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'.
The ESR paper The EU General Data Protection Regulation: what the radiologist should know includes an overview of the parts of the legislation most relevant to radiologists, clarifies key rules and terms, and provides insights into what impact the GDPR will have on clinical practice.
It was published in Insights into Imaging in April 2017.
In April 2017, the European Parliament's vote on the regulation on medical devices, and its subsequent publication in the Official Journal of the European Union, concluded a lengthy legislative process, overhauling the regulatory environment for medical devices in the EU designed to enhance the safety of medical devices while allowing patients to benefit from harmonised rules for timely and innovative healthcare solutions.
The new rules, which will apply from 2020, mandate that 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, with a requirement to monitor and act promptly if emergencies arise. Apart from new classification rules and stricter requirements for re-using single use devices, specific rules for software as a medical device are introduced, accounting for the significant developments in this area in the past 20 years. In addition, a pre-market scrutiny procedure is introduced for certain types of high-risk devices.
Throughout the legislative process, the ESR advocated for a balanced approach centred on patient safety, while safeguarding an efficient regulatory system that ensures timely access to new and innovative technologies.
The medical devices regulation introduces changes including:
The EU has defined the following three goals with regard to eHealth:
These goals are embodied primarily in two policy initiatives:
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:
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.
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:
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.
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.
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:
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.
The ESR has been involved in various European Commission funded tender projects related to imaging, radiation protection and safety.