[Legal aspects of quality assurance : Example of operative intravitreal injection therapy]

In the legal evaluation of medical treatments it is important to know which legal and contractual regulations apply.

This article discusses in which context treatment errors play a role and are identified as such.

Relevant German legal framework conditions are discussed and examples with reference to intravitreal injection therapy are given.

The civil law treatment contract between physician and patient results in the medical obligations of a service contract. As a consequence, the physician is obliged to provide the patient with treatment according to the current generally accepted professional standard, including information obligations, the certainty of a diagnosis, the execution of treatment and aftercare. Before claims for compensation and damages for pain and suffering can be enforced, proof of a treatment error and the causal connection must be provided. In court, mostly expert opinions are used to assess what the professional standard is and whether the physician was sufficiently qualified, whether informed consent and documentation met the legal requirements and whether a (gross) treatment error must be assumed. The Patients' Rights Act emphasizes the importance of an open error culture by requiring a practitioner to inform patients of third party/own treatment errors on request or in order to avert health risks, if circumstances are discernible to the practitioner that justify the assumption of a treatment error.

Although ophthalmologists cannot guarantee healing or success but only the treatment, there are many medical obligations for intravitreal therapy. Increased standards of quality assurance can be implemented within the framework of selective contracts.