In diesen Unterschieden reflektieren sich die Wohnsituation,kulturelle Vorstellungen zur Versorgung und Abwgungen aufgrund der entstehenden privaten Kosten der Dienstleistungen(Schmidt/Schneekloth 2011;Schwinger et al.2016).Die Herangehensweise des Pflegemix spiegelt sich auch in den Vorstellungen einer wnschenswerten Versorgung.Schon 2002 fand eine Reprsentativbefragung in Pflegehaushalten den Pflegemix als berwiegende Norm der Versorgung.Bei einer Wahl zwischen Betreutem Wohnen,privater Pflege ohne Pflegekrfte und privater Pflege mit Pflegekrften empfahlen nur 30r Pflegenden lediglich private Pflege,48%die private Pflege mit Pflegekrften und 22treutes Wohnen(Runde et al.2003).Die Entwicklung des Pflegemix ist in einen breiteren Wandlungsprozess zentraler Facetten der informellen Versorgung eingebettet,wobei ein Zusammenspiel von Vernderungen und Beharrung erkennbar wird(siehe Tabelle 2).Tabelle 2:Wandel informeller,familirer Versorgung Themenbereich 1998 2010 2016 Erwerbsttigkeit Hauptpflegeperson:Nicht-erwerbsttig 64A5%Geringfgig 8%Teilzeit 13 &%Vollzeit 16(%Fortsetzung der Erwerbsttigkeit der Hauptpflegeperson:Aufgabe der Erwerbsttigkeit 15%Einschrnkung der Erwerbsttigkeit 34%-Einschrnkung der Erwerbsttigkeit wegen der Pflege -23%Aufgabe/Einschrnkung aus anderen Grnden -8%Unvernderte Fortsetzung 51T%Zeitaufwand Versorgung pro Woche 45,5 Std.37,5 Std.30,1 Std.Wahrgenommene Belastung informelle Pflege:Gar nicht 2%3%3%Eher wenig 12 %Eher stark 43HQ%Sehr stark 40)&%Informell Pflegende Anteile in%:(Ehe)Partnerin 20%(Ehe)Partner 12%Tochter 23&%Sohn 5%Mnner insgesamt 20(1%Quelle:Reprsentativbefragungen Schneekloth et al.(2017)Der Wandel der traditionellen familiren Versorgung reflektiert sich zunchst in der zunehmenden Erwerbsttigkeit der Hauptpflegepersonen im erwerbsfhigen Alter von 3698 auf FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 11 65 16.Gleichzeitig zeichnet sich eine Reduktion der informellen Pflegezeit pro Woche von 46 Std.1998 auf 30 Std.2016 ab.Auerdem berichten Hauptpflegepersonen seltener von einer starken Belastung.Zunehmend mehr Mnner nehmen die Rolle der Hauptpflegeperson ein,was durch die Zugnglichkeit ambulanter Dienste gefrdert wird(Schneekloth et al.2017).Der Abbau informeller Pflegezeit ermglicht eine gleichere Verteilung der verbliebenen Pflegeaufgaben zwischen Mnnern und Frauen(Theobald 2020).Obwohl Studien belegen,dass die Vereinbarung von Pflege und Beruf entlastend wirken kann,bestehen jedoch nach wie vor erhebliche Probleme in der Vereinbarkeit.Frauen,insbesondere mit einem niedrigen sozio-konomischen Status,bernehmen hufiger unter prekren Bedingungen familire Pflege(Pinquart 2016;Naumann et al.2016;Institut DGB-Index Gute Arbeit 2018;Auth et al.2020;Schneekloth et al.2017).Neben Dienst-,und Geldleistungen bietet die Pflegeversicherung Freistellungsregelungen,die sozialpolitische Absicherung durch Rentenregelungen und Pflegekurse zur Untersttzung der Durchfhrung der Pflege(zu den Pflegekursen siehe Box).Von den verschiedenen Freistellungsregelungen wird lediglich das Recht auf einen Ausstieg fr maximal zehn Tage aus der Erwerbsarbeit pro Jahr mit einer ffentlich finanzierten Kompensation von 90s ausgefallenen Nettoarbeitsentgelts positiv in der Bevlkerung bewertet(Naumann et al.2016).Zur Verbesserung der sozialen Sicherung im Alter von Pflegepersonen im Erwerbsalter,die nicht mehr als 30 Stunden pro Woche erwerbsttig sind,entrichtet die Pflegeversicherung Beitrge zur Rentenversicherung.Im Jahr 2018 erhielten lediglich 25,3r Pflegenden von huslich versorgten Pflegebedrftigen diese Leistung(Rothgang/Mller 2019).Pflegekurse Pflegende Angehrige haben das Recht auf die Teilnahme an von der Pflegeversicherung finanzierten Pflegekursen,die sie zur eigenstndigen Durchfhrung der Pflege befhigen.Die Kurse werden im Rahmen einer Gruppenschulung,als Einzelschulung zuhause und zunehmend online angeboten.Der zeitliche Umfang liegt zwischen 1,5-3 Stunden fr allgemeine Informationen zur Pflegversicherung und umfangreichen Schulungen zu Fragen pflegerischer Versorgung von 8-15 Stunden.Nach einer Reprsentativbefragung im Jahr 2016 nahmen lediglich neun Prozent der Hauptpflegepersonen Pflegekurse in Anspruch,wobei sich der Anteil mit dem Anstieg der Pflegebedrftigkeit erhht(21%auf der hchsten Pflegestufe 3).84r Teilnehmer*innen gaben an,dass ihnen die Kurse die Pflege erleichtert haben(Schneekloth et al.2017).Donath und Kolleg*innen(2011)stellten in ihrer Untersuchung zur geringen Inanspruchnahme u.a.fest,dass die pflegenden Angehrigen in einer umfassenden Beratung von den Vorteilen eines Pflegekurses berzeugt werden mssen.Die befragten Teilnehmer*innen bewerteten besonders positiv praxisnahe Hilfen in der Versorgung und krankheitsspezifische Informationsvermittlung.FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 12 3.2 Entwicklung professioneller Infrastruktur Seit der Einfhrung der Pflegeversicherung hat ein erheblicher Ausbau ambulanter und stationrer Dienstleistungen mit einer Erhhung der Nutzer*innenzahl von 1,1 Millionen 1999 auf 1,8 Millionen 2019 stattgefunden(Statistisches Bundesamt 2001;2021d;Angaben zu einem Stichtag).Der Ausbau im Rahmen eines Pflegemarkts basierend auf einer Konkurrenz zwischen freigemeinntzigen und gewinnorientierten Anbietern fhrte dazu,dass 67r ambulanten Dienstleister und 43r Altenpflegeheime 2019 unter gewinnorientierter Trgerschaft standen(Statistisches Bundesamt 2021d).Doch der Beitrag gewinnorientierter Anbieter*innen wird zunehmend kritisch gesehen.Dies betrifft ihre zentrale Marktstrategie,die im Altenpflegeheimsektor mit im Vergleich zu gemeinntzigen Anbietern niedrigeren Preisen und einer niedrigeren Qualitt expandieren(Geraedts et al.2016;Haun 2020).Hinzu kommt eine Vernderung der Eigentmerstrukturen durch den Einstieg internationaler profit-orientierter Equity-Firmen seit 2013 in dem traditionellerweise durch Familienunternehmen getragenen Bereich(Scheuplein et al.2019).Vor dem Hintergrund unterschiedlicher Inanspruchnahmen der Leistungsarten ambulante,stationre Dienstleistungen bzw.Geldleistungen entwickelten sich regionale Unterschiede im Ausbau der Dienstleistungen.Eine Erklrung der regionalen Inanspruchnahme von Dienstleistungen liegt in der Hhe privater Zuzahlungen aufgrund der regional unterschiedlichen Preise der Dienstleistungen,die u.a.vor dem Hintergrund regionaler Lohndifferenzen entstehen(Statistisches Bundesamt 2021d;Hackmann et al.2016;Haun 2020).Neben dem Ausbau spielen auch qualitative Aspekte fr die Weiterentwicklung eine entscheidende Rolle.Als normative Zielsetzung der auerhuslichen Versorgung gilt,dass Versorgungssicherheit mit Selbstbestimmung der Pflegeempfnger*innen,der Sicherung ihrer persnlichen Identitt durch die Wahrung von ihren Wnschen und Gewohnheiten und ihre Integration in das soziale Umfeld verbunden werden soll(vgl.Kremer-Prei et al.2021).Dies fhrte zur Etablierung alternativer Wohn-,und Versorgungsformen,wie Angebote des Betreuten Wohnens(1-2r lteren ab 65 Jahren).Weiterhin zu nennen sind hier Pflegewohngemeinschaften(3.900 im Jahr 2017)zumeist in regulren Wohnungen in der Nachbarschaft(Rothgang/Mller 2019).Forschungsergebnisse belegen,dass die Zielsetzungen erreicht werden und die Nutzer*innen die Lebensqualitt positiv bewerten(Kremer-Prei et al.2021).Die Versorgung in den Altenpflegeheimen,die quantitativ bedeutsamste auerhusliche Versorgungsform(4r lteren ab 65 Jahren 2019),hat sich ebenso verndert(Statistisches Bundesamt 2021d).Das aktuellste Konzept seit 2010 das Quartiershaus-soll das Leben in der Gemeinschaft der Wohngruppe,mit der Strkung der Privatheit insbesondere durch Wohnen im Einzelzimmer mit der sozialen Integration in die lokale Umgebung verbinden.Vorhandene Konzepte werden nicht flchendeckend umgesetzt und sind nicht fr alle zugnglich.Dennoch werden positive Entwicklungen erkennbar,beispielsweise im deutlichen Anstieg des Anteils von Einzelzimmern von 1999 bis 2019(Statistisches Bundesamt 2001;2021d).Vor dem Hintergrund der zunehmenden Anzahl pflegebedrftiger lterer mit Migrationshintergrund wird eine breitere Zugnglichkeit der Versorgungsinfrastruktur notwendig.In dem ffnungsprozess mssen die soziale Situation von lteren mit Migrationshintergrund-wie niedrigere Renteneinknfte,hufig beengte Wohnverhltnisse-und die Varianz kultureller FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 13 Vorstellungen zur Pflege einbezogen werden(Khnert/Ignatzi 2019).Trotz einem traditionell familienorientierten Versorgungsideal und teilweise unzureichenden Informationen zu den vorhandenen Mglichkeiten sind zum Beispiel Familien mit trkischem Migrationshintergrund zunehmend bereit,auch Dienstleistungen einzubeziehen(Yilmaz-Aslan et al.2021;Krobisch et al.2014).Die ffnung der professionellen Angebote betrifft daher Versorgungsangebote und Beratungsstrukturen.Der zentrale Ansatz der transkulturellen ffnung geht von einem dynamischen Kulturbegriff;d.h.eines Austausches zwischen Kulturen aus,wodurch diese zunehmend transkulturell werden(Fischer 2021).Dies erfordert eine individualisierte Herangehensweise,in der nicht die fremde Kultur“im Vordergrund steht,sondern die Pflegebedrftigen und deren individuelle Situation und Vorstellungen.Die Etablierung der der sogenannten 24.Std.Betreuung“im Privathaushalt zumeist von Familien aus den Mittelschichten verdeutlicht,dass die aufgezeigten Entwicklungen nicht ausreichend sind.In dieser Versorgungsform werden die pflegebedrftigen lteren zuhause von einer im Privathaushalt lebenden Migrantin(live-in)versorgt.Diese Versorgung wird in der Regel von den Familien ber einen grauen Arbeitsmarkt oder durch Vermittlungsagenturen organisiert.Zumeist findet sie auf der Basis von nicht-regulren und hochbelastenden Beschftigungs-,und Arbeitsverhltnissen statt;beispielsweise charakterisiert durch eine durchschnittliche Wochenarbeitszeit von 69 Stunden(siehe Theobald 2021,Hielscher et al.2017).Vor diesem Hintergrund werden unterschiedliche Manahmen zur Verbesserung vorgeschlagen.Der Bundesverband fr husliche Versorgung und Pflege e.V.,der Verband der gewinnorientierten Vermittlungsorganisationen,zielt darauf ab unter dem Begriff Rechtssicherheit“,rechtliche Regelungen zu definieren,die die vorherrschende Praxis ohne Vernderungen der Bedingungen der Betreuungskrfte legitimieren.Ein wichtiges Element dabei ist die Nichtvergtung der Bereitschaftszeit.Das Bundesarbeitsgericht hat allerdings 2021 der Klage einer Betreuungskraft aus Bulgarien stattgegeben,die gefordert hat,dass Bereitschaftszeit als Arbeitszeit anerkannt und vergtet werden muss.Projekte gemeinntziger Vermittlungsorganisationen wollen im Gegensatz dazu,auf der Basis einer regulren Beschftigung die reale Arbeits-,und Beschftigungssituation den in Deutschland geltenden rechtlichen Regelungen anpassen.Die Gewerkschaft Ver.di wiederum fordert,dass die professionellen Dienste so umfassend ausgebaut und ffentlich finanziert werden,dass diese Versorgungsform nicht mehr bentigt wird.Neben den qualitativen Vernderungen spielt die Frage der hohen privaten Kosten insbesondere in Altenpflegeheimen in der ffentlichen Diskussion eine wichtige Rolle.Zivilgesellschaftlichen Akteure fordern einhellig niedrigere private Kosten,allerdings in unterschiedlichem Umfang.Weitestgehend sind die Forderungen,die pflegebedingten Kosten vollstndig ffentlich zu finanzieren,wie sie von der Gewerkschaft Ver.di und dem linken Spektrum zugehrigen Wohlfahrtsverbnden erhoben werden.Die kirchlichen Wohlfahrtsverbnde verknpfen ihre Forderungen mit Vorschlgen einer kostengnstigeren Versorgung durch die Einbeziehung Angehriger oder(bezahlter)Freiwilliger.Die Politik hat im Rahmen des Gesetzes zur Weiterentwicklung der Gesundheitsversorgung 2021 mit einer Erhhung des Anteils ffentlicher Finanzierung reagiert.Doch diese Erhhung wird gerade vor dem Hintergrund der geplanten Reformen,wie der Einfhrung von Tariflhnen oder der Erhhung der Personalschlssel,als langfristig wenig wirksam bezeichnet.FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 14 3.3 Die kommunale Ebene In der Debatte wird zunehmend die Rolle der Kommune im Aufbau einer bedarfsgerechten lokalen Versorgungsstruktur betont,die eine vorrangige Versorgung in der eigenen Huslichkeit gestattet.Der Begriff lokale Versorgungsstruktur bezieht sich auf die Etablierung von Beratungs-,und Untersttzungsangeboten,die Frderung der Integration pflegebedrftiger lterer,lokale Planung und Vernetzung der beteiligten Akteure.Die Steuerung der grundlegenden ambulanten und(teil)stationren Infrastruktur hingegen obliegt der Pflegeversicherung bzw.der Bundesebene und den Bundeslndern,whrend die kommunalen Kompetenzen sehr begrenzt sind.Anhand von drei ausgewhlten Anstzen werden die kommunalen Herangehensweisen dargelegt.ffnung der Beratung fr ltere mit Migrationshintergrund Mit dem Modellprojekt Interkulturelle Brckenbauer*innen(2015-2018)soll durch den Abbau sprachlicher und kultureller Barrieren beim Zugang zu Beratung gleichzeitig der Zugang zu Versorgungsleistungen von lteren mit Migrationshintergrund im Pflegebereich verbessert werden(folgende Ausfhrungen vgl.Sari/Khan-Zvornican 2018).Im Modellprojekt wurden Brckenbauer*innen in Themen der Pflege ausfhrlich geschult,um sprach-,und kulturvermittelnd in definierten Beratungssituationen ttig zu werden.Ausgewhlt wurden dazu die Beratung fr Pflegebedrftige in den lokalen Pflegesttzpunkten bzw.durch ambulante Pflegedienste und die Begutachtungen zur Aufnahme in die Pflegeversicherung.Die Beratungen wurden als Tandemberatung von einer professionellen Berater*in und den Brckenbauer*innen gemeinsam durchgefhrt.Im Rahmen der ffentlichkeitsarbeit suchten die Brckenbauer*innen zudem gezielt Migrationsvereine,Seniorentreffs etc.zur Vermittlung von Informationen auf.In der Evaluation zeigte sich u.a.eine steigende Anzahl von Ratsuchenden mit Migrationshintergrund in den Pflegesttzpunkten und eine zunehmende Beteiligung der Brckenbauer*innen bei den Begutachtungen.Diese Einrichtungen waren nach Abschluss des Projekts an einer Verstetigung des Angebots interessiert.Trotz ebenfalls positiver Ergebnisse sahen die ambulanten Pflegedienste keine Mglichkeit der Verstetigung.Positiv bewertet wurde die Herangehensweise auch von den lteren mit Migrationshintergrund bzw.ihren Familien selbst.Lokale Demenzstrategie Das Bundesprogramm Lokale Allianzen fr Menschen mit Demenz“(2012-2018;2020-2026)untersttzt den Aufbau demenzfreundlicher Kommunen.Die gefrderten lokalen Allianzen sollen dazu beitragen,dass Menschen mit Demenz am gesellschaftlichen Leben teilhaben knnen,die Angehrigen die passenden Hilfen erhalten und die Gesellschaft fr Demenz sensibilisiert wird(folgende Auswertungen zur ersten Periode vgl.Mder 2019;2020).Die Trger dieser lokalen Allianzen waren die Kommunen selbst,Wohlfahrtsverbnde oder zivilgesellschaftliche Akteure,wie die Alzheimer Gesellschaft.Als Zielgruppen wurden eine breite Varianz von Personen definiert.Dazu gehrten Menschen mit Demenz und ihre Angehrigen,Brger*innen,Beschftigte in ausgewhlten gesellschaftlichen Feldern,wie die Polizei,Expert*innen in der Verwaltung und Kommunalpolitiker*innen.Zentrale Ttigkeitsfelder waren Informationsveranstaltungen und Schulungen sowie ffentlichkeitsarbeit.In FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 15 der Umsetzung wurde deutlich,dass pflegende Angehrige breite Untersttzung bentigen,die sie im Alltag begleiten,fachlich informieren und emotional untersttzen.Freiwilligenarbeit nahm eine zentrale Rolle ein.Ein bedeutender Anteil der Beteiligten war selbst freiwillig ttig.Freiwillige wurden auch fr spezifische Ttigkeiten ausgebildet,wie die Demenzbegleiter*innen.Die Situation in den lndlichen Kreisen erwies sich schwieriger als in den Stdten.Entwicklung lokaler Sorgekulturen Dem Anstieg pflegebedrftiger lterer und der gleichzeitige Rckgang der familiren Versorgung soll mit der Entwicklung lokaler Sorgestrukturen,der Sorgenden Gemeinschaft“entgegengewirkt werden.Nach dem Konzept soll durch den Beitrag von Nachbar*innen und Freiwilligen in Zusammenarbeit mit professionellen Krften eine lokale Sorgekultur entstehen,die eine angemessene Versorgung,die Untersttzung der Familien und die Integration in die lokale Gemeinschaft frdert.Notwendig zur Realisierung sind insbesondere die Beteiligung der Brger*innen in der Auswahl und Umsetzung der Manahmen,die gezielte Entwicklung von Freiwilligenarbeit,die Organisation von lokalen Netzwerken und die Zusammenarbeit mit kommunalen Instanzen.In der Umsetzung finden sich in den Kommunen hnliche Anstze,wie die Einrichtung einer Anlaufstelle in der Nachbarschaft,Hausbesuche zur Vermittlung von Informationen,die Entwicklung von Elementen der Alltagsuntersttzung bis hin zur Einrichtung von Pflegewohngruppen(vgl.Kricheldorff et al.2015).Neuere Forschungen gehen davon aus,dass in jngerer Zeit ca.1,000 Projekte mit dieser Zielsetzung in sehr unterschiedlichen Kommunen entstanden sind(Wehrbein/Hanemann 2021).In der Debatte um den Aufbau sorgender Gemeinschaften wird kritisiert,dass der Beitrag der freiwilligen oder nachbarschaftlichen Untersttzung zu zeitlich umfassender Versorgung berschtzt wird(vgl.Ergebnisse des Freiwilligensurvey Vogel/Tesch-Rmer 2017).Forschungen zu umfangreichen Betreuungsangeboten durch Freiwillige erbrachten,dass diese Betreuung oft von lteren Frauen mit niedrigem Qualifikationsniveau als niedrig bezahlte“Freiwilligenarbeit oder in Form einer geringfgigen Beschftigung ausgefhrt wird(Hochgraeber et al.2015).4.Herausforderungen und Vernderungsanstze aus einer Perspektive der Gerechtigkeit Im Fokus das Lnderdossiers steht die Frage,wie vor den demographischen und sozialen Wandlungsprozessen eine nachhaltige und gerechte professionelle und informelle Sorgestruktur aufgebaut werden kann.Der Aspekt der Gerechtigkeit,der neben Geschlecht den soziokonomischen Status und Migrationshintergrund einschliet,bezieht sich auf den Zugang zu ffentlich untersttzten Formen der Versorgung,Wahlmglichkeiten in der bernahme informeller Sorgearbeit,Verteilung informeller Sorgearbeit zwischen Mnnern und Frauen unabhngig vom sozio-konomischem Status und Migrationshintergrund sowie die soziale Wertschtzung der informellen und professionellen Sorgearbeit,die sich auch in den verfgbaren gesellschaftlichen Ressourcen zeigt.Die Ausfhrungen haben erbracht,dass seit der Einfhrung der Pflegeversicherung eine grundlegende ambulante und stationre Pflegeinfrastruktur bundesweit aufgebaut und auch an die vernderten Normen angepassten Versorgungsanstze entwickelt wurden.Die Mehrheit der Bevlkerung votiert fr einen Pflegemix aus familirer und professioneller Versorgung,der abhngig FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 16 vom Umfang der Reduktion familirer Versorgung zu einer gleicheren Verteilung der Aufgaben zwischen Mnnern und Frauen fhren kann.Die Ausfhrungen verdeutlichen Grenzen in der Umsetzung,die gleichzeitig notwendige Weiterentwicklungsmglichkeiten der Pflegepolitik aufzeigen.Die Pflegeinfrastruktur und insbesondere breitere Versorgungs-,Untersttzungs-,und Beratungsstrukturen fr Pflegebedrftige und pflegende Angehrige sind nicht flchendeckend vorhanden,und aufgrund privater Kosten oder auch der Orientierung der Anstze nicht fr alle verfgbar.Trotz einer steigenden Beteiligung von Mnnern an der informellen Sorgearbeit bestehen nach wie vor Ungerechtigkeiten in der Arbeitsverteilung im Vergleich zu Frauen.Die Vereinbarung von Beruf und Pflege in Kombination mit unzulnglichen Formen der Untersttzung stellen informelle Pflegende weiterhin vor Herausforderungen.Die Betonung der Freiwilligenarbeit anstelle professioneller Ttigkeiten birgt das Risiko der Entwicklung eines prekren,ungleichheits-verstrkenden Beschftigungsfelds.Eine wichtige Herausforderung stellen auch die besonders prekren Bedingungen in der live-in Betreuung dar.Die Kommunen haben wenig Einfluss auf die grundlegende Pflegeinfrastruktur und sind fr die Bewltigung der Aufgaben zu wenig finanziell ausgestattet.Grundlegende Voraussetzung fr die flchendeckende,nachhaltige und gerechte Weiterentwicklung ohne prekre Beschftigung ist die bessere finanzielle Ausstattung der Pflegepolitik,geringere private Kosten,strkere Steuerungskompetenz der Kommunen zur Etablierung einer angemessenen Versorgungsstruktur und eine qualitative Weiterentwicklung,wie die transkulturelle ffnung fr ltere mit Migrationshintergrund.Ausreichend qualifizierte Pflegekrfte bilden die Basis fr die professionelle Versorgung.Die Voraussetzungen dafr bilden soziale Wertschtzung der Ttigkeit und dafr verfgbare angemessene gesellschaftliche Ressourcen.Die Manahmen zu erfolgreicher Rekrutierung und Bindung der Pflegekrfte zeigen unterschiedliche Effekte.Die Anstrengungen,die Ausbildungszahlen zu erhhen waren erfolgreich und strkten die soziale Wertschtzung der Sorgearbeit.Weitere derzeit in der Umsetzung begriffene Anstze zur Erhhung der Lhne oder der Personalschlssel in der stationren Versorgung lassen widersprchliche Ergebnisse hinsichtlich der Aufwertung und Abw ertung der Ttigkeit erkennen.Wichtig fr eine positive Weiterentwicklung sind bundesweit angemessene Vorgaben fr Lhne und die Betonung der Qualifikation als Voraussetzung der Pflegettigkeit(Theobald 2018).Zur Verbesserung der Bedingungen sind auch Vernderung in den Einrichtungen notwendig.Die nachhaltige Bewltigung der Herausforderungen erfordert eine Erhhung gesellschaftlicher Ressourcen und damit der ffentlichen Finanzierung.Die breit diskutierte Einfhrung einer Brgerversicherung in der Pflegeversicherung,die deren Finanzierungsgrundlagen erweitert und damit verbessert sowie die Strkung der Finanzen durch einen Steuerzuschuss bilden dazu 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ersten Pflegestrkungsgesetzes(PSG I).Mnchen Schwinger,Antje/Jrchott,Kathrin/Tsiasioti,Chryrsanthi/Rehbein,Isabel(2016).Pflegebedrftigkeit in Deutschland.In:Jacobs,Klaus/Kuhlmey,Adelheid/Gre,Stefan/Klauber,Jrgen/Schwinger,Antje(Hrsg).Pflege-Report 2016.Die Pflegenden im Fokus.Stuttgart:Schattauer,S.275-328 Schwinger,Antje/Klauber,Jrgen/Tsiasioti,Chrysranthi,(2019).Pflegepersonal heute und morgen.In:Jacobs,Klaus/Kuhlmey,Adelheid/Gre,Stefan/Klauber,Jrgen/Schwinger,Antje(Hrsg.).Pflegereport 2019.Mehr Personal in der Langzeitpflege aber woher?.Springer Open:Open Access Publikation,S.3-20.Slotala,Lukas(2019).Stellschrauben mit groer Wirkung.Anstze zur Gewinnung neuer Auszubildender in der Altenpflege.In:Jacobs,Klaus/Kuhlmey,Adelheid/Gre,Stefan/Klauber,Jrgen/Schwinger,Antje(Hrsg.).Pflegereport 2019.Mehr Personal in der Langzeitpflege aber woher?.Springer Open:Open Access Publikation,S.71-83.FRIEDRICH-EBERT-STIFTUNG SHANGHAI|弗里德里希艾伯特基金会上海代表处 20 Statistisches 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der Berufsverlufe ein deutsch-schwedischer Vergleich.Berlin:Edition Sigma.Theobald,Hildegard(2018).Pflegearbeit in Deutschland,Schweden und Japan.Wie werden Pflegekrfte mit Migrationshintergrund und Mnner in die Pflegearbeit einbezogen?.Unter Mitarbeit von Holger Andreas Leidig.Hans-Bckler-Stiftung(Hrsg.)Study 383.Dsseldorf.Theobald,Hildegard(2020).Sorgepolitiken und die Konsequenzen fr die Gleichstellung von pflegenden Familienangehrigen:Deutschland und Schweden im Vergleich.Sozialer Fortschritt,69,3,S.183-201.Theobald,Hildegard(2021).Gute Arbeit in der Pflege?Staatliche Steuerungsversuche im internationalen Vergleich.In:Emunds,Bernhard/Degan,Julian/Habel,Simone/Hagedorn,Jonas(Hrsg).Freiheit Gleichheit Selbstausbeutung.Zur Zukunft der Demokratie und des Sozialstaats in der Dienstleistungsgesellschaft.Jahrbuch Die Wirtschaft der Gesellschaft 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Angebotsstrukturen.Springer Open:Open access publication,S.210-217.Yilmaz-Aslan,Yce/Aksabal,Tugba/Annac,Kbra/Razum,Oliver/zer-Erdogdu,Ilknur/Tezcan-Gntekin,Hrrem/Brzoska,Patrick(2021).Diversitt am Beispiel von Menschen mit Migrationshintergrund.In:Bonacker,Marco/Geiger,Gunter(Hrsg.).Migration in der Pflege.Wie Diversitt und Individualisierung die Pflege verndern.Berlin:Springer Nature,S.155-171.ber die Autorin Prof.Hildegard Theobald ist Leiterin des Fachgebiets Organisationelle Gerontologie an der Universitt Vechta und Vertrauens-dozentin der Friedrich-Ebert-Stiftung.Auflagehinweis 2023 Friedrich-Ebert-Stiftung Shanghai Representative Office Bellas Tower,7th Floor,705 1325 Huaihai Zhong Lu 200031 Shanghai,PR China Verantwortlich Ren Bormann|Chefreprsentant Anna Fiedler|Projektkoordination&Wissenschaftliche Begleitung Tobias Beck|Projektmanager T 86-21-6431 0026|F 86-21-6431 0069 https:/china.fes.de/Die in dieser Publikation geuerten Ansichten sind nicht notwendigerweise die der Friedrich-Ebert-Stiftung.Die kommerzielle Nutzung aller von der Friedrich-Ebert-Stiftung(FES)herausge-gebenen Medien ist ohne schriftliche Zustimmung der FES nicht gestattet.
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