Is the public information available from the US Food and Drug Administration on digital medical devices used in just-in-time interventions (JITIs) transparent enough to understand their operation, performance and effectiveness?
This systematic review appraised 38 product summaries of digital medical devices that were approved from 2019 to 2021. Only 26.3% of the product summaries allowed a full understanding of how the devices operated to deliver JITIs, and less than 50% reported on their performance and effectiveness.
The results of this systematic review suggest that product summaries of US Food and Drug Administration–approved digital devices used in JITIs often include heterogeneous information.
Just-in-time interventions (JITIs) are a type of digital therapeutic intervention that combines remote monitoring tools and algorithms to personalize the delivery of specific interventions at the right time. The US Food and Drug Administration (FDA) regulatory approval documents are often the only available source of information on the effectiveness of therapeutic interventions based on these devices.
To systematically review the publicly available information from the FDA on all recently approved medical devices used in JITIs to (1) assess how they operate to deliver JITIs and (2) appraise the evidence supporting their performance and clinical effectiveness.
Two reviewers systematically searched the Premarket Notifications (510(k)), Premarket Approvals, De Novo, and Humanitarian Device Exemption databases from January 2019 to December 2021 for all entries associated with devices that monitored patients’ data over time to personalize the delivery of interventions to treat, prevent, or mitigate health conditions or events. They assessed whether the product summaries (1) enabled an understanding of how the device operated to deliver a JITI (eg, the nature, type, and frequency of the monitoring, the nature of the decision algorithm, and the nature and intended receiver of the intervention); (2) informed about the performance and effectiveness of the JITI; and (3) included information on data security and ownership.
In total, 38 devices were included in this review. These were mainly intended for cardiac conditions (12 [31.6%]), diabetes (10 [26.3%]), and neurological diseases (4 [10.5%]). Monitoring devices ranged from wearable (18 of 28 [64.4%]; eg, smartwatches) to implanted sensors (6 of 28 [21.4%]; eg, inserted electrocardiographic sensors). Only 10 of 38 product summaries (26.3%) allowed a full understanding of how the device operated to deliver a JITI. Similarly, only 12 of 28 (42.9%), 12 of 36 (33.3%), and 5 of 38 (13.2%) reported the assessment of the performance of the monitoring device, assessment of the decision algorithm, and results of clinical studies assessing the effectiveness of the JITI, respectively. Finally, 14 of 36 product summaries (38.9%) included some information on data security, but none included information on data ownership.
Conclusion and Relevance
The results of this systematic review suggest that the information publicly available in the FDA databases on the performance and effectiveness of digital medical devices used in JITIs is heterogeneous.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: February 28, 2023.
Published Online: July 17, 2023. doi:10.1001/jamainternmed.2023.2864
Corresponding Author: Ngan Thi Thuy Phi, MSc, Center for Research in Epidemiology and StatisticS (CRESS), INSERM, Hôpital Hôtel Dieu, 1 Place du Parvis Notre Dame, 75004 Paris, France (email@example.com).
Author Contributions: Drs Tran and Phi had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Phi, Oikonomidi, Tran.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Phi.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Phi.
Obtained funding: Ravaud.
Administrative, technical, or material support: Ravaud, Tran.
Supervision: Oikonomidi, Tran.
Conflict of Interest Disclosures: Dr Ravaud reported grants from the French governement (Banque Publique d'investissement) during the conduct of the study. Dr Oikonomidi reports being an employee of IQVIA and contributing to the study as an individual researcher.No other disclosures were reported.
Funding/Support: Ngan Thi Thuy Phi received a PhD fellowship from the Université Paris Cité (IDEX, Programme d’ Investissement d’Avenir). The study was realized in the context of the @Hotel-Dieu project, which was funded by the Banque Publique d’Investissement in France.
Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: The original data from the study are publicly available from the US Food and Drug Administration websites. Data extracted from product summaries and data extraction grids are available from the corresponding author on reasonable request.
Additional Contributions: The authors thank Elise Diard, M Poli Sci (Centre d'epidémiologie clinique, AP-HP, Hôpital Hôtel Dieu) for her help in drawing the figures and Marleen Kunneman, PhD (Leiden University Medical Centre) and Isabelle Boutron, PhD (Université Paris Cité), for their critical input during writing. They did not receive any compensation for their contributions.
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