Electronic Signature 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 2025 report). Yet electronic signature in the healthcare sector remains underutilised, hindered 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 issues, choose the right signature level and deploy a sovereign solution adapted to healthcare specifics.

---

1. Why electronic signature has become essential in healthcare

1.1 Massive and constraining document volumes

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

Medical electronic signature reduces these delays to just a few hours whilst offering superior legal traceability compared to paper. For healthcare facility 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, nominative and retained.

• Healthcare professional contracts and amendments: 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 contracts: subject to the Public Procurement Code and qualified signature requirements.

---

2. GDPR and health data: specific obligations to master

2.1 Health data, a 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 allowing identification of a patient or healthcare professional in a medical context processes health data in the broad sense. This implies:

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

• The conduct of a Data Protection Impact Assessment (DPIA) whenever the processing is likely to pose a high risk.

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

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

2.2 Data localisation: a sovereignty issue

Article 44 of the GDPR strictly governs data transfers 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 sanctions potentially reaching 4% of global turnover or 20 million euros.

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

This certification, based on ISO 27001 extended to HDS specifics, covers six activities including the provision of infrastructure, managed services and information systems hosting. 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 of 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.

---

3. eIDAS, signature levels and strategic choice for healthcare

3.1 The 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, the choice of which determines probative value and technical requirements:

| Level | Description | Typical medical use | |---|---|---| | SES (Simple) | Electronic data attached to other data | Receipts, 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 acts, clinical research |

For the majority of common medical acts (informed consents, employment contracts, electronic 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).

For more information on regulatory levels, consult our article.

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 electronic identification means. 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 editor that itself relies on a QTSP on the national list is an essential guarantee of the legal value of signed documents.

---

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

4.1 Mapping document flows and identifying priorities

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

Medical electronic signature is only effective if it integrates natively 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 SIH systems on the market (Mediboard, Hospital 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 tool.

4.3 Training teams and supporting 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 (signing whilst travelling, between consultations)

• Intuitive in less than 3 clicks for the signatory

• 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 an adoption rate of over 85% within the first 30 days.

---

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 dedicated encryption key policies per customer.

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

5.2 Healthcare sector-specific features

• 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 a minimum of 10 years (legal retention period for medical records)

• Pro Santé Connect compatibility for strong authentication of professionals

• Available DPO to support your impact assessment (DPIA)

5.3 Migration from non-HDS-compliant solutions

Many healthcare facilities still use general-public 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 checks since 2024.

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

---

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

Electronic signature in the healthcare sector is no longer an optional matter. Between increasing regulatory obligations (GDPR, HDS, eIDAS 2.0, Mon Espace Santé programme), pressure on administrative timelines and cybersecurity challenges (healthcare is the most targeted sector for 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 the operational needs of medical and administrative teams.

Ready to secure your medical document flows? Contact us or 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 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 retained under conditions designed 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 is assured and the integrity of the deed is guaranteed, under conditions laid down by decree in Council of State." This decree (No. 2017-1416 of 28 September 2017) explicitly refers to the requirements of the eIDAS regulation for qualified signatures.

eIDAS Regulation and eIDAS 2.0

EU Regulation No. 910/2014 (eIDAS), supplemented by EU Regulation 2024/1183 (eIDAS 2.0) which entered into progressive application 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 standards EN 319 132 (XAdES), ETSI EN 319 122 (CAdES) and ETSI EN 319 401 (general requirements for TSP). Qualified signatures have equivalent value to a handwritten signature in all Member States.

GDPR and health data

EU Regulation No. 2016/679 (GDPR), Articles 9, 35, 37 and 44, impose specific obligations for the processing of health data: explicit consent or alternative legal basis, mandatory DPIA for high-risk processing, DPO appointment, and prohibition of transfer to third countries without adequate guarantees. Violations may 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, stemming from Law No. 2016-41 of 26 January 2016, requires HDS certification for any host of personal health data. The HDS certification framework, published by the ANS and based on ISO 27001:2022, covers six hosting activities. Any electronic signature solution editor 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

NIS2 Directive (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 stringent obligations regarding risk management, incident notification (72 hours) and regular audit. 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), faced with a loss or incomplete informed consent form rate 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 on the EHR.

Results after 6 months: Incomplete consent rate reduced from 8% to 0.3%, average collection timeframe 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 10 years.

Use case 2: MEDIPRIVÉ Group – Healthcare practitioner contracts

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 duration for signing an amendment reached 9 working days, penalising operating theatre scheduling.

After deploying Certyneo with API integration into their HR software, amendments are now signed with advanced signature in less than 6 hours on average. The time saving represents the equivalent of 1.8 FTE administrative positions per year, reallocated to value-adding tasks. The group has also eliminated any risk related to data transfers outside the EU (the previous service provider hosted in Ireland with outsourcing to the United States).

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

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