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AI Act: Regulations on the Use of AI in Europe and in Healthcare

Updated: Jan 18


Artificial Intelligence has taken an increasingly central role in digital age society, progressively transforming both our lives and entire sectors such as industry, education, finance, and healthcare. However, AI is not only offering huge opportunities but is also raising complex issues related to security, ethics, and the protection of human rights. The AI Act has been introduced by the European Union to prevent the risks of Artificial Intelligence by regulating its use.

AI Act: A European Regulatory Framework

On June 14, 2023, the European Parliament approved the AI Act, a regulatory framework aiming for a responsible and transparent use of Artificial Intelligence. This is a legislative proposal that fits within the"Europe fit for the digital age" strategy and will come into force between 2024 and 2025, as the world's first AI regulation.

The law establishes a uniform legal framework aimed at regulating the development, marketing, and use of generative AI systems and basic AI models in accordance with the values and rights of the European Union.


The AI Act and the Risk-Based Approach

The goal of the rules on the use of Artificial Intelligence in Europe is to ensure a balance between technological innovation and the protection of the fundamental rights of European citizens, associating more or less stringent regulation based on 4 levels of risk, which are divided into:

  • Unacceptable risk:

  • Cognitive behavioral manipulation (e.g., voice-activated toys that encourage dangerous behaviors in children)

  • Classification of people based on behavior, socio-economic status, or personal characteristics

  • Real-time and remote biometric identification systems, such as facial recognition. With exceptions for post-event use in the case of searching for a missing minor, to prevent a specific and imminent terrorist threat, or to identify a suspect of a serious crime

  • High risk:

  • AI systems used in products that fall under EU product safety legislation. This includes toys, aviation, automobiles, medical devices, and elevators

  • AI systems that fall into 8 specific areas that must be registered in an EU database:

  1. Biometric identification and categorization of natural persons

  2. Management and operation of critical infrastructure (e.g., electrical networks, hospitals)

  3. Education and vocational training

  4. Employment, worker management, and access to self-employment

  5. Access to and enjoyment of essential private services and public benefits

  6. Law enforcement

  7. Management of migration, asylum, and border control

  8. Assistance in interpreting and applying the law (e.g., credit assessment)

  • Limited risk: applications used for translation, image recognition, or weather forecasting

  • Minimal or no risk: free use of AI in applications such as AI-enabled video games or anti-spam filters.


Implications for the Healthcare Sector

There are many benefits brought by Artificial Intelligence, as mentioned in a previous article, especially in Healthcare, which, thanks to its innovative technology, has made significant strides in terms of efficiency, quality, and education.

Indeed, AI applied to the healthcare sector and medicine has a significant impact, especially since it involves dealing with people's health. For this reason, it is essential to ensure their safety through the AI Act, which focuses on aspects such as:

  1. Certification and Evaluation of AI Systems:

  2. Responsibility and Transparency: The importance of attributing responsibility to healthcare operators using AI systems is emphasized. Algorithms must be transparent, understandable, and traceable, so it is possible to identify the causes of any errors or problems and ensure that appropriate measures are taken.

  3. Data Protection and Privacy: Emphasis is placed on the protection of data and patient privacy, as the use of AI requires extensive collection and analysis of sensitive personal data. Robust measures are needed to ensure that data are managed securely and in compliance with privacy regulations, such as GDPR.

  4. Monitoring and Control: Continuous monitoring of AI systems used in the healthcare sector is required to ensure compliance with regulations and to detect any risks or negative impacts. Control mechanisms are necessary to prevent the abuse of AI and to ensure the protection of patient rights.

  5. Innovation and Research:


The AI Act represents an important step towards responsible and safe use of AI in Europe and specifically in the healthcare sector. While AI offers enormous opportunities to improve diagnosis, treatment, and management of diseases, it is crucial to ensure that its use respects ethical and legal principles. The AI Act aims to balance innovation and responsibility, protecting patient rights and ensuring the safety of AI systems used in healthcare. If properly implemented, the AI Act can bring significant benefits, improving the quality of care and promoting a safer and more ethical healthcare environment.


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