Digital Information Sheets: Customizable, Bilingual, Legally Compliant
Digital informed consent forms are more than just a paperless alternative. medudoc generates Informed Consent Sheets (IC Sheets) that are tailored to each individual patient— —fully automatically, based on medical history data, across specialties, and in up to 23 languages. Embedded in a comprehensive, electronically processable workflow.
What an information sheet must accomplish — and where the current standard falls short
The informed consent form is the central document for informed consent. It documents that patients received complete and understandable information prior to a procedure. Legally, it is indispensable; in practice, however, its potential often goes untapped.
- Generic forms include risks that are not relevant to this patient—and omit relevant information. The informed consent discussion must address what the form failed to cover.
- Foreign-language versions are often sent as a separate document—in a language that the physician providing the explanation does not understand. This compromises transparency and liability protection.
- Case law and guidelines change. Who determines whether the form currently in use still reflects the state of the art—and when?
Each patient receives exactly the information that is relevant based on their medical history, procedure, and risk profile—not a generic, one-size-fits-all solution.
Automated monthly review of changes to the legal framework and case law at — combined with an annual medical validation.
The IC Sheet is not a standalone document, but rather the result of a fully digitized, electronically processable reconnaissance process.
Truly personalized information sheets—not generic, but tailored to each specific case
medudoc generates the Informed Consent Sheet (IC Sheet) fully automatically based on the medical history data structured according to the , the procedure definition, and the individual risk profile. Generic forms are available as an option—the primary delivery model is the patient-specific form.
- Pre-existing conditions, medications, and allergies are all included in the IC Sheet—the form adapts to the patient, not the other way around.
- The type of procedure and anesthesia method determine which risk factors, preparation instructions, and behavioral recommendations are displayed.
- Digital annotations by physicians prior to signing: Additions and notes are documented in an audit-proof manner—as evidence of individualized, case-specific informed consent.
- Generated in seconds: Depending on the extent of customization, it takes 14 to 90 seconds to generate an IC sheet.
Source: Case study: St. Gallen Cantonal Hospital
Six Features That Make a Digital Information Sheet Complete
medudoc IC Sheets are integrated into an end-to-end workflow. The following features are not optional add-ons—they are part of the standard.
Patient-Specific Generation
Each IC Sheet is generated fully automatically based on the patient’s medical history, the procedure, and risk profile. The form contains exactly the information relevant to this case — no more, no less.
Bilingual in the Same Document
German and a foreign language are displayed side by side in columns—in a single PDF at . The doctor explaining the information can see at any time what the patient is reading at . Up to 23 languages are available.
Interdisciplinary in a single arc
Surgery and Anesthesiology—or other combinations of specialties—are consolidated into a single document at . No separate forms, no duplicate signatures at , and no increased paperwork.
Monthly Legal Review
All IC Sheets are automatically analyzed on a monthly basis for changes in the legal framework and current case law. Medically or legally relevant changes trigger ad hoc updates.
Annual Medical Validation
All content is reviewed at least once a year to ensure it remains medically up-to-date. External validation by professors and medical specialists ensures medical accuracy, independent of the internal content management process.
All eIDAS signature levels are available
Depending on clinical requirements and configuration, medudoc supports Simple Electronic Signatures ( , EES), Advanced Electronic Signatures ( , FES), and Qualified Electronic Signatures ( , QES) in accordance with the eIDAS Regulation (EU 910/2014).
Two languages, one document — so that the doctor also understands what the patient is reading
The standard practice for foreign-language patients: a German-language form for the clinic, and a document in the patient’s native language. Two documents, two signatures—and in case of doubt, the medical staff cannot understand the content of the document signed by the patient .
medudoc solves this problem structurally. German and the patient’s foreign language are displayed side by side in columns—all within a single IC Sheet. The physician providing the explanation can see at any time what the patient is reading in their own document.
What this means in practice
A patient whose native language is Russian receives an IC Sheet that contains the complete German text in the left column ( ) and the Russian translation in the right column ( )—not two separate documents, but a single, audit-proof, archived PDF/A file.
Legally binding consent is based on the original German-language version. This translation is intended solely to help patients who speak a foreign language understand the text.
This reduces the number of documents in the filing system, and medical staff do not have to switch between two files to review the full content of the informed consent form .
From the medical history to the signed informed consent form—entirely electronic
The IC Sheet is the result of an integrated workflow—not a starting point for “ .” All data required for customization is already structured before the sheet is created.
Complete patient information through a digital medical history
Patients complete their medical history before their appointment—on their own device, at home or at the clinic. medudoc’s workflow engine processes the structured data using medical reasoning: pre-existing conditions, medications, allergies , and risk factors are recorded completely and without omission.
Medical Evaluation and Definition of the Procedure
Medical staff review the medical history data in the Health Care Professional Dashboard (HCP Dashboard). The procedure, anesthesia method, and clinical specifics are defined—the basis for generating the personalized IC Sheet.
Automatic generation of a patient-specific informed consent form
Based on the patient’s medical history, procedure, and risk profile, medudoc generates the IC Sheet fully automatically. Interdisciplinary combinations (e.g., surgery and anesthesia) are consolidated into a single document. For patients who speak a foreign language , the bilingual version is automatically displayed.
The patient reads the information, asks questions, and signs electronically
The IC Sheet is provided along with the personalized informational video. Patients read the sheet at their own pace before their consultation with the doctor—with the option to ask specific questions. Informed consent is provided electronically, in accordance with the signature level selected by the clinic (EES, FES, or QES).
Complete documentation and transfer back to the HIS
The complete consent trail—who viewed what content and when, what questions were asked , and the signature timestamp—is archived in an audit-proof manner at . Medical history data, consent status, and the signed IC Sheet are transmitted back to the hospital information system (HIS) or PDMS via FHIR at . The process is fully electronic, with no media discontinuity.
Digital Informed Consent Forms in Practice: What Studies Show
The effectiveness of digital, video-based Patient Education using medudoc has been demonstrated in a prospective cluster-randomized study published at at the University Hospital of Würzburg, as well as in the case study from the Cantonal Hospital of St. Gallen available at .
-Cholecystectomy
Time spent on preoperative counseling per cholecystectomy — reduction from 9.7 to 2.2 minutes (p < 0.001), with patient satisfaction remaining consistently high.
Patient satisfaction at the St. Gallen Cantonal Hospital: 276 patients rated the digital information resources 4.9 out of 5 points.
Time saved per consultation in general surgery at the KSSG. The time freed up can be used for diagnostics, treatment, and other clinical activities.
All eIDAS signature levels — the clinic chooses the one that best fits its process
medudoc supports all three levels of electronic signatures in accordance with the eIDAS Regulation (EU 910/2014). Configuration is client-specific— , different departments can be assigned different signature levels.
Fast and accessible
For example, a typed name or a signature image. Suitable for processes where speed and accessibility are the top priorities. The evidentiary value is limited compared to FES and QES.
Identifiable and tamper-proof
Unambiguously assigned to the signer and tamper-proof, linked to the document signed with the . Higher level of evidentiary value—the recommended standard for many clinical procedures.
Legally equivalent to a handwritten signature
With a qualified certificate from an accredited trust service provider. Highest eIDAS level — legally fully equivalent to a handwritten signature (Art. 25(2) eIDAS).
ISO 27001, BSI C5, and GDPR — medudoc is certified, not just compliant
Digital consent forms process health data as defined in Article 9 of the GDPR. This places special demands on security, data protection, and auditability. medudoc demonstrably meets these requirements.
ISO/IEC 27001:2022
medudoc has been certified to ISO/IEC 27001:2022 since April 2026 — Scope: Development, operation, maintenance, and distribution of the platform, including the processing of patient-related information at . Valid through March 2029.
BSI C5
BSI C5 Type 1 successfully completed (as of May 8, 2026). BSI C5 Type 2 during the current assessment period through October 2026. The BSI C5 certification is the recognized standard for cloud services in German government agencies and hospitals.
Data exclusively in Germany
All patient data is processed and stored in Germany. AI-supported processing steps take place exclusively within the European Union. No data is transferred to third countries.
GDPR Art. 9 — Health Data
medudoc acts as a data processor in accordance with Article 28 of the GDPR. The clinic remains the data controller. A data processing agreement (DPA) and a complete record of processing activities (RPA) are available by default at .
Consent Trail — Audit-Traceable Documentation
The complete disclosure process—what content was viewed and when, what questions were asked ( ), and the timestamp of the signature—is documented in an audit-proof manner at . The consent trail serves as legal proof that the disclosure took place ( ).
High Availability — 99.9%
medudoc contractually guarantees 99.9% service availability. The platform is multi-tenant and can be fully integrated into existing hospital IT environments (HIS, PDMS, patient portal) via FHIR.
Questions About Digital Information Sheets
Legal, technical, and organizational questions that clinics frequently ask before embarking on the transition.
Can a digital intake form replace a doctor’s consultation?
Is a digitally signed IC sheet legally equivalent to a handwritten signature?
How does medudoc ensure that the informed consent forms are legally up to date?
What does “bilingual” mean—and why not just use a separate sheet?
Can an IC Sheet combine sheets from different departments?
How does medudoc integrate with the hospital’s existing IT system?
Where is patient data stored?
For which departments are IC Sheets available?
Customized. Bilingual. Legally compliant. Fully integrated.
medudoc creates digital patient information forms that are truly tailored to your patients— ly integrated into an end-to-end electronic process that operates seamlessly without any media breaks.
- Approximately 240 informed consent forms covering more than 50 departments
- Fully Automated Personalization at the Patient Level
- Bilingual in a single document — up to 23 languages
- Monthly legal review, annual medical validation
- ISO/IEC 27001:2022 certified, data stored in Germany