Electronic signature in healthcare 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. By 2026, more than 73% of French healthcare facilities report having begun their document dematerialisation (source: ANS report 2025). Yet electronic signature in the healthcare sector remains underutilised, hampered by legitimate concerns about GDPR compliance, health data hosting (HDS) and eIDAS regulation requirements. This article provides you with a comprehensive framework to understand the stakes, choose the right signature level and deploy a sovereign solution adapted to the specificities of healthcare.

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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 expert reports. Handwritten signatures generate average delays of 5 to 12 working days for documents requiring multiple successive validations.

Medical electronic signature allows these delays to be reduced to a few hours, while offering superior legal traceability to paper. For territorial hospital groups (GHT), multi-site signature flows make dematerialisation no longer optional but strategic.

1.2 Priority areas of concern

Priority use cases in the healthcare sector cover:

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

• 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 orders: governed by the Mon Espace Santé programme and ANS standards.

• Public hospital 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, a special category under GDPR

The General Data Protection Regulation (GDPR, n°2016/679) classifies health data as sensitive data (article 9). Its 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 allowing identification of a patient or healthcare professional in a medical context processes health data in the broad sense. This implies:

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

• Conducting a Data Protection Impact Assessment (DPIA) whenever 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 matter of sovereignty

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 reaching 4% of global turnover or 20 million euros.

The CNIL explicitly recommends using service providers that host 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 on the modernisation of the health system (codified in article L.1111-8 of the Public Health Code), the hosting of personal health data must be entrusted to a Health Data Hosting provider (HDS) certified by the ANS (Digital Health Agency).

This certification, based on ISO 27001 extended to HDS specificities, covers six activities including the 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 accordance 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 The three levels of electronic signature according to eIDAS

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

| Level | Description | Typical medical use | |---|---|---| | SES (Simple) | Electronic data attached to other data | Receipts of acknowledgement, internal forms | | SEA (Advanced) | Linked to the signatory, detection of 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 research protocols require qualified signature (SEQ).

To learn more about 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 healthcare 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 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, mapping document flows is essential. It must identify for each type of document: the number of signatories, the signature level required, the sensitivity of the 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 is natively integrated into existing tools: EHR (Electronic Health Record), HR scheduling software, document management tools (DMS). Modern solutions offer REST APIs and native connectors for the main HIS on the market (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 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 (signature on the move, between consultations)

• Intuitive in less than 3 clicks for the signatory

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

A short training programme (2 hours maximum) combined with video tutorials integrated into the tool allows achievement of 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 heavily 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 to each client.

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 healthcare sector

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

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

• Complete audit trail retained for at least 10 years minimum (legal retention period for medical files)

• Compatibility with Pro Santé Connect for strong authentication of professionals

• Available DPO to support your impact analysis (DPIA)

5.3 Migration from non-compliant HDS solutions

Many healthcare facilities still use mainstream electronic signature solutions (DocuSign, Adobe Sign) whose hosting is not HDS-certified. This situation exposes them to increasing non-compliance risk, particularly after CNIL's enhanced controls since 2024.

Our dedicated migration programme allows all your historical documents and workflows to be transferred in less than 5 working days. Discover our 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 healthcare 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 issues (healthcare is the most targeted sector 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? Contact us or request a free evaluation to get started.

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 that it is established and retained in conditions of a nature to guarantee its integrity." Article 1367 specifies that "the reliability of this process is presumed, unless proven otherwise, when the electronic signature is created, the identity of the signatory assured and the integrity of the document guaranteed, under conditions set by decree by the Council of State." This decree (n°2017-1416 of 28 September 2017) explicitly refers to the requirements of the eIDAS regulation for qualified signatures.

eIDAS and eIDAS 2.0 Regulation

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

GDPR and health data

Regulation EU n°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, DPO designation, and prohibition of transfer to third countries without adequate safeguards. Violations can expose the facility to fines up to 20 million euros or 4% of global annual turnover.

Health Data Hosting (HDS)

Article L.1111-8 of the Public Health Code, derived from Law n°2016-41 of 26 January 2016, requires HDS certification for any host of personal health data. The HDS certification reference, 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 have HDS certification themselves or subcontract hosting to a certified service provider with a DPA (Data Processing Agreement) contract compliant with article 28 of the GDPR.

NIS2 and cybersecurity of healthcare facilities

Directive NIS2 (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 stringent obligations in terms of risk management cyber, 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: Aliénor University Hospital – Dematerialisation of informed consents

Aliénor University Hospital (3,200 beds, 6 sites), faced with a loss or incomplete rate of informed 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 transferred to their patient file on the EHR.

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 sheets of A4 paper per year, GDPR compliance assured with qualified timestamping 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 exchanges and PDFs by email, without certified probative value. The average time to sign an amendment reached 9 working days, disadvantaging surgical schedules.

After Certyneo deployment with API integration into their HR software, amendments are now signed in advanced signature on average in less than 6 hours. The time saving represents the equivalent of 1.8 administrative FTE per year, reallocated to higher-value missions. The group also eliminated all risk related to data transfers outside the EU (the former service provider hosted in Ireland with sub-contracting to the United States).

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

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