FDA Policy/General

FDA Seeking Input on Expanding Digital Health Tech in Trials

FDA is seeking industry and public input on how to expand the use of digital health technologies (DHT) in clinical trials, as part of a broader push to modernize drug and biologic development and regulatory decision-making.

DHTs — ranging from wearable sensors and smartphone apps to implantable or ingestible devices — are increasingly being used to collect real-world patient data remotely, FDA says, adding that the tools present an opportunity to enhance how clinical endpoints are measured and to make trials more patient-centric. The effort is tied to commitments under the Prescription Drug User Fee Act that directed the agency to develop a regulatory framework for incorporating digitally derived data into drug development and reviews.

Since issuing a draft guidance in 2023 on remote data acquisition, FDA says technological capabilities have advanced significantly. New tools now allow researchers to measure a wide array of clinical functions, including strength, coordination, balance, cognition, and reaction time — often using widely available consumer devices like smartphones and smartwatches, it says.

In a new FDA notice requesting information, FDA says it is particularly interested in expanding the use of “digitally derived endpoints” (clinical outcomes measured using digital tools) across a range of disease areas. Examples highlighted in the notice include:

Sensor-based measurements of physical performance
App-based assessments of fine motor skills and coordination
Screen-based tools evaluating neuropsychiatric functions such as cognition, vision, and hearing

The agency also points to emerging applications in pediatric research, including the use of gamified technologies to improve engagement in clinical testing among children.

Machine learning is another area of focus, with FDA noting its growing role in analyzing data generated by DHTs and developing algorithms to interpret clinical signals.

Despite the promise, the agency acknowledges ongoing challenges in integrating DHTs into clinical trials, including issues related to validation, data reliability, and regulatory expectations. It is asking stakeholders to weigh in on several key questions, including:

Regulatory hurdles facing sponsors and technology developers
Opportunities for the FDA to facilitate broader adoption
Areas where additional guidance is needed
Topics that may benefit from future public workshops

Feedback from the information request will help inform future guidance documents and policy development aimed at supporting the use of digital tools in drug and biologic development, FDA says.

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