FDA Issues RFI on Digital Health Clinical Trials

April 9, 2026

FDA Dives Deeper into the Use of Digital Health Technologies in Drug Development with New RFI

Anna Abram, Olive Lee, Molly Lolli Akin Gump Strauss Hauer & Feld LLP + Follow Contact LinkedIn Facebook X Send Embed

On March 31, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register requesting information and public comment (RFI) on the use of digital health technologies (DHTs) in clinical investigations for drugs and biological products. To inform potential FDA activities in this area, the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are seeking feedback to better understand the opportunities and challenges associated with using these innovative technologies in clinical investigations.

In the notice, FDA highlighted the “considerable advances” in DHTs in recent years. DHTs collect health data remotely through computing platforms, connectivity, software and/or sensors, such as wearable, implantable, ingestible and contactless technologies. Many are already integrated into smartphones and smartwatches and can be customized through mobile apps. Some are designed to support interactive clinical assessments (e.g., strength, coordination or balance), while others can measure neuropsychiatric functions (e.g., reaction time, cognition or sensory processing). FDA also noted that emerging tools tailored for pediatric use, including gamified applications that engage children in clinical testing, and further opportunities for the innovative use of DHTs in clinical investigations continue to expand.

The RFI builds on FDA’s prior actions seeking to advance DHTs in drug and biological product development and the agency’s commitment under the most recent Prescription Drug User Fee Act reauthorization (PDUFA VII) to support DHT use as appropriate. Since that reauthorization in 2022, FDA issued a Framework for the Use of DHTs in Drug and Biological Product Development in March 2023 and a December 2023 guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. FDA now seeks input on the following questions:

1. What regulatory challenges do DHT manufacturers, sponsors or other interested parties face regarding the use of DHTs in clinical investigations of drugs and biological products?
2. What opportunities are there for CDER and CBER to support and facilitate the adoption of DHTs in clinical investigations of drugs and biological products?
3. What areas of guidance would support the use of DHTs in clinical investigations?
4. What specific DHT related topics, such as digitally derived endpoints in certain disease areas, would benefit from discussion in a public workshop? Interested parties may submit comments until June 1, 2026.

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