Following the recent OASIS standards for interoperable e-health data authorisation, access and information exchange I thought I'd also mention a document which doesn't seem to have received much attention.
An EU-commissioned Study on the Legal Framework for Interoperable eHealth in Europe SMART 2007/0059 was issued on 15 September 2009. It "mainly provided a better insight in the relevant legal framework of the Member States and emphasized the complexity of the issues".
To quote from the summary, its aim was (emphasis added):
"to identify and analyse the legal and regulatory framework for electronic health services in the EU Member States and for cross-border services when provided via eHealth applications, in particular in the areas of electronic health records, telemedicine and e-prescription. The report contains the analysis and assessment of the information collected in the Member States and draws some conclusions and recommendations. The study shows that it is absolutely necessary to invest in further legal study in this field. More in-depth legal analysis is, for instance, urgently needed with regard to the upcoming national legislation with regard to electronic health records. Better insight in the current legal discussions on this topic in the Member States should feed the discussion on a European scale and prevent additional fragmentation. The same effort is without any doubt also needed in the areas of telemedicine and ePrescription."
As well as summarising healthcase systems in EU member states, the legal and regulatory framework for the healthcare profession, processing of personal health data as personal data and data protection in that context, and patients' rights including human rights, it also (as you'd expect from their summary) looks at the regulatory frameworks for e-health in member states relating to electronic health records or electronic patient records, telemedicine and electronic prescriptions.
See more on EU ehealth studies.
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