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Informed Consent - Digital Consent Records and E-Signature

Digital informed consent: versioned templates, a signature link the patient opens on their own phone, and a signed PDF that proves which text was agreed, by whom and when.

What a Consent Record Is

Written consent is compulsory before a dental, aesthetic, injectable or otherwise invasive procedure across most of Europe (in Spain, for example, Ley 41/2002 art. 8). In nutrition and counselling it is usually spoken — but consent to process health data is required of everyone.

A consent record is not a form. A form captures answers; a consent record has to prove the four things an audit asks for: which version of the text was shown, who signed it, when and how, that it applied to a specific procedure, and whether it was ever withdrawn. Vitena keeps those as first-class data rather than as a paragraph inside a questionnaire.

Route: /app/consent is your template library. Signed records live on the client card, under the Consent tab.

The signed text is copied into the record. Rewrite the template two years later and the old signature still carries the exact wording that patient read.

Templates and Versions

A template is just text, attached to nothing on its own. Publishing it freezes it: editing a published text does not overwrite it, it opens a new version, and the old one is never deleted because signatures point at it.

Vitena ships a ready-made library to start from — 9 texts in 7 languages, grouped by purpose: the general ones every practice needs (health-data processing, clinical photography, guardian consent for a minor, general treatment) plus dental and aesthetic-procedure texts.

Each template also carries how often it must be renewed: once per client, once per service, or every single time — optionally with a validity in days, which is how an aesthetics clinic gets a "renew every 6-12 months" rule.

Dicas
  • The ready-made texts are a starting point, not legal advice. Whether the wording satisfies your local regulation is the professional's responsibility — read them and adapt them.
  • Whether a drawn signature is required is set per template. Switch it off and the signature pad is not shown at all.
  • The library shows how many people have signed each text.

Attaching Consent to a Service

This is where the feature stops being paperwork. A consent template can be attached to a service in your service catalogue: "a filling always needs the treatment consent and the photography consent." After that nobody has to remember it — when a visit for that service is confirmed, the request goes out by itself.

The obligation belongs to the procedure, not to the person or the visit, which is why it hangs on the service — exactly like a prepayment requirement. And it is a list rather than a switch, because one treatment routinely needs two consents.

A missing consent warns; it does not block the session by default. A patient in the chair should not be waiting on software. A template can be marked as blocking when the procedure genuinely demands it.

When the Request Goes Out

Consent is asked for when the visit is actually going to happen — not the moment a booking request arrives. Asking someone to sign for a procedure the clinic has not accepted yet would be collecting consent for a treatment that may never take place.

  • Auto-confirmed, no prepayment: when the patient clicks the confirmation link in their email
  • Manually approved: when the practitioner approves the appointment
  • Prepaid: when the payment is confirmed

The request arrives as an email and also appears in the client portal as a card waiting to be signed. Email alone is not a channel you can rely on — it gets filtered, missed, or sent to an address nobody reads.

Dicas
  • You can also request a consent by hand from the client card at any time, with no appointment involved.
  • "Resend" reuses the same record and the same text — the patient was asked about a specific version and must still see that one. Only the expiry is reset.

How the Patient Signs

The signature screen opens from a one-time link and needs no account and no password. It is a single screen: the text, and a decision bar that stays in view while the patient scrolls.

To agree, the patient ticks the box and types their full name; if the template asks for it, they also draw a signature with a finger. Legally the tick and the typed name are enough — eIDAS art. 25 is explicit that a signature cannot be denied legal effect merely for being electronic, and informed consent is the textbook case for a simple electronic signature. A qualified signature (QES) is not required here. The legal weight comes from the evidence around the signature: the frozen text, the timestamp, the IP address, the browser, the language and the method.

Declining is a real answer, with a button of its own. And the approve button stays closed until the patient has scrolled to the end of the text — the load-bearing word in "informed consent" is the first one.

A dental or aesthetic visit routinely needs two or three consents. The screen says so up front — "2 more after this" — and moves to the next one after each signature, so the patient decides once whether to hand the tablet back.
  1. The patient opens the link from the email or from the client portal
  2. They read the text to the end — the decision bar says what is still missing
  3. They tick the box, type their name, and draw a signature if the template requires one
  4. They choose "I consent" or "I do not consent"
  5. If more consents are waiting, the screen hands over to the next one instead of ending

Signing at the Clinic

Some patients arrive without having signed, and some will never sign on a phone. From the client card you can open the consent on your own tablet and hand it over — the record then states that it was signed under supervision at the clinic, instead of claiming an email signature that never happened. No email goes out in that case: the patient is standing in front of you.

For a minor, the signature screen asks whether the person signing is the patient or a parent/guardian, and that relationship is written into the record.

Dicas
  • The front-desk board shows a badge on arriving patients with something outstanding; tapping it opens their Consent tab.
  • The appointment screen and the session workspace show a warning strip when the visit's consent is missing.

The Signed Document and Withdrawal

Every signature produces a PDF naming both parties: your practice (name, trading name if different, phone, email and website), the patient, the service, the full frozen text, the drawn signature flattened onto the page, and an evidence table. Consent is an agreement between two parties — a document that does not say which practice obtained it proves only half of what it needs to.

The practice name is copied into the record for the same reason as the text: a clinic that changes its name in 2027 must not be able to rewrite who a 2026 consent was made with.

Nothing is ever edited or deleted. Withdrawing a consent writes a new row marked as withdrawn; the signed row stays exactly as it was. That is what makes the archive worth anything in a dispute.

The client card lists signed, pending and withdrawn consents together — date, signer, method and text version — with the PDF one click away.

Plans, and What Is Deliberately Not Included

Health-data processing consent is free, on every plan; putting a legal obligation behind a paywall would be the wrong trade. Treatment consents, the ready-made template library, attaching consents to services and the PDF archive are part of the paid plans.

Deliberately not built: qualified electronic signature (QES), which eIDAS does not require here and which multiplies cost and friction; external e-signature integrations such as DocuSign, which would take the patient off your site; and wet-ink scanning workflows. The legal content of the texts is out of scope too — the library gives you a starting point, the wording remains yours.

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Perguntas frequentes

Yes. Under eIDAS art. 25 a signature cannot be denied legal effect or admissibility as evidence simply for being electronic, and informed consent is the classic case for a simple electronic signature — a qualified signature is not required. What matters in a dispute is the evidence trail around it: which version of the text was shown, when it was signed, from where, and how the signer was identified. Vitena stores all of that with the record.

A form captures answers. A consent record has to prove which version of the text was agreed to, by whom, when and how, that it applied to a specific procedure, and whether it was later withdrawn. Those four are exactly what an audit asks for and none of them are part of a general questionnaire, which is why consent is a separate record type rather than a form template.

Publishing freezes a text. Editing a published template opens a new version instead of overwriting it, and the old version is never deleted. On top of that the full text is copied into each record at the moment it is signed, so a signature from two years ago still carries the exact wording that patient read, whatever the template says today.

No. The signature link opens a single screen with no login and no password — the patient reads the text, ticks the box, types their name and, if the template requires it, draws a signature with a finger. Pending consents also appear in the client portal, so email is not the only way in.

Yes. You can open the consent from the client card and hand over your own device; the record then states that it was signed under supervision at the clinic instead of claiming an email signature that never took place, and no email is sent. This is the fallback for patients who arrive without having signed and for those who will not sign on a phone.

Not by default — it warns. A badge appears on the front-desk board and a warning strip appears on the appointment screen and in the session workspace. Putting software between the clinician and a patient already in the chair only teaches the clinic to work around the software. A template can be marked as blocking when the procedure genuinely requires it.

Withdrawal writes a new row marked as withdrawn; the original signed record is never edited or deleted. The client card then shows the consent as withdrawn alongside its original signature, which is what a withdrawal has to look like if the archive is going to be worth anything in a dispute.

Perguntas frequentes

Yes. Under eIDAS art. 25 a signature cannot be denied legal effect or admissibility as evidence simply for being electronic, and informed consent is the classic case for a simple electronic signature — a qualified signature is not required. What matters in a dispute is the evidence trail around it: which version of the text was shown, when it was signed, from where, and how the signer was identified. Vitena stores all of that with the record.

A form captures answers. A consent record has to prove which version of the text was agreed to, by whom, when and how, that it applied to a specific procedure, and whether it was later withdrawn. Those four are exactly what an audit asks for and none of them are part of a general questionnaire, which is why consent is a separate record type rather than a form template.

Publishing freezes a text. Editing a published template opens a new version instead of overwriting it, and the old version is never deleted. On top of that the full text is copied into each record at the moment it is signed, so a signature from two years ago still carries the exact wording that patient read, whatever the template says today.

No. The signature link opens a single screen with no login and no password — the patient reads the text, ticks the box, types their name and, if the template requires it, draws a signature with a finger. Pending consents also appear in the client portal, so email is not the only way in.

Yes. You can open the consent from the client card and hand over your own device; the record then states that it was signed under supervision at the clinic instead of claiming an email signature that never took place, and no email is sent. This is the fallback for patients who arrive without having signed and for those who will not sign on a phone.

Not by default — it warns. A badge appears on the front-desk board and a warning strip appears on the appointment screen and in the session workspace. Putting software between the clinician and a patient already in the chair only teaches the clinic to work around the software. A template can be marked as blocking when the procedure genuinely requires it.

Withdrawal writes a new row marked as withdrawn; the original signed record is never edited or deleted. The client card then shows the consent as withdrawn alongside its original signature, which is what a withdrawal has to look like if the archive is going to be worth anything in a dispute.