Commission study warns rules and mistrust stall AI in healthcare
'Looking for a smart and fun summer read about Artificial Intelligence in healthcare? Check this out!' joked a digital health policy officer at the Commission's DG Sante in a recent LinkedIn post, pointing to the newly published 241-page Study on the Deployment of AI in Healthcare.
While the fun parts might be hard to find, the report – published just in time for the summer holidays – provides a comprehensive overview of the topic, including its opportunities and challenges.
Between 2015 and 2024, EU research projects on AI in health received €3.5 billion in funding, averaging €6.73 million per project – figures laid out in the study that give a picture of how heavily the bloc is already invested in the field. Over the same period, AI-related healthcare patents increased from 22 in 2017 to 118 in 2023, and clinical trials of AI- and machine learning–enabled medical devices rose from six in 2015 to 657 in 2024.
The report found that AI is already being used in hospitals worldwide to automate tasks such as clinical documentation, improve diagnostic accuracy and speed, and enable personalised treatments – with demonstrable impacts on care.
Such tools are urgently needed as health systems face rising demand from an ageing population increasingly affected by chronic disease, alongside staff shortages and rising costs. However, developers and implementers must navigate overlapping rules, including the Artificial Intelligence Act, the General Data Protection Regulation (GDPR), the Medical Device Regulation and the planned European Health Data Space. "While robust, the regulatory environment governing AI in healthcare presents complexities that may contribute to hesitancy in AI deployment," reads a summary of the report.
The study points to ideas such as setting up interdisciplinary AI governance committees in clinical settings to help oversee compliance and streamline decision-making. It also mentions measures like comprehensive data governance frameworks, robust storage policies, encryption methods and privacy-by-design technologies to address security concerns.
It further notes that boosting digital health literacy and technical skills among healthcare professionals and patients could help build trust in the reliability and ethical implications of AI.
"Through strategic action and a commitment to overcoming deployment challenges, the EU can position itself as a global leader in AI-driven healthcare innovation," the report concludes.
(de)
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