Telemedicine: The increasing role of AI and telehealth

Medical devices are currently regulated in the UK under the supervision of the Medicines and Healthcare Products Regulatory Agency (MHRA). Under the UK Medical Devices Regulation 2002 (MDR), medical devices are required to be registered with the MHRA prior to placing them on the market in Great Britain. Manufacturers are also required to carry out post-market surveillance in respect of their devices and report any adverse events involving their devices to the MHRA. Devices involved in the provision of telemedicine can include hardware (e.g. health monitoring devices that allow patients to measure and stream readings from a remote location) as well as certain software (which may include AI) meeting requirements prescribed by the MDR (e.g. where the software enables another device to fulfil its intended function).

The MHRA has also recently published a roadmap for software and AI as a medical device. The MHRA echoes the approach of government in its desire 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”.

AI already plays an important role in the delivery of healthcare services (including telemedicine), and reliance on the technology is likely only to continue to grow. A report by MIT Technology Review Insights (in partnership with GE Healthcare) found that, of over 900 healthcare professionals surveyed in October 2019 (notably pre-pandemic), 80% believed AI was helping them to improve revenue opportunities, 81% believed that AI would make them more competitive providers, and 79% intended to increase budget on AI applications. In a medical context, AI can be utilised by healthcare professionals to record and analyse data efficiently, helping to improve the accuracy and speed of diagnoses and better predict treatment needs. Key AI uses in telemedicine can include, for example, support with triaging, remote patient monitoring, real-time analysis and the development of personalised treatment plans.

Regulation of AI is a hot topic at the moment, with the UK government having only recently published a white paper on its proposed approach to AI regulation. As AI is intended to supplement (not replace) healthcare professionals themselves, careful policy making is required to ensure that consumer confidence in the technology is developed without holding back innovation. For further information, please see our articles on the UK AI white paper and the response by the UK Information Commissioner’s Office.

Throughout the United Kingdom and the European Union, multiple initiatives are underway to foster the advancement of AI powered medical technologies while bolstering trust in their application. Notably, the European Commission unveiled a comprehensive report titled “Artificial Intelligence in Healthcare” in 2021, offering an extensive assessment of national strategies and the prevailing dearth of policies governing AI in healthcare. Presently, the regulatory landscape is characterized by a lack of specific legislative provisions, necessitating companies to manoeuvre through a patchwork of distinct schemes across individual countries.

As products and services are developed to facilitate remote patient interaction, care is needed to consider where they will be used and to ensure their design and implementation can accommodate local market requirements, since one size will not fit all.

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