Resource library
Our regulatory position papers and whitepapers on digital health technologies in clinical trials. Three download without an account; a free account opens the rest after email confirmation and personal approval, usually within one business day. No sales calls attached.
Position papers
Free
5 pages
Where the Data Actually Travels
A companion reading from the connectivity provider seat — what routing and egress do, and do not, do to a trial’s data-protection position
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Position papers
9 pages
Integrating DHTs with EHRs and Clinical Systems
Why the boundary between the device and the clinical system is the regulated unit — and why provenance must survive the handoff
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Position papers
8 pages
Diversity, Representativeness and Equitable Access in DHT Deployment
Why who a device can reach is a data-validity question — and why the durable regulatory anchor is the representativeness of the enrolled population.
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Position papers
9 pages
When the Phone or Gateway Is the Hub: Interoperability and Connected-Device Systems
When a hub — the participant’s phone, a tablet or a provisioned cellular gateway — bridges a sensor, wearable, spirometer or CGM, the combined system, and the device-to-device boundary, becomes the regulatory unit.
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