EHDS

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The revised MDCG 2019-11 guidance on qualification and classification of software (the Revised Guidance)  introduces a series of clarifications and expansions that impact how software is qualified and classified as a medical device under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). While the core principles remain unchanged, the Revised Guidance provides more detailed examples, specifically includes software using artificial intelligence (AI), and addresses modular software and interoperability with electronic health records (EHRs) under the European Health Data Space (EHDS).

This blog post outlines these key updates and considers their potential impact on compliance obligations for software manufacturers.Continue Reading Revised guidance on classification of Medical Device Software in the EU

On 5 March 2025, Regulation 2025/327 (EHDS Regulation), creating a European Health Data Space (EHDS), was published in the European Union Official Journal (EU Official Journal), marking the end of the legislative process of the EHDS Regulation.

As set out in a previous blog, the EHDS Regulation allows Life Sciences companies to apply for…

This digest covers key virtual and digital health regulatory and public policy developments during March.

You will note that the EU institutions have been busy during March. On March 12, 2024, the European Parliament (EP) formally adopted the revised Product Liability Directive, which makes several important changes to the existing European Union (EU) product liability regime, including that software and artificial intelligence (AI) technologies will now fall within the scope of a product. On March 13, 2024, the EP formally adopted the Artificial Intelligence Act, meaning the legislative process for the world’s first binding law on AI is nearing its conclusion. Finally, on March 15, 2024, the Council of the European Union and the EP reached a provisional agreement on the European Health Data Space (EHDS), which aims to improve access to health data electronically across the EU. Each of these important legislative provisions should shortly be finalized and will then become law in the EU.Continue Reading Virtual and Digital Health Digest, April 2024

This digest covers key virtual and digital health regulatory and public policy developments during February 2024.

Of note, the UK continues to pursue a “pro innovation” flexible approach to the regulation of AI. As outlined in the UK government’s response to the public consultation, the government will develop a set of core principles for regulating AI, while leaving regulatory authorities, like the Medicines and Healthcare products Regulatory Agency (MHRA), discretion over how the principles apply in their respective sectors. A central governmental function will coordinate regulation across sectors and encourage collaboration. The government’s aim with this approach is to enable the UK to remain flexible to address the changing AI landscape, while being robust enough to address key concerns. This is in sharp contrast to the position in the EU, where the EU AI Act is reaching the conclusion of the legislative process.Continue Reading Virtual and Digital Health Digest, March 2024

Welcome to the first installment of Arnold & Porter’s Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health and telehealth-related developments in the United States, United Kingdom, and European Union in the healthcare, regulatory, privacy, and corporate transactions space.
Continue Reading Virtual and Digital Health Digest

Earlier this month, the European Commission published a proposal for a Regulation for the European Health Data Space (EHDS) aimed at regulating and facilitating electronic health data access and sharing across the European Union (the Proposal). The two main objectives of the EHDS are to (i) enable individuals to easily access and control their electronic health data; and (ii) allow researchers, innovators and policy makers to use electronic health data in a lawful, legitimate, trusted and secure way that preserves privacy and the fundamental rights of patients.
Continue Reading EU Digital Health Policy: European Commission launches European Health Data Space