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Chiara Leoni

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In Medical Devices

The EU AI Act’s First Harmonised Standard: What’s Next for Medical Device Manufacturers?

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The first harmonised standard under the EU AI Act has landed, giving medical device manufacturers a much clearer route through one part of the AI Act compliance puzzle. EN 18286:2026 addresses the quality management system (QMS) requirements for providers of high-risk AI systems. For medtech companies whose products fall within the AI Act’s high-risk regime, it provides a practical framework for translating the requirements of Article 17 into an operational QMS. More importantly, manufacturers do…

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In Data Privacy

The Next EHDS Implementation Wave: What Pharma and MedTech Need to Do Next

by and 6 Mins Read

The European Health Data Space (EHDS) is moving from framework to build phase, with several implementing regulations already adopted and a further wave of technical rules now in preparation. Many of these measures focus on the primary-use framework and will be most relevant to healthcare providers, Member States and electronic health record (EHR) system manufacturers. However, others are big news for businesses preparing for their new obligations as health data holders and health data users.…

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In Health Data Privacy & Security

SRB Is Not a Shortcut to Anonymity: What Recent CNIL and Garante Decisions Mean for Health Data in the EU

by and 6 Mins Read

Remove the names. Replace them with codes. Place the key with a third party. Anonymous data? Not necessarily. Recent decisions by the Garante and the CNIL are clear reminders that key-coded health data does not automatically fall outside of data protection law. Although SRB offers a potential route to treating pseudonymised data as anonymous in the hands of a particular recipient, it is not a silver bullet. Pharmaceutical and medtech businesses must still address re-identification…

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