Bevan Brittan’s Vincent Buscemi, Commercial Healthcare Partner and Head of Independent Health and Care, and Brett Lambe, Technology and IP Partner, consider why coordinated global regulation of AI in healthcare is important
In recent years, we have seen incredible technological advancements due to the creation and roll-out of Artificial Intelligence (AI). From OpenAI’s ChatGPT answering complex questions in seconds (albeit with varying degrees of accuracy) to the NHS implementing AI technology to help diagnose COVID-19 from chest imaging, the range of use cases for AI in healthcare is vast and continues to grow as the technology develops.
Whilst the integration of AI in healthcare will undoubtedly transform the industry for providers and practitioners, and most importantly the lives of patients receiving care, the potential pitfalls, including ethical, regulatory and safety concerns, raise the risk of causing significant harm if not adequately addressed.
Lawmakers are working at pace to draft legislation and guidance to protect the systems and people using them; however, progress has been slow and trails far behind the pace of AI development, as is so often the case when the cultures of rapid technological innovation collide with the methodical caution of lawmakers. Even in Europe, where the EU’s AI Act was passed into law last year, widespread implementation has been slow; one year on from its approval by the EU Council, MedTech Europe was still urging policymakers to implement the legislation in cohesion with existing laws to encourage continued innovation. Beyond Europe, governments across the world are using a patchwork of historic legislation for existing technology to govern the development and use of AI in healthcare.
This discrepancy in the nature, scope and reach of AI laws at a macro level makes it difficult for technology providers to plan ahead, if they are looking to “bake in” compliant processes to their AI tools. Similarly, healthcare providers and practitioners are exercising caution in their deployment of AI, wanting to balance the benefits to patients with the need to remain compliant with current (and prospective) legal, clinical and ethical frameworks.
Data integrity and information security
Data integrity and information security are integral to this challenge. Alongside patient safety and quality of care, protecting the data inputted into the AI models, for training and general use, is paramount. Though used across the world, most AI systems are developed, trained and tested in a small handful of countries. Consequently, large data groups from around the globe are often excluded from this training and testing, which can result in output bias and an increase in the health equality gap.
Lower-income countries do not have the same expertise and funding to contribute to the development of these systems, meaning higher-income countries pull further ahead. In addition to increased bias and wider health inequalities, vital patient data is regularly transferred across jurisdictions governed by differing data protection and privacy laws. This irregularity adds further to the complex matrix of distinct but interconnected issues that need to be balanced, with technology providers and major health governing bodies looking to scale at a global level, but needing to operate within separate and frequently inconsistently (or even incompatibly) regulated national healthcare markets.
Whilst we should continue to push for effective, pragmatic legislation at the national level, in order to reap the benefits of AI at the scale needed to be truly transformative, we need to start looking beyond single-state national interests in isolation and consider solutions that can operate worldwide. The delivery of global benefits requires a global system, global co-operation and a global response.
One model for coordinating national systems to deliver a global approach may be provided by HealthAI.
Global Regulatory Network
A key component of HealthAI’s responsible AI governance and regulation is the establishment of the ‘Global Regulatory Network’. This network is designed to foster collaborative learning and sharing of best practices across different countries. It comprises ‘pioneering’ countries, enabling them to engage and collaborate with HealthAI to strive towards the common goal of improving and safeguarding the future of global health and wellbeing.
Earlier this year, the UK became the first ‘pioneer’ country to join the Global Regulatory Network, having been invited to participate by HealthAI. The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator of medicines and medical devices in the UK. With the UK being the first national member of HealthAI’s network, it positions the MHRA at the centre of the global efforts to regulate trusted and certified AI tools safely for frontline use. Singapore and India have also attained ‘pioneer country’ status by joining the network. IndiaAI and the Indian Council of Medical Research’s National Institute for Research in Digital Health and Data Science will collaborate with HealthAI to monitor the use of AI tools in practice, providing key clinical insights to inform further knowledge sharing among stakeholders across multiple countries.
Delving deeper into the Global Regulatory Network, HealthAI is targeting the development of a ‘global early warning system’. This system will be designed to detect and notify the network at the earliest stages of significant harm caused by AI software, such as malfunctions, hallucinations, and other unwanted outcomes, allowing countries to identify and respond to harm promptly. While regulation is critical, it is arguably more important to establish such preventative systems, given the broad scope and application of AI in healthcare and the potentially severe impact of any unintended consequences. However, the development of technology will always outpace the implementation of legislation.
An additional tool in regulating the AI landscape by HealthAI is the creation and maintenance of a global directory of regulatory information on AI-related and registered medical devices (e.g., FDA-cleared or CE-marked devices) into a single, transparent and globally accessible database. This move should help countries in reviewing and evaluating registered AI healthcare tools and solutions for adoption in their localities.
As an example of the interconnected nature of national and international regulatory alliances, HealthAI’s CEO Dr Ricardo Baptista Leite sits on the UK’s newly launched National Commission into the Regulation of AI in Healthcare. This commission is aimed at supporting the MHRA in establishing a new regulatory framework, which is envisaged to be published in 2026 and will be the product of collaboration with global leaders and clinicians.
National standards and global alignment
National standards are clearly essential, but using these national standards as a foundation for developing global standards is crucial for consistent and cohesive international AI regulation in healthcare.
Acknowledging the existing issues associated with using AI in healthcare, including technical and privacy risks, lack of patient trust, and the perpetuation of systemic biases, is imperative to establish a global baseline for standards in this rapidly evolving area, with a view to ensuring that all patients and communities benefit from certified, safe and equitable healthcare.
It is encouraging to see how individual governments are focusing their efforts on regulating AI in a positive way to tackle major global challenges, of which healthcare is one of the biggest. The impact of HealthAI will need to be assessed over time, and it is clearly a huge mission for a single organisation to undertake. However, for now it is promising to see commitment to meaningful global collaboration and cooperation to deliver AI health benefits on an international scale.
Conclusion
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With thanks to Aisha Matoo and Yasmin Cant, solicitors at Bevan Brittan, for their contributions to this article.
CONTACT INFORMATION
vincent.buscemi@bevanbrittan.com
brett.lambe@bevanbrittan.com
www.bevanbrittan.com