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Global reporton infection preventionand control2024Global reporton infection preventionand control2024Global report on infection prevention and control 2024ISBN 978-92-4-010398-6(electronic version)ISBN 978-92-4-010399-3(print version)World Health Organization 2024Some rights reserved.This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence(CC BY-NC-SA 3.0 IGO;https:/creativecommons.org/licenses/by-nc-sa/3.0/igo).Under the terms of this licence,you may copy,redistribute and adapt the work for non-commercial purposes,provided the work is appropriately cited,as indicated below.In any use of this work,there should be no suggestion that WHO endorses any specific organization,products or services.The use of the WHO logo is not permitted.If you adapt the work,then you must license your work under the same or equivalent Creative Commons licence.If you create a translation of this work,you should add the following disclaimer along with the suggested citation:“This translation was not created by the World Health Organization(WHO).WHO is not responsible for the content or accuracy of this translation.The original English edition shall be the binding and authentic edition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization(http:/www.wipo.int/amc/en/mediation/rules/).Suggested citation.Global report on infection prevention and control 2024.Geneva:World Health Organization;2024.Licence:CC BY-NC-SA 3.0 IGO.Cataloguing-in-Publication(CIP)data.CIP data are available at https:/iris.who.int/.Sales,rights and licensing.To purchase WHO publications,see https:/www.who.int/publications/book-orders.To submit requests for commercial use and queries on rights and licensing,see https:/www.who.int/copyright.Third-party materials.If you wish to reuse material from this work that is attributed to a third party,such as tables,figures or images,it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder.The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user.General disclaimers.The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country,territory,city or area or of its authorities,or concerning the delimitation of its frontiers or boundaries.Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned.Errors and omissions excepted,the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by WHO to verify the information contained in this publication.However,the published material is being distributed without warranty of any kind,either expressed or implied.The responsibility for the interpretation and use of the material lies with the reader.In no event shall WHO be liable for damages arising from its use.ContentsForeword viAcknowledgements viiAbbreviations and acronyms viiiGlossary xiExecutive summary xv1.Purpose,target audience and methods xvi2.The problem of unsafe care resulting from health care-associated infections and antimicrobial resistance xvii3.Situation analysis of the implementation of infection prevention and control around the world xix3.1 Infection prevention and control implementation at national level xix3.2 Infection prevention and control implementation at health care facility level xxi3.3 Infection prevention and control implementation at the regional level xxiv4.The way forward xxviReferences xxix1.Introduction,methods and target audience 11.1 What is infection prevention and control?21.2 Purpose and target audience of this report 51.3 Data sources and methodologies 62.The problem of unsafe care resulting from health care-associated infections and antimicrobial resistance 92.1 Key messages 102.2 How frequent are infections acquired in health care?112.2.1 Antimicrobial resistance in health care 152.2.2 Meticillin-resistant Staphylococcus aureus 162.2.3 Resistance to third-generation cephalosporins 162.2.4 Resistance to carbapenems 172.2.5 Resistance in Candida spp 182.2.6 Health care-associated infections and antimicrobial resistance during the COVID-19 pandemic 182.2.7 SARS-CoV-2 spread in health care settings 182.3 What are the consequences of health care-associated infections and antimicrobial resistance for patients and health workers?203.Infection prevention and control implementation at the national level 253.1 Key messages 263.2 National infection prevention and control programmes and dedicated budget 273.3 Implementation of infection prevention and control guidelines,and training and education 393.4 Documenting the progress and impact of infection prevention and control implementation:health care-associated infections surveillance and monitoring of infection prevention and control practices and feedback 443.5 Adoption of the multimodal approach for infection prevention and control implementation 494.Infection prevention and control implementation at the health care facility level 534.1 Key messages 544.2 Implementation of the infection prevention and control core components 554.3 Infection prevention and control programme,human resources,and the built environment 624.4 Implementation of infection prevention and control guidelines,training and education 694.5 Implementation of infection prevention and control monitoring,audit and feedback,and antimicrobial resistance surveillance 714.6 Implementation of hand hygiene:global status 735.Regional focus:situation analysis,actions,gaps and challenges in the implementation of infection prevention and control 775.1 Key messages 785.2 Introduction 795.3 Main challenges 795.4 African Region 805.4.1 Situation analysis 805.4.2 Actions 865.5 Region of the Americas 875.5.1 Situation analysis 875.5.2 Actions 925.6 South-East Asia Region 945.6.1 Situation analysis 945.6.2 Actions 985.7 Eastern Mediterranean Region 1005.7.1 Situation analysis 1005.7.2 Actions 1055.8 European Region 1065.8.1 Situation analysis 1065.8.2 Actions 1115.9 Western Pacific Region 1125.9.1 Situation analysis 1125.9.2 Actions 1176.The way forward 119References 129Annex 1 145WHO recommendations and minimum requirements for the core components of infection prevention and control programmes,at national and health care facility level 146Annex 2 157Global actions and indicators for the WHO Secretariat and international and national stakeholders and partners in the context of the global action plan and monitoring framework on infection prevention and control 158Annex 3 165Country examples of implementation and progress in achieving the WHO core components for infection 166Turn Nigeria Orange:the birth of a strong infection prevention and control programme at national and facility level 166Leading with excellence-National infection prevention and control initiative on reducing central-line bloodstream infections in Saudi Arabia 170Global report on infection prevention and control 2024viForewordHealth care-associated infections(HAIs)affect patients and health systems every day,causing immense suffering,driving higher health-care costs and hampering efforts to achieve high-quality care for all.HAIs are often difficult to treat,are the major driver of antimicrobial resistance(AMR)and cause premature deaths and disability.The COVID-19 pandemic,as well as outbreaks of Ebola,Marburg and mpox are the most dramatic demonstrations of how pathogens can spread rapidly and be amplified in health care settings.But HAIs are a daily threat in every hospital and clinic,not only during epidemics and pandemics.Lack of water,sanitation and hygiene(WASH)in health care settings not only affects the application of infection prevention and control(IPC)best practices but also equity and dignity among both those providing and receiving care.However,there is strong evidence that a large proportion of these infections could be prevented with IPC measures and basic WASH services,with a high return on investment.This second global report on IPC provides updated evidence on the harm caused to patients and health workers by HAIs and AMR,and presents an updated global analysis of the implementation of IPC programmes at the national and health care facility levels across all WHO regions.The emerging picture is that HAIs continue to be among the most frequent adverse events in health service delivery,with the highest burden in low-and middle-income countries.Significant gaps and challenges remain,particularly in countries with limited resources,and some disinvestments from IPC and WASH have been noted as the COVID-19 pandemic has waned.On a positive note,based on key priorities and directions indicated in the 2022 report and the response to the COVID-19 pandemic,many countries have strengthened IPC programmes and the implementation of best practices.At the 77th World Health Assembly,WHO Member States adopted the first global strategy,action plan and monitoring framework on IPC,and established an accountability mechanism to track progress towards agreed targets up to 2030.WHO is supporting countries to achieve the 2030 targets,in collaboration with international and national partners and stakeholders.These joint efforts will make health systems safer and contribute to other major global health priorities.Strong IPC is essential for strong health systems and quality care,in emergencies and as part of every countrys journey towards universal health coverage.Dr Tedros Adhanom Ghebreyesus Director-General World Health OrganizationviiAcknowledgementsThe World Health Organization(WHO)gratefully acknowledges the many individuals and organizations who contributed to the development of this report.The development of the report was coordinated by the Department of Integrated Health Services(IHS),Universal Health Coverage and Life Course Division of the WHO.Benedetta Allegranzi(Department of IHS)coordinated the overall development process and was a co-writer of the document.Peter Bischoff(infection prevention and control(IPC)consultant,Department of IHS)co-led the writing of the document together with Benedetta Allegranzi.Sara Tomczyk(WHO Collaborating Centre,Robert Koch Institute,Berlin,Germany)and Annika Meinen(WHO Collaborating Centre,Robert Koch Institute,Berlin,Germany)carried out the statistical analyses for part of the data presented in this report.The following WHO staff and consultants provided input for Chapters 2,3,4,and 5 of the report:Anand Balachandran(Department of Surveillance,Prevention and Control,Antimicrobial Resistance Division);Yolanda Bayugo(Country Capacity Assessment and Planning,WHO Health Emergencies);Landry Cihambanya(WHO Regional Office for Africa,Brazzaville,Congo);Ana Paula Coutinho Rehse(WHO Regional Office for Europe,Copenhagen,Denmark);Shanlong Ding(Country Capacity Assessment and Planning,WHO Health Emergencies);Sergey Eremin(Department of Surveillance,Prevention and Control,Antimicrobial Resistance Division);Nikhil Prakash Gupta(Department of IHS);Iman Heweidy(WHO Regional Office for the Eastern Mediterranean,Cairo,Egypt);Richard Johnston(Department of Environment,Climate Change and Health,Healthier Populations Division);Zhao Li(WHO Regional Office for the Western Pacific,Manila,Philippines);Babacar Ndoye(IPC consultant,WHO Regional Office for Africa,Brazzaville,Congo);Pravarsha Prakash(Department of Surveillance,Prevention and Control,Antimicrobial Resistance Division);Pilar Ramon-Pardo(WHO Regional Office for the Americas,Washington,DC,United States of America);Giovanni Satta(Department of IHS);Aparna Singh Shah(WHO Regional Office for South-East Asia,New Delhi,India).WHO particularly acknowledges the written contribution to and approval of the country examples by the following individuals:Faisal Mohammed Alsheddi(General Directorate of IPC,Ministry of Health,Riyadh,Saudi Arabia);Nadeen Mahmoud Burhan(General Directorate of IPC,Ministry of Health,Riyadh,Saudi Arabia);Tochi Okwor(Nigeria Centre for Disease Control,Abuja,Nigeria).WHO extends its gratitude to the following external reviewers of this report:Anucha Apisarnthanarak(Thammasat University Hospital,Khlong Nueng,Thailand);Alessandro Cassini(Cantonal Service of Public Health,Geneva,Switzerland);Shaheen Methar(University of Stellenbosch and Infection Control Africa Network,Cape Town,South Africa);Tochi Okwor(Nigeria Centre for Disease Control,Abuja,Nigeria);Mauro Orsini(Ministry of Health,Santiago,Chile);Diamantis Plachouras(European Centre for Disease Prevention and Control,Stockholm,Sweden).All external experts mentioned completed a declaration of interest form in accordance with the WHO declaration of interests policy for experts.No potential conflicts were identified.Acknowledgements of financial and other supportCore funds from WHO headquarters and the WHO Hub for Pandemic and Epidemic Intelligence(Berlin,Germany)supported the development and publication of the report.Funding support from the Universal Health Coverage(UHC)Partnership,which includes contributions from Belgium,Canada,the European Union,Germany,France,Ireland,Japan,Luxembourg,the United Kingdom,and WHO,were also used for this report.Global report on infection prevention and control 2024viiiAbbreviations and acronymsAIDSacquired immunodeficiency syndromeAMRantimicrobial resistanceaORadjusted odds ratioBSIbloodstream infection(s)CAUTIcatheter-associated urinary tract infectionCC MRcore components minimum requirementsCDCUnited States Centers for Disease Control and PreventionCIconfidence intervalCLABSIcentral line-associated bloodstream infection(s)CROcarbapenem-resistant organisms(carbapenem-resistant Enterobacterales and/or Acinetobacter baumannii and/or Pseudomonas aeruginosa)CREcarbapenem-resistant EnterobacteralesDALYsdisability-adjusted life yearsEARS-NetEuropean Antimicrobial Resistance Surveillance NetworkECDCEuropean Centre for Disease Control and PreventionEU/EEAEuropean Union and European Economic AreaFAOFood and Agriculture Organization of the United NationsGAPglobal action planGATHERGuidelines for Accurate and Transparent Health Estimates ReportingGLAAS(United Nations)Global Analysis and Assessment of Sanitation and Drinking Water surveyGLASSGlobal Antimicrobial Resistance and Use Surveillance SystemHAIhealth care-associated infectionHAI-NetHealthcare-associated Infections Surveillance NetworkHHSAFHand Hygiene Self-Assessment FrameworkHIChigh-income countryHIVhuman immunodeficiency virusAbbreviations and acronymsixICUintensive care unitIHRInternational Health RegulationsIPCinfection prevention and controlIPCAFIPC Assessment FrameworkIQRinterquartile rangeJEEJoint External Evaluation(tool)JMPWHO/UNICEF Joint Monitoring Programme for Water Supply,Sanitation and HygieneLIClow-income countryLMIClow-and middle-income country MDRmultidrug-resistantMDROmultidrug-resistant organismsMFmonitoring frameworkMMISmultimodal improvement strategy(ies)MRSAmeticillin-resistant Staphylococcus aureusMSSAmeticillin-susceptible Staphylococcus aureusOECDOrganisation for Economic Co-operation and DevelopmentOIEWorld Organisation for Animal HealthORodds ratioPAHOPan American Health OrganizationPPEpersonal protective equipmentSDGsSustainable Development GoalsSOPstandard operating protocolsSPARStates Party Self-assessment annual reporting(tool)SSIsurgical site infectionTrACSSTracking AMR Country Self-assessment SurveyUIuncertainty intervalUNFPAUnited Nations Population FundUNICEFUnited Nations Childrens FundGlobal report on infection prevention and control 2024xVAEventilator-associated eventsWASHwater,sanitation and hygieneWASH FITWater and Sanitation for Health Facility Improvement ToolWHOWorld Health OrganizationGlossaryxiGlossaryAntimicrobial resistance(AMR)and use:AMR threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria,parasites,viruses and fungi.AMR occurs when bacteria,viruses,fungi and parasites change over time and no longer respond to medicines making infections harder to treat and increasing the risk of disease spread,severe illness and death.As a result,the medicines become ineffective and infections persist in the body,increasing the risk of spread to others.Antimicrobials-including antibiotics,antivirals,antifungals and antiparasitics-are medicines used to prevent and treat infections in humans,animals and plants.Microorganisms that develop antimicrobial resistance are sometimes referred to as“superbugs”(1).Country designations:WHO Member States are grouped into four income groups(low,lower-middle,upper-middle and high)according to the World Banks analytical classification of economies calculated using the World Bank Atlas method and based on the gross national income(GNI)per capita of each country.For the 2022 fiscal year,low-income countries(LICs)are defined as those with a gross national income(GNI)per capita of$1045 or less in 2020;lower-middle-income countries are those with a GNI per capita between$1046 and$4095;upper-middle-income countries are those with a GNI per capita between$4096 and$12 695;and high-income countries(HICs)are those with a GNI per capita of$12 696 or more.We use low-and middle-income countries(LMICs)to refer to a grouping of the first three income levels(i.e.,low-income,lower-middle-income and upper-middle-income countries)(2).Disability-adjusted life years(DALYs):One DALY represents the loss of the equivalent of one year of full health.DALYs for a disease or health condition are the sum of the years of life lost due to premature mortality(YLLs)and the years lived with a disability(YLDs)due to prevalent cases of the disease or health condition in a population(3).Hand hygiene:A general term referring to any action of hand cleansing,that is,the action of performing hand hygiene for the purpose of physically or mechanically removing dirt,organic material,and/or microorganisms(4).Health care-associated infection(also referred to as“nosocomial”or“hospital-acquired infection”):an infection acquired by a patient during the process of care(including preventive,diagnostic and treatment services)in a hospital or other health care facility,which was not present or incubating at the time of admission;HAIs can also appear after discharge.HAIs are also acquired by health workers during health care delivery,and by visitors(5).Infection prevention and control(IPC)minimum requirements:IPC standards that should be in place at both national and health facility level to provide minimum protection and safety to patients,health care workers and visitors,based on the WHO core components for IPC programmes.The existence of these requirements constitutes the initial starting point for building additional critical elements of the IPC core components according to a stepwise approach based on assessments of the local situation(6).IPC committee:A multidisciplinary group with interested stakeholders across the facility,which interacts with and advises the IPC team.For example,the IPC committee could include senior facility leadership;senior clinical staff;leads of other relevant complementary areas,such as biosafety,pharmacy,microbiology or clinical laboratory,waste management,water,sanitation and hygiene services and quality and safety,where in place(6).IPC professional:Health care professional(medical doctor,nurse,or other health-related professional)who has completed a certified postgraduate IPC training course,or a nationally or internationally recognized postgraduate course on IPC,or another core discipline including IPC as a core part of the curriculum as well as IPC practical and clinical training(7).Global report on infection prevention and control 2024xiiIPC link person:Nurse or doctor(or other health professional)in a ward or within the facility(for example,staff working in clinical services such as intensive care unit or maternal and neonatal care,or water,sanitation and hygiene or occupational health professionals)who has been trained in IPC and links to an IPC focal point/team at a higher level in the organization(for example,IPC focal point/team at the facility or district level).IPC is not the primary assignment of this professional but,among others,he/she may undertake tasks in support to IPC,including for example supporting implementation of IPC practices;providing mentorship to colleagues;monitoring activities;and alerting on possible infectious risks(7).IPC focal point:IPC professional(according to the above definition)appointed to be in charge of IPC at the national,sub-national or facility/organization level(7).Multimodal improvement strategy:A multimodal strategy comprises several components or elements(three or more,usually five)implemented in an integrated way with the aim of improving an outcome and changing behaviour.It includes tools,such as bundles and checklists,developed by multidisciplinary teams that take into account local conditions.The five most common elements include:(i)system change(availability of the appropriate infrastructure and supplies to enable infection prevention and control good practices);(ii)education and training of health care workers and key players(for example,managers);(iii)monitoring infrastructures,practices,processes,outcomes and providing data feedback;(iv)reminders in the workplace/communications;and(v)culture change within the establishment or the strengthening of a safety climate(6).Personal protective equipment(PPE):Equipment and/or clothing worn by personnel to provide a barrier against biological agents,thereby minimizing the likelihood of exposure.PPE includes,but is not limited to,laboratory coats,gowns,full-body suits,gloves,protective footwear,safety glasses,safety goggles,masks and respirators(8).Point of care:The place where three elements come together:the patient,the health care worker and care or treatment involving contact with the patient or his/her surroundings(within the patient zone)(4).Primary health care facilities:Facilities that provide outpatient services,family planning,antenatal care,maternal,newborn and child health services(including delivery),for example,health centres,health posts and small district hospitals(9).Secondary-level hospitals/health care facilities:Highly differentiated by its function with 5 to 10 clinical specialties;size ranges from 200 to 800 beds;often referred to as a provincial or district hospital(6).Tertiary-level hospitals/health care facilities:Highly specialized staff and technical equipment,for example,cardiology,intensive care unit and specialized imaging units;clinical services highly differentiated by function;may have teaching activities;size ranges from 300 to 1500 beds;often referred to as a teaching or university or regional hospital(10).Universal health coverage(UHC):UHC means that all individuals and communities receive the health services they need without suffering financial hardship.It includes the full spectrum of essential,quality health services,from health promotion to prevention,treatment,rehabilitation,and palliative care across the life course(11).GlossaryxiiiReferences for the glossary1.Antimicrobial resistance website.Geneva:World Health Organization;2022(https:/www.who.int/health-topics/antimicrobial-resistance,accessed 10 October 2024)2.World Bank Country and Lending Groups website.Washington(DC):World Bank;2022(https:/datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups,accessed 10 October 2024)3.The Global Health Observatory.Disability-adjusted life years(DALYs).In:Indicator metadata registry list.Geneva:World Health Organization;2015(https:/www.who.int/data/gho/indicator-metadata-registry/imr-details/158,accessed 10 October 2024).4.WHO guidelines on hand hygiene in health care.Geneva:World Health Organization;2009(https:/www.who.int/publications/i/item/9789241597906,accessed 10 October 2024).5.Adapted from Guidelines on core components of infection prevention and control programmes at the national and acute health care facility level.Geneva:World Health Organization;2016(https:/www.who.int/publications/i/item/9789241549929,accessed 10 October 2024).6.Minimum requirements for infection prevention and control programmes.Geneva:World Health Organization;2019(https:/apps.who.int/iris/handle/10665/330080,accessed 10 October 2024).7.Core competencies for infection prevention and control professionals.Geneva:World Health Organization;2020.(https:/iris.who.int/bitstream/handle/10665/335821/9789240011656-eng.pdf,accessed 10 October 2024).8.Personal protective equipment.Geneva:World Health Organization;2020(https:/apps.who.int/iris/rest/bitstreams/1323440/retrieve,accessed 10 October 2024).9.Water and sanitation for health facility improvement tool(WASH FIT).Geneva:World Health Organization;2017(https:/apps.who.int/iris/bitstream/handle/10665/254910/9789241511698-eng.pdf?sequence=1&isAllowed=y,accessed 10 October 2024).10.Alleyne G,Breman JG,Claeson M,Evans DB,Jamison DT,Jha P,Measham AR,Mills A,Musgrove P,editors.Disease control priorities in developing countries,second edition(English).Washington,D.C.:World Bank Group;2006(http:/documents.worldbank.org/curated/en/632721468313531105/Disease-control-priorities-in-developing-countries-second-edition,accessed 24 November 2024).11.Universal health coverage(UHC)website.Geneva:World Health Organization;2021(https:/www.who.int/news-room/fact-sheets/detail/universal-health-coverage-(uhc),accessed 10 October 2024).A vaccinator washes her hands before administering vaccines to the public at the launch of a vaccine campaign in Isinya,Kenya.WHO/Billy MiaronExecutivesummaryGlobal report on infection prevention and control 2024xviExecutive summary1.Purpose,target audience and methodsOver the last decade,major outbreaks such as those due to the Ebola and Marburg virus diseases,the COVID-19 pandemic and,more recently,monkeypox viral disease(mpox),have demonstrated how epidemic-prone pathogens can spread rapidly through health care settings.These events have exposed the gaps in infection prevention and control(IPC)programmes that exist,irrespective of the resources available or the national income level.Furthermore,every day across all health care systems worldwide,patients and health workers are affected by infections acquired during health care delivery,including those caused by antimicrobial-resistant microorganisms.IPC is a clinical and public health specialty,and a set of measures based on a practical,evidence-based approach.The aim of IPC is to prevent patients,health workers and visitors to health care facilities from being harmed by avoidable infections acquired during the provision of health care services(1).IPC occupies a unique position in the field of patient and health worker safety and quality of care as it is universally relevant to every health worker and patient at every care interaction.This Executive summary provides a synthesis of the 2024 World Health Organization(WHO)Global report on infection prevention and control.Notably,it highlights the burden of health care-associated infections(HAIs)and antimicrobial resistance(AMR)and the related harm to both patients and health workers in care settings.It presents also an updated global situation analysis of the implementation of IPC programmes at the national and health care facility levels,including a focus on the WHO regions.Finally,it highlights recent landmark political and implementation documents,which indicate directions,actions,indicators and targets for countries and the international IPC community to help them to progress in the implementation and improvement of IPC.The report and its Executive summary are primarily aimed at those in charge of making decisions and formulating policies in the field of IPC at national,subnational and facility levels.This includes policy-makers,senior managers,administrators who are managing health budgets,and IPC focal points at national(ministry of health,public health institutes,etc.),subnational and health care facility levels.The report is the result of a cross-cutting and multidisciplinary effort involving staff at WHO headquarters and in regional offices,as well as key partners in the field of IPC.It includes information and data from many sources,including the scientific literature,WHO global databases,WHO surveys using standardized tools,as well as WHO publications and reports published by other institutions.It also includes a compilation of data and information providing overviews of IPC at the global and regional levels and by country income level,with examples of IPC implementation at both country and facility level.Executive summaryxviiAlmost up to one third(30%)of patients in intensive care can be affected by HAIs,with an incidence that is two to 20 times higher in LMICs than in HICs,in particular among neonates(2,7).Approximately one in four(23.6%)of all hospital-treated sepsis cases are health care-associated and this increases to almost one half(48.7%)of all cases of sepsis with organ dysfunction treated in adult intensive care units(ICUs)(6,8).Based on data from 20222023,the European Centre for Disease Prevention and Control(ECDC)estimated that 4.8 million episodes of HAIs occur every year in patients admitted to acute care hospitals in EEA countries(5).The global number of HAIs resistant to antibiotics was estimated to be 136 million annually(9).?Abbreviations:HAI,health care-associated infection;LMICs,low-and middle-income countries;HICs,high-income countries;EU/EEA,European Union/European Economic Area.Source:(3,4,5).2.The problem of unsafe care resulting from HAIs and AMRHAIs are among the most frequent adverse events occurring in the context of health service delivery.These infections,many of which are caused by multidrug-resistant organisms,harm patients,visitors and health workers and place a significant burden on health systems,including the associated increased costs(2).On average,out of every 100 patients in acute-care hospitals,seven patients in high-income countries(HICs)and 15 patients in low-and middle-income countries(LMICs)will acquire at least one HAI during their hospital stay(3,4)(Fig.1).The most recent multi-country point prevalence survey conducted in 20222023 in 28 countries of the European Union and European Economic Area(EU/EEA)and three Western Balkan countries/territories estimated that eight out of every 100 patients had acquired at least one HAI during their hospital stay in acute care hospitals(5)(Fig 1).The prevalence of HAIs varies,depending on the study methods and the local situation.However,in most studies,HAI frequency is significantly higher in LMICs than in HICs(2,3,4,6).Fig.1.Average global percentage of patients with at least one HAI in acute care hospitals,20222023.Global report on infection prevention and control 2024xviii?Abbreviations:DALYs,disability-adjusted life years;HAIs,health care-associated infections;EU/EEA,European Union/European Economic Area;AMR,antimicrobial resistance.Source:(10,11).Mortality among patients infected with resistant microorganisms is at least two to three times higher than among those infected with sensitive microorganisms(4,12-17).According to recent WHO and OECD estimates2,globally,IPC interventions implemented in health care facilities using MMIS,with national coordination could potentially avert 821 000 deaths per year up to 2050(WHO/OECD unpublished data).Estimates suggested that improving IPC programmes in LMIC health care settings could prevent at least 337 000 AMR-associated deaths per year(18).Investment in AMR initiatives are estimated to avert up to 200 000 deaths annually in Africa,including 90 000 deaths among children under five years of age(19).The consequences of HAIs and AMR are severe,leading to prolonged hospital stays,long-term complications,disability and premature death.They also impose significant social and psychological burdens on patients,families and communities.For health systems,the burden translates into added overload and extra costs(2),(WHO,unpublished data).A pooled analysis revealed that health care-associated sepsis has a staggering impact on patient outcomes,with one in four affected individuals dying(24.4%).This figure rises dramatically to over one half(52.3%)when patients are treated in an ICU(6,8).Globally,according to the Organization for Economic Co-operation and Development(OECD)and WHO,nearly 3.5 million people can lose their lives due to HAIs every year up to 2050.This corresponds to 4.4 times the number of global deaths in 2021 due to human immunodeficiency virus(HIV)/acquired immunodeficiency syndrome(AIDS)and sexually transmitted diseases combined(WHO/OECD unpublished data).In EU/EEA countries,the burden of the six most frequent HAIs in terms of disability-adjusted life years(DALYs)1 was twice the burden of 32 other infectious diseases combined(10)(Fig.2A).Furthermore,it was estimated that 75%of the burden associated with AMR in terms of disabilities and premature mortality was due to HAIs(11)(Fig.2B).Fig.2.Burden of the six most frequent HAIs compared to 32 other infectious diseases in the EU/EEA(A);burden of AMR associated with HAIs(B)1 DALYs:years of life lost due to premature mortality and years lived with a disability resulting from a condition.2 For these calculations a modified version of the OECD Strategic Public Health Planning for infectious diseases model was used.OECD;2023(http:/oecdpublichealthexplorer.org/amr-doc/).Executive summaryxix3.Situation analysis of the implementation of IPC around the world3.1 IPC implementation at national levelIn 20232024,according to the system established to monitor the status of country progress towards the implementation of the AMR global action plan(the Tracking AMR Country Self-assessment Survey TrACSS),9%of countries did not yet have an IPC programme or plan(Fig.3,level A).Only 39%of countries had IPC programmes fully implemented nationwide(Fig.3,levels D and E),with some being monitored for their effectiveness(Fig.3,level E)(20).Fig.3.Country/area map of the 2024 TrACSS results according to levels A to E(indicator 3.5)The results of a detailed global survey on the minimum requirements for national IPC programmes carried out by WHO in 20232024 showed that an active national IPC programme(that is,a functioning programme with an annual workplan and budget)existed in 71.3%(107 of 150)of countries(WHO,unpublished data).Only 6%(9 of 150)of countries met all the WHO minimum requirements and 14%(21 of 150)met 90%at the national level(WHO,unpublished data)(Fig.4).Abbreviations:TrACSS,Tracking AMR Country Self-Assessment Survey;IPC,infection prevention and control.Map creation date:04 October 2024.Map production:WHO Geographic Information Systems(GIS)Centre for Health,Department of Data and Analytics(DNA)within the Division of Data,Analytics and Delivery for Impact(DDI).Source:(20).A.No national infection prevention and control(IPC)programme or operational plan is available.B.A national IPC programme or operational plan is available.National IPC and water,sanitation and hygienea(WASH)and environmental health standards exist but are not fully implemented.C.A national IPC programme and operational plan are available and national guidelines for health care IPC are available and disseminated.Selected health facilities are implementing the guidelines,with monitoring and feedback in place.D.A national IPC programme available,according to the WHO IPC core components guidelines and IPC plans and guidelines implemented nationwide.All health care facilities have a functional built environment(including water and sanitation),and necessary materials and equipment to perform IPC,per national standards.E.IPC programmes are in place and functioning at national and health facility levels,according to the WHO IPC core components guidelines.Compliance and effectiveness are regularly evaluated and published.Plans and guidance are updated in response to monitoring.Data not availableNot applicable0250050001250kmGlobal report on infection prevention and control 2024xxThis survey showed areas of advanced implementation and gaps for further improvement in national IPC programmes.Significant discrepancies were observed across income levels,with HICs generally reporting better implementation,but gaps remaining in budget allocation,training,HAI surveillance and monitoring systems,especially in LICs.High level of implementation Guideline development:approximately 9 out of 10 countries(90.76 of 150)have mandates to produce guidelines for preventing HAIs.Among these,88%of countries(132 of 150)reported to use evidence-based,scientific knowledge in the development of IPC guidelines and 82%(123 of 150)actively addressed guideline adaptation to local conditions.Multimodal improvement strategies(MMIS):approximately 7 out of 10 countries(71.37 of 150)have trained IPC focal points and 75.3%(113 of 150)promote multimodal strategies.HICs show high implementation,with 72.9%(35 of 49)having trained IPC focal points and 83.3%(40 of 49)promoting MMIS.Gaps needing improvement Budget allocation:fewer than one half(44f of 150)of countries have a dedicated IPC budget and only 33%in LICs(8 of 24).Training and education:while in more than 8 out of 10 countries(81.32 of 150)the national IPC programme provides content for IPC training,only 38%(57 of 150)have a national IPC curriculum,indicating a need for broader training programmes.HAI surveillance:just over one half(53.3 of 150)of countries have a multidisciplinary technical group for HAI surveillance,but LICs lag notably,with only 25%(6 of 24)having established such a group.Monitoring and evaluation:slightly more than one half(51.3w of 150)of countries have a strategic plan and system for IPC monitoring,with HICs leading at 58.3%(28 of 49)and lower proportions in LICs(45.8 of 24).Fig.4.Proportion of countries meeting IPC minimum requirements by World Bank income level,202320240%Pu0%Met 50%of CC MRMet 90%of CC MRMet 100%of CC MRProportion(%)of countriesTotalLow incomeLower middle incomeUpper middle incomeHigh incomeAbbreviations:CC MR:core components minimum requirements.Source:WHO global survey on IPC minimum requirements at the national level,20232024(WHO,unpublished data).Executive summaryxxiNumbers are percentages of countries(N=194)reporting levels A to E for that survey year.Abbreviations:IPC,infection prevention and control;TrACSS,Tracking AMR Country Self-assessment Survey.Source:(20).Striking differences in the implementation of IPC at national level were observed across World Bank country income levels across all surveys and data sets mentioned in this report,with low-and lower middle-income countries,significantly less advanced than other income levels(Fig.4).A review of data from TrACSS(20)over the past seven-year period(20182024)showed slow progress in IPC globally.However,a steady increase in the proportion of countries implementing national IPC programmes nationwide(levels D-E)was observed between 2020(26%)and 2024(37%)(Fig.5,solid red line).Fig.5.IPC programme levels according to TrACSS results,2018202412 ()!# %9%9%7%9%7%8%8#0%9%5%# 18201920202021202220232024Seven-year trend:national IPC programmes(%of N=194)EDCBANo responseCountries with nationwide implementationof national IPC programmes(D-E)26)257%3.2 IPC implementation at health care facility levelIn the WHO global survey conducted in 20232024,only 15.8%of 5537 participating health care facilities met all WHO IPC minimum requirements,but 34%met 90%(WHO,unpublished data)(Fig.6).Notable differences in the level of implementation of IPC programmes were observed according to the country income level(Fig.6).Overall,among primary,secondary and tertiary care facilities,75.5%of facilities met at least 50%of the IPC minimum requirements,while 15.8%fulfilled all of them.In LICs,only 35.7%of facilities met at least 50%of requirements,and a mere 0.6%met all of them.In contrast,HICs showed a much higher rate of meeting the requirements,with 98.8%meeting at least 50%and 27.9%fulfilling all requirements(WHO,unpublished data).Global report on infection prevention and control 2024xxiiFig.6.Proportion of facilities meeting IPC minimum requirements by World Bank income level,202320240%Pu0%Met 50%of CC MRMet 90%of CC MRMet 100%of CC MRTotalLow incomeLower middle incomeUpper middle incomeHigh incomeProportion(%)of countriesAbbreviations:CC MR:core components minimum requirements.Source:WHO global survey on IPC minimum requirements at the national level,20232024(WHO,unpublished data).HICs were more advanced in the implementation of all IPC core components,while LICs had a notably limited implementation of IPC guidelines,training and education,monitoring,audit,feedback and HAI surveillance(WHO,unpublished data).Even where IPC programmes exist,they are often not able to function appropriately and sustainably in an enabling environment.In 2019,IPC programmes existed in almost all secondary and tertiary health care facilities(21).However,particularly in LMICs,the facilities lacked full-time IPC professionals,an allocated IPC budget,routine microbiological laboratory support,and appropriate workload,staffing and bed occupancy.This is still the case with respect to overall scores on the implementation of IPC minimum requirements in 20232024,highlighting the ongoing disparity in IPC programme effectiveness and resource availability between different income levels.In particular,this is evident regarding human and financial resources dedicated to IPC.Conversely,the median scores for HAI surveillance and IPC monitoring were very high in tertiary and secondary health care facilities.However,the WHO minimum requirements for HAI surveillance are not demanding as they cover only having a strategic plan and not a system for HAI surveillance.Despite the surge in response to the COVID-19 pandemic,not all essential IPC human resources,supplies and products are available in 20232024.For example,a lack or limited availability of personal protective equipment was reported in four WHO pulse surveys on the continuity of essentiaal health services during the COVID-19 pandemic(22-25).In these surveys,conducted in 2020 and repeated until the first quarter of 2023,up to 65%of countries cited the lack of IPC supplies and a poor application of best practices as major reasons for the disruption of essential health services(26).As a sign of recovery of the health systems in the fourth survey round in 2023,only 24%(23 of 93 countries)reported disruption to their in-country supply chain system,a decrease from almost 50%in the fourth quarter of 2021(25).Executive summaryxxiiiIn the 20232024 WHO global survey on IPC minimum requirements,65.6%of primary facilities,75.4%of secondary facilities,and 83.2%of tertiary facilities reported having sufficient personal protective equipment,with significant differences across income levels(WHO,unpublished data).The 2024 report by the WHO/United Nations Childrens Fund(UNICEF)Joint Monitoring Programme(JMP)for Water Supply,Sanitation and Hygiene provided a striking picture(2022 data;(27):1.7 billion people were using health care facilities that lack basic water services and 697 million were using facilities with unimproved toilets or no toilets.Yet,implementing water,sanitation and hygiene(WASH)services in health care facilities across the 46 least-developed countries would require a relatively modest investments(US$6.5 to US$9.6 billion until 2030)(28).In the 20232024 WHO global survey,74.7%,83.3%and 85.4%of primary,secondary and tertiary care facilities,respectively,reported having continuously available water services,with HICs always reporting 100%availability and significant differences with other income levels.Appropriate hand hygiene can save lives.Such hand hygiene practices prevent infections,generate economic savings and are therefore a minimum requirement for IPC in all health care facilities.In 2019,the WHO global survey on hand hygiene programmes in 3206 health care facilities in 90 countries showed an intermediate implementation level(350 of 500 points)overall,with significant differences according to the income level of participating countries(“advanced”in HICs and“basic”in LICs),showing a disparity between hand hygiene practice implementation in resource-rich and resource-poor settings(29).The 2024 JMP report revealed that globally,about two out of five(43%)health care facilities lacked hand hygiene services(either soap and water or alcohol-based handrubs)at the point of care or at toilets(27).This translated to 3.4 billion people using health care facilities that lacked basic hygiene services(hand hygiene facilities at points of care and toilets).However,in the facilities included in the WHO 20232024 global survey,75.2%,81%and 84.2%of primary,secondary,and tertiary health care facilities,respectively,reported having functioning hand hygiene stations at all points of care,with significant differences between HICs and LICs(WHO,unpublished data).This difference with JMP data may depend on the differences in the study sample and the fact that facilities participated in the WHO global survey on IPC on a voluntary basis and might be more advanced in IPC than others.Global report on infection prevention and control 2024xxiv3.3 IPC implementation at the regional levelSince the COVID-19 pandemic,countries have demonstrated recognition of the critical role played by IPC during public health emergencies and a strong commitment to sustain IPC policies and practices.Overall,the strengthening of IPC programmes and implementation of best IPC practices have accelerated across all regions.However,significant gaps and challenges still remain,especially regarding those elements of IPC programmes that require investments and long-term sustainability.All WHO regional and country offices have been using a uniform approach to support countries in capacity building and progressing IPC action.This relies on joint assessments of the status of IPC programmes and IPC interventions with local authorities and partners,plan development,including impact and sustainability evaluations using a quality improvement cycle and a step-wise approach,as well as MMIS.The 20232024 WHO global survey on IPC minimum requirements at the national level revealed some differences across WHO regions in the implementation of IPC core components(WHO,unpublished data).Improvements were reported by countries,particularly in the following areas:having an appointed IPC-trained national focal point;updating and further developing evidence-based,national IPC guidelines according to international standards;local adaptation of guidelines and implementation through standard operating procedures;and establishing hand hygiene compliance as a key national indicator.Some significant gaps remained across WHO regions in the implementation of IPC core components.In particular,securing dedicated budgets,ensuring operational IPC programmes at national and facility levels,evaluation of training effectiveness,the use of results for targeted improvements in IPC,and the improvement of HAI surveillance and monitoring systems.These gaps were particularly evident in the African Region,especially concerning financial and human resources and national strategic plans for HAI surveillance and IPC monitoring.Although the overall scores were higher,a similar situation was reported in the Eastern Mediterranean Region regarding the gaps.The Region of the Americas reported remarkable improvements in several core components compared to data collected in 20212022,but only very rare availability of a curriculum for IPC in-service training.The most frequent gaps in the South-East Asia Region were a lack of a dedicated budget,an in-service training curriculum for IPC,and strategic plans for HAI surveillance.In the Western Pacific and European Regions,strong improvements were recently achieved.However,gaps still exist in the minimum requirements related to training in the Western Pacific Region,and a lack of active national IPC programmes with a dedicated budget and national guidelines in the European region.In 2023,the global average for IPC capacity assessed through the States Parties Self-assessment annual reporting(SPAR)tool remained at the same level as in previous years.However,among the WHO regions,the South-East Asia Region reported an increase in capacity level over the years while the Western Pacific Region reported a decrease.Overall,the European Region showed the highest and the African Region the lowest capacity levels(30)(Fig.7).Executive summaryxxv3545556575202120222023Average score per SPAR indicator for IPC C.9 GlobalAfrican RegionRegion of the AmericasSouth-East Asia RegionEastern Mediterranean RegionEuropean RegionWestern Pacific RegionAbbreviations:IPC,infection prevention and control;SPAR:State Party self-assessment annual reporting(tool).Source:(30).Fig.7.Average score per SPAR indicator for IPC(C.9)globally and per WHO region,20212023Global report on infection prevention and control 2024xxvi4.The way forwardThe report provides a situation analysis of the status of IPC programmes worldwide and highlights that although some progress has been made,several gaps in implementation still exist.Furthermore,some improvements achieved during the COVID-19 pandemic may have been recently lost,due to disinvestment from IPC and WASH and reallocation of resources and funds to other areas.Significant and striking differences emerge in IPC capacity and progress between LICs and LMICs and other income levels across all data sets on IPC indicators at the national and facility level.The 2022 edition of the report(2)highlighted the call for action made by the WHO Global IPC Network since 2017(31)and indicated key priorities and directions.Based on these and lessons learned during the COVID-19 pandemic,Member States have made unprecedented steps forward in the past two years in recognizing and elevating the importance of IPC in the global and national health agenda.A resolution focusing on IPC as a critical priority across the continuum of the health system was adopted at the 75th World Health Assembly(32)in 2022,requesting the development of a global strategy,action plan and monitoring framework on IPC.One year later,the first ever WHO global strategy(33)was approved by all Member States and served as the backbone of the 20242030 WHO global action plan and monitoring framework(GAP/MF)(34)adopted by all countries at the 77th World Health Assembly in May 2024(35).The strategy is underpinned by an ambitious,yet inspirational vision.By 2030,everyone accessing or providing health care is safe from associated infections.Eight strategic directions are indicated in the WHO global strategy as being critical to achieve improvement in IPC(Fig.8).The GAP/MF describes actions,indicators and targets to achieve the effective implementation of these strategic directions and to track and report progress over time between 2024 and 2030 at the global,national,subnational and facility level.The GAP/MF primarily targets those responsible for developing plans and implementing action on IPC at the national and health care facility level and is aimed at guiding and supporting them.Within the WHO MF,eight targets have been prioritized to be achieved at national level and four at facility level(Table 1).These targets can mostly be monitored using existing monitoring systems.The achievement of the WHO IPC minimum requirements should be an urgent priority for all countries and health care facilities in order to provide minimum protection and safety to patients,health and care workers,as well as families and visitors to facilities,and achieve targets for AMR reduction.Executive summaryxxviiTable 1.Core targets of the IPC MF at the global and national levelFig.8.Strategic directions as the overall guiding framework of the WHO global strategy and action plan on IPC.IPC knowledge of health and care workers and careerpathways for IPCprofessionalsActive IPCprogrammesAdvocacy and communicationsCollaboration and stakeholders supportPoliticalcommitment and policiesIPC integrationand coordinationDatafor actionResearchand developmentSource:(33).Eight core targets at global level 1.Increase of proportion of countries with a costed and approved national action plan and monitoring framework on IPC.2.Increase of proportion of countries with legislation/regulations to address IPC.3.Increase of proportion of countries having an identified protected and dedicated budget allocated to the national IPC programme and action plan.4.Increase of proportion of countries meeting all WHO IPC minimum requirements for IPC programmes at national level(through WHO global IPC portal).5.Increase of proportion of countries with national IPC programmes at levels 4 or 5 according to SPAR C.9.1 and levels D and E in TrACSS.6.Increase of the proportion of countries with(1)basic water,(2)sanitation,(3)hygiene,and(4)waste services in all health care facilities.7.Increase of proportion of countries that have achieved their national targets on reducing HAIs.8.Increase of proportion of countries with a national HAI surveillance system.Global report on infection prevention and control 2024xxviiiAbbreviations:HAI,health care-associated infections;IPC,infection prevention and control;MF,monitoring framework;SPAR,States Party Self-assessment annual reporting tool;TrACSS,Tripartite AMR Country Self-assessment Survey;WASH,water,sanitation and hygiene;AMR,antimicrobial resistance.a Reflecting progress at national level.b Reflecting progress at facility level.Source:(34).Significant investments are required by all countries to achieve these targets and resource mobilization is also needed for stakeholders supporting them.However,compelling data demonstrate that a high return can derive from investments in IPC,both in terms of lives saved and economic gains(2,18,28),(WHO,unpublished data).WHO,at the global,regional and country levels,is at the forefront to support all countries in this endeavour.Action and investment by other international key players,donors and nongovernmental organizations will also make a huge difference both at the global level and for countries and facilities,in particular where resources and expertise are limited.Four core targets at national level 1.Increase of proportion of facilities meeting all WHO IPC minimum requirements for IPC programmes.2.Increase in the proportion of facilities with a dedicated and sufficient funding for WASH services and activities.3.Increase of proportion of facilities providing training to all frontline clinical and cleaning staff upon employment and annually and to managers upon employment.4.Increase of proportion of tertiary/secondary health care facilities having an HAI and related AMR surveillance system.Executive summaryxxixReferences1.Core competencies for infection prevention and control professionals.Geneva:World Health Organization;2020(https:/apps.who.int/iris/handle/10665/335821,accessed 8 November 2024).2.Global report on infection prevention and control.Geneva:World Health 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Organization;2022(https:/apps.who.int/gb/ebwha/pdf_files/WHA75/A75_ACONF5-en.pdf,accessed 8 November 2024).33.Global strategy on infection prevention and control.Geneva:World Health Organization;2023(https:/iris.who.int/handle/10665/376751,accessed 8 November 2024).34.Global action plan and monitoring framework on infection prevention and control(IPC),20242030.Geneva:World Health Organization;2024(https:/www.who.int/teams/integrated-health-services/infection-prevention-control/draft-global-action-plan-and-monitoring-framework-on-ipc#cms,accessed 8 November 2024).35.Decision WHA77(9).Global action plan and monitoring framework on infection prevention and control.Seventy-seventh World Health Assembly,27 May 1 June 2024.Geneva:World Health Organization;2024(https:/apps.who.int/gb/ebwha/pdf_files/WHA77/A77_(9)-en.pdf,accessed 8 November 2024).Nurses and their trainer gather after a training session at a primary healthcare centre in Tajikistan.WHO/Lindsay MackenzieIntroduction,methods and target audienceChapter 1.Global report on infection prevention and control 20242 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References AnnexesChapter 1.Introduction,methods and target audience1.1 What is infection prevention and control?Infection prevention and control(IPC)is a clinical and public health specialty and a set of measures,based on a practical,evidence-based approach.The aim of IPC is to prevent patients,health workers and visitors to health care facilities from being harmed by avoidable infections acquired during the provision of health care services,including those caused by antimicrobial-resistant pathogens and spreading through outbreaks(1).Effective IPC interventions provide timely,efficient and compassionate interventions integrated within clinical pathways.IPC occupies a unique position in the field of patient and health workers safety and quality of care as it is universally relevant to every health worker and patient at every health care interaction.IPC is based on a scientific approach grounded in infectious diseases,epidemiology,social and implementation science,engineering,and health system strengthening.Therefore,all persons involved in the IPC programme at the national,subnational(regional)and facility level must be competent,with the required knowledge,skills and attitudes to be able to practice clinical duties safely and ethically and promote the necessary multidisciplinary interactions(1).IPC is a proven and cost-effective approach to prevent the transmission of infectious hazards,but applying it requires programmatic,institutional,financial and knowledge support.Effective IPC requires constant and sustained action at all levels of the health system,ranging from policy-makers to facility managers,health workers and other relevant stakeholders,as well as all those who access health services,and their family members.Moreover,IPC is a cornerstone of health system resiliency and preparedness.The COVID-19 pandemic and other large-scale public health emergencies demonstrated not only the importance of protecting health workers and patients through IPC,but also the central role of health care facilities in the control of emerging infectious diseases and protecting communities.In 2016,the World Health Organization(WHO)issued comprehensive,evidence-based and consensus-based guidelines on the core components for effective IPC programmes,including 11 recommendations and three good practice statements(2).Six core components are recommended at the national and facility levels(2,3),with two additional core components specific to the facility level(2,4)(Fig.1.1).Recognizing that the fulfilment of all IPC core components takes time and that countries may be at different stages of progress with different capacities,available opportunities and resources,WHO established a set of international IPC minimum standards by developing minimum requirements for IPC programmes in 2019(5).These were directly derived from the IPC core components through a consensus-building process involving IPC stakeholders,experts and field implementers from around the world.Chapter 1.Introduction,methods and target audience3 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References AnnexesFig.1.1.The WHO core components of IPC programmes at the national and facility levelSource:(3).The minimum requirements represent the starting point for undertaking the journey to build strong and effective IPC programmes at the national,subnational and facility levels(Fig.1.2.)and should be in place in all countries and health care facilities to support further progress towards full and sustained implementation of all IPC core components(2)(Annex 1).In particular for countries where IPC measures are limited or non-existent,it is critical to start by ensuring that at least minimum requirements for IPC(5)are in place as soon as possible,both at the national and facility level.Countries can then gradually progress to the full achievement of all requirements of the IPC core components(2)according to local priority plans(Annex 1).Since May 2024,the WHO IPC core components and minimum requirements have been endorsed by all countries as the basis and targets for the actions and indicators of the 20242030 WHO global action plan and monitoring framework(GAP/MF)for IPC(6),adopted at the 77th World Health Assembly(7).Whether applying the minimum requirements or full requirements,the implementation of the IPC core components should always be undertaken using a stepwise approach,based on a careful assessment of the status of the IPC programme and local activities and conditions.To undertake this process,WHO proposes a five-step implementation cycle(3)(Fig.1.3.)to support any IPC improvement intervention or programme,based on implementation and quality improvement science.M5.ULTIMODAL STRATEGIES3.EDUCATION AND TRAINING2.GUIDELINES6.MONITORING,AUDIT AND FEEDBACK4.SURVEILLANCEENABLING ENVIRONMENT8.BUILT ENVIRONMENT,MATERIALS AND EQUIPMENT7.WORKLOAD,STAFFING AND BED OCCUPANCYand all relevant programme linkages1.IPC PROGRAMMESGlobal report on infection prevention and control 20244 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References AnnexesFig.1.2.Minimum versus full requirements to achieve effective IPC programmesFig.1.3.The five-step implementation cycle for IPC improvementMultidisciplinaryteamStep 5Sustaining theprogrammeover the long termStep 1Preparing foractionStep 2BaselineassessmentStep 3Developingand executingan action planStep 4EvaluatingimpactMultimodalimprovement strategyembedded within each stepin the cycle ofcontinuousimprovementSource:(5).Source:(8).Detailed guidance on the implementation of the WHO core components and minimum requirements is provided by WHO through multiple manuals and tools,including standardized assessments tools for the national and facility levels(3,4,9-15).Based on compelling evidence and WHO research,especially in the field of hand hygiene,multimodal improvement strategies(MMIS)are a central pillar of both WHO core components and minimum requirements(2,16-23)and are recognized as the gold standard approach to implementing IPC interventions at the point of care.In other words,the use of a MMIS is considered the best way to achieve the system and behavioural change and institutional climate that support sustainable IPC progress and,ultimately,the measurable impact that benefits patients and health workers.Chapter 1.Introduction,methods and target audience5 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References Annexes1.2 Purpose and target audience of this reportThis global report is an update of the previous edition issued in 2022(8)and provides a snapshot of the implementation of these WHO recommendations and standards aimed at making health care settings a safe environment through best practices in IPC,including water,sanitation and hygiene(WASH)and waste management.This report aims to provide:an overview of the problem of health care-associated infections(HAI)and antimicrobial resistance(AMR)associated with health care delivery and a global situation analysis of the implementation of IPC policies at national and facility level,including WASH;a deep-dive into the current level of IPC implementation and suggestions for priority actions accordingly for each WHO region.strategic directions,actions,indicators and targets included in recent landmark political and implementation documents,for countries and the international IPC community to progress in the implementation and improvement of IPC.Among the highest priorities for the future,the report highlights the importance of the alignment and coordination of IPC with wider efforts on WASH,AMR,health emergencies and quality and safety in order to harness the combined policy,implementation and financing efforts of key stakeholders.Primarily,this document targets those in charge of making decisions and formulating policies in the field of IPC at the national,subnational and facility levels.These include policy-makers,senior managers,and administrators who are managing health budgets,as well as IPC focal points at national(ministry of health,public health institutes,etc.),subnational and health care facility levels.It is also aimed at professionals with the mandate to develop and implement national action plans for combating AMR,setting national strategic directions for quality health services,promoting patient safety,and those responsible for preparing and responding to public health emergencies in the context of the International Health Regulations(IHR 2005)(24).This report should also be helpful to other stakeholders,including those responsible for the following areas:IPC and quality of care at facility level;health facility accreditation/regulations;occupational health;public health;infectious disease control and surveillance;WASH;antimicrobial stewardship programmes;clinical microbiology and environmental health interventions;as well as additional categories of health workers involved in care delivery.It also targets health leaders and technical staff in international organizations,nongovernmental organizations,donor organizations and foundations in global health,and other civil society actors.Two country examples are included in this report with the aim to cover the national and the facility/point of care level.The first example illustrates progress at the national level in the implementation of a comprehensive strategy to improve IPC in line with the WHO global strategy.The second describes a national and facility initiative with a demonstrated impact on HAI reduction at the point of care(Annex 3).Global report on infection prevention and control 20246 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References AnnexesThis report does not specifically address antimicrobial stewardship,although it plays an essential role,complementary to IPC,in the context of critical strategies to reduce AMR and requires specific interventions and approaches(25).1.3 Data sources and methodologiesThis report is the result of a cross-cutting and multidisciplinary effort involving WHO headquarters and regional offices.It collates information and data from many sources,including the scientific literature,WHO global monitoring systems,national surveys and studies,and reports by other institutions.It reports assessments of IPC indicators made using WHO standardized data collection tools and systems that are completed regularly,either at the national or at the facility level,such as those monitoring national action plans for AMR and patient safety,essential health services,and preparedness for health emergencies or in response to outbreaks.Data are also included from detailed WHO global surveys of national or facility IPC and hand hygiene programmes using standardized tools.Evaluations were performed through either self-or joint assessments led by the countries with the support of WHO and/or other stakeholders.The relevant scientific literature on the epidemiology and burden of infection in health care was identified through rapid reviews(WHO,unpublished).Results were derived from published documents or articles and from ad hoc analyses of relevant WHO unpublished data.Specific checklists were developed for unpublished data,according to the Guidelines for Accurate and Transparent Health Estimates Reporting(GATHER)best practices in reporting health estimates(26).The country examples were identified based upon published and unpublished evidence of dedicated specific efforts to develop and implement successful IPC strategies and activities.Furthermore,they were identified in agreement with the respective WHO regional and country offices and each country example was reviewed and approved by the ministry of health.A COVID-19 patient is treated at the isolation centre in a hospital in Misrata,Libya.WHO/Blink Media-Nada HaribThe problem of unsafe care resulting from HAIs and AMRChapter 2.Global report on infection prevention and control 202410 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References AnnexesChapter 2.The problem of unsafe care resulting from HAIs and AMR2.1 Key messages HAIs,many of which are caused by multidrug-resistant organisms,harm patients,visitors and health workers and are a significant burden to health systems,including the associated increased costs.HAIs represent one of the most frequent adverse events during health care delivery.Epidemic-prone pathogens,such as SARS-CoV-2,can spread through health care facilities and amplify outbreaks,involving also health workers due to exposure during care delivery.No country or health system,regardless of the level of development,can claim to be free of HAIs.On average,out of every 100 patients in acute care hospitals,seven patients in high-income countries(HICs)and 15 patients in low-and middle-income countries(LMICs)will acquire at least one HAI during their hospital stay.The most recent multi-country point prevalence survey conducted in 2022/2023 in 28 countries of the European Union and European Economic Area(EU/EEA)and three Western Balkan countries/territories estimated that,eight out of every 100 patients had acquired at least one HAI during their hospital stay in acute care hospitals.According to a key review in 2005,almost up to one third(30%)of patients in intensive care can be affected by HAIs,with an incidence that can be two to 20 times higher in LMICs than in HICs.This is particularly true among neonates.Approximately one in four(23.6%)of all hospital-treated sepsis cases are health care-associated.Almost one half(48.7%)of all cases of sepsis with organ dysfunction treated in adult intensive care units(ICU)are hospital-acquired.A pooled analysis revealed that healthcare-associated sepsis has a staggering impact on patient outcomes,with one in four affected individuals dying(24.4%).This figure rises dramatically to over half(52.3%)when patients are treated in an ICU.According to the European Centre for Disease Control and Prevention(ECDC),in EU/EEA countries,the burden of the six most frequent HAIs in terms of disability and premature mortality accounts for twice the burden of 32 other infectious diseases under surveillance,including influenza and tuberculosis.Increasing resistance to antimicrobials among various pathogens are making infections harder to treat and increase the risk of death.The global number of hospital-associated infections resistant to antibiotics was estimated to be 136 million annually.In countries across the EU/EEA,the most severe antimicrobial-resistant infections,which pose the highest risk of mortality,are typically acquired during hospitalization.Indeed,it was estimated that three quarters of the burden of AMR in terms of disability and premature mortality is due to HAIs.11 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References Annexes Chapter 2.The problem of unsafe care resulting from HAIs and AMR Mortality rates among hospitalized patients infected with resistant microorganisms are two to three times higher compared to those infected with susceptible ones.In 2019,it was estimated that bacterial AMR contributed to 4.95 million deaths globally,with 1.27 million directly attributable to AMR,and the greatest burden was observed in western sub-Saharan Africa.Notably,five out of six leading AMR pathogens responsible for this burden were predominantly health care-associated.According to new estimates by the Organization for Economic Co-operation and Development(OECD)and WHO,nearly 3.5 million people could lose their lives due to HAIs every year up to 2050.2.2 How frequent are infections acquired in health care?HAIs are a consequence of not only poor quality care,but also of increasingly advanced care without proper safety programmes.They can be a deadly cause of harm and a serious threat to patient and health worker safety.It is estimated that more than one in ten patients suffer from adverse events as a result of unsafe health care(27).As much as 12%of harm is estimated to cause permanent disability or patient death and,globally,unsafe care is estimated to cause more than 3 million deaths every year(28).People in LMICs are disproportionately affected,with an estimated 134 million adverse events contributing to approximately 2.6 million deaths each year in these countries as a result of unsafe health care(29).In 2009,Jha and colleagues estimated that there were 117.8 and 203.1 million hospitalizations in HICs and LMICs,respectively,and an overall incidence rate of adverse events of 14.2%and 12.7%,respectively,for a total of 42.7 million adverse events worldwide(30).The 2011 Ibero-American Study of Adverse Events estimated that the incidence of adverse events in Argentina,Colombia,Costa Rica,Mexico and Peru was 20%(31).Another study of adverse events in LMICs found that the adverse event rate varied by country,ranging from 2.5%to 18.4%.Some 30%of adverse events were associated with the death of the patient in 2012(32).According to a review published in 2018,HAIs were the third most frequent adverse event globally(33).Surgical errors were the most frequent,accounting for 40%of all adverse events(33).In the African Surgical Outcomes Study,infection was found to be the most frequent complication of surgery(34).Regarding adverse events,up to 83%(with an average of 51%)were highly preventable(33).Global estimates of HAI frequency are hampered by the lack of HAI surveillance systems in many countries,especially in LMICs.These estimates also suffer from underreporting,poor data quality,and a lack of standardization of methods and protocols.In 2010,WHO estimated that an average of seven patients acquire at least one HAI in acute care hospitals in HICs,while 15 patients acquire at least one HAI in LMICs(35,36).Global report on infection prevention and control 202412 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References AnnexesEvidence from WHO(35,36)and other studies,including recent ones,showed that the frequency of HAIs varies between countries and is often associated with the country income level or local economic conditions.In 2023,a large systematic review including 400 studies from around the world estimated the overall prevalence of HAIs to be 14%(95%confidence interval CI,12 15)and also provided estimates by WHO region(Fig.2.1)(37).While the estimates of this systematic review can be useful to understand the magnitude of the problem of HAIs,any comparisons between regions and countries should be made with caution as the studies included in the review and meta-analyses may have used different methods and a number of factors are known to influence the results depending on the local situation.Primary multicentre or multi-country prevalence or incidence surveys on HAI are conducted very rarely.The ECDC has been providing solid methods and coordinating mechanisms for such studies across EU/EEA countries since more than a decade through the Healthcare-associated Infections Surveillance Network(HAI-Net)(38).The most recent European point prevalence survey was conducted in 2022/2023 in 28 EU/EEA countries and three Western Balkan countries/territories and estimated the adjusted prevalence of patients with at least one HAI at 8.0%(95%CI,6.69.6)(Fig.2.1)(39).In the previous ECDC point prevalence survey carried out in 2016 to 2017,HAI prevalence was at 6.5%(cumulative 95%CI,5.47.8)(40).In 2017,ECDC calculated that 4.5 million episodes of HAIs occurred in patients admitted to acute care hospitals(a total of 8.9 million when also accounting for long-term care facilities)in EU/EEA countries(40).This number has not substantially changed in recent ECDC estimates related to the period 20222023(39),which reported 4.8 million HAIs(infection episodes)per year,with an estimated 93 305 patients with at least one HAI on any given day in acute care hospitals in EU/EEA countries.In 2011,ECDC estimated 91 310 attributable deaths to have occurred in acute care hospitals(41).A multi-country prevalence survey of HAIs in the WHO Eastern Mediterranean Region showed a HAI prevalence of 11.2%(42).The above-mentioned more recent review(37)included 103 studies from that region and estimated a similar overall pooled prevalence of HAIs of 12.5%(95%CI,9.815.9).According to a systematic review published in 2015(43)and the above-mentioned more recent review(37),the pooled prevalence of HAIs in the WHO South-East Asia Region was estimated to be 9.0%(95%CI,7.210.8)and 12.9%(95%CI,8.6 18.8),respectively.Forty-four studies from the Western Pacific Region were included in the above-mentioned review and the pooled prevalence of HAIs in was 9.7%(95%CI,6.913.6%)(37).National prevalence studies from Singapore and Australia,both in that region,showed an overall prevalence of HAIs in acute care hospitals of 11.9%(95%CI,11.112.8)and 9.9%(95%CI,8.811.0),respectively(44,45).Ninety-four studies from the WHO African Region were included in the above-mentioned review,which estimated an overall prevalence of HAIs of 27%(95%CI,22.232.4)(37).A systematic review published in 2024 focusing on the African continent estimated a median HAI prevalence of 15%,with a variation across studies between 1.6%and 90.2(46).Eighteen studies from the Region of the Americas were included in the above-mentioned systematic review,which estimated the overall pooled prevalence of HAIs to be 9.6%(95%CI,7.9 11.7)(37)for this region(Fig.2.1).HAI prevalence was found to be 3.2ross 199 hospitals in the United States of America in 2015,while the proportion of patients with HAIs was significantly lower than in 2011(4.0%)(47).The United States 13 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References Annexes Chapter 2.The problem of unsafe care resulting from HAIs and AMRCenters for Disease Control and Prevention(CDC)estimated that one in 31 hospital patients and one in 43 nursing home residents on any given day has a HAI(48).A national point prevalence survey conducted in Canada showed variations from 9.9%in 2002(95%CI,8.411.5)to 11.3%in 2009(95%CI,9.413.5),and then 7.9%in 2017(95%CI.6.89.0)(49).While it is important to provide an overview of data reported in different countries and regions,any comparisons of HAI rates should be made with caution as the methods used in different studies may vary and a number of factors are known to influence the results depending on the local situation.Fig.2.1.Frequency of HAIs reported in different WHO regionsWHO RegionsAMRAFREMREURSEARWPRNot applicableEUR 8%AMR 9.6R 27%EMR 12.5%SEAR 12.9%WPR 9.7breviations and(year of publication):AFR,African Region(2023);AMR,Region for the Americas(2023);EMR,Eastern Mediterranean Region(2023);EUR,European Region(2024);SEAR,South-East Asia Region(2023);WPR,Western Pacific Region(2023).Source:(37,39).The 2011 WHO report on the burden of endemic health care-associated infection worldwide indicated that surgical site infection(SSI)was the most frequent type of HAI reported hospital-wide in LMICs,with a significantly higher level of risk than in HICs(36).According to a systematic literature review on SSI in LMICs between 1995 and 2015,the pooled SSI incidence rate was 5.9%(95%CI,4.87.1)per 100 surgical operations and 11.2 per 100 surgical patients(95%CI 9.712.8),with significant variations according to the type of surgical procedures(WHO,unpublished data).The incidence of SSI following caesarean section in LMICs was 11.7%(95%CI,9.114.8),a much higher average rate than that reported in Europe(2.9%)(50).Caesarean section is considered the single most important risk factor for maternal infection after childbirth globally(51).In Africa,up to 20%of women who deliver through caesarean section get a wound infection,which affects their health and their ability to provide quality care for their newborn child(34).Similarly,SSI incidence in prosthetic orthopaedic surgery was 9.7%(95 CI,5.315.3)in LMICs and 0.7%(knee prosthesis)to 1.0%(hip prosthesis)in Europe(WHO,unpublished data).ECDC recently reported a range from 0.6%in knee prosthesis surgery to 9.5%in open colon surgery(percentage of SSIs per 100 operations),or an incidence density(in-hospital SSIs per 1000 postoperative patient-days)of 0.1(knee prosthesis)to 5.0(open colon surgery),depending on the type of surgical procedure based on data from 12 EU Member States and one EEA country in 20182020(52).A systematic review published in 2021 including 57 studies from around the world found a pooled 30-day cumulative incidence of SSI of 11%(95%CI,1013),meaning 11 out of 100 general surgical patients are 1 Albania,Argentina,Australia,Benin,Cameroon,China,China,Hong Kong Special Administrative Region,Cuba,Ethiopia,France,Georgia,Germany,Ghana,Herzegovina,India,Iran,Italy,Malawi,Nepal,Nigeria,Poland,Rwanda,Saudi Arabia,South Africa,Switzerland,United Republic of Tanzania,Thailand,Tunisia,Turkey,and the United States of America.Global report on infection prevention and control 202414 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References Annexeslikely to develop an infection 30 days after surgery(53).Another systematic review published in 2023 and including 43 studies conducted in 29 countries1 estimated an overall pooled global incidence of SSI of 2.5%(95%CI,1.63.7)among general surgical patients.A subgroup analysis by WHO region showed differences across the regions:the African Region,pooled incidence of SSI 7.2%(95%CI,4.3 11.8);Region of the Americas,3.1%(95%CI,2.24.3);Eastern Mediterranean Region,2.2%(95%CI,1.34.0);European Region,2.2%(95%CI,1.34.0);South-East Asia Region,1.2%(95%CI,0.43.1);Western Pacific Region,0.6%(95%CI,0.2 1.7)(54).These differences might reflect a higher risk of SSI in African countries,but also different study methodologies and quality.With respect to prevalence2,a systematic review including studies published in Africa from 2010 to 2022 estimated an overall SSI prevalence of 18%(95%CI,1421)in a post hoc sensitivity analysis(46).The overall prevalence of SSI estimated from 40 studies from 12 countries of the Eastern Mediterranean Region was 7.9%(95%CI,7.18.8)(55).The prevalence of SSI in cardiac and general surgery was 10%and 9.2%,respectively.Another systematic review including 99 studies across 39 developing countries estimated a prevalence of SSI in clean and clean-contaminated surgeries of 6%(95%CI,57),which increased to 15%(95%CI,627)when considering only studies that included post-discharge surveillance data(56).In EU/EEA countries and in countries of the WHO Eastern Mediterranean Region,the most frequent HAIs were respiratory tract infections,followed by urinary tract infections,SSIs and bloodstream infections(BSI)(39,42).The toll is heavier among high-risk patients,such as those admitted to ICUs,who often acquire infections from indwelling devices such as urinary or vascular catheters or invasive mechanical ventilation.Infections associated with these devices can affect as many as 30%of patients in ICUs and their incidence in LMICs is at least triple that in HICs(35,36,57).A large variation of the prevalence of ICU-acquired infections in adult patients was found among hospitals and countries,with pneumonia being the most common(57).Prevalence studies across income levels show a high percentage of overall HAIs among ICU patients:Canada,12.6%(95%CI,10.115.7)in 2017(49);China,26.07%(95%CI,23.0329.12)in 2006-20163(58);Ethiopia,25.8%(95%CI,3.5540.06)in 2011 and 20174(study period)(59);and Singapore,37.0%(95%CI,31.242.8)in 2015-2016(44).In 2022/2023,the most recent prevalence survey in 28 EU/EEA countries and three Western Balkan countries/territories estimated the prevalence for ICU patients with at least one HAI to be 20.5%compared with 6.4%for all other specialties combined(39).A multicentre study conducted from 2013 to 2018 in 664 ICUs in 133 cities of 45 countries from Latin America,Europe,Africa,the Eastern Mediterranean,South-East Asia and the Western Pacific found device-associated HAI rates to be 5.91%and 9.01/1000 bed-days.The pooled catheter-associated urinary tract infection(CAUTI)rate was 3.16/1000 urinary catheter-days,while the central line-associated BSI(CLABSI)rate was 5.30/1000 central line-days,and the ventilator-associated events(VAE)rate was even as high as 11.47/1000 mechanical ventilation-days(60).In 2019,the ECDC reported that 7.4%of patients staying in an ICU for more than two days presented with at least one HAI(pneumonia,BSI or UTI)based on data from 11 networks in 10 countries5 from 1285 hospitals and 1659 ICUs(61).2 It is difficult to confirm how the term“prevalence”was used in these reviews,considering that studies generally assess SSI incidence as the surveillance of SSI usually includes a postoperative follow-up period.3 Pooled results from a systematic review of multicentre point prevalence surveys conducted in acute care hospitals in mainland China from January 2006 to August 2016.4 Pooled results from two separate regional studies identified in a systematic review.5 Austria,Belgium,France,Germany,Hungary,Italy,Lithuania,Portugal,Spain,and the United Kingdom of Great Britain and Northern Ireland(Scotland).15 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References Annexes Chapter 2.The problem of unsafe care resulting from HAIs and AMRParticularly in these patients,but not only among this population,infection can rapidly and frequently evolve to sepsis,a life-threatening organ dysfunction.Sepsis represents a final common pathway to death from many infectious diseases worldwide.In a review of published studies,WHO calculated that among hospital-treated sepsis cases worldwide,approximately one in four cases(23.6%)were health care-associated(62).In adult ICUs,almost half of all cases(48.7%)of sepsis with organ dysfunction treated in ICUs were hospital-acquired(62,63).According to the pooled analyses in the above-mentioned WHO review,the incidence of health care-associated sepsis globally was 15.4(95%CI,9.225.7)cases per 1000 adult patients(63)and more than seven times higher among neonates(112.9 95%CI,64.2191.1)cases per 1000 neonates)(62).It was also found in a pivotal review published in 2005 that newborns were at a higher risk of acquiring HAI,with infection rates in LMICs three to 20 times the rates in HICs(64).2.2.1 AMR in health careThe spread of microorganisms that are resistant to antimicrobials is a critical issue in health care settings and IPC interventions can play a substantial role in significantly reducing the spread,along with optimal diagnostic and antimicrobial stewardship.A modelling study based on data from 474 point prevalence surveys published between 2010 and 2020 across 99 countries,coupled with country-level estimates of hospitalization rates and durations,estimated the global number of HAIs resistant to antibiotics to be 136 million(95%CI,26246)per year)(65).Among income groups,middle-income countries bore the highest burden of HAIs resistant to antibiotics per year(119 million 95%CI,23215),with an average hospitalization rate of 6ross all middle-income countries.For low-income countries,2 million(95%CI,05)HAIs resistant to antibiotics per year were estimated,with an average hospitalization rate of 3ross countries,however,providing the least data points overall.The average hospitalization rate across all HICs was 11%with an estimated 15 million(95%CI,425).In the 2022/2023 ECDC point prevalence study in EU/EEA countries,the most frequent pathogens causing HAIs were Escherichia coli(12.7%),Klebsiella spp.(11.7%),Enterococcus spp.(10.0%;overall vancomycin resistance was reported in 15.6%of isolated enterococci),SARS-CoV-2(9.5%),Staphylococcus aureus(9.0%),Clostridium difficile(8.0%),Pseudomonas aeruginosa(7.9%),coagulase-negative staphylococci(5.8%),Candida spp.(4.7%),Proteus spp.(3.2%),Acinetobacter spp.(3.2%)and Enterobacter spp.(3.0%)(39).In a global survey conducted by WHO in 2014,the prevalence of meticillin-resistant S.aureus(MRSA),E.coli resistant to third-generation cephalosporin,and carbapenem resistance by Enterobacterales,formerly known as Enterobacteriaceae(66),and P.aeruginosa from blood samples was significantly higher in LMICs than in HICs(67).This was also documented in the results of a surveillance study conducted by the International Nosocomial Infection Control Consortium between January 2010 and December 2015 in 703 ICUs in LMICs across five continents,excluding Africa.From blood cultures,the overall resistance of Pseudomonas spp.to imipenem was 44.3%(compared with 26.1%in the United States of America in the same period).Resistance of K.pneumoniae to ceftazidime was 73.2%(versus 28.8%)and to imipenem 43.27%(versus 12.8%)(68).Data Global report on infection prevention and control 202416 1.Introduction 2.HAIs and AMR 3.National level 4.Facility level 5.Regional focus 6.The way forward References Annexesfrom 664 ICUs in 133 cities of 45 countries found that overall,P.aeruginosa was non-susceptible to imipenem in 52.7%of cases,to colistin in 10.4%,to ceftazidime in 50.0%,to ciprofloxacin in 40.28%,and to amikacin in 34.05%(60).Klebsiella spp was non-susceptible to imipenem in 49.2%of cases,to ceftazidime in 78.0%,to ciprofloxacin in 66.3%,and to amikacin in 42.4%.2.2.2 MRSAThe median percentage of MRSA causing BSI reported by the Global Antimicrobial Resistance and Use Surveillance System(GLASS)was 33.9%(interquartile range IQR,13.654.9)globally in 2022,but only 7.6%(IQR,3.119.9)based on data provided by 21 countries with better testing coverage(69).Most LMICs presented lower testing coverage compared to HICs.In 2021,25%of EU/EEA countries reporting data on S.aureus had MRSA percentages below 5%.MRSA percentages equal to or above 25%were observed in 30%of EU/EEA countries(70).According to the most recent European Antimicrobial Resistance Surveillance Network(EARS-Net)report with data from EU/EEA countries,a significantly decreasing trend in the EU/EEA(excluding the United Kingdom of Great Britain and Northern Ireland)population-weighted,mean percentage of MRSA isolates,as well as in the estimated EU incidence of BSIs with MRSA,was reported during the period 20182022.In 2022,there was a 12.2crease in the estimated incidence compared to the baseline year 2019(71).In the 2022/2023 point prevalence survey in hospitals in EU/EEA countries,overall meticillin resistance was reported in 23.7%of S.aureus 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2Healthcare Industry ReportExecutive SummaryIntroductionPrecision Medicine Landscape Recent Trends and InnovationsKey Legislation and PoliciesAccess and ReimbursementHow SGA Can HelpReferencesMethodologyCONTENTS0102030405060708093Healthcare Industry ReportThe world of Precision Medicine is truly transformative and a ground-breaking approach to healthcare that tailors treatments to individual patients genetic,environmental,and lifestyle variations.New devel-opments such as mutation specific therapies,immunotherapies,and chimeric antigen receptor T(CART)cell therapy can increase life expectancy as well as quality of lifeThe journey of precision medicine,from the elucidation of Deoxyribo-nucleic acid(DNA)structure in 1953 to the approval of 26 personal-ized medicines by the US Food and Drug Administration(USFDA)in 2023,has been full of key milestones and innovations.Pharmacogenomics is a key tool in precision medicine,which aims to improve patient care by matching medications to individual genet-ics.Recent enhancements in computing power and developments in quantum computing have given a boost to the development of preci-sion medicines.This has now led to more than 40%of all approvals in 2023 being precision medicine.Other innovations such as Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR),biomarkers,and Next Generation Se-quencing(NGS)have helped precision medicine to be more effective.The advent of Artificial Intelligence(AI)has helped uncover hidden associations in genomic datasets helping clinicians to devise person-alized treatment plans for their patients.Key legislation and policies are highlighted.Various countries,includ-ing the US,the UK,Australia,Canada,India,and Israel are reviewed,providing a global perspective on the regulatory environment.Applications of precision medicine in areas such as cancer treatment,infectious disease control,and chronic disease management leading to benefits such as increased treatment efficacy,reduced side effects,and early detection and prevention,are also important.As precision medicine is generally highly priced,payers are looking at paying for outcomes and working on value-based agreements.They are also using machine learning(ML)techniques to identify high-val-ue patients.Executive Summary01Precision Medicine:A New Era in Personalized HealthcareDoctors have always recognized that every patient is unique and have tried to tailor their treatments as best they can as per the individuals.You can match a blood transfusion to a blood type that was an important discovery.What if matching a cancer cure to our genetic code was just as easy,just as standard?What if figuring out the right dose of medicine was as simple as taking our temperature?”-President Obama,January 30,20154Healthcare Industry ReportIntroduction02Importance and Significance in Life Sciences and Healthcare Study found conventional/legacy drug therapies were ineffective in 38%of patients on antidepressants,40%on asthma drugs,43%on diabetes drugs,50%taking arthritis medication,70%of patients with Alzheimers disease,and 75%taking cancer drugs.An increasing number of current examples of personalized medicines include mutation specific therapies,immunotherapies,and CAR-T cell therapy.Overview of Precision Medicines Precision medicine is a cutting-edge approach in healthcare that customizes medical treatment to the individual characteristics of each patient.This approach takes into account variations in genetics,environment,and lifestyle for each person,which allows for more accurate diagnosis,prevention,and treatment of diseases.Precision medicine,also known as personalized medicine,is an innovative approach to disease prevention and treatment that considers individual differences in genes,environments,and lifestyles.The goal of precision medicine is to target the right treatments to the right patients at the right time.This paradigm shift promises more effective interventions and reduced adverse effects,as treatments are tailored to individual patients rather than taking a one-size-fits-all approach.Overview of Precision Medicine5Healthcare Industry ReportKey ComponentsGenomic Sequencing:By analyzing a patients genetic makeup,healthcare providers can identify genetic mutations and variations that may contribute to disease.This is particularly useful in oncology,where targeted therapies can be developed to treat specific types of cancer based on their genetic profiles.Personalized Treatment Plans:Precision medicine aims to tailor treatments to individual patients rather than using a one-size-fits-all approach.This can involve selecting the most effective medications and dosages based on genetic information,reducing the likelihood of adverse drug reactions and improving outcomes.Advanced Technologies:The integration of artificial intelligence(AI)and ML along with Big Data in precision medicine helps analyze large datasets to uncover patterns and make predictions about treatment responses.These technologies enhance the ability to provide precise and effective medical care.Biomarker Identification:Biomarkers are measurable indicators of a biological condition or state.In precision medicine,biomarkers are used to predict disease risk,diagnose conditions early,and monitor treatment effectiveness.Accurate biomarker measurement is crucial for developing targeted therapies and monitoring disease progression.Individualization:Personalized medicine advocates for treatments based on a persons genetic makeup,considering the unique variations in their genome.This personalized method acknowledges that while most genetic variations do not influence well-being,they can greatly affect an individuals health when combined with environmental factors and lifestyle behaviors.The two key principles of personalized medicine are as follows:Precision:Utilizing advanced technologies,such as genome sequencing,personalized medicine can identify specific DNA mutations that are linked to diseases.This enables more precise diagnosis and treatment targeted at these specific mutations.These principles combined greatly reduce the trial-and-error inefficiencies,allowing healthcare professionals to better understand disease and address it.6Healthcare Industry ReportPharmacogenomics is the study of the relationship between genetic variations and how our body responds to medications.Under this,genomic information is used to study individual responses to drugs.When a gene variant is associated with a particular drug response in a patient,there is the potential for making clinical decisions based on genetics by adjusting the dosage or choosing a different drug.For example,scientists assess gene variants affecting an individuals drug response the same way they assess gene variants associated with diseases:by identifying genetic loci associated with known drug responses and then testing individuals whose response is unknown.Overview of Precision MedicineCancer TreatmentPrecision oncology uses genetic information to identify specific mutations in cancer cells,allowing for the development of targeted therapies that are more effective and have fewer side effects compared to traditional treatments.Infectious Disease ControlGenome sequencing helps in identifying and tracking pathogens dauring outbreaks,leading to faster and more accurate public health responses.Chronic Disease ManagementPersonalized treatment plans based on genetic,lifestyle,and environmental factors improve the management of chronic conditions such as cardiovascular diseases.ApplicationsBenefits Increased Treatment Efficacy:Tailoring treatments to individual genetic profiles increase the likelihood of successful outcomes.For example,CAR-T cell therapy,developed by ImmunoAct in collaboration with IIT Bombay and Tata Memorial Hospital,has been administered to 15 patients in India,with three achieving successful cancer remission.Reduced Side Effects:Precision medicine minimizes adverse reactions by selecting the most appropriate medications and dosages.For example,in CAR-T cell therapy side-effects depends,with about 30%to 60%of patients experiences some degree of cytokine release syndrome.This condition can vary in severity:from mild cases,where patients may only experience a fever for a day,to severe cases that can lead to significant illness and require intensive care unit admission.Early Detection and Prevention:Genetic screening and biomarker analysis enable early detection of diseases,allowing for timely intervention and prevention strategies.7Healthcare Industry ReportEvolution of Precision MedicineThe elucidation of the structure of DNA by James Watson,Francis Crick,and Rosalind Franklin1953Human Genome Project initiat-ed to create genetic blueprint of humans1990Human Genome project com-pleted with generating the first sequence of the human genome(Approximately 92%of the entire human genome sequence has been mapped)2003The Precision Medicine Coalition(PMC)was founded by 20 insti-tutions from various sectors of the healthcare system2004USFDA brings out guidance to facilitate scientific progress in the field of pharmacogenom-ics and to facilitate the use of pharmacogenomic data in drug development2005The European Alliance for Per-sonalized Medicine(EAPM)was Launched2012The USFDA approved 26 person-alized medicines,accounting for 47%of all approvals.With 19 additional indications of existing personalized medicines and 17 significant new or expanded uses for 12 diagnostic testing prod-ucts.2023Researchers successfully pro-duced the first complete,seam-less sequence of a human genome2022Emmanuelle Charpentier and Jennifer A.Doudna were award-ed the Nobel Prize in Chemistry for their discovery of CRISPR/Cas92020The USFDA approved 25 person-alized medicines,making up 42%of all approvals granted2018The White House introduced the“Precision Medicine Initia-tive Cohort Program,”which has since evolved into the“All of Us Research Program”2015Global Alliance for Genomics and Health(GA4GH)formed to expand genomic data use within a human rights framework2013The first CAR T-cell therapies tar-geting the B-lymphocyte antigen CD19 approved by the USFDA and the EMA2017&20188Healthcare Industry ReportMarket Overview Clinical TrialsMarketed ProductsRepresentative List for Clinical Trial Data of Precision Medicine in Phase III:Therapeutic Molecular Personalized Medicines Approved by the FDATitleDisease/IndicationSponsor NameClinical Trial PhaseCompletion DateLiquid Biopsy(ctDNA)Guided Treatment in Localized Pancreatic CancerPancreatic CancerElisabethinen HospitalPhase III31-Dec-26Personalized Medicine for Advanced Biliary Cancer PatientsBiliary Tract NeoplasmsUNICANCERPhase IIIJun-28Patient-derived Organoid-guided Personalized Treatment vs.Physicians Choice Treatment in Breast CancerBreast CancerSun Yat-sen UniversityPhase III15-Jan-28Precision Medicine Approach for Early Dementia&Mild Cognitive ImpairmentMild Cognitive ImpairmentAlzheimers Prevention and Reversal Project Inc.Phase IIISep-25Sr.No.Product NameIndicationClass of agentManufacturer1Casgevy(Exagamglogene Autotemcel )Sickle Cell DiseaseBiologicVertex Pharmaceuticals2Elevidys(Delandistrogene Moxeparvovec)Duchenne Muscular DystrophyBiosimilarSarepta Therapeutics3Elfabrio(Pegunigalsidase Alfa)Fabry DiseaseBiosimilar(Enzyme Replacement Therapy)CHIESI FARMACEUTICI 4Fabhalta(Iptacopan)Paroxysmal Nocturnal HemoglobinuriaSmall MoleculeNovartisRecent advancements in precision medicine have led to the approval of several molecular personal-ized medicines by the FDA,targeting a variety of diseases.A few notable approvals in 2023 include:9Healthcare Industry ReportSr.No.Product NameIndicationClass of agentManufacturer5Filspari(Sparsentan)ProteinuriaSmall MoleculeTravere Therapeutics6Joenja(Leniolisib)Activated Phosphoinositide 3-Kinase Delta SyndromeSmall MoleculePharming Group7Lamzede(Velmanase Alfa)Alpha-MannosidosisBiosimilarCHIESI FARMACEUTICI8Lyfgenia(Lovotibeglogene Autotemcel)Sickle Cell DiseaseBiologicbluebird bio9Pombiliti(Cipaglucosidase Alfa)Pompe DiseaseBiosimilarAmicus Therapeutics10Qalsody(Tofersen)Amyotrophic Lateral SclerosisBiologicBiogen11Rivfloza(Nedosiran)Primary Hyperoxaluria Type 1Small MoleculeNovo Nordisk12Roctavian(Valoctocogene Roxaparvovec)Hemophilia ABiosimilarBioMarin Pharmaceutical13Sohonos(Palovarotene)Fibrodysplasia Ossificans ProgressivaSmall MoleculeIpsen Biopharmaceuticals14Veopoz(Pozelimab)CHAPLE DiseaseBiosimilarRegeneron Pharmaceuticals15Vyjuvek(Beremagene Geperpavec)Dystrophic Epidermolysis BullosaBiosimilarKrystal Biotech16Wainua(Eplontersen)Hereditary Transthyretin-Mediated AmyloidosisSmall MoleculeAstraZeneca17Augtyro(Repotrectinib)Non-small Cell Lung CancerSmall MoleculeBMS18Loqtorzi(Toripalimab)Nasopharyngeal CarcinomaBiosimilarCoherus BioSciences19Omisirge(Omidubicel)Hematologic MalignanciesBiosimilarGamida Cell20Orserdu(Elacestrant)Metastatic Breast CancerSmall MoleculeStemline Therapeutics21Truqap(Capivasertib)Metastatic Breast CancerSmall MoleculeAstraZeneca10Healthcare Industry ReportSr.No.Product NameIndicationClass of agentManufacturer22Vanflyta(Quizartinib)Acute Myeloid LeukemiaSmall MoleculeDaiichi Sankyo23Zynyz(Retifanlimab)Merkel Cell CarcinomaBiosimilarIncyte Corporation24Leqembi(Lecanemab)Alzheimers DiseaseBiosimilarEisai Co.25Rystiggio(Rozanolixizumab)Generalized Myasthenia gravisBiosimilarUCB26Zilbrysq(Zilucoplan)Generalized Myasthenia gravisSmall MoleculeUCBYear of Drugs First FDA-approvalFDA-approved Drug FDA Drug Label Listed BiomarkerClass of AgentMechanism of Action or Drug Target 2021AmivantamabEGFR Exon 20 InsertionsMonoclonal AntibodyEGFR-MET Bispecific Antibody2021AsciminibPh (BCR-ABL1 Fusion)BiosimilarIncyte Corporationor ABL1 T315ISmall Molecule Kinase InhibitorABL/BCR-ABL1 Tyrosine Kinase InhibitorBiosimilarEisai Co.2021BelzutifanVHL Oncogenic MutationsSmall Molecule InhibitorHIF-2a Inhibitor2021Dostarlimab*dMMR *dMMR or MSI-HImmune Checkpoint InhibitorAnti PD-1 Antibody2021InfigratinibFGFR2 FusionsSmall Molecule Kinase InhibitorFGFR1/2/3 Inhibitor2021MobocertinibEGFR Exon 20 InsertionsSmall Molecule Kinase InhibitorEGFR Exon 20 Inhibitor2021SotorasibKRAS G12CSmall Molecule InhibitorKRAS G12C Inhibitor2021TepotinibMET Exon 14 Skipping MutationsSmall Molecule Kinase InhibitorMET InhibitorFDA-approved Precision Oncology Therapy:198 new oncology drugs approved by the USFDA between 1998 and 2022.Approximately 43%were precision oncology therapies,the use of which is guided by biomarker testing.11Healthcare Industry ReportYear of Drugs First FDA-approvalFDA-approved Drug FDA Drug Label Listed BiomarkerClass of AgentMechanism of Action or Drug Target 2021Trastuzumab PembrolizumabHER2 (ERBB2 Amplification)Monoclonal Antibody and Immune Checkpoint Inhibitor CombinationAnti-HER2(ERBB2)Antibody Anti-PD-1 Antibody2022AdagrasibKRAS G12CSmall Molecule InhibitorKRAS G12C Inhibitor2022FutibatinibFGFR2 FusionsSmall Molecule Kinase InhibitorFGFR1/2/3 Inhibitor2022Mirvetuximab soravtansineFRaAntibody Drug ConjugateFolate Receptor Alpha-directed Antibody Microtubule Inhibitor Conjugate2022OlutasidenibIDH1 R132C/G/H/L/SSmall Molecule InhibitorIDH1 Inhibitor2022PluvictoPSMA RadiotherapyRadioligand Therapeutic Agent2022TebentafuspHLA-A*02:01-PositivityBispecific T-cell EngagerBispecific gp100 Peptide-HLA-A*02:01-directed T-cell Receptor CD3 T cell Engager2023CapivasertibPIK3CA,AKT1,or PTEN Oncogenic Mutations and HR /HER2-Small Molecule Kinase InhibitorAKT1/2/3 Inhibitor2023ElacestrantESR1 Ligand-binding Domain Missense Mutations andSmall Molecule Kinase InhibitorMET InhibitorER /HER2-Hormone TherapySelective Estrogen Receptor Degrader(SERD)2023QuizartinibFLT3 ITD MutationsSmall Molecule InhibitorFLT3 Inhibitor2023RepotrectinibROS1 FusionsSmall Molecule Kinase InhibitorMulti-targeted Kinase Inhibitor(targets include ROS1 and NTRK1/2/3)2024TovorafenibBRAF Fusions,BRAF Rearrangement,and BRAF V600 Small Molecule Kinase InhibitorRAF Inhibitor12Healthcare Industry Report Liquid Biopsy:This method uses biomarkers in blood for non-invasive,real-time prognostic,and predictive purposes.By analyzing blood or urine samples,liquid biopsies can diagnose diseases,monitor treatment progress,and detect recurrence with minimal discomfort to patients.This is particularly useful in cancer management,where early detection and ongoing monitoring are crucial.Microfluids(Lab on a Chip):Microfluidic technologies enable extremely precise fluid control and manipulation,facilitating rapid and high-throughput sample processing in integrated micro-scale medical systems.This technology allows for the miniaturization of laboratory processes,leading to faster and more accurate diagnostic results.4D Sonography:This advanced imaging technique creates detailed images of tissues,organs,and fluid flow within the body.It enhances diagnostic ability,precision in treatment selection,and prognosis evaluation,especially in fields like obstetrics,cardiology,and oncology.iKnife:The intelligent knife(iKnife)combines an electrosurgical scalpel with a mass spectrometer to distinguish tissues during surgery.It can detect and diagnose cancer in real-time,enabling surgeons to make more informed decisions and improving surgical outcomes.Companion Diagnostic(CDx):A companion diagnostic is a medical device,often an IVD,which provides information that is essential for the safe and effective use of a corresponding drug or biological product.Recent Trends and Innovations02Cutting Edge TechnologiesIn Vitro Diagnostics In vitro diagnostics(IVD)involve testing samples taken from the human body to detect,diagnose,and monitor diseases.This field has seen significant innovations that enhance precision medicine.5-6%compounded ed annual growth rate of Global IVD market from 2023 2029 Contribution of top 7 players in the IVD market by revenue for 2024 513Healthcare Industry Reportidentify patients who are most likely to benefit from a particular therapeutic product,identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product;ormonitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.Companion Diagnostics can123The inception of CDx can be traced back to 1998,when the FDA granted concurrent approval for trastuzumab,a targeted cancer drug and HercepTest,a HER2 immunohistochemical assay.This milestone marked the birth of the drug-diagnostic co-development model,a transformative approach that has since witnessed consistent and substantial adoption.The evolution of CDx was gradual,with significant progress seen only in the last decade.From 1998 to 2012,around 20 new CDx were approved.However,this number drastically increased to 134 from 2013 to 2023,indicating a substantial acceleration in CDx development.From 2021 to 2023,the use of companion diagnostic and biomarkers in oncology decreased as compared to the targeted therapies,i.e.,52%,50%,and 28%in 2021,2022,and 2023,respectively.About 170 CDxhave been approved by the USFDA till now14Healthcare Industry ReportBiomarkersNext Generation Sequencing Biomarkers are measurable indicators used to evaluate biological processes,disease states,and responses to treatments.They are integral to precision medicine across various medical fields.Role in Precision Medicine:Biomarkers are used to identify specific diseases,monitor disease progression,and evaluate treatment efficacy.They are vital in oncology,where they can help distinguish between different types of cancer and guide targeted therapy.Epigenetic Biomarkers:These biomarkers provide insights into gene expression influenced by environmental and social factors.They are crucial for understanding disease prediction and progression,offering a more comprehensive view of an individuals health.Next-generation sequencing(NGS)has revolutionized genomic research and clinical practice.It allows for comprehensive analysis of genetic information,which is pivotal in precision medicine.Applications:NGS can sequence entire genomes or specific targeted regions,analyze epigenetic factors,and study microbial populations.This technology is essential for identifying genetic mutations,understanding disease mechanisms,and developing targeted therapies.Wearable and Implantable Biosensors:Advancements in microelectronics and electrochemical sensing have led to the development of biosensors that generate signals proportional to the concentration of analytes.For instance,glucose is an analyte in a biosensor designed to detect glucose.These devices are used for disease detection,chronic disease management,drug discovery,and health monitoring.Naeiry highlighted the importance of genomic data,stating that you must be“Able to build causality for relation rather than predictive for relation.Without genomic component it is hard to establish causality.It is like a car with no wheels.”-Naiery Vetraven,Vice President:R&D Business Development(BASE life science)15Healthcare Industry ReportGenetic TherapyGenetic therapy encompasses techniques designed to correct defective genes and explore the use of genes to treat diseases.CRISPR TechnologyClustered Regularly Interspaced Short Palindromic Repeats(CRISPR)technology uses guided RNA to cleave DNA at specific locations in a genome.This technology has the potential to address a wide range of diseases,including cancers,genetic disorders,diabetes,inflammatory diseases,cardiovascular disease,HIV/AIDS,and muscular dystrophy.During the COVID-19 pandemic,CRISPR was used to develop diagnostic tests,demonstrating its versatility.Genomic SurveillanceThis field involves the large-scale monitoring of viruses to detect,track,and control outbreaks.Genomic surveillance has expanded due to recent infectious disease outbreaks,improving our ability to understand pathogen transmission and evolution.For example,public health bodies have begun using wastewater monitoring systems to detect signs of infectious diseases.This approach allows for early detection and planning of vaccination campaigns.RNA and mRNA Diagnostics and TherapeuticsRNA-based technologies can stimulate immune responses and deliver therapeutic proteins.They are used to uncover the roles of RNA in brain development and understand the root causes of neurodegenerative diseases.Besides the most notable mRNA vaccines discovered during the pandemic,Evrysdi(Roche)and Spinraza(Biogen)are two FDA-approved mRNA drugs that treat spinal muscular atrophy(SMA)by altering the way SMN2 mRNA is createdAbout 600 pluspatent applications by top 10 organizations on mRNA vaccines or therapeutics16Healthcare Industry ReportImpact of AI and MLBig Data and AI in Precision MedicineIn the early 2000s,the rise of big data technologies enabled the stor-age and processing of massive amounts of healthcare data from di-verse sources.This paved the way for the application of AI techniques,like ML,to extract insights and patterns from these large datasets.The convergence of AI and precision medicine is revolutionizing health-care.Precision medicine methods identify unique patient phenotypes and characteristics to enable more personalized diagnosis,risk pre-diction,and treatment planning.AI and big data analytics are playing a crucial role in this transfor-mation.By leveraging sophisticated computational techniques,AI can extract insights from diverse data sources including genomics,clini-cal history,medical imaging,and digital health indicators.This allows for the integration of multimodal data to generate a comprehensive understanding of individual patient profiles.Big Data:The first step involves the collection and preparation of big data.This term refers to datasets that are so large and com-plex that they require advanced analytics tools and technologies for processing.These datasets,which may include genetic pro-files,lifestyle information,and medical histories,are often gener-ated at high speeds and require prompt processing.The ability to handle and analyze such data is crucial in precision medicine,as it enables the selection of more effective treatments tailored to individual patients.Leveraging AI:The second step is where AI takes center stage.AI has the capability to process vast amounts of real-time data,identify patterns,and generate valuable insights.In the context of precision medicine,AI can interpret extensive genomic datasets.Utilizing ML and deep learning techniques,AI can uncover hidden associations within these datasets.Consequently,clinicians are empowered to devise genome-informed treatment plans for their patients,enhancing the effectiveness of medical interventions.Immuneel Therapeutics used AI to ensure closed automated GMP production in deciding the best kind of starting material,the best process,and using AI and blockchain(as transportation is under-115C under liquid nitrogen).Health and disease states result from many-to-many interactions between genes and their products in a spatiotemporal orchestrated manner.AI-ML models built using multi-modal and multi-omics data are helping us connect data dots and decipher hidden correlations.-Dr.Urmila Kulkarni Kale,Senior Vice President,Citadel Precision Medicine17Healthcare Industry ReportCompany in Focus Tempus:AI-driven Precision MedicineRevenue in 2023-US$531.8 MillionOverviewGoogle-backed Tempus AI combines clinical and molecular data with advanced analytics to provide personalized treatment options for patients.Their platform,based on clinical records of millions of patients clinical records,collects and organizes data from various sources,including electronic health records(EHRs),genomic sequencing,imaging,and lab results.July 2024-Tempus launched its multimodal immune profile score(IPS)algorithmic test for research use only(RUO).IPS is the flagship of Tempus new immunotherapy-based portfolio,leveraging clinical,genomic,and transcriptomic data to identify potential responders to immunotherapy.Tempus is also collaborating with partners like Cleveland Clinic to expand this portfolio with additional algorithmic tests tailored for immuno-oncology.Tempus AI,Inc.announced that its PurISTSM algorithmic test has been granted a proprietary laboratory analysis(PLA)code by the American Medical Association(AMA),effective October 1,2024.This marks the first CPT code for an algorithm-only analysis using previously sequenced RNA data from a laboratory developed test(LDT).PurISTSM identifies molecular subtypes in unresectable stage III or IV pancreatic ductal adenocarcinoma(PDAC),aiding in therapy management decisions.Clinical validation shows PurISTSM can stratify overall survival among PDAC patients for first-line therapies FOLFIRINOX and gemcitabine nab-paclitaxel.AI ApplicationsGenomic Sequencing:Tempus sequences the DNA and RNA of patients tumors to identify mutations and other genetic abnormalities,helping understand the specific characteristics of a patients cancer.Data Integration and Analysis:Tempus integrates clinical data with molecular data to identify patterns and predict how patients will respond to different treatments.Predictive Modeling:The AI models developed by Tempus predict which treatments are most likely to be effective for individual patients based on their unique genetic makeup and clinical history.ImpactPersonalized Treatment Plans:Tempus provides oncologists with detailed reports that include actionable insights,helping them choose the most effective treatment options tailored to each patient.Improved Outcomes:By personalizing treatment plans,Tempus aims to improve patient outcomes,reducing the trial-and-error approach often associated with cancer treatment.Clinical Trials:Tempus helps match patients with relevant clinical trials,providing access to cutting-edge therapies suitable for their specific cancer type and genetic profile.18Healthcare Industry ReportBlockchainQuantum Computings Role in Revolutionizing Personalized MedicineImproved Data Management:The technology offers a secure and transparent system for handling large volumes of patient data,such as genetic and medical information.This enhances the integrity and accessibility of critical health data.Automated Patient Care:Through smart contracts,blockchain can automate various aspects of patient care,including medication dosages and treatment plans.This not only improves operational efficiency but also reduces the potential for errors.Fostering Collaboration and Innovation:By providing secure data sharing and maintaining transparency,blockchain encourages collaboration among researchers and accelerates innovation in personalized medicine.Enhanced Data Analysis:Quantum computers could vastly accelerate the analysis of pangenomes new representations of DNA sequences that capture population diversityata,enabling more precise and individualized genetic insights.Improved Personalization:By moving beyond traditional reference genomes,quantum computing can offer more tailored and accurate genetic information,leading to better-personalized medical treatments.Pathogen Tracking:The same technologies can improve the tracking and management of pathogens,aiding in more effective outbreak responses and public health strategies.For example-Researchers are pioneering a project that combines quantum computing with genomics to address one of the most complex problems in genomic science:analyzing datasets of pangenomes for large populations.This collaboration,involving the University of Cambridge,the Wellcome Sanger Institute,and EMBL-EBI,has received up to US$3.5 million in funding through the Wellcome Leap Q4Bio Challenge Program.Key PointsProject Goal:Develop quantum computing algorithms to enhance the creation and analysis of pangenomes,which are comprehensive representations of genetic diversity in populations.Methodology:The project aims to use quantum computing to speed up processes related to mapping genetic data onto sequence graphs and navigating these graphs efficiently.Impact:This advancement could significantly benefit personalized medicine by providing more accurate insights into individual genetic makeups compared to the traditional reference genome.It also has potential applications in tracking and managing pathogen outbreaks.19Healthcare Industry ReportKey Legislation and PoliciesPrecision medicine has garnered significant legislative support globally,reducing roadblocks to patient-centered drug development.04USUK Precision Medicine Institute(2015):In 2015 President Obama Launched PMI to support precision medicine research and patient engagement.Mission:To enable a new era of medicine through research,technology,and poli-cies that empower patients,researchers,and providers to work together toward development of individualized care.21st Century Cures Act(2016):Provided the FDA with tools to accelerate precision medicine therapies by reducing regula-tory requirements,recognizing new trial designs,and facilitating the use of re-al-world evidence.In 2013,Genomics England(GeL),a national genomics initiative under the Department of Health and Social Care in the UK,was tasked with collecting 100,000 genomes as part of the well-known 100,000 Genomes Project.Impact:The 100,000 Genomes Project was a British initiative to sequence and study the role genes play in health and disease.Recruitment was completed in December 2018,although research and analysis are still ongoing.18.5%of data from the Project turned into actionable findings 85K participants genomes sequenced for the Project 100K genomes sequenced by December 201820Healthcare Industry ReportAustraliaCanadaIsrael The National Health Genomics Policy Framework outlines steps to integrate ge-nomics into the Australian health system,demonstrating bold steps toward preci-sion medicine adoption.The Australian Genomics Health Alliance(Australian Genomics)was created in 2016 from a National Health and Medi-cal Research Council grant in Australia.Australian Genomics manages AUS$55 million of funding allocated to genomics research through the National Health and Medical Research Council and the Ge-nomics Health Futures Mission.Australian Genomics is composed of more than 100 organizations across Australia and has the aim of building a national infrastruc-ture for genomic data storage and ac-cess.The objective is to create national policies and processes to ethically access genomic data for research purposes,and to establish a system for diagnostic labs to share variant classifications.Also plan is to build a first-of-its kind national gen-otype-phenotype database.The Canadian Institute of Health Research included precision medicine within its 20152019 strategic plans,indicating a commitment to advancing personalized healthcare.The Israel Precision Medicine Partner-ship(IPMP)is a collaborative initiative supported by Yad Hanadiv,the Klarman Family Foundation,and other key partners including Israeli universities and health-care institutions.With a focus on genomic research,advanced biomedical studies,and computational technologies,IPMP aims to develop personalized diagnostics and therapies.Funded by a US$60 million grant over seven years through the Israel Science Foundation,it fosters a culture of data sharing and collaboration between clinical and research sectors to advance precision medicine for public benefit.The Mosaic Initiative for Personalized Medicine is leveraging Israels National Digital Health Plan to integrate 20 years of medical records for nine million resi-dents into a unified database.This ini-tiative aims to attract global researchers and industry leaders by providing access to comprehensive health data,covering over 98%of the population with individual consent.Supported by a US$287 million funding commitment,Mosaic also estab-lishes innovation labs to foster collabo-ration between multinational firms and Israeli digital health startups,promoting joint ventures and educational programs to advance the sector.21Healthcare Industry ReportIndiapharmaceutical sector,with a focus on gene therapy and precision medicine.The policy,being fine-tuned with input from various ministries,aims to establish centers of excellence and encourage industry-driven research.Key areas include drug discovery,innovative drug delivery systems,advanced medical devices,and gene therapy.The initiative has been well-received by the industry,with hopes that it will stimulate increased investment in research and development.The policy is part of the 2023 Union Budgets broader aim to increase healthcare expenditure.AI is revolutionizing precision medicine in India,with leading health institutions establishing specialty facilities that leverage AI for advanced care.For example:The Apollo Cancer Centre(ACC)in Bengaluru has inaugurated the countrys first AI-pow-ered Precision Oncology Centre.This center provides individu-alized care,utilizing AI for various applications:Identifying patients suitable for targeted therapy and im-munotherapy.Alerting care teams about patient deterioration.Educating patients and their families about diagnosis,treatment,and support groups through conversational AI.Monitoring adherence to standard care.Managing patients based on genomic,clinical,and patho-logical data.Recommending diagnostic tests and enrollment to val-ue-based care and other patient benefit programs.In another significant development,Immuneel Therapeutics,a Bangalore-based start-up that is focused on cell and gene therapy is on the verge of commercializing a CD-19 CAR-T cell therapy in July 2024.Immuneel was started with the intention of providing quality personalized cancer care at a fraction of the cost in developed markets.Rebu highlighted the importance of reimbursement,stating that“We are working with NBFCs to provide full or bridge funding for the treatment,which the patient can pay off in the remainder of their healthy life;and we are also targeting key central and state government accounts,that provide reimbursement for cancer care”-Rebu Ninan,Head-Commercial and Market Access,Cell and Gene Therapies(Immuneel Therapeutics)22Healthcare Industry ReportAccess and Reimbursement in Precision Medicine05While CAR-T cells have proven to be successful and useful,there are still some obstacles to overcome.These include issues related to the patient,such as the scarcity of treatment facilities and additional expenses like travel,accommodation,and food.On the other hand,providers face challenges related to logistics,allocation of staff time,resource limitations,and uncertainties around reimbursement.One way that is being explored to overcome this issue is through the use of on-site manufacture of CAR-T cells.This may reduce the costs of genetic engineering and expansion.However,there are still many challenges and other costs,including patient evaluation,selection,conditioning,and post-treatment recovery.There are also many other hidden costs in setting up and maintaining a CAR-T cell manufacturing facility,including facility costs,hidden staffing costs,and release testing.However,countries with lower GDP per capita have difficulty accessing conventional commercial products;therefore,various strategies have been adopted to overcome this barrier.Focus on Payment for OutcomesCountries are looking at innovative agreements including keeping prices confidential23Healthcare Industry ReportA review of the progress in Asian countriesIndiaIranJapanThere are two commercial CAR-T cell products available(NexCAR19 from Im-munoACT and QARTEMI from Immuneel Therapeutics).Indigenous CAR-T cell technology is being developed by the Indian Institute of Technology and the Advanced Centre for Treatment,Research,and Education in Cancer.Two investiga-tional products are in clinical trials.One local CAR-T cell clinical trial for pe-diatric patients,financed by the Council for Development Stem Cell Sciences and Technology of Iran and an investor.High-cost medical care reimbursement system.Five commercial CAR-T cells are available,all priced at approximately US$242,000.MalaysiaSingaporeThailandKoreaA CAR-T cell product sold through Auxi Therapeutics for approximately US$40,000 to US$50,000.Two commercial CAR-T cell products sold at approximately US$375,000.Several clin-ical trials are ongoing.Two studies have been conducted,both funded by the Thai government and phil-anthropic organizations.Many approved cell therapies,mostly in regenerative medicine.One commercial CAR-T cell product for cancer immunother-apy,priced at approximately US$300,000.24Healthcare Industry ReportTempus:AI-driven Precision MedicineKey FeaturesBenefitsSolutions Uses ML to identify high-value patients and enhance clini-cal decision-making.Aligns reimbursement levels with data-driven predictions.Incentivize clinical use of therapies based on real-world evidence(RWE).Encourages scalable models adaptable to stakeholder needs.Improved patient outcomes through personalized care.Increased affordability for payers,providers,and patients.Sustained innovation by manufacturers.Generation of valuable real-world data to further refine precision medicine approaches.Several approaches have been suggested to overcome the obstacles to CAR-T therapy.These encom-pass enhancing CAR-T production,involving community oncologists,increasing the number of centers providing CAR-T treatment,and addressing financial matters such as the pricing of CAR-T cells,reim-bursement,and personal expenses.However,extending academic CAR-T cell production to all locations and hospitals may not necessarily resolve these issues due to hidden costs and quality variability.Regarding financial reimbursement,its crucial to persuade funders to conduct a thorough long-term cost-effectiveness analysis.This is because the efficacy of CAR-T cells is best illustrated by the pro-longed remission observed in long-term survivors.Despite these efforts,the cost of CAR-T cell therapies remains high.Therefore,cost-sharing among various payers is essential for affording CAR-T treatments.Governments can support patients through hospital subsidies,product cost coverage,and grants.Insurance companies can help with hospi-tal stays,critical illness,and cell therapy product coverage.Pharmaceutical companies that produce CAR-T cells can contribute through patient assistance programs and subsidies.Additionally,philan-thropic organizations can offer support through program funding and crowdfunding for individual pa-tients.In terms of access to precision medicine,its important to note that these therapies are becoming increasingly available as our understanding of diseases at the molecular level improves.This allows for more targeted and effective treatments.However,access to these therapies can be limited owing to factors such as cost,availability of technology,and the need for specialized care.Efforts are being made to increase access to precision medicine through policy changes,technological advancements,and initiatives aimed at reducing costs.For example,telemedicine is being used to reach patients in remote areas and new payment models are being explored to make these therapies more affordable.Additionally,research and development in the field of precision medicine is ongoing,with the aim of discovering new therapies and improving existing ones.Tempus raised about$410 millionin its IPO in June 202425Healthcare Industry ReportHow SGA can Help in End-to-end Support for Companies in Precision Medicine?Epidemiology AnalysisUsing SGAs proprietary methodologies help companies identify the eligible and potential patient cohorts Demand AnalysisEstimated expected product demand using quantitative and qualitative market research for HCPs,patients,and caregivers ForecastingDeploy SGAs REAL forecast methodology to estimate future potential of products for next 510 years and support with executive friendly visualization through dynamic dashboards Pricing Benchmark AnalysisIdentify the overall/annual cost of therapy for competitors as well as analogs;supports strategy for penetration in emerging and non-innovator friendly markets Affordability AnalysisUnderstand socio-economic data as well as private and public insurance coverage to understand level of insurance coverage and out-of-pocket expenses(OOP)Supply Chain Research and AnalyticsResearch to find right fit vendors for supply chain logistics and analytics to optimize supply chain12345626Healthcare Industry ReportReferences Precision Medicine US Food and Drug Administration.Medical Devices.In Vitro Diagnostics.Accessed July 23,2024.Available at:https:/www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine.SDG 3 Precision Health Overview.UNICEF Innovation.Accessed July 23,2024.Available at:https:/www.unicef.org/innovation/media/20391/file/SDG 3 Precision Health Overview.pdf.pdf.SDG 3 Precision Health Technologies and Innovations.UNICEF Innovation.Accessed July 23,2024.Available at:https:/www.unicef.org/innovation/media/20396/file/SDG 3 Precision Health Technologies And Innovations.pdf.pdf.Technology Meets Precision Medicine.AstraZeneca.What Science Can Do.Accessed July 23,2024.Available at:https:/ Medicine:The Future of Tailored Treatment.PubMed Central.Published 2020.Accessed July 23,2024.Avail-able at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC10975777/.Personalized Medicine Coalition.Personalized Medicine Coalition.Accessed July 23,2024.Available at:https:/www.personalizedmedicinecoalition.org/.Feature-Precision Medicine.ISPOR.Accessed July 23,2024.Available at:https:/www.ispor.org/docs/de-fault-source/publications/value-in-health-journal/vih-feature-precision-medicine.pdf.Personalized Medicine at FDA:The Scope&Significance of Progress in 2021.Personalized Medicine Coalition.Published 2021.Accessed July 23,2024.Available at:https:/www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/Personalized_Medicine_at_FDA_The_Scope_Significance_of_Progress_in_2021.pdf.Precision reimbursement benefits all stakeholders.PubMed Central.Published 2023.Accessed July 23,2024.Avail-able at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC8651321/#:text=Precision reimbursement bene-fits all stakeholders&text=Value-based pricing is part,highly efficacious drugs for patients.Precision medicine and COVID-19:from the individual to the population.PubMed Central.Published 2021.Accessed July 23,2024.Available at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC9299639/.Precision Medicine and Its Role in Oncology:A Glance at the Current State of Affairs.PubMed Central.Published 2021.Accessed July 23,2024.Available at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC7877825/.OncoKB-Precision Oncology Knowledge Base.OncoKB.Accessed July 23,2024.Available at:https:/www.oncokb.org/oncology-therapies.WEF Global Precision Medicine Council Vision Statement 2020.World Economic Forum.Published 2020.Accessed July 23,2024.Available at:https:/www3.weforum.org/docs/WEF_Global_Precision_Medicine_Council_Vision_Statement_2020.pdf.100,000 Genomes Project.Genomics England.Accessed July 23,2024.Available at:https:/www.genomicsengland.co.uk/initiatives/100000-genomes-project.Clemson Researchers Pave the Way for Precision Medicine with AI.Clemson University.Accessed July 23,2024.Available at:https:/news.clemson.edu/clemson-researchers-pave-the-way-for-precision-medicine-with-ai/.PMC Report Shows Number of Personalized Medicines Doubled in 4 Years.AJMC.Published 2023.Accessed July 23,2024.Available at:https:/ Models for High-cost Therapies.ASCO.Published 2021.Accessed July 23,2024.Available at:https:/asco-pubs.org/doi/10.1200/EDBK_397912#:text=Payment Models for High-cost Therapies,-Even if many&text=For example, a payer may,a certain period of time.Nearly Half of Oncology Drugs Approved Since 1998 Are Precision Therapies.American Association for Cancer Re-search.Published February 18,2020.Accessed July 23,2024.Available at:https:/www.aacr.org/about-the-aacr/newsroom/news-releases/nearly-half-of-oncology-drugs-approved-since-1998-are-precision-therapies/.Precision Medicine Initiative.The White House,Office of the Press Secretary.Published January 30,2015.Accessed July 23,2024.Available at:https:/obamawhitehouse.archives.gov/precision-medicine#:text=NIH is build-ing the Precision,understanding of health and disease.27Healthcare Industry Report Primary Focus Areas-Precision Medicine.National Institute of Standards and Technology.Accessed July 23,2024.Available at:https:/www.nist.gov/mml/bbd/primary-focus-areas/precision-medicine.Precision Health:Predict and Prevent Disease.Centers for Disease Control and Prevention.Accessed July 23,2024.Available at:https:/www.cdc.gov/genomics-and-health/about/precision-health-predict-and-prevent-disease.html.Mosaic-Precision Medicine in Israel:Brief Overview.Israeli Ministry of Health.Published November 12,2018.Accessed July 23,2024.Available at:https:/health.gov.il/services/tenders/doclib/121118-mosaic-brief.pdf.GEM Israel-Precision Medicine.Innovate UK Knowledge Transfer Network.Published December 2020.Accessed July 23,2024.Available at:https:/iuk.ktn-uk.org/wp-content/uploads/2020/12/B1_1_KTN_GEM_Israel-PrecisionMedi-cine.pdf.Israeli Precision Medicine Partnership(IPMP)Roadmap.Yad Hanadiv.Published March 2019.Accessed July 23,2024.Available at:https:/www.yadhanadiv.org.il/sites/default/files/media/document/2019-03/IPMP Roadmap.pdf.Tempus Expands Immuno-Oncology Portfolio with Launch of AI-enabled Multimodal Immune Profile Algorithmic Tests.Tempus.Published March 16,2023.Accessed July 23,2024.Available at:https:/ Medical Association Grants PLA Code to Tempus Algorithmic Test Purist.Tempus.Published January 18,2024.Accessed July 23,2024.Available at:https:/ Drug Approvals 2023.US Food and Drug Administration.Accessed July 23,2024.Available at:https:/www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023.First Complete Sequence of the Human Genome.National Institutes of Health.Published April 24,2003.Accessed July 23,2024.Available at:https:/www.nih.gov/news-events/nih-research-matters/first-complete-sequence-hu-man-genome.Researchers Generate First Complete,Gapless Sequence of the Human Genome.National Institutes of Health.Published May 31,2022.Accessed July 23,2024.Available at:https:/www.nih.gov/news-events/news-releases/re-searchers-generate-first-complete-gapless-sequence-human-genome.Precision medicine:the future of tailored treatment.PubMed Central.Published 2020.Accessed July 23,2024.Avail-able at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC10937087/.Pharmacogenomics Knowledge Base(PharmGKB).PharmGKB.Accessed July 23,2024.Available at:https:/www.pharmgkb.org/.Pharmacogenomics and Personalized Medicine.Nature Education.Accessed July 23,2024.Available at:https:/ Diagnostics.US Food and Drug Administration.Medical Devices.In Vitro Diagnostics.Accessed July 23,2024.Available at:https:/www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics#:tex-t=A companion diagnostic is a,corresponding drug or biological product.Indigenous CAR-T cell therapy now available for commercial use.Indian Express.Published July 17,2024.Accessed July 28,2024.Available at:https:/ Precision Medicine Program:Roadmap 2019.Yad Hanadiv.Published March 2019.Accessed July 28,2024.https:/www.yadhanadiv.org.il/sites/default/files/media/document/2019-03/IPMP Roadmap.pdf CAR-T cell therapy update.CU Anschutz Medical Campus.Published July 26,2024.Accessed July 28,2024.https:/news.cuanschutz.edu/cancer-center/car-t-cell-therapy-update Quantum computer-powered pangenome research could lead to personalized medicine,disease outbreak tracking.The Quantum Insider.Published April 26,2024.Accessed July 28,2024.https:/ Medicine Coalition.In 2023,personalized medicines topped one-third of new drug approvals for fourth year in a row.Personalized Medicine Coalition.Available at:https:/www.personalizedmedicinecoalition.org/in-2023-personalized-medicines-topped-one-third-of-new-drug-approvals-for-fourth-year-in-a-row/#:tex-t=In 2023, FDA approved 16,for other diseases and conditions.28Healthcare Industry ReportThe research for the white paper on T Precision Medicine A New Era in Personalized Medicine was con-ducted in June and July 2024.SG Analytics used a blended methodology for this research report encompassing both secondary research(regulatory sites,government sites,scientific journals,industry publications,webinars,press releases,etc.)and in-depth research conducted with industry participants.All research compiled was analyzed and final insights and conclusions were generated.Primary Research Participants were Rebu Ninan Head-Commercial and Market Access,Cell and Gene Therapies(Immuneel Therapeutics)Naiery Vetraven Vice President:R&D Business Development(BASE life science)Dr.Urmila Kulkarni KaleSenior Vice President,Citadel Precision MedicineMethodologyDisclaimer Pune|Hyderabad|Bengaluru|London|Zurich|New York|San Francisco|Amsterdam|Toronto|WroclawThis document makes descriptive reference to trademarks that may be owned by others.The use of such trademarks herein is not an assertion of ownership of such trademarks by SG Analytics(SGA)and is not intended to represent or get commercially benefited from it or imply the existence of an association between SGA and the lawful owners of such trademarks.Information regarding third-party products,services,and organizations was obtained from publicly available sources,and SGA cannot confirm the accuracy or reliability of such sources or information.Its inclusion does not imply an endorsement by or of any third party.Copyright 2024 SG Analytics Pvt.Ltd.
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WhitepaperUnlocking the Potential of Consumer Wearables in Healthcare:Barriers to Adoption&Regulatory Impacts417333435365726814Abstract1.0 Executive summary2.0 Introduction3.0 Background9 Regulatory landscape10 Other regulatory areas11 Standards landscape12 Perceived barriers to adoption13Impactsofwearablesonhealthcare4.0 Methods15 Research design16 Data analysis5.0 Findings18 Demographics of respondents18 Awarenessandimportanceofwearables19 Perceived barriers to adoption23 Perceptions of regulatory changes24 Future adoption trends24 Standards development24Stakeholder-specificinsights6.0 Discussion27Summaryofkeyfindings30 Strengths and limitations31 Future direction and strategy recommendationsContents8.0 ConclusionReferencesInternational standardsKey comments22024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareAcknowledgementsThe research and editorial development of this whitepaper have been funded jointly by the British Standards Institution(BSI)and Huawei,with costs split equally between the two organizations.BSI has maintained complete editorial independence throughout the process,including the design and selection of survey questions and the development of the final document.The views expressed in this paper are those of the authors and do not necessarily represent the official positions of BSI or Huawei.32024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareAbstractThe integration of consumer wearables is transforming the landscape of patient care and health monitoring,particularly in the realm of cardiac health.This white paper examines the perspectives of multiple stakeholder groups,including cardiologists,insurance payers,and manufacturers of consumer wearables,on the evolving regulatory environment and the barriers that impact the adoption of wearables in healthcare settings.Focusing on cardiac applications,we provide a global perspective on regulatory comparisons between the European Union and the Asia-Pacific region and identify strategic insights to enhance the acceptance and integration of these technologies in clinical practise.Drawing from qualitative interviews and quantitative surveys with global stakeholders,this research presents a comprehensive overview of current adoption trends and future directions for wearables.It highlights the complexities faced by manufacturers,cardiologists,and insurers operating within different regulatory frameworks.The paper aims to present practical recommendations for overcoming these challenges and support the development of actionable strategies for enhancing wearable adoption globally.By reporting on these findings,we aspire to guide policymakers and industry stakeholders in fostering innovation,ensuring that wearable technologies effectively contribute to improved health outcomes.42024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare1.0 Executive summaryThe role of consumer wearables in healthcare,particularly for cardiac health monitoring,is gaining prominence amidst complex regulatory landscapes.These devices,which offer real-time data on health metrics like heart rate and sleep patterns,have evolved from niche gadgets to essential healthcare tools,with ownership rates between 41-53%in regions such as the EU,USA,and China.While promising,several challenges affect their integration into clinical settings,impacting both manufacturers and consumers.Key issues include complex regulations,usability concerns,data accuracy,and cost factors.This white paper evaluates these adoption barriers and explores the impact of regulatory and standards frameworks on the integration of wearable technologies in healthcare,focusing primarily on cardiac applications.Through a comprehensive analysis of qualitative interviews and quantitative surveys with key stakeholders,including manufacturers,cardiologists,and insurers,this paper provides insights and recommendations to enhance the adoption of wearables in healthcare systems.Key findings emphasise regional disparities in regulatory impacts on wearable adoption.The European Medical Device Regulation(MDR)2017/745 imposes more stringent requirements compared to the relatively flexible frameworks of Singapores Health Sciences Authority and the FDAs General Wellness exception in the USA.In the EU,over 1 in 2 stakeholders(57%)perceived the regulatory environment as a barrier to the clinical use of wearables,contrasting with 49%in the APAC region.Only 1 in 4 stakeholders in both regions did not perceive the regulatory environment as a barrier.52024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareStakeholders identified challenges such as usability,data accuracy,and data protection as significant barriers,with additional concerns about legal responsibilities in telemedicine and data interpretation.Among surveyed stakeholders,53%identified data security and privacy as significant barriers.Regional differences were clear60%of respondents in the Asia-Pacific(APAC)region flagged data accuracy as a significant concern,compared to only 33%in the European Union(EU).The importance of standards set by organisations like the International Electrotechnical Commission(IEC)and International Organization for Standardization(ISO)is highlighted for ensuring product quality and safety.However,a lack of awareness about these standards among stakeholders indicates the need for enhanced collaboration and education initiatives.The complexity and associated costs of MDR compliance particularly affect small to medium enterprises,restricting innovation by lengthening time-to-market.While regulatory frameworks provide a basis for trust and safety,they also introduce substantial obstacles.Positively,there is a growing inclination among insurance payers,especially in the EU,to support wearable use within medical devices,exemplified by initiatives like Prise en charge anticipe numrique(PECAN)and Digitale Gesundheitsanwendungen(DiGA)in France and Germany.Moving forward,incorporating patient perspectives,and the inclusion of global perspectives especially in the USA,are essential to fully understand wearable adoption.Moreover,the implications of emerging EU legislation,such as the EU AI Act and the European Health Data Space,require further exploration.Addressing concerns related to access,affordability,and digital literacy is vital for enhancing wearables adoption in healthcare.Overall,wearables hold significant promise for improving healthcare delivery through continuous and personalised monitoring.By addressing the identified barriers with targeted strategies,regulatory alignment,and inclusive policies,stakeholders can effectively support the integration of these technologies into healthcare systems.This white paper aims to catalyse ongoing discussion and research,reinforcing the essential role of wearables in global health management.“Positively,there is a growing inclination among insurance payers,especially in the EU,to support wearable use withing medical devices,exemplified by initiatives like PECAN and DiGA in France and Germany.”53%identified data security and privacy as significant barriers.62024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare2.0 IntroductionThe integration of consumer wearables is redefining the landscape of patient care and health monitoring,especially within cardiac health applications.These devices,which are designed for individual use and equipped with multiple sensors,provide real-time data on various health metrics such as heart rate,sleep patterns,and physical activity.In addition to these basic functions,wearables now include features like ECG and blood pressure monitoring,with the capability for preliminary data analysis to detect abnormalities such as heart arrhythmias.Over the past decade,wearables have transitioned from niche gadgets to essential tools in the healthcare arsenal,marked by a substantial increase in device ownership,reported between 41-53%in regions including the EU,USA,and China(Statistica,2024).Despite their potential to significantly enhance health monitoring and chronic condition management(Kim 2019),the adoption of wearables in clinical settings faces various barriers.These range from usability challenges and data management complexities to interoperability issues and concerns around security and privacy(Chakrabarti 2022).Moreover,the evolving regulatory landscapes further complicate their integration into healthcare systems.In particular,the redefinition of medical devices under the European Unions Medical Device Regulation(MDR)presents unique challenges,as different countries require varying levels of registration for certain functionalities.This technical paper seeks to explore these challenges in detail,focusing on cardiac applications and providing a global perspective on the differences in regulatory frameworks between the EU and the Asia-Pacific region.Through qualitative interviews and quantitative surveys with key stakeholders,including manufacturers,cardiologists,and insurers,we offer a comprehensive analysis of current adoption trends and future directions.Our aim is to identify strategic insights and practical recommendations that can help overcome regulatory barriers,thereby facilitating the integration of wearables in healthcare.By disseminating our findings,we aim to guide policymakers and industry stakeholders in adopting strategies that support innovation while ensuring that wearable technologies contribute effectively to health outcomes.This paper will serve as a foundation for ongoing dialogue and research,contributing to the development of global common standards and enhancing the utility of wearables in clinical practise.72024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare3.0 BackgroundUnlocking the Potential of Consumer Wearables in Healthcare82024 BSI.All rights reserved.3.1 Regulatory landscapeThe regulatory landscape for consumer wearables in healthcare is characterised by diverse frameworks that differ across regions.In the European Union(EU),the Medical Device Regulation(MDR)2017/745 provides a comprehensive system for determining whether wearables qualify as medical devices.The classification largely depends on the intended use defined by manufacturers,potentially categorising devices intended for diagnosis,monitoring,or treatment under the MDR.Accessories integral to the functionality of these medical devices also fall under this regulation.However,wearables often reside in a grey area between general consumer electronics and medical devices,which results in regulatory ambiguity.This ambiguity is particularly evident as the functionality of wearables extends beyond basic activity tracking to include more advanced capabilities,such as ECG and blood pressure monitoring and the detection of cardiac arrhythmias.As metrics and technological capabilities advance,the distinction between simple fitness trackers and sophisticated health monitoring devices which fall under SaMD regulation becomes increasingly important.In the United States,the Food and Drug Administration(FDA)adopts a different stance by allowing a General Wellness exception.This exception offers a regulatory pathway for low-risk devices aimed at promoting general health without medical claims.This provision allows companies such as Apple and Fitbit to introduce wearables with health-monitoring features without extensive medical device clearances,although they frequently secure 510(k)clearances for specific functionalities like ECG(Food,Drug,and Cosmetic Act,Section 201(h).In Asia-Pacific,Singapores healthcare sector combines public regulation and private innovation.The Health Sciences Authority(HSA)regulates Software as a Medical Device(SaMD),setting criteria for software that performs medical functions independently from hardware.These regulations ensure SaMD products meet safety and efficacy standards,aligning with international digital health best practises(HSA Medical Device Framework).Collectively there are large variances in the regulatory requirements between different regions with the EU MDR viewed as having the highest regulatory burden.92024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare3.2 Other regulatory areasEuropean Union(EU)In addition to regulations primarily focused on medical devices,the EU enforces the General Data Protection Regulation(GDPR),ensuring the proper handling of users personal and health data by consumer wearables.The EU Data Act aims to facilitate data access and sharing,while the Cybersecurity Act sets an EU-wide certification framework to bolster trust in digital products,including wearables.Furthermore,the EU AI Act seeks to establish secure and ethically aligned use of AI systems,which are increasingly integral to health monitoring in wearables.United States(USA)In the United States,the Health Insurance Portability and Accountability Act(HIPAA)remains a significant federal regulation for protecting patient information,which extends to data managed by consumer wearables interacting with healthcare providers.Beyond federal oversight,the Federal Trade Commission(FTC)ensures transparency in advertising claims and data security practises for wearables.In addition,twenty states(including California,Virginia and Colorado)have introduced data privacy regulations with several at committee stage.Asia-Pacific(APAC)The Asia-Pacific region exhibits a variety of regulatory approaches concerning data privacy and consumer wearables in the Act on the Protection of Personal Information(APPI)in Japan,Australias Privacy Act and The Personal Data Protection Act(PDPA)of Singapore all seek to safeguard individual personal data against misuse.Additionally various national cybersecurity regulations are in play such as Singapores Cybersecurity Act,enforced by the Cyber Security Agency(CSA),ensuring the protection of critical information infrastructure,addressing the security needs of data processed through wearables and other health-related digital devices.Overall,while regions like the EU and APAC maintain multiple regulatory structures for data privacy and cybersecurity,the USA primarily relies on HIPAA as a central component in managing technology use in healthcare environments.“As metrics and technological capabilities advance,the distinction between simple fitness trackers and sophisticated health monitoring devices which fall under SaMD regulation becomes increasingly important.”102024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare3.3 Standards landscapeStandards play a fundamental role in the development and deployment of technologies across various sectors,including consumer wearables in healthcare.They provide a framework for ensuring product quality,safety,interoperability,and performance consistency.The creation of standards is a collaborative process,involving representatives from industry bodies,research institutions,government agencies,consumers,and users of standards.These stakeholders come together in technical committees to draught and review standards,facilitated by national organisations.In the global arena,two key organisations responsible for developing and maintaining international standards are the International Electrotechnical Commission(IEC)and the International Organisation for Standardisation(ISO).The IEC,a global membership body of experts developing standards for electrical and electronic goods,ensuring safety and interoperability of devices and systems.ISO,brings together global experts to set standards for various fields and industries,promoting quality and efficiency and facilitating international trade and cooperation.The standards,developed through a consensus-driven process,with joint working between ISO and IEC are used by manufacturers to enhance quality management and,where applicable,to support conformity assessment.By adopting these standards,manufacturers can ensure that their products meet the required safety and performance benchmarks,enabling consistent quality and fostering trust in the global market.In regard to wearables,the standards landscape is predominately driven by IEC committee TC124(Wearable electronic devices and technologies),which focuses on standardisation across a broad range application.This committee emphasises performance measurement standards for wearables,seeking consistency and reliability in metrics like heart rate and step counting.Current published standards include IEC 63203-402-3:2024,which addresses heart rate accuracy,and IEC 63203-402-2:2024,focusing on step counting precision.Looking forward,future standards under development aim to cover stress measurements,sleep tracking,and mobile data security,aligning with emerging needs in wearable technology.These efforts aim to ensure interoperable,reliable,and secure wearable device integration within healthcare systems with significant buy-in from manufacturers.Joint Working Group 7(JWG7)is a collaborative initiative between ISO/TC 215 and IEC/SC 62A aimed at standardising health software and IT systems including medical devices.It focuses on developing joint standards to ensure these technologies are safe,effective,and secure throughout their lifecycle.The group covers significant areas like risk management for IT networks and health software,ensuring high safety and performance standards in clinical settings and coordinates the 82304,81001 and 80001 series of standards.112024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare3.4 Perceived barriers to adoptionUsability challengesThe adoption of consumer wearables in healthcare encounters several usability challenges primarily related to user characteristics,interaction and device utilisation.A key concern is ensuring that users achieve accurate and consistent measurements,as the effectiveness of these devices can be significantly influenced by individual differences.For example,variations in skin colour,body weight,and body composition can affect how users interact with wearable sensors and the quality of data captured.These considerations necessitate design features that are adaptable to diverse user profiles.Factors like temperature,altitude,and humidity further complicate maintaining consistent data quality.Additionally,efficient internet connectivity is essential for these devices to function properly as it enables data transmission and processing;a lack of connectivity can hinder real-time health data analysis,particularly in rural or developing areas(Chakrabarti 2022).Variability in accuracy across devicesThe accuracy of the sensors themselves presents another adoption barrier.There are inconsistencies in the biometric data reported by various consumer wearables,such as heart rate,blood pressure,and oxygen saturation measurements(Hahnen 2020 and Nelson 2019).For these devices to gain trust and acceptance within healthcare settings,it is important that their sensors consistently meet the precision levels of traditional diagnostic tools.Moreover,while some devices have been approved by the FDA,others lack complete CE marking,which affects their perceived reliability and emphasises the necessity for thorough validation(Brnneke 2021).Volume and analysis of wearable dataCardiologists already have concerns of being overwhelmed by data from consumer wearables,even before anticipating future adoption(Cardiologist FR)with the current manual sharing of data with clinicians(via email and PDF)needing to be summarised rather than directly integrating raw data.(Cardiologist,SGP).As wearable devices continue to integrate into medical practice,they introduce several legal considerations that stakeholders must address to ensure their safe use(DeClue 2023).A key issue is the legal responsibility of clinicians when receiving,interpreting,and acting upon data from wearables(Cardiologist FR).122024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareEnsuring data protection and complianceData privacy and security are of critical importance for consumer wearables,given their close association with personal health information.Regulatory requirements such as the GDPR in the EU and HIPAA in the US mandate robust privacy information management systems to safeguard user data(Brnneke 2021).However wearable devices are susceptible to cybersecurity risks,particularly those that are networked or internet-connected,which introduces vulnerabilities due to dependencies on third-party components(Brnneke 2021).Whilst the nature of complex calculation and data flows gives rise to major data security and privacy challenges exacerbated by poor data encryption and protection.(Chakrabarti 2022).Compliance with these privacy and data security regulations is essential for gaining market access and ensuring the adoption of wearables in applications like cardiac monitoring(Brnneke 2021).As these regulations are fundamental to building consumer trust,attention must be paid to integrating strong compliance measures into product development processes.3.5 Impacts of wearables on healthcareThe integration of consumer wearables into national healthcare programmes across different regions highlights its growing role in enhancing health management and patient outcomes.In Europe,France and Germany are leading with reimbursement processes such as PECAN and DiGA,requiring evidence of cost and clinical effectiveness,alongside technical standards.Germany has incorporated wearables into digital therapeutics,focusing on obesity and insomnia,while Frances collaboration with Withings facilitated a significant integration of consumer health data into the national health record through Mon Espace Sant.Conversely,in the APAC region,South Koreas My HealthWay platform aims to integrate wearable data into chronic disease management,enhancing diabetes care through consolidated health records.Similarly,Japans partnership between Fujitsu and Sapporo Medical University Hospital underscores efforts to improve healthcare data accessibility and management,setting a precedent for future digital health initiatives.These initiatives,while still evolving,reflect a global trend towards leveraging wearable technology to enhance healthcare delivery and patient empowerment,potentially leading to improved healthcare outcomes and economic benefits.132024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare142024 BSI.All rights reserved.4.0 Methods142024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare4.1 Research designThis study employs a mixed-methods approach to explore the impact of regulatory environments on the adoption and utilisation of consumer wearables in healthcare settings,particularly focusing on cardiac health applications.Our research design integrates both qualitative and quantitative methodologies to obtain a comprehensive view of current practises and challenges.Literature reviewThe literature review employed a structured approach to assess resources aligned with the research interests.Initially,objectives and hypotheses were articulated to develop detailed search strings using PubMed Boolean operators.This involved identifying key search terms and their synonyms to ensure a comprehensive yet precise search.A PubMed search API was utilised to retrieve relevant articles efficiently with content analysis conducted to evaluate the relevance of each study to the research aims.Summaries were generated employing the PICOS framework to systematically consider the Participants,Interventions,Comparisons,Outcomes,and Study Design within each study.This methodology assisted in integrating insights from the literature into the broader research context focusing on regulatory environments and the adoption of consumer wearables in healthcare settings.Qualitative interviewsFor the qualitative component,we conducted semi-structured one-to-one 30-minute interviews with stakeholders,including cardiologists,manufacturers,insurance payers,and regulators.A total of 20 interviews were held with participants from France,Germany,Finland,Singapore,China,and Japan.These interviews were conducted in English via Zoom,allowing for flexible scheduling to accommodate participants time zones and ensuring a diverse range of perspectives.Transcripts were made with participant consent,and all data was anonymised to maintain confidentiality.Quantitative surveyThe quantitative aspect consisted of an online survey administered to 139 participants across France,Germany and Singapore designed following the CHERRIES framework to ensure methodological rigour and consistency.The survey population included cardiologists,manufacturers of wearables and insurance payers.The survey was developed in light of themes identified in the preliminary literature review and input from qualitative interviews,ensuring relevance and comprehensiveness.152024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare4.2 Data analysisThematic analysisThe qualitative data collected from interviews were analysed through thematic analysis.Our approach began with a review of existing literature to develop an initial coding framework,which guided the identification of key themes.We employed a Large Language Model(GPT-3.5-16k-turbo)for AI-assisted coding.The model was deployed via a commercial API specifically prompted and guard railed to perform analysis,allowing it to accurately identify and categorise themes within the data.This AI integration facilitated efficient data processing while allowing for flexibility,enabling new themes to emerge naturally from the data without being constrained by pre-established categories.This dual strategy ensured that our analysis was grounded in established knowledge yet responsive to fresh insights,capturing diverse stakeholder perspectives across different international contexts.Statistical analysisFor the quantitative survey data,we employed both descriptive and exploratory methods.In the descriptive phase,we calculated means and frequency distributions to summarise participant responses,providing an initial understanding of the data.Cross-tabulations were performed based on region(EU vs.APAC)and stakeholder roles(cardiologists,manufacturers,insurers)to identify potential trends or differences within the data.These preliminary analyses were initially conducted in the Forsta Surveys platform and subsequently detailed in Excel,ensuring consistent and organised data management.While we did not perform formal significance testing our analysis included cross-tabulation techniques that offers preliminary exploratory insights.This dual approach facilitated a comprehensive understanding of patterns within the sample and provided a quantitative counterpart to the qualitative themes,allowing a triangulation of findings that supports robust conclusions and recommendations.162024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare172024 BSI.All rights reserved.5.0 FindingsUnlocking the Potential of Consumer Wearables in Healthcare172024 BSI.All rights reserved.5.1 Demographics of respondentsThe interviews were conducted with a mix of stakeholders,consisting of 9 manufacturers of consumer wearables,5 cardiologists,4 insurance payers,and 2 regulators.Participants were distributed across regions with 11 from the EU and 9 from APAC countries.The survey reached a wider audience of 137 respondents,including diverse stakeholders such as cardiologists(34),insurance payers(53),and manufacturers(50),with almost equal representation from the EU and APAC regions from France,Germany and Singapore.This demographic data offers an expanded understanding,reflecting balanced insights from both regional and professional standpoints.5.2 Awareness and importance of wearablesFamiliarity with consumer wearables was high,with 60%reporting they were“very familiar”with their use.Manufacturers showed the highest familiarity(70%),underscoring the industrys focus on these technologies.The majority,57%,rated wearables as“very important”for improving health outcomes,especially in post-treatment recovery and chronic disease management.This finding is echoed by an APAC cardiologist:“Wearable devices provide continuous health data,allowing doctors to monitor long-term health conditions.”This was consistent with interview insights,where most stakeholders,except for some cardiologists,recognised their importance in enhancing patient care(Cardiologist FR).57%The majority,57%,rated wearables as“very important”for improving health outcomes,especially in post-treatment recovery and chronic disease management.182024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare5.3 Perceived barriers to adoptionRegulatory complianceAPAC Cardiologists29%APAC Insurance Payers46%APAC Manufacturers of Wearables29%EU Cardiologists53%EU Insurance Payers15%EU Manufacturers of Wearables46%TotalAPAC CardiologistsN=17APAC Insurance PayersN=26N=24APAC Manufacturers of WearablesEU CardiologistsN=17N=27EU Insurance PayersEU Manufacturers of WearablesN=26Data security/privacyAPAC Cardiologists53%APAC Insurance Payers58%APAC Manufacturers of Wearables67%EU Cardiologists47%EU Insurance Payers37%EU Manufacturers of Wearables582024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareCost of devicesAPAC Cardiologists59%APAC Insurance Payers62%APAC Manufacturers of Wearables38%EU Cardiologists59%EU Insurance Payers52%EU Manufacturers of Wearables38%Lack of clinician trustAPAC Cardiologists29%APAC Insurance Payers54%APAC Manufacturers of Wearables38%EU Cardiologists41%EU Insurance Payers30%EU Manufacturers of Wearables23ta accuracyAPAC Cardiologists53%APAC Insurance Payers62%APAC Manufacturers of Wearables63%EU Cardiologists29%EU Insurance Payers33%EU Manufacturers of Wearables35%Usability concernsAPAC Cardiologists41%APAC Insurance Payers42%APAC Manufacturers of Wearables17%EU Cardiologists29%EU Insurance Payers44%EU Manufacturers of Wearables31 2024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcarePatient usage/complianceAPAC Cardiologists41%APAC Insurance Payers62%APAC Manufacturers of Wearables25%EU Cardiologists71%EU Insurance Payers41%EU Manufacturers of Wearables35%Reimbursement from insuranceAPAC Cardiologists41%APAC Insurance Payers58%APAC Manufacturers of Wearables25%EU Cardiologists53%EU Insurance Payers26%EU Manufacturers of Wearables31%Regulatory impactThe regulatory environment emerged as a significant factor influencing consumer wearable adoption.While some interviewees saw regulation as a barrier,particularly EU regulations under the MDR,there was also recognition that classifying wearables as medical devices might improve safety and encourage adoption among clinicians(Payor,FR;Cardiologist,FR).Global perspectives showed less stringent regulatory frameworks in Singapore encouraging innovation,though there was an acknowledgment that regulations might tighten over time(Cardiologist,SGP).Regulatory environments significantly influence wearable adoption in our wider survey,with 36%perceiving regulatory compliance as a barrier,notably higher among EU cardiologists(53%)compared to APAC(29%).The classification of smart wearables as medical devices has elicited varied responses regarding its impact on adoption and innovation in healthcare.Among manufacturers of wearables,a notable 86%view this classification positively.Meanwhile,cardiologists express more caution;38%expect somewhat negative impacts on device adoption and patient usage if costs rise due to reclassification.212024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareData accuracyData accuracy remains a concern,identified by 46%of respondents,particularly within APAC groups(60%)over the EU(33%).Concerns were highlighted regarding the reliability of wearable data for clinical decisions,especially among the elderly,with quotes reflecting expectations for“accuracy improvements.”Usability concerns,particularly involving older adults with limited digital literacy,were particularly noted by EU cardiologists(71%).Security and privacy concernsData security and privacy were viewed as significant barriers,with strong support for robust data protection measures.Although these issues were highlighted,they were often considered secondary to accuracy and usability in both survey responses and interviews.With 53%identifying data security and privacy as barriers,these issues hold substantial weight,especially within APAC(60%)compared to the EU(47%).Concerns regarding data compliance with privacy regulations were common,with respondents expressing apprehensions about security breaches:“Although wearable devices can collect large amounts of health data,whether they comply with privacy and security regulations is still a question.”71%Usability concerns,particularly involving older adults with limited digital literacy,were particularly noted by EU cardiologists(71%).This cautious stance is particularly pronounced among EU cardiologists,where 53%hold similar concerns.On the investment front,stakeholders generally foresee growth,with 79%predicting either an increase or slight increase in technology investment in wearables.Specifically,54%of EU manufacturers believe this classification will slightly increase innovation,while 62%of APAC manufacturers anticipate a significant increase.Insurance payers,however,remain concerned about cost implications,with 11%of APAC insurance payers anticipating negative effects on adoption.Acknowledgment of less restrictive environments in the USA and Singapore also emerged,with 39%citing these as more favourable,indicative of their influence on innovation and market strategies.UsabilityInterview results consistently identified data accuracy as a critical barrier.Concerns over the reliability of consumer wearables to support clinical decisions were prevalent,echoing interview findings centred on sensor accuracy and usability challenges(Cardiologist,FR;Manufacturer,FR).Usability issues,particularly among older patients with low digital literacy,were also noted,affecting both user and clinician adoption(Cardiologist,FR).222024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareCost and reimbursementThe cost of devices emerged as another barrier in both the EU and APAC,with reimbursement policies under debate.While some currently offer reimbursement,types of coverage vary,and new regulations could induce changes(Manufacturer,DE).This concern was indicated in 50%of participants,highlighted prominently by non-manufacturers.Reimbursement from insurance was noted as a potential barrier at 38%,reflecting diverse regional policies.Cost remains a key factor ”As the item is not cheap,perhaps we need to increase the reimbursement budget.”suggests a need for systemic involvement to mitigate financial barriers.5.4.Perceptions of regulatory changesAwareness of the introduction of the European MDR in 2017 was high among respondents.Opinions varied on whether these regulatory changes would positively or negatively impact adoption,although some believed it could enhance safety and trust(Cardiologist SGP).While high awareness of recent EU MDR changes was observed,perspectives on their impact were mixed.In the EU,57%agreed the regulatory environment poses a barrier,whereas 49%of APAC stakeholders shared this view.Positively,regulatory adjustments are anticipated to enhance safety and trust,though concerns about delaying adoption exist across both regions with 77%saying they believe that will positively impact the adoption of consumer wearables in a clinical setting.“Although wearable devices can collect large amounts of health data,whether they comply with privacy and security regulations is still a question.”232024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare5.5 Future adoption trendsForward-looking insights reveal increasing clinician advocacy for consumer wearables over the coming decade,with 65%very likely to recommend these devices in the next 5-10 years.Optimism was slightly higher in APAC,reflecting regional regulatory perceptions.Manufacturers are particularly optimistic,expecting these technologies to significantly impact healthcare delivery.Despite current regulatory and operational challenges,the anticipation for future integration of wearables remains strong,underscoring a shared belief in their potential to influence healthcare positively.This optimism was echoed in interviews,particularly from manufacturers who are exploring strategies to navigate complex regulations through partnerships and understanding regional guidelines(Manufacturer,DE).5.6 Standards developmentThe development of global standards for consumer wearables was strongly supported by respondents,with 85%expressing a positive stance.This support was notably higher among manufacturers,with 96%in favour,indicating a broad recognition of the importance of standardisation in ensuring quality,safety,and performance.The emphasis on developing standards was reflected across various stakeholder groups,with cardiologists and insurers also showing significant backing.Key areas for standard development included data security and interoperability,underscoring the need for clear guidelines in data handling practises.Additionally,environmental standards in production and packaging were noted,reflecting broader sustainability concerns within the industry.5.7 Stakeholder-specific insightsCardiologistsCardiologists demonstrated varied implementation levels,with some already using consumer wearables for cardiac monitoring.Notably,areas where wearables could potentially aid such as cardiac disease(Cardiologist FR)and lifestyle interventions were identified as impactful.Within the survey data cardiologists show acknowledged wearables potential in managing cardiac diseases and lifestyle interventions.EU practitioners were more likely to embrace wearables for cardiac care(88%)compared to APAC(71%).Data reliability issues persist,with 41%expressing concern over clinical application.Regulatory compliance remains a challenge,contrasting with more flexible environments seen in APAC.88%EU practitioners were more likely to embrace wearables for cardiac care(88%).65%Forward-looking insights reveal increasing clinician advocacy for wearables over the coming decade,with 65%very likely to recommend these devices in the next 5-10 years.242024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareManufacturers of consumer wearablesManufacturers highlighted regulatory compliance as a challenge during our interviews,with costs and data standards posing hurdles(Manufacturer,SGP).They are seeking more collaboration to streamline processes and facilitate market entry.Consumer wearable manufacturers emphasise regulatory compliance as a barrier to adoption,with 62%highlighting country-specific laws strategic relevance,particularly in the EU(73%).Despite challenges,regulations are also seen as opportunities to enhance market trust.Manufacturers value partnerships with healthcare providers,with 64%underscoring this importance,expected to facilitate future integration and wearable adoption.Insurance payers Insurance payers emphasised the need for data-driven evidence from manufacturers to support reimbursement.They also expressed concerns about ensuring cost-effectiveness,reflecting the complexities in justifying consumer wearables from an insurance perspective (Payor,FR).The survey confirmed Insurance payers willingness to support wearable use,with 81%in the EU and 92%in APAC engaged in reimbursement plans.However,concerns over privacy,security,and elevated reimbursement costs persist.APAC payers are less constrained by regulatory barriers compared to their EU counterparts,promoting a more proactive stance towards wearable adoption.Optimism for technological integration aligns with expectations for improved healthcare outcomes,albeit with careful cost management.62%Wearable manufacturers emphasise regulatory compliance as a barrier to adoption,with 62%highlighting country-specific laws a strategic relevance.252024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare262024 BSI.All rights reserved.6.0 DiscussionUnlocking the Potential of Consumer Wearables in Healthcare262024 BSI.All rights reserved.The integration of consumer wearables into the healthcare system,particularly in the realm of cardiac care,represents a significant shift in how patient data is collected and utilised.Our study has shown that despite numerous challenges,there is a strong interest among stakeholders ranging from clinicians and manufacturers to payers to adopt and integrate thesetechnologies.6.1 Summary of key findingsDifferences in concerns over privacy and accuracyOur study highlights a notable disparity in concerns regarding data privacy and accuracy between stakeholders in the APAC and EU regions.In the EU,stringent regulations,such as GDPR and MDR,seem to mitigate concerns related to these areas.This is likely due to the strong regulatory framework that addresses data protection comprehensively.On the other hand,stakeholders in APAC report higher concerns regarding data accuracyparticularly among cliniciansbut express less apprehension about barriers like clinician trust and patient compliance,despite operating within a more flexible regulatory environment.This variance suggests that while regulatory contexts shape stakeholder concerns and expectations,they do not automatically ensure a consistent reduction in adoption barriers across regions.Regulatory environments positive impactInterestingly,despite initial perceptions of regulation as a hurdle,many respondents note the positive impact of regulatory frameworks on the effective use of consumer wearables within clinical settings.This is particularly relevant in ensuring safety,effectiveness,and usability among stakeholders.The findings around current adoption by clinicians in the EU is higher than APAC may be due to regulation and impact on trusts and reimbursement.The challenge,however,lies in balancing these benefits with the increased costs and complexities associated with compliance to create an increased level of trust in wearables across groups.Adoption supported by insurance payersOur findings also highlight a growing willingness among insurance payers to support the use of consumer wearables in clinical environments,particularly in the EU.This support is crucial,particularly for cardiac applications,where continuous monitoring across the pathway can significantly enhance patient care and outcomes.Payers are beginning to appreciate the long-term benefits of wearables,paving the way for broader adoption as part of standard healthcare practises.The difference in Insurance Payers attitudes to reimbursement may be due to the advanced pathways for wearables in France and German under the PECAN and DiGA frameworks.272024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare“The ability of wearables to provide continuous monitoring and real-time feedback is seen as a key advantage,offering insights into patients health that were previously unavailable.”Broad applications across care pathwaysConsumer wearables are gaining traction across cardiac pathways with only a small minority of physicians(6-9%)reporting they would not consider using wearables.This demonstrates a versatile application across various stages of patient care from prevention,diagnoses,pre-treatment and recovery reinforcing their utility beyond traditional clinical settings.The ability of wearables to provide continuous monitoring and real-time feedback is seen as a key advantage,offering insights into patients health that were previously unavailable.Concerns about increasing costsDespite these positive trends,the costs of consumer wearables present an area of concern for adoption.This is seen as more acute given the expenses stemming from increased regulation.The potential impact of these costs touches not only on individual adoption rates but also on systemic issues such as widening health inequalities.The perceptions of cost and value are critical in addressing these;while some stakeholders may not view wearables as expensive,there is a need for clear communication on the benefits these devices offer.This could help offset concerns about their cost,particularly when compared to other consumer technologies like mobile devices.Demonstrating the tangible benefits and value of wearables can play an essential role in enhancing their perceived worth and justifying the investment to both consumers and healthcare systems.If left unaddressed,these financial barriers could disproportionately affect underserved populations,limiting their access and further entrenching existing disparities in healthcare.Optimism for future integrationThe findings are encouraging as there remains a strong sense of optimism about the future role of consumer wearables in healthcare.This sentiment is shared across regions,though it seems particularly robust in APAC,however this may be due to the higher rate of adoption in the EU where benefits are already being realised.Stakeholders envisage an era where wearables become seamlessly integrated into clinical practise,a vision supported by ongoing improvements in technology and data management.The focus now shifts to how swiftly these technologies can be incorporated into everyday healthcare while addressing existing challenges.282024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareThe role of standards and pragmatic balancingThe strong support for the development of global standards for consumer wearables reflects a consensus among stakeholders on the necessity of creating a reliable framework for the integration of these devices into healthcare.However,it is not entirely clear from the research whether respondents are fully informed of the existing standards relevant to wearable technology and its use in healthcare environments(For example the work of IEC committee TC214 or ISO TC215/IEC SC62A Joint Working Group 7).There appears to be a gap in awareness about the broader scope of non-medical device regulations and general standards that might support the adoption of wearables.Addressing barriers such as usability,accuracy,data privacy,and security could be facilitated through these broader standards,enhancing clinician trust and integration into clinical practise.As stakeholders consider the development of new standards,it is essential to also leverage existing frameworks that could indirectly support wearable technologys inclusion in healthcare and fostering adoption.Overall perspectiveThe integration of consumer wearables into healthcare systems brings with it both challenges and opportunities.This discussion underscores the need for balanced approaches that consider regional regulatory impacts,cost implications,and the diverse needs of stakeholders.It is of note that more stringent regulation does not act as a panacea for all barriers to adoption.As wearables continue to evolve,ensuring equitable access and robust data systems will be central to realising their full potential.The future of wearables in healthcare looks promising,provided stakeholders work collaboratively to address existing barriers and leverage the technologys benefits comprehensively.292024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare6.2 Strengths and limitationsStrengths of the research undertaken centres on the comprehensive stakeholder involvement across payer,manufacturer and clinicians.The participants direct experience of the use of consumer wearables in healthcare environments gives us solid evidence from which to develop the next stage of the research.The participants give a solid contrast between the EU and Asia-Pacific.Limitations exposed in the interview stage were lack of engagement from Japanese stakeholders.Responses from regulators were also hard to obtain,however their position was not considered necessary as this paper relates to stakeholders response to the regulatory environments they work within.The initial interviews(n=22)completed were felt to be an appropriate sample to identify key themes to develop and administer the survey.Participants(n=137)from Germany,France and Singapore are felt to be suitably representative to indicate robust contrast between clinical and regulatory environments in the EU and APAC at survey stage.Whilst a cross section of stakeholders is included,they have all been self-selecting or identified by the research team and the risk of bias is acknowledged.In addition,all interviews and surveys were conducted in English,which is not the vast majority of participants first language which may have impacts on interpretation,however where practical the interviewer was a native speaker able to assist where needed and survey respondents were self-selecting on the basis of English proficiency.Finally due to the focus on regulatory impacts and clinical use the research does not include patient or user input who are integral to adoption of wearables in healthcare.The findings of this paper could act as a basis for future work to determine patient and citizen insights.302024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare7.0 Future direction and strategy recommendationsInnovation facilitationStakeholders should proactively engage with evolving policies,like the European Health Data Space and the EU AI Act,to better align consumer wearables with regulatory requirements and opportunities.While advanced sensing capabilities continue to evolve,the focus should be on enabling data integration and interoperability across diverse healthcare environments.Wearables should aim to integrate seamlessly into these frameworks,potentially offering solutions to broader healthcare data challenges and be able to enable software developers to meet their obligations around data collection and sharing.Policy implications and reimbursement processesPolicymakers should focus on the intricacies of reimbursement processes,acknowledging their country-specific elements while ensuring cross-border applicability balanced against costs and resources required of evaluation.Engaging with digital health technology assessment initiatives,currently underway in the EU,can keep stakeholders informed on emerging trends that might impact standards and reimbursement.Aligning these processes with international healthcare systems and considering similar developments in the US through organisations such as the Peterson Health Technology Institute,will support a unified approach to technology adoption in healthcare.Standards awareness and developmentEnhancing awareness around existing standards is key to advancing the integration of consumer wearables in healthcare.Encouraging collaboration among standards groups can facilitate greater clarity on how these standards apply to various aspects of wearable technology and their use in healthcare settings.It is crucial for both the industry and healthcare organisations to ensure these standards address specific market needs,particularly regarding data privacy and security.By leveraging standards beyond medical device regulations,such as ISO 82304-2 for healthcare software products,stakeholders can effectively address and overcome adoption barriers through product labelling.312024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareFuture research directionsFuture research should incorporate patient perspectives,providing insights into how consumer wearables can support general health and chronic condition management.Exploring the US market alongside EU and APAC comparisons can reveal strategies for broader adoption.Focusing on how wearables can empower individuals in managing their health outside traditional clinical settings can help reduce the burden on healthcare systems and enhance overall patient care.Industry guidelinesManufacturers are encouraged to develop their product roadmaps with a comprehensive view of both regulatory requirements and clinical needs.Maintaining flexibility by staying informed on upcoming regulatory changes can enhance product readiness and market adaptability.Notwithstanding medical device regulation,manufactures should look to have processes and policies in place for Quality,Data Privacy and Information Security Management combined with a robust understanding of clinical risk in place to build trust amongst stakeholders.This approach ensures that wearables not only adhere to current regulations but are also well placed to meet future demands for safety,effectiveness,and security.322024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare8.0 ConclusionAs consumer wearables continue to advance,they hold significant promise for enhancing patient care and health monitoring,particularly within cardiac applications.This white paper has outlined the diverse benefits and challenges associated with integrating these devices into healthcare settings.Our findings indicate a strong interest among stakeholders across regions and sectors in adopting wearable technology,despite the various hurdles.Key findings from this study include notable regional differences in data privacy and accuracy concerns and a recognition of the positive role robust regulatory environments can play in facilitating adoption.The support from insurance payers,especially in regions where reimbursement pathways are developed,underscores the growing acceptance of wearables in clinical settings.Nonetheless,issues such as cost,data accuracy,usability,and privacy remain significant barriers that need addressing to further enhance adoption rates.The potential of consumer wearables to reshape healthcare extends far beyond cardiac monitoring.With advancements in technology and regulatory pathways providing better clarity,the integration of wearables in patient care is increasingly becoming a reality.By leveraging these technologies and addressing current limitations,stakeholders can improve health outcomes and foster innovative healthcare solutions.Future opportunities lie in fostering greater awareness of standards,facilitating better collaboration among various stakeholders,and integrating patient perspectives into the development and deployment of wearable technologies.By refining regulatory frameworks and ensuring inclusivity in access,the adoption of wearables in healthcare settings can be expedited,allowing patients and providers alike to reap the benefits of these technologies.The journey ahead involves overcoming existing challenges,but the outlook for the integration of consumer wearables in healthcare is optimistic.332024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareReferencesStatista.(2024).Wearable devices ownership in selected countries as of March 2024 Data set.Released June 2024.Retrieved November 22,2024,from https:/ J,Campbell AS,de vila BE,Wang J.Wearable biosensors for healthcare monitoring.Nat Biotechnol.2019 Apr;37(4):389-406.doi:10.1038/s41587-019-0045-y.Epub 2019 Feb 25.PMID:30804534;PMCID:PMC8183422.European Parliament and Council.(2017).Regulation(EU)2017/745 on medical devices,amending Directive 2001/83/EC,Regulation(EC)No 178/2002 and Regulation(EC)No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.Accessed November 22,2024,from https:/eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745U.S.Food and Drug Administration(FDA).(2019).General Wellness:Policy for Low Risk Devices-Guidance for Industry and Food and Drug Administration Staff.Last updated September 2019.Accessed November 22,2024,from https:/www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devicesInternational Association of Privacy Professionals(IAPP).(2024).US State Privacy Legislation Tracker.Last updated November 18,2024.Accessed November 22,2024,from https:/iapp.org/resources/article/us-state-privacy-legislation-tracker/Brnneke JB,Mller J,Mouratis K,Hagen J,Stern AD.Regulatory,Legal,and Market Aspects of Smart Wearables for Cardiac Monitoring.Sensors(Basel).2021 Jul 20;21(14):4937.doi:10.3390/s21144937.PMID:34300680;PMCID:PMC8309890.Chakrabarti S,Biswas N,Jones LD,Kesari S,Ashili S.Smart Consumer Wearables as Digital Diagnostic Tools:A Review.Diagnostics(Basel).2022 Aug 31;12(9):2110.doi:10.3390/diagnostics12092110.PMID:36140511;PMCID:PMC949827Awad S,Aljuburi L,Lumsden RS,Mpandzou M,Marinus R.Connected health in US,EU,and China:opportunities to accelerate regulation of connected health technologies to optimize their role in medicines development.Front Med(Lausanne).2023 Aug 7;10:1248912.doi:10.3389/fmed.2023.1248912.PMID:37608832;PMCID:PMC10441228.Pepplinkhuizen S,Hoeksema WF,van der Stuijt W,van Steijn NJ,Winter MM,Wilde AAM,Smeding L,Knops RE.Accuracy and clinical relevance of the single-lead Apple Watch electrocardiogram to identify atrial fibrillation.Cardiovasc Digit Health J.2022 Dec 15;3(6 Suppl):S17-S22.doi:10.1016/j.cvdhj.2022.10.004.PMID:36589758;PMCID:PMC9795256.Hahnen C,Freeman CG,Haldar N,Hamati JN,Bard DM,Murali V,Merli GJ,Joseph JI,van Helmond N.Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device:Validation Study.JMIR Mhealth Uhealth.2020 Feb 12;8(2):e16811.doi:10.2196/16811.PMID:32049066;PMCID:PMC7055753.DeClue,Polina.(2023).Health Monitoring From Home:Legal Considerations of Wearable Technology in Telemedicine.SMU Science and Technology Law Review.26.111.10.25172/smustlr.26.1.7.Nelson BW,Allen NB.Accuracy of Consumer Wearable Heart Rate Measurement During an Ecologically Valid 24-Hour Period:Intraindividual Validation Study.JMIR Mhealth Uhealth.2019 Mar 11;7(3):e10828.doi:10.2196/10828.PMID:30855232;PMCID:PMC6431828.International Electrotechnical Commission(IEC).(n.d.).IEC TC 124 Wearable electronic devices and technologies.Retrieved November 22,2024,from https:/www.iec.ch/dyn/www/f?p=103:23:627962597046073:FSP_ORG_ID,FSP_LANG_ID:20537,25Withings.(2022,November 3).Withings intgre Mon espace sant Press release.Retrieved November 22,2024,from https:/ T,Kang S,Yeo NY,Kim TH,Kim WJ,Yi BK,Jang JW,Park SW.Status of MyHealthWay and Suggestions for Widespread Implementation,Emphasizing the Utilization and Practical Use of Personal Medical Data.Healthc Inform Res.2024 Apr;30(2):103-112.doi:10.4258/hir.2024.30.2.103.Epub 2024 Apr 30.PMID:38755101;PMCID:PMC11098772.342024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareInternational standardsCurrent IEC 63203-402-3:2024 Wearable electronic devices and technologies Part 402-3:Performance measurement of fitness wearables Test methods for the determination of the accuracy of heart rate.IEC 63203-402-2:2024 Wearable electronic devices and technologies Part 402-2:Performance measurement of fitness wearables Step counting.IEC 63203-406-1:2021 Wearable electronic devices and technologies Part 406-1:Test method for measuring surface temperature of wrist-worn wearable electronic devices while in contact with human skin.In development 124-9 Future IEC 63203-402-X:Wearable electronic devices and technologies Part 402-X:Performance of Stress Measurements in wearables.124-11 Future IEC 63203-402-X:Wearable electronic devices and technologies Part 402-X:Performance Measurement of Fitness Wearables Sleep Measurements.124-12 Future IEC 63203-40X-X:Wearable electronic devices and technologies Part 40X-X:Mobile wearable device data security.352024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in Healthcare“Because most of the people have a consumer wearable for example from Apple or Samsung watch,it brings additional benefits.But of course,we would need to also consider the people who dont have a watch and may find it expensive,they might have difficulty getting one.”Insurer,APAC“To facilitate the broader use of wearables in clinical settings,Id like to see clearer guidelines on data privacy and security,ensuring that wearable data can be safely integrated into electronic health records.”Manufacturer,EU“Although wearables provide encouraging results,further study is required to guarantee consistency.”Cardiologist,EU“Wearables should be a mandatory requirement especially for seniors with chronic illness that need immediate medical attention.”Cardiologist,EU“Such regulations are important for our customers too,its good for both the company and consumer.”Manufacturer,EU“As the item is not cheap,perhaps we need to increase the reimbursement budget.There might be influx of reimbursements.After consumer purchases the watch,I fear that they might not be compliant in using it.”Insurer,APAC“I believe the regulatory changes will positively impact the adoption of wearables in healthcare.By classifying them as medical devices,wearables must meet higher standards for accuracy and safety,which can increase trust among healthcare providers and patients.This ensures better data quality and integration with healthcare systems,ultimately leading to improved patient outcomes and wideracceptance.”Manufacturer,APAC“Fostering collaboration between regulatory bodies,healthcare providers,and technology developers can help create a more cohesive framework for integrating wearables into clinical practice.Regular dialogue and feedback loops can ensure that regulations keep pace with technological advancements and address the practical needs of healthcare settings.These changes would help in making wearables more accessible and widely adopted in clinical environments.”Manufacturer,APACKey comments362024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareBSI Group389 Chiswick High RoadLondon,W4 4AL United Kingdom 44 345 080 2024 BSI.All rights reserved.
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