Evidence map›Paper›PMID 40928810›Full record

ArticleJAMA cardiology2025

Approach to the Postmarket Evaluation of Consumer Wearable Technologies.

Krishna Pundi, Sanjeev Bhavnani, Clark Seninger, Bram Zuckerman, Jessica Paulsen, Felipe Aguel, Natasha Din, Ben Viggiano, Richard M Yoo, Nirav Dalal and 15 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JAMA cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Krishna PundiDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Sanjeev BhavnaniCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Clark SeningerDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Bram ZuckermanCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Jessica PaulsenCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Felipe AguelCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Natasha DinDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Ben ViggianoDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Richard M YooDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Nirav DalalAbbott, Sylmar, California.
Alan S GoDivision of Research, Kaiser Permanente Northern California, Oakland, California.
Christopher GrangerDuke Clinical Research Institute, Durham, North Carolina.
Harlan KrumholzCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
Kathleen LacarDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Ron LiDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Steven LinDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Kenneth W MahaffeyDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Megan MahoneyDepartment of Family and Community Medicine, University of California, San Francisco.
Debbe McCallHealth eHeart Alliance, San Francisco, California.
Mellanie True HillsStopAfib.org, American Foundation for Women's Health, Decatur, Texas.
Robert A HarringtonWeill Cornell Medicine, New York, New York.
Tina Hernandez-BoussardDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Anindita SahaCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Nigam ShahDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.
Mintu P TurakhiaDepartment of Medicine, Cardiovascular Medicine, Stanford University, Stanford, California.

Funding

FDA HHS U01 FD005978
6 · The paper itself

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.

Indexed as

Product Surveillance, PostmarketingWearable Electronic DevicesHumansUnited StatesUnited States Food and Drug Administration

Identifiers

PMID40928810
PMCPMC13011983

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.