This fall, DEEP Measures and members of the Global Advocacy Network (GAN) will convene a focused, one-day workshop with subject matter experts from the FDA's CDER, CDRH, and CBER. The FDA Workshop Mission brings together pharmaceutical and biotechnology companies, technology providers, academia, data standards organizations, and patient advocacy groups to help shape the future regulatory landscape for digital health technologies (DHTs) and accelerate adoption of harmonized digital measures.
We're opening participation to outside organizations that want a seat at the table.
The Challenge
As DHT-derived data becomes increasingly important in regulatory submissions, sponsors continue to recreate DHT provenance documentation from scratch across individual studies and programs. This often results in:
- Duplicative, manual effort
- Additional information requests from regulators
- Longer review timelines from trial-specific work
- Inconsistent outcomes for similar technologies
The challenge becomes even greater when sponsors need to manage evolving sensors, software applications, algorithms, and AI-enabled methods while maintaining a clear and inspectable chain of custody for regulatory review.
At the same time, questions remain around how regulators and FDA reviewers should efficiently access large-scale, patient-centric DHT datasets and supporting evidence packages.
Our Goal
The FDA Workshop Mission is designed to accelerate adoption of harmonized digital measure solutions and advance practical, submission-ready approaches for DHT-derived regulatory evidence.
Through direct engagement with FDA experts, participants will help identify opportunities to improve the completeness, consistency, and efficiency of future DHT regulatory submissions.
What Happens at the Workshop
Participants will engage in collaborative discussions focused on:
- Evaluation of FDA's current thinking on DHT frameworks, guidance expectations, compliance requirements, and industry data standards for DHT-derived evidence.
- Demonstration of the DEEP DHT Trusted Regulatory System (TRS) and its role in supporting DHT regulatory evidence submission packages.
- Presentation of four to six DHT regulatory engagement use cases across multiple therapeutic areas, DHT modalities, and regulatory contexts (i.e., application types, drug review lifecycle, etc.), showcasing structured DHT evidence packages and patient-centric DHT datasets.
- Alignment on future FDA pilot programs and case studies designed to improve DHT evidence submissions.
Expected Outcomes
Participants will help establish a foundation for future regulatory collaboration, including:
- Direct FDA feedback on DHT evidence submissions and patient-centric DHT datasets ahead of finalized guidance.
- Establishment of future pilot programs, roadmaps, timelines, and a cadence for regulatory touchpoints
- Creation of a Post-Workshop Assessment Report, white papers, and joint conference presentations in collaboration with DEEP Measures & the GAN
Why This Matters
No single organization can solve DHT regulatory challenges alone. Consortium-level engagement creates a stronger collective voice with the FDA and provides a forum to align on common approaches.
The workshop is intended to:
- Advance consistency across DHT regulatory evidence generation and submission practices
- Promote common terminology, definitions, and standards across the entire DHT ecosystem
- Reduce regulatory uncertainty and duplication efforts
- Accelerate learning for both regulators and industry
- Inform future guidance, pilot programs, and regulatory policy development
Who Should Participate
This mission is intended for organizations actively developing, evaluating, or planning DHT-enabled clinical research, including:
- Pharmaceutical and biotechnology sponsors incorporating or considering DHT-derived endpoints / digital measures into clinical development
- Technology providers developing DHT solutions
- Academic and clinical research organizations focused on digital measurement and validation
- Data standards organizations and patient advocacy groups engaged in the evolving DHT regulatory ecosystem
Timing
- August 2026: Determine use cases and finalize planning by end of August
- September 2026: Recruitment for participating organizations closes end of September
- November 2026: FDA Workshop Meeting (requested dates: November 3, 5, or 10)
- December 2026: Complete Post-Workshop Assessment Report
Have a Seat at the Table
Participation is limited and workshop activities will be shaped around participating organizations.
If your organization is interested in helping define the future of DHT regulatory evidence submissions, we'd love to hear from you.
We’re excited about this important initiative and encourage the community to connect with us to learn more about contributing to this mission or launching something similar in a different domain. For additional information or to receive updates on this mission, please contact us here.
