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2.
BMC Med Inform Decis Mak ; 19(1): 254, 2019 12 04.
Artigo em Inglês | MEDLINE | ID: mdl-31801545

RESUMO

BACKGROUND: This study explored the possible antecedents that will motivate hospital employees' compliance with privacy policy related to electronic medical records (EMR) from a deterrence perspective. Further, we also investigated the moderating effect of computer monitoring on relationships among the antecedents and the level of hospital employees' compliance intention. METHODS: Data was collected from a large Taiwanese medical center using survey methodology. A total of 303 responses was analyzed via hierarchical regression analysis. RESULTS: The results revealed that sanction severity and sanction certainty significantly predict hospital employees' compliance intention, respectively. Further, our study found external computer monitoring significantly moderates the relationship between sanction certainty and compliance intention. CONCLUSIONS: Based on our findings, the study suggests that healthcare facilities should take proactive countermeasures, such as computer monitoring, to better protect the privacy of EMR in addition to stated privacy policy. However, the extent of computer monitoring should be kept to minimum requirements as stated by relevant regulations.


Assuntos
Segurança Computacional/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Fidelidade a Diretrizes/legislação & jurisprudência , Recursos Humanos em Hospital/legislação & jurisprudência , Privacidade/legislação & jurisprudência , Adulto , China , Redes de Comunicação de Computadores/legislação & jurisprudência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
9.
Ann Biol Clin (Paris) ; 77(5): 514-516, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31466939

RESUMO

In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.


Assuntos
Equipamentos e Provisões/normas , Indústria Manufatureira/legislação & jurisprudência , Legislação de Dispositivos Médicos , Documentação , Segurança de Equipamentos , Equipamentos e Provisões/economia , União Europeia/organização & administração , Fidelidade a Diretrizes/legislação & jurisprudência , Fidelidade a Diretrizes/organização & administração , Fidelidade a Diretrizes/normas , Humanos , Indústria Manufatureira/normas , Indústria Manufatureira/tendências , Legislação de Dispositivos Médicos/organização & administração , Legislação de Dispositivos Médicos/tendências , Segurança do Paciente
10.
Subst Abus ; 40(4): 466-468, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31361588

RESUMO

On March 6, 2019, a self-designated committee sent a public letter to the Centers for Disease Control and Prevention (CDC) urging the agency to address the widespread misapplication of its 2016 guideline on prescribing opioids. Three hundred and eighteen health care professionals, and three former Directors of the White House Office of National Drug Control Policy (Drug Czars) signed the letter, as did the parent organization for Substance Abuse Journal, the Association for Multidisciplinary Education and Research on Substance use and Addiction. The letter reflected concern about a wide range of initiatives and policies by payers, quality metric agencies, health care organizations, and other regulators enforced to strongly incentivize or mandate forced opioid dose reductions on long-term opioid recipients who were otherwise stable. In April of 2019, both the United States Food and Drug Administration and the CDC's Director issued statements that could help to reduce ongoing harms resulting from such forced reductions, provided they are taken seriously. This commentary explains the rationale for the original letter, and the optimum course of action now that the CDC has responded.


Assuntos
Centers for Disease Control and Prevention, U.S. , Ética Institucional , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Centers for Disease Control and Prevention, U.S./legislação & jurisprudência , Fidelidade a Diretrizes/legislação & jurisprudência , Uso Excessivo de Medicamentos Prescritos/legislação & jurisprudência , Uso Excessivo de Medicamentos Prescritos/prevenção & controle , Política Pública/legislação & jurisprudência , Estados Unidos
11.
Nutrients ; 11(7)2019 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-31261665

RESUMO

Sodium intake in Argentina has been estimated to be at least double the dose of 2000 mg/day recommended by WHO, mostly coming from processed foods. Argentina is one of the few countries in the world that have regulated sodium content in certain food products. This study presents an assessment of sodium content in a selection of food groups and categories as reported in the nutrient information panels. We surveyed 3674 food products, and the sodium content of 864 and 1375 of them was compared to the maximum levels according to the Argentinean law and the regional targets, respectively. All food categories presented high variability of sodium content. Over 90% of the products included in the national sodium reduction law were found to be compliant. Food groups with high median sodium, such as condiments, sauces and spreads, and fish and fish products, are not included in the national law. In turn, comparisons with the lower regional targets indicated that almost 50% of the products analyzed had sodium contents above the recommended values. This evidence suggests that enhancing sodium reduction in processed foods may be a necessity for public health objectives and it is also technically feasible in Argentina.


Assuntos
Manipulação de Alimentos/legislação & jurisprudência , Rotulagem de Alimentos/legislação & jurisprudência , Indústria de Processamento de Alimentos/legislação & jurisprudência , Fidelidade a Diretrizes/legislação & jurisprudência , Guias como Assunto , Recomendações Nutricionais/legislação & jurisprudência , Sódio na Dieta/análise , Argentina , Estudos Transversais , Manipulação de Alimentos/normas , Rotulagem de Alimentos/normas , Indústria de Processamento de Alimentos/normas , Fidelidade a Diretrizes/normas , Guias como Assunto/normas , Humanos , Controle de Qualidade , Melhoria de Qualidade , Sódio na Dieta/efeitos adversos , Sódio na Dieta/normas
12.
J Acad Nutr Diet ; 119(11): 1903-1915, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31202694

RESUMO

BACKGROUND: Emergency foods distributed during a federal disaster relief response must follow the federal Dietary Guidelines for Americans according to the 1990 National Nutrition Monitoring Related Research Act. Nutrition information about emergency foods for household distribution is scarce. METHODS: According to structured observation protocols, foods received daily at a federal distribution center in Puerto Rico after Hurricane María (November 10-25, 2017) were grouped into Dietary Guidelines for Americans ChooseMyPlate food groups. Data about their sodium, saturated fat, added sugar, and fiber content per serving were captured. Registered dietitians designed meal plans with the foods distributed. RESULTS: Of 107 unique food items, 41% were snacks and sweets; and 13%, 4%, 13%, and 7% were fruits, vegetables, proteins, and grains, respectively. Fifty-eight percent of all foods were low in fiber (≤1 g); 46% included high amounts of sodium, saturated fats, or added sugars (≥20% daily value). The registered dietitians were able to design meal plans that complied with the Dietary Guidelines for Americans food group recommendations, but they exceeded upper daily limits for sodium, saturated fat, or added sugars. CONCLUSIONS: In view of projected increases in natural disasters and diet-related chronic diseases, DGA compliance must be improved so that federal emergency foods can support the health of survivors.


Assuntos
Tempestades Ciclônicas , Desastres , Governo Federal , Assistência Alimentar/legislação & jurisprudência , Fidelidade a Diretrizes/legislação & jurisprudência , Política Nutricional/legislação & jurisprudência , Planejamento em Desastres , Qualidade dos Alimentos , Humanos , Refeições , Valor Nutritivo , Estudos de Casos Organizacionais , Porto Rico , População Rural , Estados Unidos , População Urbana
13.
Matern Child Nutr ; 15 Suppl 4: e12795, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31225713

RESUMO

Globally, monitoring and enforcement mechanisms for the World Health Organization's International Code of Marketing of Breast-milk Substitutes are often lacking. The Cambodian government adopted the Code as the national standard in Sub-Decree 133 on Marketing of Products for Infant and Young Child Feeding. Following the formation of a multisectoral Oversight Board and development of detailed guidance documents for the implementation and enforcement of Sub-Decree 133, a 7-month pilot was conducted in 2017 to trial a monitoring system in four urban areas of Cambodia. The pilot included training of monitors from the Ministries of Health and Commerce, screening for violations at retail locations and health facilities, testing reporting mechanisms, and taking actions against violators. During the pilot, 85 national- and subnational-level monitors were trained, 392 site visits were made, 2,377 monitoring checklists were completed, and 11 warning letters were issued to violators. Half of the completed checklists (52.9%) indicated Code violations, yet monitors submitted zero violation reports. The pilot revealed modifications needed to the monitoring system: integrate monitor trainings into existing ministry training curricula for sustainability; enhance targeting of monitors for Sub-Decree training; delineate clear roles and responsibilities for the national and subnational levels; simplify monitoring checklists and violation reports; and improve integration of monitoring activities into routine ministry operations. Before the Sub-Decree 133 monitoring and enforcement system is implemented throughout Cambodia, revisions must be made to ensure the viability of this system. Challenges and lessons learned can also guide Code monitoring efforts being undertaken by other countries.


Assuntos
Fidelidade a Diretrizes/legislação & jurisprudência , Fidelidade a Diretrizes/normas , Marketing/legislação & jurisprudência , Marketing/normas , Substitutos do Leite/ética , Substitutos do Leite/legislação & jurisprudência , Política Nutricional , Pessoal Administrativo/educação , Camboja , Humanos , Leite Humano , Projetos Piloto , Guias de Prática Clínica como Assunto , Rotulagem de Produtos/legislação & jurisprudência , Rotulagem de Produtos/normas , Organização Mundial da Saúde
15.
Aktuelle Urol ; 50(4): 413-423, 2019 Aug.
Artigo em Alemão | MEDLINE | ID: mdl-31067580

RESUMO

The online marketing of physicians must be measured against the same advertising regulations as conventional marketing. In this context, the Medical Professional Code of Conduct, the Medical Products Advertising Act ("Heilmittelwerbegesetz") and the Law against Unfair Competition are particularly relevant. In addition, data and personal rights aspects have to be considered in the area of online marketing. Despite increasing liberalisation tendencies, there continue to be considerable legal advertising limits for doctors, which are outlined in this article. The relatively high number of current court rulings cited in the article also shows that there are questions yet to be clarified with regard to all regulations. The judgements, which are often strongly related to the individual cases, have not answered all questions conclusively. Nevertheless, it can be stated that the legal limits of medical marketing have never been more liberal than they are now.


Assuntos
Marketing de Serviços de Saúde/legislação & jurisprudência , Papel do Médico , Urologia/legislação & jurisprudência , Alemanha , Fidelidade a Diretrizes/legislação & jurisprudência , Troca de Informação em Saúde/legislação & jurisprudência , Humanos , Relações Médico-Paciente , Consulta Remota/legislação & jurisprudência
16.
Vet Radiol Ultrasound ; 60(3): 265-272, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30604431

RESUMO

There is an increasing use of mobile radiographic units in equine ambulatory practices in Norway. Horse owners or handlers often participate in the radiographic examination in a non-controlled area. The aim of this descriptive, cross-sectional, survey study was to evaluate the radiation safety and protection in use of mobile radiography, and to identify areas where special attention from the regulatory authorities as well as veterinary educators would be required. A questionnaire was distributed to all equine veterinarians assumed to have access to mobile radiographic units, as part of a formal inspection in cooperation with the Norwegian Radiation Protection Authority. Few practices met the regulatory requirements of notifying the authorities of their radiographic units and designation of a radiation protection officer. The minority of the practices performed periodic quality assurance of their equipment. Many of the practices performed all of their radiographic examinations off-site. The examinations were most often performed in the aisle outside the horses' stalls, and few practices established an operating zone. The horse owner or handler participated in the radiographic examination in almost all of the practices. Few practices used dosimeters for determination of the radiation exposure. The study shows that there are major deficits in regulatory compliance in ambulatory equine radiography practices in Norway. The study also suggests that less stringent regulations and supervision may translate into less stringent radioprotection practices.


Assuntos
Fidelidade a Diretrizes/estatística & dados numéricos , Conhecimentos, Atitudes e Prática em Saúde , Cavalos , Proteção Radiológica/normas , Radiografia/psicologia , Médicos Veterinários/psicologia , Animais , Estudos Transversais , Fidelidade a Diretrizes/legislação & jurisprudência , Noruega
18.
Ann Plast Surg ; 82(5): 486-492, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30648996

RESUMO

BACKGROUND: Today, plastic surgeons have largely transitioned to digital photography. This shift has introduced new risks to daily workflows, notably data theft and Health Insurance Portability and Accountability Act (HIPAA) violations. METHODS: We performed a national survey of digital photograph management patterns among members of the American Society of Plastic Surgery and trainees in Accreditation Council for Graduate Medical Education-accredited plastic surgery programs. RESULTS: Our findings showed that attendings preferred the use of stand-alone digital cameras (91.4%), whereas trainees preferred the use of smartphones (96.1%) for capturing patient photographs. The rate of noncompliance was nearly identical; 82.8% of attendings were HIPAA noncompliant when using stand-alone digital cameras compared with 90.2% of trainees using smartphones. Both groups also breached HIPAA rules when using other photographic management modalities. CONCLUSIONS: This is the first study to quantify the prevalence of noncompliance with regard to an entire digital photograph management workflow. These findings were consistent with previous studies that reported that younger physicians tend to embrace newer technologies, whereas older attendings are more reluctant. The findings also suggest that HIPAA noncompliance in digital photograph security and management is a significant problem within the plastic surgery community.


Assuntos
Fidelidade a Diretrizes/legislação & jurisprudência , Health Insurance Portability and Accountability Act , Fotografação/legislação & jurisprudência , Padrões de Prática Médica/legislação & jurisprudência , Cirurgia Plástica/legislação & jurisprudência , Feminino , Humanos , Masculino , Smartphone , Estados Unidos
19.
Law Hum Behav ; 43(2): 180-192, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30556703

RESUMO

Little is known about actual incidents of gender-based violence reported by college students or the campus adjudication process or outcomes of reported cases. Data from Annual Security Reports (ASRs) and Title IX Coordinators was used to examine the context, processes, and outcomes of reported incidents of sexual misconduct (N = 1,054) at institutions of higher education (IHEs) in a Mid-Atlantic state. Results showed that ASRs undercounted incidents of sexual misconduct. Few incidents reported to Title IX Coordinators resulted in a formal Title IX complaint, and fewer still resulted in a finding of responsibility or suspension/expulsion of the responsible student. The primary outcome of reports were victim services, not perpetrator punishments. Significant variability within and between IHE types was also uncovered. Findings suggest that better data collection as well as research on victim engagement in the Title IX complaint process and on sexual misconduct at community colleges and independent IHEs is needed. (PsycINFO Database Record (c) 2019 APA, all rights reserved).


Assuntos
Delitos Sexuais/legislação & jurisprudência , Delitos Sexuais/estatística & dados numéricos , Universidades/legislação & jurisprudência , Regulamentação Governamental , Fidelidade a Diretrizes/legislação & jurisprudência , Humanos , Estados Unidos
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