The short version
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.
The four questions - and where DEEP stands
Q: How should the validity and quality of DHT-derived measures be established for use in clinical investigations?
DEEP’s take: Through a structured evidentiary framework - the DEEP Stack Model - that ties each digital measure to documented validation evidence and a fit-for-purpose justification, so reviewers can see exactly how a measure was developed and why it’s appropriate.
Q: What data management, processing, and standards considerations matter most for DHT data?
DEEP’s take: Full data lineage from capture through processing, validation, and traceability - aligned to industry data standards - so DHT-derived evidence is consistent, auditable, and reviewable rather than a black box.
Q: How can digital endpoints be made reusable and interpretable across programs and contexts?
DEEP’s take: A modular evidence concept that lets validated measures be re-used across programs instead of rebuilt for every submission - an approach already piloted with the EMA and now being extended with payer institutions.
Q: What would reduce regulatory uncertainty and burden as DHT use scales?
DEEP’s take: Clearer, final FDA guidance and consistent submission expectations across pathways (IND, NDA/BLA, and DDT qualification), plus harmonized, patient-centric datasets across sponsors — so the FDA reviews converging evidence, not isolated one-offs.
Why it matters to you
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:
- Pharma: A route to consistent, reviewable DHT submissions across your portfolio - and a seat at the table as expectations form.
- Biotech: Punch above your weight by engaging through a consortium rather than navigating the FDA alone.
- Academia: See how methodological rigor translates into regulatory acceptance and how validation evidence travels into submissions.
- Technology providers: Understand the evidence and data-standard expectations your platforms will need to meet.
- Medical-device companies: Clarity on how DHT-derived data is treated across regulatory pathways.
- Patient-advocacy groups: A push for patient-centric measures that reflect how people actually live.
- C-PATH and other consortia: Alignment on harmonized, reusable evidence that serves the whole ecosystem.
What’s next: A use-case-driven FDA workshop
As a follow-up to the comment letter, DEEP is forming an industry consortium - our GAN partners plus interested biotech firms, academia, and patient-advocacy groups - 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.
Get involved
→ 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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