National Digital Health Strategy
National Telehealth Plan
Declares that the development of information and communications technologies, telecommunications, and associated resources are in the public interest, establishing and guaranteeing the complete neutrality of the networks
Digital Agenda 2030
Classifies health data as sensitive data with special regulatory protection
On the guiding criteria for enforcing Law No. 25326
Creates the National Interoperability Network to integrate the information systems of all the jurisdictions and sectors of the health system, including the public and private subsectors
Recommended security measures for the processing and storage of personal data in computerized media
Approves the Guidelines for Research Involving Human Subjects and Objectives (secondary use of health data, decisions about confidentiality in research)
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.
Approves interoperability standards
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.
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.
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.
Establishes the liability of independent professionals