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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 August 2026 from the EU and UK.

The more significant developments this month have been in the data protection space. Notably, Uber was fined almost €825 million following a finding that they breached the general prohibition on fully automated decision-making in the General Data Protection Regulation (GDPR). This decision serves as an important reminder for the need for meaningful human review in the Life Sciences industry as companies increasingly rely on AI-assisted decision-making, for example in screening candidates for eligibility to take part in clinical trials.

Further, the European Data Protection Board (EDPB) has written to the European Commission to request that the commission “closely assess” the recent U.S. Supreme Court decision of Trump v. Slaughter and its impact on the EU-U.S. Data Privacy Framework (DPF) adequacy decision. The EDBP has raised that this decision, which holds that the statutory protection against removal of Federal Trade Commissioners are unconstitutional, may affect the validity of the DPF decision.

Other developments include that the International Medical Device Regulators Forum (IMDRF) has published technical guidance regarding Predetermined Change of Control Plans (PCCP) for medical device software. This guidance intends to foster regulatory harmonization by identifying the essential principles for developing PCCP. 

Continue Reading Virtual and Digital Health Digest – September 2026

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 2026 from the the United Kingdom, and European Union.

February 2026 saw a period of substantial regulatory activity across both the UK and EU, particularly in relation to AI governance, medical technologies, and data protection. In the UK, the policy landscape continued to evolve with initiatives affecting the regulation of medical devices, clinical research, and AI deployment. Key developments included the Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation on the indefinite recognition of CE-marked medical devices, record levels of medical device testing, and the Prescription Medicines Code of Practice Authority’s (PMCPA) revised guidance on the use of social media. AI remained a major focus in the UK, with the UK government’s response to the consultation on the AI Management Essentials tool, increased industry involvement in the UK AI Security Institute’s alignment program, and feedback relating to governmental research on AI adoption across UK businesses. Additional international collaboration efforts included UK engagement at the India AI Impact Summit and an expanded science and technology partnership with Japan, as well as the launch of the first-ever AI Strategy for UK Research and Innovation.

Continue Reading Virtual and Digital Health Digest – February 2026

The Prescription Medicines Code of Practice Authority (PMCPA) has published revised guidance on social media.

Social media has remained a significant focus for the PMCPA in recent years, with numerous companies found in breach of the ABPI Code (the Code) due to activity on social media by the companies themselves, their employees, or associated third parties. Compliance in this space is particularly challenging given the global reach of social media and its inherently public nature, especially when the promotion of prescription-only medicines (POMs) to the public is prohibited in the UK.

Continue Reading UK PMCPA publishes revised guidance for the use of social media

The Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance to provide clarity on the disclosure obligations and commercial governance expected from companies in relation to package deals (Guidance). The Guidance responds to analysis conducted by PMCPA in 2025 which revealed “varying longstanding practices in relation to package deals among companies, particularly in relation to disclosure of transfers of value”.  

Continue Reading UK PMCPA releases new guidance on Package Deals: key takeaways for industry

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?

Advocate General Szpunar has opined that they do not. The opinion comes in the latest of a stream of cases on advertising practices involving DocMorris (Case C-517/23), a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The AG concluded that the discount campaigns regarding 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 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.

Continue Reading When discount campaigns regarding prescription only medicines do not fall within the definition of advertising in the EU

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

On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published by PMCPA in 2016, the large number of complaints since that time is evidence of continued uncertainty regarding permitted activity in this area.    

However, while the Guidance acknowledges the challenges introduced by the “open and transitory” nature of social media, it broadly reflects recent PMCPA decisions and rejects the more permissive approach that some stakeholders had advocated was appropriate.  Nevertheless, the additional clarity provided by the Guidance is welcome and, by defining general principles applicable to use of social media and issuing more detailed guidance in certain areas, PMCPA has provided a framework to assist companies in managing their social media activity going forward. 

Continue Reading UK PMCPA publishes long-awaited guidance on use of social media

The international and European self-regulatory bodies for the research-based pharmaceutical industry (IFPMA, International Federation of Pharmaceutical Manufacturers and Associations and EFPIA, European Federation of Pharmaceutical Industries and Associations) yesterday published a Note for Guidance to assist member companies with their use of social media and digital channels.

In the EU and UK, direct to consumer (DTC) promotion of prescription only medicines (POMs) is prohibited. Given the reach of social media, the Guidance correctly identifies the highest risk for companies as unauthorised promotion of POMs to the public. In addition, it notes that information shared through digital channels that can be accessed globally generates risk and uncertainty for industry. These risks, combined with the difficulty of controlling the content and audience of posts (both geographically and due to the prevalent use of social media by employees and affiliated third parties), have resulted in many companies being found in breach of self-regulatory codes.

The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code. IFPMA and EFPIA intend the Guidance to act as an “evolving resource”. This is welcome; uses of social media are continually expanding and it has been difficult for industry to apply pre-social media legislation and guidance to the modern world. It would be helpful if local self-regulatory authorities provide their own (or update previous) guidance in line with the new Guidance to ensure it is appropriately implemented within the national Codes.Continue Reading ATTENTION SOCIAL MEDIA USERS: New IFPMA and EFPIA Guidance on use of social media by industry