Erweiterung des Konzeptes einer Patientenakte nach § 291a SGB V um eine Schnittstelle für die medizinische Forschung

Abstract

A central topic of medical informatics is the exchange of patient data between the different actors in the health care system. The German Government has recognized the need for a unified, national telematics infrastructure for cross-institutional data exchange. In 2003, the passing of the German Bill on the modernization of public health care [GMG] marked the first step. According to Article 291a SGB V of the Bill, one of the applications that this telematics infrastructure is supposed to enable is the electronic patient record. This application shall enable patients to access data collected during their routine medical care and communicate electronically with the systems used by their clinicians. The scope of the law was kept narrow in order to limit the use and dissemination of data in the electronic patient record, for privacy reasons. Important topics, such as patients’ participation in medical research, were left out. Looking at the process of electronic data capture both in a routine care and a medical-clinical research environment (for example, in university hospitals), it appears that the data relevant to care and research are often identical. Yet, as the systems for research and routine care are operated separately, the information is recorded twice. This duplication of data seems illogical to a user who has to key the same data into both systems. It does not promote inclusion of patients in research studies either. The goal of this thesis is to develop the conceptual design of an interface between an electronic patient record and the medical research systems, according to the specifications of the national telematics infrastructure. This interface should resolve the problem of double data entry by enabling the interchange of patient data between systems used in routine care and for research via the electronic patient record. First, both systems of routine care and medical research are analyzed and a communication model, as well as data protection requirements for the communication between the electronic patient record and the systems of research, drawn up. Then, based on the communication model and the data protection requirements, both a technical framework and a security framework for this interface are described. As a result it is argued that a connection of the IT systems for medical research via the electronic patient record can be realized in a secure way while still maintaining data protection standards. Finally, the solution is critically examined by comparing it to other, existing approaches for the use of routine care data for medical research. The advantages of a solution integrated into the national telematics infrastructure as compared to an isolated solution are shown. The author concludes that the theories are validated in a scenario with limited scope, but there still are significant challenges to make it nationally available. Proposals for further work towards a functioning system as well as other opportunities, based on the results of this thesis, are described.