Digital Prescriptions: Legal Framework and Obligations 2026

Since the gradual rollout of e-prescribing in France, the digital prescription has become a cornerstone of the digital transformation of the healthcare system. Governed by the Public Health Code, European Regulation 2017/745 and the Ségur digital health programme, this mode of prescription fundamentally changes medical, pharmaceutical and paramedical practices. Understanding its legal framework is essential to ensure healthcare professional compliance and legal certainty for patients.

The legal foundation of the digital prescription

The legal basis for digital prescriptions is primarily based on Article L.4071-1 of the Public Health Code, introduced by Ordinance No. 2020-1408 of 18 November 2020. This text defines electronic prescriptions as prescriptions issued, transmitted and archived in dematerialised form, having the same legal value as a paper prescription signed by the prescriber.

Decree No. 2022-1329 of 17 October 2022 specifies the technical methods of implementation, in particular the obligation to use a teleservice compliant with the benchmarks of the Health Digital Agency (ANS). The generalisation of e-prescribing is scheduled for December 2024, making its adoption mandatory for all private and hospital doctors.

Security, authentication and traceability

The digital prescription must meet strict security requirements. The qualified electronic signature, in compliance with eIDAS regulation (EU No. 910/2014), is required to guarantee the integrity and authenticity of the document. Professionals must use their HCP card (Healthcare Professional Card) or e-HCP to authenticate each prescription.

Each prescription is identified by a unique QR code generated by the national teleservice, allowing the pharmacist or receiving healthcare professional to retrieve all data via a secure centralised database, hosted by the CNAM. This traceability considerably reduces the risks of falsification, duplicate dispensing and medication errors.

Data protection and GDPR compliance

Digital prescriptions process health data that is sensitive in nature under Article 9 of the GDPR. Their processing is subject to the provisions of the amended Data Protection Act and CNIL benchmarks. Hosts must mandatorily obtain HDS certification (Health Data Host) as provided for in Article L.1111-8 of the Public Health Code.

The patient retains a right of access, rectification and objection to his or her data. They must be clearly informed of the dematerialisation of their prescription and the methods of transmission. In the event of a breach, penalties can reach 4% of annual turnover under the GDPR, without counting disciplinary sanctions.

Responsibilities of healthcare professionals

The prescriber remains entirely responsible for the content of the prescription, whether digital or paper. They must ensure the accuracy of the prescription, the dosage and the correct identification of the patient via their INS (National Health Identifier). The pharmacist, for their part, has the obligation to verify the authenticity of the prescription via the teleservice before any dispensing.

Practical examples

Example 1 – Private medical practice: A general practitioner uses their Ségur-certified practice management software to generate a digital prescription. The patient receives an SMS with a QR code which they present at the pharmacy, thus avoiding the loss of the paper document.

Example 2 – Telemedicine: During a remote consultation, the doctor issues an e-prescription signed electronically via e-HCP. The prescription is transmitted directly to the pharmacy chosen by the patient, in accordance with Article R.6316-1 of the Public Health Code.

Example 3 – Hospital establishment: A university hospital integrates e-prescribing into its HDS-certified hospital information system, enabling hospital prescriptions executed in the community (HPEC) with complete traceability between services.

Conclusion

The digital prescription represents a major advance in securing the patient care pathway, but its rollout requires absolute legal and technical rigour. Healthcare professionals, software publishers and establishments must anticipate regulatory deadlines and invest in compliant solutions to avoid legal risks and ensure quality of care.