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Experts concerned over recently adopted European AI Act

Experts are concerned that the recently adopted European Artificial Intelligence (AI) Act is in some ways incompatible with the Medical Device Regulation (MDR), in part due to conflicting terminology across the two documents.

During the 2024 RAPS Euro Convergence, a panel of experts discussed how medical devices under the AI Act, adopted by the EU in March, are treated compared to how they’re handled under MDR.

Koen Cobbaert, a senior manager for quality, standards, and regulations at Philips, and Ariana Sliwa, a project lead at TÜV-Verband, described the AI Act and MDR as an arranged marriage.

Cobbaert noted that he wanted to avoid two overlapping frameworks for AI-based medical devices and instead wanted such requirements added to MDR based on international standards. Now, he said the AI Act and MDR can be thought of as conjoined twins.

“We’ll have to make it work because we will not be able to separate them anymore,” said Cobbaert. “I hope that we’ll find a way to reduce the number of arms, legs, and mouths that all speak in different languages.”

Sliwa agreed that the AI Act and MDR structures are similar but not the same, but stakeholders will have to find a way to make them work.

“I think that’s possible,” she said. “I think what’s really important is that now is the time to get the stakeholders together to talk and discuss how we get things to work and not work in silos but bring everything to the table.”

Stephen Gilbert, a professor at the Else Kröner Fresenius Center for Digital Health, said the AI Act was needed because of the direction the technology has been going, especially when looking at how AI has become integrated into wellness devices and electronic health records.

“I don’t accept the argument that AI is a tool or a manufacturing process,” said Gilbert. “It is one of the fundamental paradigm shifts we’re seeing in our world where we’re moving towards aspects of artificial intelligence in medicine.”

“It was needed by Europe and is needed by Europe to acknowledge the paradigm shift we’re seeing in the technology space,” he added. “We weren’t living in a world previously where machines could make decisions as well as humans, and we’re starting to enter that world.”

Erik Vollebregt, a partner at Axon Lawyers, said that the AI Act was necessary from a trade policy perspective because of “The Brussels Effect,” which allows the EU to influence global standards and policies with its own market requirements. However, he said the problem is that the regulations often conflict and “don’t dovetail very well.”

Vollebregt said one problem is that the AI Act was developed as a new legislation framework but is set up as a blend of production and technology regulations that also focus on ethical issues. He also said the AI Act and MDR often don’t share the same terminologies, which may lead to confusion. RAPS.org

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