Medical Device Cybersecurity Risks & Best Practices - Webinar Recording/Transcript
Medical Device Cybersecurity Risks & Best Practices: Navigating the Nuanced Cyber Regulatory Waters
Smart medical devices 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 — faces 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.
Over the course of 90 fast-paced minutes, Ms. Krayem will move from the Cybersecurity Executive Order 13800 to HIPAA, Homeland Security and more:
- Cybersecurity-triggered changes in the 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
With U.S. agencies — FDA, HHS, DHS — all at work on new sector risk bulletins and re-evaluation of current rules such as HIPAA, and global regulators equally involved, this is a pressing matter. Address it now, by committing an hour and a half of your time to this timely learning session.