Proposal for a Regulation Laying Down Harmonised Rules on Artificial Intelligence

Artificial Intelligence (AI) is a fast evolving family of technologies that can bring a wide array of economic and societal benefits across the entire spectrum of industries and social activities. By improving prediction, optimising operations and resource allocation, and personalising service delivery, the use of artificial intelligence can support socially and environmentally beneficial outcomes and provide key competitive advantages to companies and the European economy. Such action is especially needed in high-impact sectors, including climate change, environment and health, the public sector, finance, mobility, home affairs and agriculture. However, the same elements and techniques that power the socio-economic benefits of AI can also bring about new risks or negative consequences for individuals or the society. In light of the speed of technological change and possible challenges, the EU is committed to strive for a balanced approach. It is in the Union interest to preserve the EU’s technological leadership and to ensure that Europeans can benefit from new technologies developed and functioning according to Union values, fundamental rights and principles.

This proposal delivers on the political commitment by President von der Leyen, who announced in her political guidelines for the 2019-2024 Commission "A Union that strives for more", that the Commission would put forward legislation for a coordinated European approach on the human and ethical implications of AI. Following on that announcement, on 19 February 2020 the Commission published the White Paper on AI - A European approach to excellence and trust2. The White Paper sets out policy options on how to achieve the twin objective of promoting the uptake of AI and of addressing the risks associated with certain uses of such technology. This proposal aims to implement the second objective for the development of an ecosystem of trust by proposing a legal framework for trustworthy AI. The proposal is based on EU values and fundamental rights and aims to give people and other users the confidence to embrace AI-based solutions, while encouraging businesses to develop them. AI should be a tool for people and be a force for good in society with the ultimate aim of increasing human well-being. Rules for AI available in the Union market or otherwise affecting people in the Union should therefore be human centric, so that people can trust that the technology is used in a way that is safe and compliant with the law, including the respect of fundamental rights. Following the publication of the White Paper, the Commission launched a broad stakeholder consultation, which was met with a great interest by a large number of stakeholders who were largely supportive of regulatory intervention to address the challenges and concerns raised by the increasing use of AI.

Download: Proposal for a Regulation Laying Down Harmonised Rules on Artificial Intelligence (889 KB).

Download from DIGITAL HEALTH NEWS: Proposal for a Regulation Laying Down Harmonised Rules on Artificial Intelligence (889 KB).

Most Popular Now

AI Tool Helps Predict Relapse of Pediatr…

Artificial intelligence (AI) shows tremendous promise for analyzing vast medical imaging datasets and identifying patterns that may be missed by human observers. AI-assisted interpretation of brain scans may help improve...

Detecting Lung Cancer 4 Months Earlier a…

GPs may soon be able to identify patients with an increased risk of lung cancer up to 4 months earlier than is currently the case. The GP should be able...

Infectious Disease Surveillance Platform…

The Biothreats Emergence, Analysis and Communications Network (BEACON) leverages advanced artificial intelligence (AI), large language models (LLMs) and a network of globally based experts to rapidly collect, analyze, and disseminate...

Children's Health Ireland to Transf…

Healthcare teams responsible for paediatric care in Ireland are to save significant time in accessing important diagnostic imaging and reports, with the help of a new agreement with medical imaging...

NHS, Councils, and Housing could Share N…

A new technology partnership formally announced, could help NHS, local government, and housing organisations collaborate to create an unprecedented understanding of the risks and needs of people in their care...

AI-Powered Analysis of Stent Healing

Each year, more than three million people worldwide are treated with stents to open blocked blood vessels caused by heart disease. However, monitoring the healing process after implantation remains a...

Right Patient, Right Dose, Right Time

While artificial intelligence (AI) has shown promising potential, much of its use has remained theoretical or retrospective. Turning its potential into real-world healthcare outcomes, researchers at the Yong Loo Lin...

An AI Tool Grounded in Evidence-Based Me…

A powerful clinical artificial intelligence tool developed by University at Buffalo biomedical informatics researchers has demonstrated remarkable accuracy on all three parts of the United States Medical Licensing Exam (Step...

AXREM and BHTA Name Highland as 'Fu…

Hosted by trade associations AXREM and the British Healthcare Trades Association (BHTA), 'The Future of MedTech - Innovating for Tomorrow', will allow delegates to engage with speakers from the government...