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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 September and early October 2025 from the the United Kingdom, and European Union.

This month, the EU and UK have been actively processing the future of AI development and regulation in life sciences and health care through a combination of legislative initiatives, opportunities for stakeholder engagement, and investment in infrastructure. In the EU, the European Commission has published draft guidance on reporting serious AI incidents under the AI Act, and the European Medicines Agency has initiated a stakeholder survey to define AI priorities in medicines regulation. In the UK, the UK government has announced a National Commission on the Regulation of AI in Healthcare and a new AIR-SP cloud platform. These developments signal a shift from theoretical regulation to practical implementation. There have also been two important decisions from the Court of Justice of the European Union refining the legal boundaries of digital health services and data protection.Continue Reading Virtual and Digital Health Digest – October 2025

On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to parallel trade of medicines, including whether German language and packaging requirements are proportionate or compatible with EU law.  The request follows an order for a preliminary reference made by the BVerwG in March 2025.  Notably, the request does not disclose the identity of the parallel importer, the manufacturer of the medicinal product, or the name of the product itself.Continue Reading CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of Medicines

On 4 September 2025, the Court of Justice of the European Union (“CJEU”) delivered a notable judgment on what is considered pseudonymised personal data under EU data protection law. While, technically speaking, the judgment concerns the interpretation of Regulation (EU) 2018/1725 (which governs the processing of personal data by the EU institutions and bodies), it fully applies to the interpretation of the concepts of personal data and pseudonymised data under Regulation (EU) 2016/679 (“GDPR”).

This question is essential for many companies operating in the EU, and in particular Life Sciences companies handling key-coded or otherwise pseudonymised patients’ personal data in the context of research and development, supply of healthcare products and related safety monitoring.Continue Reading CJEU clarifies the concept of pseudonymised data

The European Court of Justice (the “Court”) has ruled that Poland’s law prohibiting advertising by pharmacies and pharmaceutical outlets is overly restrictive and contrary to EU law.

The Polish legislation (Article 94a(1) of the Law on Medicines, as amended) which had been in force since 2012, prohibits pharmacies and pharmaceutical outlets from engaging in any form of advertising or promotional activity other than providing limited information on their location and opening hours. Any person who is found to be in breach of the provisions is liable to a fine of up to 50,000 Polish zloty (PLN) (approximately EUR 12,000).Continue Reading The European Court of Justice rules that Poland’s laws prohibiting pharmacies from advertising are overly restrictive

Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products? The European Court of Justice (CJEU) in the case of Apothekerkammer Nordrhein (C-517/23) has held that they do not.

Following on from the AG Opinion of Advocate General Szpunar, which we provided an update on earlier in the year, this case is the latest in a stream of cases on advertising practices involving DocMorris, a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The CJEU concluded that the discount campaigns regarding unspecified POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM.  The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the Court held that the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.

The facts of the case are set out in our previous blog available here.Continue Reading An update from the European Court of Justice on discount campaigns run by mail order pharmacies

In the last month, both the European Data Protection Board (“EDPB”) and the Court of Justice of the European Union (“CJEU”) provided their interpretation of key data protection concepts that are crucial for ensuring compliance with Regulation (EU) 2016/679 (“GDPR”).

In Opinion 22/2024, the EDPB provided guidance to data controllers on how to effectively oversee the activities of their (sub-)processors in a GDPR-compliant manner. The opinion was requested by the Danish data protection authority and likely related to the enforcement actions against Danish hospitals which allegedly failed to oversee processors (see our blog – https://www.biosliceblog.com/2024/02/proposed-fine-against-danish-hospital-for-failure-to-supervise-data-processors/).

In early October, the CJEU provided an answer to a key question raised by the courts in the Netherlands – can the legitimate interests legal basis be used for processing of personal data for commercial purposes (e.g., sharing with third parties for advertising and promotion) (Case C‑621/22).Continue Reading Notable developments in the interpretation of key GDPR concepts – why should Life Sciences companies care?

The Court of Justice of the EU (CJEU) has provided guidance on claims permitted to be made in the labelling and advertising for biocidal products under the Biocidal Products Regulation (Regulation (EU) No 528/2012 (BPR). 

The BPR aims to improve the free movement of biocidal products (substances intended to destroy, deter, render harmless, prevent the action of or otherwise control harmful organisms) while ensuring a high level of protection for human and animal health and the environment.Continue Reading CJEU rules on biocidal product advertising

In three separate preliminary rulings delivered by the Court of Justice of the European Union (CJEU) on 17 November 2022 (Novartis v Abacus Medicine, Bayer v kolpharma, and Merck Sharp & Dohme (MSD) v Abacus Medicine), the pharmaceutical industry received welcome guidance as to the extent to which brand owners may oppose the repackaging of medicinal products to comply with EU rules on tamperproof packaging.Continue Reading Tampering with the packaging? Further EU Court of Justice guidance for parallel traders

On 17 November 2022, the Court of Justice of the European Union (CJEU) delivered its preliminary ruling in joined cases C-253/20 Impexeco NV v Novartis (Impexeco), and C-254/20 PI Pharma v Novartis (PI Pharma), finding that where a parallel importer affixes the trade mark of a branded reference medicinal product onto the packaging of a generic product, the brand owner may oppose the placing of that generic product by the parallel importer on the market of a Member State. Though the CJEU provides an exception to this general rule, the authors query whether the exception will ever apply.

Importantly, this case compares: (i) the rules on when a parallel import licence can be obtained (which is a regulatory question), and (ii) when rebranding can legitimately take place for such products (which is an IP question). As set out below, the need for “identicality” is not the same for these two considerations.Continue Reading Parallel imports: identicality of products when repackaging

Today, the Court of Justice of the European Union delivered a landmark judgement with significant practical impact for companies transferring personal data outside the European Economic Area to the United States. The Court of Justice confirmed the validity of the Standard Contractual Clauses for transfer of personal data between a controller in the EU and a processor in a third country (e.g., the US) adopted by the European Commission in Decision 2010/87/EU. The Court has, however, invalidated European Commission Decision (EU) 2016/1250 on the adequacy of the protection provided by the EU-US Privacy Shield.
Continue Reading The CJEU confirms the validity of the Standard Contractual Clauses but invalidates the EU-US Privacy Shield