Electronic health records. A systematic review on quality requirements.

Objectives: Since the first concepts for electronic health records (EHRs) in the 1990s, the content, structure, and technology of such records were frequently changed and adapted. The basic idea to support and enhance health care stayed the same over time. To reach these goals, it is crucial that EHRs themselves adhere to rigid quality requirements. The present review aims at describing the currently available, mainly non-functional, quality requirements with regard to electronic health records.

Methods: A combined approach - systematic literature analysis and expert interviews - was used. The literature analysis as well as the expert interviews included sources/experts from different domains such as standards and norms, scientific literature and guidelines, and best practice. The expert interviews were performed by using problem-centric qualitative computer-assisted telephone interviews (CATIs) or face-to-face interviews. All of the data that was obtained was analyzed using qualitative content analysis techniques.

Results: In total, more than 1200 requirements were identified of which 203 requirements were also mentioned during the expert interviews. The requirements are organized according to the ISO 9126 and the eEurope 2002 criteria. Categories with the highest number of requirements found include global requirements, (general) functional requirements and data security. The number of non-functional requirements found is by contrast lower.

Conclusion: The manuscript gives comprehensive insight into the currently available, primarily non-functional, EHR requirements. To our knowledge, there are no other publications that have holistically reported on this topic. The requirements identified can be used in different ways, e.g. the conceptual design, the development of EHR systems, as a starting point for further refinement or as a basis for the development of specific sets of requirements.