The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and intellectual property considerations. If you are developing a digital health or software product, it may contain software functions that are considered “devices” as that term is defined in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act and are subject to US. Food and Drug Administration (FDA) oversight as devices.
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