Sign a patient's informed consent online
Free, informed and revocable consent of the patient before a medical act, surgery, experimental treatment or participation in biomedical research. In accordance with Article L1111-4 of the Public Health Code (Kuschner Law of 4 March 2002) and the eIDAS Regulation recommended advance signature, qualified time stamping, optional medical trail, long-term archiving included.
- Legal framework
- Article L1111-4 of the CPC · law of Kouchner
- Signature level
- AES eIDAS recommended
- Legal archives
- 10 years included
What is patient informed consent?
Informed consent is the principle that a patient cannot undergo a medical procedure without his or her consent, given after receiving fair, clear and appropriate information about the benefits, risks and therapeutic alternatives. Article L1111-4 of the Public Health Code (from the Kouchner Law of 4 March 2002) makes it a fundamental right of the patient, revocable at any time. For some acts (aesthetic surgery, biomedical research, AMP, IVG ...), a written is mandatory.
Why sign electronically?
Prior information with time stamp
Article L1111-2 CSP requires prior information of the patient.The advance signature of the Certyneo specifies the date of delivery of the information sheet AND the signature of the consent indisputable proof of the expiry of the period of reflection (case law: 7-15 days depending on the act).
Patient identity verified
OTP SMS verification on patient phone number + email. Preventing fraud (consent signed by a relative, pre-filled signature). Meets the evidentiary requirements in case of litigation for lack of consent.
Long-term storage
The medical record must be kept for 20 years from the patient's last visit (Article R1112-7 CSP), 30 years for certain acts (biomedical research, AMP).
The audit trail forensic evidence
Each consent is accompanied by a PDF of proof: patient identity (verified OTP SMS), qualified time stamp, SHA-256 hash, IP. Opposable in case of litigation for lack of information or lack of consent (medical liability, action for redress).
The four-step procedure
From prep to legal filing in less than five minutes.
1. Prepare the information sheet
Documents complying with Article L1111-2 CSP: description of the act, expected benefits, frequent and serious risks, treatment alternatives, consequences in case of refusal.
2. Provide information to the patient
Certyneo tracks precisely when the patient accesses the information basis for calculating the cooling-off period (usually 7-15 days).
3. time for reflection + signature
The patient can consult the information at his own pace and sign when ready with OTP SMS on his phone. For acts requiring a delay (cosmetic surgery: 15 days), Certyneo blocks the signature before the deadline.
4. File in the patient file
The consent + audit trail are archived in accordance with the retention period of medical records (20 years, 30 years for some acts).
Frequently Asked Questions
- Can a patient's informed consent be signed electronically?
- Yes, without restriction. Article L1111-4 CSP requires consent (in writing for certain acts) but does not prescribe any particular form. The advanced signature (AES) Certyneo fulfils the requirements of proof and is even superior to paper (qualified time stamping = indisputable proof of the reflection period).
- For which medical procedures is written consent required?
- Aesthetic surgery (Article L6322-2 CSP, 15 days), biomedical research (Article L1122-1-1), medical assistance for procreation (Article L2141-2), IVG (Article L2212-5 but oral consent is sufficient), organ harvesting (Article L1232-1).
- How can the cooling-off period (cosmetic surgery 15 days) be respected?
- Certyneo gives the precise date of the information being provided (timestamp qualified in the eIDAS sense). The time limit runs from this moment onwards.
- Can the patient revoke his consent?
- Yes, at any time and without reason (Art. L1111-4 CSP).Revocation may be notified by any means including a second electronic signature of revocation via Certyneo.The audit trail tracks precisely the date and means of revocation.
- What signature level for informed consent?
- The AES is recommended, it provides a presumption of reliability (Article 1367 of the Civil Code) and meets the requirements for evidence in medical litigation.
- How long do you have to keep the consent?
- 20 years from the patient's last visit (art. R1112-7 CSP), 30 years for biomedical research and MPA. Certyneo automatically archives consent + audit trail during this time.
- Can consent be signed by a minor?
- For a minor, consent is given by the holders of parental authority (usually both parents for important medical acts). From 16-18 years of age, the minor can consent alone for certain acts (contraception, IVF).
- Is electronically signed consent enforceable in medical disputes?
- The presumption of reliability of Article 1367 of the Civil Code makes the advanced signature (AES) objectionable. In the event of medical liability for lack of information, the Certyneo trail audit is direct evidence.
See also
How to collect your future online consent
Permanent free plan (5 envelopes/month), no credit card. Compliant with Public Health Code and eIDAS. Forensic track audit and long-term archiving included.