Sign a patient informed consent online
Free, informed and revocable consent of the patient before a medical procedure, surgical intervention, experimental treatment or participation in biomedical research. Compliant with Article L1111-4 of the Public Health Code (Kouchner Law of March 4, 2002) and the eIDAS regulation — advanced signature recommended, RFC 3161 timestamp, enforceable medical audit trail, long-term archiving included.
- Legal framework
- Article L1111-4 CSP · Kouchner Law
- Signature level
- AES eIDAS recommended
- Legal archiving
- 10 years included
What is patient informed consent?
Informed consent is the principle that a patient cannot undergo a medical procedure without their agreement, given after receiving honest, clear and appropriate information about the benefits, risks and therapeutic alternatives. Article L1111-4 of the Public Health Code (from the Kouchner Law of March 4, 2002) makes it a fundamental patient right, revocable at any time. For certain procedures (cosmetic surgery, biomedical research, ART, abortion, etc.), written consent is mandatory. Advanced electronic signature (AES) allows precise tracing of the provision of prior information and patient acceptance, with RFC 3161 timestamp — a major element in case of disputes over failure to inform.
Why sign electronically?
Prior information timestamped
Article L1111-2 CSP requires prior patient information. Certyneo's advanced signature precisely timestamps both the provision of the information sheet AND the signature of the consent — undisputable proof of the reflection period (case law: 7-15 days depending on the procedure).
Patient identity verified
OTP SMS verification on the patient's phone number + email. Prevents fraud (consent signed by a relative, pre-filled signature). Compliant with evidentiary requirements in case of disputes over lack of consent.
Long-term archiving
Medical records must be kept for 20 years from the patient's last visit (art. R1112-7 CSP), 30 years for certain procedures (biomedical research, AMP). Certyneo automatically archives consent + audit trail in compliance with these requirements.
Medico-legal audit trail with legal standing
Each consent is delivered with a proof PDF: patient identity (verified SMS OTP), RFC 3161 timestamp, SHA-256 hash, IP. Legally binding in case of litigation for lack of information or lack of consent (medical liability, damages claim).
4-step procedure
From preparation to legal archiving, in less than 5 minutes.
1. Prepare the information sheet
Documents compliant with art. L1111-2 CSP: description of the procedure, expected benefits, frequent and serious risks, therapeutic alternatives, consequences of refusal. HAS templates available for many specialties.
2. Provide information to the patient
Email delivery with RFC 3161 timestamp of receipt. Certyneo precisely tracks when the patient accesses the information — basis for calculating the reflection period (typically 7-15 days).
3. Reflection period + signature
The patient reviews the information at their own pace and signs when ready with SMS OTP on their phone. For procedures requiring a delay (cosmetic surgery: 15 days), Certyneo blocks signature before deadline.
4. Archive in the patient's file
The finalized consent + audit trail are archived in compliance with medical record retention periods (20 years, 30 years for certain procedures). Accessible in one click for any review or litigation.
Frequently asked questions
- Can a patient's informed consent be signed electronically?
- Yes for care: Article L1111-4 of the French Public Health Code requires consent — in writing for certain procedures — without prescribing any particular form, and an advanced signature (AES) timestamps exactly when the information was handed over, which paper does not. Research involving the human person (Article L1122-1-1), on the other hand, has a framework of its own: the Ministry of Health's recommendations of 26 June 2026 on dematerialised consent, which require the arrangement to be documented and checked by the ethics committee (CPP). "Without restriction" therefore does not apply to a research consent.
- For which medical procedures is written consent mandatory?
- Cosmetic surgery (art. L6322-2 CSP, 15-day delay), biomedical research (art. L1122-1-1), assisted reproductive technology (art. L2141-2), abortion (art. L2212-5 — but oral consent suffices), organ procurement (art. L1232-1). For routine procedures, writing is not mandatory but strongly recommended.
- How to comply with the reflection period (cosmetic surgery 15 days)?
- Certyneo precisely timestamps the delivery of information (RFC 3161 timestamp). The period runs from that moment. The platform technically blocks any signature before deadline — legally binding in case of litigation for non-compliance with the delay.
- Can the patient revoke consent?
- Yes, at any time and without reason (art. L1111-4 CSP). Revocation may be notified by any means — including a second electronic revocation signature via Certyneo. The audit trail precisely records the date and means of revocation.
- What signature level for informed consent?
- An advanced signature (AES). For research, that is the level set out in the Ministry of Health's recommendations of 26 June 2026, confirmed by an SMS code sent to a registered number tied to the signatory's identity; the qualified level is kept for the most exposed cases. They also require an explicit act by the signatory — not merely clicking a button or ticking a box, but typing a set phrase or a code. For care, AES remains the right level: admissible as evidence (Article 1367 of the Civil Code), the presumption of reliability being reserved for qualified signatures.
- How long must consent be kept?
- 20 years from the patient's last visit (art. R1112-7 CSP), 30 years for biomedical research and AMP. Certyneo automatically archives consent + audit trail for this duration.
- Can a minor sign consent?
- For a minor, consent is given by those holding parental authority (usually both parents for significant medical procedures). From age 16-18, the minor can consent alone for certain procedures (contraception, abortion). Certyneo manages multi-signatory signatures.
- Is electronically signed consent legally binding in case of medical litigation?
- Yes — French case law (Cass. civ. 1st) recognizes eIDAS-compliant electronic signature. Advanced signature (AES) is admissible as evidence (art. 1367 Civil Code), its reliability being demonstrated by the evidence file. In case of medical liability action for lack of information, Certyneo's audit trail is direct evidence.
Also read
Collect your next consents online
Permanent free plan (5 envelopes for 14 days, then 2/mo), no credit card required. Compliant with Public Health Code and eIDAS. Medico-legal audit trail and long-term archiving included.