On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

Purpose

AI and ML have the “potential to transform health care” through their ability to analyse vast amounts of data and learn from real-world use.  However, these technologies also pose unique challenges, given their complexity and the constantly evolving, data-driven nature of their development.  The Regulators formed the guiding principles to “help promote safe, effective, and high-quality medical devices that use . . . AI/ML” and to “cultivate future growth” in this fast paced field.

The Regulators predict that the guiding principles could be used to: (i) adopt good practices from other sectors; (ii) tailor these practices to the medical technology/healthcare sector; and (iii) create new practices specific to the medical technology/healthcare sector.  The Regulators expect these joint principles to inform broader international engagements as well.

The 10 Guiding Principles

 The guidance published by the Regulators set out the 10 principles in full; however, in short, they recommend:

  1. Leveraging multi-disciplinary expertise throughout the total product life cycle
  2. Implementing good software engineering and security practices
  3. Ensuring clinical study participants and data sets are representative of the intended patient population
  4. Making training data sets independent of test sets
  5. Basing selected reference datasets upon best available methods
  6. Tailoring the model design to the available data and ensuring it reflects the intended use of the device
  7. Placing focus on the performance of the human-AI team
  8. Ensuring testing demonstrates device performance during clinically relevant conditions
  9. Providing users with clear, essential information
  10. Monitoring deployed models for performance and managing re-training risks

These principles cover the entire life cycle of devices with the aim of ensuring safety and efficacy.  The Regulators have focused on use of appropriate datasets and carrying out sufficient testing before marketing AI/ML-based devices.  These guiding principles set out an ongoing recommendation to manage risks, which will involve monitoring and potentially re-training AI/ML-based devices after deployment.

These principles are merely a starting point.  The Regulators stated, “[a]s the AI/ML medical device field evolves, so too must GMLP best practice and consensus standards.”

Possible Impact & International Considerations

AI and ML are clearly top priorities from a global health regulatory perspective.  The Regulators expect this collaboration to lead to further and broader international collaborative work.  As noted above, the Regulators expect these guidelines to evolve and emphasize the importance of “strong partnerships with [their] international public health partners.”

As one example, the guiding principles identify areas of possible collaboration for the International Medical Device Regulators Forum (“IMDRF”), international standards organizations, and other collaborative bodies.  These areas include “research, creating educational tools and resources, international harmonization, and consensus standards.”

This collaboration is important as it follows on from the individual work each agency has been doing in this space.  For example, MHRA has consulted on the future regulation of medical devices in the UK, including by developing a Work Programme for Software and AI-based Medical Devices (which we previously discussed in our blog post).  FDA has also been active in the AI/ML space, and several more FDA digital health developments are on the horizon for 2022.  Through this international regulatory collaboration it appears the Regulators are working towards a united front through close alignment on best practice and international regimes.  It also shows, for example, that the UK is considering international regimes broadly, rather than simply aligning with the European Union.

In sum, it appears there is an appetite for further international regulatory collaboration, so watch this space for the potential development of more detailed and sector specific international standards and practices for AI/ML-based technologies.

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Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, and is the Graduate Recruitment Partner for Covington’s London office.

Sarah regularly advises on:

  • classification determinations for software medical devices, including on developments resulting from the implementation of the EU Medical Devices Regulation;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah’s pro bono work includes advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives, and assisting in a project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah has undertaken several client secondments, including to the in-house legal department of a multinational pharmaceutical company.

Photo of Ellie Handy Ellie Handy

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling…

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling and promotion, reporting obligations, medical devices, and digital health. Ellie also advises companies in the food, cosmetic and consumer products sectors regarding regulatory compliance and borderline issues. Ellie provides advice in relation to corporate transactions and restructuring, in particular performing regulatory due diligence.

Ellie represents and works with a wide range of clients working in the life sciences and technology sectors on both contentious and non-contentious regulatory matters.

Ellie’s pro bono work includes assisting charities. In addition to her role at Covington, Ellie spent three years working life sciences regulatory practice in London.

Photo of Olivia Dworkin Olivia Dworkin

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge…

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge medical technologies and digital health products and services, Olivia regularly helps new and established companies navigate a variety of state and federal regulatory, legislative, and compliance matters throughout the total product lifecycle. She has experience counseling clients on the development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical applications, general wellness products, medical device data systems, administrative support software, and products that incorporate artificial intelligence, machine learning, and other emerging technologies.

Olivia also assists clients in advocating for legislative and regulatory policies that will support innovation and the safe deployment of digital health tools, including by drafting comments on proposed legislation, frameworks, whitepapers, and guidance documents. Olivia keeps close to the evolving regulatory landscape and is a frequent contributor to Covington’s Digital Health blog. Her work also has been featured in the Journal of Robotics, Artificial Intelligence & Law, Law360, and the Michigan Journal of Law and Mobility.