EUROPEAN UNION

Regulation on the European Health Data Space (EHDS) Officially Published

The European Health Data Space (EHDS) Regulation has been published in the Official Journal of the EU, marking a key milestone in the EU’s digital health strategy. The EHDS establishes a secure and standardized framework for accessing and using electronic health data across Member States. Implementation will roll out in phases, with the first major milestone in March 2029.

Regulation (EU) 2025/327 lays the foundation for the European Health Data Space (EHDS), enhancing individuals' access to and control over their electronic health data while facilitating its use for research, innovation, policymaking, and public health preparedness. By ensuring interoperability, security, and ethical data handling, the EHDS aims to strengthen healthcare across the EU and improve responses to health threats. The regulation also establishes a unified legal and technical framework for electronic health record (EHR) systems, supporting the development of a resilient and inclusive European Health Union.

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BRAZIL

Stay Updated with Avisalegis – ANVISA’s New Regulatory Notification Service

ANVISA's legislation portal now offers Avisalegis, a subscription-based notification service that alerts users about the Agency’s latest regulatory publications. Subscribers can customize their alerts by selecting specific types of acts (e.g., Public Consultations, Resolutions) or key themes like Food and Medicines. Stay informed with real-time updates or browse the latest publications directly on the platform. Sign up today to never miss an important regulatory update!

You can read the full announcement and subscribe to Avisalegis here: Avisalegis - Subcription

Learn more about ANVISA Brazil Medical Device Registration.

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