In December, the FDA issued their first report on the impact of changes to the regulation of non-device software functions under the 21st Century Cures Act. These changes removed certain software functions from the definition of a medical device in the amended FD&C Act. These software functions are:

1. administrative support of a health care facility;
2. maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; 
3. serving as electronic patient records when not intended to interpret or analyze patient records;
4. transferring, storing, converting formats, or displaying data; or
5. providing certain types of clinical decision support to a health care provider unless interpreting or analyzing a clinical test or other device data.

Section 3060(b) of the 21st Century Cures Act requires the Secretary of Health and Human Services to issue a report every 2 years that summarizes the information on any risks and benefits to patient safety and health as well as best practice recommendations to promote safety, education, and competency. This is the first report, and while its data is limited by the short time frame (December 2016 – July 2018), it’s valuable reading for anyone planning to market software in one of the non-regulated categories. The best practice sections have the most value in my opinion – these contain ideas that could be used to differentiate and add real market value to a new product in what is likely to become a very competitive field.

Text Copyright © 2019 Katrina Rogers