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 usability play in maintaining data integrity?

How can sponsors implement a risk-based approach to DHT qualification?

Which real-world lessons show how validation failures can derail trials?

Is your organization’s QMS built to manage devices, data, and endpoints together?

Would your DHT-derived evidence survive a multi-country audit?

Who in your team owns algorithm validation and version control?

How prepared are your vendors to meet ISO 13485 and MDR Article 22 obligations?

Can you trace every data point from patient to protocol—and back again?

How can sponsors eliminate “data breaks” across global DHT logistics networks?

What are regulators expecting in traceability documentation under MDR and GCP?

How can validated device reuse align with sustainability goals?

What role does blockchain play in improving audit traceability?

How do logistics systems influence data integrity in decentralized trials?

Are your DHTs classified and registered in every country where they’re used?

Have you appointed local importers and authorized representatives?

Do your vendor contracts cover data residency and cross-border transfers?

Can you demonstrate ALCOA++ traceability across countries and cloud regions?

Would your trial survive a multi-authority inspection tomorrow?

Are you certain your organization’s role under MDR or FDA law is correctly defined?

Have you appointed authorized importers or representatives for DHT deployments abroad?

Does your CRO or vendor contract include device vigilance responsibilities?

Are your system combinations documented under MDR Article 22 requirements?

If your DHT malfunctioned, could you prove who’s legally accountable?

Will your digital endpoints still hold up under regulatory scrutiny in 2026?

Could you explain your DHT data pipeline to an inspector—without guessing?

Are your algorithms governed as medical instruments or treated like IT tools?

Do you know which regulatory roles your organization already holds globally?

Is your QMS built for digital evidence—or for a pre-DHT world?

Can your audit trail reconstruct every DHT data transformation from source to submission?

Are firmware, algorithms, and databases synchronized under one ALCOA++ framework?

How do you manage data integrity across multiple vendors and jurisdictions?

Could your digital endpoints withstand an FDA or EMA data lineage audit?

Does your QMS explicitly integrate ALCOA++ and metadata provenance controls?

Are your current DHTs validated for analytical, clinical, and usability accuracy?

Who in your organization owns responsibility for device version control?

Would your DHT endpoints withstand an ALCOA++ traceability audit?

Have you mapped classification and importer roles for every deployment country?

Does your QMS integrate ISO 13485 and 14971 for device-level oversight?

What makes usability testing a regulatory requirement for DHTs?

How can poor usability compromise data integrity in decentralized trials?

What are the most effective methods for formative and summative usability testing?

How can sponsors ensure inclusivity and accessibility in usability testing?

How does usability engineering align with ISO 14971 risk management?

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 deployment countries?

How do you control firmware and algorithm updates during studies?

Who in your organization owns usability validation and change control?

Would your DHT-derived endpoints survive regulatory scrutiny tomorrow?

How do sponsors avoid becoming “accidental manufacturers” when deploying wearables in trials?

What happens if a consumer-grade DHT fails to meet regulatory validation standards mid-trial?

Why does FDA treat DHT oversight in drug trials with the same rigor as device investigations?

How can poor sponsor oversight of DHTs derail regulatory submissions and cause trial failure?

What practical frameworks exist to help sponsors manage DHT responsibilities across borders?

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 are they assuming someone else is handling the risk?

Do your SOPs actually support decentralized trials, or are they relics from the site-centric era?

Would your DHT data hold up across review divisions, or would firmware drift and missing lineage collapse your evidence?

Is your organization prepared for the roles it already holds—sponsor, architect, system producer, and regulated partner?

Does your QMS include design-history and validation records for every DHT you use?

Are firmware, algorithms, and human-factors results governed under change control?

Can your vendor audits prove ISO 13485 and IEC 62304 compliance?

How do you integrate ALCOA++ and device traceability into your audit system?

Would your QMS withstand an FDA or MDR inspection focused on digital endpoints?

Are your current DHTs validated for analytical, clinical, and usability accuracy?

Who in your organization owns responsibility for device version control?

Would your DHT endpoints withstand an ALCOA++ traceability audit?

Have you mapped classification and importer roles for every deployment country?

Does your QMS integrate ISO 13485 and 14971 for device-level oversight?

What hidden operational traps are still tripping sponsors under the 2024 FDA DCT guidance?

How can sponsors maintain investigator oversight across decentralized models?

Why does device validation remain a recurring inspection finding?

What data integrity gaps most concern regulators in decentralized trials?

How can operational alignment with FDA guidance accelerate study approvals?

Is your QMS framework prepared to manage device-level risk and traceability?

How can sponsors extend quality oversight to digital endpoints without duplication?

What are the must-have elements of a DHT-ready quality system?

How are CROs redefining quality roles in decentralized, device-enabled studies?

Could a missing DHT process in your QMS create inspection exposure?

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 legal liability for your connected device right now—the manufacturer, the sponsor, or… you?

When your next trial audit lands, will your documentation prove compliance—or just prove confusion?

How confident are you that your “wellness app” wouldn’t trigger MDR or FDA oversight if used tomorrow in a global study?

While others are quietly securing their regulatory status, are you still assuming “we’re not a medical device company”?

For years, Digital Health Technologies sat in an awkward middle ground in clinical trials.

Sponsors relied on them but didn’t always own them.
Vendors built them but weren’t always treated as GCP-relevant.
And regulators tolerated the ambiguity.

ICH GCP E6 (R3) quietly ends that arrangement.

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.