Managing Cybersecurity Risks in the Medical Device and Healthcare Sectors

Monday, April 23, 2018 · 1:30 p.m. - 3:00 p.m. EDT

“Smart” medical devices also have underlying cybersecurity and privacy risks. They are also top targets from a host of global attackers from nation states to sophisticated criminal gangs. The health sector — including medical device manufacturers as well as pharmaceutical and biotech companies — face uncharted regulatory and liability risks.

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

Mark your calendar for Monday, April 23, when Ms. Krayem and Mr. Werner paints the picture over 90 fast-paced minutes. From Cybersecurity Executive Order 13800, to HIPAA, FDA activities, 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
  • FDA’s evolving focus on cybersecurity and how it impacts the risk, responsibilities, and regulation of companies
  • The Cybersecurity Information Sharing Act (CISA) and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors”
  • New international privacy and cybersecurity laws impacting the health sector
  • 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 cybersecurity attacks are only growing. Don’t risk your organization’s well-being in the scary new cyber era. Register now.

Who Will Benefit

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

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Meet Your Presenters

Norma Krayem

Senior Policy Advisor and Co-Chair, Cybersecurity and Privacy Team
Holland & Knight

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 Webinar 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.

Michael Werner

Holland & Knight

Michael Werner, is a Partner at Holland & Knight, is a Washington, D.C. He’s a public policy and regulatory attorney and a co-leader of Holland & Knight's Healthcare & Life Sciences Team. Mr. Werner has almost three decades of healthcare law, lobbying, regulatory and reimbursement experience in Washington. He focuses on issues affecting FDA-regulated entities, including biotechnology and pharmaceutical companies developing and manufacturing prescription and over-the-counter (OTC) drugs, biosimilars, cosmetics, dietary supplements and digital-health technologies.

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