Unclear information levels, impossible planning of ICE

Using the current standardized information pamphlets, informed consent explanations are hard to schedule. Patients hand in their anamnesis forms and information pamphlets when they come in to see their physician, giving them no time to plan ahead, look at their documents or to „triage“ patients according to the time their conversation might take.

MAIA provides a summary of everything the patient has already learned and seen, thus no „learning-time“ is necessary for doctors, the conversation can be focused on open questions and uncertainties. The huge chunk of time required for the actual transmission of information to patients is already happening before the hospital stay, which means that a faster procedure in the clinic is possible. The technical finesse of MAIA is the intelligent and accurate, automated evaluation, interpretation and presentation of the preliminary information that was presented to the patients. Through this automation and pre-evaluation, misunderstandings, omissions or errors in the process can be avoided, while at the same time better legal validity of the documentation can be acchieved.

With MAIA, doctors know at a glance how much their patients know about their treatment and which media/information they consumed when to learn about it.

Lack of time & alternatives

In a 2014 study, the British NHS identified 50% of a doctor’s time is spent on clinical documentation. Recent initiatives and approaches by informed consent media producers, to ease the pressure, are all digital. But those digital solutions are only slowly replacing paper forms.

Currently ALL digital solutions for informed consent are struggling on the market. And that is because they offer no major benefits compared to paper. Documentation, across ALL existing solutions, is still done mostly by hand, just now on a tablet or PC screen. Current solutions are not using modern technology to its full potential and hence are not saving time or improving documentation security.

Additionally, doctors often have no idea about their patients and their knowledge levels before they come in to see them, so the whole process in impossible to prepare for or improve. A patient could be well informed and knowledgable so that the conversation is finished in 5 minutes, or a patient could be anxious, frightened, full of questions and doubt, in which case the conversation could last for an hour or more.

All of these systemic flaws add to constantly rising costs for the whole system, but that’s a story for another article.

Costs of informed consent media

Patient education is currently a major cost factor. Depending on the language of the consent form, hospitals pay between EUR 0.20 and EUR 1.20 per individual usage license for a single informed consent form. In addition, there are printing costs and administrative costs, which are added, for example, in the subsequent digitization of the sheets. For each patient, an average of 2.3 consent forms is required per surgery, since in addition to the surgery itself, there is also a need for risk explanation and consent for anesthesia and other vital information regarding the surgery. The market leader in the print segment, who covers a large part of the market, also charges an update fee of EUR 10,000.00 per year and hospital, for the digital consent form library.
MAIA is also operating on a license model, but regardless of the language used. The price will be between EUR 0.20 and 0.25 per informed consent. There is no annual fee for the software and the costly installation into hospital IT systems is completely eliminated since MAIA is browser-based, with a browser interface that connects to almost all IT solutions currently on the market. Additionally, MAIA only costs a one-time setup fee, which is charged according to clinical requirements. In that setup, the platform is also adapted to the corporate design of the clinic. MAIA does not produce any subsequent digitization and printing costs since no paper is used.

Legal basics for informed consent routines

Informed consent explanation is a doctor’s legal duty before operating on a patient. Standardized paper forms have been used for clinical documentation extensively, but are NOT legally mandatory in most Countries.

A doctor does not have the right to touch, operate on or treat a patient. Any medical treatment, especially such that pose a risk to the patients health, is classified as a physical assault against the patient and is punishable by law. A patient must consent to treatment in order for the treatment to be considered a legal treatment instead of shere battery. So obtaining consent by the patient is a must for anything other than a routine examination.

In most countries, the only legally valid part of an informed consent explanation procedure is the part where a doctor explains the planned treatment and all its risks, side effects, alternatives and the medical urgency in detail. A signature on a „waiver“-form without prior explanation is not enough for obtaining consent. In fact, in many countries including Austria, the signature is not at all necessary by law. Of course, a doctor can secure the signature by their patient. The patient thereby confirms that they have competently read and understood all information about the treatment as well as all its risks, alternatives, etc. But theoretically, a signature is not even needed. The patient can consent by simply allowing their doctor to perform a particular medical treatment.

The devil lies in the details. Informed consent must be documented thoroughly by doctors and clinics, because actually most malpractice lawsuits are not won for medical reasons or because side effects have occurred, but because of a failure to reach informed consent. Malpractise must be proven by the patient whereas legal consent must be proven by doctors.
Consent can be challenged on the grounds that important or understandable information has not been relayed to enable the patient to take a proper and knowledgeable decision. The patient could have refused the challenged course of treatment, had they known all details, thereby rendering the whole treatment illegal and subject to recompensation.