Data for health research must remain available for the benefit of society as a whole, whilst respecting the rights of the individual.
27 February, Brussels – The European Commission proposal for a regulation concerning data protection, released in January 2013, contains a number of exemptions and provisions crucial to facilitating vital health research within a framework of individual rights and protections.
The public health community welcomed the proposal and its recognition of the value of health research for individual patient care and the health of society as a whole.
In particular, EPHA strongly supports the derogations allowing for research data to be processed without consent in certain cases and to be stored for extended periods of time, in light of the unpredictable nature of research requirements. Furthermore, EPHA welcomes the balance found in Article 83 between facilitating secure processing of patient data for research and the rights of individuals to control and protect their personal data.
Some elements of the proposal require clarification. For instance it is not clear whether Recital 40 and Article 6.4 are to be interpreted as meaning that the processing of data for research is considered a compatible purpose in itself. Similarly, the draft text clearly excludes anonymous data from its scope, but its intentions as regards pseudonymous data, and the processes by which these two types of data are converted, are hard to establish.
Further burdens are created by the right to information and the right to rectification. For example, EPHA feels that each of these provisions could, whilst still preserving and protecting the rights and interests of individuals, contain less onerous requirements for research bodies.
EPHA calls upon MEPs to support the Commission text as regards health research and to maintain Article 83 and its associated derogations. We urge the Parliament to provide clarification on the scope of the proposed regulation as concerns anonymous and pseudonymous data, and to take special consideration of registry- and population-based research where provisions regarding collection of consent, rectification of information and deletion of records have particularly burdensome implications.
Finally, EPHA rejects the position of the Committee on Civil Liberties, Justice and Home Affairs (LIBE), which regards facilitation of research as ‘not as urgent or compelling as public health or data protection’. EPHA stresses that personal data, such as patient data, has both an individual and a collective value – the latter should be recognised and utilised as much as possible in the pursuit of better health outcomes for European societies.
As such, EPHA strongly urges MEPs to preserve the Commission text regarding health research and ensure that rights of individuals are balanced with the rights of the collective to comprehensive and well-founded research.
Photo source: © European Union, 1995-2013
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– Downloadable version: (EPHA Statement) General Data Protection Regulation & implications for Health Research
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