Simulation and informed consent: what to include

When a professional shows a simulated image to a patient, they are using a photo of the face to generate another image and presenting it as an illustration of a possible plan. Every step of this process involves sensitive personal data and an expectation that needs managing. The consent form is the instrument that organizes these points. This page lists what is worth including, without replacing your service's legal review.

Why does the simulation deserve its own clause?

The traditional facial harmonization consent covers the procedure: risks, benefits, alternatives and care. The simulation adds new elements the traditional consent does not reach. There is a new purpose (using the photo to generate an image), a data processing step (the photo moves between systems) and a communication of expectation (the image can be read as a promise). Each deserves to be spelled out.

See the concept in informed consent, the notice in illustrative simulation and the data view in LGPD.

Which clauses usually make sense?

These items are a framework. Each service adapts it to its own flow and requirements.

What to explain about photo handling in Harmy?

In Harmy, the photo is sent to a third-party AI to generate the image, with the professional's acceptance in the app, and the face contours are calculated on the device itself and are not stored. This is the kind of information the patient has the right to know in simple terms. Explain, in plain words, that the photo goes to a system that generates the image, that it is used for that purpose and that it will not be published. Record that the patient was informed.

See the overview in consent and LGPD for photos and the filing routine in recording the simulation in the patient record.

Which consents should be kept separate?

Mixing purposes in a single text makes it harder to read and weakens each consent. A practical separation usually involves three documents, or three clearly delimited sections.

A patient's refusal to allow publication must not affect their care. Consent for publication must be freely given. See separate consent for publishing images and what you may publish (CFO and CONAR). In Brazil, the CFO is the Federal Dental Council and CONAR is the advertising self-regulation council.

Which phrases should be avoided in the form and in conversation?

Some terms create a promise. Avoid: "expected result," "you will look like this," "satisfaction guaranteed" and any expression that gives the image the weight of a contract. Prefer "illustration," "illustrative simulation," "possible plan" and "no guarantee of results." The difference in vocabulary can be decisive in a future dispute. See explaining that a simulation is not a guarantee and notice text for an illustrative simulation.

How to present the form to the patient?

Do not hand over the paper to sign without reading. Set aside a moment to explain the main points in simple words and ask if there are questions. Give them time to read. A form signed in a hurry is worth less, legally and ethically, than one that was read and understood. For how to handle the conversation, see how to explain the consent form and how to ask the patient to read the consent form.

What if the patient is a minor or has a guardian?

Image authorization and consent involve the legal guardian, and there are specific rules for this kind of care that vary with professional board rules and legislation. Facial harmonization simulation for a minor is a sensitive topic and, in many cases, the right move is to decline. See image authorization for a minor and saying no to a minor patient.

How to handle withdrawal of consent?

The patient may change their mind about the image. The service needs a defined flow: who receives the request, how the images are located, what can be deleted and what must stay because of the patient record retention requirement. Avoid promising total deletion before you know those limits. Explain to the patient what is possible, transparently. Data subject to mandatory retention follows the professional board's rules, and the rest can be erased.

Also keep a simple record of the withdrawal: the date of the request, what was done and the confirmation to the patient. This short routine prevents gaps and shows good faith. See deleting a patient's photo on request.

What should the simulation consent form leave out?

Less is more. A form full of promises, adjectives and guarantees increases risk instead of reducing it. Leave out result predictions, comparisons with other patients, marketing language and any clause the patient cannot understand on a first read. Clauses that try to exempt the professional from responsibility for any problem, in a generic way, tend to be viewed with skepticism. The form's job is to inform clearly, not to shield.

Also avoid including in the same document authorizations the patient does not realize they are giving, such as the use of the image on social media. Mixing purposes weakens each consent and can invalidate it. If the service wants to ask for permission to publish, do so in a separate document or section, with a clear option to decline and no connection to the care itself.

When to update the form?

Update it whenever the flow for using the image changes: a new simulation tool, a new storage location, a new purpose or a new type of sharing. Record the form's version date on each signed document, so you know which text the patient accepted. A periodic review, done with the service's legal support, keeps the text aligned with professional board rules and the LGPD. See also digital visual planning in facial harmonization.