More Benefit than Risk in Non-Device Software: FDA
An FDA analysis required by the 21st Century Cures Act says that there generally are more benefits than risk to patient safety and health from the use of non-medical device software digital health products. The Cures Act excludes certain software functions from the statutory definition of a medical device and FDA regulation.
The report details best practices for healthcare providers, patients, and developers related to implementation and training that could promote safety, education, and use of the devices.
In its analysis, FDA focused on the five types of software functions mandated by Congress—administrative support of a healthcare facility; products that encourage or maintain a healthy lifestyle; certain types of electronic patient records; certain types of software that transfers, stores, or displays clinical laboratory tests or other device data and results; and certain types of decision support software.
The analysis will be updated every two years.