RESUMO
This final rule replaces the Statewide and Tribal Automated Child Welfare Information Systems (S/TACWIS) rule with the Comprehensive Child Welfare Information System (CCWIS) rule. The rule also makes conforming amendments in rules in related requirements. This rule will assist title IV-E agencies in developing information management systems that leverage new innovations and technology in order to better serve children and families. More specifically, this final rule supports the use of cost-effective, innovative technologies to automate the collection of high-quality case management data and to promote its analysis, distribution, and use by workers, supervisors, administrators, researchers, and policy makers.
Assuntos
Administração de Caso/organização & administração , Serviços de Proteção Infantil/organização & administração , Proteção da Criança/legislação & jurisprudência , Processamento Eletrônico de Dados/organização & administração , Gestão da Informação/organização & administração , Sistemas de Informação/organização & administração , Administração de Caso/legislação & jurisprudência , Criança , Processamento Eletrônico de Dados/legislação & jurisprudência , Humanos , Sistemas de Informação/legislação & jurisprudência , Estados UnidosAssuntos
Confidencialidade/legislação & jurisprudência , Health Insurance Portability and Accountability Act , Sistemas de Informação/legislação & jurisprudência , Internet/legislação & jurisprudência , Aplicativos Móveis/legislação & jurisprudência , Cirurgia Plástica/legislação & jurisprudência , HumanosAssuntos
Confidencialidade/legislação & jurisprudência , Health Insurance Portability and Accountability Act , Sistemas de Informação/legislação & jurisprudência , Internet/legislação & jurisprudência , Aplicativos Móveis/legislação & jurisprudência , Cirurgia Plástica/legislação & jurisprudência , HumanosRESUMO
The Drug Enforcement Administration is updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.
Assuntos
Comércio/legislação & jurisprudência , Substâncias Controladas , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Desvio de Medicamentos sob Prescrição/legislação & jurisprudência , Cápsulas , Composição de Medicamentos/instrumentação , Rotulagem de Medicamentos/legislação & jurisprudência , Embalagem de Medicamentos/legislação & jurisprudência , Processamento Eletrônico de Dados/legislação & jurisprudência , Efedrina , Humanos , Hidroxibutiratos , Sistemas de Informação/legislação & jurisprudência , Fenilpropanolamina , Projetos Piloto , Desvio de Medicamentos sob Prescrição/prevenção & controle , Pseudoefedrina , Comprimidos , Estados UnidosAssuntos
Sistemas de Informação/legislação & jurisprudência , Saúde Mental , Segurança Computacional/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência , Health Insurance Portability and Accountability Act , Política de Saúde , Humanos , Internet , Aplicativos Móveis , Estados Unidos , United States Federal Trade Commission/organização & administração , United States Food and Drug Administration/organização & administraçãoRESUMO
The development of software supporting inter-disciplinary systems like the type 2 diabetes mellitus care requires the deployment of methodologies designed for this type of interoperability. The GCM framework allows the architectural description of such systems and the development of software solutions based on it. A first step of the GCM methodology is the definition of a generic architecture, followed by its specialization for specific use cases. This paper describes the specialization of the generic architecture of a system, supporting Type 2 diabetes mellitus glycemic control, for a pharmacotherapy use case. It focuses on the behavioral aspect of the system, i.e. the policy domain and the definition of the rules governing the system. The design of this architecture reflects the inter-disciplinary feature of the methodology. Finally, the resulting architecture allows building adaptive, intelligent and complete systems.
Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Gerenciamento Clínico , Sistemas de Informação/organização & administração , Design de Software , Automonitorização da Glicemia , Confidencialidade/legislação & jurisprudência , Diabetes Mellitus Tipo 2/sangue , Humanos , Sistemas de Informação/legislação & jurisprudência , Políticas , Integração de SistemasRESUMO
Photography and electronic media are indispensable tools for dental education and clinical practice. Although previous research has focused on privacy issues and general strategies to protect patient privacy when sharing clinical photographs for educational purposes, there are no published recommendations for developing a functional, privacy-compliant institutional framework for the capture, storage, transfer, and use of clinical photographs and other electronic media. The aims of this study were to research patient rights relating to electronic media and propose a framework for the use of patient media in education and clinical care. After a review of the relevant literature and consultation with the University of Washington's director of privacy and compliance and assistant attorney general, the researchers developed a privacy-compliant framework to ensure appropriate capture, storage, transfer, and use of clinical photography and electronic media. A four-part framework was created to guide the use of patient media that reflects considerations of patient autonomy and privacy, informed consent, capture and storage of media, and its transfer, use, and display. The best practices proposed for capture, storage, transfer, and use of clinical photographs and electronic media adhere to the health care code of ethics (based on patient autonomy, nonmaleficence, beneficence, justice, and veracity), which is most effectively upheld by a practical framework designed to protect patients and limit institutional liability. Educators have the opportunity and duty to convey these principles to students who will become the next generation of dentists, researchers, and educators.
Assuntos
Assistência Odontológica/ética , Educação em Odontologia/ética , Fotografia Dentária/ética , Materiais de Ensino , Telecomunicações/ética , Beneficência , Segurança Computacional/ética , Segurança Computacional/legislação & jurisprudência , Confidencialidade/ética , Confidencialidade/legislação & jurisprudência , Assistência Odontológica/legislação & jurisprudência , Educação em Odontologia/legislação & jurisprudência , Humanos , Armazenamento e Recuperação da Informação/ética , Armazenamento e Recuperação da Informação/legislação & jurisprudência , Sistemas de Informação/ética , Sistemas de Informação/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Responsabilidade Legal , Multimídia/ética , Multimídia/legislação & jurisprudência , Direitos do Paciente/ética , Direitos do Paciente/legislação & jurisprudência , Autonomia Pessoal , Justiça Social/ética , Justiça Social/legislação & jurisprudência , Telecomunicações/legislação & jurisprudência , Revelação da Verdade/éticaAssuntos
Confidencialidade/legislação & jurisprudência , Health Insurance Portability and Accountability Act , Sistemas de Informação/legislação & jurisprudência , Internet/legislação & jurisprudência , Aplicativos Móveis/legislação & jurisprudência , Cirurgia Plástica/legislação & jurisprudência , Humanos , Estados UnidosRESUMO
This article reports on a study of laws, regulations, and policies governing Immunization Information Systems (IIS, also known as "immunization registries") in states and selected urban areas of the United States. The study included a search of relevant statutes, administrative codes and published attorney general opinions/findings, an online questionnaire completed by immunization program managers and/or their staff, and follow-up telephone interviews.The legal/regulatory framework for IIS has changed considerably since 2000, largely in ways that improve IIS' ability to perform their public health functions while continuing to maintain strict confidentiality and privacy controls. Nevertheless, the exchange of immunization data and other health information between care providers and public health and between entities in different jurisdictions remains difficult due in part to ongoing regulatory diversity.To continue to be leaders in health information exchange and facilitate immunization of children and adults, IIS will need to address the challenges presented by the interplay of federal and state legislation, regulations, and policies and continue to move toward standardized data collection and sharing necessary for interoperable systems.
Assuntos
Política de Saúde/tendências , Programas de Imunização/tendências , Sistemas de Informação/legislação & jurisprudência , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Humanos , Programas de Imunização/estatística & dados numéricos , Lactente , Recém-Nascido , Pessoa de Meia-Idade , Sistema de Registros/estatística & dados numéricos , Inquéritos e Questionários , Estados Unidos , Vacinação/estatística & dados numéricosRESUMO
OBJECTIVES: We reviewed the complexities of school-related immunization policies, their relation to immunization information systems (IIS) and immunization registries, and the historical context to better understand this convoluted policy system. METHODS: We used legal databases (Lexis-Nexis and Westlaw) to identify school immunization records policies for 50 states, 5 cities, and the District of Columbia (Centers for Disease Control and Prevention "grantees"). The original search took place from May to September 2010 (cross-referenced in July 2013 with the list on http://www.immunize.org/laws ). We describe the requirements, agreement with IIS policies, and penalties for policy violations. RESULTS: We found a complex web of public health, medical, and education-directed policies, which complicates immunization data sharing. Most (79%) require records of immunizations for children to attend school or for a child-care institution licensure, but only a few (11%) require coordination between IIS and schools or child-care facilities. CONCLUSIONS: To realize the full benefit of IIS investment, including improved immunization and school health program efficiencies, IIS and school immunization records policies must be better coordinated. States with well-integrated policies may serve as models for effective harmonization.
Assuntos
Política de Saúde , Sistemas de Informação/organização & administração , Instituições Acadêmicas/legislação & jurisprudência , Vacinação/legislação & jurisprudência , Criança , Cuidado da Criança/legislação & jurisprudência , Pré-Escolar , Humanos , Lactente , Sistemas de Informação/legislação & jurisprudência , Sistema de Registros , Estados UnidosAssuntos
Atenção à Saúde/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Regulamentação Governamental , Política , Centers for Medicare and Medicaid Services, U.S./legislação & jurisprudência , Connecticut , Health Insurance Portability and Accountability Act/legislação & jurisprudência , Humanos , Sistemas de Informação/legislação & jurisprudência , Patient Protection and Affordable Care Act/legislação & jurisprudência , Estados UnidosRESUMO
Electronic health records and electronic health information exchange are essential to improving quality of care, reducing medical errors and health disparities, and advancing the delivery of patient-centered medical care. In the US correctional setting, these goals are critical because of the high numbers of Americans affected, yet the use of health information technology is quite limited. In this article, I describe the legal environment surrounding health information sharing in corrections by focusing on 2 key federal privacy laws: the Health Insurance Portability and Accountability Act of 1996 and the federal Confidentiality of Alcohol and Drug Abuse Patient Records laws. In addition, I review stakeholder concerns and describe possible ways forward that enable electronic exchange while ensuring protection of inmate information and legal compliance.
Assuntos
Confidencialidade , Registros Eletrônicos de Saúde/organização & administração , Health Insurance Portability and Accountability Act/organização & administração , Sistemas de Informação/organização & administração , Prisões/organização & administração , Segurança Computacional/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Health Insurance Portability and Accountability Act/legislação & jurisprudência , Humanos , Sistemas de Informação/legislação & jurisprudência , Prisões/legislação & jurisprudência , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Estados UnidosRESUMO
In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.
Assuntos
Equipamentos e Provisões , Sistemas de Informação/organização & administração , Segurança do Paciente/normas , Gestão da Segurança/organização & administração , Comunicação , Desenho de Equipamento , Falha de Equipamento , Regulamentação Governamental , Humanos , Sistemas de Informação/legislação & jurisprudência , Sistemas de Informação/normas , Segurança do Paciente/legislação & jurisprudência , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Medição de Risco , Gestão da Segurança/legislação & jurisprudênciaRESUMO
Data from electronic medical records can be used in describing clinical problems not covered by traditional clinical databases or traditional quality assurance systems. In this article three main barriers for the use of these data are identified: system knowledge, legislation and technical barriers. Legislative deregulation and implementation of strategic initiatives to further the use of the data is suggested.
Assuntos
Bases de Dados Factuais , Sistemas de Informação , Bases de Dados Factuais/legislação & jurisprudência , Bases de Dados Factuais/normas , Dinamarca , Humanos , Sistemas de Informação/legislação & jurisprudência , Sistemas de Informação/normas , Sistemas Computadorizados de Registros Médicos/legislação & jurisprudência , Sistemas Computadorizados de Registros Médicos/normas , Garantia da Qualidade dos Cuidados de Saúde , Sistema de Registros/normasRESUMO
Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this article. This article analyses firstly the short-term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonized medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g., the way in which hospitals are organized in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper will finally analyse also how health monitoring projects may change the traditional (non-) relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require to new legal rules.
Assuntos
Confidencialidade/legislação & jurisprudência , Sistemas de Informação/legislação & jurisprudência , Telemedicina/legislação & jurisprudência , Europa (Continente) , Humanos , Sistemas Computadorizados de Registros Médicos/legislação & jurisprudênciaRESUMO
CONTEXT: Immunization Information Systems (IIS), or registries, were developed to improve effectiveness and efficiency in immunization services. Complex laws that govern IIS and immunization records are developed at the state-level, interact with each other, and may impact utility for all immunization stakeholders. As states develop Health Information Exchange laws they may also interact with IIS laws. OBJECTIVES: To provide immunization stakeholders an overview of the laws applicable to healthcare providers and health departments. Comparisons are provided to illustrate the trends since the previous studies. METHODS: IIS relevant statutes, regulations and ordinances of jurisdictions (states, large cities) of 56 "Grantees" receiving funding under the 317b Public Health Service Act were identified via legal databases then systematically reviewed for authorization, reporting and consent requirements. Key provisions were coded and mapped according to 131 variables. RESULTS: Including subsections, 984 laws across Grantees relate to immunization records, falling under many administrative sections of state and city government. Most Grantees have more than one law that addresses immunization records reporting, exchange and privacy protections. Not all of these laws are in alignment, but there is a trend toward increased Grantee IIS authorizing laws, mandated reporting and implied consent provisions. Of the 56 Grantees, 37 (66%) had IIS authorizing laws, and 46 (82%) had laws addressing healthcare provider and vital statistics reporting. However, much variation remains, even within the provisions of these laws. The coding instrument received 93.7% agreement and a K-α of 0.791. CONCLUSIONS: The trend toward laws that encourage participation should continue to improve functionality and value, but inconsistencies among laws should be addressed, both across jurisdictions within states and between different states. They may impair the value of the information that is collected. Greater uniformity could improve the overall usefulness of IIS.
Assuntos
Programas de Imunização/legislação & jurisprudência , Programas de Imunização/normas , Sistemas de Informação/legislação & jurisprudência , Vacinação/legislação & jurisprudência , Vacinação/normas , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Programas de Imunização/estatística & dados numéricos , Lactente , Recém-Nascido , Sistemas de Informação/tendências , Masculino , Estados Unidos , Vacinação/estatística & dados numéricosAssuntos
Humanos , Masculino , Feminino , Educação de Pacientes como Assunto/métodos , Educação de Pacientes como Assunto/tendências , Direitos do Paciente/ética , Direitos do Paciente/normas , Assistência ao Paciente/métodos , Assistência ao Paciente , Neoplasias Pancreáticas/epidemiologia , Confidencialidade/ética , Confidencialidade/tendências , Serviços de Informação/organização & administração , Serviços de Informação , Sistemas de Informação/legislação & jurisprudência , Sistemas de InformaçãoRESUMO
In 2010, the Centers for Medicare and Medicaid Services (CMS) published its final rule describing plans for incentivizing eligible professionals (EPs) and eligible hospitals to become meaningful users of electronic health record (EHR) technology using funds provided by the Health Information Technology for Economic and Clinical Health (HITECH) Act. Beginning in 2011, non-hospital-based EPs can earn monetary benefits for meeting meaningful use criteria through implementation of certified EHR technology. Most anesthesiologists qualify as non-hospital-based EPs under CMS' new hospital-based definition. The authors distill CMS' final rule into its most basic facts and requirements and explain the implications for US anesthesiologists.
Assuntos
Sistemas de Informação/economia , Anestesiologia/tendências , Centers for Medicare and Medicaid Services, U.S. , Hospitais , Humanos , Sistemas de Informação/legislação & jurisprudência , Medicare , Planos de Incentivos Médicos , Reembolso de Incentivo/economia , Resultado do Tratamento , Estados UnidosRESUMO
If provider organizations are serious about improving quality and efficiency, they must advance their electronic health record capabilities far beyond just meeting the U.S. federal regulations.