Managing Cybersecurity Risks in the Medical Device and Healthcare Sectors - Webinar Recording/Transcript

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Managing Cybersecurity Risks in the Medical Device and Healthcare Sectors

“Smart” medical devices offer juicy targets to mischief-makers, and the threat is a global one. From garden-variety hackers, to cyber-mercenaries, to nation-states bent on global chaos, devicemakers face uncharted regulatory and liability risks.

FDAnews has invited global cybersecurity expert Norma Krayem to walk you through the rapidly changing global regulatory landscape and show you new coping strategies.

Ms. Krayem paints the picture over 90 fast-paced minutes. From Cybersecurity Executive Order 13800, to HIPAA, Homeland Security and more, you’ll explore:

  • Cybersecurity-triggered changes in interpretation of HIPAA, and enforcement by the HHS Office of Civil Rights, as they affect quality and regulatory matters
  • Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms
  • Homeland security: How DHS cybersecurity initiatives, including the Automated Information Sharing (AIS) program, can help you understand the threat from nation-states, non-state actors and other potential attackers
  • The Cybersecurity Information Sharing Act and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors”
  • And much more!

Do you know what the FDA, HHS, DHS and global regulators are planning? The cost of ignorance could include regulatory sanctions and liability judgments, and could strike from anywhere in the world. Don’t risk your organization’s well-being in the scary new cyber era.

Cybersecurity is a multi-discipline activity, so team participation in the presentation is important. Team members include:

  • Design engineers
  • Software engineers
  • Software validation specialists
  • Risk managers
  • Complaint managers
  • QA/QC/QR
  • Regulatory affairs
  • Submission specialists
  • C-Suite
  • Information Security professionals
  • Security officers
  • Product developers

Norma Krayem is a senior policy advisor and co-chair, Cybersecurity and Privacy Team, Holland & Knight. A frequent speaker on global cyber risk, she has a special interest on the global cybersecurity regulatory structure for medical devices. In this presentation she’ll focus on the emerging global cybersecurity regulatory environment of medical devices, and discuss the nexus of cyber risk to the Internet of Things (IoT) as it promises to affect devicemakers.