The German Healthcare system moves one step closer to Electronic Patient Records
Gematik (the Society for Telematics Applications) recently published the specifications, approval procedures and field test concepts for the components and services for a German electronic patient record.
The published document has been developed as a result of cooperation between the Federal Ministry of Health, the Federal Office for Information Security (BSI) and the Federal Commissioner for Data Protection and Freedom of Information (BfDI).
According to the law, the electronic patient file/record serves to improve the quality, transparency and cost-effectiveness of healthcare outcomes. "The gematik designed electronic patient file is intended to improve and facilitate care. This is in the interest of both the patients and the service providers and health insurances, "said Dr. med. Doris Pfeiffer, CEO of the GKV-Spitzenverband and chairman of the shareholders' meeting of gematik.
Dr. Thomas Kriedel, Board Member of the National Association of Statutory Health Insurance Physicians and Deputy Chairman of the Shareholders' Meeting, summarizes: "The file providers can now rely on an interoperable system architecture with defined interfaces when developing their solutions."
As a specialist application of the nationwide available and secure telematics infrastructure, the electronic patient record is available lifelong across facilities and sectors, as long as the insured wishes so. "The sovereignty over the data lies completely with the insured person. He alone decides who he wants to provide which medical documents, who is allowed to hire them or who can be deleted, "emphasizes Alexander Beyer, managing director of gematik.
The gematik ensures that all approved components and services for the electronic patient record are interoperable. "Thus, insured persons who wish to use an electronic patient record can also freely choose between providers and completely transfer all file contents, including metadata, protocols and access authorizations, to the new provider as part of a provider change," emphasizes Beyer. "And service providers can work with every file through their primary system, regardless of their provider. The insured person must have previously authorized the service provider for this only. "
The new Legislation
Legislators have codified the electronic patient record as an essential specialist application of the telematics infrastructure. According to section 291a SGB V (fifth book of the German Social Code), gematik must define the necessary specifications, admission procedures and field test concepts for the electronic patient file and publish them by 31 December 2018.
The Professional Electronic Patient File (ePA) application consists of the following components and services: "ePA file systems" (backend), "ePAD module connectors", "ePAN frontend for insured persons" and "primary systems" (for service providers) that are intended for the electronic patient record is developed or adapted. Accordingly, gematik provides the specifications, implementation guidelines as well as approval and confirmation procedures in the subject portal for all these components and services.
Based on these documents, manufacturers can implement their respective products and apply for an authorization from gematik. In order to be admitted to gematik, the applicant must prove that his or her electronic patient record component or service complies with the functionality, interoperability and safety requirements of the specifications.
The stipulations of gematik already take into account in substantial parts the bill on the Term Service and Supply Act (TSVG). The alternative authentication option demanded in the draft for the insured, which should particularly facilitate access with mobile terminals, and the possibility of transferring health insurance card data into the electronic patient record of the insured are implemented downstream in the subsequent stage 1.1 of the electronic patient record. According to the bill, the TSVG is expected to come into force in the spring of 2019. At the same time, the publication of stage 1.1 should also take place.
Manufacturers can already submit an application for approval to gematik, begin implementing the electronic patient record in stage 1.0 and incorporate the specification enhancements of stage 1.1 into their ongoing implementation.
According to the bill on the TSVG, the statutory health insurance funds are obliged to provide their insured persons with an electronic patient file approved by gematik by 1 January 2021 at the latest.