Wire · opportunities
FDA Weighs in on the Development and Use of Digitally Derived Measures for Clinical Investigations
◆ Sectors
◆ Geography
◆ Source
◆ Verified
Fusion42 · 20 August 2026 · Fusion42 review
The FDA has published a white paper outlining key considerations for the development and use of digitally derived measures (DDMs) from digital health technologies in clinical investigations, emphasising patient-centred, evidence-based validation approaches to support innovation and regulatory clarity.
This Wire brief sits within Fusion42's coverage of Digital Health.
◆ ◆ The Wire takeaway
You must now focus on demonstrating clinical relevance and patient value when developing digital clinical measures, not just their technical sophistication. Patient input and thorough validation become your quickest route to regulatory acceptance and clinical trial integration.
◆ Coverage
1 source · 20 Aug 2026
◆ Related on Wire
◆ Topics