Patient rights act

Duty of the physician to document

The Patients' Rights Act, which came into force at the end of February 2013, codified the law on treatment and medical liability, thus also anchoring medical documentation in the German Civil Code (BGB). According to § 630f paragraph 1 BGB, the treating physician is obliged to keep a patient file in paper or electronic form for the purpose of documentation in direct temporal connection with the treatment. Corrections and amendments to entries in the patient file are only permitted if, in addition to the original content, it remains recognisable when they were made. This must also be ensured for electronically managed patient files".

The type and content as well as the scope of the documentation are determined by its purpose. The documentation primarily serves the therapeutic interest of the patient as well as ensuring proper treatment and must be made in "immediate temporal connection with the treatment" or the intervention. According to the legal justification, this serves to "avoid inaccuracies". Up to now, case law has considered 2 - 14 days to be permissible according to the circumstances of the individual case (a delay of > 2 weeks or even months, however, would be problematic in any case). Subsequent changes, corrections and additions to the documentation must be indicated. Original entries must remain visible, i.e. complete deletion is not permitted. According to the reasoning of the legislator, the aim of this legal amendment is to ensure that the documentation is "organised in such a way that it is forgery-proof".

Content of the documentation

The medical documentation obligation extends only to circumstances that are essential for diagnosis and therapy according to medical standards. In § 630f paragraph 2 BGB it says: "The person providing treatment is obliged to record in the patient file all measures and their results that are essential from a professional point of view for current and future treatment, in particular the medical history, diagnoses, examinations, examination results, findings, therapies and effects, interventions and effects, consents and explanations. Doctor's letters shall be included in the patient's file." It is true that until now there was no explicit obligation to include the consent and information of the patient in the patient file. However, in the past this was already recommended for evidence purposes. If the documentation is externally correct and there are no concrete indications that could cast doubt on its reliability, the documented course of treatment must be used as a basis for the assessment of whether a treatment error has occurred.

Retention period

The retention period - up to now not uniformly regulated in medical malpractice law - is now "10 years after completion of treatment, unless other retention periods exist under other regulations" (§ 630f paragraph 3 BGB).

Right of inspection of the patient file

In principle, the patient has a right of access to the medical records concerning him or her vis-à-vis the doctor and the hospital even outside of a legal dispute. The basis is the patient's right of self-determination (Article 2 of the Basic Law). Accordingly, the legislator formulates in § 630 Para. 1 BGB "the patient must be granted, on request, immediate access to the complete patient file concerning him or her, unless there are significant therapeutic reasons or other rights of third parties that prevent access". Reasons must be given for any refusal to grant access. § Section 811 shall apply accordingly." As before, the patient can - at his own expense - "request electronic copies of the patient file" (§ 630g paragraph 2 BGB).

Consequences under the law of evidence

The existence of a treatment error and the causal relationship between the treatment error and the primary damage that occurred must always be proven by the patient. If the documentation obligation is violated, the presumption - in connection with the previous case law - leads to the fact that the measure requiring documentation must be regarded as omitted. Accordingly, § 630h, Subsection 3, BGB, now states: "If the person providing treatment has not recorded a medically-bound essential measure and its result in the patient file, contrary to § 630f, Subsections 1 and 2, or if he has not kept the patient file, contrary to § 630f, Subsection 3, it is presumed that he has not taken these measures. However, the presumption does not automatically extend to the fact that the failure to take such measures caused the damage to health. The doctor has the opportunity to refute the presumed failure and to prove the contrary.