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Articles on Documentation

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
Law & regulation
Legally sound patient education in 2025: why comprehensive information is indispensable today – insights from current case law and digital innovation
Under both German and Austrian law, patient information must be complete, individual, comprehensible and provable (Germany: Sections 630a–630e of the German Civil Code, BGB; Austria: ABGB and patients' rights). Courts examine not only whether patients were informed, but how individually and how well this was documented. This includes rare but serious risks and genuine treatment alternatives. Digital patient education can strengthen comprehensibility and documentation; the personal consent discussion with a physician remains mandatory.
October 18, 2026 · 5 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
Articles & guides
The consent sheet is not a form, but the result of a process
With medudoc, a digital informed consent sheet is not created by selecting a suitable form from a library, but generated automatically from upstream data: the medical history, type of procedure and individual risk profile come together to produce the patient-specific Informed Consent Sheet (IC Sheet). The sheet is thus the end product of a data flow – not the starting point of a form-filling process.
July 10, 2026 · 8 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

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Articles on Documentation

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

Legally sound patient education in 2025: why comprehensive information is indispensable today – insights from current case law and digital innovation

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

The consent sheet is not a form, but the result of a process

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

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