Regulatory development within the EU

In February, EU took some important steps on the road towards a data-driven society!

The European Health Data Space (EHDS) was signed on February 11th and was published in the EU Official Journal on March 5th. When the EHDS turns applicable in 2027, it will become significantly easier to share health data across Europe. This can be a game-changer for AI development projects within health care, which require large amounts of data.

The first parts of the AI Act became applicable on February 2nd. This means that actors within EU must now comply with rules regarding:

• AI Literacy (AI Act, Chapter I)

The obligations concerning AI Literacy means that all providers and deployers within EU (i.e. entities that develop, market, or deploy AI systems or use AI systems professionally) are required to ensure that their staff has a sufficient level of AI literacy, regarding e.g. opportunities, risks, and potential harms associated with AI.

• Prohibited AI Practices (AI Act, Chapter II)

The rules concerning prohibited practices means that AI is now prohibited within certain areas, where the risks are classified as unacceptable. Examples of prohibited AI practices include:

• • Subliminal manipulation: AI systems that manipulate human behavior in a way that causes physical or psychological harm.
  • Exploitation of vulnerabilities: AI systems that exploit vulnerable groups based on age, disability, or socioeconomic status to manipulate individuals.
  • Social scoring: AI systems used for social scoring by public authorities, leading to detrimental or unfavorable treatment unrelated to the context in which the data was originally gathered.
  • Real-time Biometric Identification in Public Spaces: The use of AI for real-time remote biometric identification (e.g. facial recognition) in publicly accessible spaces is banned, except in specific cases like serious crimes or terrorism prevention.
  • Predictive Policing Based on Profiling: AI systems that predict criminal behavior based solely on profiling or past data patterns rather than actual individual actions.

AI systems falling under any of the areas mentioned above are considered a threat to fundamental EU rights, safety, and democratic value, and are therefore prohibited. Rules regarding General Purpose AI (GPAI) will become applicable in August 2025.

Read more:

Frequently Asked Questions on the European Health Data Space – European Commission

Author:

Stina B Jonasson
Project manager, PhD
Skane University Hospital, Lund, Sweden

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