The planned Health Data Utilization Act is intended to create a research data infrastructure that will enable scientific use of the data. The “medicine of the future” must not dwell on “small discussions” and must get out of the “paralyzing discussion” about data protection, said Bavaria’s Health Minister Klaus Holetschek at the first Bavarian eHealth Congress on Wednesday in Augsburg.
Digitization in the healthcare system is intended to improve patient care, particularly with regard to diagnostic and therapeutic methods and operations. At the same time, it should enable doctors to exchange information quickly and securely. Currently there is still “a lot of paperwork with the doctor, in nursing and in hospitals,” warned Holetschek.
Ban “dealing with data”.
The Bavarian Minister of State for Health and Care also advocates linking science and business. Although the sovereignty of the users is important, health data must still be available for research in an anonymous and pseudonymised form, said Holetschek. However, “business with the data” must be strictly forbidden, warned the Bavarian Prime Minister Markus Söder (CSU), who opened the eHealth Congress.
Bavaria wants to become a pioneer as a “digital hub” and “march forward,” said Holetschek. You no longer want to “just remain in doubt”. In the future there will be a health cloud for Bavaria. The politicians did not give any reasons why Bavaria no longer acts as a test region for the e-prescription.
Opt-out for eMR and organ donation
For the electronic patient file (ePA) and organ donation, Holetschek calls for the switch to an opt-out procedure. “The best tool is useless if it lies around unused,” said the Minister of State and criticized the fact that over-regulation is unnecessarily slowing down progress. With an opt-out procedure, insured persons would have to actively object to the creation of a digital patient file and the organ donation.
Bavaria wants to work with all its might on the Health Data Utilization Act. Instead of Karl Lauterbach, Sabine Dittmar, State Secretary of the Federal Ministry of Health (BMG), was sent to the congress. She also advocated an opt-out procedure so that insured persons and service providers can “benefit from the ePA as quickly as possible”.
Sabine Dittmar (SPD), Parliamentary State Secretary in the Federal Ministry of Health, considers the fact that the ePA 2.0 with only around 500,000 files is currently still little used to be “unsatisfactory”. It works better in France, Austria and Spain. It is currently being examined how the ePA can develop into a data platform. Access to the data should be “more efficient”. Version 2.5 of the ePR is expected for January 1, 2023. The controversial data release for research purposes and the integration of data from digital health applications (DiGAs) are planned for version 2.5.
Electronic patient summary
At the end of 2023, version 3.0 should come, for which the electronic medication plan (eMP) and the electronic patient summary (ePKA) are planned. The latter contains the insured’s Emergency Data Record (NFD) and Personal Declarations Record (DPE). So far, this data has been summarized as emergency data management (NFDM).
Dittmar warned that the health data should be available to those treating people more quickly. There is still a lot to be done in this regard, but the course has already been set with the development and expansion of the telematics infrastructure (TI) for “secure digital communication”. In addition to players such as practices, clinics and pharmacies, midwives and nursing staff are also to be connected to the TI in the future. Dittmar described the emergency data management, the medication plan and the KIM service – communication in the medical sector – as the first useful applications.
E-Prescription: First level reached
With the e-prescription, you finally say goodbye to the “paper economy” and switch to a “modern” procedure, said Dittmar. As of September 1, 2022, “the first stage of the rollout of the e-prescription has finally been reached”. The regions of Westphalia-Lippe and Schleswig-Holstein are pioneers. Irrespective of this, according to Dittmar, pharmacies nationwide will be able to accept e-prescriptions from September 1st.
The federal government has already introduced appropriate measures so that data can be used for research and development. In 2023, data from the ePA should be “available voluntarily and in compliance with data protection via the Health Research Data Center”. Only with high-quality and representative data can one benefit from the possibilities of research and treatments can be “revolutionized” – for training data, for testing and for the evaluation of algorithms in healthcare.
European Health Data Space
The availability of data is to be improved through the development of a decentralized research data infrastructure and the planned Health Data Utilization Act (GDNG). In addition to a federal-state working group on digitization, a working group on the subject of data protection is also being planned. In the future, there should not only be national and federal cooperation, but also cross-border cooperation, especially for research into rare diseases. European test and training data would be needed for this, said Dittmar and welcomed the planned European Health Data Space (EHDS).
Dittmar demanded open and standardized interfaces for both the primary and the secondary data. For this purpose, a coordination center for interoperability was set up at Gematik last year – so far there has been a lack of suitable data standards. For the exchange of health data with different primary systems, Gematik is currently working on a standard, the information technology systems in hospitals (ISiK).
800 million euros will already flow into the promotion of the public health service (ÖGD) by 2026. One goal is to ensure interoperability at different levels and to create the necessary interfaces for reporting under compliance with standards. The same applies to the Hospital Future Act, which was also passed in 2020 and is intended to advance digitization in the healthcare system. Both are important for an “interoperable ecosystem”. Finally, Dittmar emphasized again that “the measures for the further development […] all of them had no “end in themselves” and would only serve modern health care.
Patient rights not provided for
The Bavarian state data protection officer Thomas Petri, on the other hand, was critical of a first draft for a common health data room. According to the Commission, healthcare providers such as doctors should “make the data they have received from patients available to an access point for health data set up by the EU member states”. This is the case to an extent that “far exceeds the scope of primary use”.
In the case of primary use, data is collected and processed in direct connection with a healthcare service provided – users can usually object to this use. Secondary use means the use of health data outside of a health service, for example in the public health service or in research.
In Petri’s view, it would not only be about the ePA, but about “a lot more data”. As soon as someone wants to use data for secondary purposes, an application must be made to the access point. It is then checked in which form – pseudonymised or anonymous – the applicant receives the data. Petri criticized the fact that patients’ rights do not exist and are not provided for in the context of this type of data transfer. Although the General Data Protection Regulation remains “unaffected” in this way, the data would still be passed on due to an unexceptional obligation to transmit and provide the same.
“Extremely dubious in terms of fundamental rights”
Clinics or large practices are subject to this obligation to pass on highly sensitive data, without patients having a say. This is “extremely questionable in terms of fundamental rights” and contradicts Article 8 of the EU Charter of Fundamental Rights, which guarantees everyone the right to the protection of their personal data. In this context, he called for the further development of the role of patients in the context of primary use. Without citizens’ trust in the infrastructure and the right to co-determination, the subject of eHealth can never be successfully launched.
In order to create the legal framework, according to Ulrich Gassner from the University of Augsburg, a Health Data Utilization Act (GDNG) is required that involves various stakeholders such as research, insurance companies and insured persons, clinics or civil society organizations.
In connection with a feared misuse of health data, Gassner listed the complaint by the Society for Freedom Rights. This was directed against a core requirement of the “Digital Health Care Act” (DVG), according to which the statutory health insurance companies are to transmit pseudonymised sensitive health data for research purposes and without the consent of the citizens to the GKV-Spitzenverband by October 1 at the latest. He also listed implementation options for the planned opt-out procedure for the ePA, such as low-threshold objection options. The Doctors’ Day also called for “adequate, user-friendly consent models” for the release of health data.
To home page
#Bavarias #Health #Minister #Data #protection #discussion #paralyzes #eHealth #progress