Use of Digital Health Technologies (DHTs) to Acquire Data Remotely

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

Following the draft guideline published in March 2022 the FDA issued the final guidance that provides industry, investigators and others with recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical trials.

Background

There is a large spectrum of DHTs available for potential use in clinical trials. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. This may include software enabled by artificial intelligence (AI).

The guidance outlines recommendations intended to facilitate the use of DHTs in clinical trials as appropriate for the evaluation of medical products. These recommendations also address some of the information regarding DHTs that sponsors should include in:

• investigational new drug applications (INDs)
• investigational device exemption (IDE) applications
• marketing applications
• Drug Development Tool (DDT) submissions
• Medical Device Development Tool (MDDT) submissions

Moreover the document contains an appendix providing examples of potential DHTs. According to the agency the examples are intended to illustrate various types of DHTs that can be used in clinical trials. However, the examples should not be taken to mean that the DHTs described do or do not adequately measure an endpoint of interest.

More information can be found in Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.