How Can The EU Health Sector Combat Rising Cyber Threats?
The health sector has experienced an increase in cybersecurity incidents since the COVID-19 pandemic. While health systems are becoming more prepared for attacks and breaches, the sector remains vulnerable, EU cyber agency ENISA warns.
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EU AI Act Legal Deep-Dive Part 1: What Can Medtech Expect, And When?
The text of the European Commission’s proposed AI Act is expected to enter the EU high-level negotiation stage within weeks, yet many questions remain as to what the final regulation will entail. Lawyers from Cooley LLP tell Medtech Insight why considerable changes to the text are possible, and what the new law is likely to mean for medtech.
MedTech Forum 2023: Europe’s Regulatory Maze Must Be Simplified, But How?
Navigating Europe’s increasingly complex maze of regulations was the topic du jour at this year’s MedTech Forum conference. Despite growing concerns that the EU is losing its historic attractiveness for companies, a spirit of resilience characterized the busy three-day meeting.
EU Regulatory Roundup, May 2023: MDR Extension Updates Resume
May saw a resurgence of EU MDR news, following a few quieter weeks. Guidance on demonstrating compliance with extended transition periods and compiling clinical investigation reports were among the top-read articles in Medtech Insight in the past month.