Guidelines and procedures for platforms and systems to register for electronic or digital prescription in ReNaPDiS | Disposition No. 1/2024
Healthcare & Life Sciences department report | Guidelines and procedures for platforms and systems to register for electronic or digital prescription in ReNaPDiS | Disposition No. 1/2024
Yesterday, Disposition No. 1/2024 (the “Disposition”) issued by the National Direction of Health Information Systems (“DNSIS”), was published in the Official Gazette. This Disposition establishes that platforms and/or systems for electronic and/or digital prescription, repositories of prescriptions, and medication validation wishing to register in the Electronic Prescription Registry within the framework of the National Registry of Digital Health Platforms (“ReNaPDiS”), created by Resolution No. 1959/24 published last week, must report compliance with the requirements of Article 4 of Decree No. 98/2023 and the specific requirements detailed in the Annex of the Disposition.
The Annex of the Disposition specifies the following data that must be provided for registration in the Electronic Prescription Registry:
1-Identification of the applicant, Technical Reference, and entity
2-Platform and/or System Data:
-Software name
-Production implemented version
-Prescription of medications: (Generic/Commercial/Both)
-Use of Refeps (Federal Network of Health Professionals’ Registries of the Integrated Argentine Health Information System)
-Website URL
-Electronic Prescription Standard: (ADESFA / HL7 FHIR / JSON not FHIR (check – sends minimum data / Others)
3-Sworn statement regarding compliance with: (i) the requirements established in Article 4 of the Annex of Decree No. 98/23; (ii) Law No. 25.326 “Habeas Data”; (iii) Law No. 26.529 “Patient Rights”; (iv) Law No. 27.553 “Electronic or Digital Prescriptions”; (v) Law No. 25.649 “Generic Drugs Act”; (vi) Pharmacy access to the repository. Additionally, the sworn statement must include a commitment to keep the information updated.
Registration in the Electronic Prescription Registry will conclude with the issuance of a certificate containing the identifying data of the registered platforms and/or systems, their responsible parties, the registration component, and the validity period. The certificate will specify the identifying component corresponding to the conditions of the registered platform and/or system, which will integrate the CUIR (Unique Recipe Identification Key).
Platforms and/or systems issuing electronic and/or digital prescriptions of medications have a deadline of 120 days to register in the Electronic Prescription Registry. Furthermore, professionals and health service providers who do not currently possess platforms and/or systems capable of prescribing electronic and/or digital prescriptions have an exceptional period of 180 days from the effective date of the Disposition to incorporate and/or adapt their technologies.
The Disposition will take effect the day following its publication in the Official Gazette, which is today.
Sincerely,