The (electronic) patient file: right of access and filling

Such refusals are justified if there are significant therapeutic reasons or the rights of third parties that prevent access. In the course of digitization, the electronic patient file (ePA) - which will be automatically available to legally insured persons from next year unless they explicitly object - is increasingly replacing the doctor-managed patient file. With the ePA, as a core element of the telematics infrastructure (TI), data sovereignty lies with the patient themselves, unlike with the doctor-managed version, see Section 341 Para. 1 S. 1 SGB V. According to Section 346 SGB V, patients are entitled to support in filling in the ePA. However, this entitlement is limited accordingly by the rights of refusal under Section 630g BGB.

Inspection and requests

Patients have a legitimate interest in the use of their health data, in particular in the collection of this data and the assessment of their state of health. In accordance with Section 630g (1) BGB, the patient therefore has the right to inspect their patient file.

The right to inspect the patient file must be granted at the patient's request. A special legal interest is not required for this. According to Section 630g BGB, the patient himself is generally entitled to inspect his patient file.

However, this right to inspect files is not recognized without restriction, which is reflected in Section 630g para. 1 sentence 1 half-sentence 2 BGB: "The patient shall be granted immediate access to the complete patient file concerning him/her upon request, unless there are significant therapeutic reasons or other significant rights of third parties that prevent such access."

Scope of the right of inspection

Section 630g para. 1 sentence 1 BGB primarily entitles the patient to inspect the complete patient file. This includes all documents contained therein, including medical, objectified findings, reports on treatment measures, operations and medication. The descriptions of subjective perceptions and personal impressions of the person providing treatment are also part of the patient file.

However, the right of access can also be denied in individual cases if the rights of third parties or significant therapeutic reasons make this necessary. However, high demands must be placed on the therapeutic reasons. Therapeutic reasons generally only prevent access to the patient file if access would endanger the patient's health.

An individual assessment must always be made between the right to informational self-determination and the opposing therapeutic reasons. According to Section 630g (1) sentence 2 BGB, a decision to refuse access must be justified. In the event of the patient's death, the provisions of Section 630g (3) BGB apply.

Copy of the patient file

In accordance with Section 630g (2) sentence 1 BGB, the patient may request a copy of their patient file. The cost regulation according to Section 630g para. 2 sentence 2 BGB is no longer applicable since the judgment of the ECJ of 26.10.2023 (Ref.: Case C - 307/22). In accordance with Art. 15 GDPR, every data subject has the right to receive a copy of their personal data, which must be provided free of charge in accordance with Art. 12 para. 5 sentence 1 GDPR. The initial provision of information is free of charge; fees may only be charged for additional copies in accordance with Art. 15 para. 3 sentence 2 GDPR.

Post-mortem, however, Section 630g (2) BGB applies without restriction. The GDPR does not recognize post-mortem data protection, so heirs and relatives cannot invoke Art. 15 GDPR.

Electronic patient file (ePA)

§ Section 630g BGB presupposes that the patient file is kept and checked by the person providing treatment in order to record the treatment process. In contrast to this is the ePA, which is intended to replace the previous doctor-managed patient file. The difference is that the patient file was previously only kept by the practitioner, whereas the EPR is kept (purely) by the patient. The patient therefore has sovereignty and control over which data and information is to be stored and documented. However, the EPR does not replace the doctor's treatment documentation.

Although the health insurance companies manage the electronic patient file, data sovereignty lies with the patient. However, as patients generally do not have the specialist knowledge and treatment context, they have a claim against doctors in accordance with Section 346 (1) and (3) SGB V for filling, updating and maintaining the electronic patient file.

According to the wording of Section 346 SGBV, the entitlement to filling the EPR is granted without restriction. In contrast, however, the right to inspect the patient file may be denied for therapeutic reasons, among others. It is therefore questionable whether the right to have the ePA filled in by the treating physician may also be denied in individual cases. In our opinion, there is much to suggest that the right to have the EPC filled should not be granted without limit. Significant therapeutic reasons or the rights of third parties must also be taken into account when filling the EPC, as the protection of patients or third parties - which is the purpose of the provision in Section 630g BGB - must also be taken into account in this context. The filling of the electronic health record is limited to information that a patient could also obtain by inspecting the patient file. The right to access information in accordance with Section 346 SGB V is therefore restricted by Section 630g para. 1 sentence 1 BGB to the extent that there are significant therapeutic reasons or other third-party rights to the contrary.

In addition, the claim to filling is already subject to restrictions under Section 346 para. 1 sentence 2 SGB V, as it is limited to the current treatment. It is not necessary to re-enter older or third-party paper-based data. The ePA does not guarantee completeness.

Remuneration for filling in the ePA

The remuneration for filling the EPR, which was previously limited until 31.12.2023, will be continued beyond this period. The fee schedule item (GOP) 01648 will continue to be remunerated outside the budget, which means that remuneration of EUR 10.23 will be granted for filling the patient file. This service includes in particular the uploading of findings, doctor's letters and other relevant documents that are important for the current treatment. For additional entries, only the regular additional flat rate according to GOP 01647 in the amount of EUR 1.72 is reimbursed. This regulation will remain in force for the time being until 14.01.2025.

In conclusion, it can be stated that the right to inspect patient files in accordance with Section 630g (1) of the German Civil Code (BGB) is a central element of patient protection that substantiates the principle of informational self-determination. It ensures that patients can view their medical data, although this right can be limited by significant therapeutic reasons or the rights of third parties. The introduction of the ePA as an alternative to doctor-held records offers patients more control over their personal health data. However, it remains the case that this development does not undermine the core principle of the right of access and its limitation.