AI Act: Highlights From EIT Health Masterclass

AI Act in a Nutshell

The AI Act (law came into force on August 1, 2024) aims to foster trustworthy AI in Europe and beyond, by ensuring that AI systems respect fundamental rights, safety, and ethical principles and by addressing risks of very impactful AI models. There are several upcoming timelines and milestones for implementation of the Act in 2025, 2026, and 2027.

There's a lot to unpack about AI Act. But what stood out for me during a masterclass organized by EIT and delivered by Fernando Seoane, Senior Lecturer at Karolinska institutet, are three things:

1. You don't have to be in Europe to be impacted by the AI Act.

You'd think this is a European act and, if you're not in the EU, it doesn't apply to you. Think again. The AI Act applies to :

a. Providers (developers) of AI systems: Based in the EU, or based outside the EU but placing AI systems on the EU market or putting them into service in the EU.

b. Deployers (users) of AI systems: Individuals, companies, or public bodies that use AI systems in the EU for professional purposes (not personal use).

c. Importers and Distributors:Those who import or distribute AI systems in the EU are also subject to the act’s requirements, particularly around compliance and documentation.

d. Product manufacturers: If the AI system is a component of a product covered by existing EU safety legislation (e.g. medical devices, cars), manufacturers must ensure both product and AI compliance.

e. EU Institutions, Agencies, and Bodies: The AI Act applies to EU public sector bodies using AI systems—although there are some exceptions, particularly regarding law enforcement and national security.

2. AI literacy isn't a bonus. It's a legal requirement.

AI literacy training for your staff isn't "nice" or "progressive." It's going to be legally required. I asked during the session whether we have a definition for AI literacy, and Fernando's answer was telling. It's not just about the content of the training—being able to use AI systems effectively—but also the process. So, as an example: If you have 10,000 staff and plan to train only 20 of them per month, well, it's going to take a while to reach a critical mass of people with required AI competencies. You are probably not complying with the law. Leaders must act now to keep up with this pace of change (follow Ann Reilly for everything to do with speed of change and adaptability).

3. Keep clear documentation

There's still a lot to be figured out—by everyone—when it comes to complying with AI Act. But here's what I always tell my clients, and it's more relevant now than ever:

Keep clear documentation of your work. Define what you're doing, how you're doing it, how you're measuring it. Embed M&E into your quality management systems. You'll need it, especially as the regulatory environment continues to evolve.

Call to Action & Resources

1- Invest in 'AI literacy' training for yourself and your staff. This is a requirement by law. Not a nice to have. Ann Reilly offers great resources about everything to do with the speed of change, what leaders can do, and measuring and cultivating adaptability.

2- Work with Monitoring & Evaluation specialists to help you clearly and systematically document your work—that way, doesn't matter how things change, you always know what you did, how you measured it, and why you changed things.