If you examine the growing popularity of healthcare interoperability solutions, such as FHIR in Germany, you’ll find that governmental institutions worldwide are the main drivers of transparency in healthcare. By utilizing industry experts in digital health and medicine for healthcare analysis, many governments discover the weak points of healthcare systems that require attention on a national level and react to them by establishing relevant regulations. The desire to improve interoperability worldwide highlights the lack of digitization within healthcare systems.
COVID-19 contributed to understanding the need for the national digitization of healthcare, particularly in Germany, where healthcare actors could experience many of the benefits of telemedicine, such as contactless evaluation of beds available in healthcare facilities and online patient consultations. In 2020, over 5,000 German physicians used video consultations to provide the needed care to their patients while ensuring their safety and security during the pandemic.
As a result, the German government provided over 4 billion euros for the modernization of hospitals and created a legal base, particularly regulations and specific FHIR standards for Germany, for achieving nationwide interoperability, connecting healthcare information, ensuring its meaningful use, and empowering patients with the ability to control their healthcare.
Who is in Charge of the Digitalization of Germany’s Healthcare System?
Federal Ministry of Health | Bundesministerium für Gesundheit (BMG)
The Federal Ministry of Health (BMG) heads Germany’s healthcare digitization. The BMG’s work is to create a base for building a robust national healthcare landscape by formulating legislative measures, bills, and administrative regulations.
Beyond legislation, the BMG actively engages in preventive campaigns to enhance the population’s overall health. In essence, the Federal Ministry of Health drives Germany’s healthcare evolution by pushing industry stakeholders to improve health, prevention, and long-term care.
Gematik – Germany’s Digital Health Agency
Created by the Ministry of Health, Gematik is the national digital health agency tasked to develop the telematics infrastructure for German healthcare and force healthcare digitalization for further medical development.
Telematics Infrastructure (TI) – is a unified network of technologies facilitating secure data exchange in healthcare.
Gematik defines and enforces standards to use within TI, develops digital services, and acts as a coordinating body for interoperability, ensuring seamless digital collaboration among diverse healthcare institutions. A key component in this process is the implementation of FHIR bundle, which facilitates the structured exchange of healthcare information.
Health Innovation Hub (HIH)
Health Minister Jens Spahn initiated the Health Innovation Hub to encourage industry experts to consult the Ministry of Health and other bodies to develop robust digitization strategies and achieve national interoperability.
National Association of Statutory Health Insurance Physicians | Kassenärztliche Bundesvereinigung (KBV)
KBV works on quality assurance measures for outpatient medical care. This involves agreements on special methods and adherence to guidelines outlined by the Federal Joint Committee, which formulates binding regulations and makes various decisions related to healthcare in Germany aimed at improving conditions, promoting diagnostic freedom, and balancing provider interests with the patient-doctor relationship to advance Germany’s healthcare digitization.
The cooperation between these bodies allowed Germany to improve their healthcare system and leverage modern and industry-proven strategies for rapid digitalization and advanced interoperability in healthcare.
Regulations for German Healthcare Interoperability
Despite Germany owning the third-largest global medical technology market, following the United States and Japan, its healthcare system’s decentralized and self-governing nature makes it intricate in embracing new trends. Still, Germany’s medical equipment market anticipates a 5.1% CAGR in Euro from 2020 to 2025 due to the interoperability regulations and collaborative effort of HL7 Germany and Gematik, who are developing the FHIR standards Germany uses for healthcare digitization and interoperability.
Social Code (SGB) Book Five (V) Statutory Health Insurance | Sozialgesetzbuch (SGB) Fünftes Buch (V) Gesetzliche Krankenversicherung
SGB V is the fifth book of German laws called the Social Code (Sozialgesetzbuch – SGB). SGB V establishes fundamental health rules and setting roles within healthcare, addressing insurance challenges, organizational structures, financing, medical services, data protection, transparent health data handling, and consequences for non-compliance (penalties and fines).
SGB V Articles for Interoperability:
- Article § 355 SGB V: mandates the KBV with authority to create interfaces for electronic patient records (ePAs) and medical information objects (MIOs), encompassing electronic medical treatment plans and emergency data.
- Article § 371 SGB V: sets criteria for personal data processing systems, introducing laws that outline requirements for IT systems handling personal data in diverse healthcare settings, covering medication prescribing and interfaces for inpatient and clinical applications.
- Article § 372 SGB V: outlines criteria for open and standardized interfaces in information technology systems used in contracted medical and dental care.
- Article § 373 SGB V: sets rules for the information technology systems used in hospitals and nursing care and mandates confirmed systems for hospitals and certain service providers by specific dates. Under this article, Gematik was assigned to make the specifications for the open and standardized interfaces and run confirmation procedures to ensure smooth and standardized data exchange in healthcare systems.
- Article § 374a SGB V: mandates aids or implants covered by health insurance to support digital health applications by July 1, 2025. Manufacturers must ensure accessible, interoperable interfaces. The Federal Institute for Drugs and Medical Devices oversees an electronic directory for these interfaces. Exceptions after July 1, 2025, are permitted for medical reasons or if regular provision is at risk. By October 31, 2023, Gematik had to define technical specifications for secure data transmission.
Health IT Interoperability Governance Regulation | Gesundheits IT Interoperabilitäts Governance Verordnung (GIGV)
The GIGV regulation was designed to address challenges in healthcare interoperability in Germany and took effect on October 1, 2021. It established a coordinating body that can target issues such as the lack of agreement on standards and unclear or incomplete standards. The coordinating body under the Gematik, along with expert committees and working groups, identifies, prioritizes, and suggests or creates mandatory interoperability standards that manufacturers should adhere to within 24 months. Overall, the GIGV aimed to bring order to the interoperability landscape.
The Hospital Future Act | Krankenhauszukunftsgesetz (KHZG)
Apart from providing decent funding for hospitals’ digitalization under the act (over 4 billion euros), the law emphasized the importance of interoperability in isolated healthcare systems, such as multiple data entries and errors. The act established achieving interoperability and adhering to General Data Protection Regulations (GDPR) as mandatory for healthcare digitization funding: this ensures healthcare systems receive financial support and align with interoperability standards and data protection regulations, promoting a more integrated and secure digital healthcare landscape.
FHIR Use Cases in Germany
ISiK Project: FHIR Implementation for Integrated Healthcare in Germany
Gematik’s ISiK project resulted from Article § 373 SGB V‘s requirement for specifications for open and standardized interfaces to improve fragmented hospital systems by leveraging FHIR in Germany. This initiative addresses the limitations of media-free data exchange arising from the heterogeneous nature of the hospital system landscape by creating an interoperable healthcare system.
Key aspects of the ISiK Project:
- Standardized Interface: Under the ISiK initiative, Gematik established a binding standard and standardized interface, ensuring health data exchange compliance in information technology systems as mandated by legal requirements.
- FHIR Resources: The “ISiK Basic Module” specification specifies FHIR resources developed by Gematik, providing a comprehensive guide for manufacturers. All resources under the basic module are transferred via a REST-based API.
- Use Case Functionalities: The ISiK base module supports cross-use case functionalities, including patient searches based on demographic criteria, insurance information queries, diagnosis retrieval, current location searches, and case information searches.
- Extended Use Cases: Apart from the basic functionalities, the ISiK’s FHIR profile in Germany, combined with other profiles and standards, facilitates the integration of mobile devices, rarely used subsystems, decision support systems, and web-based applications.
- Confirmation Process: It involves a preliminary check and spans multiple levels, each having specific release and expiry dates, which ensures systems exchanging patient data comply with funding criteria.
To achieve ISiK compliance, hospital vendors must implement a RESTful API, an FHIR data store, or an FHIR Facade, support authentication and authorization mechanisms, and have an integration layer and the necessary infrastructure to ensure seamless healthcare data exchange within German hospital systems.
E-Rezept on FHIR: The Mandate for Leveraging FHIR in German Healthcare
The year 2024 portends many transformations for German healthcare, including further digitalization. Starting January 1, 2024, E-Rezept use is mandatory for every patient with health insurance in Germany: doctors must issue an electronic prescription, which patients can redeem via electronic health cards, dedicated apps, or paper.
Key aspects of the E-Rezept:
- Centralized Prescription Server: The heart of the E-Rezept system is a centralized FHIR server that manages and processes e-prescriptions for the country.
- Qualified Signed Data Set: Patient records are encapsulated within a qualified signed data set. This secure bundle, defined by the KBV (Association for the Resident Physicians), ensures the integrity and authenticity of patient information.
- Access Control: While the system currently employs access codes for authorization, future iterations plan to implement an authorization server. This step will enhance access control, ensuring secure and regulated retrieval of e-prescriptions.
- Workflow Module: The E-Rezept system incorporates a robust workflow module that facilitates the exchange of FHIR resources. Tasks, medication dispensary sources, communication resources, and location resources collaborate seamlessly to ensure efficient and secure prescription processes.
- Integration with Existing Systems: Given the complex landscape of Germany’s e-health system, the E-Rezept workflow integrates with existing contracts, policies, and standards. The KBV defines the e-prescription data set, while Gematik spearheads the specification of resources and workflows.
- Patient Empowerment: The system empowers patients by allowing them to download their e-prescription workflow data. This includes an access code, serving as authorization information, which patients can convey via smartphone or printed copy for seamless retrieval of prescribed medications.
- Enhancing Medication Dispensation: The workflow introduces sanity checks, quality checks, and signature checks to ensure the accuracy and safety of medication dispensation. It also addresses scenarios where patients seek prescriptions for rare medications by providing a systematic approach to pharmacy selection.
Read Also: Data Interoperability in Pharmaceutical Industry
The E-Rezept on FHIR allows for improved interoperability and supports patient empowerment. Apart from technological advancement, the e-prescription system in Germany allows for prioritizing patients’ needs and provides them with additional choices to manage their healthcare process.
Final Thoughts
The world learned the value of healthcare digitization the hard way. Fortunately, many countries, including Germany, the US, the UK, the Netherlands, Australia, and other progressive governments, have chosen to prioritize interoperability and drive digital transformation in healthcare.
These countries are making significant strides in promoting interoperability, showcasing how adopting standards like FHIR can advance and simplify healthcare workflows while empowering patients with greater control over their healthcare data and the overall healthcare process.
If you’re considering entering the German healthcare apps market but are apprehensive about the intricacies and regulatory requirements, get a consultation from our FHIR experts today: building a national e-health system in Ukraine has equipped our team with precious expertise in navigating a complex healthcare landscape on a national level.
Our team of business analysts and FHIR experts will break down how to implement FHIR standards in Germany to benefit your project and ensure compliance with standards while supporting the efficiency and interoperability of your FHIR-first system. Together, we can make a meaningful impact on healthcare technology in any country. Expanding our expertise, we also specialize in guiding FHIR implementation in Australia, tailoring solutions to local requirements and healthcare practices, ensuring compliance, and fostering innovation to make a meaningful impact on healthcare technology in the country.
