Informed consent

1. introduction: definition of informed consent

Informed consent in the medical context refers to the patient’s conscious and informed consent to treatment. It is based on the right to self-determination: only treatments that are supported by the patient’s will may be carried out. Before any intervention, the patient must therefore be informed – i.e. fully informed about the diagnosis, type and course of the procedure, risks, alternatives and prognosis – and then asked for their consent. Without effective consent, the procedure would be legally regarded as bodily harm would be considered bodily harm. Informed consent is therefore a central component of a doctor’s duty of care and patients’ rights. It ensures that patients can consent to treatment on their own responsibility and on the basis of comprehensible information. This principle has established itself internationally as a medical-ethical standard and is clearly enshrined in law in Germany and Austria.

2. legal basis in Germany (BGB, Patients’ Rights Act, StGB)

In Germany, informed consent has been expressly regulated in civil law since the Patient Rights Act 2013. § Section 630d BGB stipulates that the patient’s consent must be obtained prior to any medical procedure – following proper information in accordance with Section 630e BGB. This consent is only effective if the patient has been informed of all essential circumstances beforehand (duty to provide information). In practical terms, this means that consent is not valid without information. Doctors must inform the patient in particular about the type, scope, implementation, foreseeable consequences and risks of the treatment as well as the necessity, urgency, prospects of success and treatment alternatives. The information must be provided verbally, in good time and in an understandable manner. Patients have a right to be informed in understandable language and without medical jargon; translations or interpreters are required in the event of language barriers.

Without effective consent, any treatment would be unlawful. Under criminal law, medical treatment is considered an offense of bodily harm (Section 223 StGB), which is, however, justified by consent. § Section 228 StGB permits bodily harm with consent, provided there is no violation of public morals. Specifically, every medical intervention initially constitutes bodily harm, but this is exempt from punishment if the patient has given prior, properly informed consent. If this consent is lacking – for example because the information provided was inadequate – even a medically successful intervention can be punished as intentional or negligent bodily harm. The Federal Court of Justice has formulated this principle succinctly: “Any medical treatment […] constitutes bodily harm if it is carried out without the patient’s effective consent.”.

Under civil law, a breach of the duty to inform means that there is no effective consent – the treatment is then unlawful and can give rise to claims for damages or compensation for pain and suffering. § Section 630e BGB specifies the duty to provide information in the treatment contract, and Section 630h BGB regulates the burden of proof: in the event of a dispute, the treating party must prove that they have informed the patient in a way that enables consent. If the doctor cannot disprove inadequate information, it is assumed in favor of the patient that they would not have consented if they had received sufficient information – which establishes liability (information error). Since the introduction of the Patients’ Rights Act, these principles have been enshrined in the German Civil Code, which strengthens the legal position of patients.

In addition, special regulations apply for special situations: In the case of patients who are unable to give consent (e.g. unconscious persons or persons with dementia), an intervention may only be carried out with the consent of a legal representative (legal guardian or authorized representative), unless there is a written living will within the meaning of Section 1827 of the German Civil Code (BGB) that expressly permits or prohibits the treatment. In an emergency (measure that cannot be postponed), treatment may also be carried out without prior consent if this corresponds to the patient’s presumed wishes – for example, to avert danger to life.

In summary, all medical treatment in Germany is based on a treatment contract (Section 630a BGB), the validity of which requires the patient’s informed consent. The legal norms (Sections 630d, 630e BGB) oblige doctors to provide comprehensive Patient Education as the basis for consent. Failure to comply with these obligations makes doctors liable to civil and criminal prosecution. The requirements for providing information in practice are correspondingly high.

3. legal basis in Austria (ABGB, ÄrzteG, PatVG)

Informed consent is also enshrined in law in Austria. The Adult Protection Act 2018, which clarified patients’ rights in the General Civil Code (ABGB), brought a decisive innovation. § SECTION 252 ABGB stipulates that a person of legal age who is capable of making decisions can only consent to medical treatment themselves. No one else (e.g. relatives) may validly consent in place of a patient capable of giving consent – an expression of the right to self-determination. Medical measures may only be carried out with the consent of the informed patient. If the patient lacks decision-making capacity (e.g. in the case of unconsciousness or severe mental impairment), the following provisions apply § 253 ABGB regulates the procedure: In this case, the consent of a healthcare proxy or adult representative (formerly: guardian) is required, who takes the patient’s presumed will into account. Where possible, doctors are required to involve and support the patient in the informed consent process despite their limited decision-making capacity. In acute emergencies, a similar exception applies as in Germany: if immediate treatment is necessary, this may be carried out without prior information and consent if delaying it would seriously endanger the patient’s life or health.

A special feature of Austrian law is the explicit provision on the consent of minors in § 173 ABGB. This stipulates that a minor child who is capable of understanding and judgment can consent to medical treatment themselves. However, in the case of serious interventions that are associated with long-term impairment, the consent of the legal guardian (parent) is also required, even if the minor is capable of making decisions. This double safeguard is intended to provide special protection for children in the event of risky interventions. If the child is not capable of making decisions, the parents (or legal representative) decide in the child’s best interests. In an emergency (imminent danger), treatment may also be carried out without consent if it is not possible to obtain consent and delaying treatment would endanger the child’s life or health.

The Austrian Medical Practitioners Act 1998 (ÄrzteG) obliges doctors to provide careful information and documentation. Although there is no single paragraph equivalent to § 630e BGB in the law, the duty to provide information arises from the general duty of care and from patients’ rights. For example, patients have the right to inspect their medical history and receive comprehensive information. § Section 51 ÄrzteG regulates the documentation obligation (see section 6) and thus implies that all essential measures – including informative discussions and consents – must be recorded. The Austrian Patient Charter and professional guidelines of the Austrian Medical Association also require comprehensible information as a prerequisite for patient consent.

An important part of the Austrian legal framework is the Patient Decree Act (PatVG). Since 2006, patients in Austria have been able to use living wills to specify in advance which medical measures they refuse in the event of their own incapacity to make decisions. A distinction is made between binding and honorable living wills. A binding living will meets strict formal requirements: it must be drawn up in writing after comprehensive medical information about the nature and consequences and signed before a lawyer, notary or patient representative. It is valid for a maximum of 8 years and must then be renewed (again with medical advice). If a patient who is unable to make decisions refuses treatment in a binding advance directive, this treatment may not be carried out – the doctor must respect the wishes. The binding directive therefore has a similar weight to a currently declared consent. If there is only a considerable living will (which does not fulfill all formalities), the doctor must at least take it into account as an important indication of the patient’s wishes.

In summary, the legal situation in Austria is basically the same as in Germany: no treatment without consent. The ABGB emphasizes personal decision-making rights, the PatVG regulates advance directives, and the ÄrzteG requires documentation and information. Differences lie in the details of implementation (see section 4).

4. differences and similarities between Germany and Austria

Similarities: Both countries place patient autonomy at the center. Medical treatment is only lawful if the patient has given their consent voluntarily after receiving sufficient information. The following applies in both Germany and Austria: a medical intervention without consent constitutes bodily harm and has legal consequences. In both countries, information must be provided in a comprehensible, complete and timely manner. The requirements are also similar in practice: A formal signature on an information sheet alone is not sufficient anywhere – a personal doctor-patient discussion is always required. In addition, both legal systems have exceptions in emergencies (imminent danger) and proxy regulations for persons unable to give consent. Living wills are recognized both in Germany (regulated in §§ 1827, 1901a BGB) and in Austria (PatVG) in order to determine the patient’s wishes in advance.

Differences: The legal framework is structured differently. In Germany, the Patients’ Rights Act, which came into force in 2013, bundled patients’ rights primarily in the German Civil Code (Sections 630a-630h). Austria, on the other hand, has distributed corresponding regulations in the ABGB (§§ 252-255) and special laws (e.g. PatVG). The consent of minors is also expressly regulated in detail only in Austrian law (Section 173 ABGB), while in Germany there is no separate provision on this in the BGB – there, the capacity of minors to give consent is determined by the capacity of understanding in individual cases and the general personal care of parents in accordance with Section 1626 BGB. In practice, however, both countries require minors to be involved in decisions in line with their maturity and require parental consent, particularly in the case of serious interventions.

Another difference lies in the formal requirements for living wills: In Austria, binding living wills are only valid if they have been notarized or certified by a lawyer and drawn up after prior medical consultation. They also have a time limit (8 years). In Germany, on the other hand, living wills can be made in writing without any formal requirements and are valid indefinitely (Sections 1901a, 1901b BGB), but must be sufficiently specific in terms of content to be binding in individual cases (according to supreme court rulings). These stricter formalities in Austria are intended to make them more binding, but require more effort to draw up.

There are also nuances in criminal law: in Germany, consent is recognized as a justification (Section 228 of the Criminal Code), as is the case in Austria (Section 90 of the Criminal Code permits dangerous HV with consent under certain circumstances). In practice, these differences are hardly relevant – in both countries, proper consent protects the doctor from prosecution.

There are also parallels with regard to documentation: Germany standardizes it in detail in § 630f BGB, Austria in ÄrzteG § 51. However, Austria traditionally prescribes a longer retention period for clinical records (at least 30 years in hospitals), while in Germany, according to the model professional code, 10 years is common (for X-rays even 30 years). Such administrative details differ, but do not affect the core of informed consent.

In summary, Germany and Austria can be characterized as very similar in the area of informed consent: Both follow the international standard of informed consent. Differences exist mainly in the legal implementation and some formal requirements (e.g. for minors and advance directives), but less in the basic procedure.

5. process of informed consent in practice

How does informed consent typically work?

First, the attending physician conducts an explanatory consultation with the patient. In this discussion, the doctor explains the diagnosis (findings or preliminary assessment), the proposed treatment or procedure, its course and objective in a clear and comprehensible manner. Risks and possible complications are addressed – both common, minor side effects and rare but serious risks, provided they are relevant to the decision. Treatment alternatives must also be pointed out, e.g. alternative methods or the option of waiting for the time being, if medically justifiable. The doctor explains the chances of success of the measure and what will happen if nothing is done (consequences of not undergoing treatment). It is important that this information is provided in an honest, balanced and layman’s way – the patient should have the opportunity to weigh up the benefits and risks.

In accordance with Section 630e (2) of the German Civil Code (BGB), the information must be provided verbally by the doctor or a qualified person, in good time before the procedure so that the patient has sufficient time to think about it, and in a way that the patient can understand. Written documents (brochures, information sheets) may be provided in addition, but they never replace a personal discussion. The patient is also given the opportunity to ask questions and clarify any uncertainties – the conversation should not be a monologue by the doctor, but a dialog. Ideally, patients are actively encouraged to ask all their questions (e.g. “How long will I be unable to work?”, “What alternatives do I have?”).

After the consultation, a written information sheet is often used to summarize the key points. The patient reads this (at home, if necessary) and signs it to confirm that the consultation has taken place and that they have understood the information. Important: The signature alone is not consent, but only proof of the informed consent discussion. The doctor asks for the actual consent verbally – for example, immediately before the procedure: “Do you agree to the proposed operation under the conditions discussed?” Only when the patient clearly affirms this (or declares it in writing by signing the consent form) is the consent valid. In practice, information and consent are often documented in a single process: The patient signs a form that both records the content of the conversation and contains the declaration of consent.

The timing is important here. Patients should have enough time to think about their decision. For planned procedures, it is recommended that the informed consent discussion takes place at least one day before the operation so that the patient does not have to make a spontaneous decision under pressure. The doctor then asks for consent again directly before the procedure. German courts expressly require that there must be sufficient time for reflection between the informed consent discussion and the signing of the consent form – an immediate signature directly after the discussion can generally be ineffective be invalid. This practice is intended to ensure that patients can make a well-considered decision.

In everyday life, many clinics use standardized information sheets (often published by Medizinischer Verlag), which list the typical risks for each procedure. These sheets are an aid to completeness, but never replace an individual consultation. Doctors must always tailor the information to the specific patient (e.g. explain special risks in the case of pre-existing conditions). It is also their job to check whether the patient has understood everything – medical issues may need to be explained in simpler terms or with the help of drawings/models.

After being fully informed, the patient gives consent – usually in writing (signature under the consent form), sometimes verbally (e.g. in emergencies or during an outpatient consultation, which is then noted in the file). In any case, the declaration of consent is recorded in the patient file.

Digital tools in the practice: Modern approaches, such as those offered by medudoc, integrate digital elements into this process. For example, patients can receive explanatory videos about their procedure in advance, which they can watch at home at their leisure. Such video-based Patient Education prepares the patient for the consultation: medical facts are explained visually and in simple language. As a result, patients often have a better understanding of what to expect and can formulate more specific questions. In the subsequent consultation, the doctor can build on the patient’s higher level of knowledge and focus on individual aspects. It remains important: The personal consultation with the doctor must still take place – digital content is a preparation and supplement, not a substitute. According to current law, verbal information from a doctor is essential.

After the discussion and clarification of all questions, the digital or analog documentation and signature are carried out. As digitalization progresses, it is now possible to have consent signed electronically – for example on a tablet or via a web link with a qualified electronic signature. If they meet the standards (e.g. eIDAS in the EU), these digital signatures can be legally equivalent to handwritten signatures. Medudoc, for example, offers a remote signature function that allows patients and doctors to sign consent digitally from any location. This allows the entire process – information, question and answer session, confirmation – to be mapped in a digital workflow, which is particularly relevant for telemedicine applications(e.g. preparation for a procedure via video consultation).

6. documentation requirements

Complete documentation of information and consent is important for two reasons: legally, in order to be able to provide evidence in the event of a dispute, and therapeutically, in order to record relevant information for the further course of treatment. In Germany, Section 630f of the German Civil Code (BGB) stipulates that treatment must be documented. According to this, the doctor must promptly keep a patient file in which all measures that are essential from a professional point of view and their results are recorded. In particular, this includes medical history, diagnoses, examination results, findings, therapies – and explicitly also the informed consent discussions and consents. Although information is not literally mentioned in Section 630f, Section 630h (2) BGB makes it clear that the doctor must prove consent and information; documentation is therefore essential. In case of doubt, anything that is not documented is deemed not to have happened. For this reason, information sheets and consent forms are always included in the patient file.

The documentation should include Date and time of the informed consent discussion, name of the doctor providing the information, content of the information (most important points: diagnosis, proposed measure, risks, alternatives), any special features (e.g. difficulties in understanding, queries from the patient) and the result – i.e. whether the patient consented or not. Ideally, both the patient and the doctor sign the protocol or form. § Section 630f (1) of the German Civil Code (BGB) requires that the documentation is made during or immediately after the treatment – the conversation should therefore be recorded promptly to ensure completeness and accuracy. Subsequent additions or corrections must be recognizable (no manipulative changes to the record).

In Austria, Section 51 of the Austrian Medical Practitioners Act (ÄrzteG) regulates the documentation obligation: doctors are obliged to keep records of every treatment – including the condition on admission, diagnosis, course and scope of services. type and scope of services. Information is also implicitly included here, as it is part of the service. Patients have the right to inspect this documentation or receive copies, which emphasizes that the records should be complete and comprehensible. The retention periods in Austria vary depending on the sector (usually 30 years for hospitals and a minimum period of 10 years for registered doctors).

Documentation not only serves to protect the doctor in the event of liability, but also to ensure continuity of treatment. An incompletely documented informed consent discussion can be legally assessed as an informed consent error – it is then assumed in court that the informed consent was inadequate. Conversely, well-documented consent (signed form with a note of the discussion) can be decisive evidence that the patient has given informed consent. Modern digital solutions often document the process automatically: for example, medudoc saves the time and content of the videos provided as well as the digital signature, which can make it easier to provide evidence.

7. challenges and common mistakes in practice

The implementation of informed consent is challenging and in the hustle and bustle of everyday hospital and practice life, mistakes occur time and again. Here are some common challenges and pitfalls:

• Lack of time and routine: Doctors often only have a few minutes per patient. There is a danger that informational discussions will be shortened or treated as an annoying formality. However, copy-pasting standard risks without addressing the individual case does not do justice to the obligation. Every patient has different requirements and fears – these must be taken into account. Routine must also not lead to negligence in frequently performed procedures: Every patient is entitled to a patient explanation, no matter how many times the doctor has already explained the same procedure.
• Technical jargon and comprehensibility: A classic mistake is the overload of medical terminology. Terms such as “laparo-endoscopic cholecystectomy” mean nothing to a layperson – the doctor has to translate them into everyday language (“surgical removal of the gallbladder using the keyhole technique”). § Section 630e para. 2 no. 3 of the German Civil Code (BGB) explicitly requires comprehensible information. Patients often feel that they understand everything at the time of the consultation, but do not dare to ask. It is the doctor’s job to ask questions (e.g. “Can you tell me in your own words what we intend to do?”) to ensure that the information has really been received.
• Inadequate presentation of risks: An information error often lies in concealing or downplaying certain risks. There is a legal limit here: very rare risks (<1‰) only need to be mentioned if they are typical and serious for the specific procedure (e.g. fatal anaesthetic incidents, even if extremely rare, must be mentioned because they are a matter of life and death). Frequent or moderate risks must always be mentioned. It is a common mistake not to mention alternatives – even if the only option is another clinic with an experimental method or no treatment at all, the patient should be aware of this option. For example, if a new surgical method is being used, the patient must be told that it is new and that there may be little long-term experience (so that they can choose an established method as an alternative if necessary).
• Timing and reflection period: In practice, patients are sometimes informed very late or in a state of mental stress – for example, only on the operating table or shortly beforehand under time pressure. This contradicts the requirements. A typical wrong approach: The patient is presented with the information sheet to sign at 10 p.m. for an operation planned in the morning, without a real conversation having taken place. Or consent is taken from the sedated patient in the anteroom. Such omissions can lead to the consent being invalid. Courts require sufficient time between the informed consent and the decision – usually at least the day before elective surgery.
• Delegation to unsuitable personnel: Although an experienced assistant doctor or another licensed doctor may conduct the consultation (if sufficiently knowledgeable in the field), it is not permissible to delegate the explanation of a complex operation to nursing staff. Simply handing out brochures without consulting a doctor is also a mistake. The doctor providing information in person must be sufficiently qualified to be able to answer all questions. He must also be fully aware of the obligation to provide information. An example: A surgeon provides information about surgery, but forgets to mention the alternative of non-surgical treatment because this falls more into the area of an internist – this would also be an error in providing information.
• Documentation deficiencies: An error that is often only noticed afterwards is the incomplete documentation of the informed consent process. In everyday clinical practice, patients sometimes sign the form, but the section “Discussion conducted by Dr. … on …” remains blank, or the form does not end up in the file. If the patient later claims “Nothing was explained to me, I just signed something”, the doctor is in a bad position without proper documentation. According to the law, the doctor bears the burden of proof. Therefore: “He who writes, stays.” Every explanation must be carefully documented (see section 6). It is also a common mistake to refer solely to the signed form in an emergency – courts attach little value to an insufficiently informed but signed form. The decisive factor is whether information was actually provided. The signature only proves that a consultation took place, not its quality. Therefore, the best documentation is of little use if the information itself was inadequate.
• Language and cultural barriers: In practice, doctors often encounter patients who do not speak the local language or have communication barriers for cultural reasons. A common mistake is to try to explain things to such patients without an interpreter or to call in relatives as translators, who may not be able to cope professionally themselves. The result can be a blatant misunderstanding. In this case, it is advisable to use professional translation aids or provide written materials in the native language. Non-verbal communication also plays a role: a frightened patient may not absorb information correctly – an empathetic conversational climate can help.

In summary, errors in the provision of information usually occur due to time pressure, standardization and assumptions that the patient will already have understood. Practical tip: Always carry out the information process with the same care as if you were asked about it later in court – i.e. completely, individually and documented. Patients should never have the feeling that they are being a nuisance if they ask questions. A question that remains unanswered can later become legally significant. The team (doctors and nursing staff) should also be trained to know the importance of informed consent – for example, no surgical nurse should take a patient to the operating room who says “I’m not sure” without informing the doctor.

8. increasing relevance due to digitalization and telemedicine

Advancing digitalization in the healthcare sector is also influencing informed consent. On the one hand, digital tools open up new opportunities to improve information, while on the other hand they place new demands on the legal framework.

Digital educational materials: As mentioned in section 5, multimedia content – videos, animations, interactive apps – is increasingly being used to educate patients. Studies show that audiovisual information can significantly increase the comprehension and retention rate. Complex issues (e.g. a planned cardiac catheterization procedure) can be presented clearly in an explanatory video. This promotes understanding, especially among patient groups with low health literacy or language barriers (many tools offer multilingualism). Medudoc, for example, relies on video-based, personalized Patient Education that is based on guideline content and has been legally reviewed Such content can be adapted exactly to the patient’s individual indication – a great advantage over static standard forms.

Remote consent and telemedicine: With the advent of telemedicine, the question arises as to how informed consent can work when doctor and patient are not physically face-to-face. During the COVID-19 pandemic, for example, treatments were increasingly initiated via video consultations. In principle, the same requirements apply: the doctor must inform the patient via video or telephone in the same comprehensible way and obtain consent. The technical means now allow forms to be transmitted digitally and signed electronically. Remote consent platforms (including medudoc) offer remote signatures that meet the legal written form requirements. In Austria, it was clarified in the Medical Practitioners Act in 2022 that telemedical information is also permitted under certain conditions, provided that documentation and identification are guaranteed. In Germany, the German Medical Association has permitted telemedical consultations in its (model) professional regulations as long as the quality of communication is ensured (e.g. good video connection, sufficient time).

Legal recognition of electronic consent: One important aspect is the legal equivalence of electronic signatures. Throughout the EU, the eIDAS Regulation stipulates that a qualified electronic signature is equivalent to a handwritten signature. Solutions such as medudoc use such technologies to legally compliant digital consent to enable legally secure digital consent. This means, for example, that a patient can watch the information video at home via smartphone, ask questions via chat, then read a digital form and sign it with a click/signature pad. The signature is certified and stored in a tamper-proof manner. The doctor countersigns and receives a PDF for the file. IT security and data protection are particularly relevant here: Medical education data is highly sensitive health data that may only be processed in secure, possibly ISO 27001-certified environments.

Opportunities of digitalization: It can increase efficiency – studies with digital information systems show considerable time savings for doctors (up to 50-70% less effort) with higher patient satisfaction at the same time. Patients can absorb information at their own pace, rewind it and involve relatives. Difficulties in understanding can be identified and addressed with interactive quizzes or query tools. Digitalization also enables standardized quality: every patient receives complete, guideline-compliant information and no aspect is forgotten.

Challenges of digitalization: However, care must be taken to ensure that personal contact is not lost. Tech-savvy patients welcome eConsent methods, but others – such as older or less tech-savvy people – may be overwhelmed. A hybrid approach makes sense here: digital help plus a personal consultation. In addition, the legal acceptance of digital education is still in a state of flux. So far, courts have rarely dealt with purely digital consent. It is important to be able to prove who saw and understood what and when. Systematic logging of the digital process creates transparency here.

Telemedicine also raises questions: Can a patient consent via video to an operation that is performed days later without ever having met the surgeon in person? In practice, it is usually the case that a brief personal discussion takes place at the latest on the day of the operation (e.g. patient meets surgeon before anesthesia) in order to clarify any unanswered questions. From a purely legal point of view, however, the prior video consultation could be sufficient as long as all requirements have been met and documented.

Finally, data protection must be taken into account: Digital education platforms process personal health data, which is specially protected (GDPR, Austrian Data Protection Act). Patients must consent to their data being processed electronically (this is usually done together with the consent to treatment).

Overall, the relevance of digital health solutions in Patient Education is increasing significantly. Telemedical consent will probably be part of everyday life in the future – e.g. in the preparation of operations across regions, second opinions or in decentralized clinical research (keyword eConsent in studies). However, the basic principles remain unchanged: inform – understand – clarify questions – obtain consent – document. Technology can support the process and make it more efficient, but it must not eliminate the human factor.

9th reference chapter: Relevant legal standards and their significance

Germany

Finally, an overview of important legal provisions in connection with informed consent and what they mean:

• § Section 630d BGB – Consent: Part of the German Patients’ Rights Act. Obliges the person providing treatment to obtain the patient’s consent before any medical intervention. If the patient is unable to give consent, an authorized person (guardian/authorized representative) must give their consent, unless a living will applies. Without consent, action may only be taken in accordance with the patient’s presumed wishes in an emergency. This standard establishes consent as the sine qua non of any treatment.
• § Section 630e BGB – Duty to provide information: In Germany, regulates the content and form of how Patient Education must be provided. Para. 1 lists the essential circumstances: Type, scope, risks, necessity, urgency, prospects of success and alternatives of the measure. Para. 2 stipulates that the information must be provided verbally, in a timely and comprehensible manner by the doctor (or qualified employee). In addition, copies of all documents signed by the patient must be given to the patient. Para. 3 permits exceptions (dispensability), for example if the patient does not wish to be informed or if there is no time in the event of acute danger to life. Paras. 4-5 regulate the provision of information to authorized representatives or patients with limited capacity (e.g. children) analogously. This standard therefore specifies what information is to be provided and how.
• § Section 630f BGB – Documentation of treatment: stipulates that a patient file must be kept immediately after treatment, electronically or in paper form. Para. 2 BGB stipulates the minimum content: “all measures and their results that are essential for the current and future treatment from a professional point of view” must be documented, in particular medical history, diagnoses, examinations, findings, therapies and interventions. This means that informed consent discussions and consents must also be documented as essential measures. Para. 3 prohibits unauthorized changes (prohibition of manipulation). This standard ensures complete treatment documentation, which also serves to preserve evidence.
• § Section 630h BGB – Burden of proof in the case of liability for errors in providing information: Paragraph 2 states that the treating physician must prove that they obtained consent and provided proper information. If he does not succeed in doing so, it is presumed against the doctor that there was an error in providing information which was causal for the damage. This standard therefore reverses the burden of proof in court and makes complete documentation so important.
• § Section 223 StGB – bodily injury (DE): Defines simple bodily injury. Relevant here: Any medical act that affects physical integrity (injection, surgical incision, etc.) fulfills the objective elements of the offence. § Section 228 StGB – Consent: clarifies that bodily harm carried out with consent is not unlawful unless it is contrary to public morality. For medicine, this means that properly obtained consent justifies the physical intervention and the doctor remains unpunished. Without consent, the doctor would be liable to prosecution for (grievous) bodily harm, even if the procedure was medically indicated.

Austria

Finally, an overview of important legal provisions in connection with informed consent and what they mean:

• ABGB §§ 252-255 (AT): Contains the civil law regulations on consent to medical treatment since 2018. § SECTION 252 ABGB: A person of legal age who is capable of understanding and judgment can only give consent themselves. Also defines “medical treatment” and clarifies that members of other healthcare professions are subject to the same rules. § SECTION 253 ABGB: Regulates treatment for adults lacking decision-making capacity – consent required from healthcare proxy/adult representative, except in cases of imminent danger (emergency). Also contains the important para. 4: If there is a binding living will that prohibits treatment, this must be respected (no representative’s decision necessary). § Section 254 ABGB (for the sake of completeness): Concerns consent to medical treatment in the case of interventions with particularly serious consequences – additional judicial authorizations are required here (e.g. permanent inability to reproduce, § 255 ABGB regulates such special cases). Together, these paragraphs safeguard patient autonomy and define the procedure in cases of lack of decision-making capacity.
• § Section 173 ABGB (AT): Special provision for minors. Paragraph 1: A child who is capable of making decisions (this is generally assumed to be the case from the age of ~14) can give their consent themselves; if they are not capable of making decisions, the guardians decide. Paragraph 2: In the case of serious interventions, even a child with decision-making capacity requires the additional consent of the guardian Paragraph 3: Emergency regulation – in the event of danger to life/serious damage to health, treatment may also be carried out without consent. This standard is intended to protect minors and at the same time take account of their growing autonomy.
• Medical Act 1998 § 51 (AT): Obliges doctors to keep records of every treatment (medical history). This includes admission findings, anamnesis, diagnoses, therapies etc. and – implicitly – also information and consent. Patients (or their legal representatives) are entitled to information and access. The medical documentation obligation is thus enshrined in law in Austria, similar to § 630f BGB.
• Patient Decree Act (PatVG, AT): regulates binding and notable living wills. § Section 2 PatVG defines a living will as a declaration of intent in which a patient rejects future treatment that is to apply if he or she is incapable of making decisions. § Section 6 PatVG (not quoted in the text above): sets out the requirements for binding advance directives – including medical information, legal information, written form with signature before a notary/lawyer/patient advocate. § Section 7 PatVG: duration of the binding nature (8 years). § Section 8 PatVG: Considerable PV (form not fulfilled) must be taken into account as an indication. The PatVG ensures that the wishes set out in a living will are implemented in an emergency and gives doctors legal certainty if they adhere to them.

These standards form the legal framework within which doctors and medical staff operate when providing Patient Education. They clearly show that informed consent is not a mere formality, but a legally protected right of the patient – and at the same time a “protective shield” for the doctor who adheres to it. Legal sources and guidelines underpin this framework (see external links). As a result, these provisions promote a relationship of trust: well-informed patients can consent to treatment, which is the best basis for successful treatment not only legally, but also ethically and therapeutically.