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How to use patient information forms in a legally compliant manner

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How to use patient information forms in a legally compliant manner

Many doctors provide information about major and minor interventions with the help of information sheets. But the patient’s signature on the form is not enough. How to use information sheets correctly and thus minimize your liability risks.

Pre-printed information sheets have become indispensable in medical practice. They inform the patient about an upcoming examination or an intervention and help doctors to structure and individualize the medical information in the family doctor’s practice. They usually contain a detailed description of the procedure, an anamnesis and documentation section and the final declaration of consent for the patient. A major medical publisher has over 2,000 of these forms available for almost any type of exam or procedure.

Errors in explanation can constitute a treatment error

However, anyone who, as a doctor, relies on the obligation to provide information (You can read about the information obligations of doctors here) To do enough if he simply presents the patient with an information sheet to sign, which is wrong. Consent given in this way by the patient to a treatment or an intervention is usually invalid. This means that an error in treatment can exist in the form of an error in the disclosure – with serious liability consequences. Because the sheets are only an instrument to support medical education, but do not replace them. However, a correctly conducted explanation with the help of an information form together with documentation can relieve a doctor enormously in the event of a medical liability lawsuit. It is therefore also important in the family doctor’s practice to use the information sheets correctly.

In principle, every medical intervention represents an intervention in the physical integrity of the patient. Such an intervention is only not regarded as unlawful bodily harm if the patient has consented to the intervention and the doctor has informed him or her in detail beforehand so that he can decide for himself whether he wants the procedure, knowing the process, the purpose and the risks as well as possible alternatives (so-called informed consent).

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Medical information must always be given orally

Enlightenment is at its core Section 630e of the German Civil Code (BGB) regulated. It must always be done verbally, i.e. in a conversation between doctor and patient. Although forms can prepare the informational discussion and ensure the documentation, they cannot replace an informational discussion. The interview must also be conducted by a doctor who is technically qualified for the required measure, but a formal further training qualification is not important. It is also permissible for the information to be provided by a doctor who does not carry out the measure himself. However, delegation to non-medical staff is not permitted.

If the information is provided using an information sheet, this must be handed over

If a doctor clarifies a patient with the help of an information sheet in addition to verbal information, this type of information is only effective if the patient is given the text. Doctors should document the delivery of the text.

In the case of vaccinations that are recommended by the Standing Vaccination Commission, case law also considers, as an exception, clarification by the timely delivery of an information sheet to be sufficient if the patient is given the opportunity to ask the doctor questions about what has been read and to obtain further information.

The correct information given to a patient is particularly important when allegations of treatment errors are made afterwards. After unsuccessful treatment or an unsuccessful procedure, patients often claim that they were not properly informed and would never have consented to the treatment or the procedure if they were fully informed. In a trial, it is not uncommon for statements to be made against statements.

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hypothetical consent
If the information provided prior to an intervention or treatment was insufficient and the patient’s consent was therefore invalid, the doctor treating the patient may, under certain circumstances, invoke the patient’s hypothetical consent. This is regulated in § 630h paragraph 2 sentence 2 of the German Civil Code. After that, the treating person can claim that the patient would have consented to the measure if they had been properly informed. In this case, the lack of information does not lead to medical liability. However, the hypothetical consent is subject to very strict conditions and is only an emergency anchor.

In principle, the doctor must prove that the patient has been properly informed. According to § 630h paragraph 2 in conjunction with § 630e BGB, the doctor must explain and prove that he has obtained the patient’s consent and has informed the patient correctly. But with the large number of patients and the long time that can lie between treatment and litigation, memories can fade. The doctor may remember the process differently than the patient. Witnesses who could be questioned were not always present. The information sheet then represents an important indication for the judge. This has a high probative value. It can also be a valuable reminder for the doctor.

Information sheet can support correct information

It is important that it has been individualized by hand by the doctor providing the information, for example with comments, underlining, notes, additions or drawings. Conversely, the doctor should also note if the patient has no further questions. Of course, the information sheet must not be changed later. If the form is filled out and completed by hand in the presence of the patient, this is an indication that the aspects noted there were also the subject of the oral informational discussion. Conversely, there is also an indication that a point requiring clarification has not been clarified if it is not included or noted on the sheet. The individualized information sheet should both be signed by the doctor and the patient after the information has been provided.

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The proof of proper clarification can be supplemented by the so-called always-so proof. This can help if the doctor no longer has any concrete memories of the process, but can make it credible that he always points out certain aspects of a certain intervention or treatment to his patients, i.e. always explains them in a certain way.

Current verdict on handwritten comments in the information sheet
Only fill out the information sheet in the presence of the patient
An information sheet supplemented by individualized comments can represent important evidence in the event of an allegation of treatment errors. For this reason, some doctors make notes on the form before the informational interview, so as not to forget any aspect or to proceed particularly correctly. This is not recommended. This is because these handwritten entries do not serve as an indication in a possible trial that the patient was actually informed orally about the specific risks of an intervention. This was decided by the Munich I Regional Court (08.06.2021, Az. 1 O 2310/19). A form that was completed by hand prior to the verbal explanation therefore has no significant added value compared to a pre-printed form without handwritten comments.

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