Data Protection

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

EUR-Lex: GDPR

EC - data protection

Medical Devices

In May 2016,  the EU Council and the European Parliament agreed on a new regulation for medical devices, designed to enhance the safety of medical devices while allowing patients to benefit from harmonised rules for timely and innovative healthcare solutions.

Devices will become fully traceable and patients receiving implantable devices must be informed of the product’s key facts. Non-confidential information will be made available publicly through a central database, the European Databank on Medical Devices (Eudamed).

The new regulation will also introduce stricter rules for notified bodies that assess medical devices, ensuring they have qualified personnel available to conduct factory inspections. Manufacturers will be held responsible for continuous follow-up on the quality and safety of devices placed on the market, mandating manufacturers to monitor and act promptly if emergencies arise.

The agreement still needs to be formally adopted to conclude the legislative process which is expected in late 2016.

The medical devices regulation introduces changes including:

  • expansion of the definition of a medical device
  • pre-market scrutiny process, rules for clinical evaluation and risk assessment
  • unique device identification and device tracking
  • expansion of Eurpean Databank on Medical Devices (Eudamed)
  • standard rules for notified bodies and introduction of special notified bodies for high-risk devices
  • enhanced post-market oversight powers for notified bodies incl. unannounced audits
  • stricter rules for reprocessing of single-use devices

eHealth

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.

ESR statements on eHealth, telemedicine and teleradiology

Personalised Medicine

In 2013, the European Commission Health & Food Safety Directorate-General (DG SANTE) published a staff working document (SWD) on the use of ‘–omics’ technologies in the development of personalised medicine.

The report focuses on:

  1. the potential and issues with the use of –omics technologies in the research and development of personalised medicine and current EU research funding in the area;
  2. recent developments in EU legislation for placing medicinal products and medical devices on the market;
  3. factors affecting the uptake of personalised medicine in healthcare systems.

The European Commission is currently exploring ways of improving collaboration in funding of personalised medicine research in Europe. Hence, in parallel to several ongoing international research initiatives, the Commission has started discussions with funding organisations in the EU Member States about setting up a joint collaboration in this field. Two recent EU-funded projects with particular policy relevance to personalised medicine are Eurobioforum and PerMed.

Professional Qualifications

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 is laying down basic safety standards against the dangers arising from exposure to ionising radiation. It was passed on 5 December 2013 and is consolidating European radiation protection laws into a single piece of legislation. The new 'Basic Safety Standards Directive' (BSS Directive) replaces Directive 89/618/Euratom (Public Information), Directive 90/641/Euratom (Outside Workers), Directive 96/29/Euratom (Basic Safety Standards), Directive 97/43/Euratom (Medical Exposures) and Directive 2003/122/Euratom (High Activity Sources).

EU Member States must transpose the BSS Directive into national law by 6 February 2018.

The new BSS Directive introduces and changes a number of requirements that affect healthcare professionals in radiology, for example regarding justification of exposure, patient information, responsibilities for radiation safety, dose reporting, and diagnostic reference levels.

By representing the radiology profession vis-à-vis HERCA (Heads of the European Radiological protection Competent Authorities), the European Commission and other stakeholders, the ESR is involved in the implementation of the BSS Directive to make sure radiologists' views are taken into account. E.g. ESR participates in a series of multi-stakeholder meetings organised by HERCA, which focus on different aspects of the new directive, such as generic justification or accidental and unintended exposures.

The principle that imaging referral guidelines must be available in all Member States is reaffirmed in the directive, as is the requirement for clinical audits in all imaging departments. In this context, the ESR has launched two major initiatives to support healthcare professionals in fulfilling these requirements and achieve best practice: ESR Basic Patient Safety Standards and Audit Tool and ESR iGuide.

Electromagnetic Fields

A revised Electromagnetic Fields Directive (2013/35/EU) was adopted in 2013, setting safety standards concerning the exposure of workers to electromagnetic fields. The directive applies since July 2016.

It includes a conditional derogation for MRI scanners from the requirement to comply with the exposure limit values. This is a direct result of the efforts of the ESR-led Alliance for MRI, a multi-stakeholder alliance that convinced lawmakers to safeguard the future use of MRI. The proposed limit values would have prohibited MRI-guided surgery, forbidden nurses from remaining with patients during a scanning procedure, and impeded a number of other MR applications, denying Europe's patients access to this life-saving technology.

The ESR also participated in drafting the Non-binding guide to good practice for implementing Directive 2013/35/EU Electromagnetic Fields, which was published in November 2015.

The ESR is pleased that, after several years of multi-stakeholder engagement, the Alliance for MRI can end its activities.

Clinical Trials

The EU Clinical Trials Regulation (Regulation No. 536/2014) was adopted in April 2014, replacing the 2001 clinical trials directive (2001/20/EC). The regulation applies since May 2016, without the need for legislation by member states.

Following its implementation in 2004, the clinical trials directive had been criticised for its inconsistent application by member states and increased red tape. After a 25 percent drop in the number of clinical trials between 2007 and 2010, the European Commission decided it was necessary to revise the legislation for clinical trials and address the directive's shortcomings.

The regulation aims at streamlining and simplifying rules in order to revive research activity in Europe, for example by introducing a unified application process through a single EU portal for cross-border trials.

Overview of the most important changes:

  • streamlined application procedure via a single entry point for all clinical trials conducted in Europe
  • single authorisation procedure for all clinical trials with assessment of applications by all Member States concerned with one assessment outcome and authorisation per Member State
  • extension of the tacit agreement principle to the whole authorisation process for more legal certainty
  • strengthened transparency for clinical trials data and new rules for informed consent for use of subjects' data

Cancer Initiatives

Given the essential role of imaging in cancer control, the ESR is closely monitoring EU inititiaves tackling cancer to ensure that the radiology profession's input is adequately reflected in these EU initiatives.

The ESR is currently involved in various initiatives and is a member of the European Commission expert group on Cancer Control.

European Commission’s Initiative on Breast Cancer (ECIBC)

Since 2015, the ESR has been involved as a stakeholder in the European Commission’s Initiative on Breast Cancer (ECIBC) which is currently developing European guidelines for breast cancer screening with a focus on long term sustainability, building upon a platform bringing together a wide range of actors at EU level in a transparent way.

The main aim of the initiative is to ensure and harmonise quality of breast cancer services across European countries. ECIBC will develop a European quality assurance scheme for breast cancer services supported by accreditation and referring to high-quality, evidence-based guidelines, and thus already published a number of calls providing the opportunity for stakeholders to provide their feedback.

European Partnership for Action Against Cancer (EPAAC)

The ESR was a collaborating partner of the European Partnership for Action Against Cancer (EPAAC), which aimed to have integrated cancer plans for all Member States. It was launched in December 2009 and concluded at the end of November 2013. The core deliverables of the initiative included the development of National Cancer Control Plans (NCCP) and the publication of key findings.

Cancer Control Joint Action (CanCon JA)

Following EPAAC, the EC launched in March 2014 the follow-up Joint Action on the Development of the European Guide on Quality Improvement in Comprehensive Cancer Control (CanCon), in which the ESR acts as collaborating partner contributing in particular to the policy papers drafting group.
The main objectives of CanCon are to identify the elements and quality standards for optimal and comprehensive cancer control in Europe and to foster Member States’ cooperation to ensure comprehensive cancer control through a common platform as well as the guidance development.

Tender Projects

The ESR has been involved in various European Commission funded tender projects related to imaging, radiation protection and safety.

BSS Transposition in the Medical Sector

Since the transposition and implementation of the new Basic Safety Standards Directive (Council Directive 2013/59/Euratom) will constitute a major challenge for the respective national legislators and regulators in European Union Member States, Candidate States, and EFTA States, the EC approved this 15-month tender project which started in May 2016.

The objective of this project is to evaluate Member States’ activities for the transposition and implementation of Council Directive 2013/59/Euratom in the medical area.

It is carried out by a consortium headed by the European Federation of Organisations for Medical Physics (EFOMP). Other participating organisations are the European Society of Radiology (ESR) and the European Federation of Radiographer Societies (EFRS).

PiDRL – European DRLs for Paediatric Imaging

The 27-month EC tender project PiDRL on the establishment of European DRLs for paediatric patients started in December 2013 and finished in February 2016. The consortium was headed by the European Society of Radiology (ESR).

The specific objectives of the PiDRL project were to agree on a methodology for establishing and using DRLs for paediatric imaging, as well as to update and extend the European DRLs to cover more procedures and a wider patient age/weight range based on current knowledge.

The "European Guidelines on DRLs for Paediatric Imaging" were finalised by the consortium in January 2016 and approved by the European Commission soon thereafter. The guidelines will be published in the EC Radiation Protection series.

More details

Referral Guidelines for Imaging

The objective of this EC-funded tender project was to review the situation in the EU Member States regarding the fulfilment of their obligations under the Medical Exposure Directive Article 6.2 (97/43/EURATOM), which requires Member States “to ensure that recommendations concerning referral criteria for medical exposures, including radiation doses, are available to the prescriber of medical exposures”.

The project started in December 2011 and finished in February 2013. The project consortium was headed by the European Society of Radiology (ESR).

The project concluded with the publication of the European Commission Publication Radiation Protection No. 178 - Referral Guidelines for Medical Imaging, Availability and Use in the European Union.

More details

EMAN - European Medical ALARA Network

In order to strengthen radiological protection in the field of medicine a variety of stakeholders have to be addressed and involved, pinpointing the specific roles of the different experts, as well as training, organisational and ethical aspects. To support the task regarding optimisation of procedures, the European Commission funded the EMAN tender project that formally ended in October 2012.

The main objective of EMAN was to establish a sustainable network where different stakeholders within the medical sector had the opportunity to discuss and to exchange information relating to the implementation of the ALARA principle in the medical field.

The project consortium was composed of seven European organisations, including the European Society of Radiology (ESR).

More details

MEDRAPET - Medical Radiation Protection Education and Training

The EC-funded tender project MEDRAPET was conducted between December 2010 and March 2013.

The overall aim of this project was to improve implementation of the Medical Exposure Directive provisions (Council Directive 97/43/Euratom) related to radiation protection education and training of medical professionals in the EU Member States.

The project consortium was headed by the European Society of Radiology (ESR).

The main outcome of MEDRAPET was the European Guidance on Radiation Protection Training of Medical Professionals

More details

ESR Supporting Members

Gold