Product Liability

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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 July and early August 2025 from the the United Kingdom, and European Union.

The UK government has published a number of initiatives and responses to consultations this month that have included important proposals for devices and digital health. The 10 Year Health Plan and Life Sciences Sector Plan both refer to integration of digital health into the National Health Service. Further, the Medicines and Healthcare products Regulatory Agency’s statement on the future regulation of devices makes some key changes relevant to software, including that the proposed international reliance pathways will include software. There has also been some useful guidance on synthetic data, and on reporting adverse events for software devices. These initiatives continue to demonstrate that digital technologies are seen as a growth area and are important for delivering the government’s long-term healthcare plans. Continue Reading Virtual and Digital Health Digest – August 2025

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 April and early May 2025 from the United States, United Kingdom, and European Union.

Cybersecurity is a hot topic in the UK and EU this month. In both, cybersecurity plans are developing, with the European Commission conducting a consultation on the EU Action Plan to strengthen cybersecurity within hospitals and health care providers, and the UK Cyber Security and Resilience Bill being published, introduced partly because of cyberattacks on UK hospitals. This is clearly an important area for developers of digital products and services, who should watch the progress of these policies closely.Continue Reading Virtual and Digital Health Digest – May 2025

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 February and early March 2025 from the United States, United Kingdom, and European Union.

Artificial intelligence (AI) has been the focus this month, with certain aspects of the EU AI Act now in force and key guidance being published by the European Commission. In addition, the much criticized AI Liability Directive has been withdrawn by the European Commission. In the UK, the UK government published its AI Action Plan setting out its proportionate, flexible regulatory approach towards AI, and the Medicines and Healthcare products Regulatory Agency (MHRA) hosted an Innovation Showcase demonstrating how it is using digital technologies and AI throughout the regulatory lifecycle. Continue Reading Virtual and Digital Health Digest – March 2025

This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024  from United Kingdom, and European Union.

Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy agenda. Of particular importance to the life sciences sector are the Product Safety and Metrology Bill and the Digital Information and Smart Data Bill. Although the scope and content of each bill is currently unknown, they could impact medical devices and innovative scientific research. Further, there was no artificial intelligence bill in the agenda, although the government will “seek to establish the appropriate legislation” in the future.Continue Reading Virtual and Digital Health Digest – August 2024

Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its legislative and policy agenda.

The agenda includes a Product Safety and Metrology Bill.  Some form of legislation to address UK product regulation was expected in order to take account of market developments and new technologies, such as online selling and AI.  We set out below a brief summary of the Bill.Continue Reading The King’s Speech: Product Safety and Metrology Bill

Developments in product liability law are always potentially significant for pharmaceutical and medical device manufacturers.

On 13 March 2024, the European Parliament adopted new EU consumer protection legislation to repeal and replace the EU Product Liability Directive 85/374/EEC, which has been in force for almost 40 years.  Once the new legislation has been approved by the European Council it will become law, and is likely to come into force in around mid-2026. The intention is for EU consumers to have easier access to compensation caused by defective products. 

The International Comparative Legal Guide (ICLG) on Product Liability Laws and Regulations 2024 is now available, and we have prepared:

Continue Reading Implications of the New EU Product Liability Directive

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

Spurred, in part, by the COVID-19 pandemic and the need for new ways to reach patients at home, 2023 saw a boom in digital technologies and healthcare solutions: one-stop-shop telemedicine platforms, app-based remote patient monitoring, direct-to-consumer online pharmacies, software-based medical devices, and artificial intelligence/machine learning to bolster delivery of telehealth services. Then came a robust government response. In the EU and UK, regulatory bodies grappled with the introduction of machine learning, AI, and other software into healthcare services by, for example, new guidance from the EU Medical Device Coordination Group and UK Medicines and Healthcare products Regulatory Agency on software medical devices, the EU’s AI Act and the UK government’s AI White paper, the European Medicines Agency reflection paper on use of AI in the product lifecycle, the EU Data Privacy Framework and the equivalent UK-U.S. data bridge, and the European Health Data Space. 

We call this the “Race to Regulate.” This push-pull dynamic between digital health innovation and government regulation is key to evaluating regulatory risks in today’s shifting legal landscape. This digest seeks to keep up with these changes and provide you with an overview of the key guidelines and developments as the landscape develops. As we come to the end of 2023 and publish our latest Digest, join us on December 13 as we unpack pivotal moments in the 2023 Race to Regulate and discuss what’s next for virtual and digital health. Continue Reading Virtual and Digital Health Digest and webinar