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# Remote Data Digital Health Guidance
- URL: https://www.fdaweb.com/remote-data-digital-health-guidance/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:27:05.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5150814

FDA has published a draft guidance, *Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,* with recommendations for sponsors, investigators, and other interested parties on the use of digital health technologies for remote data acquisition from participants in clinical investigations evaluating medical products. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations?ref=fdaweb.com) defines a digital health technology as a system that uses computing platforms, connectivity, software, and/or sensors for healthcare and related uses.

The guidance says it outlines recommendations intended to facilitate the use of digital health technologies in a clinical investigation as appropriate for the evaluation of medical products.

The recommendations address: 

- the selection of technologies that are suitable for use in the clinical investigation;
- verification and validation of technologies for use in clinical investigations;
- use of digital technologies to collect data for trial endpoints;
- identification of risks associated with the use of digital technologies during the clinical investigation; and
- management of risks associated with using digital health technologies in clinical investigations.