Krishna Pundi,Sanjeev Bhavnani,Clark Seninger,Bram Zuckerman,Jessica Paulsen,Felipe Aguel,Natasha Din,Ben Viggiano,Richard M Yoo,Nirav Dalal,Alan S Go,Christopher Granger,Harlan Krumholz,Kathleen Lacar,Ron Li,Steven Lin,Kenneth W Mahaffey,Megan Mahoney,Debbe McCall,Mellanie True Hills,Robert A Harrington,Tina Hernandez-Boussard,Anindita Saha,Nigam Shah,Mintu P Turakhia
{"title":"Approach to the Postmarket Evaluation of Consumer Wearable Technologies.","authors":"Krishna Pundi,Sanjeev Bhavnani,Clark Seninger,Bram Zuckerman,Jessica Paulsen,Felipe Aguel,Natasha Din,Ben Viggiano,Richard M Yoo,Nirav Dalal,Alan S Go,Christopher Granger,Harlan Krumholz,Kathleen Lacar,Ron Li,Steven Lin,Kenneth W Mahaffey,Megan Mahoney,Debbe McCall,Mellanie True Hills,Robert A Harrington,Tina Hernandez-Boussard,Anindita Saha,Nigam Shah,Mintu P Turakhia","doi":"10.1001/jamacardio.2025.3006","DOIUrl":null,"url":null,"abstract":"Importance\r\nConsumer wearable technologies have wide applications, including some that have US Food and Drug Administration clearance for health-related notifications. While wearable technologies may have premarket testing, validation, and safety evaluation as part of a regulatory authorization process, information on their postmarket use remains limited. The Stanford Center for Digital Health organized 2 pan-stakeholder think tank meetings to develop an organizing concept for empirical research on the postmarket evaluation of consumer-facing wearables.\r\n\r\nObservations\r\nThe postmarket evaluation of consumer wearables involves broad consideration of an individual consumer's journey from acquisition, intended and unintended use of the wearable, and access to health care resources on receipt of a notification. For individuals who do access the health care system, a wearable's downstream effects can be studied through appropriate clinical evaluation, delivery of guideline-directed treatments, shared decision-making in areas of clinical equipoise, and analysis of clinical end points and patient harms. Effective postmarket research draws from denominators appropriate to the clinical question, with clearly defined parameters for success and failure. Generalizability related to data completeness and reliability should also be considered. As patients increasingly integrate wearables into their health monitoring, cross-platform data sharing with a focus on privacy and data quality can drive patient-centered innovation and identify opportunities to bridge gaps in medical care.\r\n\r\nRelevance\r\nThe think tank identified priorities in postmarket research, comprising the journey from consumer to patient and accounting for patient, clinician, health care delivery system, and societal impacts of consumer wearables. Overall, this approach serves not only to organize the study of consumer wearables but also to act as a guidepost for using real-world data in postmarket research.","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"49 1","pages":""},"PeriodicalIF":14.1000,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamacardio.2025.3006","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Importance
Consumer wearable technologies have wide applications, including some that have US Food and Drug Administration clearance for health-related notifications. While wearable technologies may have premarket testing, validation, and safety evaluation as part of a regulatory authorization process, information on their postmarket use remains limited. The Stanford Center for Digital Health organized 2 pan-stakeholder think tank meetings to develop an organizing concept for empirical research on the postmarket evaluation of consumer-facing wearables.
Observations
The postmarket evaluation of consumer wearables involves broad consideration of an individual consumer's journey from acquisition, intended and unintended use of the wearable, and access to health care resources on receipt of a notification. For individuals who do access the health care system, a wearable's downstream effects can be studied through appropriate clinical evaluation, delivery of guideline-directed treatments, shared decision-making in areas of clinical equipoise, and analysis of clinical end points and patient harms. Effective postmarket research draws from denominators appropriate to the clinical question, with clearly defined parameters for success and failure. Generalizability related to data completeness and reliability should also be considered. As patients increasingly integrate wearables into their health monitoring, cross-platform data sharing with a focus on privacy and data quality can drive patient-centered innovation and identify opportunities to bridge gaps in medical care.
Relevance
The think tank identified priorities in postmarket research, comprising the journey from consumer to patient and accounting for patient, clinician, health care delivery system, and societal impacts of consumer wearables. Overall, this approach serves not only to organize the study of consumer wearables but also to act as a guidepost for using real-world data in postmarket research.
JAMA cardiologyMedicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍:
JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications.
Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program.
Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.