As of July 1, 2024, Provision No. 1/2024 of the National Directorate of Health Information Systems came into effect, requiring digital platforms related to healthcare —particularly prescription systems and repositories of electronic or digital prescriptions— to register with the National Registry of Digital Health Platforms (ReNaPDiS). This requirement is part of the full implementation of Law No. 27,553 and its regulatory framework, which governs the use of technology in medical prescribing.
What is ReNaPDiS?
ReNaPDiS was created by Resolution 1959/2024 of the National Ministry of Health and aims to register and audit platforms and systems connected to digital health in Argentina. This registry includes the Registry of Electronic Prescriptions, which is mandatory for any system that enables the issuance, validation, or dispensing of electronic or digital prescriptions.
It is important to note that Emergency Decree No. 70/2023 amended Law No. 27,553 on Electronic or Digital Prescriptions, establishing that the prescription and dispensing of medicines —as well as any other medical prescription— may only be drafted and signed through authorized electronic platforms.
Who is required to register?
The following must register:
- Platforms or systems that issue electronic and/or digital prescriptions for medicines.
- Repositories of digital prescriptions.
- Medicine validation systems.
- Systems for ordering diagnostic tests, medical procedures, or any other digital medical prescriptions.
Both health software providers and medical institutions operating their own systems must comply with this requirement.
Key deadlines for compliance
According to Provision 1/2024 of the National Directorate of Health Information Systems:
- Prescription platforms and/or systems must register with the Registry of Electronic Prescriptions within 120 days of the regulation’s effective date (July 1, 2024).
- Healthcare professionals and providers who do not yet have platforms for issuing electronic prescriptions have up to 180 days to implement or adapt the necessary technology.
- In line with this timeline and the provisions of Law No. 27,553, starting January 1, 2025, electronic prescriptions will be the only valid method for prescribing medicines in Argentina, and platforms issuing them must be duly registered with ReNaPDiS.
How does the registration process work?
Applications must be submitted through Argentina’s Remote Procedures System (known as TAD). Applicants must provide details about the applicant, technical contact, responsible entity, and the software, along with documentation such as sample prescriptions and a sworn statement of regulatory compliance.
Among the key requirements, the system must prove compliance with:
- Law No. 25,326 on Personal Data Protection
- Law No. 26,529 on Patients’ Rights
- Law No. 27,553 on Electronic or Digital Prescriptions
- Law No. 25,649 on Generic Medicine Names
What happens if a platform does not comply?
Failure to register means a system cannot legally operate as a prescription or telehealth platform in Argentina. It may also expose companies to regulatory sanctions and claims from patients or healthcare institutions using the system. Note that in contingency situations (e.g., technical failures), paper prescriptions may be temporarily authorized, but only as an exceptional measure.
What should platforms keep in mind?
In addition to registration, platforms and electronic or digital prescriptions must comply with the obligations and requirements established by the regulations under Law No. 27,553 (Decree 98/2023, Articles 1 and 4 of Annex II), including:
- Ensuring the security, integrity, and immutability of data.
- Interoperability with other health systems.
- Confidentiality of medical information.
- Encryption and secure technology, kept up to date, especially if video calls are included.
- Ensuring that any use of artificial intelligence is supportive only and always under professional supervision.
Upon completing the registration, the platform receives a certificate with its details and validity, along with an identifier that will be part of the Unique Prescription Identification Code (CUIR), which enables tracking the entire prescription and dispensing cycle.
At Legal Core Group, we provide comprehensive legal advice on telemedicine, data protection, and regulatory compliance. We support tech companies and healthcare providers throughout the ReNaPDiS registration process, contract review, privacy policies, and more.
Contact us to ensure your platform complies with current regulations.
