Electronic Medical File: 2026 Security Standards

Electronic Medical Record: 2026 Safety Standards

Introduction

The electronic medical record (EMR) has now established itself as the pillar of the digital transformation of the French health system. By 2026, the security standards applicable to digital patient records will evolve considerably, driven by the national digital health strategy and the reinforced requirements of the Digital Health Agency (ANS). Healthcare establishments, 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 organizational obligations which will apply from 2026.

The regulatory framework strengthened in 2026

The regulatory framework strengthened in 2026

The electronic medical record is part of a dense regulatory ecosystem. The HDS (Health Data Host) certification, mandatory since 2018 pursuant to article L.1111-8 of the Public Health Code, is undergoing a major update in 2026 to integrate the requirements of the EUCS (European Cybersecurity Certification Scheme) standard. The GDPR (EU Regulation 2016/679) also requires a data protection impact analysis (DPIA) for any massive processing of health data.

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

• Technical security requirementsThe 2026 standards impose several essential technical measures to secure the electronic medical record:
• The 2026 standards impose several essential technical measures to secure the electronic medical 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 or e-CPS card.Complete traceability ⬥⬥⬥: time-stamped logging of all accesses, kept for a minimum of 10 years in accordance with article R.1112-7 of the Public Health Code.
• Backup and PRA ⬥⬥⬥: business recovery plan with RTO less than 4 hours for MCO establishments.Backup and PRA ⬥⬥⬥: business recovery plan with RTO less than 4 hours for MCO establishments.
• Pseudonymization ⬥⬥⬥: mandatory for any secondary use of data (research, management).Publishers must also comply with the Ségur digital health framework, which now conditions public funding of business software.

Organizational obligations

Beyond the technical aspects, the organizational aspect is reinforced. Each structure must appoint a Data Protection Officer (DPO) and an Information Systems Security Representative (CISO). Mandatory annual cybersecurity training concerns all staff handling digital records, following the 2023 ministerial instruction on cybersecurity in health establishments.

Beyond the technical aspects, the organizational aspect is reinforced. Each structure must appoint a Data Protection Officer (DPO) and an Information Systems Security Representative (CISO). Mandatory annual cybersecurity training concerns all staff handling digital records, following the 2023 ministerial instruction on cybersecurity in health establishments.

The reporting of security incidents to the ANS via the signalement.social-sante.gouv.fr portal will become automated in 2026, with a maximum delay of 72 hours in accordance with article 33 of the GDPR.

Conclusion

Securing the electronic medical record in 2026 does not come down to technical compliance: it constitutes a real commitment of trust towards the patient. Healthcare structures that anticipate these standards will benefit from a significant operational advantage and limit their exposure to CNIL sanctions of up to 4% of annual turnover. A digital maturity audit now is the first step to successful compliance.