Hospital Health Information System EU HIS Contract No. IPA/2012/283-805 Final version July 2015 Visibility: Public Target Audience: EHR Developers EHR Administrators EPR Systems Developers This document has been produced with the financial assistance of the European Union. The views expressed herein can in no way be taken to reflect the official opinion of the European Union. This project is funded by Republic of Serbia Implemented by the the European Union Ministry of Health WHO and UNOPS
Contents Introduction... 2 EHR-IF Components... 3 HIS/PC EPR Interface... 3 Repository and Registry... 3 EHR Interface... 4 Validation System... 5 Log and Audit Services... 5 Security Layer... 5 EU-IHIS, Šumatovačka 78-80, Beograd, Serbia, +381 11 2449 565 1/6
Introduction The primary purpose of an interoperability framework is to develop a shared repository of common standards, processes and information components, as well as methodologies for their use, across a diverse range of systems. In this regard, the main responsibility of the EHR Interoperability Framework (EHR-IF) is to provide to Hospital Information Systems (HIS), Primary Healthcare Centres Information Systems (PC EPR) and other health-related services up-to-date access to the EHR ensuring seamless and secure flow of data between systems. The implementation of EHR-IF is based on the Integrating the Healthcare Enterprise (IHE) approach, which specifies how data standards should be implemented to meet specific healthcare needs making systems integration more efficient and less expensive. IHE focuses on the development of open and global Integration Profiles that describe clinical information needs or workflows and document how to use established standards such as HL7. The overall EHR-IF architecture is presented in the following diagram: INTEROPERABILITY FRAMEWORK SECURITY LAYER (Authentication & Authorization) EHR EHR INTERFACE DOCUMENT REPOSITORY & REGISTRY HIS/PC EPR INTERFACE HIS PC EPR VALIDATION SYSTEM LOG AND AUDIT SERVICES Figure 1: EHR Interoperability Framework Architecture EU-IHIS, Šumatovačka 78-80, Beograd, Serbia, +381 11 2449 565 2/6
EHR-IF Components The EHR-IF comprise the following components: HIS/PC EPR Interface This component provides the methods necessary for HIS/PC EPR to exchange information with the EHR defining the access and interactions on healthcare information. First interactions to be implemented between HIS/PC EPR and the EHR are: Patient Registration/Update: This interaction comprises the request to add a new patient into the EHR or to update the patient's administrative/demographical data. Content of this interaction is defined by the Patient Registration/Update CDA document. Send to EHR: This is the interaction that supports the transmission of new or updated patient health data from HIS/PC EPR to the EHR. CDA documents currently comprised by this interaction are: Encounter summary, which is a document that represents a synopsis of a patient's encounter i.e., ambulatory or hospitalization. Hospitalization report, which is an individual report of the hospitalization of a patient that forms part of the statutory medical records of hospitalized patients. Request from EHR: This interaction comprises the query and retrieval of patients' data from the EHR meeting certain parameter based criteria. CDA documents currently comprised by this interaction are: Patient Summary, which is the snapshot of the pertinent data from the EHR about patient. Encounter Summary or Hospitalization Report, as described above, in case specific data about a specific encounter or hospitalization related to a patient is requested. Healthcare Professional Registration/Update: This interaction comprises the request to add a new healthcare professional into the EHR or to update related data. Content of this interaction is defined by the HCP Registration/Update document, which is FHIR-based XML format. Repository and Registry This component is based on the Cross-Enterprise Sharing (XDS) Integration Profile from IHE which provides a standard-based specification for managing the sharing and exchange of medical data (in the form of structured documents) between HIS/PC EPR and the EHR. In this regard, this component will store only those documents sent by HIS/PC EPR, which can be retrieved later on directly from this repository as "original" documents without the need to extract such data from EHR database (currently the Encounter Summary and Hospitalization Report). EU-IHIS, Šumatovačka 78-80, Beograd, Serbia, +381 11 2449 565 3/6
DOCUMENT REPOSITORY AND REGISTRY Actors and Transactions Repository Provide and Register Register Retrieve Source Registry Query Consumer Figure 2: Repository and Registry The documents repository and registry component contains the following entities with separate responsibilities: Repository: It is responsible for the storage of the documents in a transparent, secure, reliable and persistent manner, to submit associated metadata for their registration in the Registry as well to retrieve the documents requested by the Consumer. Registry: It provides an index to all registered documents of the system. It support searches and maintains metadata about each registered document in a document entry including a link to the Repository where each document is stored. This provides a way to find, select and retrieve documents irrespective of where they are stored. To maintain security, the Registry has no access to the content of any document, but relies on standardized metadata for their retrieval. Source: It is the producer and publisher of documents. It is responsible for sending documents to a Repository as well as associated metadata for subsequent registration in the Registry. Consumer: It is consumer of documents. It queries documents to the Registry and retrieves such documents from the Repository. EHR Interface This component is the responsible to extract the information from the documents received from HIS/PC EPR for its storage in the EHR database as well as to get, upon request, the appropriate data from the EHR to be forwarded to HIS/PC EPR. Therefore, it provides the necessary methods to access insert and update data in the EHR database. EU-IHIS, Šumatovačka 78-80, Beograd, Serbia, +381 11 2449 565 4/6
Validation System The validation component contains the process by which syntactic and semantic validation of the documents is performed i.e., whether a document complies with rules of the standard adopted, i.e., HL7 Clinical Architecture (CDA) and whether its content is correct. This ensures that the data being exchanged between the HIS/PHC systems and other health-related services with the EHR is complete, accurate and correct. Once the validation of a document is performed, in case of being correct, such document will be forwarded to the Registry and Repository to be archived. Otherwise, it will be rejected and the error messages will be audited and recorded by the Log and Audit component. Log and Audit Services This component provides patient information confidentiality, data integrity and user accountability throught the audit and log services that record all accesses to data and resources as well as collect all security-related events for potential use in intrusion detection and/or security audits. The audit trails will provide sufficient data to enable responsible authorities to document required actions on health records, detect inappropriate actions on health records, and signal abuse of privileges. Security Layer The security layer provides the authentication and authorization mechanisms needed to enable a secure communication between HIS/PC EPR and the EHR. It mainly comprises the following services: Authentication of source systems in order to ensure communications between HIS/PC EPR and the EHR providing the interoperability platform required for the EHR system, which enables the secure exchange of information over the network. Authorization and access control of users in order to provide healthcare professionals with different levels of access based on role based access control (RBAC) approach to overcome the complexities of managing individual user permissions. EU-IHIS, Šumatovačka 78-80, Beograd, Serbia, +381 11 2449 565 5/6