Over the past several years, FDA has undertaken a significant and diverse set of efforts aimed at improving not only medical device cybersecurity, but cybersecurity across the healthcare sector. The agency has worked internally on efforts such as updated guidance with respect to satisfying regulatory requirements for cybersecurity within medical devices, the development of a playbook related to regional response, “boot camps” for threat modeling, and others. FDA has also supported the development of a vulnerability scoring system specifically targeted at medical devices. At the same time, FDA has been working closely with its government and private sector partners, patients, security researchers, and more. This includes groups like the International Medical Device Regulators Forum, the Healthcare Sector Coordinating Council, and the National Telecommunications and Information Administration’s multistakeholder process on software transparency. This talk will provide an update and overview of these efforts.
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