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Applying Risk Management Responsibilities to Medical Device Cybersecurity Stakeholders

Industry standards such as IEC 80001 and legislation such as the Omnibus Bill can serve as a framework to help improve communications between medical device manufacturers (MDMs) and healthcare delivery organizations (HDOs) and clarify how responsibility is allocated between the two.

Join Claroty Healthcare Industry Principal Ty Greenhalgh, Ascension Director of Cybersecurity Skip Sorrels, and H-ISAC VP of Medical Device Security Phil Englert to learn how understanding the legal requirements of MDMs can help HDOs more effectively ensure safety, effectiveness, and security across increasingly interconnected care delivery networks.

Topics covered will include:

  • How the Omnibus Bill has empowered the FDA to add new requirements to MDM submissions, patching, vulnerability disclosure, SBOM, and lifecycle management

  • How the IEC 80001 provides clear guidance on applying risk management best practices to IoMT environments — including risk assessment, planning, mitigation, access controls, and change management

  • How IEC 80001 key control points can be applied to new legislation requirements to more clearly define responsibilities between HDOs and MDMs in managing the cybersecurity of medical devices

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