FDA Releases Guidance for Digital Health Tech – The National Law Review
On December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from participants in clinical investigations. DHTs (s…….
On December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from participants in clinical investigations. DHTs (such as wearables and sensors) are playing a growing role in clinical research, accelerated by the need for decentralized clinical trials and remote patient monitoring during the COVID-19 pandemic. Though largely directed to study sponsors using DHTs, the guidance raises issues that developers and manufacturers of these technologies will want to be mindful of given the ways in which their products might be used in a broader clinical use case than originally anticipated. Comments on the draft guidance are due March 23, 2022. The full text of the guidance can be accessed here.
What is a DHT?
DHT is defined as a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. For example, an app that uses the sensors on a smartwatch to collect heart rate information, may be a DHT. DHTs enable the transmission of data across distances, which increases opportunities for patients to participate in trials and to more frequently collect patient data. The guidance details some key considerations for study sponsors when using DHTs for clinical investigations.
Selecting an Appropriate DHT for the Clinical Investigation
When selecting a DHT for use in a clinical investigation, sponsors should ensure that it is “fit-for-purpose”—meaning that the level of validation associated with the DHT is sufficient to support its use and interpretability in the investigation. In making the determination that a DHT is fit-for-purpose, the FDA recommends that sponsors consider:
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the clinical event or characteristic of disease/condition that is being measured
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the proposed trial population, including whether usability studies are necessary
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design of the clinical investigation
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characteristics of the DHT that may influence trial participant use (e.g., whether a subject would use the DHT for the duration of a trial).
The sponsor must provide an explanation of why the DHT is fit-for-purpose for the clinical investigation in a premarket submission (i.e., an application for 510(k) clearance or approval). The explanation should contain basic information about the DHT (e.g., relevant physical characteristics, information on how it measures the clinical event or characteristics of the disease/condition), a description of usability-related features, and a description of …….
