Telemedicine in Argentina and the advanced practice of medicine
Martín Javier Mosteirin
Marval O’Farrell Mairal, Buenos Aires
mjmo@marval.com
Camila Leone
Marval O’Farrell Mairal, Buenos Aires
cal@marval.com
Carolina Andrea Ramírez
Marval O’Farrell Mairal, Buenos Aires
candr@marval.com
Telemedicine
At the federal level, telemedicine is defined as the ‘provision of healthcare services through information and communication technologies (ICT)’ (Ministry of Health (MoH) Regulation 3316/2023). Thus, under the current legal framework, telemedicine constitutes a form of ‘telehealth’.
Main regulatory framework applicable to telemedicine
As of August 2020, Law 27,553 (Law on Electronic or Digital Prescriptions) set down the rules related to the use of tele-assistance platforms in healthcare, enabling telecare technologies to be used for the practice of medicine, dentistry and related collaborative activities (Article 2 bis of Law 17,132, as amended by the Law on Electronic or Digital Prescriptions).
Similarly, psychologists may also practice through the use of tele-assistance platforms licensed and authorised by the national MoH, provided that the rights set forth in Law 26,529 (the Rights of the Patient) are guaranteed (Section 3, Law 23,277).
In 2023, in light of the ongoing development of telemedicine, the Guidelines for the Organisation and Operation of Teleconsultations were issued according to MoH Regulation 3316/2023. These non-binding recommendations provided a baseline for good practices in regard to the provision of healthcare services through ICT. In this sense, the guidelines suggest that the following conditions, among others, should be met: (1) the space where the professional activity takes place shall be soundproof and private, providing assurance to the patient that no one outside the healthcare team will be able to listen to the consultation; (2) the physical space should not be seen or heard from anyone outside the space in order to guarantee the patient’s privacy; (3) the space should be equipped with adequate indirect ambient lighting to ensure that the healthcare attendant can be easily identified; and (4) the space should be supplied with furnishings and equipment appropriate to the medical specialty.
Types of teleservices
Even though the Argentine regulatory framework applicable to telemedicine does not limit the types of teleservices allowed to be used in practice, it includes the following definitions only (MoH Regulation 3316/2023):
- telehealth relates to all health-related activities and services carried out through the use of ICT;
- telemedicine is defined as the use of ICT for the provision of healthcare services; and
- teleconsultation is defined as a healthcare process that involves the interpretation of medical information and decision-making provided through ICT that takes place between two or more healthcare professionals (HCPs), as well as between the healthcare team and the individual receiving the healthcare service. Moreover, teleconsultations are divided into two types:
- depending on the time in which it takes place, teleconsultation can be: synchronous, if it takes place in real time, or asynchronous, when content is transferred from one point to another, with the processing or interpretation of such content occurring at one time and its return in another; and
- depending on the participants involved, a teleconsultation can be: between the patient and a member of the healthcare team (teleconsultation with the patient); between two or more members of the healthcare team, without the presence of the patient (teleconsultation for a second opinion); or between two or more members of the healthcare team, while one of them is present with the patient (teleconsultation at the bedside).
Requirements applicable to HCPs and institutions
In order for a teleconsultation to take place, HCPs must either be registered in the jurisdiction where the service is going to be provided or they must hold a federal sanitary licence (MoH Regulation 3316/2023 and Decree 98/2023). Such HCP licences are registered on the Federal Network of Healthcare Professionals Register (Red Federal de Registros de Profesionales de la Salud) and a unique identification number is given to the healthcare professional, which allows HCPs to be univocally identified and enables them to access interoperable systems for the implementation of ICT in the Argentine health system.
In addition, HCPs with a medical specialty must be registered with the specific jurisdictional authority (the MoH or professional association, according to the jurisdiction).
Furthermore, HCPs that provide telemedicine and teleconsultation services must undergo prior training regarding the tools and systems to be used. In this sense, a standard and monitored training programme must be ensured for all members of the healthcare team involved in the use of new ICT. Also, in the case of the provision of telemedicine through the use of synchronous technologies, user handbooks and awareness-raising and training strategies for citizens are required.
Additionally, the healthcare team should have access, whenever possible and when explicitly indicated, to the patient’s clinical information prior to the consultation through the electronic clinical record system. The members of the healthcare team performing the teleconsultation should always keep a complete record of the healthcare services provided, ideally through the use of the electronic medical record system at the health centre where the patient is usually treated.
Regarding the requirements applicable to healthcare professionals and institutions, all the facilities where teleconsultations are performed must have a director and/or a person in charge. The telehealth area must be part of the organisational chart, as part of the institutional policy for the provision of healthcare in the facility.
Lastly, according to MoH Regulation 3316/2023, the patient must give their prior informed consent in regard to the provision of telemedicine. For this purpose, it is desirable for institutions to have a procedure in place that guarantees that the patient fully understands the benefits and potential risks concerning the use of telemedicine technologies, in accordance with the provisions of Law 26,529 (Articles 5 to 10) and the Argentine Civil and Commercial Code (Article 59).
The requirements applicable to telemedicine services
Platforms that support electronic prescription and telemedicine services must establish themselves as responsible entities in Argentina for the processing of data, committing to do so confidentially and securely, in accordance with the applicable regulatory requirements. They are also required to implement mechanisms to safeguard the credentials and access of the actors involved, guaranteeing the security, privacy, purpose, timeliness, accuracy and inviolability of the data. Additionally, platform servers must be hosted in secure locations that comply with the relevant regulatory requirements, maintaining data availability, authenticity and confidentiality (Decree 98/2023, which regulates the Law on Electronic or Digital Prescriptions).
The regulations on personal data protection and patients’ rights must be followed, guaranteeing that healthcare users or their authorised representatives have access to and control over their data. Timely access to health data is required, guaranteeing its privacy, purpose, integrity and confidentiality. In the case of data transfers, the recipient must comply with the same obligations as the data originator. Moreover, platforms are obliged to take necessary measures to prevent data breaches, unauthorised access and misuse, while detecting any deviations, whether caused by human actions or technical failures.
The technological requirements include the deployment of systems aligned with regulatory standards for health information management, integrating encryption and cybersecurity protocols to ensure a high level of data protection, particularly in regard to audio and video transmissions.
The decree also underscores the importance of the protection of healthcare data, including medical and administrative records, ensuring their authenticity, availability and that suitable recovery mechanisms are in place. It establishes that artificial intelligence (AI) may only serve as a decision support tool under the supervision of healthcare professionals.
Moreover, facilities used for teleconsultations must meet environmental, hygiene and privacy standards, ensuring that consultations are conducted in private, soundproof spaces, with appropriate lightning and equipment. The regulation also requires the use of encrypted, up-to-date and auditable communication systems that guarantee the protection of personal data. Telemedicine platforms must be integrated with national health information systems, comply with interoperability standards and be subject to regulatory audits. They must also be registered with the corresponding health authority in the jurisdiction and the MoH. Adequate internet connectivity must be ensured throughout the consultation, with alternative communication methods agreed upon in case of service interruptions. Lastly, the regulation states that platforms must provide mechanisms to analyse information, generate metrics and evaluate outcomes, ensuring data availability, integrity and reliability to support healthcare improvements.
Finally, telecare systems and the individuals responsible for them must be registered with the National Registry of Digital Health Platforms (ReNaPDiS), in accordance with the technical requirements issued by the National Directorate of Health Information Systems (MoH Regulation 1,959/2024).
The advanced practice of medicine
Recent developments in healthcare delivery have expanded access to personalised care, paving the way for technological innovations that are reshaping medical practice and improving patient outcomes.
Software as a medical device
Software as a medical device (SaMD) is defined as ‘[a]ny instrument, device, equipment, implant, in vitro diagnostic product, software, material or other article, intended by the manufacturer to be used, alone or in combination, in human beings, for any of the following specific medical purposes, when the main intended action is not achieved by any pharmacological, immunological or metabolic means in the human body, but may contribute to its intended action: (i) diagnosis, monitoring, treatment or relief of a disease; (ii) diagnosis, monitoring, treatment or repair of an injury or disability; (iii) investigation, replacement or modification of anatomy, physiological or pathological process or state; (iv) sustaining or supporting life; (v) monitoring or supporting conception; and (vi) obtaining information by in vitro examination of specimens from the human body, including organ and tissue donations’ (National Administration of Medicines, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica or ANMAT) Regulation 64/2025).
Meanwhile, both ANMAT Regulation 9,688/2019 and ANMAT Regulation 64/2025 define SaMD as ‘[a] software product or application that is intended for one or more of the purposes listed in the definition of a medical device and that performs its functions without being part of the hardware of a medical device’.
In this sense, programs that constitute the software itself (standalone) shall be considered as active medical devices, excluding general administrative use of software that is used in the context of healthcare (ANMAT Regulation 9,688/2019).
Clinical decision support (CDS)
Although clinical decision software is not expressly regulated in Argentina, it could be considered SaMD if it falls within the definition of a SaMD. If, for example, the virtual assistant has a role in the decision-making process in which there is an adverse health outcome, liability claims may arise.
AI
From a regulatory perspective, there is no specific regulatory scheme in Argentina dedicated exclusively to AI technologies in the context of healthcare. However, if a device/product uses AI that meets the definition of a medical device or a SaMD then it could be subject to the regulatory framework and fall under the control of the ANMAT.
Given that Argentina’s digital regulatory landscape is evolving, it is likely that tailor-made regulations will be issued in the future. In this sense, ANMAT has submitted for public opinion a bill that aims to elaborate on the technical considerations and regulatory aspects related to the design and manufacturing processes involved in the development of AI and machine learning-based software to all stakeholders involved. In response, stakeholders have been expressing their opinions regarding the bill.