Security evaluation and assurance of electronic health records

Electronic Health Records (EHRs) maintain information of sensitive nature. Security requirements in this context are typically multilateral, encompassing the viewpoints of multiple stakeholders. Two main research questions arise from a security assurance point of view, namely how to demonstrate the internal correctness of EHRs and how to demonstrate their conformance in relation to multilateral security regulations. The above notions of correctness and conformance directly relate to the general concept of system verification, which asks the question "are we building the system right?" This should not be confused with the concept of system validation, which asks the question "are we building the right system?" Much of the research in the medical informatics community has been concerned with the latter aspect (validation). However, trustworthy security requires assurances that standards are followed and specifications are met. The objective of this paper is to contribute to filling this gap. We give an introduction to fundamentals of security assurance, summarize current assurance standards, and report on experiences with using security assurance methodology applied to the EHR domain, specifically focusing on case studies in the Canadian context.