Electronic Medical Record: Security Standards 2026

Introduction

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

The reinforced regulatory framework in 2026

The electronic medical record is part of a dense regulatory ecosystem. HDS certification (Health Data Hosting), mandatory since 2018 in application of article L.1111-8 of the French Public Health Code, is undergoing a major update in 2026 to integrate 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 health data processing.

The technical healthcare digitalization doctrine 2026 also requires 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

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: timestamped logging of all accesses, retained for at least 10 years in accordance with article R.1112-7 of the French Public Health Code.

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

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

Publishers must also comply with the Segur healthcare digitalization framework, which now conditions the public financing of business software.

Organizational obligations

Beyond the technical aspects, the organizational component is strengthened. Each organization 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 healthcare establishments.

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

Conclusion

Securing the electronic medical record in 2026 is not just about technical compliance: it constitutes a genuine commitment of trust to the patient. Healthcare organizations that anticipate these standards will gain significant operational advantage and limit their exposure to CNIL sanctions which can reach 4% of annual revenue. A digital maturity audit starting now is essential as the first step in a successful compliance implementation.