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Transforming the future of healthcare will rest on the new technologies and therapies emerging within the life sciences sector as well as the introduction of complementary and supporting regulations underpinned by government policy. There is a lot going on across the industry but these are my top 5 developments to keep an eye out for….
1. Medicines and Healthcare Regulatory Authority's 'Software and AI as a Medical Device Change Programme'
Software including Artificial Intelligence (AI) plays an essential part in health and social care and many of these products are regulated as medical devices.
For example, AI improves the processing and analysis of large amounts of data that medical devices gather. With patient-specific health data, companies use AI to identify diseases or the onset of medical conditions. Further, AI enables predictive analysis and monitors treatment efficiency. Medical device manufacturers are also integrating AI technologies like computer vision to accelerate diagnosis and enable robotic surgery.
The MHRA have embarked upon an ambitious change programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI). Launched in October 2022, the Medicines and Healthcare Regulatory Authority's (MHRA) Guidance 'Software and AI as a Medical Device (SaMD) Change Programme – Roadmap', aims to significantly assist the expansion of this area of health.
The MHRA Programme is broad in nature in that it covers a wide variety of regulatory issues for all software as a medical device, not just AI. The Programme covers software from classification through to access and monitoring, and aims to ensure patient safety while instilling clarity for developers.
By working with key partners such as the National Institute for Health and Care Excellence (NICE) and NHSX, it is hoped the route to market will be improved.
Key aims of the MHRA programme include:
- The requirements for software and AI as a medical device provide assurance that these devices are acceptably safe and function as intended, thereby protecting patients and public.
- The requirements for manufacturers are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to demonstrate compliance, for instance, via the designation of standards.
- Friction is taken out of the market by working with key partners such as the National Institute for Health and Care Excellence (NICE) and NHS England to align domestically, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK.
Some (but not the majority) of the changes intended will be in the form of secondary legislation, and much of the programme builds upon legislation through guidance, for instance, by clarifying what medical device requirements mean in the context of software and AI.
The MHRA has working groups developing policy on the different elements mentioned in its Medical Device Change Programme and work products in each of the different streams will continue to be released during 2023.
2. Increased focus on security for data driven Life sciences companies
Given that medical devices and IVDs can generate large amounts of personal data, there is increasing demand to protect digital medical systems from hijacking and guarantee the safety of patients.
Healthcare providers have to place more attention on security matters and invest more in security tools for example such as encryption software, firewalls, AI-based data protection.
As outlined in the government response to the consultation on the Medical Devices legislation, the MHRA as part of the Change Programme intend to develop secondary legislation to impose cybersecurity and IT requirements to guard against the above risks. This secondary legislation will:
- Align with the Connected Medical Device Security Steering Group principles
- Be consistent with and build upon complementary requirements such as the Department of Culture, Media, and Sport’s Product Security and Telecommunications Infrastructure Bill, NHS DCB (Data Coordination Board) standards, and NHS Digital Technology Assessment Criteria requirements
- Be harmonised with international best practice
Further, the MHRA aims to work closely with industry to clarify, bolster, and make consistent reporting of cybersecurity incidents and any vulnerability identified from manufacturers. The MHRA will also make plain the requirements to report these vulnerabilities.
3. Good machine learning practice for medical device development mapping
In 2021 the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s MHRA jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
As Manufacturers can find it difficult to identify how GMLP links to existing legal requirements the MHRA's Change Programme document will map how the identified GMLP principles can be tied to key responsibilities outlined in the Medical Device Regulations 2002 (as amended) and relevant guidance.
4. UK Government's Life Sciences vision policy
The government has recognised the opportunity of data-driven life sciences for the UK with the Life Sciences vision, which highlights the need "to harness the UKs unique health data", seeking to simplify the oversight of the NHS health data to drive research and innovation. The vision has been followed by the first national artificial intelligence (AI) strategy in the UK.
The 10-year plan seeks to strengthen the country's position as a global leader in AI innovation, regulation and adoption. Also, the UK's National Data Strategy, the Data saves lives policy paper and the broader use of Goldacre Review will further promote and embed broader use of health data for research and innovation. Together, this activity represents a clear drive to make the UK a global leader in AI and data-driven life science.
5. Protecting data-driven life sciences products
In 2021, the UK government published its response to a call for view on Artificial Intelligence (AI) and Intellectual Property (IP), which asked if inventions derived from AI, should be afforded the same protections as human inventions. In an effort to ensure greater flexibility and clarity on IP and patent laws, the government will be consulting on new proposals for protecting AI generated inventions.
For further information on the points raised above, or to talk more generally about digital health issues and developments please contact me on cliodhna.mcdonough@fieldfisher.com or any member of our Digital Health team.