Bevan Brittan’s Vincent Buscemi, Brett Lambe, Aisha Matoo and Yasmin Cant consider the importance of international co-operation on healthcare AI regulation
Artificial intelligence is already transforming healthcare, from answering complex questions to supporting diagnosis from medical imaging. Its potential for providers and patients is considerable, but ethical and safety concerns could cause significant harm if they are not addressed.
Lawmakers are working to develop appropriate legislation and guidance, although regulation continues to trail behind technological change. Even in Europe, where the EU AI Act has become law, implementation must be aligned with existing requirements without hindering innovation. Elsewhere, governments often rely on a patchwork of legislation created for earlier technologies.
The regulatory gap
Differences in the scope and reach of national laws make it difficult for technology companies to build compliant processes into products intended for several markets. Healthcare providers must balance potential benefits for patients against current and prospective legal frameworks.
Data integrity and information security add further complexity. Most AI systems are developed and tested in a relatively small number of countries, meaning large population groups may be excluded from the underlying data. Resulting bias can widen existing health inequalities.
Lower-income countries may lack the funding or expertise needed to contribute to development, while patient data can cross jurisdictions governed by different privacy laws. Technology companies seeking global scale must therefore operate across national healthcare markets with regulations that may be inconsistent or incompatible. Effective national legislation remains essential, but delivering AI’s benefits at scale will require international co-operation and systems capable of working across borders.
The HealthAI model
HealthAI is an independent, non-profit organisation promoting equitable access to AI and responsible governance. It works with governments and health leaders to help countries develop robust regulation while addressing the disparity between wealthier states and those with more limited access to emerging technologies.
Peer-to-peer learning among countries should not only bridge the gap, but also hopefully increase the range and quality of overall data needed to inform optimum outcomes for global health challenges. HealthAI also aims to reduce the risks and costs associated with adopting AI in healthcare systems.
Its approach depends on applying proven global standards in practice. AI-powered health technologies could then be validated more quickly against agreed criteria, allowing countries to align certification without abandoning national oversight.
The regulatory network
HealthAI’s Global Regulatory Network is intended to support collaborative learning between participating countries. The UK became the first ‘pioneer country’ to join, placing the Medicines and Healthcare products Regulatory Agency at the centre of efforts to regulate trusted AI tools for frontline use.
Singapore and India have since joined the network. IndiaAI and the Indian Council of Medical Research’s National Institute for Research in Digital Health and Data Science will monitor AI tools in practice, providing clinical insight for wider international learning.
Risk and transparency
HealthAI is also developing a global early warning system to identify significant harm caused by AI software. Problems could include malfunctions or software changes, with alerts allowing participating countries to respond promptly. Preventive monitoring is particularly important because technology will continue to develop faster than legislation.
A further proposal is a global directory bringing together regulatory information on registered AI medical devices, including products cleared by the US Food and Drug Administration or carrying a CE mark. A transparent database could help countries assess technologies for local adoption and learn from decisions made elsewhere.
National and international work is already becoming interconnected. HealthAI CEO Dr Ricardo Baptista Leite sits on the UK’s National Commission into the Regulation of AI in Healthcare, which is supporting the MHRA as it develops a new framework expected in 2026.
Global alignment could make compliance more predictable for developers and give healthcare organisations greater confidence when procuring new tools. A common evidence base would support faster decisions while retaining safeguards for privacy and patient safety. It could also reduce duplicated assessment across countries, freeing regulatory capacity for emerging risks.
A global baseline
National standards provide the foundation, but a global baseline is needed if healthcare AI regulation is to become more consistent. Common expectations could address technical risks and patient trust while reducing the danger that AI perpetuates systemic bias.
HealthAI’s impact will need to be assessed over time, and its ambitions represent an undertaking for one organisation. However, its model shows how collaboration could help governments protect patients without denying them the benefits of innovation.
International co-operation cannot remove every difference between national systems. It can nevertheless create shared expectations for safe, certified AI made available equitably, helping ensure that advances in healthcare technology benefit patients across countries rather than widening the divide between them.
Bevan Brittan advises health and care organisations on legal, governance and regulatory matters in the UK and internationally
Vincent Buscemi: Vincent.Buscemi@bevanbrittan.com
Brett Lambe: Brett.Lambe@bevanbrittan.com
Have some thoughts on the topic? Share them with the community here