Analyzing FDA Data on Just-in-Time Interventions, Digital Therapeutics

Digital therapeutic interventions, such as just-in-time interventions (JITIs), use remote monitoring tools and algorithms to provide personalized interventions at the right moment. The US FDA regulatory documents are key information sources regarding these devices' effectiveness. To explore its efficacy, researchers conducted a study published in JAMA Internal Medicine to systematically analyze publicly available FDA data on recently approved medical devices for JITIs. This analysis aimed to understand how these devices operate and evaluate the evidence supporting their clinical effectiveness.

Researchers searched FDA databases from January 2019 to December 2021 to identify devices used in JITIs for monitoring and treating various health conditions. 38 devices reviewed. Devices reviewed were for cardiac conditions, diabetes, and neurological diseases. Researchers also identified the type of devices found, eg, monitoring devices like wearables to implanted sensors. Researchers aimed to assess whether the FDA documents provided insights into how these devices delivered JITIs, information on their performance, and data security details.

However, only a fraction of the product summaries (26.3%) offered a comprehensive understanding of how the devices operated to deliver JITIs. Similarly, researchers discovered a limited number of summaries provided information on device performance (42.9%), assessment of the decision algorithm (33.3%), and clinical study results regarding the JITIs' effectiveness (13.2%). Additionally, a modest portion of the summaries (38.9%) mentioned data security, while none addressed data ownership.

The systematic review suggests that the available information in FDA databases regarding the performance and effectiveness of digital medical devices used in JITIs is quite diverse and often lacks comprehensive details, such as product summaries, assessment of decision algorithms, effectiveness, and data security. This variability in information may impact the assessment and trustworthiness of these devices in delivering timely interventions for various health conditions.

Reference

Phi NTT, Oikonomidi T, Ravaud P, Tran VT. Assessment of US Food and Drug Administration–Approved digital medical devices for just-in-time interventions: A systematic review. JAMA Internal Medicine. 2023;183(8):858-869. doi:10.1001/jamainternmed.2023.2864