Today we're tackling some of the biggest questions around the EU regulations landscape in cybersecurity of medical devices.
Our guest is Elisabetta Biasin, a legal researcher specializing in cybersecurity, AI regulation, and EU laws. Elisabetta provides critical insights into the complex regulatory landscape facing medical device manufacturers implementing AI in Europe. She expertly breaks down how multiple frameworks—including the AI Act, MDR, NIS2, and GDPR—overlap and create compliance challenges, explains the specific cybersecurity requirements for AI systems under Article 15, and clarifies how data protection requirements extend beyond just personal data.
With real-world examples of potential cybersecurity vulnerabilities in medical devices like pacemakers, this episode delivers essential knowledge for manufacturers navigating the evolving European regulatory environment.
Want weekly actionable advice on medical device cybersecurity from yours truly? go here -> http://cyberdoctornotes.com
Elisabetta's profile:
https://mastodon.social/@bisilisib@eupolicy.social
https://www.linkedin.com/in/elisabetta-biasin-550a4711a/
Please share with a friend & rate the show 💚
Securely yours,
Cyber Doctor