AI Literacy Requirements Under the EU AI Act: What Healthcare Leaders Need to Know

The European Union reached a significant milestone in AI regulation on 2 Feb. 2025, as the first compliance measures of the EU AI Act became applicable.

This pioneering legislation — the world’s first comprehensive AI law — aims to foster trustworthy AI across all sectors, including healthcare. A critical yet often overlooked aspect of the AI Act is its AI literacy requirements, which impact organisations developing, providing and deploying AI solutions.

Understanding AI Literacy and Its Impact on Healthcare

AI literacy, as defined by the regulation, refers to the knowledge, skills and awareness needed to use AI systems responsibly. For the healthcare sector, this means ensuring both technical and non-technical staff — such as doctors, nurses and administrators — can interpret AI outputs and make informed decisions.

Given AI’s growing role in medical diagnostics, patient monitoring and workflow automation, the AI Act mandates that hospitals and other healthcare providers ensure their workforce meets an adequate level of AI literacy. The specific requirements vary depending on technical expertise, education and experience, as well as the use case of the AI system.

To support organisations in meeting these requirements, the European AI Office recently launched a Living Repository to Foster Learning and Exchange on AI Literacy, offering examples of best practices and ongoing AI education initiatives.

Compliance Considerations: What Healthcare Organisations Need to Do

The AI literacy requirements apply to all AI systems allowed to operate under the AI Act, regardless of their risk classification. This means that both high-risk AI applications, such as AI-powered medical diagnostics, and lower-risk tools like AI-enabled chatbots for patient engagement fall under these obligations. However, AI applications deemed to pose unacceptable risks, such as social scoring or manipulative AI, are strictly banned.

“AI literacy may be an often-overlooked obligation of the AI Act, but it is a much-needed push that the healthcare sector requires to facilitate the adoption of AI solutions at scale,” said Tom Leary, HIMSS Senior Vice President & Head of Government Relations. “By educating and upskilling the healthcare workforce, we can build trust not only in AI technology itself but also in its ability to enhance care delivery and improve patient outcomes.”

Learn More at a HIMSS Webinar

Understanding these new AI literacy requirements is critical for healthcare leaders, technology providers and policymakers. Building on a previous webinar, Shaping the Future of Healthcare: A Deep Dive into the EU’s Latest Regulations, HIMSS looks to explore the implications of the EU AI Act and how organisations can prepare.

Join the upcoming HIMSS webinar:

The EU AI Act Unpacked: What It Means for Digital Health and Innovation

• 25 Feb., 2025
• 10 a.m. ET / 4 p.m. CET
• Register now

HIMSS experts will unpack the AI Act’s impact on digital health and discuss strategies for compliance. Don’t miss this opportunity to stay ahead of regulatory changes and ensure your organisation is AI-ready.

Learn more about HIMSS AI Global Policy Principles.