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…
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during January and early February 2025 from the United States, United Kingdom, and European Union.
In this issue, we discuss some useful international guidance documents from the International Medical Device Regulators Forum (IMDRF). These include Guiding Principles on Good Machine Learning Practices (GMLP) that build on the principles previously set out by the U.S. Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada, and guidance on characterization and risks of medical device software. The continued development of international guidance in this area highlights the importance of coordination between regulatory authorities and standardized guidance for these products. There have also been important developments in ongoing litigation relating to digital technologies, although whether these developments provide clear guidance to manufacturers remains to be seen.Continue Reading Virtual and Digital Health Digest – February 2025
This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024.
You will note that France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the lack of reimbursement rates means up-take has been low. The order of April 22, 2024 introduces the new pricing structure, with the maximum amount of financial compensation set at €780 per year, per patient. This is an important step in ensuring digital therapeutic products can be widely available in France while also ensuring that developers can obtain appropriate reimbursement.Continue Reading Virtual and Digital Health Digest, May 2024
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
On 15 March 2024, the European Parliament and the Council of the European Union (EU legislators) reached a provisional agreement on the text of the Regulation creating a European Health Data Space (EHDS).
Please note that the text of the agreement has not yet been officially published. This blog is solely based on the press releases that have been published by each of the institutions on their websites (available here, here and here) and has been updated considering some additional indications as to the content of the agreed text.Continue Reading EU legislators reach provisional agreement on the European Health Data Space
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
