The use of digital health technologies in clinical research must include security measures to prevent any tampering, but the FDA acknowledged those controls may be harder to implement for wearable technology versus mobile apps.
The Food and Drug Administration re-released draft guidance Wednesday on using electronic systems, electronic records, and electronic signatures in clinical investigations to address what the agency described as “numerous comments” to the draft version it issued nearly six years ago. One of the changes in the updated draft includes recommendations on how to implement and apply security measures and data integrity controls to digital health …
