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.
On the use of WhatsApp
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).
Provides for video calls between patients admitted to health services who are unable to receive visitors and their families
Establishes principles, guarantees, rights, and duties for use of the internet in Brazil
Establishes the National Policy for Health Information and Informatics (PNIIS)
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.
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).
Pursuant to Article 5, health data is classified as sensitive data and its processing is provided for in Section II of the regulations.
Personal data protection guide issued by the National Data Protection Authority
The law defines the crime of computer intrusion and the crime of disruption or tampering with telegraph, telephone, computer, telematic, or public utility information services.
Provides for the National Policy for Health Information and Informatics (PNIIS)
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)
Digitization and use of computerized systems for the storage and management of patient records
Provides for the use of electronic signatures in interactions with public entities, in actions of legal entities, and in health matters
Provides for the health oversight of medicines, drugs, pharmaceutical and related supplies, cosmetics, disinfectants, and other products
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
Regulates medical activities
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.
Pursuant to Article 5, health data is classified as sensitive data and its processing is provided for in Section II of the regulations.