Electronic signature medical sector: GDPR & HDS

Introduction: digital transformation of healthcare facilities

The healthcare sector is one of the most demanding environments in terms of data security and regulatory compliance. In 2026, more than 73% of French healthcare facilities report having begun their document dematerialisation (source: ANS 2025 report). Yet, electronic signature in the medical sector remains underutilised, hindered by legitimate concerns about GDPR compliance, health data hosting (HDS) and eIDAS regulation requirements. This article provides you with a complete framework to understand the challenges, choose the right signature level and deploy a sovereign solution tailored to healthcare specifics.

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1. Why electronic signature has become essential in healthcare

1.1 Massive and constraining document volume

A French university hospital produces an average of 4 to 6 million documents per year: prescriptions, informed consents, employment contracts, inter-facility agreements, admission forms, medical expertise reports. Handwritten signatures generate average delays of 5 to 12 working days for documents requiring multiple successive validations.

Medical electronic signature reduces these delays to a few hours, whilst offering legal traceability superior to paper. For healthcare territory groups (GHT), multi-site signature flows make dematerialisation no longer optional but strategic.

1.2 Priority documents covered

Priority use cases in the healthcare sector include:

• Patient informed consent: mandatory before any invasive procedure (article L.1111-4 of the Public Health Code), it must be dated, named and retained.

• Contracts and amendments for healthcare professionals: independent physicians, nurses, interim staff; signing delays directly impact scheduling.

• Partnership agreements and clinical trial protocols: subject to multi-layer validation requirements (sponsor, investigator, CNIL, CPP).

• Prescriptions and electronic orders (digital prescription): governed by the Mon Espace Santé programme and ANS standards.

• Public healthcare procurement: subject to the Public Procurement Code and qualified signature requirements.

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2. GDPR and health data: specific obligations to master

2.1 Health data, special category under GDPR

The General Data Protection Regulation (GDPR, n°2016/679) classifies health data as a sensitive data category (article 9). Their processing is in principle prohibited, except for explicit exceptions: explicit consent from the data subject, necessity for medical care, or public interest in the health field.

In the context of electronic signature, any solution that collects, transmits or stores data allowing identification of a patient or healthcare professional in a medical context processes health data in the broad sense. This entails:

• Designation of a Data Protection Officer (DPO) mandatory for healthcare facilities (article 37 GDPR).

• Completion of a Data Protection Impact Assessment (DPIA) whenever the processing is likely to result in high risk.

• Compliance with the principle of data minimisation: collect only information strictly necessary for the signature act.

• Implementation of appropriate technical and organisational measures: end-to-end encryption, pseudonymisation, access control.

2.2 Data location: a sovereignty issue

Article 44 of the GDPR strictly governs transfers of data outside the European Union. For healthcare facilities, choosing an electronic signature solution hosted in the United States or a third country without an adequacy decision exposes them to major legal risks: CNIL penalties reaching 4% of worldwide turnover or 20 million euros.

The CNIL explicitly recommends using service providers hosting their infrastructure within the European Union, ideally in France for the most sensitive health data.

2.3 Health Data Hosting (HDS): mandatory certification

Since the law of 26 January 2016 modernising the healthcare system (codified in article L.1111-8 of the Public Health Code), hosting of personal health data must be entrusted to a service provider certified HDS (Health Data Hosting Provider) by the ANS (National Digital Agency).

This certification, based on the ISO 27001 standard extended to HDS specifics, covers six activities including infrastructure provision, managed services and information system hosting. An electronic signature solution used in a medical context must therefore be hosted on HDS-certified infrastructure or rely on a certified sub-processor.

Certyneo hosts all its data on cloud infrastructure certified HDS and ISO 27001 located in France, in compliance with ANS requirements. Visit our dedicated page for electronic signature in healthcare to discover our technical architecture.

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3. eIDAS, signature levels and strategic choice for healthcare

3.1 Three signature levels under eIDAS

The European regulation eIDAS (n°910/2014) and its evolution eIDAS 2.0 (EU Regulation 2024/1183) define three levels of electronic signature, the choice of which determines probative value and technical requirements:

| Level | Description | Typical medical usage | |---|---|---| | SES (Simple) | Electronic data attached to other data | Delivery confirmations, internal forms | | SEA (Advanced) | Linked to the signatory, detects any modification | Consents, HR contracts, agreements | | SEQ (Qualified) | Highest level, qualified creation device, qualified trust service provider | Public procurement, notarial deeds, clinical research |

For the majority of common medical acts (informed consents, employment contracts, digital prescriptions), advanced electronic signature (SEA) offers the best balance between security level and ease of use. Hospital procurement and certain clinical trial protocols require qualified signature (SEQ).

For more information on regulatory levels, consult our comprehensive guide on eIDAS regulation.

3.2 Digital identity of healthcare professionals: the CPS and Pro Santé Connect

In France, healthcare professionals have the Healthcare Professional Card (CPS), issued by the ANS, which constitutes a recognised means of electronic identification. The Pro Santé Connect solution, the healthcare equivalent of FranceConnect, allows strong authentication of professionals.

An electronic signature solution intended for the healthcare sector should ideally be compatible with these sectoral digital identity systems to achieve the level of advanced or even qualified signature required by certain document flows.

3.3 ETSI compliance and qualified trust service providers

Qualified trust service providers (QTSP) listed on the European Trust List (TSL) guarantee that their services comply with ETSI standards EN 319 132 (XAdES), EN 319 122 (CAdES) and EN 319 162 (ASiC). In France, ANSSI publishes and maintains this national trust list.

For healthcare facilities, relying on a SaaS publisher who themselves relies on a QTSP referenced by ANSSI is an essential guarantee of the legal value of signed documents.

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4. Deploying electronic signature in a healthcare facility: practical guide

4.1 Map document flows and identify priorities

Before any deployment, a mapping of document flows is essential. It must identify for each document type: the number of signatories, the required signature level, the sensitivity of data involved and time constraints.

A medium-sized GHT will prioritise patient consents (high volume, immediate gains), then HR contracts (impact on attractiveness), and finally inter-facility agreements (multi-signatory complexity).

4.2 Integration into the hospital information system (HIS)

Medical electronic signature is only effective if it natively integrates into existing tools: EHR (Electronic Health Record), HR planning software, document management tools (DMS). Modern solutions offer REST APIs and native connectors for the main hospital information systems on the market (Mediboard, Hopital Manager, etc.).

Certyneo offers a documented API enabling integration in less than 48 hours in most hospital environments. You can estimate the return on investment of this deployment using our dedicated ROI calculator.

4.3 Train teams and support change management

The human factor is often the main obstacle to dematerialisation in healthcare. Healthcare professionals have extreme time constraints and low tolerance for technological friction. A signature solution must therefore be:

• Accessible on mobile (signing on the move, between two consultations)

• Intuitive in less than 3 clicks for the signer

• Compatible with existing approval workflows (service manager validation, management)

A short training programme (2 hours maximum) combined with video tutorials integrated into the tool allows achieving an adoption rate above 85% within the first 30 days.

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5. Certyneo: the electronic signature solution designed for healthcare

5.1 Sovereign architecture and certifications

Certyneo was designed from the outset to meet the requirements of highly regulated sectors. Our infrastructure is based on European datacentres (IONOS SE, Germany). We are actively pursuing certifications: HDS (in progress), ISO 27001 (planned Q4 2026), SOC 2 Type II (planned 2027). All data is encrypted in transit (TLS 1.3) and at rest (AES-256), with encryption key policies dedicated per client.

Our service relies on qualified trust service providers referenced by ANSSI to guarantee maximum legal value of signatures produced. Qualified timestamps and signature certificates comply with applicable ETSI standards.

5.2 Features specific to the healthcare sector

• Multi-party signature journey: workflow management with distinct roles (patient, physician, management, legal)

• Medical document templates compliant with HAS recommendations (consents, protocols)

• Complete audit trail retained for a minimum of 10 years (legal retention period for medical records)

• Pro Santé Connect compatibility for strong authentication of healthcare professionals

• Available DPO to support your impact analysis (DPIA)

5.3 Migration from non-HDS compliant solutions

Many healthcare facilities still use consumer electronic signature solutions (DocuSign, Adobe Sign) whose hosting is not HDS-certified. This situation exposes them to increasing non-compliance risk, particularly following CNIL strengthened audits since 2024.

Our dedicated migration programme allows transferring all your historical documents and workflows in less than 5 working days. Discover our migration offer to Certyneo designed for facilities constrained by regulatory timelines.

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Conclusion: HDS-GDPR compliance, an investment, not a constraint

Electronic signature in the healthcare sector is no longer optional. Between growing regulatory obligations (GDPR, HDS, eIDAS 2.0, Mon Espace Santé programme), pressure on administrative timelines and cybersecurity challenges (healthcare is the sector most targeted by cyberattacks in France in 2025 according to ANSSI), facilities that have not yet deployed a sovereign and certified solution are taking major legal and operational risks.

Certyneo offers the most comprehensive solution on the French market to simultaneously meet HDS-GDPR-eIDAS compliance requirements and operational needs of medical and administrative teams.

Ready to secure your medical document flows? Discover Certyneo solution for healthcare or consult our rates adapted to healthcare facilities to start your free evaluation.

Legal framework applicable to medical electronic signature

Civil Code and probative value

Article 1366 of the Civil Code establishes the principle of equivalence between electronic signature and handwritten signature: "Electronic writing has the same probative force as writing on paper medium, provided that the person from whom it emanates can be duly identified and it is established and retained under conditions of nature to guarantee its integrity." Article 1367 clarifies that "the reliability of this process is presumed, until proof to the contrary, when the electronic signature is created, the signatory's identity assured and the act's integrity guaranteed, under conditions set by decree in Council of State." This decree (n°2017-1416 of 28 September 2017) explicitly refers to eIDAS requirements for qualified signatures.

eIDAS and eIDAS 2.0 Regulation

The EU Regulation n°910/2014 (eIDAS), supplemented by EU Regulation 2024/1183 (eIDAS 2.0) which came into force progressively from March 2024, establishes the European legal framework for trust services. It distinguishes three signature levels (simple, advanced, qualified) whose technical requirements are specified by ETSI EN 319 132 (XAdES), ETSI EN 319 122 (CAdES) and ETSI EN 319 401 (general TSP requirements) standards. Qualified signatures have equivalent value to a handwritten signature in all Member States.

GDPR and health data

The EU Regulation n°2016/679 (GDPR), articles 9, 35, 37 and 44, impose specific obligations for processing health data: explicit consent or alternative legal basis, completion of a mandatory DPIA for high-risk processing, DPO designation, and prohibition of transfers to third countries without adequate safeguards. Violations may expose the facility to fines up to 20 million euros or 4% of worldwide annual turnover.

Health Data Hosting (HDS)

Article L.1111-8 of the Public Health Code, from law n°2016-41 of 26 January 2016, requires HDS certification for any hoster of personal health data. The HDS certification framework, published by ANS and based on ISO 27001:2022, covers six hosting activities. Any editor of an electronic signature solution used in a medical context must either hold HDS certification itself or outsource hosting to a certified service provider with a DPA (Data Processing Agreement) compliant with article 28 of the GDPR.

NIS2 and cybersecurity of healthcare facilities

The NIS2 Directive (EU 2022/2555), transposed into French law by law n°2024-449, classifies hospitals and healthcare facilities as essential entities (EE), subjecting them to the most constraining obligations regarding cyber risk management, incident notification (72 hours) and regular audits. The electronic signature solution is part of the security perimeter to be audited.

Concrete use cases: medical electronic signature in action

Use case 1: CHU Aliénor – Dematerialisation of informed consents

CHU Aliénor (3,200 beds, 6 sites), facing a rate of lost or incomplete consent forms of 8%, deployed Certyneo to dematerialise 100% of its informed consents in surgery and oncology. The patient receives an SMS or email link before admission, signs from their smartphone in less than 2 minutes, and the certified document is automatically added to their patient record in the EHR.

Results after 6 months: Rate of incomplete consents reduced from 8% to 0.3%, average collection delay reduced from 48 hours to 4 hours, savings of 127,000 A4 sheets per year, GDPR compliance assured with qualified timestamp and audit trail retained for 10 years.

Use case 2: MEDIPRIVÉ Group – Contracts for independent practitioners

MEDIPRIVÉ, a group of 14 private clinics in the PACA region, managed its collaboration contracts and amendments with its 340 independent practitioners via paper and PDF email exchanges, without certified probative value. The average time to sign an amendment reached 9 working days, hindering operating theatre scheduling.

After Certyneo deployment with API integration into their HR software, amendments are now signed in advanced signature in an average of less than 6 hours. Time savings represent the equivalent of 1.8 FTE administrative staff per year, reallocated to higher-value tasks. The group also eliminated all risk related to data transfers outside the EU (the previous service provider hosted in Ireland with subcontracting to the United States).

Use case 3: BIOPHARMA NORD Research Institute – Clinical trial protocols

BIOPHARMA NORD Institute annually manages 23 clinical trial protocols requiring the signature of at least 6 parties (sponsor, principal investigator, co-investigators, CPP, ANSM, facility). Each signature had to reach the qualified level (SEQ) to meet ICH E6 requirements and ANSM recommendations.

Certyneo was deployed with integration of qualified certificates via an ANSSI-referenced QTSP, enabling sequential or parallel signature workflows depending on document type. The average time to obtain all signatures for a protocol went from 34 days to 8 days, significantly accelerating trial initiation. Enhanced traceability also facilitated audits by competent authorities.