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European Health Data Space Regulation sets requirements for electronic health record systems

On March 5, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (the Regulation)...more

Council approves EU AI Act

Highlight of the week - On 21 May 2024, the Council of the European Union (the Council) issued a press release announcing it had approved the Proposal for a Regulation of the European Parliament and of the Council Laying Down...more

EU legislative proposals to impose additional obligations on medical device companies

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

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