Digital Prescriptions: Legal Framework and Obligations

Digital Prescriptions: Legal Framework and Obligations

Since the gradual deployment of e-prescription in France, the digital prescription has established itself as a pillar of the digital transformation of the health system. Framed by the Public Health Code, European Regulation 2017/745 and the Ségur du digital en santé program, this prescribing method profoundly changes medical, pharmaceutical and paramedical practices. Understanding your legal framework is essential to guarantee the compliance of healthcare professionals and the legal security of patients.

The legal basis of the digital prescriptionThe legal basis of the digital prescription is mainly based onarticle L.4071-1 of the Public Health Code ⬥⬥⬥, introduced by ordinance n°2020-1408 of November 18, 2020. This text defines the electronic prescription as a prescription issued, transmitted and archived electronically, having the same legal value as a paper prescription signed by the prescriber.

article L.4071-1 of the Public Health Code ⬥⬥⬥, introduced by ordinance n°2020-1408 of November 18, 2020. This text defines the electronic prescription as a prescription issued, transmitted and archived electronically, having the same legal value as a paper prescription signed by the prescriber.Decree No. 2022-1329 of October 17, 2022specifies the technical modalities of implementation, in particular the obligation to use a teleservice compliant with the standards of the Digital Health Agency (ANS). The generalization of e-prescription is planned for December 2024, making its adoption compulsory for all private and hospital doctors.

Security, authentication and traceability

The digital prescription must meet strict security requirements. Thequalified electronic signature ⬥⬥⬥, compliant with the eIDAS regulation (EU n°910/2014), is required to guarantee the integrity and authenticity of the document. Professionals must use theirqualified electronic signature ⬥⬥⬥, compliant with the eIDAS regulation (EU n°910/2014), is required to guarantee the integrity and authenticity of the document. Professionals must use theirCPS card (Health Professional Card)or e-CPS to authenticate each prescription.

Each prescription is identified by a uniqueQR codeQR code

generated by the national teleservice, allowing the recipient pharmacist or healthcare professional to retrieve all of the data via a secure centralized database, hosted by the CNAM. This traceability considerably reduces the risks of falsification, double dispensing and medication errors.

Data protection and GDPR complianceDigital prescriptions processsensitive health datawithin the meaning of Article 9 of the GDPR. Their processing is subject to the provisions of the amended Data Protection Act and the CNIL standards. Hosts must have thewithin the meaning of Article 9 of the GDPR. Their processing is subject to the provisions of the amended Data Protection Act and the CNIL standards. Hosts must have the

HDS (Health Data Host)certification provided for by article L.1111-8 of the Public Health Code.The patient retains a right of access, rectification and opposition to his data. He must be clearly informed of the dematerialization of his prescription and the methods of transmission. In the event of a breach, sanctions can reach

4% of annual turnover

4% of annual turnoveraccording to the GDPR, not counting ordinal sanctions.Responsibilities of healthcare professionals

The prescriber remains fully responsible for the content of the prescription, whether digital or paper. He must ensure the accuracy of the prescription, the dosage and the correct identification of the patient via his

INS (National Health Identifier) ​​⬥⬥⬥. The pharmacist, for his part, is obliged to verify the authenticity of the prescription via the teleservice before any dispensing.Practical examples

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

Example 2 – Teleconsultation ⬥⬥⬥: During a remote consultation, the doctor issues an electronically signed e-prescription via e-CPS. The prescription is sent 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 HIS, allowing hospital prescriptions executed in town (PHEV) with complete traceability between services.

Conclusion

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