What you need to know about the Artificial Intelligence Act

On May 21, the EU Council reached a final agreement on the so-called first major law regulating artificial intelligence. There are many questions surrounding the new law, such as implementation, enforcement and deadlines.

Anne-Gabrielle Haie, partner at Steptoe LLP, joins us on this episode of Let’s Talk Medtech to discuss the Artificial Intelligence Act and how medical device and life sciences companies can prepare for it.

Below is a short excerpt from the conversation. Editor’s note: (One important thing to note is that when we first recorded this conversation, the EU’s Artificial Intelligence Act had not received the final green light.)

Well, good morning and welcome to Let’s Talk Medtech, Anne Gabrielle. Thank you for joining us. Before we move on to our conversation about the EU Artificial Intelligence Act, could you tell us a little about your background and the work you do to help your clients?

Anna-Gabrielle: Sure and thank you for inviting me. My name is Anne Gabrielle and I am a lawyer with French qualifications and a partner in the law firm Steptoe, a law firm based in Brussels. I lead the EU’s Artificial Intelligence, Data and Digital Practice, which covers data protection, privacy, cybersecurity, digital services regulation and artificial intelligence. I advise clients on compliance with EU law in these areas and represent them in explanatory and enforcement proceedings. I focus primarily on the technology and life science sectors.

Amazing, it’s amazing. Let’s move on to the EU Artificial Intelligence Act. Can you provide an overview of the Act and discuss a potential timeline for enforcement?

Anna-Gabrielle: Surely. This is an important topic because it is the first artificial intelligence regulation in the world that is close to adoption. However, this has not yet been formally adopted, which is attracting attention around the world. The EU Artificial Intelligence Act is a comprehensive regulation with cross-sectoral application and covering a wide range of artificial intelligence systems. These systems specified in the Act are characterized by autonomy and adaptability. Importantly, the act extends its reach beyond companies based in the EU and covers those that have an impact on the EU market. For example, a medical device company based in Atlanta, Georgia would be subject to these guidelines if its AI system was used in the EU. In terms of timetable, the act is expected to be approved by the EU Council next week, followed by publication and translation. Some regulations, such as those banning certain artificial intelligence systems, may enter into force in early 2025, while others may be delayed until 2027.

Fascinating. Have businesses fully understood the implications of this law, given its broad scope?

Anna-Gabrielle: The reaction was mixed. While some stakeholders have pushed for its adoption, others have expressed concerns about the potential for stifling innovation. Awareness of the Act’s scope varies, but given its reach across the AI ​​value chain, companies need to prepare for compliance.

It appears that compliance efforts will be extensive. How can companies, especially smaller ones, navigate this regulatory landscape?

Anna-Gabrielle: Anticipation and planning are crucial. Companies should create cross-departmental teams and assess the qualifications and roles of their AI systems. They must also conduct a gap analysis to determine compliance needs and develop an action plan accordingly. While smaller companies may face resource challenges, their experience in highly regulated sectors such as life sciences can provide a competitive advantage.

Enforcing such laws seems complicated. What can companies expect in terms of enforcement mechanisms and penalties?

Anna-Gabrielle: Enforcement will involve multiple stakeholders at EU and national level, and penalties for non-compliance will be severe, up to €15 million or 3% of global turnover for high-risk AI systems.

Thank you for sharing these insights, Ann Gabrielle. How can people contact you if they are looking for more information or help?

Speaker B: They can find my contact information on the website Steptoe website or connect with me LinkedIn.