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 Virtual and Digital Health Digest, December 2023

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 19 September 2023, the UK Government launched the pilot phase of the Innovative Devices Access Pathway (IDAP), an initiative to help bring innovative technologies to the NHS where there is an unmet medical need. As discussed in a previous post, IDAP has been designed to accelerate the development of innovative medical devices, with the aim of taking delays and uncertainty out of the route to market. IDAP will provide an integrated support service for medical device developers that will include enhanced opportunities for engagement with the regulatory authorities and a streamlined adoption process.

Companies of all sizes are being invited to apply, both internationally and in the UK, where they intend to launch a device for the UK market. 8 products will be selected during the pilot phase, which is designed to test the main elements of the pathway to inform how best to build the future IDAP.

Applications for the pilot phase are open and will close after 29 October 2023; they can be made via an online application form and associated guidance.Continue Reading UK Government launches Innovative Devices Access Pathway (IDAP)

On 19 July 2023, the European Medicines Agency (EMA) published a draft Reflection paper on the use of artificial intelligence (AI) in the lifecycle of medicines (the Paper). The Paper recognises the value of this technology as part of the digital transformation within healthcare, and acknowledges its increasing use and potential to “support the acquisition, transformation, analysis, and interpretation of data within the medicinal product lifecycle”, provided of course it is “used correctly”.

The Paper reflects EMA’s early experience with and considerations on the use of AI, and gives a sense of how EMA expects applicants and holders of marketing authorisations to use AI and machine learning (ML) tools. The EMA has made clear that the use of AI should comply with existing rules on data requirements as applicable to the particular function that the AI is undertaking. It is clear that any data generated by AI/ML will be closely scrutinised by the EMA, and a risk-based approach should be taken depending on the AI functionality and the use for which the data is generated.

The Paper is open for consultation until 31 December 2023. EMA also plans to hold a workshop on 20-21 November 2023 to further discuss the draft Paper. EMA’s plan is to use the feedback from the public consultation to finalise the Paper and produce future detailed guidance. Our summary below sets out the key takeaways and the key issues that arise in the Paper.Continue Reading EMA publishes first draft of reflection paper on the use of AI in the medicinal product lifecycle

On June 14, 2023, an overwhelming majority of the European Parliament (Parliament) recently voted to pass the Artificial Intelligence Act (AI Act), marking another major step toward the legislation becoming law. As we previously reported, the AI Act regulates artificial intelligence (AI) systems according to risk level and imposes highly prescriptive requirements on systems considered to be high-risk. The AI Act has a broad extraterritorial scope, sweeping into its purview providers and deployers of AI systems regardless of whether they are established in the EU. Businesses serving the EU market and selling AI-derived products or deploying AI systems in their operations should continue preparing for compliance.

Now, the Parliament, Council, and Commission have embarked on the trilogue, a negotiation among the three bodies to arrive at a final version for ratification by the Parliament and Council. They aim for ratification before the end of 2023 with the AI Act to come into force two (or possibly three) years later.

In our recent advisory, we summarize the major changes introduced by the Parliament and guide businesses on preparing for compliance with the substantial new mandates the legislation will impose.Continue Reading European Parliament Adopts Its Version of AI Act

Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the medical devices regime in the UK.

  • On 27 April 2023, the MHRA updated its guidance on the implementation of the future medical devices regulations (the UK Regulations) to confirm the intention for the “core aspects” of the UK Regulations to apply from 1 July 2025.
  • The UK government has also introduced legislation that will be finalised before 30 June 2023 to allow valid EU CE marked medical devices to continue to be placed on the market in Great Britain. The extended periods will align with the transitional periods under the new UK Regulations.
  • On 26 May 2023, a proposed new regulatory pathway, the Innovative Devices Access Pathway (IDAP), set for pilot launch later in 2023, was announced, published as part of a suite of announcements that we will cover in a separate post.

Stakeholders will no doubt be pleased to hear of the development to extend the validity of EU CE marking in Great Britain, which allows for more realistic timeframes for manufacturers to obtain a UKCA mark, given the current state of flux of the UK medical device market following Brexit and the COVID-19 pandemic. The proposed IDAP pilot will also be a welcome development, and is another step taken by the MHRA to enhance innovation and stimulate interest in the UK medical devices industry, ahead of the implementation of the new UK medical devices regime in 2025.Continue Reading UK Medical Devices Update: Implementation of the UK Medical Devices Regulations and new Innovative Devices Access Pathway

With much fanfare, in January 2023, the European Commission released its proposal to extend the MDR transition periods and abolish the ‘sell-off’ deadline, after which medical devices and in vitro diagnostics (IVDs) would have to be withdrawn from the EU and EEA market. Today, the proposal has been adopted via Regulation 2023/607 (the Regulation), and will come into force today, 20 March 2023. This date is now important, as CE certificates that expired before today may be able to be considered as valid if certain conditions are met. Certificates that expire from today until the new transition periods will be considered as valid if the conditions set out below are met. This provides important breathing space for companies and should ensure that a large number of devices are not withdrawn from the market over the next year.Continue Reading Extension to EU MDR transition periods finalised

It is well known that there are significant problems with the implementation of the Medical Devices Regulation 2017/745 (MDR), in particular notified body capacity and the vast number of products that need to go through the new regime before the end of the transitional period. After sustained pressure from companies and Member States alike, late last week (on 9 December), the Commission finally confirmed that it intends to extend the transitional period under the MDR. Member States are said to have agreed with the proposals. We set out a summary of what is known so far below.
Continue Reading Delay to EU MDR is on the horizon

Welcome to the first installment of Arnold & Porter’s Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health and telehealth-related developments in the United States, United Kingdom, and European Union in the healthcare, regulatory, privacy, and corporate transactions space.
Continue Reading Virtual and Digital Health Digest