It is essentially a codification of existing law. The core of the Patient Rights Act is the anchoring of the treatment contract in the German Civil Code (BGB). It regulates the rights and obligations arising from the treatment contract with § 630 a ff BGB n.F.
by Lawyer and Specialist in Medical Law Dorothea Wagner – As of 3/2013
1. Previously regulated by case law on so-called therapeutic or safety information.
- 630 c BGB n.F regulates the medical information obligations at the beginning and in the course of the treatment. Information must be provided about "all essential circumstances of the treatment". In particular, diagnosis, therapy and the "measures to be taken for the diagnosis and therapy."
2. Previously regulated by case law on economic education
New is § 630 c para. 3 BGB n.F. Patients are to be informed before the start of treatment about costs that are not covered by health insurance funds (e.g. individual health services, IGeL services).
These are to be agreed in writing.
3. Previously regulated by case law on informed consent.
630 d BGB n.F. requires the patient's consent for every procedure. The patient can only effectively consent if he has been informed in advance in accordance with the requirements of § 630 e BGB n.F.
If the patient is incapable of consent (e.g. because the patient is a minor, has dementia or is unconscious), the consent of the authorized person (legal representative, authorized agent, supervisor) must be obtained. A new regulation is that this is not required if a corresponding living will in accordance with § 1901a BGB is available that permits the planned intervention. Furthermore, the principles of presumed consent continue to apply in the case of interventions that cannot be postponed.
Section 630 e BGB (new version) specifies the physician's duty to inform.
The treating party is obliged to inform the patient of all circumstances relevant to consent. These include, in particular, the type, scope, implementation, expected consequences and risks of the measure, as well as its necessity, urgency, suitability and prospects of success with regard to diagnosis or therapy. During the consultation, the patient must also be informed of any alternatives to the procedure if several medically indicated and customary methods can lead to significantly different levels of stress, risks or chances of recovery.
Furthermore, it is stipulated that the information must be provided orally and in a manner that the patient can understand – whereby reference can be made to the information documents. The informed consent discussion must take place in person and in good time before an intervention so that the patient can sufficiently consider their decision.
The obligation to provide the patient with copies of documents that he has signed in connection with the informed consent is new. Section 630 e para. 2 no. 1 BGB new version
What is new is the regulation that the information must be provided by a "participant in the procedure". However, Section 630 e (2) BGB (new version) also states: "If the procedure is carried out by a doctor, the information must be provided by a doctor."
The obligation to provide information about a medical error is new (Section 630 c, paragraph 2, sentences 2 and 3 of the new version of the BGB).
If a physician recognizes medical malpractice, even if it was caused by himself, he must inform the patient under certain conditions.
4. Previously regulated by case law on the burden of proof:
Information according to § 630 e BGB n.F. (i.e. only the intervention information) and consent according to § 630d BGB n.F. must in principle be proven by the doctor. Insufficient clarification leads to the assumption that the patient would not have agreed to the procedure.
If the information does not meet the requirements, the treating party can claim that the patient would have consented to the measure even if the information had been provided properly.</span><span>." (previously known as the principles of hypothetical consent)
5. Previously regulated by case law on documentation
According to § 630 f BGB n.F., patient records must be kept in direct temporal connection with the treatment of the patient, completely and in a tamper-proof manner. This also applies to electronic documents.
Patients have the right to inspect their medical records. Physicians may only refuse this in justified individual cases. For example, if a patient with a mental illness should not know the contents for therapeutic reasons.
After the death of a patient, his heirs and, under certain circumstances, his relatives also have the right to inspect them.
6. Previously regulated by case law on the burden of proof in the event of liability for medical malpractice
Fully controllable risks, gross treatment errors, errors in the collection of findings, and errors made by novices lead to a reversal of the burden of proof at the expense of the treating party, Section 630 h BGB n.F. This also means in particular that the lack of suitability or qualification of the physician for the treatment performed leads to the assumption that this was the cause of the damage.
7. Outlook: Hardship Fund
The establishment of hardship funds is intended, from which patients will be financially compensated if they suffer harm in an accredited hospital without proof of fault, are significantly harmed or if the enforcement of their claim for damages would take too long.
The statements represent initial information that was current for the law applicable in Germany at the time of initial publication. The legal situation may have changed since then. Furthermore, the information provided cannot replace individual advice on a specific matter. Please contact us for this purpose.