Patient education is one of the central legal duties in the physician–patient relationship – and it is becoming increasingly complex. New case law, growing documentation requirements and the pressure to digitalise present physicians and hospitals with specific challenges. What applies in 2026? And how can practices and hospitals obtain informed consent in a legally sound way without overloading everyday practice? This article on the legal position on informed consent in 2026 provides a well-founded overview.

1. What is informed consent – and why is it so significant legally?

Informed consent – in German “informierte Einwilligung” – means a patient’s legally effective agreement to a medical procedure after they have been comprehensively informed about its nature, risks, alternatives and consequences.

Without effective informed consent, even a medically flawless procedure is legally considered bodily harm. This is not an exaggeration but settled case law in Germany and Austria. The German Federal Court of Justice (BGH) has confirmed this in numerous decisions: the physician’s duty to inform corresponds to an independent, enforceable claim of the patient.

Informing patients protects not only the patient – it also protects the physician. Physicians who do not inform are liable. Physicians who do not document cannot prove in case of doubt that they informed the patient.

Germany: Sections 630a–630h of the German Civil Code (BGB) (Patients’ Rights Act, in force since 2013) – governs the duty to inform, documentation and the burden of proof

Austria: § 8 of the Federal Hospitals and Sanatoria Act (KAKuG) and the case law of the Austrian Supreme Court (OGH) – similar principles, in some cases a stricter interpretation of risk information

EU level: GDPR (data protection for health data), EU AI Act (transparency obligations since August 2, 2026; obligations for high-risk AI in medical devices from August 2, 2028)

The basic framework of informed consent is stable – but courts and regulators are continuously tightening the requirements for documentation, individualisation and verifiability. Three developments are particularly relevant for physicians and hospitals:

2.1 Stronger burden-of-proof rules

Since the Patients’ Rights Act, the physician has in principle borne the burden of proof that a proper consent discussion took place (§ 630h(2) BGB). This means that in the event of a dispute, the physician must prove that they informed the patient – not the patient that they were not informed.

Courts are applying an increasingly high standard to the quality of this evidence. An illegibly completed paper form is less and less sufficient. What is required is complete, dated, individualised documentation.

2.2 Individualised information as a mark of quality

In several judgments, the BGH has emphasised that the consent discussion must be tailored to the specific patient – general template forms are not sufficient if the patient has particular risk factors (e.g. pre-existing conditions, concomitant medication, age).

This presents traditional paper-based workflows with a structural problem: standard forms are by definition not individual.

2.3 EU AI Act and the duty to inform in AI-supported diagnoses

Since August 2, 2026, the transparency obligations under Art. 50 of the EU AI Act (Regulation (EU) 2024/1689) have applied. They mainly cover two cases: people who interact directly with an AI system, such as a chatbot, must be told so. And AI-generated content must be labelled.

The obligations for high-risk AI in medical devices (Art. 6(1) in conjunction with Annex I) apply later. Under the so-called AI Omnibus (Regulation (EU) 2026/1744, in force since July 27, 2026), they apply from August 2, 2028.

The AI Act does not contain a general duty to tell patients that AI is used in diagnostics. In our assessment, however, such a duty can follow from the physician’s duty to inform if the use of AI is material to the patient’s decision.

Practical tip: check whether diagnostic AI systems are used in your facility (e.g. in radiology or pathology). If so, clarify whether the use of AI is material to the patient’s decision and belongs in the consent discussion. Chatbots in patient contact must be recognisable as AI.

3. Important judgments of recent years – what physicians should know

The following selection illustrates how courts are specifying the requirements for informed consent:

BGH, judgment on risk information for rare complications

Even statistically rare risks (< 1%) must be explained if they would be serious for the patient should they occur (e.g. paralysis, blindness). Frequency alone is not an exclusion criterion.

OGH Austria: information about treatment alternatives

The Austrian Supreme Court (OGH) has repeatedly emphasised that the patient must be informed about genuine treatment alternatives – including the option of not treating at all. Consent is not considered free if the patient was left no choice.

The consent discussion must take place sufficiently long before the procedure for the patient to process the information, ask questions and make a well-considered decision (§ 630e(2) sentence 1 no. 2 BGB). There is no fixed waiting period: the BGH has clarified that the patient may also give consent immediately after the conversation if they do not need time to reflect (BGH, judgment of December 20, 2022 – VI ZR 375/21). A consent discussion under time pressure or after premedication, on the other hand, may be invalid.

4. The 5 most common errors in patient education

When was the patient informed? If a paper form bears no date and no time, it cannot be proven in the event of a dispute that the consent discussion took place in good time.

Error 2: Standard form without individualisation

A form that is identical for every patient contradicts the requirement of individual information. The particular risks of the specific patient must be addressed explicitly.

The consent sheet documents what was handed to the patient – not necessarily what was discussed. The conversation itself should be documented in note form.

Error 4: Language barriers ignored

Information given in a language the patient does not sufficiently understand is legally worthless. Hospitals with an international patient base need multilingual solutions.

Error 5: Analogue archiving without backup

Paper forms get lost, fade or are archived incorrectly. In the event of a dispute – which often arises years after the procedure – the evidence is missing entirely.

The good news: digital solutions for patient education address precisely the weaknesses mentioned above – and, according to the current state of case law, are fully legally valid, provided they are implemented correctly.

What a legally sound digital patient education solution must deliver

  • Timestamps: when was the patient education sent, when was it opened, when was it signed?
  • Consent trail: complete logging of all of the patient’s interactions with the patient education material
  • Electronic signature: legally valid under the eIDAS Regulation
  • Individualisation: the patient education content must be adapted to the patient, the procedure and their risk factors
  • Multilingualism: patient education in the patient’s first language
  • Archiving: audit-proof, long-term storage of all documents

Platforms such as medudoc map this entire process digitally – from individual patient education by video and digital consent sheet to electronic consent and audit-proof archiving. A study at University Hospital Würzburg shows up to 81% shorter physician conversation time compared with conventional patient education.

Study result: In a prospective study at University Hospital Würzburg, the median physician conversation time before cholecystectomy with video-assisted patient education fell from 8.1 to 1.5 minutes (−81%); patients’ understanding and satisfaction remained high. (Source: Leicht et al., World J Surg 2026)

Digital medical history as an extension: the complete pre-hospital process

Alongside legally sound patient education, the digital medical history is becoming increasingly important as an upstream process step. When patients submit their medical history, medication and pre-existing conditions digitally and in a structured way before their hospital appointment, the result is a higher-quality data basis – and the physician is fully prepared. This approach is a considerable gain in quality, particularly in the pre-anaesthesia clinic, where the risk assessment (ASA classification) depends on the quality of the information provided in advance.

Conclusion: what physicians and hospitals should do now

In 2026, informed consent is not a bureaucratic appendage – it is a central element of patient safety, legal certainty and the quality of medical care. The requirements are rising, documentation obligations are becoming more precise, and new technologies (AI, telemedicine) are creating new areas that require patient information.

Specifically, we recommend:

  • Review your current consent process for gaps: timing, individualisation, documentation
  • Make sure your consent sheets are up to date, complete and tailored to the respective procedures
  • Evaluate digital solutions that cover the consent trail, electronic signature and archiving
  • Check where you use AI systems and which transparency and information duties follow from this
  • Think of the medical history and patient education as one integrated pre-hospital process