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GAO recommends FDA, CISA update agreement to address medical device cybersecurity challenges - Industrial Cyber

January 5, 2024
GAO advises FDA, CISA to update agreement reflecting organizational changes to address medical device cybersecurity. FDA, CISA should enhance roles clarity in cybersecurity strategy. The outdated agreement doesn't cover all collaboration practices. Cyber threats to medical devices could delay patient care, expose sensitive data, disrupt healthcare operations and require costly recovery. FDA ensures safety and effectiveness of medical devices sold in U.S. The report addresses non-federal entities accessing federal support, federal agencies facing challenges, coordination of key agencies, and limits in agencies' authority over medical device cybersecurity. The report cites vulnerabilities in medical devices leading to cyber incidents. Last month, GAO identified need for full implementation of incident response requirements among federal agencies.
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