AI in Healthcare: The AI Act and other Regulatory Issues

The extraordinary developments in artificial intelligence in recent years hold the promise of facilitating advances in many different fields, and healthcare is no exception.

The three projects presented in this webinar (SmartCHANGE together with AI4HF and DataTools4Heart) have all been funded by the EU to carry out exciting research in the use of AI in areas ranging from chronic heart failure to lifestyle improvement in youth.

However, the approval of the Artificial Intelligence Act (the final text of the Regulation 2024/1689 published in the Official Journal of the European Union is available here) on 13 March 2024 by the European Parliament reminds us that healthcare - surely the most human-centric sector of all - needs regulation in order to ensure our safety, privacy, and general well-being.

The AI Act introduces a risk-based approach that tries to strike a balance between necessary regulation and innovation. In addition, it interacts with existing legislation such as the European Medical Device Regulation, which has governed the certification of digital health instruments for several years.

In this first webinar, of the SmartCHANGE’s series, our experts provided information and insights from several different perspectives resulting from their work in untangling the many new concerns and uncertainties arising from these recent regulatory developments. This post-webinar report summarises insights emerging during the webinar as well as recommendations from our expert speakers.

The complete speaker presentations, together with a video recording of the full session, are now available. 

Download the entire report below.