The European Academies Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM) 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.
It has been written by a working group of 22 scientists from across Europe, including Miikka Korja, specialist in neurosurgery, HUS Helsinki University Hospital.
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 and risks
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.
“According to recent studies, one rapidly materializing risk is the erosion of expert knowledge (de-skilling). As doctors increasingly outsource their thinking, analyses, writing, and problem-solving to AI applications, their own skills and deep understanding collapse shockingly fast. If the AI system crashes after some time, the required skills may no longer be found within the medical profession to the same extent as before. The adoption of fully autonomous AI applications among healthcare professionals should be approached with caution,” states Miikka Korja, a Finnish member of the working group.
The EU AI Act and the European Health Data Space create an important foundation, but researchers identify gaps in their practical application to healthcare. According to the report, clear criteria are needed across different population groups and settings to demonstrate clinical benefit. In addition, healthcare systems must avoid becoming dependent on individual technology providers.
Key messages
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.
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.
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.
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.
Link to the report: AI in healthcare (EASAC & FEAM)
The European Academies’ Science Advisory Council (EASAC) is a cooperation organization of European science academies. The Council of Finnish Academies (CoFA) is a national member of EASAC.
The Federation of European Academies of Medicine (FEAM) is a cooperation organization of academies of medicine, pharmacy and veterinary science in Europe.