Your source of practical guides, expert webinars, interesting articles, industry events and opinion pieces to accelerate digital endpoint research and collaboration
On 3 June 2026, decentralised trials, pragmatic designs and real-world data got their own good clinical practice rulebook. For the wearables, sensors and apps that power modern trials, it is a...
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...
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...
