What distinguishes a form from the end product of a data flow?
Summary: a form is filled with content by a person. The end product of a data flow is compiled automatically from structured data that already exists – the patient reads and signs the finished document instead of filling it in themselves.
Conventional consent sheets, whether on paper or as PDFs, are templates: one form per type of procedure, to which the treating physician adds patient-specific information. The digital informed consent sheet at medudoc works the other way round. The medical history, procedure data and risk profile are already available in structured form before the sheet is even created – the IC Sheet is generated from this data, not filled in by hand.
| Feature | Conventional consent sheet | IC Sheet as the end product of a data flow |
|---|---|---|
| Starting point | Blank or partially completed template | Medical history and procedure data that already exist |
| Individualisation | Manually, through additions by the physician | Automatically, from the risk profile and procedure data |
| Multilingual support | Separate documents for each language | One document: German original plus translation |
| Updates | Individual sheets have to be replaced | Content is maintained centrally in the medical editorial network |
| Proof of patient education | Signature on paper or PDF | Consent trail with reading time, questions, time stamp |
What data goes into an individual IC Sheet?
At least four data sources go into an IC Sheet: the medical history, the planned type of procedure, the calculated risk profile and the patient’s language setting.
- Medical history data – pre-existing conditions, medication, allergies, relevant previous procedures
- Procedure and technique data – planned operation or examination, chosen anaesthetic technique
- Risk profile – pre-evaluated automatically by Medical Reasoning
- Language setting – up to 23 languages, see below
- Previous patient education – for repeat procedures, where documented
How this medical history data is recorded in structured form in the first place is described on the pillar page smart medical history vs. digital questionnaire. At medudoc, the term Medical Reasoning refers to the automated, rule-based evaluation of structured medical history data to pre-evaluate completeness and risk factors. This pre-evaluation does not replace a medical diagnosis or decision – the final medical assessment always remains with the physician; Medical Reasoning merely prepares the data for this assessment.
How is an individual IC Sheet generated automatically from this?
Summary: generation takes place in five steps, without the patient having to fill in any content manually.
- Record the medical history – in structured form via the hospital’s digital medical history
- Calculate the risk profile – Medical Reasoning pre-evaluates the medical history data
- Assign content – suitable patient education content from medudoc’s medical editorial network
- Generate the video and IC Sheet – patient-specific, in 14 to 90 seconds per case according to an internal evaluation in the Cantonal Hospital St. Gallen case study
- Provide for signature – electronically, as a simple, advanced or qualified electronic signature, depending on requirements
The following explainer video from medudoc shows what such automatically generated, personalised content looks like in practice:
Video on YouTube: Digital patient education with medudoc
Digital patient education with medudoc – official explainer video (medudoc, YouTube).
Why is a template library not enough for this?
Summary: a library of standard sheets remains static at the level of the individual sheet. A data flow responds dynamically to the individual case because it does not choose from ready-made documents but recombines content for each case.
Many solutions on the market offer extensive libraries of hundreds to thousands of standard sheets to choose from. This is a legitimate and proven approach – but it shifts individualisation to the person making the selection, who determines the best-fitting sheet from the available templates and adds to it by hand where necessary. With a data flow approach, this selection step is no longer needed: the combination of medical history, type of procedure and risk profile automatically determines which content goes into the document and in what form. This is particularly evident with multilingual support: instead of keeping pre-produced sheets for each language, medudoc combines the German original and a foreign-language version in a single document generated for the case in question.
What does the data flow mean for proving that patient education took place?
Summary: because the IC Sheet is created from a documented data flow, not only the signature but the entire patient education process can be fully evidenced.
At medudoc, this complete documentation is called the consent trail – it records which content was viewed when, which passage was reopened and which question was asked, in addition to the time stamp of the signature. This is a qualitative difference from a mere signature on a form, because in the event of a dispute it documents not only that patient education took place, but also to what extent. The page informed consent in medicine summarises the basics of informed consent; the technical and organisational framework for handling this data is documented in medudoc’s security information.
Is the physician’s consent discussion still necessary?
Summary: yes. An automatically generated IC Sheet prepares and documents the consent discussion – it does not replace oral, face-to-face patient education by the physician.
Under § 630e BGB, the physician must provide patient information orally and in a way the patient can understand; written form is not mandatory, but is useful for documentation. An individually generated IC Sheet moves the pure intake of information forward in time, so that the discussion itself leaves more room for questions and personal, case-specific explanation. The page legal basis of patient education summarises the complete legal basis of patient education in the DACH region.
You will find a full overview of individualised digital informed consent sheets, available signature levels and their integration into the overall preoperative process on the page on digital informed consent sheets.
The article why generic consent sheets are a liability risk describes the specific liability risks that generic sheets pose. From medical history to patient education: more time for high-risk patients shows how a smart medical history also creates time for high-risk patients.
