Key Takeaways

1. Digital product statutes need to be reconstructed by Congress for the FDA concerning the emerging technology of software as a medical device (SAMD).

2. When clear and concise language is not present, legal ramifications include court misinterpretation, misinformation, misclassification of evolving AI/ML technology, and ‘high-risk’ products approved prematurely by the FDA.

3. Just as classification and regulation distinguish drug and medical device definitions, we suggest a new classification for SAMD applicable regulation – medical software.

There is a social crisis in America. Many symptoms are medical, but not the root causes. Those most often date back to childhood.

This is America’s mental health crisis.

This paper is an attempt to reframe America’s approach to solving the crisis. Much of the current U.S. strategy is focused on medical care for adults with a serious mental health condition. We think the federal government should do more to educate and train all Americans, especially children, on how to use non-medical care approaches to improve their state of mental health daily.