Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Ottawa Marriott Hotel

Oct 30, 2018 7:00 AM - Oct 31, 2018 3:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

Transformation with Collaboration

Session 5: Track A: Cybersecurity

Session Chair(s)

Marc  Lamoureux

Marc Lamoureux

Manager, Digital Health Division, Medical Devices Directorate

Health Canada, Canada

Increases in the level of interconnectedness and data exchange between medical devices have large benefits to patients and the healthcare system but can leave devices vulnerable to unauthorized access. These vulnerabilities can negatively impact safety by causing diagnostic or therapeutic errors, or by affecting clinical operations. Health Canada, as the federal regulator of medical device safety and effectiveness, will now be considering cybersecurity vulnerabilities in medical devices as a potential risk to patients that manufacturers of medical devices must mitigate or eliminate. This session will describe the regulatory approach Health Canada is taking, what safety standards are relevant for this topic, and examples of industry approaches to medical device cybersecurity.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe Health Canada’s planned regulatory approach on medical device cybersecurity
  • Identify relevant standards for industry to follow and adopt when designing, manufacturing, and testing medical devices
  • Discuss industry approaches in dealing with medical device cybersecurity
  • Speaker(s)

    Laura  Élan, RAC

    Standards Landscape for Medical Device Cybersecurity

    Laura Élan, RAC

    CSA Group, United States

    Senior Manager, Cybersecurity

    Colin  Morgan

    Product Security Overview from a Medical Device Manufacturer

    Colin Morgan

    Johnson & Johnson, United States

    Director, Product Security & Services

    Marc  Lamoureux

    Session 5: Track A: Cybersecurity

    Marc Lamoureux

    Health Canada, Canada

    Manager, Digital Health Division, Medical Devices Directorate

    Have an account?

    Be informed and stay engaged.

    Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.