The new EU General Data Protection Regulation was adopted on 27 April 2016 and published on the EU Official Journal on 4 May 2016. It fully applies since 25 May 2018. The new Regulation contains provisions with an important impact on health services and research. It strengthens the principles of data protection by putting more focus on accountability and security.
Since the publication of the draft proposal by the European Commission in January 2012, HOPE has been very active in monitoring the legislative process.
In May 2016, HOPE had published in collaboration with the NHS European Office a briefing intended for staff working on privacy or information governance in hospitals and other health and care organisations. The study highlighted the main changes that can be expected for the health and care sector when meeting the data privacy requirements laid out in the Regulation. It also provided recommendations for national and EU implementers on how to prepare for a smooth transition to the new law in the health and care sector.
In September 2015, HOPE joined the European Data in Health Research Alliance, which brings together stakeholders from academia, patient and research organisations from across Europe committed to ensure that the review of the Data Protection Regulation does not limit the use of personal data for health research purposes. HOPE signed a joint statement published in October 2015. The joint statement highlights key issues to be taken into account by policymakers during the trilogues negotiations.
In January 2013, HOPE published a position paper on the Commission’s proposal. In this document, HOPE welcomed the Commission’s effort to further harmonise data protection requirements in the European Union and the provisions to support healthcare and health research. However, HOPE brought attention to some areas in need of being enhanced to facilitate improvements in care delivery, continuous medical innovation and support of medical research for the benefits of society. HOPE stood against a considerable number of draft provisions restricting the availability of health data, delaying innovation, creating legal uncertainty and increasing compliance costs.
Additionally, ahead of the vote on 21 October 2013 in the Parliamentary Committee on Civil Liberties, Justice and Home Affairs (LIBE) HOPE sent a briefing to MEPs putting forward some recommendations for vote on crucial provisions for the health sector.
HOPE joined the Healthcare Coalition on Data Protection at the end of 2012. A Coalition composed of key stakeholders of the healthcare sector in Europe gathering representatives of medical research, healthcare providers, the pharmaceutical industry and the medical technology industry. The objective of the Coalition was to raise awareness about the importance of access and sharing of data, in a secure environment, for the delivery of timely, effective and good quality healthcare to patients and guarantee their safety.
Position papers adopted by the Coalition:
- 4 keys recommendations to facilitate healthcare and health research for the benefit of patients (5 June 2015)
- Recommendations and joint statement supporting citizens’ interests in the benefits of data driven healthcare in a secure environment (10 March 2014)
- Benefits of data processing in healthcare and medical sciences while protecting patient’s personal data (29 January 2013)