Find out about our policy topics on the following page.
European AI Act
On April 12, 2021, a significant milestone was reached when the European Commission unveiled the EU AI Act proposal, a pioneering draft legislation aimed at fostering trustworthy AI within the European Union. Following several years of negotiations and extensive discussions, the European Parliament took a major step forward on June 14, 2023, by adopting its negotiating position on the AI Act. If an agreement is reached during the trilogues procedure in later 2023, the AI Act could be formally enacted by 2024.
The AI Act is the first comprehensive set of rules that tackles AI regulation, placing a strong emphasis on safety, transparency, and ethical development. The new regulation, based on MEPs’ proposed amendments, seeks to substantially change AI system oversight. Its primary focus is to ensure safe, transparent, traceable, and non-discriminatory AI technologies, with a uniform definition adaptable to future advancements, aiming to respond to concerns from the medical community regarding the risks associated with AI in healthcare, including potential patient harm due to AI errors, the possibility of misuse of medical AI tools, a lack of transparency in AI, and privacy and security issues.
The AI Act potential implications on the medical technology industry have prompted the ESR to take a proactive stance in advocating for the responsible and optimal application of AI. The European Society of Radiology soon recognised its significance and participated in public consultations, soon followed by collaborative initiatives across Europe, where efforts have focused on fostering innovation in the AI healthcare space while urging consideration in four main areas during the Act’s negotiations:
- Foster trust and confidence in AI-based medical technologies, ensuring they are ethically developed and deployed.
- Promote transparency, enabling individuals to understand and trust the AI systems they interact with in healthcare settings.
- Prioritize patient safety and data privacy, establishing robust measures to safeguard sensitive health information.
- Encourage innovation in the medical technology industry while maintaining high standards of safety and efficacy.
The ESR eHealth & Informatics Subcommittee continues to closely monitor the AI Act legislation process, aiming to ensure that the legislation effectively addresses the evolving challenges and opportunities in the realm of AI in healthcare, committed to advocating for the ethical and secure use of AI technologies, with a focus on enhancing safety, improving healthcare definitions, and streamlining legislations.
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European Heath Data Space
On 3 May 2022, the European Commission unveiled the proposal for the European Health Data Space (EHDS), offering an unprecedented opportunity for EU countries to leverage health data to enhance healthcare outcomes and address health disparities. The legislative process is expected to conclude by the end of 2023, with plans to implement the EU Health Data Space by 2025. This initiative is an integral part of the broader European Health Union and aligns with the European data strategy adopted in February 2020, which emphasised the creation of European data spaces, including in the healthcare sector.
The EHDS aims to establish a comprehensive ecosystem empowering individuals with increased digital access and control over their personal health data at both national and EU levels. It seeks to facilitate seamless data movement and research on treatments, medicines, medical devices, and medical outcomes, while also promoting the accessibility and utilisation of health data for research, policy-making, and regulatory purposes. Furthermore, the initiative aims to offer support for the development and implementation of digital health services, enhancing healthcare accessibility and efficiency while aiming to address concerns surrounding the safety and liability aspects of utilising artificial intelligence in the field of healthcare.
As an active member of the BioMed Alliance and the European Cancer Organisation, and a dedicated participant in the EU Commission eHealth Stakeholder Group, the European Society of Radiology recognises the transformative power of the European Health Data Space in advancing modern European medical technology and is firmly committed to advocating for healthcare professionals and researchers to have appropriate access to data, as this will undoubtedly bolster healthcare outcomes and drive innovation.
The ESR remains dedicated to advocating for the advancement of medical knowledge and technology while safeguarding the rights and well-being of all individuals involve.
For more information view the European Commission’s proposal here →
- Europe’s Beating Cancer Plan
- EU Cancer Screening Recommendation
- European Cancer Imaging Initiative
- SAMIRA Action Plan
Europe’s Beating Cancer Plan
In 2021, the European Commission presented Europe’s Beating Cancer Plan, designed to revolutionise cancer prevention, treatment, and care throughout the continent. This comprehensive plan acknowledges the evolving challenges posed by cancer and identifies remarkable opportunities to surmount them. By fostering stronger cooperation, it intends to bridge existing disparities, aiming to redefine the way cancer is addressed on a European scale, ultimately leading to improved health outcomes for patients across Europe. By aligning efforts and resources, it paves the way for a healthier and more resilient future for all citizens of Europe.
The Plan tackles the entire disease pathway. It is structured around four key action areas where the European Union can add the most value: (1) prevention; (2) early detection; (3) diagnosis and treatment; and (4) quality of life of cancer patients and survivors.
The European Society of Radiology (ESR) endorses the Commission’s plan to combat cancer. In particular, the ESR welcomed the plan’s commitment to improving access and quality of existing screening programs for breast, cervical, and colorectal cancers through the proposed Cancer Screening Scheme and warmly welcomed the European Cancer Imaging Initiative, which aims to create an EU ‘atlas’ of cancer-related images, providing anonymised images accessible to various stakeholders.
Prof. Regina Beets-Tan, the current ESR Past President, participated as member of the EU Cancer Mission Board, assisting the Commission in the preparation of legislative proposals and policy initiatives by providing advice in several areas, which included, among others, the identification and design of one or more missions in the respective mission area; content of work programmes and their revision as needed for achieving the mission objectives, and characteristics of project portfolios for missions.
The ESR continues to carefully monitor Europe’s Beating Cancer plan developments and to support its implementation, e.g. by involvement in the keystone project of the European Commission initiated European Cancer Imaging Initiative.
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European Cancer Imaging Initiative
The European Cancer Initiative is a flagship of Europe’s Beating Cancer Plan and aims to leverage the potential of data and digital technologies such as Artificial Intelligence (AI), or High-Performance Computing (HPC), to combat cancer, by advancing research and fostering innovation in cancer treatment and care.
A key aspect of the Initiative is showcasing how medical images can be accessed, used, and shared while upholding high ethical standards, trust, security, and personal data protection in line with EU values and regulations. By enabling more precise and rapid clinical decision-making, diagnostics, treatments, and predictive medicine for cancer patients, the Initiative aims to connect resources and databases within an open, user-friendly infrastructure of cancer images accessible to all stakeholders. This effort will define accessible and integrated cancer imaging datasets, fostering collaboration and progress in the fight against cancer.
The European Institute for Biomedical Imaging Research (EIBIR), ESR’s research management organisation supporting biomedical imaging research, is coordinating the European Federation for Cancer Images (EUCAIM) project, which serves as the cornerstone of the European Cancer Imaging Initiative. This groundbreaking project aims to harness the potential of imaging and AI for precision medicine, benefiting cancer patients and citizens across Europe and driving advancements in cancer care and research.
The project is a comprehensive endeavour that unites clinical data providers, researchers, and innovators, to establish a pan-European digital infrastructure of FAIR cancer-related, de-identified images. This infrastructure not only preserves data sovereignty for providers but also serves as a dynamic platform, featuring an Atlas of Cancer Images, to facilitate the development and benchmarking of AI tools for precision medicine.
Ultimately, by leveraging existing cancer image repositories and fostering connections between resources and databases across the EU, the project addresses fragmentation while upholding high ethical standards, trust, security, and data protection. It aims to bridge EU-level and national initiatives, hospital networks, and research repositories, integrating imaging data and other relevant health information for enhanced collaboration and progress in cancer research and treatment.
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EU Cancer Screening Recommendation
The EU Commission’s proposal to enhance cancer prevention through early detection has been adopted by the Council of the European Union in December 2022. This new approach updates previous provisions and recommends a broader range of screening tests and protocols. It also suggests extending screening programs to additional target groups and cancer types, taking into account new evidence and technological advancements.
Part of the new EU Cancer Screening Scheme, a flagship initiative under Europe’s Beating Cancer Plan, this initiative helps Member States ensure that 90% of eligible individuals in the EU will be offered breast, cervical, and colorectal cancer screenings by 2025. Furthermore, the approach outlines a stepwise plan to extend screening programs to include prostate, lung, and, under certain conditions, gastric cancer.
The ESR warmly welcomed the new proposals and the broadening of screening programs to encompass lung, prostate, and gastric cancer and anticipates collaborating with other European health stakeholders to ensure successful implementation and to facilitate the understanding, acceleration, and harmonisation of the updated cancer screening protocols across all Member States.
In detail, the new EU approach recommends lowering the age limit to 45 and extending the upper age limit to 74 for mammography screening, while HPV testing is suggested for cervical cancer screening in women aged 30 to 65, and quantitative FIT is proposed for colorectal cancer screening in individuals aged 50 to 74. The recommendation further encourages exploring low-dose computed tomography for high-risk individuals on lung cancer and evaluating organised PSA testing with MRI follow-up for prostate cancer in men. It also advises implementing screen-and-test strategies for Helicobacter pylori in regions with high gastric cancer incidence and mortality.
Information can be also find here:
SAMIRA Action Plan
Introduced in February 2021, the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA) stands as a pivotal component within the framework of Europe’s Beating Cancer Plan.
The Action Plan encompasses three principal fields: securing the supply of medical radioisotopes, improving radiation quality and safety in medicine, and facilitating innovation and the technological development of medical ionising radiation applications.
Nuclear and radiation sciences and technologies are indispensable in the battle against cancer, exerting substantial influence across every facet of care for cancer patients, ranging from early detection and diagnosis to treatment and palliative care. The SAMIRA Action Plan aims to ensure access to these technologies at the highest safety standards.
The ESR EuroSafe Imaging campaign and the European Institute for Biomedical Imaging Research (EIBIR), contribute to the actions laid down by the SAMIRA Action plan, driving multiple projects in collaboration with various organisations, professional societies, and stakeholders, all aimed at increasing quality and safety of imaging in clinical practice and promoting collaboration across the field.
As part of this overarching effort, the EU-REST study is dedicated to conducting a comprehensive analysis of workforce availability, education, and training needs within the EU. This strategic endeavour is aimed at ensuring the quality and safety of medical applications involving ionising radiation. Likewise, the EU-JUST-CT initiative is focused on elevating the justification standards for computed tomography across Europe by means of coordinated actions.
In parallel, the SIMPLERAD project led by EIBIR, takes on the vital task of securing EU citizens’ access to top-tier and safe nuclear technologies in the realm of medicine. This initiative goes beyond identification, highlighting potential barriers to implementation, and offering practical guidance to overcome these challenges.
The recently started MARLIN study aims to improve reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology.
Collectively, these initiatives signify a dedicated commitment to advancing the safety, quality, and accessibility of medical imaging technologies in Europe.
Future of Health in the EU
The European Union institutions are currently engaged in negotiations about the new Multiannual Financial Framework (MFF), which governs all EU spending in the period from 2021-2027.
In the context of the proposal for this new EU budget, the European Commission committed itself to continue investing in health policies at EU level. The European Commission published a proposal integrating the EU Health Programme into a restructured “European Social Fund+” with the aim of increasing alignment between policy areas. In addition, new initiatives were launched to enhance digitalisation of healthcare services across member states. The ESR looks forward to collaborating with the EU institutions and health organisations to further develop and implement new initiatives in the field of health.
Read full statement here →
For more information visit the European Commission of Health Funding here →
In April 2017, the European Parliament concluded a lengthy legislative process, overhauling the regulatory environment for medical devices in the EU. The new rules, effective from 2020, aim to enhance the safety of medical devices while providing harmonized rules for timely and innovative healthcare solutions.
Key changes include making devices fully traceable, informing patients about implantable devices, and creating a central database called the European Databank on Medical Devices (Eudamed) for publicly available non-confidential information.
The regulation also imposes stricter requirements for notified bodies assessing medical devices, ensuring qualified personnel for factory inspections. Manufacturers are now responsible for continuous monitoring of device quality and safety, with prompt actions in emergencies. New classification rules and re-use restrictions for single-use devices are introduced, along with specific rules for software as a medical device.
Certain high-risk devices now undergo a pre-market scrutiny procedure. Throughout the process, the focus was on patient safety and efficient access to innovative technologies.
Industry groups like MedTech Europe and COCIR, as well as stakeholders such as the European Society of Cardiology and the European Patients’ Forum, welcomed these regulations.
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The EU has defined the following three goals with regard to eHealth:
- to improve citizens’ health by making life-saving information available – between countries when necessary – using eHealth tools
- to increase healthcare quality and access by making eHealth part of health policy and coordinating EU countries’ political, financial and technical strategies
- to make eHealth tools more effective, user-friendly and widely accepted by involving professionals and patients in strategy, design and implementation.
These goals are embodied primarily in two policy initiatives:
- eHealth Action Plan 2012-2020: Innovative healthcare for the 21st century: a roadmap to empower patients and healthcare workers, to link up devices and technologies, and to invest in research towards the personalised medicine of the future.
- Digital Single Market Strategy: making the EU’s single market freedoms ‘go digital’, including telemedicine and ehealth, which is a step forward in promoting interoperability and standards of these digital technologies in the EU for the benefit of patients, health professionals, health systems and industry.
The General Data Protection Regulation (GDPR), a major overhaul of data protection legislation in the EU, was formally adopted on April 27, 2016, with the new rules becoming applicable from May 25, 2018. Replacing the 1995 data protection directive, the new regulation unifies data protection throughout the EU as it does not require any enabling legislation to be passed by member states.
The GDPR significantly expands the scope of EU privacy legislation, applying also to organisations from outside the EU who process EU residents’ data. Consent requirements for collecting and processing data are strengthened, complemented by a right to erasure. Non-compliance with the regulations can result in heavy fines of up to 4 percent of the annual turnover of the organisation found to be in breach.
Primarily a privacy law, the European Commission also views the GDPR as central to the digital single market and hopes it will boost digital innovation.
Research was afforded certain exemptions within the regulation, which has adopted a relatively broad definition of ‘research’.
- Article 6(1)(f): in certain circumstances, personal data may be used for research purposes without the person’s consent
- Article 6(4): some restrictions on processing sensitive data categories do not apply to e.g. scientific or health research
- Article 89: given appropriate safeguards researchers may even override a person’s objection to processing of his data or requests for erasure
For more information download ESR’s statement on EC’s proposal on Data Protection Regulation here.
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With the aim to facilitate and enhance the mobility of professionals across the EU and to help alleviate staff shortages in some Member States, the European Parliament and the Council of the European Union adopted Directive 2013/55/EU, amending Directive 2005/36/EC. It was implemented in January 2016.
The ESR has been very active on this dossier from the beginning of the publication of the European Commission’s initial draft proposal and has held several bilateral meetings with MEPs, representatives of the European Commission and Member State representatives reiterating the key issues to the EU institutions throughout the process.
The most important elements include:
- European Professional Card: an electronic certificate containing the Professionals data and documents.
- Automatic recognition – process for 7 professions incl. doctors, nurses, midwives and pharmacists.
- A harmonisation of the minimum training requirements, i.e. regarding the duration, tests etc. for the 7 professions of the automatic recognition.
- Creation of a specific alert mechanism in all Member States for all, but especially for health professionals who are no longer allowed to exercise their profession in a Member State.
- Extension of the scope of the directive to partially qualified professionals (i.e. professionals who hold a diploma but have yet to complete a traineeship).
Radiation Protection–Basic Safety Standards
Council Directive 2013/59/Euratom, passed on 5 December 2013, lays down safety standards against the dangers of ionising radiation exposure. It consolidates European radiation protection laws into a single piece of legislation, replacing several previous directives. EU Member States were required to implement it into national law by 6 February 2018.
The new directive introduced changes that impact healthcare professionals in radiology, including justification of exposure, patient information, radiation safety responsibilities, dose reporting, and diagnostic reference levels. The ESR represented the radiology profession in the implementation process, ensuring radiologists’ views were considered in multi-stakeholder meetings.
The directive reaffirms the availability of imaging referral guidelines and the need for clinical audits in imaging departments. To support healthcare professionals, the ESR launched two initiatives: ESR Basic Patient Safety Standards and Audit Tool, and the ESR iGuide
The EC and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published its final Opinion on the need of a technical revision of the annexe sin Council Recommendation 1999/519/EC and Directive 2013/35/EU with regard to radiofrequency (100 kHz to 300 GHz).
The ESR will keep monitoring the developments around the technical revision in order to ensure that the use of MRI will not be unintendedly impeded or restricted by any proposed updates.