FDA releases "Framework for the Use of Digital Health Technologies in Drug and Biological Product Development"

The document "Framework for the Use of Digital Health Technologies in Drug and Biological Product Development" has been released by the FDA.  The PDUFA VII commitment letter includes the Congressional mandates for the FDA and it includes "the use of digital health technologies (DHTs) to support drug development and review". This document is notes as a guide and not guidance. The definition section defines what the Agency considers falling under the umbrella of DHTs, but they can be hardware AND/OR software.

From the section "Current Landscape of DHTs"

DHTs include technologies such as wearable, implantable, ingestible, and environ- mental sensors and software applications on mobile phones, among others. Advances in sensor technology, general-purpose computing platforms, and methods for data capture, transmission, and storage have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals. DHTs used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research. DHTs can support traditional site-based clinical trials and enable the conduct of DCTs, which are clinical investigations where some or all trial-related activities occur at locations other than traditional clinical trial sites. DHT software can also be disseminated for use with a prescription drug. 

The Agency expects to develop its technical expertise and train staff on 5 topics:

a. Verification and Validation

b. Use of a Participant’s Own DHT or General-Purpose Computing Platform

c. Upgrades and Updates of DHTs in Drug Development

d. Artificial Intelligence and Machine Learning

e. Technical Consultation of Experts and Staff Training 

This will not be a completely internal process and will include interactions with :

a.      FDA Meetings With Sponsors

b.     Drug Development Tool Qualification Program

c.      Developing and promulgating Guidance

d.     Public Meetings

e.      Demonstration Projects

f.      External Organizations 

 

If you are in drug development, you may want to read this to see what the Agency plans are that will enable or cause you to plan differently to ensure the data resulting from DHTs is acceptable within your filing.