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.
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 September 2026 from the EU and UK.
The most significant development this…
On 21 October 2026, the UK Government confirmed that it will make the unilateral recognition of EU CE marks for medical devices and in vitro diagnostic devices (IVDs) in Great Britain indefinite. The confirmation is set out in the Government’s…
As reported in our February 2026 blog post, in 2025 the Law Commission, an independent statutory body established to keep the law of England and Wales under review and recommend reform, launched a review of the law on liability…
On 23 September 2026, the Italian data protection authority (the Garante) fined IQVIA Solutions Italy €7 million under the GDPR. The decision concerns a database of patient records collected from around 800 general practitioners and covering around a million patients.…
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 August 2026 from the EU and UK.
The more significant developments this…
On 30 June 2026, the UK government introduced the Immigration and Asylum Bill (the Bill), proposing the most significant reforms to the Modern Slavery Act 2015 (the MSA) since its enactment. The MSA’s transparency-in-supply-chains regime relies on voluntary disclosure is…
On 3 September 2026, Advocate General Kokott delivered a significant Opinion in Case C‑193/25, Poland v Parliament and Council, recommending the annulment of the provisions of the revised Urban Waste Water Treatment Directive 2024/3019 (UWWTD) that require pharmaceutical and cosmetics…
The CJEU has delivered a preliminary ruling in Case C-427/24 Diagramm Halbach, which provides guidance on determining whether a product is a medical device within the meaning of Regulation (EU) 2017/745 (“MDR”). The judgment confirms that the manufacturer’s advertising…
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 2026 from the EU and UK.
During July 2026,…
