The draft for the German Patient Data Protection Act (PDSG) is now available, federal health minister Jens Spahn announced at the end of January.

The draft bill, now subject the vote of the federal government, is intended to regulate access rights to patient data in the electronic patient record and digital health applications, but also to make use of it to the benefit of patients.

If the draft is passed in its present form, numerous provisions will come into force that promote the self-determination of patients with regard to their health data, such as the possibility of data donation without personal reference for scientific research, the regulation of electronic patient record access rights for physicians under patient sovereignty, the right of insured persons to have their treatment data made available, and also their one-time instruction in EPR use.

Furthermore, numerous deadlines have been set, including for gematik, the company for telematics applications of the health card, to provide an ePrescription app. In order to strengthen semantic interoperability in the German healthcare system, the PDSG provides for binding terminologies and standards such as SNOMED.

WHY IT MATTERS

According to the current schedule, the EPR will be available to German-insured people from the beginning of 2021. Insured persons will then be able to access their own medical data via a smartphone app provided by the health insurance company.

However, complex functions such as the viewing of vaccination data, maternity records or U-book, an examination booklet that German doctors provide for young children for obligatory examinations from birth to the age of 12, will only be possible from 2022 onwards, the minister announced. The possibility of donating research data is being considered from 2023.

The goal of the new PDSG is to prevent electronic patient data from falling into the wrong hands, the minister emphasised in his announcement. At the same time, patients should be given the chance to use their data sensibly.

“In this respect, this law is a patient protection but also a patient benefit law,” explained Spahn, referring to the improvement of care, the immediate availability of treatment and medication data and the acceleration of doctor-patient communication.

“The patient decides what he wants to store and which doctor accesses it. In return, he gets the key and the right that the doctor will have to fill the patient file in future if the patient wishes him to do so,” he continued, emphasising the added value that the EPR will bring to German patients in their everyday lives.

With this dual mandate - data protection and the utilisation of data - the PDSG is now in the crossfire of interests between data protectionists, physician and patient representatives on the one hand and industry and research on the other.

With the announcement of the draft law, therefore, many voiced their opinions, and some of them were critical. In a press release, the Association of Independent Doctors (FÄ) criticised the submitted draft in that patient data would not be secured in the new EPR.

ON THE RECORD

“Confidentiality, integrity and data security do not correspond to the security profile 'high', but this is required for medical data,” explained the FÄ vice chairwoman Dr Silke Lüder. She criticised the fact that health insurance companies had created an EPR where all medical data would in future be stored centrally at IT companies via insecure mobile phone apps.

She also criticised the fact that, at least in the first year after the introduction of the EPR, the insured would not be able to decide which doctors could view which parts of the files.

Other stakeholders in the healthcare system, on the other hand, found the protection of patient data in the PDSG much too tight. In a recent statement, the Association of Research-based Pharmaceutical Companies (vfa) said the draft would slow down the possibilities of digital patient files because the data would be limited and not directly usable for industrial research.

The German Association of Replacement Funds (vdek), which represents the interests of all six replacement funds, which together insure approximately 28 million people in Germany, once again expressed its positive view of the draft law in a press release:

“With the proposed regulations, the EPR will be filled with life. It will make innovative digital medical applications available to all insured persons in the future. We expressly welcome this,” stressed Dr Jörg Meyers-Middendorf, Chairman of the vdek. It is particularly good that the sovereignty of the insured is strengthened, Meyers-Middendorf continued.

In contrast, the vdek did not consider it appropriate for doctors to be allowed for a surcharge for processing data in the EPR. Documentation and anamnesis would already be reimbursed via the basic and insured flat rates. The association stated that extra remuneration was not understandable.