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Articles on Consent

Law & regulation
Informed consent 2026: what has changed legally for physicians and hospitals
The basic framework of informed consent is stable, but the requirements for evidence, individualisation and documentation are rising. In Germany, the treating party bears the burden of proof for a proper consent discussion (§ 630h(2) BGB); general template forms are not sufficient if there are particular risk factors. Since August 2026, the transparency obligations of the EU AI Act also apply, for example to chatbots and AI-generated content. Common errors are missing proof of timing, standard forms without individualisation, undocumented conversations, ignored language barriers and analogue archiving.
October 28, 2026 · 9 min read
Articles & guides
Digital patient education: how modern medical practices make “informed consent” legally sound and efficient
Today, informed consent is a traceable process, not just a signature on a form. Using the combination of medudoc and the practice software Simpleprax as an example, this article shows how medical practices connect medical history, patient education and consent digitally, which legal requirements apply and how the switch succeeds – from system integration through training and data protection to the pilot phase.
October 15, 2026 · 6 min read
Law & regulation
SES, AES or QES for surgical informed consent — which eIDAS level is legally sound? A factual assessment for hospitals in the DACH region.
For standard surgical informed consent, medical law in Germany and Austria does not prescribe a specific signature level. An advanced electronic signature (AES) is generally sufficient if it is embedded in a complete consent trail. The qualified electronic signature (QES) is the appropriate instrument for clinical trials under the AMG or MPDG, or where required by compliance or the liability insurer. A simple electronic signature (SES) — such as a finger signature on a tablet without proof of identity — is in principle not sufficient under medical law.
October 9, 2026 · 11 min read
Law & regulation
Burden of proof for informed consent: why a signature is not enough in a liability case
Under Section 630h(2) of the German Civil Code (BGB), the treating party bears the burden of proving patient information and consent — not the patient. A signed consent form only proves that a document was signed, not that the patient was informed individually, comprehensibly and in good time. The hospital's position becomes robust when the entire consent process can be reconstructed: which content was viewed when, which questions were asked and when the document was signed. In Austria, established OGH case law applies a comparable allocation of the burden of proof.
July 7, 2026 · 7 min read
Law & regulation
Informed consent in Austria: legal framework, practice and challenges for medical staff
In Austria, medical treatment is only permissible with valid consent (§§ 252–255 ABGB); without it, treatment is in principle unlawful, even if it was medically indicated. Consent requires oral, comprehensible and timely information about the nature and aim of the treatment, its risks, alternatives, prospects of success and the consequences of not treating. For hospitals, §§ 5a and 8 KAKuG also apply; there, § 10 KAKuG requires the patient information to be documented, while § 51 ÄrzteG sets out physicians' general duty to document. Consent sheets and videos supplement the physician's discussion, but do not replace it.
June 24, 2026 · 8 min read
Law & regulation
Why generic consent sheets become a liability risk in hospitals
Under Section 630e of the German Civil Code (BGB), patient information must be tailored to the specific patient. Generic consent sheets document that information was provided, but do not prove that the patient was informed about the risks relevant to them individually. Three sources of risk stand out: lack of relevance to the individual risk profile, outdated content and foreign-language versions that are not kept in sync with the German version. Consent documents generated individually for each patient address all three.
June 23, 2026 · 7 min read
Articles & guides
Digital patient education in practice: greater legal certainty, less time pressure
Under § 630e BGB (Germany) and § 252 ABGB (Austria), patients must be informed individually, comprehensibly and in good time – standard texts alone are not sufficient. Individualised patient education videos convey the standard content in advance, so the physician's discussion can concentrate on individual risks and alternatives. The videos do not replace the personal discussion; they prepare it and make the informed consent process traceable.
December 16, 2025 · 6 min read

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Articles on Consent

Informed consent 2026: what has changed legally for physicians and hospitals

Digital patient education: how modern medical practices make “informed consent” legally sound and efficient

SES, AES or QES for surgical informed consent — which eIDAS level is legally sound? A factual assessment for hospitals in the DACH region.

Burden of proof for informed consent: why a signature is not enough in a liability case

Informed consent in Austria: legal framework, practice and challenges for medical staff

Why generic consent sheets become a liability risk in hospitals

Digital patient education in practice: greater legal certainty, less time pressure

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