Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes

On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020.

One of the main objectives of the bill is to make everyday life easier for patients and healthcare professionals by increasing use of innovative digital applications, while protecting sensitive health data. It is assumed that increased digitalisation in the healthcare sector will open up opportunities at all levels of healthcare, both for patients and healthcare providers. As such, it is expected that digitalisation will help to take care of the growing number of chronically ill patients, to relieve the burden on specialists, to make better use of resources and to prepare the healthcare system for the challenges of the future.

A series of documents that so far has only been provided and used in hardcopy, such as certain prescriptions or patient files, will now be made available in digital form. In addition, a special app shall be made available to enable patients to redeem digital prescriptions in pharmacies. Alternatively, patients may present a 2D barcode on paper. In this case, the prescription will also be transmitted to the pharmacy in digital format. Further, the law aims to enable patient referrals from one doctor to medical specialists to be made in digital form (currently this is done in writing and requires the referral to be collected from the doctor’s office).

From 2021, statutory health insurance providers will be obliged to offer their insured persons electronic patient files (ePA). To ensure that this is effectively used, patients may request that their doctor include their medical records in their personal ePA. In addition, from 2022, the ePA will also be able to display other information that is currently only documented in hardcopy, for example, maternity logs, paediatric health records and vaccination cards. To incentivise doctors, they will be paid to use ePAs. Patients will ultimately have control over their ePAs and be able to decide which data is stored there and who will have access. For example, patients may specify that a doctor may have access to the ePA, but that certain findings are not displayed. The protection of the processed patient data is ensured by a gapless regulation of the chain of responsibilities.

From 2023 onwards, patients will have the option of voluntarily making the data in their ePAs available to researchers as part of a “data donation”. The donation could become an important element to increasing the availability of real-world evidence on new treatments and medicines. Informed consent will be required from each of the patients, and it will be possible for that consent to be given digitally. Patients will be free to choose the scope of their data donation and can limit access to certain information. The data that is released will be restricted to certain research purposes, like research on improving the quality of healthcare.

This new law will have a significant impact on the digitalisation of the entire German healthcare system. It will also create a better infrastructure for research with patient data and for collecting real-world-evidence for scientific and regulatory purposes.

Healthcare companies, providers and payors as well as technology and research companies should closely follow the next steps of this legislative development in Germany.

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