Recently, the U.S. Food and Drug Administration (FDA) published a suite of guidance documents relating to software, automation, and artificial intelligence. One guidance document in particular, addressing clinical decision support (CDS) software, may signal a tightening in FDA’s oversight on software tools with artificial intelligence and machine learning (AI/ML) that could introduce confusion and frustrate innovation in this important, fast-developing area. On October 18, 2022, FDA held a webinar to provide additional clarifications on this final guidance.
On January 28, 2019, the Healthcare and Public Health Sector Coordinating Council released the “Medical Device and Health IT Joint Security Plan” (“JSP” or “Plan”)—cybersecurity recommendations for medical device manufacturers, healthcare information technology vendors, and healthcare providers. U.S. Government entities, including the FDA, participated in the development of the Plan. The JSP comes close on the heels of the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” a similar effort by a public-private partnership to provide cybersecurity guidance to healthcare industry stakeholders. (more…)