H-ISAC Press Release, July 1, 2020


Medical Device Security Whitepaper Series Part 1:
Landscape of Global Regulatory Guidance

Titusville, FL, July 1, 2020Health-ISAC releases Medical Device Security Whitepaper to address the landscape of global regulatory guidance.
The Global Regulatory Landscape

Salwa Rafee, VP Global Development at H-ISAC and co-author, says that it is “critical to understand the complex landscape of cybersecurity regulations for medical devices across the globe, especially since many of the principal regulatory bodies have accelerated the release of their guidance over the past few years.” This report is intended to help the Medical Device Industry navigate, align, and comply with those regulations.


The report provides a summary of guidance documents and directives from major regulatory bodies, including the US, EU countries, Canada, Australia, Japan, China and the Middle East, covering premarket concerns and postmarket considerations as well.


Part One in a Medical Device Security Whitepaper Series

This is part one of four subsequent reports on global medical device security compliance. “Upcoming topics include analyzing trends among these medical device security guidance documents, shedding light on standards and technical reports, says Michelle Jump, Global Regulatory Advisor at MedSec and co-author, “and will be followed by a series of interviews with global regulators to solicit their perspective and thoughts on future trends.”


Founded in 2010, Health Information Sharing and Analysis Center (H-ISAC) is a trusted global community focused on sharing timely, relevant and actionable information to prevent, detect, and respond to cyber and physical security events so that members can focus on improving health and saving lives.


Membership is open to public & private hospitals, ambulatory providers, health insurance, pharmaceutical/biotech manufacturers, laboratory, diagnostic, medical device manufacturers, medical schools, medical R&D organizations and other relevant health sector stakeholders.


H-ISAC partners with other global security organizations such as governments, law enforcement, other ISACs, threat intelligence partners, and global CERTs to share information, create situational awareness, and mitigate against threats and incidents.


Member organizations become stronger by working together, benefitting the entire health sector and its vital role in critical infrastructure worldwide. Join today.

Visit www.h-isac.org and follow us on LinkedIn.

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