>> “We only receive suitable specific data from the KBV if the weather is good, a very specific constellation has occurred, or if someone has not been paying attention,” said Prof. Dr. Bertram Häussler told “MVF” (03/2013). That was six years ago now. In the same cover interview, he called for the power instrument “data availability” to be curtailed. “More options for accessing data are needed.” Healthcare researchers would finally need a public use file that is openly accessible to everyone, regardless of the question. With the use and testing of the first EGA, this demand is gaining momentum, as structures could now be created that enable healthcare research to access the resulting data.
The introduction of the electronic patient record (EHR) is also gaining momentum at the political level. The Bundestag only recently passed the Appointment Service and Supply Act (TSVG). Health insurance companies must therefore provide their insured persons with an electronic patient file (EPA) by 2021 at the latest. X-ray images, findings, emergency data, medication plans or laboratory data should be digitally accessible - for treating doctors, but also for patients via smartphone. This is a paradigm shift from the previous approach within the framework developed by gematik over many years.
developed telematics infrastructure, which stipulated that patients should only have access to their data in the presence of a practitioner - by using the patient and professional card at the same time.
The change in the law further paves the way for a uniform EPA within the telematics infrastructure. Doctors, health insurance companies and gematik agreed on the specific design at the end of 2018. The basic concept for the EPA is based on the gematik model for the EPA architecture and provides for central storage of the data. In addition, the National Association of Statutory Health Insurance Funds should coordinate a working group of health insurance companies that defines the structure of the EPA. This should:
• a standardized area for storing medical information,
• a competition area with information from the individual health insurance companies
• as well as an area for patients to manage their fitness or nutritional data.
Shortly before Christmas 2018, gematik also published specifications, approval procedures and field test concepts for the components and services for the electronic patient record. “The file providers can now rely on an inter-operable system architecture with defined interfaces when developing their solutions,” assured Dr. Thomas Kriedel, board member of the National Association of Statutory Health Insurance Physicians and deputy chairman of the shareholders' meeting.
And this is an important orientation for the EGA, who are already in action. These will initially continue to run, but will later be merged into the EPA as part of the telematics infrastructure. Several EGA solutions are currently available on the market or are being tested in pilot projects.
They can be differentiated into solutions from health insurance companies, universities and private providers. The only ones who have already given concrete thought to health services research's access to the relevant data are - one might say naturally - the university hospitals. As part of the “INFOPAT” project (information technology for patient-oriented healthcare in the Rhine-Neckar metropolitan region), for example, scientists at Heidelberg University Hospital are developing a cross-institutional electronic patient file (PEPA). This is intended to improve the treatment processes. In four clusters, interdisciplinary teams each deal with a specific topic of digitalization within the healthcare system. The topic of Cluster 4: Use of health data for research purposes using a research platform.
Aline Kunz (MSc), research associate from the department of general medicine and health services research at Heidelberg University Hospital, explains exactly what this cluster is about: “As part of the INFOPAT project, a monitoring and reporting platform should improve the cross-sector quality of care for patients with colorectal cancer “Early detection, diagnostics, therapy and aftercare and serve as a basis for quality improvements.” The aim of the application project managed in her department was to implement cross-sector quality indicators (QI) using the example of colorectal cancer. This QI combined clinical data with data documented by patients (Patient Reported Outcomes), explains Kunz. Within the “Data Mart” to be developed by the Center for Information and Medical Technology at Heidelberg University Hospital, clinical data and patient surveys from the PEPA should then be integrated using algorithms, condensed, analyzed and finally used to calculate the QI.
In addition to hurdles in terms of technical feasibility, dependencies between different components of the PEPA presented a challenge on the way to becoming a research platform, said Kunz. As a result of the cluster, a concept is now available that links data from different data sources within a PEPA and thus innovatively addresses the existing challenges of data linkage in quality assurance, reports the research assistant. “In addition, the focus groups conducted showed that the topic of public reporting receives little attention from patients in everyday life,” she states. It is therefore important to approach the benefits and design of public reporting in a more differentiated manner. “Above all, the very different perspectives and expectations of patients should be taken into account in more detail.” According to the different needs and expectations of patients, appropriate customization of the reports could result, she suggests.
Which institutional, technical and
What technical requirements are now required on the scientific side in order to be able to prepare and evaluate the digitally recorded health data for health services research? “Despite all the technical possibilities, it should always be and remain the top priority not to collect any data that does not serve a meaningful and ethically justifiable scientific purpose,” warns Kunz. For this reason, the targeted and far-sighted planning of research projects is an important prerequisite for being able to use this new vehicle for generating scientific knowledge for a long time and successfully. “The very important component of 'Patient Reported Outcomes' will only remain available to us in the long term if patients have trust and can assume that their data will be handled correctly,” the scientist is convinced.
In contrast to the EGA projects of university hospitals, the EGA of the health insurance companies does not yet provide an option for data use by health services research. Markus Juhls, press officer at AOK Nordost, provides an insight into the current status and expansion of the AOK network. In March 2018, the joint project between AOK Nordost, the doctor network HaffNet and the AMEOS Klinikum in Ueckermünde went live. The first focus was digital admission and discharge management. With the patient's consent, the referring doctor allows the clinic to gain insight into the patient's medical history and findings.
In July 2018, the health work in Berlin started with the focus on pregnancy. The partners Vivantes and Sana are involved in the capital, as Juhls reports. “In this pilot, the ongoing implementation focuses on the exchange between the maternity clinic and the expectant mothers. For example, they can provide their maternity record, reports on previous births and the results of outpatient preventive examinations.” The clinicians can in turn upload structured documents such as ultrasound findings, laboratory findings, surgical reports or discharge letters into the digital health network, says Juhls.
The health insurance companies are currently primarily concerned with expanding the technical basis of the EGA. This is also shown by the statement from the Techniker Krankenkasse (TK). “Our focus at the moment is on building the basic functionalities and networking,” says Silvia Wirth, press officer at TK and responsible for the topics of digitalization and e-health, electronic health records and digital care. The topic of data donation is on the to-do list, but the main focus initially is on creating a database and building an attractive, beneficial offer for “TK-Safe” users.
Data donation – one
“option worth considering”
But would the health insurance companies actually be willing to make the health data from the EGA available to health services research? The CEO of the DAK, Andreas Storm, can basically imagine making the funds available to his fund available “naturally anonymized and pseudonymized” (see p. 12). Wirth also sees “a great opportunity in the future to achieve new insights for better care through health care research with EPA and EGA data.” What is crucial is that “it must be within the sovereignty of each individual patient whether he wants to donate his data for research purposes”. In addition, according to her statement, some technical and legal hurdles still need to be overcome. It sounds similar in the statement from AXA: Currently, a corresponding function is not part of the “My Health” service. “In perspective, this is an option worth considering, taking into account all data protection regulations, which are our top priority for the benefit of our customers,” it continues.
“Vivy” CEO Christian Rebernik also emphasizes the user’s sovereignty over his data in connection with the data access issue. “If they want to make them available anonymously, this can of course create new opportunities, especially in the area of health services research.”
Michael Noll, project manager at the AOK Digital Health Network and digitalization program manager at AOK Baden-Württemberg, emphasizes that patients should know exactly which data donation they have agreed to. He assumes that the effort involved in making the data available as part of this donation depends on whether unstructured data or structured data is used. Anonymization is more difficult for unstructured data, such as PDFs or image files. “We think that the goal should be to use structured data in healthcare as quickly and extensively as possible.” The anonymization of structured data is relatively easy compared to the AOK’s entire network project. “The infrastructure exists or is being built. And then data can also be used by healthcare research as part of the data donation,” assures Noll. “Of course you need the appropriate legal framework for this,” he adds.
In this context, his colleague Juhls emphasizes that although the AOK offers its insured persons the platform for exchanging their medical data, it does not at any time have access to the data and documents of the participating insured persons and doctors, nor does it have any health data via the portal the EGA collects. “If insured persons give their consent to the anonymized use of the data (for the purpose of health services research) for future value-added applications, then individual health data could be used for this purpose,” says Juhls. “However, this option is currently not provided.”
In this context, Juhls also refers to the experiences of other countries, which show how the data from the EPAs there can often be used for research purposes. “In Germany too, these models could contribute to greater quality of care for the benefit of all insured people.” Just a fraction of all future patient record users could thus (due to many anonymized data points) ensure an improved research basis, which in turn would benefit the entirety of affected patients. can benefit patients. “The condition, however, is that data access is strictly regulated,” he clarifies. The Federal Data Protection Act and the Social Code would have to be adapted so that corresponding research associations are permitted in the future.
The private EGA provider vitabook is a big step further than the health insurance companies when it comes to data donation. Its managing director Markus Bönig says that the data collected with the help of “vitabook” could potentially be used for health services research. “This is possible without any problems if the patient expressly agrees that their data may be used by their doctor for health care research purposes,” explains Bönig. “The patient is the sole owner of his data, and he can authorize and revoke this authorization as he wishes in his IT system.”
Bönig illustrates that this practice is already a reality using the example of the NeuroTransData doctor network for the indications MS and migraine: The network's patients can make the collected data available to their doctors digitally for healthcare research purposes. “It is very important for medical progress that real live data from patients reaches doctors,” the managing director is convinced. “This is actually very rarely the case today,” he complains and calls for more commitment from EGA providers: “We can be an important basis for patients and doctors to exchange data digitally – for individual treatment benefits, but also for research purposes .”
In this case, the procedure for donating data looks like this: The patient puts a check mark on a written form to the doctor under “My data may be used anonymously for health care research purposes” and a “vitabook” health account is created. “With such an account, the measured values recorded by the patient are returned to their doctor at NeuroTransData and are already used for research purposes,” explains Bönig.
The managing director believes it is realistic that the data from EPA and EGA will be incorporated into health services research in the future. Because “significant progress is only possible if patient data about everyday care is available.” However, if no one defines what kind of data the patient should collect, the patient cannot collect the corresponding data. “So this data, which was never collected, cannot be analyzed to gain insights,” the expert concludes. What has long been normal for migraine patients, for example, is that their living conditions are also asked. “This is not yet standard for almost all other diseases, not even in an analogous form. “If thousands of patients are now asked and answered the right questions, it will be a spectacular breakthrough,” says Bönig. This is exactly what his company has achieved with the therapy configurator “Therapyplan.Plus”.
Using the “ArztundPatient.Plus” program, the doctor creates a therapy plan template in which he states the patient’s indications and medication. A “vitabook” health account is automatically created for the patient. This person will be asked by email to change the corresponding password. The “Patient.Plus” health file forms the basic building block of the “vitabook” account, where the exchange of documents and the connection to other players in the healthcare system are possible. vitabook launched the “Arzt&Patient.Plus” platform in October 2018. Doctors and patients are supposed to work together on this IT platform and thus close the gap in doctor-patient communication. Doctor-doctor communication is already covered by the TI (see interview with Markus Bönig in “Pharma Relations” 10/2018).
In the end, it will depend on how politicians deal with data use and possibly even donation. While Prof. Josef Hecken, the impartial chairman of the G-BA, spoke out in favor of mandatory data donation at the “Future E-Health” parliamentary group congress of the CDU/CSU parliamentary group, the state secretary in the BMG, Lutz Stroppe, spoke at the “Diabetes 2030” symposium ( see p. 18) that the digitalization law due this year should regulate which data can be made available for research. Stroppe: “Before the EGA comes at the beginning of 2021, we have to clarify the question of data use for research.”
There needs to be a change among doctors and patients
Whether and which institution is required where the EGA data could be collected – none of the respondents gave a concrete answer to this question. Noll tends to reject the idea that an additional institution is needed that brings together all data from EPA and EGA in a central location, manages it and makes it available to health services research. He is an advocate of a decentralized idea of data storage and access on distributed networks. “But we probably need a neutral, trustworthy institution to which the patient transfers the rights to his data in the form of a data donation - to ensure that this data is used for medical research,” admits Noll. “It’s up to others to decide which institution should actually do this.”
“What is most important to us is that every insured person becomes, is and remains master of their data – and that it is stored in accordance with the highest security and data protection standards,” says Rebernik. Bönig counters with the counter question: “Do I want all of this data to be in state hands?” From his point of view, it could also be a medical organization or a university clinic. But that also raises questions, such as: “Are the patient’s interests being sufficiently taken into account and, above all, is it happening quickly enough?”
But he is convinced that it could also be an organization that serves patients – like vitabook. In his opinion, it's not about all data and not just about insured people. “It's about the individual patient, the individual citizen, who, above all, needs their own IT system with which they can record data themselves and exchange this data with any doctor.” In addition, he emphasizes, they can data are explored. “Above all, what is important here is transparency so that unpleasant topics are not suppressed – but rather that the entire spectrum of findings is made possible for research.”
But that still seems to be a long way off, because the EGA providers themselves also have a lot to learn. For example, the vitabook expert explains that expectations and reality are often still far apart. Although over 90 percent of patients stated in surveys that they would like to have their data digitally, “in fact, less than 5 percent ask their doctor specifically. The patient type “digitally savvy, self-confident and enlightened” reaches its limits if the doctor doesn’t cooperate. “We had to learn that an isolated IT system for the patient in which doctors are not involved does not work.” Self-determination back and forth, in fact it is essentially about the relationship between doctor and patient - this can be supported technically. A patient's own IT world without the doctor just doesn't work. “There needs to be a change in the behavior of both the medical profession and patients so that this vision can become reality on a broad front,” concludes Bönig. << Author: Olga Gilbers

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