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The U.S. Food and Drug Administration (FDA) published the Report on Risks and Benefits to Health of Non-Device Software Functions – December 2024. 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 maintain a healthy lifestyle but is not specific to the treatment of a disease. The report includes:
- Findings on positive and negative impacts on patient safety and health benefits related to the use of the non-device software functions.
- Best practices related to design, implementation, training techniques, and use that could promote safety, education, and competency related to the non-device software functions.
The report analysis includes information from experts external to the FDA, peer-reviewed literature, adverse event report databases, and public input that the FDA received through a public docket.
About the DHCoE
Launched in September 2020 and located in the FDA's Center for Devices and Radiological Health (CDRH), DHCoE is committed to strategically advance science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. DHCoE’s goal 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 DHCoE at digitalhealth@fda.hhs.gov. To receive the latest digital health news, subscribe to CDRH emails.
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