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 Helps Physicians Better Assess the Ef…

In a small but multi-institutional study, an artificial intelligence (AI)-based system improved providers' assessments of whether patients with bladder cancer had complete response to chemotherapy before a radical cystectomy (bladder...

Smartwatches and Fitness Bands Reveal In…

A new digital health study by researchers at Scripps Research shows how data from wearable sensors, such as smartwatches and fitness bands, can track a person’s physiological response to the...

AI may Detect Earliest Signs of Pancreat…

An artificial intelligence (AI) tool developed by Cedars-Sinai investigators accurately predicted who would develop pancreatic cancer based on what their CT scan images looked like years prior to being diagnosed...

Open Call U4H-2022-PJ2: Call for Proposa…

The Ukraine crisis has an unprecedented impact on the mental health of the displaced people in the EU coming from Ukraine. The conflict and experiences of people in war zones...

AI Reduces Miss Rate of Precancerous Pol…

Artificial intelligence reduced by twofold the rate at which precancerous polyps were missed in colorectal cancer screening, reported a team of international researchers led by Mayo Clinic. The study is...

Medical Valley EMN & Volitan Global …

The two healthcare innovation experts Medical Valley EMN and Volitan Global strengthen their existing inbound- and outbound activities through a strategic partnership. The aim is to offer companies access to...

DMEA - Connecting Digital Health Opens w…

26 - 28 April 2022, Berlin, Germany. What plans does the new federal government have concerning the digital transformation of the healthcare sector? What are the initial experiences of doctors regarding...

AI can Predict Probability of COVID-19 v…

Testing shortages, long waits for results, and an over-taxed health care system have made headlines throughout the COVID-19 pandemic. These issues can be further exacerbated in small or rural communities...

Using AI to Detect Cancer from Patient D…

A new way of using artificial intelligence to predict cancer from patient data without putting personal information at risk has been developed by a team including University of Leeds medical...

Oulu University Hospital Expands Partner…

Siemens Healthineers and Oulu University Hospital in Finland have entered a strategic partnership for the next ten years, adding to an existing radiotherapy collaboration to jointly expand and modernize the...

Positive Conclusion to DMEA - Connecting…

26 - 28 April 2022, Berlin, Germany. After three days DMEA, Europe's leading digital health event, came to a successful conclusion - with around 11,000 visitors, more than 500 exhibitors and...

AI-Enabled ECGs may Identify Patients at…

Atrial fibrillation, the most common cardiac rhythm abnormality, has been linked to one-third of ischemic strokes, the most common type of stroke. But atrial fibrillation is underdiagnosed, partly because many...