On 1 February 2024, the Danish Data Protection Agency announced that it reported the private hospital HP Gildhøj Privathospital ApS’s (Capio A/S) to the Danish police and recommended imposing a fine of not less than DKK 1,500,000 (over 200.000 euros). In their investigation, the Danish Data Protection Agency found that the hospital had failed to effectively supervise the data processors they used for the processing of large amounts of patients’ sensitive  personal data.

Continue Reading Proposed fine against Danish hospital for failure to supervise data processors

On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation, which sets out the FDA’s quality management system (QMS) requirements for medical devices. The amendments seek to align more closely with International Standard Organization (ISO) standard 13485:2016, Medical Devices — Quality Management System Requirements for Regulatory Purposes. The ISO standard is the version used in much of the world and provides a good framework for meeting the requirements in the EU Medical Devices Regulation (MDR).

The FDA’s decision to align the US QMS requirements to international standards is one of many efforts undertaken by the Agency to promote global regulatory harmonization. Ex-US device and tech developers will hopefully receive some of the efficiency and alignment they were hoping for when it comes to quality system compliance requirements in the US.

You can read more in our advisory.

On 23 January 2024, the European Commission announced proposals to amend the Medical Device Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (IVDR), as applicable, to:

  • extend the transition provisions for certain in vitro diagnostic medical devices (IVDs) under the IVDR
  • allow for a gradual roll-out of Eudamed so that certain modules will be mandatory from late 2025
  • include a notification obligation in case of interruption of supply

The proposal will now need to be adopted by the European Parliament and Council before it enters into force. However, as the proposal follows a similar structure to the recent amendments to the MDR, we do not anticipate significant changes during the legislative process.

Continue Reading Commission proposes extension to IVDR transition periods and accelerated launch of Eudamed

The end of 2023 featured two significant judgments concerning AI inventions: (i) a highly awaited decision from the Supreme Court in Thaler on the ability of AI systems to be named inventors of patents; and (ii) a decision from the High Court in Emotional Perception considering the application of the computer program exclusion in the UK, leading to prompt changes in patent examination practices by the UKIPO. The Thaler decision was unsurprising and consistent with decisions in other jurisdictions. Consequently, this article focuses on the second of these judgments, especially as Emotional Perception could have ramifications for life sciences companies utilising artificial neural networks (ANN); inventions using ANNs will no longer be excluded from patentability on the basis that it engages the computer program exclusion to patentability in the UK.

Continue Reading Landmark UK High Court decision makes it easier to patent AI-related inventions that utilise ANNs

Thank you to all who joined us for our December 13 panel titled the “Race to Regulate.” In case you missed it, unpack this year’s pivotal legal challenges impacting the 2023 — and 2024 — digital legal landscape in our Year in Review Pocket Book.

Continue Reading Latest Virtual and Digital Health Digest

On 12 December 2023, the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) published the first version of the Union list of critical medicines (the list). Along with the list, the EMA published a Questions & Answers document (Q&A).

Continue Reading European Commission, HMA and EMA Publish First Union List of Critical Medicines

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

On 24 October 2023, the European Commission published a Communication on “Addressing medicine shortages in the EU” (the Communication). The Communication responds to the European Council’s call in June for urgent measures to ensure production and availability of critical medicines (i.e., the unavailability of which may cause patients serious harm, and whose supply must be ensured even in crisis periods) and to diversify international supply chains. On the same date, the European Medicines Agency (EMA) published details on the Solidarity Mechanism, recently created by the EMA Medicines Shortages Steering Group (MSSG) to facilitate redistribution of medicines between Member States (MS) in cases of critical shortages (i.e., medicine shortages where no alternative is available).

These EU-level actions are in addition to the mechanisms to tackle shortages already included in the European Commission’s proposal for a reform of the EU Pharmaceutical Legislation (read our advisory).

Continue Reading New EU-level actions addressing shortages

In a previous blog post, we discussed the UK government’s proposed changes to the regulatory framework governing clinical trials. Marking the start of this legislative change is a new notification scheme for the lowest-risk clinical trials (the scheme), published on 12 October 2023. The scheme is based on the proposal set out in the Medicines and Healthcare Regulatory Agency’s (MHRA) consultation earlier this year, which was supported by 74% of respondents.

The scheme allows for the processing of eligible clinical trials by the MHRA in less than 14 days, instead of the statutory 30 days. The scheme currently only applies to clinical trial authorisation (CTA) applications for Phase 4 and certain Phase 3 clinical trials deemed as low risk, and provided they meet the MHRA’s eligibility criteria, set out below. Initial “first in human” Phase 1 or Phase 2 trials and clinical trial amendment applications will not be eligible.

The scheme aims to reduce the time taken to get lowest-risk clinical trials up and running, to give UK patients quicker access to potentially life-saving medicines, without undermining patient safety. The MHRA encourages clinical trial sponsors to use the scheme for all eligible trials and estimates that this will include 20% of UK initial clinical trial applications.

Continue Reading UK clinical trials – new notification scheme for lowest-risk clinical trials