Comparison between countries in the región Latinoamérica y el Caribe (LAC)
The information is organized according to the seven main categories for implementing telemedicine systems:
Region: LAC
In this section, all the countries of the LAC are distributed according to the progress made on their regulatory framework for implementing telemedicine services.
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Country-by-country breakdown of: LAC
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 survey
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Regulatory aspects of telemedicine8
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Telemedicine governance7
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Personal data protection in telemedicine97
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Technological aspects of telemedicine37
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Role of health institutions and teams in telemedicine25
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Role of patients in telecare20
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Core principles and human rights in telemedicine0
- Resolution No. 189/2018
National Digital Health Strategy
- Resolution No. 21/2019
National Telehealth Plan
- Law No. 27078 on ICTs (Argentina Digital)
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
- Decree No. 996/2018
Digital Agenda 2030
- Law No. 25326 on personal data protection
Classifies health data as sensitive data with special regulatory protection
- AAIP Resolution No. 4/2019
On the guiding criteria for enforcing Law No. 25326
- Ministerial Resolution No. 115/2019
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
- Resolution No. 47/2018
Recommended security measures for the processing and storage of personal data in computerized media
- Resolution No. 1480/2011
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
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
- 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.
- National Civil and Commercial Code, Article 1768
Establishes the liability of independent professionals
- No data to display
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine60
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Technological aspects of telemedicine0
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Role of health institutions and teams in telemedicine23
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Role of patients in telecare9
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Core principles and human rights in telemedicine0
- No data to display
- No data to display
- Act Data Protection (Privacy of personal information)
General framework for the protection of personal data
- No data to display
- Medical Act, 2014: Part V, Registration and Licensing, 22. Temporary, provisional and special registrations, (5)
Telemedicine services are mentioned within the general framework, so it can be concluded that providing such services is authorized. Additionally, it establishes that the authority responsible for this law will have the authority to register professionals who offer telemedicine services.
- Act Data Protection (Privacy of personal information)
Provides for patients’ access to their data
- No data to display
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine100
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Technological aspects of telemedicine0
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare13
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Core principles and human rights in telemedicine0
- No data to display
- No data to display
- Data Protection Bill, 2019
General framework for the protection of personal data
- No data to display
- No data to display
- Data Protection Bill, 2019
Provides for patients’ access to their data
- No data to display
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine71
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Technological aspects of telemedicine9
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare9
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Core principles and human rights in telemedicine0
- No data to display
- No data to display
- Data Protection Bill, 2021
General framework for the protection of personal data
- Belize Health Sector Strategic Plan 2014-2024
Provides for infrastructure and connectivity actions for the health sector
- No data to display
- Data Protection Bill, 2021
Provides for patients’ access to their data
- No data to display
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Regulatory aspects of telemedicine8
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Telemedicine governance0
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Personal data protection in telemedicine16
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Technological aspects of telemedicine32
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare4
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Core principles and human rights in telemedicine0
- Ministerial Resolution No. 0891, National Telehealth Program
Creation of the National Telehealth Program
- No data to display
- Supreme Decree No. 1793 with implementing regulations for Law No. 164
Although not specific to the protection of personal data, the decree includes provisions for processing that information
- Law No. 164
Addresses issues of connectivity and infrastructure related to the technological aspects of telemedicine
- Supreme Decree No. 1793 with implementing regulations for Law No. 164
Establishes provisions on digital signatures
- No data to display
- Supreme Decree No. 1793 with implementing regulations for Law No. 164
Provides for patients’ access to their data
- No data to display
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Regulatory aspects of telemedicine16
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Telemedicine governance12
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Personal data protection in telemedicine83
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Technological aspects of telemedicine27
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Role of health institutions and teams in telemedicine35
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Role of patients in telecare10
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Core principles and human rights in telemedicine0
- 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.
- 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).
- General Data Protection Law No. 13709
Pursuant to Article 5, health data is classified as sensitive data and its processing is provided for in Section II of the regulations.
- Internet Security Guide
Personal data protection guide issued by the National Data Protection Authority
- Law No. 12737 on cybercrime (amends the Criminal Code)
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.
- 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.
- General Data Protection Law No. 13709
Pursuant to Article 5, health data is classified as sensitive data and its processing is provided for in Section II of the regulations.
- No data to display
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Regulatory aspects of telemedicine29
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Telemedicine governance7
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Personal data protection in telemedicine54
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Technological aspects of telemedicine31
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Role of health institutions and teams in telemedicine43
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Role of patients in telecare36
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Core principles and human rights in telemedicine0
- Resolution No. 204/2020 of the Ministry of Public Health, Deputy Minister of Public Health
Authorizes telemedicine services for the duration of the COVID-19 pandemic, addressing some aspects of providing such services
- IP Official Regulatory Letter No. 7 of the Superintendency of Health Providers
Subjects remote care services to compliance with Law No. 20584, which regulates the rights and duties of individuals regarding actions related to their health care
- Ordinance No. A15 No. 2448, of the care network management division of the Ministry of Health, on the use of information and communication technologies in health care
Among other issues, it expressly establishes the need for informed consent in the same terms as Law No. 20584
- Exempt Resolution No. 342 of the Ministry of Health, National Telehealth Program
Incorporates telemedicine in a strategic sense, while mentioning the need for quality standards and providing for telemedicine at all levels of care
- Law No. 19628 on protection of privacy
Although it addresses issues that are broader than the protection of personal data, it is nonetheless relevant
- National Telehealth Program/Basic Principles for Telemedicine and Telehealth Development Guidelines in Chile
Government documents that do not have regulatory status but that nonetheless highlight the importance of connectivity and infrastructure for implementing telemedicine
- Resolution No. 204/2020 of the Ministry of Public Health, Deputy Minister of Public Health
Requirement to register telemedicine activities, with a duty to identify and confirm the identities of the parties involved
- Law No. 20584 on people's rights and duties regarding actions related to their health care
Establishes provisions on clinical records
- Decree No. 41
Regulations on clinical records
- IP Official Regulatory Letter No. 7 of the Superintendency of Health Providers
Subjects remote care services to compliance with Law No. 20.584, which regulates the rights and duties of individuals regarding actions related to their health care
- Law No. 19799
Electronic documents, electronic signatures, and electronic signature authentication services
- Law No. 20724
Amends the health code in relation to the regulation of pharmacies and medicines
- Resolution No. 58/2019 of the Ministry of Public Health
Amends Decree No. 466, which approves the regulations for authorized pharmacies, drugstores, pharmaceutical warehouses, medical supplies units, and pharmaceutical depots on electronic commerce of medicines
- Exempt Decree No. 643
Technical regulation on health information standards, which establishes rules for the interoperability of systems
- 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
- Resolution No. 204/2020 of the Ministry of Public Health, Deputy Minister of Public Health
Regulates the rights and obligations of patients and conditions for eligibility for and carrying out virtual consultations. Subjects remote care services to compliance with Law No. 20584, which regulates people's rights and duties regarding actions related to their health care. 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
- Law No. 19628 on privacy protection
Provides for patients’ access to their personal data
- IP Official Letter No. 7 of the Superintendency of Health Providers
Subjects remote care services to compliance with Law No. 20584, which regulates people's rights and duties regarding actions related to their health care
- No data to display
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Regulatory aspects of telemedicine57
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Telemedicine governance11
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Personal data protection in telemedicine94
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Technological aspects of telemedicine59
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Role of health institutions and teams in telemedicine33
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Role of patients in telecare58
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Core principles and human rights in telemedicine30
- Law No. 1419
Guidelines for telehealth development
- Resolution No. 00026540
Defines parameters for telemedicine services
- Resolution No. 3100/2019
Establishes mechanisms for authorizing health services, including telemedicine and the requirements for providing services abroad
- Law No. 1419
Highlights the closing of digital gaps as one of the objectives of telemedicine, promoting access without discrepancies based on socioeconomic conditions and respecting cultural diversity, beliefs, and values of individuals and groups in vulnerable situations
- Statutory Law No. 1581, 2012
General framework for the protection of personal data
- Decree No. 1377, 2013
Implementing regulations for Law No. 1581
- Resolution No. 00026540
Establishes provisions on technological aspects of telemedicine services
- Resolution No. 3100/2019
Establishes provisions on technological aspects of telemedicine services
- Law No. 2015, 2020
Creates interoperable electronic health records
- Law No. 527
Establishes provisions on digital signatures
- Decree No. 2200 of 2005, Chapter IV, Article 16, Point 3
Establishes the possibility of prescribing medicines by electronic and/or computerized means
- Resolution No. 00026540
Defines parameters for telemedicine services
- Resolution No. 3100/2019
Establishes mechanisms for authorizing health services, including telemedicine and the requirements for the provision of services abroad
- Law No. 1419
Provides for access to telemedicine services and guarantees patients' right to autonomy and self-determination
- Statutory Law No. 1581, 2012
Access to health data
- Law No. 1419
Highlights the closing of digital gaps as one of the objectives of telemedicine, promoting access without discrepancies based on socioeconomic conditions and respecting cultural diversity, beliefs, and values of individuals and groups in vulnerable situations
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine63
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Technological aspects of telemedicine39
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Role of health institutions and teams in telemedicine20
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Role of patients in telecare9
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Core principles and human rights in telemedicine0
- No data to display
- No data to display
- Law No. 8968
General framework for personal data protection
- Law No. 9162 on the Unified Digital Health Record
Establishes provisions for data protection
- National Telecommunications Development Plan (PNDT) 2015-2021
Addresses the importance of developing health infrastructure and connectivity
- Law No. 9162 on the Unified Digital Health Record
Unified Digital Health Record
- Law No. 8454
Certificates, digital signatures, and electronic documents
- Decree No. 39984-S
Regulations for the use and operation of the automated digital prescription system for psychotropic and narcotic drugs, establishing provisions for digital prescriptions
- Decree No. 39.652-S
Regulations on the use of health data standards in patient care and creation of the National Health Data Standardization Committee, establishing provisions for interoperability
- Law No. 8968
Provides for patients’ access to their data
- No data to display
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Regulatory aspects of telemedicine9
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Telemedicine governance2
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Personal data protection in telemedicine82
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Technological aspects of telemedicine13
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Role of health institutions and teams in telemedicine20
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Role of patients in telecare7
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Core principles and human rights in telemedicine0
- Technical Regulations for the Authorization of Clinical and Surgical Services (2017)
Provides a definition of telemedicine services: an outpatient consultation performed without physical contact by direct remote means between the health professional and the person requesting the service, including cross-consultations between professionals, carried out by means of any information and communication technology system to provide medical care or support, regardless of the distance between those involved in the service. The computer technology and communications required to request and provide the care must be available. Proper management of aspects related to informed consent, confidentiality, respect, and professional discretion must be ensured, as well as the control of health records and patient information, in accordance with current regulations. There must be management agreements with specific local health facilities. The person providing the telemedicine service must be a health professional who meets the requirements in these regulations and relevant standards.
- Law No. 172-13
Comprehensive protection of personal data stored in files, public registries, databases, or other technical means of data processing for generating reports, whether public or private (2013)
- Law No. 53-07
High-tech crimes (2007)
- National Regulation No. 32
Clinical records in health care (2003) - Establishes the mandatory scientific, technological, and administrative criteria for the preparation, integration, use, and filing of clinical records
- Decree No. 246-06 of June 9, 2006
This decree establishes the regulations governing the manufacture, preparation, quality control, supply, circulation, distribution, commercialization, information, advertising, importation, storage, distribution, evaluation, registration, and donation of medicines. It also covers pharmaceutical facilities and their specifications and functions, as well as the principles, standards, criteria, requirements, and basic conditions related to the safety, efficacy, and quality of medicines, medical devices, cosmetics, personal hygiene products, pharmaceuticals of natural origin marketed for therapeutic purposes, and household hygiene products.
- Technical Regulations for the Authorization of Clinical and Surgical Services (2017)
Provides a definition of telemedicine services: an outpatient consultation performed without physical contact by direct remote means between the health professional and the person requesting the service, including cross-consultations between professionals, carried out by means of any information and communication technology system to provide medical care or support, regardless of the distance between those involved in the service. The computer technology and communications required to request and provide the care must be available. Proper management of aspects related to informed consent, confidentiality, respect, and professional discretion must be ensured, as well as the control of health records and patient information, in accordance with current regulations. There must be management agreements with specific local health facilities. The person providing the telemedicine service must be a health professional who meets the requirements in these regulations and relevant standards.
- Law No. 172-13
Comprehensive protection of personal data stored in files, public registries, databases, or other technical means of data processing for generating reports, whether public or private (2013)
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine67
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Technological aspects of telemedicine29
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare9
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Core principles and human rights in telemedicine0
- No data to display
- No data to display
- Regulation No. 00005216-A on confidential information in the national health system
General framework of data protection
- Digital Ecuador Program
Highlights the importance of promoting infrastructure and connectivity actions in the health sector
- Regulation No. 0009-2017
Management of electronic health records
- Regulation No. 0098-2020
Content and requirements of medical prescriptions
- Regulation No. 00001190
Use of HL7 standards
- No data to display
- Regulation No. 00005216-A on confidential information in the national health system
Confidential information in the national health system, establishing patients’ right to access their data
- No data to display
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Regulatory aspects of telemedicine8
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Telemedicine governance0
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Personal data protection in telemedicine65
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Technological aspects of telemedicine21
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Role of health institutions and teams in telemedicine19
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Role of patients in telecare7
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Core principles and human rights in telemedicine0
- Technical guidelines for telehealth preventive programs in the context of the COVID-19 pandemic
The document provides definitions of telehealth and telemedicine. Telehealth: the incorporation of information and communication technologies into health systems, including medical, academic, administrative, and technical services, for the purpose of exchanging health information. Telemedicine: The provision of health care services, in cases where distance is a critical factor, by health professionals using information and communication technologies to exchange valid information for the diagnosis, prevention, and treatment of diseases; continuing education for health care professionals; and research and evaluation activities, with the aim of improving the health of individuals and their communities.
- Agenda Digital.pdf (innovacion.gob.sv)
Scientific and Technological Development Act: Promotes science development guidelines and key institutional and operational guidelines for the implementation of a National Innovation, Science, and Technology Policy
- Resolution No. 941
Technical regulation on the composition, custody, and querying of medical records
- Regulation on medicines, cosmetics, and hygiene products
There are no regulations on medical devices, but there are regulations on medicines, cosmetics, and hygiene products
- Decree No. 307
Patients' rights
- Report on a telehealth project
Report on a telehealth project ongoing since October 2010 and developed with the IDB
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Regulatory aspects of telemedicine0
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Telemedicine governance2
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Personal data protection in telemedicine12
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Technological aspects of telemedicine26
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare4
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Core principles and human rights in telemedicine0
- No data to display
- No data to display
- Guatemala's 2016-2032 Digital Nation Agenda
Digital Nation is the name chosen for Guatemala's digital agenda. The document lays out relevant ICT issues and addresses five lines of action aimed at furthering the population's economic and social development. Aligned with the 2016-2020 General Government Policy, the five lines of action are: education, health, security, development, and transparency.
- Ley General de Telecomunicaciones Decreto 94 – 96
Tiene por objeto establecer un marco legal para desarrollar actividades de telecomunicaciones y normar el aprovechamiento y la explotación del espectro radioeléctrico, con la finalidad de apoyar y promover el desarrollo eficiente de las telecomunicaciones, estimular las inversiones en el sector, fomentar la competencia entre los diferentes prestadores de servicios de telecomunicaciones; proteger los derechos de los usuarios y de las empresas proveedoras de servicios de telecomunicaciones, y apoyar el uso racional y eficiente del espectro radioeléctrico.
- Decree No. 57-2008, Access to Public Information Act
The decree guarantees the right to know and protect one’s personal data contained in government files. This decree means there is a legal vacuum in Guatemala regarding the processing of personal data by private parties and, therefore, regarding the right to data protection or the right to informational self-determination in all its dimensions, forms, and scope. It also provides definitions of personal data and classifies health data as sensitive. The regulatory authority that issues the Access to Public Information Act is the Human Rights Ombudsman.
- Constitution of Guatemala
Article 24: Inviolability of correspondence, documents, and books and Article 31: Access to state files and records
- Guatemalan Criminal Code
Decree No. 17-73, Articles 274D and 274F
- Decree No. 47-2008
Recognition of Electronic Communications and Signatures Act
- Regulations of the Recognition of Electronic Communications and Signatures Act
Amended by Resolution No. 262-2009
- Technical Regulation No. 37/2003
Issued by the Department of Regulation and Control of Pharmaceuticals and Related Products of the Ministry of Public Health and Social Assistance for the registration of medical devices
- No data to display
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Regulatory aspects of telemedicine0
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Telemedicine governance2
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Personal data protection in telemedicine6
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Technological aspects of telemedicine0
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare4
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Core principles and human rights in telemedicine0
- No data to display
- Guyana Cooperation Strategy
Focus Area No. 3 provides for the development of e-health and telemedicine
- e-Government Program
Managed by the National Data Management Authority (NDMA), the long-term objectives of Guyana’s e-Government Program are to provide all citizens with equitable digital access and transparent, accountable, responsive, and efficient governance.
- Access to information Act 2011
Guyana does not have a data privacy or protection law. However, it does have specific legislation for the financial sector.
- Law No. 21 of 2011, Access to Information Act of 2011
The Bank of Guyana oversees anti-money laundering activities and activities to combat the financing of terrorists. In addition, citizens have the right to access information held by or under the control of any public authority.
- Legislation authorizing medical devices
Food and Drugs Act, Chapter 34:03
- No data to display
- McMaster University and the Ministry of Public Health
McMaster University and the Ministry of Public Health partnered to launch a telemedicine project aimed at expanding telemedicine to four health facilities in Regions 2, 6, 7, and 10 in Guyana.
- Emergency Management Actions
There is no information on regulations adopted during the COVID-19 pandemic, but there is information on emergency management actions.
- Parliamentary bill to regulate electronic communications
There is no digital or electronic signature standard, but there is a parliamentary bill to regulate electronic communications
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine0
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Technological aspects of telemedicine0
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare0
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Core principles and human rights in telemedicine0
- No data to display
- No data to display
- No data to display
- No data to display
- No data to display
- No data to display
- No data to display
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine21
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Technological aspects of telemedicine14
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Role of health institutions and teams in telemedicine19
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Role of patients in telecare4
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Core principles and human rights in telemedicine0
- No data to display
- Transparency and Access to Public Information Act
Chapter V: Personal Data, Legislative Decree No. 170 – 2006
- Decree No. 149 of 2013
Electronic signatures
- Decree No. 33-2020, No. 35217 of April 3, 2020
Pandemic Amendment to Decree No. 33-2020, No. 35217 of April 3, 2020: Relief for the Productive Sector and Workers from the Effects of the COVID-19 Pandemic Act - Article 38
- Regulations for the Oversight of Health Products, Services, and Facilities
Defines medical devices and equipment as an instrument, apparatus, tool, machine, implant, or other similar or related item that is used by itself or in combination with any accessory or program needed for it to function property for prevention, treatment, rehabilitation, and research in the field of health.
- Employed Physicians Statutory Law
The Employed Physicians Statutory Law regulates the work and services of physicians and surgeons in Honduras. Its objectives are: a) To protect, enhance the status of, and train duly licensed physicians; b) To increase the efficiency of the work performed by physicians; c) To establish fair income and salary standards for employed physicians; d) To guarantee job stability for employed physicians; e) To regulate working hours, shifts, and mandatory breaks in order to ensure efficiency in the medical profession; f) To guarantee a fair distribution of their assignments; g) To guarantee adequate working conditions in accordance with the standards established between the Honduran Medical Board and employing institutions; and h) To ensure compliance with national and international agreements in order to promote sources of employment. It also establishes the requirements for practicing medicine, namely: Obtain a Doctor of Medicine degree issued or recognized by the National Autonomous University of Honduras, be registered with the Honduran Medical Board, not have any restrictions or disciplinary actions limiting professional practice, not be in arrears with the Honduran Medical Board, not have any infectious diseases, pass the licensing examination, and fulfill any other requirements established in the internal regulations of the employing entity. We note that there are no express provisions on telemedicine and/or practicing medicine using information and communication technologies.
- Code of Ethics of the Honduran Medical Board
Code of Ethics of the Honduran Medical Board: Among the Code's obligations, Article 14 regulates patient confidentiality, defining it as follows: “Patient confidentiality is understood as the act of protecting information that, as a result of the professional practice, the physician becomes aware of in the doctor-patient relationship and its context, either because the patient shared the information, or because the physician observed or deduced it. This information should not be shared except with the prior consent of the patient, because of potential harm to the patient or third parties." However, Article 15 of the Code states that physicians may disclose the information of patients under their care when "they are unable to evaluate and solve the problem by their own means, or when remaining silent may cause harm to the patient, third parties, or society.” With regard to the use of information systems, it establishes that “when medical informatics systems are used, they must not compromise patients’ right to privacy without their consent” (Article 18).
- Health Code
Establishes general regulations for the Honduran health system
- Health Code
Establishes general regulations for the Honduran health system
- Inter-Institutional Agreement Between CONATEL, SESAL, and UNAH 2018-2022
Establishes a framework of coordination and cooperation under the conditions established by the parties, working together to strengthen and increase the quality of public health in Honduras through the provision of internet service to the areas of interconnection of the Integrated Health Information System, telemedicine services, enhancement of the Virtual Health Library, deployment of internet service in public areas of common interest, and the joint development of projects through free internet connections.
- PAHO/WHO 2017-2021 Honduras Country Cooperation Strategy
The strategic guidelines of this document highlight the importance of updating legislation and regulations to ensure access to essential medicines and other health technologies that are effective, safe, and cost-efficient as a step toward universal health coverage
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine94
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Technological aspects of telemedicine0
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare13
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Core principles and human rights in telemedicine0
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- The Data Protection Act, 2021
General framework for personal data protection
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- The Data Protection Act, 2021
Establishes patients’ right to access their data
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Regulatory aspects of telemedicine14
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Telemedicine governance0
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Personal data protection in telemedicine63
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Technological aspects of telemedicine39
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Role of health institutions and teams in telemedicine19
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Role of patients in telecare15
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Core principles and human rights in telemedicine0
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- Law No. DOF 05-07-2010
Protection of personal data held by private-sector parties
- 2021-2024 National Digital Strategy
Establishes infrastructure and connectivity actions for the health sector
- NOM-024-SSA3-2010
Establishes the functional objectives and functionalities that the products of the Electronic Medical Files Systems should have, containing provisions relevant to electronic health records, electronic prescriptions, and the interoperability of systems
- Law No. DOF 11-01-2012
Electronic signatures
- Remote Medical Care Model
Establishes the need to create a specific registry for health teams providing this type of service, as well as the need to establish the rules of conduct governing the practice of telemedicine
- Law No. DOF 05-07-2010
Protection of personal data held by private-sector parties, establishing patients’ right to access their data
- Remote Medical Care Model
Grants patients a leading role in telemedicine services, giving them the right to autonomy and self-determination and defining the conditions for eligibility for virtual consultations and how those consultations will be carried out.
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine94
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Technological aspects of telemedicine9
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare7
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Core principles and human rights in telemedicine0
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- Regulation No. 064 for the registration of medical devices
The definition of medical device under this regulation is any instrument, apparatus, tool, machine, appliance, implant, material, or other similar or related item used alone or in combination with each other, including accessories and software necessary for its proper application as proposed by the manufacturer for use on human beings, 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.
- No. 177 Guide for Teleconsultation in the Context of COVID-19 (minsa.gob.ni)
The teleconsultation guide aims to provide clear and timely information to the population on aspects related to COVID-19. It does not address how care should be provided using ICTs.
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Regulatory aspects of telemedicine56
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Telemedicine governance32
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Personal data protection in telemedicine91
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Technological aspects of telemedicine58
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Role of health institutions and teams in telemedicine40
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Role of patients in telecare40
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Core principles and human rights in telemedicine20
- Law No. 81 on personal data protection, Article 4.11
Health data is classified as sensitive data The Telehealth Act addresses data quality and availability, Article 12 with implementing regulations in Executive Decree No. 285/2021
- Decree
Provides for the use of the electronic health record/clinical file - Article 46 ff.
- Electronic Prescriptions
Provided for in the amendment to the Medicines Act. Authorization of electronic prescriptions - Article 16 of Law No. 97/2019.
- Law No. 51
Electronic signatures (amended by Law No. 82 creating the Public Registry of Panama), with implementing regulations in Decree No. 684
- Law No. 90 of December 26, 2017
Law No. 90 of December 26, 2017 on medical devices and related products (amended by Law No. 92 of 2019)
- Law No. 4 of January 20, 1995
Amends Articles 485, 564, 577, and 578 of Law No. 3 of May 17, 1994 (which promulgates the Family Code)
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Regulatory aspects of telemedicine51
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Telemedicine governance26
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Personal data protection in telemedicine61
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Technological aspects of telemedicine20
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Role of health institutions and teams in telemedicine45
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Role of patients in telecare10
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Core principles and human rights in telemedicine15
- 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. 5482
Creates the National Telehealth Program, with implementing regulations in SG Resolution No. 367/2020
- 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)
- Health Code Law No. 836
Regulates the functions of the state in relation to comprehensive health care for its people and people's related rights and obligations
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Regulatory aspects of telemedicine67
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Telemedicine governance51
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Personal data protection in telemedicine92
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Technological aspects of telemedicine39
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Role of health institutions and teams in telemedicine45
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Role of patients in telecare43
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Core principles and human rights in telemedicine35
- Telemedicine Act No. 30421 of Peru
Peruvian Official Gazette, Telehealth Framework Act, Law No. 30421, Legislative Branch, Peruvian Congress
- Legislative Decree No. 1490
Expands the scope of telehealth
- Supreme Decree No. 005-2021-SA
Approves the implementing regulations for Law No. 30421
- Ministerial Resolution No. 1045-2020-MINSA
Scheduling health personnel shifts and assigning slots for telemedicine care services to health users in the context of the COVID-19 emergency (Emergency Decree No. 109/2020)
- Emergency Decree No. 109/2020, Article 6
Remote work assignments for telemedicine / 6.1 Emergency authorization for the Ministry of Health, through the General Directorate of Telehealth, Referrals, and Emergencies, to schedule shifts for health personnel and assign slots to patients requesting telemedicine services, which will be carried out through the platforms provided by the Ministry of Health
- Peruvian National Telehealth Plan 2020-2023
Ministerial Resolution No. 1010-2020-MINSA of December 9, 2020
- Emergency Decree No. 006-2020
Creates the National Digital Transformation System which includes, but is not limited to, the areas of digital government, digital economy, digital connectivity, digital education, digital technologies, digital innovation, digital services, digital society, digital citizenship and inclusion, digital trust, digital health, digital justice, digital talent, e-commerce, and all areas affecting the country’s digital transformation process, in accordance with the current legal framework
- Legislative Decree No. 1490
The decree expands the scope of telehealth by modifying the scope of the Telehealth Act and definitions, among other aspects.
- Personal Data Protection Act
Its implementing regulations are approved by Supreme Decree No. 003-2013-JUS and the Information Security Directive issued by the authority. Health data is classified as sensitive data - Article 2.5.
- Supreme Decree No. 003-2020-SA
Approves regulations establishing the rules of classification and essential principles of safety and performance of medical devices
- Ministerial Resolution No. 464/2019
Administrative directive authorizing the use of digital signatures in medical and health activities (approves Administrative Directive No. 266 on interoperability)
- Law No. 30024
Creation of the National Registry of Electronic Health Records
- Supreme Decree No. 009-2017-SA
The decree approves the implementing regulations for the law creating the National Registry of Electronic Health Records and establishes provisions for the implementation of and adequate compliance with Law No. 30024, which creates the National Registry of Electronic Health Records and its amendments
- Ministerial Resolution No. 1104-2018/MINSA
Creates the National Repository of Standardized Health Data Identifiers (RNIEDS) to serve as the single point for storing and managing the catalogs of the Standardized Health Data Identifiers mentioned in the standardization section
- Ministerial Resolution No. 464-2019/MINSA
Approves Administrative Directive No. 266-MINSA/2019/OGTI, which regulates the interoperability of health care information systems Establishes guidelines for interoperability in health care information systems to enable the exchange of information between the various actors in the health sector
- Ministerial Resolution No. 117-2020-MINSA
Directive for the implementation and development of synchronous and asynchronous telemedicine servers
- Supreme Decree No. 013-2020-SA
Measures to ensure the continuity of COVID-19 prevention, control, diagnosis, and treatment actions
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine0
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Technological aspects of telemedicine0
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare0
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Core principles and human rights in telemedicine0
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- Individual Medical Care Funding Bill
The bill proposes regulations related to the system for organizing and funding individual health care (Individual Medical Care Funding Act). The objective of the bill is to establish regulations for the implementation of Article 36 of the Suriname Constitution and the Public Health Framework Act and to overhaul the individual health care funding system.
- Public Health Framework Bill
The bill proposes general regulations for the health care system and public and individual health care. The objective of the bill is to establish new regulations for the health care system and public and individual health care in the context of health law reforms.
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Regulatory aspects of telemedicine0
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Telemedicine governance0
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Personal data protection in telemedicine58
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Technological aspects of telemedicine0
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Role of health institutions and teams in telemedicine16
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Role of patients in telecare7
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Core principles and human rights in telemedicine0
- No data to display
- No data to display
- Data Protection Acta 13, 2011
General regulatory framework for data protection
- No data to display
- No data to display
- Data Protection Acta 13, 2011
Establishes patients’ right to access their data
- No data to display
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Regulatory aspects of telemedicine40
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Telemedicine governance15
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Personal data protection in telemedicine91
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Technological aspects of telemedicine46
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Role of health institutions and teams in telemedicine28
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Role of patients in telecare27
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Core principles and human rights in telemedicine25
- Law No. 19869
General guidelines for the implementation and development of telemedicine
- Decree No. 134/21
Uruguay Digital Agenda 2015
- Law No. 18331
General framework for personal data protection
- Decreto N° 414/2009
Reglamentario de Ley N° 18.331.
- 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
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Regulatory aspects of telemedicine33
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Telemedicine governance0
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Personal data protection in telemedicine17
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Technological aspects of telemedicine8
-
Role of health institutions and teams in telemedicine24
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Role of patients in telecare13
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Core principles and human rights in telemedicine0
- Telehealth Act published in Official Gazette No. 6207
General framework for telemedicine services
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- Telehealth Act published in Official Gazette No. 6207
Contains provisions that specifically address personal data protection
- Decree No. 9051
Regulates access to and electronic exchange of data, information, and documents between government bodies and entities.
- Decree No. 9051
Establishes provisions on electronic signatures as well as standards for the interoperability of the systems
- Telehealth Act published in Official Gazette No. 6207
Since it regulates the provision of telemedicine services, this law can be considered an enabling regulation
- Telehealth Act published in Official Gazette No. 6207
The general guidelines recognize patients’ rights and obligations in relation to telemedicine services
- Decree No. 9051
Establishes patients’ right to access their data
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