RESUMO
BACKGROUND: The use of medical data for research purposes requires an informed consent of the patient that is compliant with the EU General Data Protection Regulation. In the context of multi-centre research initiatives and a multitude of clinical and epidemiological studies scalable and automatable measures for digital consent management are required. Modular form, structure, and contents render a patient's consent reusable for varying project settings in order to effectively manage and minimise organisational and technical efforts. RESULTS: Within the DFG-funded project "MAGIC" (Grant Number HO 1937/5-1) the digital consent management service tool gICS was enhanced to comply with the recommendations published in the TMF data protection guideline for medical research. In addition, a structured exchange format for modular consent templates considering established standards and formats in the area of digital informed consent management was designed. Using the new FHIR standard and the HAPI FHIR library, the first version for an exchange format and necessary import-/export-functionalities were successfully implemented. CONCLUSIONS: The proposed exchange format is a "work in progress". It represents a starting point for current discussions concerning digital consent management. It also attempts to improve interoperability between different approaches within the wider IHE-/HL7-/FHIR community. Independent of the exchange format, providing the possibility to export, modify and import templates for consents and withdrawals to be reused in similar clinical and epidemiological studies is an essential precondition for the sustainable operation of digital consent management.
Assuntos
Interoperabilidade da Informação em Saúde , Software , Humanos , Consentimento Livre e Esclarecido , Padrões de ReferênciaRESUMO
This comparative study examines the transition from isolated registries to a consolidated data-centric approach at University Hospital Schleswig-Holstein, focusing on migrating the Atrioventricular Valve Intervention Registry (AVIR) from REDCap to a Medical Data Integration Center based openEHR registry. Through qualitative analysis, we identify key disparities and strategic decisions guiding this transition. While REDCap has historical utility, its limitations in automated data integration and traceability highlight the advantages of a data-centric approach, which include streamlined data (integration) management at a single-point-of-truth based on e.g., centralized consent management. Our findings lay the groundwork for the AVIR project and a proof-of-concept data-centric registry, reflecting a broader industry trend towards data-centric healthcare initiatives.
Assuntos
Sistema de Registros , Humanos , Registros Eletrônicos de Saúde , Alemanha , Doenças das Valvas CardíacasRESUMO
This paper explores the challenges and lessons learned during the mapping of HL7 v2 messages structured using custom schema to openEHR for the Medical Data Integration Center (MeDIC) of the University Hospital, Schleswig-Holstein (UKSH). Missing timestamps in observations, missing units of measurement, inconsistencies in decimal separators and unexpected datatypes were identified as critical inconsistencies in this process. These anomalies highlight the difficulty of automating the transformation of HL7 v2 data to any standard, particularly openEHR, using off-the-shelf tools. Addressing these anomalies is crucial for enhancing data interoperability, supporting evidence-based research, and optimizing clinical decision-making. Implementing proper data quality measures and governance will unlock the potential of integrated clinical data, empowering clinicians and researchers and fostering a robust healthcare ecosystem.
Assuntos
Nível Sete de Saúde , Registros Eletrônicos de Saúde , Interoperabilidade da Informação em Saúde , Alemanha , Integração de Sistemas , Humanos , Registro Médico Coordenado/métodosRESUMO
Integrating data from various source systems to gain knowledge and meaningful data about patients for care and research is challenging. This work demonstrates how medication knowledge data from the database of the Federal Union of German Associations of Pharmacists (ABDA) can be used for storing and annotating medicinal products in an openEHR medication archetype.
Assuntos
Registros Eletrônicos de Saúde , Metadados , Humanos , FarmacêuticosRESUMO
The re-use of healthcare information for biomedical research is increasing and with it the importance of a consent management framework implementing computable consents. Based on requirements concerning a consent representation the Advanced Patient Privacy Consents (APPC) Profile of Integrating the Healthcare Enterprise (IHE) is evaluated and mapped to these requirements. As IHE APPC was developed for computable patient consents, the mapping of consents for research projects is possible by re-using the elements defined. Compared to other approaches like gICS, approaches using APPC can be based on commercial software products and integrated into IHE environments. IHE APPC was already successfully used in EHR projects like INFOPAT. For interoperability reasons IT platforms intending to support biomedical research including clinical data, research data, biomaterial and imaging data, IHE APPC seems to be an appropriate standard to choose.
Assuntos
Registros Eletrônicos de Saúde , Consentimento Livre e Esclarecido , Humanos , Privacidade , Pesquisa , Integração de SistemasRESUMO
A patient portal with access to a personal cross-enterprise electronic health record (PEHR) had to be developed for the project "INFormation technology for PATient-oriented healthcare in the Rhine-Neckar metropolitan region" (INFOPAT). Liferay was chosen as the platform technology in previous researches. Multiple portlets for patients, study members, security officers and administrators had been developed in Java. In this paper all portlets are presented. For three portlets the communication between them, Liferay and the PEHR are described in detail. To communicate with the PEHR a façade called IHE Connector had been implemented too. Despite the broad functionality of the Liferay Core some workarounds had to be implemented. The lack of information in the provided documentation of Liferay lead to delays in development. The Liferay IDE and Liferay itself showed an unstable state.
Assuntos
Registros Eletrônicos de Saúde/organização & administração , Troca de Informação em Saúde , Alemanha , Humanos , Portais do Paciente , Design de SoftwareRESUMO
Over the last years we stepwise implemented our vision of a personal cross-enterprise electronic health record (PEHR) in the Rhine-Neckar-Region in Germany. The patient portal is one part of the PEHR architecture with IHE connectivity. The patient is enabled to access and manage his medical record by use of the patient portal. Moreover, he can give his consent regarding which healthcare providers are allowed to send data into or read data from his medical record. Forthcoming studies will give evidence for improvements and further requirements to develop.
Assuntos
Registros Eletrônicos de Saúde/organização & administração , Troca de Informação em Saúde , Confidencialidade , Alemanha , Humanos , Portais do Paciente , Design de SoftwareRESUMO
Providing patients with access to their medical data has recently evolved as a topic in several countries. Different approaches are possible. For example patient portals are used for patient access towards medical data. The University Hospital Heidelberg is engaged in a research project to develop a personal cross-enterprise electronic health record (PEHR). The objective of this work is to describe the architecture and implementation of a component called IHE Connector which represents the native IHE-based integration between the patient portal and the PEHR core components. The architecture of the PEHR is accepted based on international standards. The core components consist out of ready to use software products like a master patient index. The patient portal has been developed using Liferay framework. The IHE Connector is mainly based on the Open eHealth Integration Platform (IPF) Framework, which has been deeply integrated into the patient portal to support the needed IHE transactions. Several IHE profiles for sharing documents and patient information are supported by the IHE Connector. As IPF already provides interfaces for some IHE profiles others had to be developed from scratch. The IHE Connector can not only be used for connectivity between patient portal and PEHR core, but also provide connectivity for third party apps and healthcare providers' information systems.
Assuntos
Registros Eletrônicos de Saúde/organização & administração , Troca de Informação em Saúde/normas , Integração de Sistemas , Registros Eletrônicos de Saúde/normas , Alemanha , Humanos , Portais do Paciente/normas , Design de SoftwareRESUMO
Giving the patient full control over his medical data electronically remains one of the most discussed topics in healthcare today. The INFOPAT project in the Rhine-Neckar region focuses on a personal cross-enterprise electronic health record (PEHR) in which the patient plays a major role. Thus, he should be provided with the possibility of granting access to his medical data which could be realized using a consent creator service. This paper presents a user interface concept for such a service as well as aspects for the technical implementation. In addition, a pattern for integrating the service into an existing IHE based infrastructure is shown. These concepts could be further adapted for improving patient empowerment in health care projects.
Assuntos
Registros Eletrônicos de Saúde/organização & administração , Troca de Informação em Saúde , Interface Usuário-Computador , Alemanha , Humanos , Portais do Paciente , Design de SoftwareRESUMO
Making clinical information available for research is not only relevant for healthcare institutions, but also for regional EHRs, as cross-sectorial information can be made accessible. In the INFOPAT (INFOrmation technology for PATient-oriented health care in the Rhine-Neckar metropolitan region) project we are thus implementing both, a regional personal cross-enterprise electronic health record (PEHR) and a regional research platform (RRP) based on information from the PEHR. IHE profiles are implemented to achieve interoperability between healthcare institutions electronic medical records (EMR) and PEHR on the one hand, as well as PEHR and RRP on the other hand. The use case for the RRP is cross-sectorial quality assessment and improvement for colorectal cancer based on a quality indicator (QI) approach including patients' perspectives. For semantic interoperability the responses are transferred in the form of HL7 CDA L2 documents. The resulting architecture for a RRP shows that implementing a PEHR in combination with a RRP based on international communication standards is possible. Also IHE XDS can be used for integration of patient care and biomedical research infrastructures.