Your source of practical guides, expert webinars, interesting articles, industry events and opinion pieces to accelerate digital endpoint research and collaboration
Why is this important? Understanding if your digital health technology (DHT) qualifies as a medical device is essential for determining its regulatory pathway, market access strategy and compliance...
Start with the measure, not the digital health technology (DHT) Define the measure first: its Context of Use (the population, the concept of interest, and the decision it must support) dictates what...
The short version On March 31, 2026, the FDA issued a Request for Information (RFI) - Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products...
Date: May 20–21, 2026 Location: Milan, Italy Three days in Milan, a poster session that turned into a queue and a meeting with CDISC's DHT Lead has reframed how I'm thinking about the next twelve...
What if digital measures could be defined once, reused across technologies, and seamlessly extended to new clinical contexts? The DEEP–EFPIA–EMA pilot offers the first real‑world glimpse of how that...
The DEEP Stack model was designed to structure digital measures from concept through to clinical evidence. But how well does that structure translate into the data standards required for regulatory...
Late last year, DEEP's Jacqueline Thong (GM US) sat down with Carrie Northcott (Pfizer, Head of Digital Medicine and Translational Imaging) and Jared Worful (Bayer, Global Head of Digital Health...
Looking Back at ADDS 2025: Steps Toward Regulatory-Ready Digital Endpoints As we settle into 2026, it is valuable to revisit the key milestones that shaped the digital health landscape last year. One...
What if a single digital endpoint could change the trajectory of an entire clinical program? Faced with a small Phase 2 study and endpoints not able to show true therapeutic impact, a biotech turned...
Pharma has spent years generating evidence for digital measures - yet much of it sits unused, scattered across public‑private partnerships and legacy research. What if the key to accelerating...
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