{"id":2240,"date":"2026-06-29T09:15:00","date_gmt":"2026-06-29T07:15:00","guid":{"rendered":"https:\/\/medudoc.com\/?p=2240"},"modified":"2026-06-25T15:19:03","modified_gmt":"2026-06-25T13:19:03","slug":"ses-aes-or-qes-for-preoperative-processes","status":"publish","type":"post","link":"https:\/\/medudoc.com\/en\/legal-framework\/ses-aes-or-qes-for-preoperative-processes\/","title":{"rendered":"SES, AES, or QES for preoperative counseling\u2014which eIDAS level is legally compliant? An objective assessment for hospitals in the DACH region."},"content":{"rendered":"\n

Anyone evaluating the digitization of Patient Education forms in a hospital today cannot avoid one question: Which level of electronic signature ( <\/strong>e-signature) is legally sufficient\u2014and which represents an unnecessary burden? The answer determines whether a QES rollout with qualified identification of each patient is necessary, or whether an advanced electronic signature meets the legal requirements. <\/p>\n\n

This article is intended for administrative directors, data protection officers, and senior physicians who want to make an informed decision\u2014without being pressured by vendors into an unnecessarily complex solution, but also without underestimating the legal risks. The fundamentals of the legal requirements for Patient Education<\/a> in the DACH region serve as the essential starting point. <\/p>\n\n

What the eIDAS Regulation Requires: The Three Levels of Electronic Signatures<\/h2>\n\n

The European Regulation on Electronic Identification and Trust Services (eIDAS, EU No. 910\/2014) defines three levels of electronic signatures. These apply uniformly throughout the EU single market\u2014including for hospitals in the DACH region. <\/p>\n\n

Simple Electronic Signature (EES):<\/strong> The lowest level. This includes anything that digitally represents an expression of intent: a typed name at the end of an email, a scanned image of a signature, or a click on \u201cI agree.\u201d Its evidentiary value is limited\u2014EES merely proves that an action took place, but not necessarily by whom or under what circumstances. <\/p>\n\n

Advanced Electronic Signature (AES):<\/strong> This level is uniquely associated with the signatory and is tamper-proof and linked to the signed document. Any subsequent alteration to the document is detectable. No qualified certificates or government-approved trust service providers are required to create an AES\u2014but technical procedures that ensure identification and binding are necessary. <\/p>\n\n

Qualified Electronic Signature (QES):<\/strong> The highest level. It is based on a qualified certificate issued by a recognized Trust Service Provider (TSP) and requires reliable identification of the signatory. According to Article 25(2) of eIDAS,<\/a> the QES is legally equivalent to a handwritten signature\u2014which, in some areas of law, constitutes the only legally secure basis. <\/p>\n\n

These three levels are often used interchangeably in product descriptions within the industry. What exactly each one means\u2014and what implications this has for preoperative counseling\u2014is therefore a question that every hospital must address specifically. <\/p>\n\n

What Medical Law Requires: The Duty to Inform and Informed Consent Are Not the Same Thing<\/h2>\n\n

This is a critical flaw in many evaluation processes. The requirements regarding the duty to provide information<\/strong> and the requirements regarding the format<\/strong> of the information document are two separate issues. <\/p>\n\n

In Germany, Sections 630c\u2013630e of the German Civil Code (BGB) govern the physician\u2019s duty to provide informed consent. Section 630e(1) of the BGB requires comprehensive, understandable, and timely disclosure\u2014verbally, in a face-to-face conversation. Section 630e(2) requires that documents be provided in a timely manner. However, the law does not<\/strong> explicitly prescribe the specific level of electronic signature that must be applied to the informed consent form. <\/p>\n\n

The information sheet\u2014known in the digital world as the Informed Consent Sheet (IC Sheet)\u2014serves primarily as a supporting document<\/strong>: In the event of a dispute, it is intended to prove that an informed consent process took place, that the patient had the opportunity to ask questions, and that consent was given voluntarily and in an informed manner. This evidentiary function is crucial: The goal is not the signature itself, but rather the legally admissible documentation of the informed consent process. <\/p>\n\n

In Austria, the situation is structurally similar: Section 173 of the ABGB and Section 51 of the \u00c4rzteG 1998 establish the duty to provide informed consent, but likewise do not require explicit signatures on informed consent forms. Those who wish to examine the Austrian legal situation in detail will find a comprehensive overview in the article on the legal framework for informed consent in Austria<\/a>. <\/p>\n\n

Where QES Is Truly Mandatory \u2014 and Where FES Is Sufficient<\/h2>\n\n

The question, therefore, is not a simple yes-or-no decision, but rather depends on the context. An honest assessment looks like this: <\/p>\n\n

FES is generally sufficient for standard preoperative consent<\/strong> if it is embedded in a consistent, traceable documentation system. An FES uniquely identifies the signatory, protects the document from tampering, and generates a verifiable timestamp for the signature. German and Austrian courts have accepted digitally signed documents at the FES level as evidence in medical malpractice proceedings. The decisive factor here is not the signature level in isolation, but the overall quality of the documentation\u2014more on that in a moment. <\/p>\n\n

QES is the right tool in specific contexts<\/strong>, namely:<\/p>\n\n