Digitalization in the healthcare system

On 13 January 2015, the Federal German Health Ministry forwarded the draft bill on an “Act on safe digital communication and applications in the healthcare system”, previously slated for the end of 2014, to the German federal government for a vote, whilst at the same time making it public. Following the announcement of the introduction of the first “eHealth Act” in Germany, Federal Minister for Health Hermann Gröhe is now putting his words into action.

The draft bill’s proposed bundle of measures which will supplement and amend the existing provisions of Book V of the German Social Code (SGB V) aims to improve patient care by implementing modern information and communication technologies. It particularly aims to lay the foundations for an electronic network interlinking service providers and linking service providers with statutory health insurance companies, and to expedite the interlinking of a variety of IT systems in the healthcare landscape (interoperability).

1. Background – Status quo and objectives of the draft bill

Years of controversial discussions by various interest groups in connection with the digitalization of healthcare data mean that the development of relevant innovations (and the development of telemedicine applications) in Germany is still in its infancy.

The current legal situation already aims to ensure the electronic recording and exchange of healthcare data – the prerequisite for everything that can be termed eHealth – using the electronic healthcare card as the recording medium and using a separate infrastructure for safe communication within the healthcare system (telematics infrastructure). The electronic healthcare card has been the sole proof of health insurance cover for all patients with statutory cover. The development of the telematics infrastructure is being led by Gesellschaft für Telematik (gematik), the company supported by the top-level organizations of German healthcare service providers and funding bodies and was initiated for the planning of two test projects set for 2015.

On this basis, the “eHealth Act” proposed in the draft bill is now set, in particular, to form the basis for profitable applications of the electronic healthcare card, the establishment and opening of the telematics infrastructure, the improvement of interoperability and the promotion of telemedicine applications.

2. Core points of the draft bill

The major features of the draft bill can be summarized as follows:

• Development and opening of the telematics infrastructure

It is the aim of the Federal German Health Ministry to establish the telematics infrastructure in Germany as an open system – this means that it will not be limited to use of the electronic healthcare card. Thus, there are plans for it also to be used for other healthcare system applications, such as safe telecommunications between several doctors, provided for a fee. In the long term, the telematics infrastructure is intended to be the major way for exchanging healthcare data involving other (non-medical) service providers.

gematik will be responsible for gradually establishing and expanding the telematics infrastructure in line with data protection provisions and setting up authentication procedures for data access. On the other hand, gematik is able to contract out operation of the infrastructure to third parties, although it can only do this following a proper tender procedure or via the non-discriminatory granting of licences.

The requirements for initial use of the electronic healthcare card (verification and updating of core patient data held on the electronic healthcare card in line with Section 291(1) and 291(2) of Book V of the German Social Code (SGB V) by the service provider and sharing this data with the statutory health insurance companies) must be ensured by gematik by 30 June 2016. As of 1 January 2018, the electronic healthcare card is also to include enhanced emergency data.

In order to enable it to perform its responsibilities, various measures will be taken to reinforce and expand gematik’s structure (for example, creation of an arbitration board or legal powers for risk aversion and clarification of cross-border matters).

• Economic incentives for doctors and hospitals

The draft bill also provides for a system of incentives to motivate doctors and hospitals to cooperate in the implementation of particular innovations.

Thus, from 1 January 2018, doctors are to receive special remuneration for the creation of emergency data. Hospitals are also to receive special remuneration for creating an electronic discharge letter, the aim being to ensure the additional promotion of continued care at the transition between inpatient and outpatient treatment. Doctors involved in follow-up treatment are also to receive remuneration for the reading of an electronic discharge letter. This provision on incentives is intended as jump-start financing for a limited period from 1 July 2016 to 30 June 2018.

A lump sum of EUR 0.55 will be charged for the safe transmission of an electronic letter between care-giving doctors and institutions in 2016 and 2017 (adjusted from 2018 onwards).

• Sanctions

Following Federal Health Minister Gröhe’s recent words, “Whoever blocks this will pay”, the draft bill also provides for a system of sanctions. Should gematik not have ensured the above-mentioned requirements for use of the electronic healthcare card by 30 June 2016, its shareholders stand to face financial penalties. Doctors who, from Summer 2016 onwards, do not implement and use electronic healthcare cards (verification and updating of core patient data on the electronic healthcare card) face a cut in their fee.

• Patient entitlement to drug regimen

One specific measure for promoting drug treatment safety has been created by the Federal German Health Ministry with the creation of a patient entitlement to the issuing of a uniform drug regimen from 1 October 2016.

This measure entitles patients covered by statutory health insurance who are using at least five prescribed medicines to have a drug regimen issued to them by their general practitioner (GP). This will list both the prescribed and non-prescription medication and contain information on medicinal products of relevance for their drug treatment. If their treatment changes, the GP is then responsible for updating the drug regime. To facilitate the updating process, there are long-term plans to introduce an electronic drug regime in addition to the physical version.

• Networking of IT systems

In order to curb and avoid technical “stand-alone solutions” in hospitals and medical practices without networking capabilities, uniform standards, profiles and interfaces are to be identified for IT systems. To this end, gematik will draw up a clear interoperability register and establish an information portal in order to enable new applications to be developed with reference to existing documented standards.

In addition, IT systems for the use of patient data will also integrate open interfaces to facilitate transfer of this data (among other things to comply with the electronic data administration archiving obligations under professional law and the law governing statutory health insurance physicians).

• Support of telemedicine services

The support of telemedicine services is a further aim of the draft bill, although the Federal Health Ministry does not really go into the specifics of this. Thus, it is merely stated that regional supplements for services eligible of support also cover those services that can be provided using telemedicine (Section 87a(2) Book V of the new version of the German Social Code (SGB V neu)). The aim is also to at least verify by 30 June 2016 whether safe telecommunications can be used for the consultative evaluation of x-ray findings via telemedicine (if the answer to this question is “yes”, then the doctors’ fee schedule (Einheitlicher Bewertungsmaßstab – EBM) should be adjusted accordingly.

3. Conclusion and outlook – Telemedicine in Germany

The Federal Health Ministry’s draft bill on an “Act on safe digital communication and applications in the healthcare system” is to be welcomed, particularly with regard to the basic idea of a system of incentives and sanctions to promote and implement the legislator’s objectives. The planned establishment of a standard telematics infrastructure for the safe exchange of health-related data within the healthcare system certainly makes sense and will be efficient in the long term. It remains to be seen whether the draft bill will actually become law in its present form and amend Book V of the German Social Code (SGB V).

Even if the act did enter into force as proposed, this would only be an initial step towards creating the requirements for true innovation in telemedicine in Germany as aside from the major discussions of data protection issues, numerous other problem areas remain unresolved. For example, the professional-law ban on long-distance treatment (Section 7(4) of the Model Professional Code of Conduct for Doctors (Musterberufsordnung der Ärzte - MBO-Ä)), the professional-law precept of observing the “recognized state of medical knowledge” (Section 2(3) MBO-Ä) and the unresolved matter of liability where patients are treated by several doctors continue to remain barriers to innovative forms of treatment.

In this regard, the parties involved could yet face a further obstacle of an entirely non-legal nature: should the German medical profession continue to take the view formally decided at the German Medical Assembly (Deutscher Ärztetag) that telemedicine services merely constitute an addition to (but not as a replacement for) conventional treatment methods, real progress in telemedicine could be very hard to achieve in Germany, at least in the short term.

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