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# DHT Remote Data Acquisition Guidance
- URL: https://www.fdaweb.com/dht-remote-data-acquisition-guidance/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:18:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156023

FDA has published a guidance, *Digital Health Technologies for Remote Data Acquisition in Clinical Investigations*, with recommendations for sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) for remote data acquisition. 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 DHT as a system that uses computing platforms, connectivity, software, and/or sensors for healthcare and related uses.

The guidance contains recommendations for ensuring that a DHT is fit for purpose, which involves considerations of both the DHT’s form and function. “DHTs may rely on or work with other technologies that support their operation such as general-purpose computing platforms and communication networks,” it says. “Therefore, when implementing the recommendations in this guidance related to DHTs, sponsors should ensure that these other technologies are adequate to support the function of the DHT. The recommendations in this guidance may be relevant to the other technologies used to support remote data acquisition in a clinical investigation.”

FDA says the recommendations address:

- the selection of DHTs that are suitable for use in clinical investigations;
- a description of DHTs in regulatory submissions;
- the verification and validation of DHTs for use in clinical investigations;
- the use of DHTs to collect data for trial endpoints;
- the identification and management of risks associated with the use of DHTs during clinical investigations;
- the retention and protection of data collected by DHTs; and
- the roles of sponsors and investigators related to the use of DHTs in clinical investigations.

The document says these topics are beyond the scope of the guidance:

- whether a DHT meets the definition of a device in the Federal Food, Drug, and Cosmetic Act; and
- the approaches to selecting, modifying, developing, and validating clinical outcome assessments to measure outcomes of importance to patients in clinical investigations.

The guidance was issued, in part, to satisfy the mandate in the FDA Omnibus Reform Act of 2022 to issue guidance regarding the appropriate use of DHTs in clinical trials, FDA says.