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The European Institute for Innovation through Health Data ( i ~HD) has developed a Quality Seal for Research Platforms (QS4RP) in order to provide assurance to the market, especially to healthcare organisations, research centres and research sponsors, that ICT products and services used to conduct research analyses using electronic health record (EHR) information do so in secure ways that protect data privacy.
Products are now emerging that offer significant opportunities to accelerate the conduct of clinical research by enabling remote or on-site querying of EHRs – normally a de-identified extract of the operational EHR – in order to optimise clinical research protocols before they are finalised, and to assist healthcare organisations to efficiently identify suitable trial recruitment candidates. In parallel, the European General Data Protection Regulation places stricter obligations on organisations that hold personal data, such as healthcare organisations, to protect the privacy of their data subjects and to use personal (i.e. identifiable) information under strict controls. These new-generation research platforms use architectures that limit researcher access only to de-identified (and usually only aggregated) information and do not enable researchers to access personal health information at patient level. The purpose of the QS4RP Seal is to verify that such ICT products do indeed restrict access in this way and that the information governance policies and information security measures adopted by the product vendor provide sufficient assurance of privacy protection.
i ~HD has chosen to commission the EuroRec Institute to develop the content of this Seal and to conduct the formal assessments of products and services. EuroRec is Europe´s leading body for quality labelling electronic health record systems, and brings nearly a decade of experience in developing quality seals and conformance-testing of EHR systems. The seal criteria draw on the software requirements specifications and standard operating rules developed during the EHR4CR project, and also on the EMIF project´s code of practice, instruments developed by the ETRIKs project, the IMI Secondary Use code and ISO/IEC 27000 series of standards on information security management systems.
On the basis of a test report issued by EuroRec, i ~HD will issue a Quality Seal of Conformity to successful service providers.
i ~HD intends that the possession of this Quality Seal will give added confidence to healthcare organisations and to research sponsors about joining such research platforms and networks.
Click here to find more info about the Quality Seal for Research Platforms (QS4RP).