UK Law and Practice Contributed by: Amélie Chollet, Hannah Curtis and David Dennis, CMS
• safety, security and robustness; • appropriate transparency and explainability; • fairness; • accountability and governance; and
marketed in NI. Businesses operating in or sup- plying to NI should therefore be aware of both UK and EU regulatory obligations. In addition, if they develop, supply or deploy AI systems to the EU market, or provide AI-related services to EU- based customers, they must ensure compliance with the EU AI Act to maintain market access. Environmental, Social and Governance (ESG) Digital healthcare companies must comply with relevant ESG-related UK legislation, including the Equality Act 2010 and Modern Slavery Act 2015. When operating in EU markets, compa- nies may also need to comply with EU ESG regulations with extraterritorial effect, such as sustainability reporting requirements. The ESG regulatory landscape continues to evolve, with increasing focus on corporate trans- parency and due diligence obligations. Telehealth Telehealth is regulated through health and social care laws (eg, CQC registration for remote medi- cal advice), professional standards (GMC Good Medical Practice) and data protection laws. The CQC registers telehealth/telemedicine service providers in England for the regulated activity of providing triage and medical advice remotely when certain criteria are met. Additionally, GP practices in England are required to offer online consultation tools, video consultation capabilities and secure electronic communication methods alongside traditional access methods. 2.6 Sufficiency of Legislative Framework The current legislative framework in the UK pro- vides a comprehensive basis for regulating digi- tal healthcare, particularly in relation to medical devices, data protection and consumer safety.
• contestability and redress. Sector-specific guidance
In digital health, the MHRA has issued guidance on software and AI as a medical device (SaMD and AIaMD), including requirements for clinical evaluation, risk management and post-market surveillance. The National Institute for Health and Care Excellence (NICE) and NHSX have also published guidance on the evaluation and deployment of AI in healthcare. Ongoing reform and consultation The UK government is actively consulting on the future of AI regulation. In February 2024, the government published its response to the AI Regulation White Paper consultation, con- firming its intention to continue with a flexible, context-specific approach, rather than adopting a comprehensive, prescriptive regime like the EU Artificial Intelligence Act (the “EU AI Act”). International alignment and divergence While the UK is monitoring international devel- opments, including the EU AI Act, it has sig- nalled that it will not simply replicate the EU’s approach. The UK aims to balance innovation with safety and public trust, and to remain agile in response to technological advances. NI Owing to the Windsor Framework and the North- ern Ireland Protocol, certain EU product regula- tions – including the EU AI Act – apply directly to relevant goods placed on the market in NI. This means that AI/ML-based medical devices and other regulated AI products must comply with both UK and EU requirements if they are to be
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