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Digital Health Update: 2022 Report on Non-Device Software Functions Now Available

Today, the U.S. Food and Drug Administration (FDA) published the Report on Risks and Benefits to Health on Non-Device Software Functions – December 2022. This report highlights the FDA’s Digital Health Center of Excellence (DHCoE) findings on the five software functions excluded from the device definition by the 21st Century Cures Act.

These software functions range from software that offers administrative support to a health care facility to software that helps patients keep a healthy lifestyle but is not specific to a treatment of a disease.

The report includes:

• findings on positive and negative impacts on patient safety and health benefits related to use of the five software functions.
• best practices related to implementation, training, and use that could promote safety, education, and competency.

The analysis includes information from, but not limited to, experts external to the FDA, peer-reviewed literature, adverse event report databases, and public input that the FDA received through a Federal Register.

About the Digital Health Center of Excellence

Launched in September 2020 and located in the FDA's Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence is committed to strategically advance science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. The goal of the Digital Health Center of Excellence is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

Questions?

If you have questions or comments on how the FDA regulates medical software, email the Digital Health Center of Excellence (DHCoE) at digitalhealth@fda.hhs.gov.