In Argentina, the Electronic or Digital Prescriptions Law authorizes the use of telehealth platforms nationwide. Its purpose is to enable every prescription for medication—as well as any other medical indication— to be issued electronically through authorized platforms and/or prescription. These activities must be carried out in compliance with Personal Data Protection Law and the Patient Rights, Medical Records, and Informed Consent Law.
This legal framework makes medical assistance accessible to more people while promoting system interoperability, ensuring information security, safeguarding personal data, and protecting patient rights when healthcare services are provided remotely.
Electronic Prescriptions: A Transformative Change
As of January 1st, 2025, the way medications are prescribed in Argentina has undergone a significant transformation. Pursuant to Decree 345/2024, all electronically-issued medical prescriptions, must be issued exclusively through platforms that are duly registered and approved by the competent authority.
This represents a major step toward modernizing and digitizing the healthcare system and brings significant benefits—most notably, streamlining and simplifying healthcare processes, strengthening the quality of healthcare services, and enhancing the security, interoperability, traceability, accessibility, and efficiency of medical prescriptions.
To ensure the proper implementation of this system, the National Registry of Digital Health Platforms (ReNaPDiS) was created. This registry operates under the Subsecretariat of Epidemiological Surveillance, Information, and Health Statistics, with the operational coordination of the National Directorate of Health Information Systems—both of which are function within the Ministry of Health. The ReNaPDis is responsible for supervising that the technology systems of the telehealth platforms meet regulatory standards and have the technical capacity to issue electronic prescriptions.
Technical and Personal Data Protection Requirements for Platforms
Notably, the system does not mandate the use of any specific technology but instead defines a single format and model for electronic prescriptions that must be followed by platforms that issue them, ensuring security and interoperability. In addition, the Ministry of Health has introduced a comprehensive regulatory approach, including requirements related to compliance with personal data protection regulations. Thus, any company operating a platform to issue electronic prescriptions must not only meet certain technical specifications but also:
- Register as a Data Controller within the Public Information Access Agency (“AAIP”).
- Declare compliance with the Personal Data Protection Law, which includes—among many other obligations—fulfilling security requirements and registering the Personal Databases the company processes in its capacity as the responsible party with the AAIP.
All steps can be completed entirely online via TAD, facilitating and expediting the necessary paperwork.
It is important to note that, while international trends tend to eliminate the requirement for Data Controllers to register and record their personal databases, this requirement remains in force in Argentina. Therefore, to register with ReNaPDiS, digital platforms issuing electronic prescriptions must first be registered as Data Controllers of Personal Databases, and as a result, they must also register the Personal Databases they manage in that capacity—thus avoiding cancellation of their registration as a Controller.
Obligations for Health Professionals and Service Providers
Additionally, the new legal framework establishes that health professionals who do not have a platform and/or system with the technical capacity to issue electronic and/or digital prescriptions are required to incorporate such technologies, as the 180-day implementation period lapsed at the end of 2024. Furthermore, these professionals must also comply with personal data protection regulations by registering as Personal Database Controllers and, in turn, registering the databases they handle in that capacity, particularly those pertaining to their patients.
At Lerman & Szlak, we have a team of specialists ready to provide guidance on compliance with the current regulations for both digital platforms that issue electronic prescriptions and for healthcare professionals and service providers. We can also assist with any applicable registration processes. Do not hesitate to contact us at info@lermanszlak.com.
Gabriela Szlak (T° 79 F° 516 CPACF), Maria Agustina Hagelstrom (T° 139 F° 344 CPACF) y Delfina Bianchi.
