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Status of the Data Protection Regulation and impact on research


For the course of 2014, health stakeholders in Brussels feared the impact of the proposed General Data Protection Regulation (GDPR) on health research. MEPs seeking to limit the influence of insurance companies and other major players in data imposed strict conditions on the transfer of health data and its very use. This would also apply to medical researchers all over Europe.


The European Council by contrast was much more concerned with how its public services would be able to use data. Seeking to protect Member State agencies, the Council’s position shifted ever more towards the liberal use of data.

These two positions now stand completely opposed and agreement under these terms seems unlikely. With the Council having diminished requirements on the need for even consent for the use of health data and the Parliament’s Green Rapporteur Jan-Philipp Albrecht taking a strong stance in protecting privacy it is hard to see what kind of outcome would entirely satisfy each institution who must negotiate and agree on the content.

While the Council position may be seen as somewhat “too liberal” for the ethics boards of many medical organisations, it most certainly is a step up from that of the Parliament’s and allows greater freedom for using health data for research. Those engaged in research would undoubtedly side with the Council if given a choice.

There is a real danger however that no progress will be made and the entire document will have to go through a 2nd reading which would significantly delay any adoption.

 

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