On March 31, 2026, the FDA issued a Request for Information (RFI) - Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products (Docket FDA-2026-N-2476) - with four questions aimed at understanding the opportunities and challenges of using DHTs in clinical investigations, to inform future FDA activities across CDER and CBER. DEEP Measures was one of 40+ organizations to respond. Our FDA RFI Comment Letter answers all four questions - and below we share the gist, plus why it’s worth a read no matter where you sit in the ecosystem.
Q: 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?
DEEP’s take: Sponsors continue to encounter operational and regulatory burden because of manual, trial-specific evidence assembly and reinvention of documentation and processes across clinical programs, leading to inefficiencies and inconsistent DHT evidence submission quality, along with increased delays during the FDA review process, number of issued information requests, and inconsistent regulatory outcomes for materially similar technologies. Additionally, there is difficulty in demonstrating how DHT data are captured, processed, validated, and used to derive endpoints across multi-vendor pipelines and evolving device/software versions.
Q: 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?
DEEP’s take: We encourage FDA to support scalable, cross FDA-Industry multi-sponsor consortia workshops and pilots that translate policy into usable examples, templates, and shared learning. We also encourage the expansion of PDUFA VII demonstration projects that are focused on regulatory evidence submission readiness across IND, NDA/BLA, and DDT Qualification program submissions and encourage cross-Center collaboration (i.e. CDER, CDRH, CBER) to test practical implementation approaches. Finally, we highlighted the need for alignment on structured and transparent evidence frameworks that separate measurement concepts, technology requirements, and clinical validation, which can enable consistent submissions and reuse of evidence across programs.
Q: 3. What areas of guidance would support the use of DHTs in clinical investigations?
DEEP’s take: We encourage the FDA to implement operational guidance for end-to-end DHT data processing pipeline traceability and documentation. We also highlighted the need for FDA to provide clarity on algorithm lifecycle management as it relates to change control and evidence updates for DHT algorithms, including AI/ML-based approaches used to derive endpoints, especially within a single study. Lastly, Sponsors would benefit from the FDA’s identification for fit-for-purpose considerations for pediatric DHT use cases and interactive/gamified assessments to include patient and caregiver usability considerations such as: accessibility, digital literacy, caregiver involvement, age-appropriate design, and patient burden.
Q: 4. What specific DHT-related topics, such as digitally derived endpoints in certain disease areas, would benefit from discussion in a public workshop?
DEEP’s take: We encourage the FDA to discuss how to demonstrate clinical meaning, interpretability, and fit-for-purpose validation for novel endpoints across therapeutic areas and include interactive and neuropsychiatric assessments. There is also a need to discuss standardization of DHT regulatory evidence submissions and practical expectations for documenting end-to-end data processing pipelines and supporting submissions for large patient-centric datasets. It would be useful to also discuss alignment on structured submission content and relevant data standards (i.e. CDISC, ICH, DiME V3+, and the DEEP Stack model) to increase consistency across regulatory submissions. Lastly, we suggested that FDA should identify demonstration projects and FDA-Industry multi-sponsor consortia workshops that support cross-study learning and promote regulatory confidence.
The rules for DHT-derived regulatory evidence are being shaped now. Here’s the value in reading the letter — and getting involved — depending on where you sit:
As a follow-up to the comment letter, DEEP is forming an industry consortium - our GAN member companies plus other interested pharma and biotech companies, academia, patient-advocacy groups, and C-PATH - to convene a focused, one-day workshop with the FDA in the Fall 2026 timeframe. The aim: move from hypothetical policy discussions to applied policy, anchored in real programs and submission-ready evidence, and explore pilot opportunities that reduce regulatory uncertainty for everyone.
→ Read the FDA RFI Comment Letter here: Regulations.gov
→ Contact Us to learn more about DEEP, join the conversation through the GAN, or take part in the upcoming FDA workshop.
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