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ViewAttendees 6

Digital Health

Regulating for cybersecurity in AI-enabled MDs

Wednesday, May 6, 2026
08:30 - 09:30 WEST
Location: Auditorium 2
Learning Level: Intermediate

    Speaker(s)

  • Oscar Freyer (he/him/his)

    Research Associate
    Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
    Dresden, Sachsen, Germany

  • Max Ostermann, M.Sc.

    Research Associate
    Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
    Dresden, Germany

  • Brandi Conardy, MA

    Health Regulatory Policy & Cybersecurity Strategist
    Arizona State University
    Saint Charles, Missouri

    Slides (PDF)
Description: As healthcare systems increasingly rely on connected and AI-enabled medical devices (AIeMDs), the traditional method of “patching vulnerabilities” is no longer sufficient. However, existing frameworks, including MDR, FDA pre- and post-market guidance, and IEC 81001-5-1, have gaps in lifecycle management, modular documentation, and responsiveness to AI-driven risks.
Regulatory professionals, manufacturers, and clinical stakeholders must move towards building genuine resilience — enabling health systems to absorb,
adapt, and transform in the face of cyber threats. This session offers insights into the cybersecurity landscape of AIeMDs, the current state of regulation in Europe and the US as well as an outlook on how things could be changed, to address this ever changing field.
Attendees will learn what cybersecurity threats AIeMDs face, how these are tested against. Beyond these technical aspects, they will learn about the differences between US and EU regulation of AIeMDs as well as stakeholder perspective on desired changes and current regulatory science research themes.

Learning Objectives:

  • participants will be aware of the current threat landscape of AIeMDs and state-of-the-art testing
  • participants will be able to evaluate the limitations of existing regulatory frameworks (e.g., MDR, FDA guidance, IEC 81001-5-1 IEC 62304) and identify critical gaps in lifecycle security, modular documentation, and AI-driven risk management.
  • participants will be able to navigate and anticipate emerging legislation (AI Act, Cyber Resilience Act, NIS2) to proactively shape compliance strategies and contribute to resilience-by-design policymaking.