Insights on DHT compliance
EU MDR, FDA DHT guidance, EUDAMED, data integrity and the operational reality of digital health in clinical trials.
Navigating CE Marking and Global Compliance for DHTs in Clinical Trials
Does your CE mark actually protect you outside the EU? Most sponsors assume it does — until their US arm hits an IDE requirement. What happens when the MHRA…
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BYOD/eCOA in 2026: Timestamp Drift, Part 11/GDPR, and Audit Trails No One Wants to Own
What is “timestamp drift,” and how can a few minutes of clock deviation invalidate your eCOA endpoint data? Who actually owns the audit trail when…
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Are Consumer Devices (e.g. Fitbits, …) Compliant for Endpoint Data Collection?
Can consumer wearables like Fitbits generate regulatory-grade clinical trial data? What risks arise when sponsors use consumer devices for endpoint…
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The May 2026 EUDAMED Deadline: What It Means for Digital Health Technologies in Clinical Trials
The first EUDAMED modules became mandatory on 28 May 2026 — is the wearable sensor in your trial registered, and did it need to be? What happens to your EU clinical trial if the device manufacturer…
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Fit-for-Purpose or Bust: A Real-World Rubric for DHT Verification, Validation & Usability
What makes a DHT truly “fit-for-purpose” in a clinical trial context? How do verification and validation differ—and why does it matter? What role does…
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How to Survive – and Win – in the New Digital Health Economy (Part 8/8)
Is your organisation’s QMS built to manage devices, data, and endpoints together? Would your DHT-derived evidence survive a multi-country audit? Who in your…
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Reverse Logistics: Recovering DHTs Without Breaking Data Chains
How can sponsors eliminate “data breaks” across global DHT logistics networks? What are regulators expecting in traceability documentation under MDR and GCP?…
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The Global Compliance Map: Deploying DHTs Across Borders (Part 7/8)
Are your DHTs classified and registered in every country where they’re used? Have you appointed local importers and authorised representatives? Do your…
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Roles Redefined: Manufacturer, Importer, System Producer — Which Are You? (Part 6/8)
Are you certain your organisation’s role under MDR or FDA law is correctly defined? Have you appointed authorised importers or representatives for DHT…
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ALCOA++ in the Age of Digital Health Technologies (Part 5/8)
Can your audit trail reconstruct every DHT data transformation from source to submission? Are firmware, algorithms, and databases synchronised under one…
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Endpoints and Algorithms: How Firmware Can Break Your Study (Part 4/8)
Can a single firmware update, algorithm change or data-sync failure invalidate months of trial data? How did the FDA’s DHT guidances change who answers for endpoint traceability and version control?
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Best Practices for Usability Testing in DHTs
What makes usability testing a regulatory requirement for DHTs? How can poor usability compromise data integrity in decentralised trials? What are the most…
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Device Fit and Classification: When “Commercial” Becomes “Clinical” (Part 3/8)
Have you validated every DHT used in your trial for analytical, clinical, and usability accuracy? Are you certain of each device’s risk class in all…
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Quality-by-Design for DCTs: Turning FDA’s DHT Framework Into an Inspection-Ready Reality
Could your digital endpoints survive if an FDA inspector asked you to “show how this was generated”? Are your device, algorithm, and data teams aligned—or…
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DHT QMS: The Missing Link Between Mature Systems and Digital Health Readiness
Is your QMS framework prepared to manage device-level risk and traceability? How can sponsors extend quality oversight to digital endpoints without…
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When a Digital Health Tool Becomes a Medical Device: The Hidden Regulatory Roles No One Told You About
If your digital health tool is already collecting endpoint data, are you absolutely sure regulators don’t see it as a medical device? Who’s carrying the…
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ICH GCP E6 Is Changing — And Digital Health Technologies Are at the Centre
For years, Digital Health Technologies lived slightly outside the GCP spotlight. Useful? Yes. Innovative? Absolutely. GCP-critical? Not always. ICH GCP E6 (R3) changes that.
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