On 9 March, the Council of the EU issued a partial general approach on a key chapter of the EU Data Protection Regulation which has implications for the regulation of health data. The Council’s stance has been welcomed by a number of healthcare commentators as it promotes a more flexible approach to the use of health data and accords with the tenor of the revised version of the draft Regulation that emerged from the Council in December last year.
Technology has transformed and disrupted long standing industries as well as created new industries along the way. The digital revolution in the healthcare industry appears to have been long promised but much delayed. There may be a number of understandable reasons why the wheels have not turned so quickly. For instance, unlike say the financial services industry which is private sector led, the healthcare industry has obvious public sector touch points which can make any sort of change slower. But just as information about an individual’s bank balance or salary is considered confidential, so a person’s health information is particularly sensitive, both in a legal sense (because health information is categorised as sensitive under EU data protection law) but also in an obviously everyday sense – people feel that their health information (in most but not all circumstances) is private.
All eyes are currently on the Council of the EU to figure out when and in what form we are likely to see a new EU data protection law emerging. The adoption of this law, which has been in the making since the European Commission presented its vision for a modern privacy regime in 2010, will have vital and global implications for the future of our data-driven existence. This explains the cautious progress so far, but the need for a modernised regime is pressing. Six presidencies have so far managed the adoption process within the Council—which together with the European Parliament has legislative responsibility for passing EU laws—and each has made its own contribution to the process. But the Council has been the key focus of attention of the ongoing legislative process since the European Parliament approved its own draft of the EU Data Protection Regulation in early 2014.
Assuming a fair amount of hard work and that the EU institutions are able to put their political skills to good use, 2015 may be the year that sees the culmination of a legal modernisation process that has been running for the best part of four years. It was in 2010 when the European Commission formally acknowledged that the 1995 Data Protection Directive was ready for a makeover to address the privacy and data protection needs of the 21 century. Since then, stakeholders covering a whole spectrum of views have participated in a process that is approaching a decisive stage. In early 2014, the European Parliament came forward with a bold proposal to amend the Commission’s original draft and put the ball firmly in the Council of the EU’s court. As the Council finalises its own proposal, a picture of what the new framework will look like is starting to emerge.
On 12 March 2014, the European Parliament voted overwhelmingly in favour of the European Commission’s data protection reform with 621 votes for, 10 against, and 22 abstentions for the proposed General Data Protection Regulation. The vote is significant because it confirms the approval of the European Parliament, one of the required participants in the s0-calle “trilogue” process along with the Commission and the Council, which will not change even if the composition of the Parliament changes following the European elections in May.
The EU’s Work on Data Protection Reform continues following the vote of the EU Parliament’s Committee on Civil Liberties, Justice and Home Affairs (LIBE) on 21 October 2013 to adopt compromise amendments. The 104 compromise amendments represent a consolidation of proposals submitted by various European Parliament committees. Hogan Lovells has prepared a detailed analysis of the compromise amendments approved by the LIBE committee, which is attached to this post.