Pactuação da minuta de Portaria CPF na 6ª Reunião Ordinária CIT - 27/08/2020

Regulamenta o uso do Cadastro de Pessoas Físicas - CPF como instrumento suficiente e substitutivo para a identificação de indivíduos nos registros de saúde.

Medicine, Machines, and Medical Education.

While advances in science and technology continue to be at the forefront of the evolution of medical practice, the 21st century is also undergoing a unique and profound cultural shift that is changing the very nature of what it means to be a medical professional, namely humankind's transition to an information-based internet society. Medical care will increasingly depend on computer-generated probabilities guided and supported by a growing variety of individuals in health care-related professions, including statisticians, technologists, and information managers. Perhaps the biggest challenge to the profession will come from the erosion of professional autonomy, driven by smart machines, social networks, and internet search engines. As a result of these and other changes, physicians are facing a systematic loss of control, often without the direct input and leadership of the profession itself. In this commentary, the author urges the profession to adopt several strategies, including shifting its focus from reimbursement to the care patients value most, meaningfully addressing critical issues in health policy, becoming the definitive source for publicly available medical information, reimagining medical education, and overhauling the existing accreditation and licensing systems. Medical education must go beyond a focus on physicians whose professional identity revolves around being the exclusive source of medical knowledge. In the digitized 21st century, medical education should emphasize the centrality of the humanistic interface with patients such that the doctor-patient relationship is paramount in the complex medical world of machines and social media. Removing the roadblocks to successful professional reform is no small task, but the process can begin with a grassroots movement that empowers physicians and facilitates organizational and behavioral change. Failure to take action may well hasten the diminishment of patient care and the profession's trusted role in society.

HITECH to 21st century cures: clinician burden and evolving health IT policy.

Adoption and use of health information technology (IT) was identified as 1 solution to quality and safety issues that permeate the United States health care system. Implementation of health IT has accelerated across the US over the past decade, in part, as a result of legislative and regulatory requirements and incentives. However, adoption of these systems has burdened clinician users due to design, configuration, and implementation issues, resulting in poor usability, challenges to workflow integration, and cumbersome documentation requirements. The path to alleviating these clinician burdens requires a clear understanding of the intent and evolution of pertinent regulations and the context in which they exist. This article reviews the Office of the National Coordinator of Health Information Technology's efforts, documents current regulatory actions, and discusses additional policy opportunities that can further improve clinician satisfaction and effectiveness in providing health care with health IT that is an asset, not an obstacle.

Protection of digital health information: Examining guidance from the physician regulatory colleges in Canada.

BACKGROUND: The use of information and communication technology (ICT) has tremendous potential to enhance communication among physicians, leading to improvements in service delivery. However, the protection of health information in digital/electronic format is an ongoing concern. OBJECTIVE: The purpose of this study was to examine guidance for the protection of health information when using ICT from all 10 of Canada's provincial regulatory colleges for physicians and to discuss the potential policy and service delivery implications. METHOD: A search of the regulatory college websites was conducted, followed by a document analysis (content and thematic). RESULTS: The college website search identified 522 documents; 12 of these documents (from 8 of the 10 colleges) met the study criteria. These documents were notable for the considerable variation in the scope and detail of guidance provided across the colleges. CONCLUSION: While the federal-provincial division of powers in Canada enables different jurisdictional approaches to health service delivery and, thus, opportunities for policy learning, this governing structure may also contribute to a lack of incentive for collaboration, leading to an absence of standardised guidance for health information protection when using ICT. This, in turn, may result in unequal and inequitable protection of health information across the provinces. Therefore, a macro-level approach to policy development in this area may hold the greatest promise for enhancing the protection of health information and doing so in a more standardised manner in countries with federal systems of governance.

REVISITING HEALTH INFORMATION TECHNOLOGY ETHICAL, LEGAL, and SOCIAL ISSUES and EVALUATION: TELEHEALTH/TELEMEDICINE and COVID-19.

BACKGROUND: Information technologies have been vital during the COVID-19 pandemic. Telehealth and telemedicine services, especially, fulfilled their promise by allowing patients to receive advice and care at a distance, making it safer for all concerned. Over the preceding years, professional societies, governments, and scholars examined ethical, legal, and social issues (ELSI) related to telemedicine and telehealth. Primary concerns evident from reviewing this literature have been quality of care, access, consent, and privacy. OBJECTIVES: To identify and summarize ethical, legal, and social issues related to information technology in healthcare, as exemplified by telehealth and telemedicine. To expand on prior analyses and address gaps illuminated by the COVID-19 experience. To propose future research directions. METHODS: Literature was identified through searches, forward and backward citation chaining, and the author's knowledge of scholars and works in the area. EU and professional organizations' guidelines, and nineteen scholarly papers were examined and categories created to identify ethical, legal, and social issues they addressed. A synthesis matrix was developed to categorize issues addressed by each source. RESULTS: A synthesis matrix was developed and issues categorized as: quality of care, consent and autonomy, access to care and technology, legal and regulatory, clinician responsibilities, patient responsibilities, changed relationships, commercialization, policy, information needs, and evaluation, with subcategories that fleshed out each category. The literature primarily addressed quality of care, access, consent, and privacy. Other identified considerations were little discussed. These and newer concerns include: usability, tailoring services to each patient, curriculum and training, implementation, commercialization, and licensing and liability. The need for interoperability, data availability, cybersecurity, and informatics infrastructure also is more apparent. These issues are applicable to other information technologies in healthcare. CONCLUSIONS: Clinicians and organizations need updated guidelines for ethical use of telemedicine and telehealth care, and decision- and policy-makers need evidence to inform decisions. The variety of newly implemented telemedicine services is an on-going natural experiment presenting an unparalleled opportunity to develop an evidence-based way forward. The paper recommends evaluation using an applied ethics, context-sensitive approach that explores interactions among multiple factors and considerations. It suggests evaluation questions to investigate ethical, social, and legal issues through multi-method, sociotechnical, interpretive and ethnographic, and interactionist evaluation approaches. Such evaluation can help telehealth, and other information technologies, be integrated into healthcare ethically and effectively.

Infracciones de la Ley Orgánica de Protección de Datos en el ámbito sanitario. Descripción estadística de las infracciones / Infringements of the Organic Data Protection Law in the health area. Statistical description of the infringements / Infraccions de la Llei orgànica de Protecció de Dades en l'àmbit sanitari. Descripció estadística de les infraccions

La Ley Orgánica de Protección de Datos (LOPD) es necesaria para garantizar el derecho a la intimidad reconocido en la Constitución Española. La gestión de los datos personales debe ser especialmente sensible en el ámbito sanitario por las características de los protegidos. Este trabajo revisa las resoluciones dictadas desde el 28 de octubre de 2005 hasta el 29 de octubre de 2018 por la Agencia Española de Protección de Datos (AEPD), agrupando las infracciones por frecuencia de infracción y describiendo las peculiaridades de algunas resoluciones. En la medida de la información aportada por la denuncia, se trata de valorar la intención de la misma

The Organic Law on Data Protection (LOPD) is necessary to guarantee the right to privacy recognized in the Spanish Constitution. The management of personal data must be especially sensitive in the health field due to the characteristics of the protected persons. This paper reviews the resolutions issued from October 28 2005 to October 29 2018 by the Spanish Agency for Data Protection (AEPD), grouping the infractions by frequency of infringement and describing the peculiarities of some resolutions. To the extent of the information provided by the complaint, the aim is to assess its intention

La Llei Orgànica de Protecció de Dades (LOPD) és necessària per a garantir el dret a la intimitat reconegut en la Constitució Espanyola. La gestió de les dades personals ha de ser especialment sensible en l'àmbit sanitari per les característiques dels protegits. Aquest treball revisa les resolucions dictades des del 28 d'octubre de 2005 fins al 29 d'octubre de 2018 per l'Agència Espanyola de Protecció de Dades (AEPD), agrupant les infraccions per freqüència d'infracció I descrivint les peculiaritats d'algunes resolucions. En la mesura de la informació aportada per la denúncia, es tracta de valorar la intenció d'aquesta

[The responsibilities arising from the use of information and communication technologies in health professional practice]. / Las responsabilidades derivadas del uso de las tecnologías de la información y comunicación en el ejercicio de las profesiones sanitarias.

The increasing use of Information and Communication Technologies (ICT) in the health setting has given rise to the current phenomenon of eHealth or eMedicine, terms equivalent to the cyberspace concept, but refer exclusively to health. Due to the appearance of Web 2.0 it can be stated that we are dealing with a phenomenon much greater than just using the technologies: we are facing a real social change, giving rise to that called Health 2.0. The legal regulation of this cyberspace requires two different types of rules. Some that regulate cyberspace itself, and others, the actions performed with its use and to those that appear applicable to conventional law. In this latter case, we are referring to the applying of already existing laws to actions performed using ICT, as is the case of medical actions. Within these latter situations, two clearly different ones have to be distinguished: the professional responsibilities arising from medical actions carried out within health organisation settings when the use of ICT is introduced, and those other actions carried out voluntarily, individually and privately, using personal media and devices. It is in these types of actions where the legality, as regards data protection and privacy of the patient, appears to be violated, and at the same time the professional may be held responsible.

Privacy and Policy Implications for Big Data and Health Information Technology for Patients: A Historical and Legal Analysis.

The consideration of privacy and policy implications for big data is essential to designing patient-centered health technology. A literature review demonstrated a significant gap to moving forward with information technology in healthcare. Ovid Medline and Google Scholar were searched to identify papers related to health technology, patient outcomes, and policy implications of Big Data. The findings of this research showed that despite a robust legal framework and clear outline of the legislation, there exists an innovative opportunity for health technologies to evolve and become patient-centered by integrating privacy and policy knowledge in health information technology. This historical legal analysis is valuable to health system leaders, decision-makers, health technology companies that are creating innovative platforms, and clinicians in both Canada and the United States.

Fourth Amendment Protections of Health Information After Carpenter v. United States: The Devil's In The Database.

Every day, companies collect health information from customers and analyze it for commercial purposes. This poses a significant threat to privacy, particularly as the Fourth Amendment protection of this deeply personal information is limited. Generally, law enforcement officers do not need probable cause and a warrant to access these private health information databases; only a subpoena is required, and sometimes nothing at all. The Fourth Amendment protections for health information may, however, have changed after the Supreme Court's 2018 decision in Carpenter v. United States, which held that the Fourth Amendment protects people from warrantless searches of historical cell-site location information possessed by their cell phone providers. The Court explained that, because of the nature of historical cell-site location information, individuals retain a reasonable expectation of privacy despite the information being in the possession of a third party. In reaching its holding, the Supreme Court considered the type of data, the uniqueness of cell-site location information, the impact of technological advancement on privacy, the voluntariness of the disclosure, and the property rights associated with the records. Many of these factors could support heightened Fourth Amendment protection for health information. This Article argues that Carpenter v. United States provides additional protections for future searches of health information in private databases.

The 21st Century Cures Act and electronic health records one year later: will patients see the benefits?

While federal regulation provides patients the right to access their electronic health records and promotes increased use of health information technology, patient access to electronic health records remains limited. The 21st Century Cures Act, signed into law over a year ago, has important provisions that could significantly improve access and availability of health data. Specifically, the provisions call for partnerships among health information exchange networks, educational and research initiatives, and health information technology certification requirements that encourage interoperability. The article reviews the potential benefits and concerns regarding implementation of these provisions, particularly the difficulty of aligning incentives and requirements for data sharing and the question of whether currently proposed rules and guidance will support the goal of improved patient access and health information exchange. Researchers, clinicians, and patients have the power to advocate for improved patient access and interoperability as policy development and implementation of the 21st Century Cures Act continues.

Public Policy and Health Informatics.

OBJECTIVES: To provide an overview of the history of electronic health policy and identify significant laws that influence health informatics. DATA SOURCES: US Department of Health and Human Services. CONCLUSION: The development of health information technology has influenced the process for delivering health care. Public policy and regulations are an important part of health informatics and establish the structure of electronic health systems. Regulatory bodies of the government initiate policies to ease the execution of electronic health record implementation. These same bureaucratic entities regulate the system to protect the rights of the patients and providers. IMPLICATIONS FOR NURSING PRACTICE: Nurses should have an overall understanding of the system behind health informatics and be able to advocate for change. Nurses can utilize this information to optimize the use of health informatics and campaign for safe, effective, and efficient health information technology.

History of Romanian Medical Informatics: Learning from the Past to Reshape the Future.

OBJECTIVES: The paper presents a review of the history of medical informatics in Romania, starting from the pioneering works, relating the present, and foreseeing the future. METHODS: Major milestones of the development of this field have not been simply enumerated, but described within the specific socio-political frame, grasping the entire context over the last four decades in Romania. Two main perspectives have been traced: education and training in medical informatics and implementations in healthcare. RESULTS: Four distinctive historical periods are identified and the major events of each period are described in a critical manner. The history of the Romanian Society of Medical Informatics is presented in a separate chapter. The last section is dedicated to the present state of the field in Romania. CONCLUSION: The history of Romanian Medical Informatics spans many years and is rich in content. The Romanian Society of Medical Informatics is mainly the result of the efforts undertaken by an enthusiastic and sound professional community, trying to continue the tradition, to achieve new goals, and to work as an active member of the international biomedical/health informatics community.

Falling short: how state laws can address health information exchange barriers and enablers.

Objective: Research on the implementation of health information exchange (HIE) organizations has identified both positive and negative effects of laws relating to governance, incentives, mandates, sustainability, stakeholder participation, patient engagement, privacy, confidentiality, and security. We fill a substantial research gap by describing whether comprehensive state and territorial HIE legal frameworks address identified legal facilitators and barriers. Materials and Methods: We used the Westlaw database to identify state and territorial laws relating to HIEs in effect on June 7, 2016 (53 jurisdictions). We blind-coded all laws and addressed coding discrepancies in peer-review meetings. We recorded a consensus code for each law in a master database. We compared 20 HIE legal attributes with identified barriers to and enablers of HIE activity in the literature. Results: Forty-two states, the District of Columbia, and 2 territories have laws relating to HIEs. On average, jurisdictions address 8.32 of the 20 criteria selected in statutes and regulations. Twenty jurisdictions unambiguously address ≤5 criteria in statutes and regulations. None of the significant legal criteria are unambiguously addressed in >60% of the 53 jurisdictions. Discussion: Laws can be barriers to or enablers of HIEs. However, jurisdictions are not addressing many significant issues identified by researchers. Consequently, there is a substantial risk that existing legal frameworks are not adequately supporting HIEs. Conclusion: The current evidence base is insufficient for comparative assessments or impact rankings of the various factors. However, the detailed Centers for Disease Control and Prevention dataset of HIE laws could enable investigations into the types of laws that promote or impede HIEs.