President Obama recently signed the 21st Century Cures Act into law. Among other things, this new law removes certain health-related and mobile medical apps from the definition of medical device under the Federal Food, Drug, and Cosmetic Act.
Removing many mobile health-related and medical apps from the FDCA's definition of medical device, including any software function that is intended:
for a health care facility's administrative support;
for maintaining or encouraging a healthy lifestyle (as long as the software is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition);
to serve as electronic patient records; or
for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device.
Requiring the Food and Drug Administration (FDA) to issue a final order through notice and comment rule-making to identify software functions that should still be considered medical devices because they would be reasonably likely to have serious adverse health consequences.