An Extensible security infrastructure for the secondary use of electronic health records in clinical research

Eryılmaz, Elif
In order to facilitate clinical research studies re-using Electronic Health Records (EHR) has a great potential. Besides interoperability, safeguarding the security and privacy of the medical data in the context of secondary use for clinical research is one of the most important challenges in this respect. In order to ensure that the clinical information is shared among EHR systems and clinical research systems in an ethical and safe way, there needs to be standards-based and adaptable security and privacy mechanisms that can be used by both clinical care and clinical research parties in an interoperable manner by taking into account policies, consent and use agreements of the participating parties. In this thesis, an extensible security infrastructure has been developed that supports re-use of the EHRs for strengthening the post-approval drug safety studies in the area of clinical research. This work involves the implementation of the security architecture, including novel data protection mechanisms applied to the queried clinical instances as well as additional security services compatible with standard profiles that guarantees the safe use of EHRs for the clinical research studies. In conformance to the selected standards, guidelines, and well-accepted methodologies, this thesis has addressed to find a balance between the privacy concerns for the use of personal data and the requirements of clinical research environments that aim to serve to the public good. In this respect, flexible security architecture is designed and made configurable for the Data Protection Offices of EHR sources according to their preferences.


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Citation Formats
E. Eryılmaz, “An Extensible security infrastructure for the secondary use of electronic health records in clinical research,” M.S. - Master of Science, Middle East Technical University, 2013.