The European Union (EU) Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe.
- Public Health Ethics
- Quality of Health Care
- Scientific Research
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Read the full text or download the PDF:
Other content recommended for you
- Proposed EU data protection regulation is a threat to medical research
- General data protection regulation: What does this mean for research?
- Assessing data protection and governance in health information systems: a novel methodology of Privacy and Ethics Impact and Performance Assessment (PEIPA)
- The devil is in the details: an analysis of patient rights in Swiss cancer registries
- Privacy impact assessment in the design of transnational public health information systems: the BIRO project
- National survey of British public's views on use of identifiable medical data by the National Cancer Registry
- What is policy and where do we look for it when we want to research it?
- Do we need consent to obtain consent? Public and participant feedback to using personal health data for recruitment
- The social licence for research: why care.data ran into trouble
- Impact of privacy legislation on the number and characteristics of people who are recruited for research: a randomised controlled trial