Digital Prescriptions: Legal Framework and Obligations 2026

Since the progressive rollout of e-prescription 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 prescribing method fundamentally changes medical, pharmaceutical and paramedical practices. Understanding its legal framework is essential to ensure healthcare professionals' compliance and patients' legal security.

The legal foundation of digital prescription

The legal basis for digital prescription is mainly 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 prescription as a prescription issued, transmitted and archived dematerialised, with the same legal value as a paper prescription signed by the prescriber.

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

Security, authentication and traceability

Digital prescription must meet strict security requirements. The qualified electronic signature, compliant with the eIDAS regulation (EU No. 910/2014), is required to guarantee the integrity and authenticity of the document. Professionals must use their CPS card (Healthcare Professional Card) or e-CPS 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 the data via a secure centralised database, hosted by the CNAM. This traceability significantly reduces the risks of falsification, double dispensing and medication errors.

Data protection and GDPR compliance

Digital prescriptions process sensitive health data within the meaning of Article 9 of the GDPR. Their processing is subject to the provisions of the amended Data Protection Act and CNIL standards. Hosting providers must mandatory have HDS certification (Health Data Hosting Provider) provided for in Article L.1111-8 of the Public Health Code.

The patient retains a right of access, rectification and objection to their data. They must be clearly informed of the dematerialisation of their prescription and the transmission arrangements. In case of non-compliance, sanctions can reach 4% of annual turnover under the GDPR, not to mention professional sanctions.

Responsibilities of healthcare professionals

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

Practical examples

Example 1 – Independent 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 – Remote consultation: During a remote consultation, the physician issues an e-prescription electronically signed via e-CPS. The prescription is transmitted directly to the pharmacy chosen by the patient, in accordance with Article R.6316-1 of the CSP.

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

Conclusion

Digital prescription represents a major advance in securing the care pathway, but its deployment requires absolute legal and technical rigour. Healthcare professionals, software editors and establishments must anticipate regulatory deadlines and invest in compliant solutions to avoid legal risks and guarantee quality care.