„The“ Electronic Health Record: Standardization and Implementation

Electronic patient record systems (EPRS) are doubtless a key component of every institutional healthcare information system (HCIS). With their capability of storing patient related data concerning patient related facts like problems, diagnoses, illness history etc. together with data concerning medical activities and their results like “Medical treatment planning by Dr. X: treatment plan” or “Taking an ECG by Dr. Y: ECG” EPRS are a central means of documentation, information exchange and collaboration in a modern healthcare organization. Like EPRS for HCIS, electronic health record systems (EHRS) are a key component of current and coming health telematic platforms. EHRS are a means for exchanging health data concerning an individual person between communication partners within the healthcare sector controlled by the individuals the communicated data are belonging to. EHRS are integrating EPRS of healthcare organisations as well as the personal health record of the person itself including for example illness related diary entries. The objectives of an EHRS are diverse, but as for EPRS the main objective is clearly to support the treatment of patients by provision of information needed for decisions by health care professionals. Problems concerning the introduction of EHRS as a part of a regional, nationwide or at best worldwide health telematic platform are diverse and so “the” EHRS does not exists yet. The major problem is the huge amount of different proprietary or standardized interfaces information systems to be potentially integrated today are using: message or interface standards like HL 7, EDIFACT, DICOM, rather content oriented standards like LOINC, ICD-10, ICPM or hybrid approaches like CEN 13606, openEHR to name but a few. Standards are the key for a successful implementation of any EHRS. Four layers of standardization can be recognized. The content layer and the structure layer both are concerned with the standardization of the elements of an EHR, that are meant to be exchanged between communication partners. The content layer addresses aspects of coding the content of EHR-Element using terminological systems like classifications or controlled vocabularies. The structure layer focuses on regulations concerning the structure of communicated EHRElements, e.g. XML-files following corresponding DTDs or XML-Schemes. The border between structure and content layer is often blurred, because several content oriented aspects of e.g. a discharge letter are usually modelled by defining its structure. The two remaining layers are the technological and the organizational layer. The technological layer contains regulations concerning aspects like software and hardware components, distribution, objects and services, the PKI etc. The organizational layer focuses on organizational changes caused by the usage of an EHRS: business processes, guidelines, protocols, roles, PKI etc. Organizational and technological regulations are even more dependent on national strategies as regulations on the structural or content layer and therefore the rest of the paper deals with standardization activities concerned mainly with the structural and the content layer.