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Comparison between countries in the Southern Cone subregion

The information is organized according to the seven main categories for implementing telemedicine systems:

  • Regulatory aspects of telemedicineAR#ef42527.78
  • Telemedicine governanceAR#ef42527.41
  • Personal data protection in telemedicineAR#ef425296.88
  • Technological aspects of telemedicineAR#ef425236.52
  • Role of health institutions and teams in telemedicineAR#ef425224.80
  • Role of patients in telecareAR#ef425220.00
  • Core principles and human rights in telemedicineAR#ef42520.00
  • Regulatory aspects of telemedicineBR#c9912a16.11
  • Telemedicine governanceBR#c9912a11.85
  • Personal data protection in telemedicineBR#c9912a82.50
  • Technological aspects of telemedicineBR#c9912a26.96
  • Role of health institutions and teams in telemedicineBR#c9912a34.67
  • Role of patients in telecareBR#c9912a9.78
  • Core principles and human rights in telemedicineBR#c9912a0.00
  • Regulatory aspects of telemedicineCL#f6873128.61
  • Telemedicine governanceCL#f687317.41
  • Personal data protection in telemedicineCL#f6873153.54
  • Technological aspects of telemedicineCL#f6873131.01
  • Role of health institutions and teams in telemedicineCL#f6873143.20
  • Role of patients in telecareCL#f6873136.44
  • Core principles and human rights in telemedicineCL#f687310.00
  • Regulatory aspects of telemedicinePY#1e978e51.39
  • Telemedicine governancePY#1e978e25.93
  • Personal data protection in telemedicinePY#1e978e60.83
  • Technological aspects of telemedicinePY#1e978e20.29
  • Role of health institutions and teams in telemedicinePY#1e978e45.33
  • Role of patients in telecarePY#1e978e9.78
  • Core principles and human rights in telemedicinePY#1e978e15.00
  • Regulatory aspects of telemedicineUY#ff9b7140.28
  • Telemedicine governanceUY#ff9b7114.81
  • Personal data protection in telemedicineUY#ff9b7190.63
  • Technological aspects of telemedicineUY#ff9b7145.51
  • Role of health institutions and teams in telemedicineUY#ff9b7128.00
  • Role of patients in telecareUY#ff9b7126.67
  • Core principles and human rights in telemedicineUY#ff9b7124.67

Region: Southern Cone

In this section, all the countries of the Southern Cone are distributed according to the progress made on their regulatory framework for implementing telemedicine services.

  • ArgentinaSouthern ConeAR#ef425234.5495
  • ArgentinaSouthern ConeAR#ef425234.5495
  • ArgentinaSouthern ConeAR#ef425234.5495
  • ArgentinaSouthern ConeAR#ef425234.5495
  • BrazilSouthern ConeBR#c9912a32.2072
  • BrazilSouthern ConeBR#c9912a32.2072
  • BrazilSouthern ConeBR#c9912a32.2072
  • BrazilSouthern ConeBR#c9912a32.2072
  • ChileSouthern ConeCL#f6873132.4775
  • ChileSouthern ConeCL#f6873132.4775
  • ChileSouthern ConeCL#f6873132.4775
  • ChileSouthern ConeCL#f6873132.4775
  • ParaguaySouthern ConePY#1e978e36.8919
  • ParaguaySouthern ConePY#1e978e36.8919
  • ParaguaySouthern ConePY#1e978e36.8919
  • ParaguaySouthern ConePY#1e978e36.8919
  • UruguaySouthern ConeUY#ff9b7144.8649
  • UruguaySouthern ConeUY#ff9b7144.8649
  • UruguaySouthern ConeUY#ff9b7144.8649
  • UruguaySouthern ConeUY#ff9b7144.8649
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Country-by-country breakdown of: Southern Cone

This section provides links to the main legal texts of each country for the different categories and dimensions of their regulatory framework.

Categories and dimensions

Regulatory aspects of telemedicine
Telemedicine governance
Personal data protection in telemedicine
Technological aspects of telemedicine
Role of health institutions and teams in telemedicine
Role of patients in telecare
Core principles and human rights in telemedicine

Regulatory survey

  • Law No. 27553 on electronic or digital prescriptions

    Law No. 27553 on electronic or digital prescriptions establishes that telecare platforms may be used anywhere in the country, in accordance with Law No. 25326 on personal data protection and Law No. 26529 on patients' rights. It also authorizes the modality of telecare for the practice of medicine, dentistry, and complementary services, guaranteeing the rights established in Law No. 26529 on patients’ rights. Telecare services may only be provided by authorized practices, according to protocols and platforms approved by the relevant authority.

  • Resolution No. 680/2018

    Approves interoperability standards

  • Compendium of cybersecurity regulations
  • Law No. 25506 on digital signatures
  • Regulatory Decree No. 182/2019
  • Provisions of Article 288 of the National Civil and Commercial Code
  • Ministerial Resolution No. 696/2020

    Authorizes the prescription of medicines for patients undergoing cancer treatment or patients undergoing treatment for chronic noncommunicable diseases (NCDs), as well as any other medicine used under prescription, excluding narcotic drugs, in the form of text messages or messages sent through messaging applications via the internet, email, or fax, in the context of the preventive and mandatory social distancing established by Decree No. 297/2020 and for the duration of the quarantine ordered by the same decree.

  • Disposición ANMAT N° 2318/02 (t.o. 2004)

    Se incorporó al ordenamiento jurídico nacional el “REGLAMENTO TÉCNICO MERCOSUR DE REGISTRO DE PRODUCTOS MÉDICOS” aprobado por MERCOSUR/GMC/RES. No 40/00, que establece las normas generales concernientes al registro de productos médicos.

  • ANMAT Resolution No. 2318/02 (Amended Text 2004)

    Incorporates into the national legal system the MERCOSUR Technical Regulations for the Registration of Medical Devices approved by MERCOSUR/GMC Resolution No. 40/00, which establishes the general regulations concerning the registration of medical devices.

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  • CFM Resolution No. 1643/2002

    The resolution defines telemedicine as the practice of medicine through the use of interactive communication methodologies and audiovisual data for health care, education, and research purposes. It does not comprehensively address the issue and does not include any express or enabling requirements for ordinary remote medical consultations. In emergencies, or when requested by the attending physician, the physician issuing the report remotely may provide appropriate diagnostic and therapeutic support.

  • CFM Opinion No. 14/2017

    On the use of WhatsApp

  • Law No. 13989 on telemedicine during the COVID-19 pandemic

    The law authorizes the use of telemedicine for the duration of the public health crisis caused by the COVID-19 pandemic. Specifically, it establishes that telemedicine services shall adhere to the same regulatory and ethical standards as in-person care, including in relation to financial compensation for services provided, and that the authorities are not responsible for funding or paying for such activities when they are not an exclusive service of the Universal Health System (SUS).

  • Law No. 14198

    Provides for video calls between patients admitted to health services who are unable to receive visitors and their families

  • Law No. 12965

    Establishes principles, guarantees, rights, and duties for use of the internet in Brazil

  • GM/MS Ordinance No. 1768/2021

    Establishes the National Policy for Health Information and Informatics (PNIIS)

  • E-Health Strategy (2017)

    The strategy was approved by Resolution No. 19 of June 22, 2017 of the Tripartite Inter-Management Committee (CIT) and reinforced by the Action, Monitoring, and Evaluation Plan (PAM&A), approved at the 34th Regular Meeting of the Digital Health Strategy Steering Committee on December 13, 2019, and agreed to ad referendum by the CIT on March 30, 2020. The PAM&A made it possible to identify, prioritize and integrate health programs, projects, and actions in a coordinated manner in order to implement the initiatives of Connect SUS, a federal government program tasked with implementing Brazil's Digital Health Strategy. The agency also promotes support for digitization and the exchange of information between facilities in the country’s vast health care network.

  • National Telehealth Network Program
  • Ordinance No. 467

    Ordinance No. 467 of the Ministry of Health establishes an action, monitoring, and evaluation plan for Brazil’s Digital Health Strategy 2019-2023, the chief aim of which is to identify, prioritize, and integrate health programs, projects, actions, information and communication services and systems, financing mechanisms, infrastructure, governance, technologies, and human resources in a coordinated manner in order to turn the vision of the Digital Health Strategy (of which the action, monitoring, and evaluation plan is an integral part) into a reality. Brazil’s Digital Health Strategy 2020-2028 (ESD28) (English version), which was agreed to at the 6th Regular Meeting of the CIT on August 27, 2020 and published in GM/MS Ordinance No. 3632 on December 21, 2020, seeks to systematize and consolidate the progress made over the last decade, which has been recorded in various documents, particularly in the PNIIS (2015, and being revised during the preparation of the ESD28), Brazil’s e-Health Strategy (2017), and the PAM&A (2019-2023).

  • GM/MS Ordinance No. 1768/2021

    Provides for the National Policy for Health Information and Informatics (PNIIS)

  • Directive No. 2073

    Regulates the use of interoperability and health information standards for health information systems in the Unified Health System, at the municipal, district, state, and federal levels, and for private and supplementary health systems Establishes the National Policy for Health Information and Informatics (PNIIS)

  • Law No. 13787

    Digitization and use of computerized systems for the storage and management of patient records

  • Law No. 14063

    Provides for the use of electronic signatures in interactions with public entities, in actions of legal entities, and in health matters

  • Law No. 6360/1976

    Provides for the health oversight of medicines, drugs, pharmaceutical and related supplies, cosmetics, disinfectants, and other products

  • RDC No. 185/2001 on registering, post-registering, or notifying about medical devices

    Technical regulation that addresses the registration, amendment, revalidation, and cancellation of the registration of medical devices with the Brazilian Health Regulatory Agency (ANVISA). Amended by: RDC No. 207/2006, RDC No. 40/2015, RDC No. 211/2018, RDC No. 340/2020, and RDC No. 458/2020. Defines medical devices as any: Health device such as equipment, apparatuses, materials, items, or systems for medical, dental, or laboratory use or application and intended for prevention, diagnosis, treatment, rehabilitation, or contraception, and which does not use pharmacological, immunological, or metabolic means to perform its primary function in humans, although its functions may be assisted by such means. See: ANVISA Health Products Resource Center https://www.gov.br/anvisa/pt-br/assuntos/regulamentacao/legislacao/bibliotecas-tematicas/arquivos/produtos

  • CFM Resolution No. 1627/2001

    Regulates medical activities

  • Code of Ethics of the Federal Council of Medicine (CFM), Article 37

    Physicians are prohibited from prescribing treatment or other procedures without directly examining the patient, except in in urgent or emergency cases and when the impossibility of doing so has been demonstrated, in which case examination must be performed immediately after the impediment ceases. Consulting, diagnosing, or prescribing by any means of mass communication is also prohibited. § 1 Remote medical care, in the form of telemedicine or any other method, shall be provided under the regulations of the Federal Council of Medicine. § 2 When using social networks and related channels, the physician must respect the rules developed by the Federal Council of Medicine.

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  • Resolution No. 204/2020 of the Ministry of Public Health, Deputy Minister of Public Health

    Establishes a registry for telemedicine service providers, identifies the rules of conduct during such services, lists the rights and obligations of professionals, and establishes guidelines for determining fees in a manner equivalent to traditional consultations

  • IP Official Regulatory Letter No. 7 of the Superintendency of Health Providers

    The regulatory letter subjects remote care services to compliance with Law No. 20.584, which regulates people's rights and duties regarding actions related to their health care It establishes a registry for those who provide telemedicine services, identifies the rules of conduct during such services, lists the rights and obligations of professionals, and establishes guidelines for determining fees in a manner equivalent to traditional consultations

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  • SG Resolution No. 139/2020

    As a result of the health emergency declared by Decree No. 3456/2020, this resolution authorizes health service providers and medical professionals to provide remote health services for promotion, prevention, diagnosis, treatment, and rehabilitation through the use of information and telecommunication technologies, with the purpose of improving access to and the timeliness the services provided to the population, without detriment to those who require personalized attention

  • Law No. 4017

    Legal validity of electronic signatures, digital signatures, data messages, and electronic files (amended by Law No. 4610)

  • Law No. 1119/97

    On health products and other similar items. This law regulates the manufacture, preparation, fractionation, quality control, distribution, prescription, dispensation, commercialization, representation, import, export, storage, rational use, pricing, information, advertising, evaluation, authorization, and registration of medicines for human use, drugs, chemical products, reagents, and all other products for use and application in human medicine, as well as products classified as cosmetics and household cleaning products

  • Law No. 4659/2012

    The law implements safety procedures and mechanisms and risk prevention mechanisms for health professionals. It defines a medical device as instruments, apparatuses, hospital supplies, and other items, including their packaging and the raw materials, components, parts, or accessories that comprise them, to be used alone or in combination with each other for human beings. They are primarily intended for the diagnosis, prevention, monitoring, treatment, and alleviation of disease, injury, or disability. They are also used in research, replacement or modification of the anatomy, physiological processes, and the control of conception. Types include: I) Active medical device: any device whose operation depends on a source of electrical energy or any source of energy other than that generated directly by the human body or by gravity, and which acts by converting that energy. II) Invasive medical device: any device that, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. III) Surgically invasive medical device: any device that penetrates inside the body through the surface of the body by means of a surgical intervention.

  • MERCOSUR/GMC Resolution No. 40/00

    Mercosur Technical Regulations for the Registration of Medical Devices (Repealing GMC Resolution No. 37/96 added to the national legal system by Decree No. 5939/2005)

  • Law No. 19869

    General guidelines for the implementation and development of telemedicine

  • Decree No. 134/21

    Highlights the importance of developing connectivity and infrastructure for telemedicine

  • Decree No. 242/017

    Mechanisms for exchanging clinical information for health care purposes through the National Electronic Health Record system

  • Decree No. 122/019

    On incorporating health institutions and individuals into the National Electronic Health Record system

  • Law No. 18600

    Electronic signatures

  • Law No. 19335

    Article 467 on electronic medical prescriptions

  • Law No. 19869

    Since it regulates the provision of telemedicine services, this law can be considered an enabling regulation

  • Law No. 19869

    Included in the main telemedicine guidelines is patients’ right to autonomy and self-determination

  • Law No. 18331

    Establishes patients’ right to access their data

  • Law No. 19869

    Included in the principles is the goal of closing digital gaps, providing access without any discrepancies between socioeconomic conditions, and promoting safe practice environments for children, adolescents, and people with disabilities

We are grateful for the valuable comments, suggestions, and contributions of Myrna Marti, Giselle Ricur, Daniel Luna, Marcelo Carrascal, Alexandre Bagolle, Marcelo Lamy, Angélica Baptista Silva, Juan Alberto Lecaros, Felipe Mejía Medina, Alejandro Marin Mora, Adrián Pacheco López, Javier Carnicero, Irene Melamed and Luis Morales, who help validate the work method and its results.

We are likewise grateful for the participation of the following institutions, which were contacted throughout the preparation of this site to validate the methods used and results: the Central American Health Informatics Network (RECAINSA), Argentinian Civil Association of Telemedicine (ACTRA), Ibero-American Association of Telehealth and Telemedicine (AITT), American Telemedicine Association (ATA), Venezuelan Association of Telehealth and Telemedicine (AVTT), and Telemedicine University Network (RUTE).