FDA strengthens its medical device cybersecurity program

FDA Commissioner Scott Gottlieb discusses recent efforts at his agency to strengthen its medical device cybersecurity program. In coordination with the MITRE Corporation, FDA has announced the launch of a cybersecurity "playbook" for health care delivery organizations that is focused on promoting cybersecurity readiness.

FDA Commissioner Scott Gottlieb discusses recent efforts at his agency to strengthen its medical device cybersecurity program. In coordination with the MITRE Corporation, FDA has announced the launch of a cybersecurity "playbook" for health care delivery organizations that is focused on promoting cybersecurity readiness. FDA also announced on Monday two new memoranda of understanding with multiple stakeholder groups to create information sharing analysis organizations (ISAOs) — groups of experts that gather, analyze, and disseminate important information about cyber threats. In these ISAO forums, manufacturers have the opportunity to share information about potential vulnerabilities and emerging threats. The agency is also taking steps to bring additional resources to FDA to continue building its medical device cybersecurity program. In FDA's Fiscal Year 2019 Budget, it proposed to create a Center of Excellence for Digital Health. This Center of Excellence would help establish more efficient regulatory paradigms, consider the building of new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices.