In December of 2021, the FDA released a Draft Guidance document on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.”
Clinical trials may use digital health technologies, or DHTs to gather health-related information from remote clinical trial participants. The FDA guidance provides recommendations to facilitate the use of DHTs in research, including what should be included in an IND or IDE application when using DHTs, selection and verification and validation of DHTs, and identification and management of potential risks of harm.
The guidance includes sections on:
- Regulatory Considerations and Engagement With the Agency
- Considerations When Using DHTs in Clinical Investigations
- Examples of Potential DHT Use in Clinical Investigations
- Examples of Selecting a DHT for a Clinical Investigation