AI in Swedish Patient Care: The Existing Legal Building Blocks

Artificial intelligence, as a field of technology, has advanced significantly over the last decade. Although it has not reached its peak, it has already found its place in Swedish healthcare, including in patient care. It is therefore highly desirable to clarify how the law addresses AI in healthcare in Sweden. However, comprehensive insights remain quite limited. This article aims to fill this gap and explore the existing legal building blocks for the use of AI in healthcare. It highlights the scope and limitations of applicable laws in ensuring patient protection, as well as the complex interplay between EU law on the quality and safety of AI in healthcare, on the one hand, and national healthcare regulation, on the other. It puts forward a four-tier model for integrating EU requirements surrounding AI in the Swedish standard of care, science and proven experience, and shows how informed consent elements can support disclosure of AI use in patient care. Finally, it illuminates the challenges that emerge when integrating AI into patient care in Sweden and indicates areas for further legal inquiry to enhance legal certainty in the field.