FDAnews Announces — Medical Device Cybersecurity Risks & Best Practices: Navigating the Nuanced Cyber Regulatory Waters Webinar, Dec. 18, 2018

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A smart medical device is a vulnerable medical device. Learn how to manage the risk.

WCG Market Intelligence and Insights

WCG Market Intelligence and Insights

Medical Device Cybersecurity Risks & Best Practices
Navigating the Nuanced Cyber Regulatory Waters
**An FDAnews Webinar**
Tuesday, Dec. 18, 2018, 1:30 p.m. - 3:00 p.m. ET
https://www.fdanews.com/mdcybersecurityrisks

The smarter medical devices get, the more vulnerable they become.

Cybersecurity is becoming an everyday risk.

FDAnews has reached out to global cybersecurity expert Norma Krayem to spell out the risks and what to do about them.

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 explain 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

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 to this timely learning session.

Meet The Presenter:
Norma Krayem, Sr. Policy Advisor and Co-Chair, Cybersecurity and Privacy Team, Holland & Knight

Norma is a well-known cybersecurity expert in a host of sectors including health and understands the global regulatory structure for medical devices. She will talk about the current and emerging regulatory environment and discuss the nexus of cyber risk to the Internet of Things (IoT) as well which will impact the medical device industry. She is regularly sought out by the media, policy and elected officials around the world on cyber risk.

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
  • Complaint Analysts
  • Regulatory Affairs Managers
  • Submission Specialists

Webinar Details:
Navigating the Nuanced Cyber Regulatory Waters
**An FDAnews Webinar**
Tuesday, Dec. 18, 2018, 1:30 p.m. - 3:00 p.m. ET
https://www.fdanews.com/mdcybersecurityrisks

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/mdcybersecurityrisks
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDAnews
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