Anyone evaluating the digitalisation of patient education in a hospital today cannot avoid one question: which level of electronic signature (e-signature) is legally sufficient — and which is unnecessary effort? The answer determines whether a QES rollout with qualified identification of every patient is necessary, or whether an advanced electronic signature meets the legal requirements.

This article is aimed at hospital administrators, data protection officers and senior physicians who want to make this decision on a sound basis — without being pushed by vendors into an unnecessarily complex solution, but also without underestimating legal risks. The basics of the legal requirements for patient education in the DACH region are the indispensable starting point.

What the eIDAS Regulation governs: the three levels of electronic signature

The European Regulation on electronic identification and trust services (eIDAS, EU No. 910/2014) defines three levels of e-signature. These apply uniformly throughout the EU single market.

Simple electronic signature (SES): The lowest level. It covers anything that represents an expression of intent digitally: a typed name at the end of an email, a scanned image of a signature, a click on “I agree”. Its evidential value is limited — an SES merely proves that an action took place, not necessarily by whom or under what circumstances.

Advanced electronic signature (AES): This level is uniquely linked to the signatory and bound to the signed document in a tamper-evident way. Any subsequent change to the document is detectable. Creating an AES does not require qualified certificates or state-approved trust service providers — but it does require technical procedures that ensure identification and binding.

Qualified electronic signature (QES): The highest level. It is based on a qualified certificate from a recognised trust service provider (TSP) and requires reliable identification of the signatory. Under Art. 25(2) eIDAS, the QES has the same legal effect as a handwritten signature — which in some areas of law is the only legally sound basis.

These three levels are often used loosely in the industry’s product descriptions. What exactly each one means — and what consequences this has for surgical informed consent — is therefore a question every hospital has to ask itself specifically.

What medical law requires: the duty to inform and the signature are not the same thing

This is where a decisive error in reasoning lies in many evaluation processes. The requirements for the duty to inform and the requirements for the signature on the consent document are two different questions.

In Germany, Sections 630c–630e of the German Civil Code (BGB) govern the physician’s duty to provide information and obtain informed consent. § 630e BGB requires comprehensive, comprehensible and timely information — orally, in a personal conversation. § 630e(2) requires copies of the documents that the patient has signed in connection with the consent discussion or consent to be handed over. What the law does not explicitly prescribe, however, is the type of signature with which consent sheets must be signed.

The consent sheet — in the digital world, the Informed Consent Sheet (IC Sheet) — serves primarily as a document of evidence: in the event of a dispute, it should be able to prove that a consent discussion took place, that the patient had the opportunity to ask questions, and that consent was given voluntarily and on an informed basis. This evidential function is decisive: the goal is not the signature itself, but documentation of the consent process that stands up in court.

In Austria, the picture is structurally similar: the duty to inform follows from the treatment contract and the case law of the Austrian Supreme Court (OGH), and in hospitals also from § 5a of the Federal Hospitals Act (KAKuG). Consent is governed by §§ 173 and 252 et seq. of the Austrian Civil Code (ABGB); documentation by § 51 of the Physicians Act (ÄrzteG) 1998 and, in hospitals, § 10(1) no. 2 lit. a KAKuG. The ABGB and ÄrzteG likewise do not lay down an explicit signature requirement for consent sheets. Anyone who wants to look at the Austrian legal position in detail will find a comprehensive account in the article on the legal position on informed consent in Austria.

Where a QES is genuinely mandatory — and where an AES is sufficient

The answer to the question depends on the context.

An AES is generally sufficient for standard surgical informed consent if it is embedded in a consistent, traceable documentation system. An AES uniquely identifies the signatory, protects the document against manipulation and creates a verifiable timestamp of the signature. What matters, therefore, is not the signature procedure in isolation, but the overall quality of the documentation — more on this shortly.

A QES is the appropriate instrument in specific contexts, namely:

  • In clinical trials subject to the German Medicinal Products Act (AMG) or the Medical Devices Implementation Act (MPDG). Here, the sponsor and the competent ethics committee should agree on the signature level for consent documentation in advance.
  • If the in-house compliance policy or the liability insurer explicitly requires a QES. Some insurance contracts specify minimum requirements for documentation — this should be checked before the system decision is made.
  • If a hospital aims for maximum legal protection beyond what is required by law and can accept the additional operational effort (identification procedures, TSP connection, patient experience).

An SES alone is in principle not sufficient in medical law contexts. A click or a scanned image provides neither reliable identification of the person nor protection against manipulation. Anyone who uses an SES exposes themselves to a considerable evidential risk in the event of a dispute.

The article Informed consent 2026: the current legal position provides an overview of legal developments in this area.

The finger signature on the iPad: often underestimated

In many hospitals, the following procedure has become standard: patients sign the consent sheet with their finger on a tablet. It looks digital and more modern than paper — and yet, in most implementations, legally it produces nothing other than a simple electronic signature (SES). What is created is a bitmap image of the signature that is neither cryptographically bound to the document nor reliably proves who it came from. Anyone at all could have signed on this device at that moment — which is exactly the legal definition of an SES under Art. 3(10) of the eIDAS Regulation.

Some solutions additionally capture biometric signature data while signing — pressure, speed, stroke movement, timestamp — and embed this data in the document in encrypted form. If the signatory’s identity has also been verified, for example through patient identification at admission, this can move into the AES category. However, this is a question of technical implementation, and many of the tablet solutions currently used in German and Austrian hospitals do not meet these requirements, or only partially.

For hospitals that have already switched to tablets, a critical review is therefore worthwhile: what does the solution in use actually deliver? An SES on a digital document without a complete consent trail is not necessarily better than a signature on paper in the event of a dispute.

What is decisive for evidential certainty in a liability case is the question: can the hospital prove without gaps what patients received, saw and understood, and when?

This is precisely the structural disadvantage of paper-based processes — and a key advantage of fully digital consent processes. A consent trail — the complete, audit-proof documentation of the entire consent process — records not only the final signature but also:

  • which patient education content was provided to the patient and at what time,
  • whether and to what extent patient education videos were played,
  • which passages in the consent sheet were viewed again,
  • which questions were asked,
  • when and under what technical conditions consent was given.

This complete documentary evidence considerably improves the evidential value in the event of a dispute. The “one word against another” problem — a frequent starting point for liability proceedings with analogue consent — is structurally addressed by a complete consent trail. Hospitals that still use paper consent sheets today simply cannot provide this evidence.

You can read more about what this documentary evidence looks like in everyday clinical practice in the article Digital patient education in practice: more legal certainty, less time pressure.

How medudoc supports all three levels

medudoc does not decide for hospitals which signature procedures to use — because this decision belongs in the hands of legal and compliance departments. medudoc therefore technically supports all three eIDAS levels and makes the choice of the appropriate level configurable per hospital, specialty or procedure category.

Specifically, this means: the digitally generated Informed Consent Sheet (IC Sheet) — the consent document generated individually for each patient on the basis of medical history and procedure data — can be signed with an SES, AES or QES depending on the configuration. Implementing a QES requires a connection to a recognised trust service provider and corresponding identification steps; medudoc provides the technical interface for this without acting as a TSP itself.

Regardless of the signature level chosen, medudoc documents the complete consent trail: viewing behaviour, timestamps, questions asked and the final signature are archived in an audit-proof manner. The IC Sheet itself is stored as a PDF/A document — a long-term archiving format that will still be readable and interpretable in court in 15 years’ time.

Physicians can also annotate the IC Sheet digitally before signing — for example, to document individual particularities or deviating consent content on a case-by-case basis. This combination of signature, consent trail and digital annotation reflects what actually counts in court.

You can find technical details on the platform and the supported integration options on the patient education platform page and in the overview of digital informed consent sheets.

What hospitals should check now

Without replacing individual legal advice, four specific review steps for hospitals can be derived from the legal position set out above:

1. Check which procedure categories in your hospital create which requirements. Clinical trials (AMG/MPDG), high-risk procedures and standard operations have different compliance profiles. A blanket decision for the entire hospital can rarely do justice to these differentiated requirements.

2. Clarify your liability insurer’s requirements. Insurance contracts may contain minimum documentation requirements that (indirectly) prescribe a particular signature level.

3. Involve your legal department or a lawyer specialising in medical law early in the evaluation. The decision on the signature level is not an IT decision — it is a legal and corporate policy decision.

4. Prioritise the quality of the overall documentation over the choice of signature level. An AES in a fully documented, complete consent trail is legally sounder than a QES in a fragmented process with no evidence of what patients actually received and saw.

Conclusion

The question of SES, AES or QES is legitimate and important — but it is neither the only nor the most decisive question when evaluating digital consent systems. Medical law does not explicitly prescribe a particular type of signature for standard surgical informed consent. An AES is legally defensible for most routine clinical processes if it is embedded in a consistent, traceable documentation system. A QES is the right tool in specific regulatory contexts and offers the highest legal certainty, equivalent to a handwritten signature.

What most strongly influences legal certainty in practice is the quality of the overall process: what was the patient informed about? How? When? Can this be proven?

Digital patient education platforms that provide this evidence without gaps address the liability risk in the right place. Hospitals that still run the consent process on paper should worry less about signature levels and more about the fundamental legal soundness of their current practice.

If you would like to find out more about what the fully digital consent process looks like in practice and which configuration makes sense for your hospital, you can request a demo call.