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.
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software devices
Latest on software and AI devices from the MHRA
By Jackie Mulryne & Eleri Abreo on
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
UK Policy Paper on regulation of AI
By Jackie Mulryne, Peter Schildkraut & Eleri Abreo on
There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply. These laws, such as the rules on data protection and medical devices, have to be adapted to specific AI technologies and uses. They sometimes overlap, which can cause confusion for businesses trying to identify the relevant requirements that have to be met, or to reconcile potentially conflicting provisions.
As a step towards a clearer, more coherent approach, on 18 July, the UK government published a policy paper on regulating AI in the UK. The government proposes to establish a pro-innovation framework of principles for regulating AI, while leaving regulatory authorities discretion over how the principles apply in their respective sectors. The government intends the framework to be “proportionate, light-touch and forward-looking” to ensure that it can keep pace with developments in these technologies, and so that it can “support responsible innovation in AI – unleashing the full potential of new technologies, while keeping people safe and secure”. This balance is aimed at ensuring that the UK is at the forefront of such developments.
The government’s proposal is broadly in line with the MHRA’s current approach to the regulation of AI. In the MHRA’s response to the consultation on the medical devices regime in the UK post-Brexit, it announced similarly broad-brush plans for regulating AI-enabled medical devices. In particular, no definition of AI as a medical device (AIaMD) will be included in the new UK legislation, and the regime is unlikely to set out specific legal requirements beyond those being considered for software as a medical device. Instead, the MHRA intends to publish guidance that clinical performance evaluation methods should be used for assessing safety and meeting essential requirements of AIaMD, and has also published the Software and AI as a medical device change programme to provide a regulatory framework with s a high degree of protection for patients and public.Continue Reading UK Policy Paper on regulation of AI
Classification of software as a medical device
By Louise Strom, Lincoln Tsang & Jackie Mulryne on
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