ISO, NIST, CMMC — if the alphabet soup of cybersecurity frameworks has you confused, we’ve got you covered. In the latest episode of the Faegre Drinker on Law and Technology Podcast, host Jason G. Weiss chats with guest Jim Watkins, former deputy laboratory director in the FBI’s Orange County Crime Lab and current certified technical assessor for the ANSI National Accreditation Board, about some of the more prominent cybersecurity frameworks, the process of cybersecurity assessments, how compliance issues are addressed, and what’s the difference between self-assessment, self-certification, and accreditation, and how a skilled attorney can make all the difference in getting accredited.
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.