The U.S. Food and Drug Administration (FDA) published Framework for the Use of Digital Health Technologies in Drug & Biological Product Development on 24 March 2023. It aligns with the FDA commitment under the 7th iteration of the Prescription Drug User Fee Act reauthorisation, incorporated as part of the FDA User Fee Reauthorisation Act of 2022.
Digital Health Technologies
Generally, this document is not a guidance document, does not propose or establish policies. By this nature, it then outlines the foundation for implementing the FDA’s Digital Health Technologies (DHT) program for drugs. In detail, the DHTs are systems using computing platforms, connectivity, software, sensors for health care and related uses. They thus include technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (devices, drugs, and biologics).
The medical organisations may use the DHTs to support drug development and review under legal requirements, administer electronic clinical outcome assessments, including electronic patient-reported outcome and electronic performance outcome instruments. The DHTs may consist of hardware and/ or software. The FDA also focused on artificial intelligence (AI)-enabled medical devices to provide a holistic approach to the subset of DHTs enabled by machine learning.
Challenges Related to the Use of DHTs to support drug development, review
The Framework presented the utilisation of the AI technology, particularly, its different techniques including models based on statistical analysis of data and knowledge-based systems that primarily rely on rules (e.g., if-then statements and Machine Learning) in the DHTs. Moreover, the AI algorithms can transform health care by deriving new and important insights from the enormous databases generated by DHTs. For drug development, they can apply AI algorithms to participant recruitment, site selection, clinical trials, data collection and analysis, and safety monitoring. However, the framework does not provide more details on the regulations to facilitate this AI practical application.
Draft guidances
Accordingly, we are looking forward to the additional guidance documents on this DHT topic to support timely access to safe, effective, innovative new medicines for patients. The FDA plans to finalise the following draft guidances:
- Draft guidance for industry, investigators, and other stakeholders Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (December 2021)
- Draft guidance for industry Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (March 2023)
- Draft guidance for industry, investigators, and other stakeholders Decentralised Clinical Trials for Drugs, Biological Products, and Devices
- Draft guidance for industry Regulatory Considerations for Prescrip- tion Drug Use-Related Software (targeted for publication by end of fiscal year 2023 per commitment letter)
The FDA welcomes the comments until 23 May 2023.
For more news on the relation between medical and technologies on AstraIA Gear: https://www.astraiagear.com/2023/03/15/opinion-relationship-between-the-medical-tech/
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