On a recent parliamentary evening in the Deutscher Bundestag, a new study carried out by iRights.Lab in collaboration with the Bundesdruckerei (Federal Printing Company) was presented: “Zukunft Gesundheitsdaten –Wegweiser zu einer forschungskompatiblen elektronischen Patientenakte” (“The future of health data – towards research-compatible electronic health records”).
The study benefited from the input of a range of perspectives and expertise. The two lead authors, Ramak Molavi and Michael Kolain of the iRights.Lab team, were careful to take into account the latest developments in this area.
Several key challenges must be overcome if Germany is to be able to utilize the full potential of digitization in the field of eHealth.
- Secure, robust, easy-to-use infrastructure: A comprehensive and robust telematics infrastructure must be established. This must be usable and easy to operate for all parties involved.
- Patient sovereignty: Health data storage is decentralized, and the patient can manage access to their data autonomously via a secure infrastructure that acts on their behalf, and which provides all necessary functions, such as identification and certified pseudonymization or the possibility of passing on data to third parties for research purposes. This infrastructure, referred to in this study as a “data trustee,” should be provided by the state free of charge.
- Research compatibility: Health data holds great potential for both the diagnosis and treatment of diseases. To ensure that its use and aggregation does not conflict with patients’ right to the special protection of their sensitive data, the study relies on distributed responsibilities and places a special focus on the security of the infrastructure.
- One proposal that emerges from the findings is that the data in electronic health records can be made available to research through a graduated process. A “trust center” would provide for pseudonymization––in which it is made more difficult to determine the identity of the patient––or anonymization––in which re-identification of the patient is impossible. Another institution, the research data centre, would then process this health data, which can then be securely and anonymously transferred to independent scientific institutions. Health data would thus always be stored in a decentralized and fragmented manner.
In order to increase patients’ willingness to support research by handing over their health data, our study suggests that research institutions should make their research results available to the public, and especially to patients, in return, and provide them in a comprehensible, visually presented form. The convergence of usability and research compatibility on the one hand and security, robustness and data protection on the other hand is a core concern of the study.
For the entire study, the focus remains on the patients. The protection of health data and the patients’ ability to use this data in a self-determined manner must have top priority. Otherwise trust and thus the success of electronic health records cannot be guaranteed.
“With a robust telematics infrastructure and an electronic patient file managed by the insured, a trustworthy digital space for health data is created. Instead of the diffuse fear that patients’ private data will become freely accessible, we will uphold the model of a sovereign and self-determined patient. This is a patient who can take their health and convalescence into their own hands and manage their health data from a private end device at their own discretion. Such a patient can make the data from their electronic health records available to medical research without worries and in return can receive tangible benefits.” (Study: The future of health data)
Here you can download the entire study.
You can find the film of the event here.