ABC | Volume 113, Nº5, November 2019

Guidelines Guideline of the Brazilian Society of Cardiology on Telemedicine in Cardiology – 2019 Arq Bras Cardiol. 2019; 113(5):1006-1056 1. Fundamentals of Telemedicine: Concepts, Bioethical Aspects, Legislation and Regulation, Applicability in Brazil, and Artificial Intelligence 1.1. Fundamentals of Telemedicine In May 2005, Ministers of Health from 192 countries members of the World Health Organization (WHO) approved the Resolution on eHealth, 12 which recognized for the first time the importance of information and communication technologies (ICTs) applied to health – digital health or eHealth – “reinforcing the fundamental human rights by increasing and improving equity, solidarity, quality of life, and quality of care.” The Brazilian Ministry of Health defines the following areas of telehealth application: 13 Innovation in digital health and telehealth Innovation in digital health is transversal to telehealth initiatives and seeks to explore via ICT new ideas to solve chronic problems with difficult solutions by usual methods. It must start with the population’s health care needs. Teleconsulting Registered consultation between health care workers, professionals, andmanagers using two-way telecommunication instruments in order to answer questions about clinical procedures, health care actions, and suggestions related to the work process in health care. Teleconsulting can occur in real time or by offline messaging. Telediagnosis Autonomous service using ICT to deliver diagnostic support services ( e.g., remote evaluation of diagnostic tests) to facilitate access to specialized services. The use of telediagnosis seeks to reduce the time to diagnosis by enabling treatment for predictable complications through early diagnosis. Telemonitoring Remote monitoring of patients’ health and/or disease parameters through ICT. Monitoring may include clinical data collection, transmission, processing, and management by a health care professional using an electronic system. Teleregulation Set of actions in regulatory systems for evaluation of adequate responses to existing demands, promoting equity and access to services, and enabling health care access. Teleregulation also includes the evaluation and planning of actions to provide regulatory operational intelligence to management teams. The objective of teleregulation is to potentiate primary health care services, thus enabling the qualification and reduction of wait for specialized care. Tele-education Availability of interactive educational materials on health- related topics delivered remotely through ICT and focused on professional education across activity areas. 1.2. Types of Intervention in Telehealth Synchronous video conference: modality of remote interaction via live conference between primary care and medical specialty services. Asynchronous video conference (“store and forward”): use of a storage system to forward diagnostic images, vital signs, and/or video clips along with patients’ data for later review by a specialist. Provides diagnostic and treatment support for the primary care system. Remote monitoring: use of equipment to remotely collect and forward patients’ data to a hospital or monitoring center for interpretation. These (wearable) devices monitor remotely a variety of indicators ranging from specific vital signs (heart rate, blood pressure [BP], and blood glucose) to other indicators. Mobile health (mHealth): defined as a medical and public health care practice supported by mobile devices like cell phones, monitoring devices, personal digital assistants (PDAs), and other wireless devices. 14 The goals of telemedicine include: • Remote assistance: teleconsultation, telediagnosis or diagnostic telemonitoring, remote patient monitoring and/ or treatment; • Administrative management of patient care: request of diagnostic tests, medical prescriptions, and actions related to service reimbursement; • Remote qualification of human resources to facilitate continuing education programs; • Network collaborative clinical research: use of ICT to share and disseminate best practices and generate knowledge. 1.3. Safe Bases for Data Transmission Information safety is fundamental for data transmission, and two immediate effects must be considered: a) understanding of the critical value of data storage and use, and b) possible implications for individuals and organizations of violating safety and compliance standards. The European General Data Protection Regulation (GDPR) and the Brazilian General Data Protection Act ( Lei Geral de Proteção de Dados , LGPD) impose heavy fines and sanctions for improper access to information under their custody. The following sections list the main requirements for establishing appropriate safety policies. 15 1.4. Data Protection and Confidentiality For proper information protection, the safety of the systems must be ensured, reducing vulnerabilities and preventing improper access and breach of confidentiality. Authorizations and hierarchical levels for access to information must be clearly determined. 16 1014