Electronic Health Record: Security Standards 2026

Introduction

The electronic health record (EHR) has now established itself as the cornerstone of digital transformation in the French healthcare system. By 2026, the security standards applicable to the patient's digital record are evolving significantly, driven by the national digital health strategy and the strengthened requirements of the Digital Health Agency (ANS). Healthcare facilities, private practices and software publishers must anticipate these developments to guarantee the confidentiality, integrity and availability of personal health data. This article details the technical and organisational obligations that will apply from 2026 onwards.

The strengthened regulatory framework in 2026

The electronic health record is part of a dense regulatory ecosystem. HDS certification (Health Data Hosting), mandatory since 2018 under Article L.1111-8 of the Public Health Code, is undergoing a major update in 2026 to incorporate the requirements of the EUCS (European Cybersecurity Certification Scheme) framework. The GDPR (EU Regulation 2016/679) also requires a data protection impact assessment (DPIA) for any large-scale processing of health data.

The 2026 digital health technical doctrine also mandates mandatory interoperability via the healthcare information systems interoperability framework (CI-SIS) and strong authentication via Pro Santé Connect for all professionals accessing the digital record.

Technical security requirements

The 2026 standards impose several essential technical measures to secure the electronic health record:

• End-to-end encryption: AES-256 encryption at rest and TLS 1.3 in transit for all health data.

• Multi-factor authentication (MFA): mandatory for all professional access, via CPS card or e-CPS.

• Complete traceability: time-stamped logging of all access, retained for a minimum of 10 years in compliance with Article R.1112-7 of the Public Health Code.

• Backup and DRP: disaster recovery plan with RTO less than 4 hours for MCO facilities.

• Pseudonymisation: mandatory for any secondary use of data (research, management).

Publishers must also comply with the Ségur digital health framework, which now conditions public funding for business software.

Organisational obligations

Beyond technical aspects, the organisational component is being strengthened. Each structure must appoint a Data Protection Officer (DPO) and an Information Systems Security Officer (ISSO). Annual mandatory cybersecurity training concerns all staff handling the digital record, following the 2023 ministerial instruction on cybersecurity of health establishments.

The declaration of security incidents to the ANS via the signalement.social-sante.gouv.fr portal becomes automated in 2026, with a maximum deadline of 72 hours in compliance with Article 33 of the GDPR.

Conclusion

Securing the electronic health record in 2026 is not limited to technical compliance: it constitutes a genuine commitment of trust towards the patient. Healthcare facilities that anticipate these standards will benefit from a significant operational advantage and limit their exposure to CNIL sanctions which can reach 4% of annual turnover. A digital maturity audit from now on is essential as the first step towards successful compliance.