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.
BioSlice Blog
The BioSlice Blog, published by Arnold & Porter Kaye Scholer LLP, focuses on regulatory, legal, and policy developments in the life sciences sector. It covers topics such as medical device regulations, pharmaceutical legislation reforms, intellectual property frameworks in healthcare, and digital health innovations. The blog provides analysis on EU and UK regulatory changes, compliance challenges, and industry impacts, including discussions on breakthrough and orphan device pathways, notified body regulations, NHS IP guidance updates, and antimicrobial resistance measures. It also addresses litigation, transactional, and public policy issues relevant to biotech, medtech, and pharmaceutical companies operating in regulated markets.
Latest from BioSlice Blog - Page 7
Commission guidelines for providers of general-purpose AI models
On July 18, 2025, the European Commission released its guidelines on the obligations for providers of general-purpose AI (GPAI) models under the European Union’s AI Act. This is an important development for companies, including in the Life Sciences sector, building…
The European Commission Publishes an EU Life Sciences Strategy
On 2 July, 2025, the European Commission published its EU Life Sciences Strategy (the ‘Strategy’), setting out a roadmap to position the European Union (EU) as a global leader in life sciences by 2030.
For pharmaceutical, MedTech, and biotech companies,…
UK proposes Early Access Service for innovative medical devices
On 31 July 2025, the UK government published a statement of policy intent, setting out its initial thinking on an Early Access Service (EAS) for innovative medical devices. The intention is for this to first focus on innovative diagnostic devices,…
Is change on the horizon for the UK product liability regime? [Updated]
The Law Commission, an independent organisation established to keep the law of England & Wales under review and recommend reform, has announced a review of the law in relation to liability for defective products.…
UK Medical Devices Regulations: further changes afoot
The UK government has published its response to the recent consultation on the UK Medical Devices Regulations. As highlighted throughout the process to date, the focus is on improving regulatory scrutiny and oversight of medical devices and IVDs in the…
Updates to the EU Pharmacovigilance Rules: Key Takeaways for Marketing Authorisation Holders
On 22 July 2025, the European Commission adopted Implementing Regulation (EU) 2025/1466 (“Regulation”), updating the EU pharmacovigilance (or “PV”) rules by way of amendments to Implementing Regulation (EU) No 520/2012. The changes aim to clarify and strengthen certain pharmacovigilance…
Virtual and Digital Health Digest – July 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 June and early July 2025 from the United Kingdom and European Union.
There…
The UK Government has plans: what does this mean for the Life Sciences Sector?
The UK Government has recently published plans for the Life Sciences Sector and the NHS in England. In this blog post, we summarise these plans and some of the initial feedback that has been published by ABPI. It is not…
EU Consults on New GMP Rules for AI in Pharma Manufacturing
On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing. The consultation proposes significant updates to the EU Good Manufacturing…