Handling Digital Health Technologies in Clinical Trials

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Why Digital Health Technologies Are Regulated in Clinical Trials

Digital Health Technologies (DHTs) — such as Point-of-Care (POC) measuring devices, wearables, and Software as a Medical Device (SaMD) — are now essential to decentralized and hybrid clinical trials. When used for diagnosis, monitoring, or treatment, or when they influence trial endpoints or patient safety, DHTs are treated as regulated medical devices in most jurisdictions — even when they are not the investigational product.

Examples include connected weight scales, ECGs, blood pressure monitors, and spirometers — tools used to remotely or onsite collect accurate, patient-level data for regulatory submissions.

Why regulation applies:

  • Any device that collects data used in regulatory submissions is regulated

  • DHTs must be classified, validated, and documented per applicable standards

  • Actors like Manufacturer, Importer, Distributor, or System Producer hold specific legal obligations by jurisdiction

  • Non-compliance can lead to: Audit findings, Trial holds, Data invalidation, Regulatory rejection

Applicable frameworks: EU MDR 2017/745 (Articles 10, 13–16, 22), ISO 13485:2016, FDA 21 CFR 820, 812, 11, IVDR 2017/746, UK MDR 2002, Canada SOR/98-282, China NMPA, Japan PMDA, …

DHTs must be treated with the same regulatory care as investigational devices — because the data they generate drives approval decisions.

Device360: Your End-to-End DHT Enablement Suite

qointa’s Device360™ is a modular platform built to support the selection, validation, integration, training, and oversight of Digital Health Technologies used in regulated clinical trials.

Built for:

  • Global regulatory alignment (FDA, EU MDR, PMDA, NMPA, ISO)

  • Decentralized & hybrid trial deployment

  • Trial-grade oversight, risk control, and audit readiness