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1、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 adoption13Impactsofw

2、earablesonhealthcare4.0 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 Discu

3、ssion27Summaryofkeyfindings30 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 editoria

4、l 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 th

5、e 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 wearabl

6、es 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 env

7、ironment 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 integ

8、ration 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

9、,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 g

10、uide 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 h

11、ealthcare,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-

12、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

13、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 manufacture

14、rs,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

15、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

16、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

17、 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 a

18、s 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 o

19、f 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 fra

20、meworks 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 Digi

21、tale 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 t

22、he 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

23、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 e

24、ssential 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

25、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 a

26、re 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 fo

27、r 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,a

28、nd 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 iss

29、ues 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

30、,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-Paci

31、fic 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

32、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 t

33、o 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.

34、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 Re

35、gulation(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

36、 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 wearable

37、s 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 devi

38、ces 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 m

39、edical 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).I

40、n 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 product

41、s 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 ri

42、ghts 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

43、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 syste

44、ms,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 in

45、teracting 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 severa

46、l 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 a

47、ll 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 need

48、s 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 envir

49、onments.“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 Heal

50、thcare3.3 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

51、 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

52、 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 electr

53、onic 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 proces

54、s,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 qual

55、ity 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

56、 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 d

57、evelopment 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

58、 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 gro

59、up 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 Healt

60、hcare3.4 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 measur

61、ements,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 f

62、eatures 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

63、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 variou

64、s 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.M

65、oreover,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 f

66、rom 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 pract

67、ice,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 Pot

68、ential 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 r

69、obust 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).W

70、hilst 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 ad

71、option 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 consu

72、mer 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 effectivenes

73、s,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

74、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 healthcar

75、e 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 outcome

76、s 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

77、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

78、 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 identif

79、ying 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 f

80、ramework 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 wearable

81、s 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,F

82、inland,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 confidentia

83、lity.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 w

84、earables 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

85、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-

86、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,enabli

87、ng 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 contex

88、ts.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 bas

89、ed 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

90、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 qua

91、litative 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 Healthcare17

92、2024 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 APA

93、C 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 expan

94、ded 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

95、 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 do

96、ctors 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,e

97、specially 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 Cardi

98、ologists53%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 M

99、anufacturers of Wearables67%EU Cardiologists47%EU Insurance Payers37%EU Manufacturers of Wearables58%192024 BSI.All rights reserved.Unlocking the Potential of Consumer Wearables in HealthcareCost of devicesAPAC Cardiologists59%APAC Insurance Payers62%APAC Manufacturers of Wearables38%EU Cardiologist

100、s59%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 Wearables23%Data accuracyAPAC Cardiologists53%APAC Insurance Payers62%APAC Manu

101、facturers 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%202024 BSI.All rights reserved.U

102、nlocking 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 Pa

103、yers58%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 reg

104、ulations 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

105、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

106、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 devi

107、ce 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 wer

108、e 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

109、(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

110、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 de

111、vices 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

112、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

113、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 a

114、lso 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 prevalen

115、t,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.Un

116、locking 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(Manu

117、facturer,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 rei

118、mbursement 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 impa

119、ct 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.Po

120、sitively,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

121、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 wearabl

122、es 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 c

123、urrent 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 n

124、avigate 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

125、 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 ar

126、eas 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-sp

127、ecific 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.W

128、ithin 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 clinica

129、l 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

130、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 stand

131、ards 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

132、(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

133、 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

134、 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 a

135、doption.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.

136、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 r

137、ealm 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 Summar

138、y 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 a

139、reas.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 co

140、mpliance,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 impa

141、ctInterestingly,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

142、.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 o

143、f 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,whe

144、re 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 reimburs

145、ement 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 ke

146、y 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 demonstrate

147、s 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 ins

148、ights 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 th

149、ese 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 benef

150、its 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 investmen

151、t 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 remain

152、s 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

153、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.

154、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

155、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 SC6

156、2A 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 br

157、oader 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 pe

158、rspectiveThe 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 mo

159、re 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 collabor

160、atively 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

161、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 expo

162、sed 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

163、=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 s

164、urvey 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 whic

165、h 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 p

166、atient 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 st

167、rategy 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,th

168、e 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 o

169、bligations 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 o

170、f 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

171、 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 healthc

172、are.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

173、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.Un

174、locking 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 comparis

175、ons 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

176、 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

177、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

178、 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 wit

179、hin 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 hurd

180、les.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

181、 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

182、 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

183、 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 framework

184、s 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

185、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

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198、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 w

199、earables 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 tec

200、hnologies 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 4

201、0X-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

202、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 ele

203、ctronic 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“Su

204、ch 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 compli

205、ant 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 ensu

206、res 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 integr

207、ating 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.