AI developments in the UK
The UK is starting to uncover significant opportunities offered by Artificial Intelligence (“AI”) solutions for keeping people healthy, improving care and saving lives. We are seeing capabilities develop in areas such as rapid image recognition, for fast and accurate medical diagnoses based on data obtained from medical images. Trained AI can create solutions such as autonomous symptom checking (e.g. Babylon Health), personalised health screening, and efficient triaging using risk stratification. However, there is still much more to uncover. It’s not just patients who can benefit, but also clinicians, enabling them to make the best use of their expertise, as AI can help inform their decisions and save valuable time.
The UK is yet to implement existing AI, developed through machine learning algorithms, within the NHS, but some AI products are at various stages of trial and evaluation. The areas of healthcare that have the potential for AI to be incorporated include (among others): interpretation of medical imaging, planning patients’ treatment, and patient-facing applications such as voice assistants, smartphone apps and wearable devices. Importantly, this landscape is also set to become more complex now that the UK has left the European Union. So, what do we know so far?
AI developments in the EU
European countries are looking closely at how this fast-developing area can change people’s lives. The European Commission is looking at developing an ecosystem of excellence that supports the rapid and ethical development of AI in Europe from research and innovation, through to incentivising adoption of solutions including by SMEs. In their White Paper, released in February 2020, the Commission acknowledged benefits of using AI in healthcare for citizens through more precise diagnosis and prevention of diseases and generation of new medicines; as well as opportunities for businesses to develop a new generation of healthcare products and services.
AI and Healthcare Research Briefing (UK Parliament)
On 18 January 2021, the UK Parliamentary Office of Science and Technology published its AI and Healthcare Research Briefing discussing the use of AI in the UK healthcare system (the “Briefing”). The Briefing considers the potential impacts of AI on the cost and quality of healthcare, and the challenges posed by the wider adoption of AI, including safety, privacy and health inequalities. It highlights the regulatory challenges posed by medical devices that incorporate AI. Particularly, devices that use AI and/or machine learning techniques could create difficulty from a regulatory perspective as such devices continue to learn and optimise even after they are placed on the market. This leads to questions regarding how such systems could be monitored to ensure they remain safe and effective.
The Briefing notes the impact of Brexit on regulations in the healthcare space. Following Brexit, the UK Government has indicated a departure from the EU medical devices rules and has announced that it will not implement the Medical Devices Regulation (EU) 2017/745 into national law when it takes effect on 26 May 2021. The UK has instead introduced a new national regime that involves the application of a UK Conformity Assessed mark to devices placed on the market in Great Britain (England, Scotland and Wales). The UK also intends to develop future regulations pursuant to the Medicines and Medical Devices Bill 2019-21 and is actively looking at ways to be more responsive to new technologies, including AI.
Guidance on the regulation of medical devices following Brexit
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021. It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement. In summary:
- Manufacturers may continue to use the CE-mark and it will be recognised in Great Britain until 30 June 2023.
- Manufactures may continue to rely on EEA Notified Body certificates until 30 June 2023 for products placed on the market in Great Britain.
- There will be a new route for conformity assessment of medical devices placed on the market in Great Britain from 1 January 2021.
- All medical devices and in vitro diagnostic medical devices (“IVDs”) placed on the market in the UK have to be registered with the MHRA. There will be certain grace periods for registering existing devices (the MHRA has published separate registration guidance on this).
- Manufacturers based outside the UK will need to appoint a UK Responsible Person, established in the UK, to register on its behalf.
To conclude, the UK’s decision to leave the EU leaves a lot of uncertainties in relation to regulating AI and new technological advancements. The UK has also made it more difficult for European researchers and manufacturers to operate in the UK over the years to come, which could impact the speed and efficiency of new developments in the sector. However, the good news is, following the official Withdrawal of the UK from the EU on the 1 January 2021, the position has become much clearer for those concerned about the resulting changes. Companies who operate in this sector should be aware of the regulatory changes to adapt accordingly.
 The CE mark means that the manufacturer takes responsibility for the compliance of a product with all applicable European health, safety, performance and environmental requirements. CE stands for “Conformité Européenne”, the French word for European conformity.