
FedRAMP Compliance in Healthcare: Electronic Signature
The FedRAMP framework imposes strict requirements on cloud solutions used by US federal health agencies. Discover how HDS and FedRAMP-compliant electronic signature addresses these challenges.
Informed consent, patient records, advance directives, inter-facility agreements: digitalise sensitive signatures in your facility with a GDPR-compliant platform, compatible with medical confidentiality and integrable with your HIS. Hosting in Germany (EU), end-to-end encryption, timestamped audit trail.

HDS certification in progress
Certyneo is not yet certified as a Health Data Host (HDS). This certification is in progress. For any processing of personal health data within the meaning of Article L. 1111-8 of the CSP, verify regulatory compliance with your DPO before deployment.
Learn more about the security roadmap →From informed consent to inter-facility agreements, including advance directives, all documents signed within a healthcare facility can be digitalised.
Free, informed and revocable patient consent before a medical procedure, surgical intervention, experimental treatment or participation in research (Article L1111-4 of the Public Health Code). Timestamped signature with audit trail.
Patient validation of medical record information, updates to allergies, medical history, consent to share with other healthcare professionals. Complete traceability of signed versions.
Consent to medical care, therapeutic protocol, coordinated care pathway. Mobile signature suited for patients on the move or hospitalised.
Patient advance directives concerning end-of-life care (Claeys-Leonetti Act of 2 February 2016). Remote signature with strong identification, 10-year retention, revocable at any time by the patient.
Cooperation agreements between healthcare facilities (public-private, hospital groups, care networks), medical service agreements, contracts for independent medical practice in a facility.
Contracts with laboratory service providers, medical device suppliers, cleaning subcontractors for sterile environments: all administrative back-office functions of a healthcare facility.
Six concrete guarantees tailored to medical confidentiality requirements and the standard of proof expected in healthcare.
Certyneo hosts all data in Germany (IONOS), in infrastructure compliant with ISO 27001 security standards. No data transfer outside the EU, no dependency on the Cloud Act.
TLS 1.3 encryption in transit, AES-256 at rest, strict data isolation by organisation. The protection level complies with medical confidentiality requirements defined in Article R4127-4 of the Public Health Code.
Strong patient identification via email OTP + SMS, unique link to the signed document, detection of any subsequent modification. Level of proof compatible with informed consent requirements.
User journey in English, WCAG AA accessible, mobile-compatible, no account creation or app download required. The patient signs in 2 minutes from their phone, at home or from their hospital bed.
Duration aligned with medical record retention obligations (20 years for certain documents, extended on request). Audit trail embedded in the PDF, exportable at any time for transmission to a colleague or to the Chamber of Commerce.
Electronic signature is not always appropriate: patient in vital emergency, unconscious patient, unrepresented minor. Our documentation explicitly addresses these cases and proposes alternative paths (signature assisted by a third party, postponement after stabilisation).
Certyneo is positioned upstream of existing healthcare information systems: it collects signatures and then the signed document joins your HIS, EHR or EHR through standard channels. No native connectors are published to date — HIS integrations (DxCare, Cristal-Link, Mon Espace Santé…) are available on a quote basis; contact us for scoping.
Hospital Information Systems (DxCare, Cristal-Link, Hopital Manager, Easily…) can trigger the sending of a Certyneo envelope via our REST API or webhooks when a document is ready to sign. Integration on a quote basis, no native certified connector to date — contact us to define the scenario suited to your HIS.
Certyneo does not replace the DMP / Mon Espace Santé: it operates upstream to collect patient consent or sign clinical documents, with the signed document subsequently deposited in the DMP via your establishment's standard tool. No native Mon Espace Santé integration to date — available on quote.
Medical practice software (Doctolib Siilo, Weda, HelloDoc, AxiSanté…): compatibility via Zapier, Make and our webhooks, particularly for fee agreements, optical/dental quotations, consent before non-reimbursable procedures. For a native connector, we can explore a partnership.
Have a specific integration project in mind? Schedule a meeting with our team. The Certyneo API is publicly documented on our API documentation.
Health data is among the most sensitive and closely regulated in Europe. Certyneo applies the entire applicable framework, with complete transparency — including regarding its current limitations (HDS certification on the roadmap, not yet obtained to date).
Certyneo is not an HDS host at this time. For documents containing personal health data, we recommend the relevant establishments request a dedicated deployment with an HDS partner host — our roadmap includes HDS certification for the second half of the year. For signatures not containing health data (inter-establishment agreements, supplier contracts, HR), Certyneo is suitable from the outset.
Article 9 of the GDPR classifies health data as sensitive data. Certyneo applies strict minimisation (only metadata necessary for signing is stored), systematic encryption, a standard DPA including preliminary impact analysis, and an up-to-date processing register.
Medical confidentiality applies to every physician and all persons collaborating with them. Certyneo applies strict data isolation by organisation, end-to-end encryption, and exhaustive access logging — all technical prerequisites for preserving medical confidentiality during the signing phase.
Consent must be free, informed and revocable. Certyneo's advanced electronic signature guarantees patient identification, precisely timestamps their consent (to start withdrawal or reflection periods), and enables later revocation through a new documented contradictory envelope recorded in the history.
As of the publication date of this page, Certyneo is not an HDS host. For documents containing personal health data, we recommend the relevant establishments discuss this with our team to identify the appropriate scenario (dedicated deployment via an HDS partner, or limitation to documents without health data). HDS certification appears on our public roadmap.
Yes. Article L1111-4 of the French Public Health Code requires consent to be free, informed and revocable, but does not prescribe any particular form. Article 1367 of the French Civil Code recognises electronic signatures as equivalent to handwritten signatures when using a reliable process — which Certyneo's advanced signature (AES) ensures.
TLS 1.3 encryption in transit, AES-256 at rest, strict data isolation by organisation, no access in clear by our teams without documented escalation. Certyneo does not store medical content itself (except what is in the PDF): only metadata necessary for managing signatures (envelope identifier, emails, timestamps) is retained in the database.
Yes. The Claeys-Leonetti Act of 2 February 2016 and Article L1111-11 of the CSP authorise free drafting of advance directives, with no imposed form. A timestamped advanced electronic signature with strong patient identification meets evidentiary requirements — advance directives remain revocable at any time through a new envelope.
Yes, technically, via our documented REST API (see /docs) and our real-time webhooks — no native connector has been published to date for French hospital systems (DxCare, Cristal-Link, Hopital Manager, Easily…). These integrations are available on quote: contact us to define the scenario suited to your establishment. For liberal practice software, Zapier and Make connectors exist for the most common applications.
Certyneo offers an 'in-person signing' mode: the healthcare professional uses their own tablet or workstation to have the patient sign, with identification via SMS OTP sent to the patient or validation by a trusted third party (carer, caregiver). The audit trail preserves the signing context.
Our plans include 10-year archiving with probative value. For medical documents requiring longer retention (20 years for certain types of hospital records, 28 years for transfusion files, lifetime for certain radiographs), extended archiving is available on request. Documents remain downloadable at any time.
The right of revocation is central in the medical context. Concretely, you create a new revocation envelope signed by the patient, which is timestamped and linked to the initial consent. The file history clearly shows both acts (consent, then revocation), perfectly documenting the situation in case of dispute.

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