Legal certainty in Patient Education

Duty of disclosure in a medical context explained simply.

The legally binding nature of
information meetings is usually underestimated.

The legally binding nature of medical content is a key aspect in the healthcare sector, especially when it comes to informing patients before medical procedures. Legal requirements play a decisive role here, providing doctors with clear guidelines for legally compliant information.

But how can it be ensured that this content complies with legal requirements and at the same time meets the needs of patients?

Legal basis
and its implementation at medudoc

01

§§ Sections 630a ff. of the German Civil Code (BGB)
Legal basis of medical information

According to Sections 630a et seq. of the German Civil Code (BGB), the patient’s informed consent is required for a legally effective treatment contract. The duty of doctors to provide information includes the transparent presentation of diagnosis, treatment alternatives and risks.

How do we implement this?
On our intelligent video platform, doctors can generate personalized medical education videos tailored to individual indications. We ensure that all content complies with legal requirements. The content is created based on the guidelines, recommendations, position papers and agreements of the professional associations as well as literature and general patient information.

02

§ Section 630e BGB
Oral duty to inform

According to Section 630e of the German Civil Code (BGB), the medical information must be provided verbally and in a way that the patient can understand. A written form is not required, but is recommended. The information must be provided in good time and tailored to the individual patient.

How do we implement this?
We do not replace an informed consent discussion, as this is essential from a legal perspective. However, with our solution we offer better preparation and information that patients can understand. This makes better use of the time spent talking to the doctor. A more pleasant experience – for both sides!

03

§ Section 630e (2) no. 3 BGB
Comprehensibility of the information

In accordance with Section 630e (2) No. 3 BGB, the medical information must be understandable for patients. The use of excessively technical language is not permitted and, in the event of language barriers, the information must be provided in a language that is understandable.

How do we implement this?
studies (see, for example, Salzwedel et al, (2008): The effect of a detailed, video-assisted anesthesia risk education on patient anxiety and the duration of the pre-anesthetic interview. A randomized controlled trial. Anesth Analg 106:202-209.) have shown that visual and auditory elements can improve the absorption and processing of information, particularly in the case of complex medical content. This is precisely why we rely on video-based Patient Education, which explains medical information in a simple and understandable way for patients. For better preparation, treatment adherence and an optimized treatment experience!

Our content can be individually tailored to patients in terms of surgical procedure, location, risk profile, etc. Rather than offering a one-size-fits-all solution, we take into account the diversity of patients and their unique situations to provide them with the best possible support and education.

“


Good and individualized Patient Education significantly reduces the liability risk for doctors.

Prof. Dr. iur. Alexandra Jorzig

Specialist lawyer for medical law / Berlin, Düsseldorf

Status Quo

While standardized information sheets undoubtedly provide a formal framework for communicating legally binding content, it is important to question whether they actually adequately address the needs of individual patients.

The process of using standard information sheets has evolved in response to the need to provide a legally binding method for communicating risks and treatment options. This results from efforts to minimize liability and ensure a consistent approach to information. However, it is important to recognize that this approach has its limitations and does not always meet the individual needs of patients.

The implementation of individualized explanations can lead to a significant increase in the effectiveness and quality of Patient Education. The communication of legally binding content in the medical field is crucial.

medudoc’s solution offers an innovative approach that meets the legal requirements and at the same time enables patient-centered education.

In this way, we are making an important contribution to improving Patient Education and contributing to greater quality and safety in the healthcare sector.

Frequently asked questions about Patient Education

Legal certainty is of central importance in the medical context because treatment is not legally permissible without effective consent (Section 630d BGB). For consent to be valid, the patient must have received comprehensive and comprehensible information (Section 630e BGB).
If this information is missing or inadequate, this can lead to liability claims, a reversal of the burden of proof and even criminal prosecution.

medudoc supports doctors in complying with the legal requirements in a precise and documented manner – for comprehensible, legally compliant Patient Education.

The legal requirements for Patient Education are set out in the German Civil Code (BGB), Sections 630a to 630h:

  • § Section 630a BGB – Treatment contract:
    Specifies that a treatment contract exists between the doctor and patient, which includes proper information as a contractual obligation.
  • § Section 630c BGB – Cooperation of the contracting parties:
    Obliges doctors to provide comprehensive and honest information about the essential circumstances of the treatment.
  • § Section 630d BGB – Consent:
    Treatment is only lawful if the patient has effectively consented to it beforehand. This consent requires sufficient information.
  • § Section 630e BGB – Duty to provide information:
    Regulates the type, scope and timing of the information – it must be provided verbally, individually and comprehensibly.
  • § Section 630f BGB – Documentation:
    All essential contents of the clarification must be properly documented. The documentation serves as central evidence in the event of a dispute.
  • § Section 630h BGB – Burden of proof:
    If a dispute arises, the doctor generally bears the burden of proof that proper information has been provided.

medudoc creates digital traceability and standardization without restricting medical individuality.
Our platform offers:

  • Video-based, documented information as a supplement to the doctor’s consultation,
  • Content based on current guidelines, directives and professional society recommendations,
  • Personalized adjustments to the procedure, location, risk profile and language of the patient,
  • Complete digital documentation that serves as proof in the event of a dispute (Section 630f BGB).

In this way, medudoc enables verifiable fulfillment of the medical duty to inform within the meaning of §§ 630d-630h BGB.

No.
According to Section 630e (2) No. 1 BGB, the information must be provided verbally by the attending physician or a qualified representative.
The consultation is essential, as this is the only way to ask individual questions and check understanding.

medudoc does not replace this conversation, but improves it:
Patients are better prepared thanks to the video, understand content more easily and can ask more specific questions. This improves the quality and verifiability of the verbal explanation and reduces the processing time, as the patient is appropriately pre-informed.

§ Section 630e BGB requires that the information:

  1. verbally,
  2. is understandable (no excessive technical language),
  3. takes place in good time before the procedure,
  4. all material risks, alternatives and prospects of success,
  5. and adapted to the patient’s individual situation.

medudoc supports doctors in complying with these requirements by generating the content individually, simplifying it linguistically and communicating it visually – for maximum comprehensibility and comprehensibility.

The documentation obligation is a central component of legal certainty.
According to Section 630f BGB, all essential measures, information content and consents must be documented completely, promptly and comprehensibly.
If the documentation is missing, the information is deemed not to have been provided (Section 630h BGB).

medudoc documents automatically:

  • Time of video creation and release,
  • individual information content,
  • Proof of patient access and confirmation.

This creates a digital chain of evidence that is legally robust.

According to Section 630h BGB, the burden of proof is reversed in favor of the patient in the event of a dispute.
This means:
If the doctor cannot prove that the information was properly provided, it is assumed in favor of the patient that it was not provided.

Thanks to the digital documentation at medudoc, objective proof of the results is available:

  • Contents,
  • Time and
  • Access to information
    – a significant contribution to legal protection.

Consent is only valid if the patient has understood the content of the information provided (Section 630d in conjunction with Section 630e (2) No. 3 BGB).
If the information is not understood, for example due to technical language or language barriers, the consent is legally invalid.

medudoc counters this risk by using the videos:

  • linguistically simplified,
  • visually supported,
  • and are available in several languages** if required.

This increases the comprehensibility and thus the effectiveness of the consent.

Legal certainty and compliance are closely linked.
medudoc documents the entire clarification process in a verifiable, standardized and individually traceable manner.
This reduces the risk of

  • Errors in clarification,
  • lack of documentation,
  • and subsequent liability claims.

For clinics, this means:
greater legal certainty, lower liability risk and greater patient satisfaction.

medudoc fulfills the requirements of §§ 630a-630h BGB by:

  • digitally supports the education process,
  • legally relevant content is verifiably documented,
  • Comprehensibility and comprehensibility improved,
  • and transparently safeguards the doctor’s duty to provide information.

In this way, medudoc makes a significant contribution to the legal safeguarding of doctors’ obligations to provide information and to quality assurance in the healthcare sector.