Can we entrust our health to artificial intelligence?

The European Academies Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM) today published a joint report on ‘AI in European healthcare: policy recommendations for optimising added value and safe, ethical and inclusive adoption.’

The report seeks to inform the implementation of the EU AI Act and the European Health Data Space, relevant pending legislative files and the upcoming EU initiative on AI in Healthcare[1]. It has been written by a working group of 22 scientists from across Europe, nominated by EASAC-FEAM national member academies.

AI is developing faster than the regulations governing it

The rapid development of AI can overwhelm societies and regulatory bodies. Warnings from leading AI researchers about a potential loss of control highlight just how difficult it is to anticipate and control risks. In the healthcare sector, the stakes are particularly high.

“AI is entering clinical and administrative practice faster than many health systems can independently evaluate, govern and monitor. It’s up to policymakers to ensure the regulatory preconditions for patient-centred, effective, safe, fair and transparent AI approaches,” says Prof. André Knottnerus, EASAC Co-Chair of the Working Group.

Benefits – but also risks and side effects

AI systems are already being used in many areas of healthcare, and have the potential of significant added value, mainly in clinical care and public health. However, without clear rules, there is a risk of data breaches, algorithmic bias and a loss of human control.

The EU AI Act and European Health Data Space provide an important foundation, but the scientists identify gaps in their practical application to healthcare. EASAC and FEAM are therefore calling for AI to be treated like any other measure in healthcare: its benefits must be proven, its risks understood and its performance continuously monitored.

“We need clear specifications for demonstrating real clinical benefit across different populations and settings and for ensuring that representative, high-quality data are used,” says Prof. Luis Martí-Bonmatí, FEAM Co-Chair of the Working Group. “Patients also need meaningful explanations and routes for recourse, liability must be clear, and healthcare systems must avoid becoming dependent on individual technology providers.”

Key messages

1. Proactive regulation is essential: The EU AI Act classifies the health sector as high-risk. The use of AI thus requires regulations that take long-term consequences into account. Provisions of the AI Act need to be integrated with existing regulatory frameworks, such as the Medical Devices Regulation, the GDPR and the European Health Data Space.
2. Prioritising equity and trust: The use of AI can exacerbate existing inequalities, including those related to gender, ethnicity and socio-economic status, as well as disparities between rich and poor countries, and can undermine public trust. The report calls for EU policies that prioritise equitable access, transparency – including the environmental footprint of AI – and public engagement. Only then can AI meet the goals of universal healthcare and be aligned with democratic values.
3. EU-wide coordination is a must: Fragmented regulation hinders the safety and scalability of AI. The EU must harmonise standards, facilitate cross-border exchange of anonymised data and promote joint oversight to ensure ethical and robust AI applications across all Member States.

A call to policymakers 

The authors also recommend testing AI in regulatory sandboxes under controlled conditions before it is deployed more widely. Furthermore, investment should be channelled into research on approaches that deliver reliable results using smaller, carefully selected datasets. “Now is the time to act, if we want to entrust our health with AI” emphasises Knottnerus. “With these recommendations, we want to help policymakers drive innovations forward safely.”

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About the European Academies Science Advisory Council (EASAC)
EASAC is formed by the national science academies of the EU Member States, Norway, Switzerland and United Kingdom, to collaborate in giving advice to European policymakers. EASAC provides a means for the collective voice of European science to be heard. Through EASAC, the academies work together to provide independent, evidence-based advice to those who make or influence European policies within the European institutions. www.easac.eu

About the Federation of European Academies of Medicine (FEAM)

FEAM brings together 24 national Academies of Medicine, Pharmacy and Veterinary Science — or the medical divisions of national Academies of Sciences — from across the WHO European region, drawing on the expertise of over 5,000 leading biomedical scientists. Through FEAM, its member academies formulate and express a common position on European matters concerning human and animal medicine, biomedical research, education and health, extending to European authorities the same advisory role they each hold in their own countries. In doing so, FEAM works to underpin European biomedical policy with the best scientific advice the continent has to offer, and to advance the health, safety and wealth of European citizens through a creative, sustainable environment for medical research and training.

 www.feam.eu

[1] Announced by Commission President Ursula von der Leyen in her State of the Union speech on 16 September

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