Digital Health Technologies (DHTs) for Drug Development (RFA-FD-26-012)

Digital Health Technologies (DHTs) for Drug Development (RFA-FD-26-012) is sponsored by U.S. Food and Drug Administration (FDA). This funding opportunity supports research addressing key questions about the use of digital health technologies (DHTs) in drug and biologic development.

Projects may focus on the 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. The program encourages innovative approaches to further support the use of real-world evidence.

The corresponding work products, including open-source computing algorithms and software, will result in new capabilities for the application of real-world clinical data in regulatory decision-making.

Digital Health Technologies (DHTs) for Drug Development | FDA Skip to in this section menu Science and Research Special Topics Digital Health Technologies (DHTs) for Drug Development Science and Research Special Topics FDA Announces Funding Opportunity for Digital Health Technologies The U.S. Food and Drug Administration announced a funding opportunity, open July 20, 2026 – August 20, 2026, for selected applicants to explore the role of digital health technologies (DHTs) (e.g., actigraphy, photography, contactless sensors) in drug development.

Projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups and other stakeholders.

The objectives of these projects are to advance DHTs for clinical drug development, expand the ability to capture early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs and enhance convenience for trial participants by allowing for remote data acquisition in clinical investigations.

The scope includes, but is not limited to, projects that focus on: Comparing digital measurements to traditional measurements in clinical trials to evaluate drugs Developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials (e.g., use of contactless room sensors to capture apnea in pediatric patients) Comparing metrics to evaluate continuous measurements (e.g., maximum activity and stamina) Capturing early manifestations of chronic diseases (e.g., non-memory related signs of dementia) through the use of DHTs (e.g., tests of balance or slowed reaction time) For more information, please see RFA-FD-26-012 Join Us!

FDA to host a public workshop on DHTs and statistical considerations for digitally-derived endpoints in clinical trials On Thursday, August 27, 2026, join the FDA for a free virtual public workshop, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, to discuss statistical considerations for digitally-derived endpoints in clinical trials for drug and biological products.

Speakers will provide updates on FDA efforts under PDUFA VII to advance the use of digital health technologies (DHTs) in drug development and regulatory review. Discussions will also explore opportunities to strengthen data standards and innovative analytical methods that support the broader use of clinically meaningful, digitally-derived endpoints in clinical trials for drug and biological products.

Speakers will also discuss the Submitting Continuous Glucose Monitoring Data in Clinical Trials Technical Specifications Document to provide foundational background for regulatory submissions for drug and biological product evaluation, device performance assessment, and analytical best practices. Learn more and register here .

Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial data directly from patients.

Portable DHTs that may be worn, implanted, ingested, or placed in the environment allow real-time collection of data from trial participants in their homes or at locations remote from clinical trial sites.

Potential advantages of these DHTs include the ability to: make continuous or frequent measurements of clinical features record or measure novel clinical features that could not be captured during traditional study visits decentralize clinical trial activities by obtaining clinical data from study participants remotely FDA is committed to supporting the use of DHTs in clinical drug development and has developed a comprehensive program to engage with interested parties in this important scientific area.

The Prescription Drug User Fee Act VII has outlined several activities related to DHTs for drug development and review, which FDA has committed to undertake.

These activities include: Publishing a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development Establishing a DHT Steering Committee Convening Public Meetings Identifying Demonstration Projects Sections 3606 and 3607 of the Food and Drug Omnibus Reform Act of 2022 outline additional requirements for FDA to publish guidance regarding the modernization of clinical trials through decentralized clinical trials and DHTs.

The CDRH Digital Health Center of Excellence , which was established to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation, can also serve as a resource on DHTs, including their regulatory status, for sponsors, DHT manufacturers, and other stakeholders.

Framework for the Use of DHTs in Drug and Biological Product Development As part of our PDUFA VII commitment, FDA developed a framework, titled Framework for the Use of DHTs in Drug and Biological Product Development .

The program will include workshops and demonstration projects; engagement with interested parties; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents.

As part of our PDUFA VII commitments, FDA has established the DHT Steering Committee which consists of senior staff from CDER, CBER, and CDRH, including the Digital Health Center of Excellence, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs.

The Steering Committee will support the implementation of the framework for the use of DHTs in drug and biological product development as well as other commitments identified in the section “Enhancing Use of Digital Health Technologies to Support Drug Development and Review” of the PDUFA VII commitment letter (e.g., public meetings, guidance documents, demonstration projects, technology needs, training).

In addition, the Steering Committee will oversee activities to assist organizational units with consistent approaches to the review of drug submissions that contain DHT-derived data. Further, the Steering Committee will engage with external interested parties on DHT-related issues in human drug development and gather information about the present state of DHTs, including specific challenges in their use.

FDA encourages interested parties who are considering the use of DHTs in drug development or conducting a decentralized clinical trials (DCTs) to reach out to the agency early. Click on Meeting with FDA to learn more about when and how to engage FDA.

Public Meetings/ Workshops Meeting our PDUFA VII Commitment By the end of the 2nd quarter of fiscal year 2023, FDA will convene the first of a series of five public meetings or workshops with key stakeholders, including patients, biopharmaceutical companies, DHT developers, and academia, to gather input on issues related to the use of DHTs in regulatory decision-making related to drug and biological product development.

June 24-25, 2024: Joint FDA/FNIH Workshop for Digital Measures March 28-29, 2023: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review June 20, 2023: SBIA Webinar : Decentralized Clinical Trials (DCT) Draft Guidance Feb 10, 2022: SBIA Webinar : Digital Health Technologies for Remote Data Acquisition Draft Guidance Digital Health Technologies for Remote Acquisition in Clinical Investigations Decentralized Clinical Trials for Drugs, Biological Products, and Devices Framework for the Use of DHTs in Drug and Biological Product Development Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers Guidances with Digital Health Content Guidance Snapshot: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (Final, issued 12/22/2023).

Resources include a snapshot about the guidance , a recap podcast , and the podcast transcript .

PDUFA VII IT and Bioinformatics Goals and Progress CDRH Digital Health Center of Excellence FDA Digital Health Regulatory Policies CDER's Drug Development Tools (DDT) Qualification Program s Innovative Science and Technology Approaches for New Drugs (ISTAND) Program CDRH’s Medical Device Development Tools (MDDT) Qualification Programs For more information about DHTs for Drug Development, please email DHTsforDrugDevelopment@fda. hhs.

gov . For information about devices and to engage the Digital Health Center of Excellence, send an email to digitalhealth@fda. hhs.

gov