Informed consent does not start with the sign button. It doesn't end up there.
It's the only clinical document that can require four signatories: patient or representative, doctor and two suitable witnesses. The sign attests to attribution and does not understand. That's why the file should be capable of showing what version of the document was signed and who participated, and that there's a sign.
The NOM-004 It supports autograph, electronic or digital signature but does not define level of authentication or minimum evidence. That neutrality allows to design risk-proportional controls as long as they are document why they are reliable.
In cases of mutilation or continuous modification, the Regulation requires two suitable witnesses as well as his or her patient or his representative and his or her doctor. A digital flow with only one sign does not cover the hospital's highest risk document.
Three products, not a consultant.
JAAK offers electronic information and signature software. Test each person directly and we are not an office and this does not replace his or her legal team's advice.
Fingerproof face biometrics, OCR official identification and list consultation, in a single flow.
- Liveness detection (anti-supurization)
- OCR official identification
- Consultation with list and risk
- Expediente digital descargable
Who sign what, according to the document.
That's the part of consent that's most simplified by digitalizing and that's most important for a review. A single-sign flow doesn't cover half of this table.
| Document | Patient or repr. | Medical | Witness 1 | Witness 2 | Risk |
|---|---|---|---|---|---|
| Evolution note | — Not applicable | ● Required signature | — Not applicable | — Not applicable | MEDIA |
| Authorisation of hospital entrance | ● Required signature | ● Required signature | — Not applicable | — Not applicable | ALTA |
| Consent to surgery or anesthesia | ● Required signature | ● Required signature | ● Required signature | ● Required signature | MUY ALTA |
| Act with mutilation or permanent change | ● Required signature | ● Required signature | ● Required signature | ● Required signature | MUY ALTA |
| Emergency or disability exception | ◐ Required as required | ● Required signature | ● Required signature | — Not applicable | MUY ALTA |
| Laboratory or photo order | — Not applicable | ● Required signature | — Not applicable | — Not applicable | MEDIA |
Classification built from NOM-004 10.1 and Regulation 80 to 83.
Urgence and disability: the flow that almost no system looks at.
The Regulation allows for actions without patient consent in clear and clear situations but requires a system that only has a happy path to force personnel to step out of the system just as at best.
Incapacity or urgency document
The system should allow us to register why the patient cannot manifest his or her will, and not just omits his or her signature.
That should be the clinical cause with an hour.
Reg's requested
The family member, guardian or his or her legal representative, and his or her document should be preserved with his or her disability.
It should be valid: an identity and quality of the representative.
If there's no agent, two doctors
The emergency allows an exception with the agreement of two doctors and written constancy. The flow should endure two professional signatories.
That's what we have to have: both sign and constancy.
Reconstructed after
When the patient regains his or her capacity or his or her representative arrives, the file should be complete without overwriting.
It should be left: original version intact and new.
- That no note can run out of date, time, full name and signature
- Record of what version of consent was shown to the patient
- Reported identity and signature of both witnesses when applying
- Reported emergency route with two doctors and constancy
- Export of the file with versions, accesses and integrity constancy
- Restraint policy aligned with last medical act, but not with date of release
What's the rule about every requirement.
Without intermediate interpretations: instrument, number and what requires in practice. The links to the Official Journal are at the end of the page.
NOM-004-SSA3-2012
Obliga5.1 · 5.4
To integrate and preserve the file for at least five years after the last medical act and the file is the property of the institution and does not remove the patient's information rights.
NOM-004-SSA3-2012
Obliga5.10 · 5.12
Any note should contain date, time and full name with autograph, electronic or digital signature. The use of electronic means is allowed if the rest of the frame is met.
NOM-004-SSA3-2012
Obliga10.1 · 10.1.4
The letters of consent have to contain information about the establishment, authorized act, risks and benefits and the signatures of the patient or representative, the doctor and two witnesses with respect to normative considerations.
Regulation of the LGS
Obliga80 · 81
Written and signed authorization at hospital entrance with specific consent for high-risk proceedings. In an inability to sign a representative, an emergency permits an exception with the agreement of two doctors and a written record.
Regulation of the LGS
Obliga82 · 83
Minimum data, authorized act, explanation and signatures. Acts involving mutilation or permanent modification require two qualified witnesses.
General Health Act
Obliga51 Bis 1 · 51 Bis 2
Sufficient, clear, timely and truthful information about diagnosis, prognosis and treatment and right to decide freely. The content and opportunity of information should be tested, and not just final signature.
Clinical signature levels
LagunaNo definition
The NOM-004 does not define authentication levels, biometrics, time sealed and certificates. It allows to design risk-proportional controls by documenting their reliability.
Statements that circulate and do not resist the number.
We hear them from vendor evaluations and internal committees in this sector.
"The NOM-004 require autograph signature, so the digital file doesn't apply. "
The 5.10 figure supports autograph, electronic or digital signature and 5.12 expressly supports the use of electronic means. What we have to be able to prove is why the chosen method is reliable and attributable.
NOM-004-SSA3-2012 · 5.10 and 5.12
"A general authorization to his entrance will cover his entire stay."
The Regulation calls for an entry authorisation and specific consent for high-risk proceedings and a general authorisation does not replace the consent of the particular act.
Regulation of the LGS · 80
Two ways to continue, as necessary.
30 minutes with a product specialist from JAAK
We check his sign matrix and show him how to configure KYCSignature NOM-151 or Signature NOM-151 + Biometrics for consent, hospital entrance and emergency and disability route. We do not give legal advice: legal questions are left to his own lawyer.
To schedule the sittingMultirole consent and exportable evidence
Flow with patient or representative, doctor and two witnesses on an identifiable version, with timestamp, log and export for audit or legal proceedings. Ninety-second demos and an architecture sheet.
Information material. It does not replace a legal opinion for a particular case. No technology itself guarantees legal validity, prevents sanctions or excludes professional liability. What can do a well-designed system is to reduce gaps of evidence and explain what happened.
Each statement of this page has its official source.
Consulted on July 27, 2026. If you find an up-to-date, write and correct with a date of visible review.