The FDA has released a new document on the use of Artificial Intelligence (AI) in the life cycle of medical products, reinforcing the need for transparency, safety and regulatory compliance. The FDA has identified four priority areas: global collaboration to protect public health, support for regulatory innovation, development of standards and best practices, and continuous monitoring of AI performance. The guidelines address everything from algorithm evaluation and bias mitigation to the resilience and cybersecurity of AI-based medical products. This initiative reinforces the FDA's commitment to responsible innovation, ensuring that AI applied to health contributes to medical advances without compromising patient safety.

Regulation (EU) 2025/327 creates the European Health Data Space (EHDS), enabling the secure sharing of medical data and promoting digital interoperability in the European Union. The introduction of the MyHealth@EU platform will ensure the connection between national healthcare systems, making it easier for patients to access their Electronic Health Records (EHRs) and for healthcare professionals in different Member States to use them. In addition, manufacturers of medical devices and in vitro diagnostic devices (IVDs) will have to comply with new security, traceability and interoperability requirements, while digital wellness applications will need a declaration of conformity with European specifications. The first obligations will come into force from March 2027, making it essential for companies in the sector to start preparing to ensure regulatory compliance and access to the European market.

Regulation (EU) 2025/327 establishes the European Health Data Space (EHDS), an innovative system that will enable the secure sharing of health data and cross-border access to Electronic Health Records (EHRs). This initiative strengthens digital interoperability in the European Union, ensuring that citizens can access their medical data in any Member State. For manufacturers of medical devices and digital health applications, the regulation imposes new rules on security, interoperability and data traceability, requiring products claiming compatibility with EHRs to comply with specific standards and, in some cases, to be registered with EUDAMED. The first obligations will come into force from March 2027, making it essential for companies in the sector to start preparing now to ensure regulatory compliance and access to the European market.