On February 11, 2019, President Trump signed an Executive Order on “Maintaining American Leadership in Artificial Intelligence.” The Executive Order (EO) recognizes that the United States is the world leader in AI research and development (R&D) and deployment,” and that “[c]ontinued American leadership in AI is of paramount importance. . . .”
On November 7, Federal Communications Commission Chairman Ajit Pai issued a Public Notice announcing a first ever FCC Forum focusing on artificial intelligence (AI) and machine learning. This Forum will convene at FCC headquarters on November 30 and will feature experts in AI and machine learning discussing the future of these technologies and their implications for the communications marketplace.
Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital, to market research at a benefits management organization, to optimizing manufacturing operations at a pharmaceutical company. The level of regulatory scrutiny of such systems depends on their intended use and associated risks.
In the U.S., for medical devices using AI, one of the key regulatory bodies is the Food and Drug Administration (FDA), especially its Center for Devices and Radiological Health (CDRH). CDRH has long followed a risk-based approach in its regulatory policies, and has officially recognized ISO Standard 14971 “Application of Risk Management to Medical Devices.” That standard is over 10 years old now, and therefore is currently undergoing revisions – some of which are meant to address challenges posed by AI and other digital tools that are flooding the medical-devices arena.