AI | MHRA – Harnessing New Technology While Ensuring Public Safety?

May, 2024 | Pharma

“AI offers great potential, [but] integrating it into medical workflow software requires caution. While potentially impeding progress, government regulations play a crucial role in protecting patients and society.”

Rob Versaw

 Vice President of innovation & growth at Envista Holdings

Artificial intelligence (AI) is poised to transform the healthcare sector, with the potential to revolutionize everything from drug discovery and clinical trials to medical equipment regulation and post-market monitoring. While AI promises major benefits like faster treatments, more personalized care, and improved access to treatment, it also risks introducing new challenges if not properly governed. As the lead regulator of medical products in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) faces the complex task of enabling innovation while protecting patients. Through prudent policies and collaborations, the agency aims to maximize AI’s upsides and mitigate its downsides.

The MHRA oversees all medical devices, medications, and biological medicines used in the UK. This includes AI-based technologies developed for clinical uses, known as AI as a medical device (AIaMD). As more startups and established companies develop AIaMDs, clear regulatory pathways are needed. Currently, most AIaMDs fall under the European Union Medical Device Regulation, which the UK has adopted as a baseline. However, this 2002 law predates modern AI, so the MHRA is reforming regulations to better fit emerging technologies while maintaining high safety standards.

A key change is increased risk-based classification. Previously, some low-risk AIaMDs faced minimal pre-market scrutiny, but many will now require independent evaluation due to their complex, software-based modes of action. Stricter post-market surveillance is also planned to monitor real-world performance. At the same time, the principle of proportionality will be followed to avoid stifling innovation. Additional MHRA guidance on topics like AI explainability, usability, and fairness aims to help developers navigate regulation sensibly. An “AI Airlock” pilot program will further investigate practical challenges through experimental, collaborative projects.

Internationally aligned regulatory approaches are likewise important in an increasingly globalized industry. The MHRA participates in the expert International Medical Device Regulators Forum and leads on AI issues. Tri-national cooperation is underway with the US Food and Drug Administration and Health Canada to harmonize best practices. As population health depends on safe, effective cross-border technologies, global cooperation incentivizes high standards without contradictory requirements slowing medical progress.

Regulation is just one part of the MHRA’s AI role, however. The agency also aims to harness promising technologies internally through prudent, principles-based piloting. Initial focus areas include streamlining application reviews with AI-assisted document screening and enhancing real-world evidence analysis to support medical product oversight. By directly experiencing AI’s benefits and limitations first-hand, the regulator builds knowledge to set evidence-based policies. Robust data governance, explainability, and fairness are prioritized to ensure public trust as new tools are trialed.

Looking ahead, the MHRA foresees AI transforming drug development paradigms, with impacts like accelerated target identification, more efficient clinical trials, and continual post-market optimization of approved treatments. As a scientific regulator, the agency is committed to maintaining agility to scrutinize innovative evidence forms enabled by advanced analytics. From new tools for adverse event detection to personalized therapy development enabled by real-world data mining, AI promises swifter medical progress – but only if changes are responsibly implemented hand-in-hand with guidance from regulators like the MHRA.

Overall, the MHRA takes a proactive, multilevel approach to facilitating AI’s contributions while safeguarding citizens. By clarifying expectations for industry, sharing learnings from test deployments, and collaborating widely, the agency aims to optimize regulations, optimize internal processes, and optimize evidence evaluation – all for the ultimate goal of optimizing population health through next-generation technologies. With care and diligence, AI’s great potential could be realized, revolutionizing UK healthcare for the better. But successful stewardship will require ongoing effort from many committed partners working as a coordinated team.




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About the Author

  • Dilruwan Herath

    Dilruwan Herath is a British infectious disease physician and pharmaceutical medical executive with over 25 years of experience. As a doctor, he specialized in infectious diseases and immunology, developing a resolute focus on public health impact. Throughout his career, Dr. Herath has held several senior medical leadership roles in large global pharmaceutical companies, leading transformative clinical changes and ensuring access to innovative medicines. Currently, he serves as an expert member for the Faculty of Pharmaceutical Medicine on it Infectious Disease Commitee and continues advising life sciences companies. When not practicing medicine, Dr. Herath enjoys painting landscapes, motorsports, computer programming, and spending time with his young family. He maintains an avid interest in science and technology. He is a founder of DarkDrug

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