May 2016

This month’s update on EU affairs includes the latest on ESR iGuide, the ESR’s clinical decision support system, the EU General Data Protection Regulation and the European Commission’s proposal for creating a Digital Single Market in Europe.

ESR iGuide – clinical decision support for European imaging referral guidelines

The development of ESR iGuide, the ESR and NDSC’s clinical decision support system, is in its closing stages, as the ESR’s experts are finalising the referral guidelines for use in Europe in cooperation with colleagues from the American College of Radiology. The first pass at the review of the ACR criteria revealed that for some areas, such as cardiac, neurologic and vascular imaging, significant adaptations need to be made for use in Europe.

General Data Protection Regulation

In 2012, the European Commission published its proposal for a regulation on the protection of individuals with regard to the processing of personal data and on the free movement of such data. The proposed ‘general data protection regulation’ aims to revise the existing legislative framework and thus enhance enforcement and address the fragmentation of national data protection legislation, legal uncertainty due to the increased scale of data sharing, as well as development of new technologies.

Besides new elements such as new definitions (e.g. genetic data or data concerning health), data minimisation (data should be limited to the minimum necessary), the right to be forgotten (data subjects can obtain the destruction of his personal data) and the one-stop-shop mechanism (one set of rules for all EU Member States and the establishment of national contact points in each Member State), the proposed legislation seeks clarification regarding the international transfer of such data and proposes sanctions for the misuse of personal data and the abuse of data subjects’ rights.

In spring 2014, the European Parliament adopted its report on the data protection proposal, including amendments on stricter rules regarding the use and transfer of personal data (i.e. requirements for explicit consent by the data subjects) that raised severe concerns within the medical scientific community with regard to the future use of health data for research purposes.

Since the publication of the proposal in 2012, the ESR has been active on this dossier and has proposed several amendments and statements on the subject. In November 2014, the ESR decided to align its efforts and joined the healthcare coalition for data protection, a coalition of medical associations led by COCIR as an observer. The healthcare coalition on data protection is currently finalising a position paper for dissemination to policy makers at EU level in order to raise the awareness on the implications the current legislative proposal would have on health research.

The proposal on the general data protection regulation is currently being discussed by the Member States, despite the European Commission’s and European Parliament’s efforts to reach agreement by mid-2014 the Council (representing the Member States) postponed the timetable to 2015. Given the ongoing controversies between the Members States, it is unlikely that an agreement will be reached in the course of this year.

A Digital Single Market for Europe

On May 6, the European Commission adopted 16 initiatives to create a Digital Single Market for Europe, based on the following three pillars:

  1. better access for consumers and businesses to digital goods and services across Europe
  2. creating the right conditions and a level playing field for digital networks and innovative services to flourish
  3. maximising the growth potential of the digital economy

The 16 key actions include, inter alia, the proposal to create a set of rules to facilitate cross-border e-commerce, a modern European copyright law as well as to further strengthen cybersecurity etc.

The so-called ‘European free flow of data initiative’ with the aim to promote the free movement of data in order to encourage innovation, including the proposal to launch a ‘research cloud’, could be of particular interest to the medical community.

Moreover, the Commission emphasises the need to define missing technological standards that are essential for supporting the digitalisation of the EU’s industrial, services sectors (e.g. big data etc.), and thus proposed to define priorities for standards and interoperability in areas critical to the Digital Single Market, including e-Health.

The European Commission plans to deliver the 16 key actions by the end of 2016.