Electronic signature in the medical sector: GDPR & HDS

Introduction: digital transformation of healthcare facilities

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

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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 on average 4 to 6 million documents per year: prescriptions, informed consents, employment contracts, inter-facility agreements, admission forms, medical expertise reports. Handwritten signature generates average delays of 5 to 12 working days for documents requiring multiple successive validations.

Medical electronic signature allows reducing these delays to just a few hours, whilst offering superior legal traceability compared to paper. For territorial hospital groupings (GHT), multi-site signature flows make dematerialisation no longer optional but strategic.

1.2 Documents prioritised for action

Priority use cases in the healthcare sector cover:

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

• Contracts and amendments for healthcare professionals: independent doctors, nurses, temporary staff; signature delays directly impact scheduling.

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

• Electronic prescriptions and prescriptions (digital prescription): covered by the Mon Espace Santé programme and ANS reference standards.

• Hospital public 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, No. 2016/679) classifies health data in the category of sensitive data (article 9). Their processing is in principle prohibited, except for explicit exceptions: explicit consent of 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 enabling identification of a patient or healthcare professional in a medical context processes health data in the broad sense. This implies:

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

• Carrying out a Data Protection Impact Assessment (DPIA) whenever processing is likely to result in high risk.

• Respect for the data minimisation principle: collecting 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 regulates 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 potentially reaching 4% of global turnover or 20 million euros.

The CNIL explicitly recommends recourse to service providers hosting their infrastructure in 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 health system (codified in article L.1111-8 of the French Public Health Code), hosting of personal health data must be entrusted to an HDS-certified hoster (Health Data Hoster) by the ANS (National Digital Agency).

This certification, based on the ISO 27001 standard extended to HDS specificities, covers six activities including provision of infrastructure, IT management and hosting of information systems. An electronic signature solution used in a medical context must therefore be hosted on HDS-certified infrastructure or rely on a certified sub-contractor.

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

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3. eIDAS, signature levels and strategic choice for healthcare

3.1 Three signature levels according to eIDAS

The European regulation eIDAS (No. 910/2014) and its evolution eIDAS 2.0 (EU Regulation 2024/1183) define three levels of electronic signature, whose choice determines probative value and technical requirements:

| Level | Description | Typical medical use | |---|---|---| | SES (Simple) | Electronic data attached to other data | Acknowledgements of receipt, internal forms | | SEA (Advanced) | Linked to 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 user-friendliness. Hospital procurement and certain clinical research protocols require qualified signature (SEQ).

For further information on regulatory levels, consult our page.

3.2 Digital identity of healthcare professionals: 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 medical sector should ideally be compatible with these sectoral digital identity devices 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 editor that itself relies on a QTSP referenced 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, mapping of document flows is essential. It must identify for each type of document: the number of signatories, the signature level required, 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-party complexity).

4.2 Integration into the hospital information system (HIS)

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

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

4.3 Train teams and accompany change

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 (signature whilst away, between consultations)

• Intuitive in fewer than 3 clicks for the signatory

• Compatible with existing approval workflows (head of department validation, management)

A short training programme (2 hours maximum) combined with integrated video tutorials in the tool allows achieving an adoption rate of over 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 data centres (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 a policy of encryption keys dedicated per customer.

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

5.2 Features specific to the medical sector

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

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

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

• Pro Santé Connect compatibility for strong authentication of professionals

• DPO available 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's enhanced controls since 2024.

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

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

Electronic signature in the medical sector is no longer an optional subject. Between increasing 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? Start your free evaluation.

Legal framework applicable to medical electronic signature

Civil Code and probative value

Article 1366 of the French Civil Code establishes the principle of equivalence between electronic signature and handwritten signature: "Electronic writing has the same probative force as writing on paper, provided that the person from whom it emanates can be duly identified and that it is established and preserved under conditions likely to guarantee its integrity." Article 1367 specifies that "the reliability of this process is presumed, unless proved otherwise, when the electronic signature is created, the identity of the signatory ensured and the integrity of the deed guaranteed, under conditions set by decree in Council of State." This decree (No. 2017-1416 of 28 September 2017) explicitly refers to the requirements of eIDAS for qualified signatures.

eIDAS and eIDAS 2.0 Regulation

Regulation (EU) No. 910/2014 (eIDAS), supplemented by Regulation (EU) 2024/1183 (eIDAS 2.0) entering into force progressively since 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 standards EN 319 132 (XAdES), ETSI EN 319 122 (CAdES) and ETSI EN 319 401 (general requirements for TSP). Qualified signatures are equivalent in value to handwritten signature in all Member States.

GDPR and health data

Regulation (EU) No. 2016/679 (GDPR), articles 9, 35, 37 and 44, impose specific obligations for processing health data: explicit consent or alternative legal basis, mandatory DPIA for high-risk processing, appointment of a DPO, and prohibition of transfer to third countries without adequate safeguards. Breaches can expose the facility to fines of up to 20 million euros or 4% of annual global turnover.

Health Data Hosting (HDS)

Article L.1111-8 of the French Public Health Code, stemming from law No. 2016-41 of 26 January 2016, requires HDS certification for any hoster of personal health data. The HDS certification reference 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 themselves or subcontract 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

Directive NIS2 (EU 2022/2555), transposed into French law by law No. 2024-449, classifies hospitals and healthcare facilities as essential entities (EE), subjecting them to the most demanding obligations regarding cyber risk management, incident notification (72 hours) and regular audits. The electronic signature solution is an integral part of the security scope 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 loss rate of informed consent forms or incomplete 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 filed in their patient record in the EPR.

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

Use case 2: MEDIPRIVÉ Group – Private practitioner contracts

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

Following deployment of Certyneo with API integration into their HR software, amendments are now signed with advanced signature in less than 6 hours on average. Time savings represent the equivalent of 1.8 administrative FTE per year, reallocated to higher-value tasks. The group also eliminated any 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 research protocols

BIOPHARMA NORD Institute manages annually 23 clinical research protocols requiring 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, allowing sequential or parallel signature workflows depending on document type. The average time to obtain all signatures for a protocol dropped from 34 days to 8 days, significantly accelerating trial start-up. Enhanced traceability also facilitated audits by competent authorities.