An interview with Prof. Dr. Alexandra Jorzig, specialist lawyer for medical law and professor at the IB University of Health and Social Sciences in Berlin in the field of health law and digital health.
Challenges of Traditional Patient Education
How would you evaluate traditional patient education, and from your perspective, is it still contemporary?
Jorzig: Traditional patient education using written informed consent forms is indeed functional when conducted correctly and meets legal requirements. However, the question of whether it is contemporary is a different matter. The challenge lies in adapting patient education methods to the evolving needs and expectations of patients and possibly integrating modern technologies to make patient education more effective, up-to-date, and comprehensible.
What technical possibilities do you see in this regard? In what direction could it become more contemporary?
Jorzig: Of course, it is of great benefit when patients have the opportunity to inform themselves comprehensively in advance. In the past, for example, a nurse would come into the room, place a form on the bedside table, and return later to obtain the signature. That is not adequate patient education. Today, we have digital tools at our disposal, such as videos, which not only facilitate preparation but also allow for shorter doctor-patient conversations.
However, it is not sufficient during the informed consent conversation to simply say, "Do you have any questions? No? Okay." Such an approach does not replace a comprehensive discussion. It is also essential to preserve the patient's autonomy, and the conversation must meet medical-legal requirements. Therefore, it is imperative to address essential points such as treatment risks, the procedure, and potential risks, and then address the patient's individual questions.
As a result, informed consent can be more efficient when well-structured. In this case, the patient can better understand the planned medical procedure and process, even without a medical background. A significant advantage is that well-presented information helps patients understand more, even without medical expertise. Sometimes, such information is even more understandable than a doctor's explanations. Additionally, we should not forget that doctors are also human and can make mistakes. They may forget information, which can lead to misunderstandings when patients later realize that they were not provided with important information.
Therefore, well-structured and comprehensive informed consent is crucial to minimize potential misunderstandings and enhance patient safety.
What tasks should decision-makers in legislation address now to improve patient safety in education? What new standards are necessary?
Jorzig: Considering the time component during informed consent is crucial. Informed consent should never be rushed or conducted under time pressure. Especially for planned elective procedures, timely informed consent is of utmost importance and should be well-planned and managed in advance.
Digital Solutions and Their Contribution to Patient Safety
Considering the rapid developments in healthcare, what new approaches do you see for clinical risk management in terms of patient safety?
Jorzig: Legal precedent regarding physician-patient informed consent has changed in a way that now doctors conducting the informed consent process can be held liable for any errors in the process, not just the performing physicians. This necessitates extremely diligent informed consent practices from all physicians to ensure patient safety. Often, critical details such as allergies are overlooked, leading to the selection of an inappropriate treatment method, even when the patient has allergies. Therefore, it is crucial to address individual patient needs and take into account their preexisting conditions.
Could digital solutions like medudoc, through individualized video-based patient education, improve patient safety here?
Jorzig: Yes, I definitely think so. Especially concerning information that is noted in the patient's records, such as allergies. Anesthesiologists, in particular, do not always have access to all documents, especially in the context of anaesthesia consent. With digital solutions like medudoc, we can use information from the patient's records to specifically inform patients about their allergies and assist doctors in choosing the correct treatment method.
Furthermore, the availability of information is beneficial in a way that patients can go through their individualized informed consent content at home at their own pace, maybe even on several evenings in a row. This has been proven to be more effective. Studies show that people retain only about 3% of the information from an informed consent conversation after three days. That's alarmingly little. But it's a protective reaction of the brain to suppress such stressful situations. By preparing outside the stress of the "doctor's appointment" situation, we can ensure that the information is better retained in memory, thus increasing patient safety and patient compliance.
Do you see advantages in digital education and documentation compared to the traditional paper-based method, especially in terms of hospital workflows and the work of doctors?
Jorzig: Digital informed consent enables comprehensive and standardized education where no information is forgotten. This ensures that all patients are equally informed and prevents subsequent accusations that informed consent did not take place or was inadequate.
However, this method carries the risk of neglecting individual patient needs. Especially in the legal context, it is crucial to find solutions to ensure that electronic informed consent remains both comprehensive and tailored to individual patient needs. For example, if a drawing was made on the informed consent form, this serves as evidence that the informed consent conversation took place. Similar evidence of individualization is needed for digital informed consent.
It is important to emphasize that there are limited legal precedents in this regard so far. To enable a final legal assessment, precedent cases in court will likely be required.
Patient Participation and Understanding
To what extent can better-informed and prepared patients contribute to a smoother treatment process?
Jorzig: Clear communication of instructions, such as the need to fast before anaesthesia or discontinue specific medications, enhances safety by ensuring that patients understand what is expected of them. If patients do not independently grasp the reasons for such measures or are stressed and forget or misinterpret the instructions, this can jeopardize patient safety. It's important to consider that not all patients are equally educated or have the capacity for self-responsibility to make these decisions independently.
Through better patient education, a smoother process can be ensured, ultimately contributing to increased patient safety and greater legal security for the physician.
Do you know of any examples where lack of information or insufficient preparation has compromised patient safety?
Jorzig: One of the most prominent examples is the inaccurate reporting of weight by patients before surgery. When patients provide false information about their weight due to shame or other reasons, it can lead to serious complications as the dosage of anaesthetics and other medications depends on it. Patients must understand that their cooperation and honesty in this area are crucial for their own safety.
Legal Protection and Documentation
How do you assess electronic documentation and signatures in terms of legal protection for clinics and doctors?
Jorzig: In principle, I don't actually need written documentation unless it's for forensic reasons in the context of a legal proceeding. This is because a patient can also give consent through implicit behavior, such as showing up for surgery, which is considered implied consent.
However, for such situations, it is advisable to make the process especially secure. The safest option would undoubtedly be to use a qualified electronic signature. Nevertheless, from a legal perspective, a simple signature is also sufficient.
Are there actually cases where patients claim they did not consent, and the signature was not theirs?
Jorzig: Yes, in serious cases, it is common practice to use identification as a means of verification. The judge then strongly requests the patient to review the informed consent form and verify the signature. In about 90% of cases, patients confirm in this situation that the signature is indeed their own. The entry in the calendar, indicating that the patient was present for the informed consent discussion, serves only as an indication. The actual signature is significant and crucial evidence.
Do you also see opportunities for improved patient safety with digital documentation?
Jorzig: The use of digital information to enhance informed consent is a double-edged sword. Benefits arise when the informed consent process is well-prepared, and the physician conducts the conversation in a structured manner. In such cases, time can be saved during the informed consent discussion, as the physician no longer needs to go into every detail with the patient. Documentation of the informed consent is also improved, as digital information cannot be lost like a sheet of paper. However, there is a risk that doctors may become complacent with too much standardization and neglect the conversation. This, in turn, has the opposite effect and can lead to liability claims. Therefore, it is crucial that despite digital support, the conversation between the doctor and the patient continues. This requires well-trained staff and effective risk management to ensure a good process. However, when these aspects are considered, there is undoubtedly the potential and huge opportunities to increase patient compliance. This not only contributes to improving patient safety but also streamlines the workflow, which, in turn, provides relief for the doctors.
Currently, the status quo also leads to the practice of taking a sheet of paper from the stack and presenting it to the patient. Is it possible that in the future, we won't rely on handwritten adjustments to informed consent documents to provide legal evidence, especially if it can be proven that patients have received high-quality, understandable, and timely informed consent materials, such as individualized informed consent videos?
Jorzig: I cannot assess that at the moment because the case law has not advanced to that extent. Currently, the case law is very restrictive, especially regarding the strict requirements of the Federal Court of Justice (BGH). What I could well imagine is the possibility of recording the informed consent discussion in the form of a video, provided the patient consents to such recording. This clarity could lead to significant simplification and transparency, as disputes and potential dishonesty regarding informed consent would be reduced. However, implementing such a system would also bring challenges related to data protection and ethics. Shaping the future of medical informed consent and its legal traceability is complex and requires careful consideration to protect the interests of both patients and doctors alike.
Is the approach of having a paper form supplemented by handwritten adjustments still timely?
Jorzig: I no longer consider it timely to rely on paper. Instead, we should fully embrace the digital world, as patients increasingly expect this. Whether informed consent is done digitally or analogue, the underlying idea remains the same.
What is your vision for the future of patient education?
Jorzig: I am convinced that AI will play a significant role in medical communication, as it can answer patients' questions before informed consent discussions - and do so at their individual pace. When doctors are stressed, this stress can transfer to patients, leading them to ask fewer questions and thus affecting their right to self-determination. AI could help meet legal requirements, especially regarding patient safety and ensuring the integrity of the decision-making process.