Improving the countries’ capacity to regulate Artificial Intelligence (AI) in the healthcare sector – this is the primary objective of HealthAI, a non-profit organisation that INESC TEC has joined as a member of the Community of Practice. The initiative includes, in addition to research institutes like INESC TEC, government policymakers and legislators, regulatory agencies, patient associations, health organisations, civil society and business entities.
The selection process involved more than 2000 applications, with INESC TEC being one of the 170 organisations selected. Through thematic groups or plenary meetings, the Institute will now participate in “knowledge exchange” actions and “direct interactions between members, ensuring that different perspectives drive innovation and influence changes in the field of AI in health”.
According to Carlos Ferreira, business developer in innovation in health at INESC TEC (TEC4Health), this selection “highlights the value and relevance of the work developed in AI applied to health”. “Our researchers take special care to go beyond the practical application of AI to improve health outcomes, also exploring ethical and regulation implications,” he added.
The growing relevance of AI in the healthcare sector highlights the importance of ensuring that advances are implemented responsibly. Still, this is still an ongoing process in the European context. On the one hand, the European Union’s Medical Device Regulation – which establishes the requirements for the certification of medical devices – is at full force; on the other hand, the Artificial Intelligence Regulation (AI Act) defines good practices for the development and use of AI systems.
However, as Carlos Ferreira explained, “there is no explicit integration between the two regulations” — the fact that not all AI applications in healthcare are classified as medical devices is one of the justifications pointed out. Promoting trust and equity in the sector – two premises at the core of HealthAI — is the main mission, closer to being fulfilled.
“We all know that there are certain underestimated aspects, and that’s why it’s essential to promote discussions and contributions that ensure comprehensive and adequate regulation,” said Carlos Ferreira. This will be the path to follow after the first plenary meeting of the HealthAI Community of Practice — led by Ricardo Batista Leite, a physician specialised in infectious diseases, with extensive experience in global health, health systems and policymaking based on scientific evidence —, which focused on defining a common ground between the various entities represented, towards the adequate operation.
The researcher mentioned in this news piece is associated with INESC TEC.
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