Informed Consent 2026: What has changed legally for doctors and clinics

Patient Education is one of the central legal obligations in the doctor-patient relationship – and it is becoming increasingly complex. New case law, growing documentation requirements and the pressure for digitalization are presenting doctors and clinics with specific challenges. What applies in 2026? And how can practices and hospitals provide legally compliant information without overburdening everyday practice? This article provides an in-depth overview of:

1. What is informed consent – and why is it so important from a legal perspective?

Informed consent is the legally effective agreement of a patient to a medical intervention after they have been fully informed about the nature, risks, alternatives and consequences.

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

Legal basis at a glance

Germany: Sections 630a-630hBGB (Patients’ Rights Act, in force since 2013) – regulates the duty to inform, documentation and burden of proof

Austria: § 8 KAKuG, § 1328 ABGB and the case law of the Supreme Court – similar principles, partly stricter interpretation in risk disclosure

EU level: GDPR (data protection for health data), EU AI Regulation (relevance for AI-supported education from 2026)

2. Current legal situation 2025/2026: What has changed?

The basic framework of informed consent is stable – but the requirements for documentation, individuality and verifiability are being continuously tightened by courts and regulators. Three developments are particularly relevant for doctors and clinics:

2.1 Stronger burden of proof rules

Since the Patients’ Rights Act, the burden of proof that proper information has been provided has generally been on the doctor (Section 630h (2) BGB). This means that in the event of a dispute, the doctor must prove that they have provided information – not the patient that they have not been informed.

Courts are setting increasingly high standards for the quality of evidence. An illegibly completed sheet of paper is increasingly no longer sufficient. What is required is complete, dated, individualized documentation.

2.2 Individuality of education as a quality feature

The BGH has emphasized in several rulings that the information must be tailored to the specific patient – general sample forms are not sufficient if the patient has special risk factors (e.g. previous illnesses, concomitant medication, age).

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

2.3 EU AI Regulation and duty of disclosure for AI-assisted diagnoses

With the full entry into force of the EU AI Regulation (AI Act), new transparency obligations will apply to AI-supported medical devices and diagnostic systems from 2026. In concrete terms, this means that if an AI system is involved in a diagnosis or treatment recommendation, the patient must be informed. How exactly this duty of disclosure will be implemented is still being interpreted – but clinics that act early will be on the safe side legally.

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

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

BGH, judgment on risk disclosure for rare complications

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

OGH Austria: Information about treatment alternatives

The Austrian Supreme Court has repeatedly emphasized that the patient must be informed about real treatment alternatives – including the option of not being treated at all. Consent is not considered free if the patient was not given a choice.

Regional court: Time of clarification

Information provided immediately before the procedure – especially under time pressure or after premedication – may be deemed ineffective. Courts require an appropriate lead time so that the patient can process the information and ask questions if necessary. For elective procedures, the following applies: at least the day before, ideally earlier.

4. The 5 most common mistakes in Patient Education

Error 1: No proof of the time of clarification

When was the information provided? If there is no date and time on a piece of paper, it is not possible to prove that the information was provided in good time in the event of a dispute.

Error 2: Standard sheet without individualization

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

Error 3: Lack of documentation of the informed consent discussion

The information sheet documents what was given to the patient – not necessarily what was discussed. The conversation itself should be documented in keywords.

Error 4: Language barriers ignored

Providing information in a language that the patient does not sufficiently understand is of no legal value. Clinics with an international patient base require multilingual solutions.

Error 5: Analog archiving without backup

Sheets of paper are lost, fade or are archived incorrectly. In the event of a dispute – which often occurs years after the procedure – the evidence is completely missing.

5. digital informed consent: legally compliant, efficient and future-proof

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

What a legally compliant digital reconnaissance solution must provide

• Time stamp: When was the clarification sent, when was it opened, when was it signed?
• Consent trail: Complete logging of all patient interactions with the educational material
• Electronic signature: Legally valid in accordance with the eIDAS Regulation
• Individuality: information content must be tailored to the patient, the procedure and its risk factors
• Multilingualism: information in the patient’s native language
• Archiving: audit-proof, long-term storage of all documents

Platforms such as medudoc map this entire process digitally – from individual informed consent via video and digital forms to electronic consent and audit-proof archiving. Independent studies, including by the University Hospital of Würzburg, have shown time savings of up to 77% compared to paper-based informed consent – with higher quality and legal certainty.

Digital anamnesis as an extension: the complete preclinical process

In addition to legally compliant information, digital anamnesis is becoming increasingly important as an upstream process step. If patients transmit their medical history, medication and previous illnesses digitally in a structured manner before the clinic appointment, a higher-quality database is created – and the doctor is optimally prepared. Especially in the pre-anaesthesia outpatient clinic, where the risk assessment (ASA classification) depends on the quality of the information provided in advance, this approach is a considerable quality gain.

Conclusion: What doctors and clinics should do now

Informed consent is not a bureaucratic appendage in 2026 – it is a central element of patient safety, legal certainty and the quality of medical care. Requirements are increasing, documentation obligations are becoming more precise and new technologies (AI, telemedicine) are creating new areas of information.

Specifically, we recommend:

• Check your current information process for gaps: Timing, individuality, documentation
• Make sure that your information sheets are up-to-date, complete and tailored to the respective procedures
• Evaluate digital solutions that map the consent trail, electronic signature and archiving
• Prepare yourself for the duty of disclosure in the context of AI systems
• Think of anamnesis and education as an integrated preclinical process