Skip to main content
Email

The latest news in Healthcare IT – straight to your inbox.

Home
  • Main Menu
  • Subscribe
  • Topics
    • Video
    • Analytics
    • Artificial Intelligence
    • Cloud Computing
    • EHR
    • Government & Policy
    • Interoperability
    • Patient Engagement
    • Population Health
    • Precision Medicine
    • Privacy & Security
    • Telehealth
    • Women In Health IT

Regions

  • ANZ
  • ASIA
  • EMEA
  • Global Edition
EMEA
Artificial Intelligence

Effects of the EU AI Act Visible After 2026

The final negotiation round between the EU Parliament, EU Council, and EU Commission in December sealed the EU AI Act, however, the official document isn’t published yet and questions still hang in the air about the final rules.
By Tjasa Zajc
January 11, 2024
10:02 AM

Photo: mediaphotos / Getty Images

2023 was the year marked by AI. With the rise of general-purpose large language models ChatGPT, Claude and Bard, AI has become tangible and accessible for millions of people. There was no shortage of excitement, but also appeals for regulation of this powerful technology. 

State of AI Regulation in Healthcare

The EU AI Act was drafted already in 2021, long before the availability of general-purpose large language model. In December of 2023 a consensus on legislation seemed to have been achieved. Across the pond in the US, under the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, Health and Human Services (HHS) needs to establish an AI Task Force which will need to develop a regulatory action plan for predictive and generative AI-enabled technologies in health care in 2024.

Regulation is always a step behind the industry and setting rules for healthcare isn’t possible without the tech industry and medical recommendations. There seem to be more and more associations forming every day. There’s the US Coalition for Health AI (CHAI™) -  a community of academic health systems, organizations, and expert practitioners of artificial intelligence (AI) and data science. It proposed a setup of special assurance labs that would allow health systems as well as tool developers and vendors to submit their AI solutions for evaluation. The New England Journal of Medicine launched NEJM AI, a monthly, online-only publication for evaluating applications of artificial intelligence in clinical medicine. The Global Agency for Responsible AI in Health strives to harmonize global healthcare standards as defined by WHO. The organization wants to connect different regulatory bodies from around the world and create early warning systems. These would notify the network if unintended effects of AI were detected anywhere in the world. The ideas are there, but it will take time for them to take form. 

AI Regulation in the EU will be felt after 2026

The official EU AI legislative document is expected early in 2024. Till then, the experts are cautious and also critical, especially in regards to open-source AI and proprietary model regulation. „Our information about the EU AI regulation stems from leaks in the negotiation process which was marked by opacity and lack of democracy oversight. Right now, anti-open source lobbyists are trying to mess with the Act after the deal, all because they're upset about the rumor that open-science based AI R&D might be exempt from regulations. I and most other AI experts advocate that regulations should only come into play at the application level. Going beyond that would suppress scientific freedom and undermine the European advantage,“ says Bart de Witte, Founder of HIPPO AI Foundation, which advocates for the development of open-source AI, to prevent consolidation of power in the hands of global tech corporations. 

EU AI Act could be disrupted by countries like France and Germany who prefer self-regulation and want changes to the legislation. Ricardo Baptista Leite, CEO at The Global Agency for Responsible AI in Health sees this as problematic: “In highly sensitive areas like health, I don't believe this is necessarily the best approach. It depends on the application of the AI, but at the end of the day, these countries are opening up a whole can of worms of discussions, which can undermine the process moving forward.” 

The upcoming European elections may also steer the conversation, as shifts in political power could influence the act's implementation. “We have the country level approach that with the rise of extreme nationalisms could lead to very, very poor policies that can undermine all the efforts of trying to find some level of harmonization. Harmonization is critical to ensure that these technologies can be used in a safe manner, but also in a way of us making sure that we're uptaking the most of the technology’s potential,” says Ricardo Baptista Leite and explains that while the AI Act is a step forward, the real impact on industries, particularly health, won't be felt until around 2026. The next two years are going to be crucial for balancing the risks and harnessing the benefits AI brings to health systems and patient care. 

How Can Industry Scale?

The Global Agency for Responsible AI in Health, will advocate for the same principles that we have for medicines approval and health technology assessment to be used for AI in healthcare. In the future, the Agency plans to create a comprehensive AI solutions repository. This platform will focus on health AI, providing an online public database. It will be a global showcase, featuring AI technologies validated by various countries.

More of these topics will be discussed at HIMSS24 Europe, which will have a dedicated AI track.  
 

Topics: 
Artificial Intelligence, Government & Policy

More regional news

Businessperson viewing graphs on a tablet

AIDAVA is harnessing data altruism to advance personalised medicine

By
Aline Noizet
April 01, 2025
NHS logo

NHS England to be scrapped, reimagined with streamlined tech focus

By
Andrea Fox
March 17, 2025
home healthcare worker with a patient

The future of care: Nurses in 2030

By
Aline Noizet
March 11, 2025
Want to get more stories like this one? Get daily news updates from Healthcare IT News.
Your subscription has been saved.
Something went wrong. Please try again.

Top Story

home healthcare worker with a patient
The future of care: Nurses in 2030

Most Read

How UCHealth is reducing fall injuries with AI-enhanced risk modeling
2025: AI enhances personalized care; caregiver experience in the spotlight
Frontera launches with $32M in seed funding
Australia infuses $85M in digital mental health and more briefs
Korea University Medical Center pursues brain, heart AI development and more briefs
Roundup: AI and cloud tackle cyber risk and improve workflows

Research

White Papers

More Whitepapers

Telehealth
Create secure, connected omnichannel communications
Telehealth
Let us guide you to HIPAA compliance
Cloud Computing
How a cloud communications platform puts connection at the center of care

Webinars

More Webinars

Analytics
Standby Eligibility and Claims Solutions: Diversify Your Risk & Ensure Business Continuity
Interoperability
Nursing Leadership, Operational Innovation, and Emerging Technologies with AONL
Artificial Intelligence
Loving the AI Revolution: How Automation is Humanizing Healthcare and Improving Provider Well-Being

Video

Ilir Kullolli, Stanford Medicine Children's Health_Las Vegas skyline Photo by halbergman/E+/Getty Images
HIMSS-ACCE working together to advance digital health
Vik Bajaj, Foresite Labs_Medical research Photo by Edward Jenner/pexels.com
Healthcare research is being affected by federal budget cuts
Priyanka Jain, Evvy_Hand holding sample vial Photo courtesy of Evvy
How one women's health startup tests fertility outcomes
Keisuke Nakagawa, UC San Diego Health_Las Vegas skyline Photo by halbergman/E+/Getty Images
Can technology help bring the human touch back to medicine?

More Stories

Lee Kim, HIMSS_Las Vegas skyline Photo by halbergman/E+/Getty Images
Past year's data breaches often stemmed from remediable cybersecurity gaps
Cathy Menkiena, Health Catalyst_Las Vegas skyline Photo by halbergman/E+/Getty Images
Innovative – and useful – tech is key to empowering care teams
Sameer Sethi of Hackensack Meridian Health on AI
Hackensack Meridian Chief AI Officer on the intersection of business and technology
Doctor checking and tracking information on a computer
HHS updates regulatory guides for the safe use of EHRs
Sameer Sethi, Hackensack Meridian Health_Computer neural network concept Photo by dan/Moment/Getty Images
Chief AI Officer on becoming one and working with the C-suite
Businessperson signing piece of paper
White House releases guidance on federal AI use and procurement
Dr. Ateev Mehrotra of Brown University School of Public Health on telehealth policy
Brown University policy expert talks about the future of telehealth flexibilities
Micky Tripathi, former HHS acting chief AI officer
Former National Coordinator headed to Mayo Clinic, reports say
Home

More News

  • MobiHealthNews
  • Healthcare Finance News
  • Healthcare Payers News

Newsletter Signup

HIMSS25 European Health Conference & Exhibition
HIMSS25 European Health Conference & Exhibition
Get ready for knowledge-sharing, all the latest innovations, and in-depth demos with Europe's most influential healthcare community.
10 - 12 June, 2025 | Paris
Learn More
AI in Healthcare Forum
AI in Healthcare Forum
The HIMSS AI in Healthcare Forum cuts through the hype to showcase real-world examples illustrating the transformative potential, and realistic challenges of AI application across the care continuum.
10 - 11 July 2025 | New York
Learn More

Footer Menu

  • About
  • Advertise
  • Reprints
  • Contact
  • Privacy Policy

© 2025 Healthcare IT News is a publication of HIMSS Media

X

Topics

  • Video
  • Analytics
  • Artificial Intelligence
  • Cloud Computing
  • EHR
  • Government & Policy
  • Interoperability
  • Patient Engagement
  • Population Health
  • Precision Medicine
  • Privacy & Security
  • Telehealth
  • Women In Health IT

Career

  • Events
  • Jobs
  • Research Papers
  • Webinars

More

  • About
  • Advertise
  • Contact
  • Special Projects
  • Video

Regions

  • ANZ
  • ASIA
  • EMEA
  • Global Edition

The Daily Brief Newsletter

Get daily news updates from Healthcare IT News.

Search form

Top Stories

Nurse checks tablet to communicate on shift
Zoom launches agentic AI-powered mobile comms for frontline staff
HIMSSCast logo
HIMSSCast: Should every healthcare organization have an AI strategy?
Vik Bajaj, Foresite Labs_Medical research Photo by Edward Jenner/pexels.com
Healthcare research is being affected by federal budget cuts