Adrian Johnson
TLDR:
- Key element 1: The FDA has ramped up resources for medical device cybersecurity, with a focus on enhanced regulatory oversight, industry collaboration, and organizational changes.
- Key element 2: The FDA has established a new super office, the Office of Readiness and Response, to address cybersecurity issues related to medical devices, led by Nastassia Tamari.
Under the recent reorganization of the FDA’s Office of Strategic Partnerships and Technology Innovation, Dr. Suzanne Schwartz is leading efforts to bolster medical device security through regulatory oversight, collaboration with industry stakeholders, and organizational changes. The FDA’s new Office of Readiness and Response, headed by Nastassia Tamari, focuses on medical device cybersecurity, including incident response and coordination. The FDA has gained expanded regulatory authority over medical device cybersecurity due to an omnibus funding bill, allowing the agency to reject premarket submissions for new devices that lack adequate cybersecurity details. Through closer collaboration between the FDA’s Office of Product Evaluation and Quality and the experts in the medical device cybersecurity division, manufacturers are encouraged to take the security of their devices more seriously. Dr. Schwartz’s leadership in formulating the FDA’s medical device cybersecurity policy and her work with government agencies and industry groups emphasize the agency’s commitment to improving cybersecurity in the healthcare sector.
