AI in Healthcare webinar: The AI Act and other Regulatory Issues

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Purpose & Scope

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 Act (the final text that will be 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.

What to expect? 

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.

Who's the ideal audience?

  • Policymakers involved in healthcare-related areas
  • Legal and regulatory experts studying the new regulations concerning healthcare
  • Providers of healthcare-related digital devices and services
  • Healthcare professionals
  • Researchers involved in related areas of healthcare and AI

What are the benefits of attending?

  • Becoming familiar with the latest developments in healthcare-related legislation
  • Finding out about exciting new research in EU-funded healthcare projects
  • Exchanging information and opinions with our experts from your own experience

To stay updated and continue exploiting these insights:

  • Follow the recording: Access the recording of this webinar to catch up on the discussions and presentations.
  • Join future webinars: Stay tuned for the next events in the SmartCHANGE series to keep up with ongoing advancements and regulatory updates in the field of AI and healthcare.

Watch the recording


Time - CEST Topic Speaker
15:00 - 15:05 Welcome & Webinar overview John Favaro | Trust-IT Services
15:05 - 15:25 Regulatory issues affecting the creation of an app for predicting long-term health factors in youth Renato Sabbadini | VUB
Paul Quinn | VUB
15:25 - 15:45 The Impact of the AI Act on the development of an AI-powered cardiology data toolbox Lorenzo Cristofaro | Panetta Consulting Group
15:45 - 16:05 The Regulation and Certification of Medical Devices in an era of the AI Act - the AI4HF perspective Achim Mayer | CE plus
16:05 - 16:25 Panel Discussion & Q&A Session All the Speakers & Moderator
16:25 - 16:30 Conclusion and final messages  John Favaro | Trust-IT Services