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Draft proposal for the German Digital Healthcare Act (Digitale Versorgung-Gesetz)

TMF issues a statement calling for involvement of research in the design of electronic patient records and for changes to the Data Transparency Ordinance (DaTrav) and innovation funding

7 June 2019. On 15 May, the Federal Ministry of Health (BMG) submitted the long-awaited draft of a more comprehensive digital transformation act for healthcare under the title “Act for Better Healthcare through Digital Transformation and Innovation (DVG).” In a statement published [in german] today, TMF, as the umbrella organisation for networked medical research in Germany, welcomed the draft legislation, and in particular the proposed further development of an electronic patient record (EPR, known in German by its abbreviation ePA).

The aim is for the EPR to consolidate all data of relevance to the individual patient from diverse sources (information systems operated by hospitals, health insurers, general practitioners, etc.). The ability to make data from routine medical healthcare activities available to medical research within a learning healthcare system is in the clear interest of the general public. Data-driven research allows, for instance, the development of more targeted treatments, and of healthcare innovations with the potential to be rolled out to the global market.

To this end, the Ministry of Health has outlined in the draft legislation its intention to task Gematik, a public owned company specialising in telematics for healthcare, with creating the technological basis for extracting research-relevant data from the EPR. This is a milestone in the use by researchers of data drawn from routine medical care in Germany. TMF has proposed that the draft legislation be augmented to ensure the corresponding data interface will be, from the outset, developed in compliance with international standards – and be interoperable with the publically funded infrastructure that already exists or that is under development, such as that operated by the Medical Informatics Initiative. Furthermore, specifications should not necessitate unreasonable capital investment or organisational measures (e.g. as would be required if all researchers were to be connected to the technical infrastructure). The draft legislation also establishes a further important precondition for the use of data from the electronic patient record for research (“donated research data”) by permitting patients themselves to make the content of their records available for this purpose. Moreover, access for research purposes will not be limited to members of recognised medical professions.

Ensuring EPR content can be used in research

The Faster Appointments and Better Healthcare Act (TSVG) came into force on 11 May 2019. Subsequently, the National Association of Statutory Health Insurance Physicians (KBV) began, on the basis of the mandate granted in the new act, to lay down semantic and syntactic requirements for the medical information objects (MIOs) that will form the content of the electronic patient record. TMF is also contributing its expertise as “the main German-wide association representing the interests of the healthcare research community.” To ensure the future interface provides content from the patient record that can be genuinely used by researchers, it will also be necessary for information objects to be specified by KBV to be based on fully-fledged international standards and to be of a codifiable depth and breadth that is not less than the core data set defined by the Medical Informatics Initiative. Moreover, more detailed documentation of the type required by research, i.e. in specialised research medical practices, needs to be financially incentivised. In addition, a nationwide programme needs to be put in place to enhance primary documentation processes, including funding for the training and appointment of data curation scientists. Furthermore, a concrete legal framework needs to be established for data provision, governance and usage if the EPR content is to be used by researchers via the interface. The joint national goal should be the creation of a standardised German and European environment for health research data that is internationally competitive.

Improved research opportunities through social insurance data

In a yet unpublished supplement, the Ministry of Health has also submitted the first stage of an amendment to the Data Transparency Ordinance (DaTrav) in accordance with Sections 303a-303f of the German Social Code (SGB V). This is largely attributable to the initiative and expertise of TMF. Especially positive for the research community is the fact the legislator will phase out the use of data from the German Federal (Social) Insurance Office (BVA), which is up to four years old. They will be replaced by far more timely and more detailed data records managed by health insurers. In addition, statutory data retention periods for the recently established Research Data Centre are to be raised to 30 years, making them far more research-friendly. A further new aspect is remote data access. However, there is a need for certain changes and additions, i.e. in terms of the concrete definition of legal sanctions in the event of re-identification of anonymised data records, and how a working group of authorised users is to be institutionally embedded.

Financial support for innovation fund to be modified

The proposed legislation foresees an extension of financial support for the innovation fund, operated under the aegis of the Joint Federal Committee (a semi-independent body for self-government of German healthcare, GBA), for a further funding period. However, TMF is critical of the lowering of the budget from 300 to 200 million euros, and the reduction in the share of the total assigned to healthcare research. Additionally, following the concept phase, funding is limited to a maximum of 15 projects per year. This falsely incentivises applicants to deliberately target large numbers of participants and large budgets, irrespective of the value added in terms of scientific insights. This entails additional risks, and systematically excludes agile projects put forward by smaller organisations. TMF also suggests the extensive support and advisory services now proposed for funded projects should not be assigned to the main office of the GBA Innovation Committee but put out to tender. A hearing on the draft legislation is scheduled for 17 June 2019 at the Ministry of Health, with TMF in attendance. The Federal Cabinet may possibly commence the parliamentary process for the draft legislation before the Bundestag enters its summer recess. In this event, it is probable that the act would come into effect on 1 January 2020.

  1. An overview of TMF statements and position papers [in German]

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