Key Takeaways
- The U.S. Food and Drug Administration (FDA) is offering up to $2.2 million to fund research addressing key questions about the use of digital health technologies (DHTs) in drug and biologic development. Applications are due by August 20, 2026.
- The agency encourages applications for projects that focus on validation of digital measures, development of DHT-derived endpoints, evaluation of continuous data streams, and use of DHTs to identify early manifestations of chronic disease.
- Even for companies that do not apply for funding, the program may be relevant to future DHT-enabled clinical development efforts.
On July 20, 2026, the FDA announced RFA-FD-26-012, a grant funding opportunity focused on the use of DHTs in clinical investigations supporting drug and biologic development. The FDA is seeking research on several DHT-related questions, including how digital measurements compare to traditional clinical assessments, how novel DHT-derived endpoints can be developed and evaluated, and how DHTs can capture early manifestations of chronic disease. The FDA is not changing its standards or endorsing specific DHTs and highlights areas where the FDA believes more evidence is needed before DHTs can be used confidently in drug and biologic development. Applications are open to for-profit and nonprofit organizations, higher education institutions, and local governments, among others, and are due by August 20, 2026. The FDA's Center for Drug Evaluation and Research (CDER) plans to provide up to $2.2 million in funding for up to two awards. Non-U.S. entities are not eligible to apply.
The FDA on DHTs
A DHT is a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. DHTs can encompass both FDA-regulated devices and software device functions as well as technologies that may not be regulated as devices.
The FDA's current thinking on DHTs is reflected in two main documents. The March 2023 Framework for the Use of Digital Health Technologies in Drug and Biological Product Development describes the FDA's broader strategy for advancing the use of DHTs. It outlines how the agency intends to build expertise, coordinate across centers, and engage with stakeholders, but it does not establish policy or regulatory expectations. The subsequent December 2023 final guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, sets forth the FDA's recommendations for selecting, verifying, validating, and using DHTs to collect data in clinical trials.
More recently, the FDA has signaled its interest in expanding the use of digitally enabled clinical development approaches through its Real-Time Clinical Trials (RTCT) initiative, signaling a continued push toward more continuous, data-driven approaches to trial oversight and regulatory review.
Focus of Funding
While DHTs can generate large volumes of data, important methodological questions remain regarding how those data will be interpreted and used in drug or biologic development. To support the advancement of DHTs for drug and biologic development, the funding encourages applications for projects that focus on the following areas of interest:
- Comparing digital measurements to traditional measurements used to evaluate drugs
- Developing and evaluating novel endpoints derived from DHTs
- Comparing the metrics used to evaluate continuous measurements
- Capturing early manifestations of chronic diseases through digital tools
Review criteria include the significance of the problem or critical barrier addressed by the project, the project's degree of innovation, the likelihood that the scientific environment will support successful execution, and the project's overall scientific and technical merit, among other factors. The FDA will also consider whether the project challenges existing research or clinical paradigms through novel concepts, methodologies, or approaches.
Relevance to Industry
The DHT funding program is significant even for companies that choose not to apply. Research funded through the program, if successful, could influence future clinical trial practices involving DHTs, including approaches to endpoint development, remote data collection, and evidence generation. The resulting work also may inform the FDA's thinking and expectations in these areas for sponsors pursuing similar development programs. In addition, because the awards are structured as cooperative agreements, the FDA is expected to work closely with award recipients on study design, endpoints, and data analysis. That level of engagement may provide awardees with valuable opportunities to discuss novel DHT-related questions directly with the agency.
For companies looking for additional opportunities to engage with the agency, the FDA and the Duke-Margolis Institute will host a virtual public workshop on August 27, 2026, to discuss statistical considerations for digitally derived endpoints in clinical trials for drugs and biologics.
For more information about DHT programs and how they are regulated by the FDA, please contact Wilson Sonsini attorneys Ty Kayam, Eva Yin, or any member of the firm's Healthcare and FDA Regulatory practice.
