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2019 report – Implementation of the smart health card and the telematics infrastructure

Jan 18, 2019

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0 Executive summary
We reviewed the implementation of the smart health card and the telematics infrastructure. Our key audit findings on this issue are as follows:

Since the beginning of 2000s, developing a telematics infrastructure has aimed at providing a secure network infrastructure for health care stakeholders. This initiative is also designed to enhance the quality and efficiency of medical care. The telematics infrastructure is to enable online applications of the smart card, e.g. an electronic health record, an electronic medication plan or electronic prescriptions.

15 years after project inception, only part of the general practitioner practices are connected to the telematics infrastructure. In particular, participation of hospitals or other provider groups is lacking. The smart card has so far not provided notable added value for care providers and beneficiaries since online applications have not yet been created. In addition to the functionality of the previous memory-only health card, the new smart card can only be used for managing the beneficiaries’ master data provided that the respective care providers are connected to the telematics infrastructure.

The task of implementing the smart card and the telematics infrastructure was assigned to umbrella health care organisations. These organisations have the duty to work together in their capacity as shareholders of gematik, the organisation managing the electronically readable card system. However, competing needs have repeatedly delayed and slowed down implementing the telematics infrastructure and smart card applications. By 2017, the costs of gematik alone had amounted to €606 million. We therefore recommend that gematik should no longer hold sole responsibility for the entire process. Landmark decisions should be made by the Federal Ministry of Health or an organisation where the Ministry has a say (top-down approach).

Since 2005, the statutory requirements applicable to the technical architecture of the telematics infrastructure have not been amended. Some requirements, e.g. the card-based system and the two-key principle, leave no room for technological progress. The Federal Ministry of Health should review to what extent technical architecture requirements are still state-of-the-art. The Ministry should urge for adapting individual technological requirements or for providing a statutory framework that enables including future technical advances in the telematics infrastructure architecture.

The Federal Ministry of Health initiated the respective statutory arrangements to ensure that in addition to the current procedure, beneficiaries can access their medical data by means of mobile devices. However, still no regulation is in place as to how the current procedure is to be shaped and implemented, how to ensure access in dental and general practitioners’ practices and who shall bear the cost. The Ministry needs to closely monitor how access is designed and implemented in line with the current procedure. The Ministry needs to take steps to ensure that the regulatory gap is closed in a timely manner.

Connection to the telematics infrastructure requires specific components and services. Industry has the task to develop and offer these components and services self-reliantly as provided for in the market model currently used by gematik. This means that there is no timetable in place to determine whether and when these components and services are delivered. The Ministry now has an ongoing role in steering the development of the telematics infrastructure. The Ministry needs to respond promptly to matters emerging from contact with industry. Under certain circumstances, it may be appropriate to deviate from the market-oriented system, to award contracts or to create other production or performance incentives for industry.

It was only in the year 2015, that is 12 years after the first statutory framework was adopted that gematik was set the deadline of 31 December 2018 to create the technical conditions required for implementing the electronic health record. Today it has not been settled whether the health insurers can meet their obligation in accordance with the draft law on appointment services and medical care to provide beneficiaries with an electronic health record certified by gematik by no later than 2021. Implementing this main application of the smart card especially depends on the industry offering certifiable products on the market in line with the technical requirements published by gematik in December 2018. Also care provider groups need to be connected to the telematics infrastructure. In our view, these are huge challenges requiring consistent project management and a meticulous control system.

In October 2018, three umbrella organisations drafted a memorandum of understanding on the vision of the electronic health record. The technical requirements of gematik are to be based on this vision. Although it came late, this memorandum is a step in the right direction. However, the memorandum is not legally binding. Furthermore, the Ministry of Health has no say as to the contents agreed and their implementation. As the body ultimately responsible, the Ministry should consider enshrining in law those contents of the memorandum it subscribes to.

There is a huge gap between financial responsibility and decision-making powers of shareholders in gematik. gematik is fully funded by the National Association of Statutory Health Insurers by means of a portion of health care contributions received by health insurers. The voting rights reflect the different share of interest held. The umbrella organisations of provider groups and the National Association of Statutory Health Insurers each hold a 50 per cent share. The Ministry of Health should consider engaging other stakeholders groups in funding gematik. It seems appropriate to link financial responsibility with decision-making powers. This will better help ensure decisions that provide value for money. The added value accruing to individual stakeholders from the telematics infrastructure should be also duly taken into account.

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