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This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024.

You will note that France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the lack of reimbursement rates means up-take has been low. The order of April 22, 2024 introduces the new pricing structure, with the maximum amount of financial compensation set at €780 per year, per patient. This is an important step in ensuring digital therapeutic products can be widely available in France while also ensuring that developers can obtain appropriate reimbursement.Continue Reading Virtual and Digital Health Digest, May 2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence (AI). The publication is in response to the request from the Secretaries of State of DSIT and DHSC dated 1 February 2024, in which the MHRA was asked to provide details about what steps it is taking in accordance with the principles and expectations of the Government’s pro-innovation approach set out in the white paper published in 2023. Further information is set out in our previous post.

The strategy provides information on how the MHRA views the risks and opportunities of AI from three perspectives:

  • MHRA as a regulator of AI products
  • MHRA as a public service organisation delivering time-critical decisions
  • MHRA as an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties

The document is likely to be of particular interest to AIaMD manufacturers as it sets out in detail current and proposed regulations and guidance, and areas where this is likely to be tightened. Following the launch of the strategic approach, the government also published details of the AI Airlock regulatory sandbox, discussed in another post.

With a raft of measures relating to AI being published and additional measures expected in the next couple of years, pharmaceutical and medical device companies operating in the UK need to continually review how they will be impacted and respond appropriately.Continue Reading MHRA sets out its AI regulatory strategy

In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the “AI-Airlock”. The pilot project went live on 9 May 2024, and government sources are citing it as a key component of the MHRA’s strategic approach to AI, published on 30 April 2024 (discussed in a separate post).Continue Reading The MHRA’s “AI Airlock” – what do you need to know?

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

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

The MHRA is continuing to publish details on how software and AI medical devices will be regulated in the UK post Brexit, with the aim of making the UK an attractive place to launch such products. The MHRA’s recent updates to its ‘Software and AI as a Medical Device Change Programme’ (the Change Programme) intend to “deliver bold steps to provide a regulatory framework that provides a high degree of protection for patients and public, but also makes sure that the UK is recognised globally as a home of responsible innovation for medical device software looking towards a global market.”

The MHRA has also recently announced it will extend the period during which EU CE marks on medical devices (including for software) will be accepted on the UK market, until July 2024.

We set out an overview of these updates below.Continue Reading Latest on software and AI devices from the MHRA

On 7 April 2020, the European Medicines Agency (EMA) issued a Notice to sponsors on validation and qualification of computerised systems used in clinical trials (Notice). This Notice was developed by the EMA’s GCP Inspectors Working Group (IWG) and the Committee for Medicinal Products for Human Use (CHMP) to highlight for clinical trial sponsors the legal and regulatory requirements which apply to software tools used in the conduct of clinical trials.

In addition, the EMA updated the Answers to Questions 8 and 9 of the Agency’s Q&A on Good Clinical Practice (GCP) (GCP Q&A) in line with the Notice.Continue Reading EMA’s Notice on validation and qualification of software tools used in clinical trials

Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way.

In response to early issues with the deployment of artificial intelligence and other algorithmic tools in healthcare, on 5 September 2018 the UK Department of Health & Social Care (DH) published an Initial Code of Conduct for Developers and Suppliers of Data-driven Health and Care Technology (the Code). The Code is not legally binding but aims to raise standards by establishing best practices.Continue Reading UK guidance for developers of health care software and technologies

Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice of the European Union (CJEU) on legal classification of software medical device is therefore instructive.

The European Court’s first decision on the classification of software in the context of medical devices legislation

On 7 December 2017, the CJEU issued its judgment in Case C-329/16. The CJEU agreed with the Advocate General’s opinion (discussed in our previous Advisory), and held that software can be classified as a medical device under EU law if the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing or calculating the dosage for treating the underlying condition. It does not matter whether the software acts directly or indirectly on the human body. The decisive factor is whether the software is specifically intended by the manufacturer to be used for one or more medical objectives specified in Article 1(2) of Directive 93/42/EEC (the Medical Devices Directive), including the diagnosis, prevention, monitoring, treatment or alleviation of disease.Continue Reading Classification of software as a medical device

On 28 June, the Advocate General of the Court of Justice of the European Union gave his opinion on the SNITEM and Philips France case against France. In this case, the Conseil d’Etat in France asked whether a particular software programme intended to be used by doctors to support prescribing decisions falls within the definition of medical device as provided by Directive 93/42/EEC (Medical Devices Directive).

Continue Reading Advocate General’s opinion on software as medical devices