AI Chatbots, Health Privacy, and Challenges to HIPAA Compliance.

This Viewpoint examines the privacy concerns raised by medical uses of large language models, such as chatbots.

Shark Cartilage Supplement Labeling Practices and Compliance with U.S. Regulations.

The objective of this study was to analyze labeling practices and compliance with regulatory standards for shark cartilage supplements sold in the United States. The product labels of 29 commercial shark cartilage supplements were assessed for compliance with U.S. regulations. Claims, including nutrient content, prohibited disease, and nutritional support statements, were examined for compliance and substantiation. Overall, 48.3% of the samples had at least one instance of noncompliance with labeling regulations. The most common labeling violations observed were: missing a domestic address/phone number, non-compliant nutrient content claim, missing/incomplete disclaimer, missing statement of identity, prohibited disease claims, and incomplete "Supplement Facts" label. The use of prohibited disease claims and nutritional support statements without the required disclaimer is concerning from a public health standpoint because consumers may delay seeking professional treatment for a disease. The results of this study indicate a need for improved labeling compliance among shark cartilage supplements.

Compliance em Contratos Administrativos

Vinícius Guimarães, Auditor do TCU fala, na CTDS do Conass, sobre o tema "Compliance em Contratos Administrativos".

Use of more expensive insulin despite guidelines in Brazil.

AIM: To verify if the guidelines are being followed for the treatment of patients with type 1 diabetes mellitus (T1DM) who receive insulin by lawsuits. METHODS: A descriptive study was conducted with secondary data of these patients in a Brazilian city. RESULTS: 53.9% acquired insulin by lawsuits without previously registered use of another insulin in the Public Health System (SUS). CONCLUSION: The guidelines are not being followed for most patients analyzed, which may result in unnecessary expenses for the SUS. Therefore, this data can support the awareness of prescribers in relation to the savings generated for municipalities through the follow-up of the guidelines.

Deterrence approach on the compliance with electronic medical records privacy policy: the moderating role of computer monitoring.

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.

[Medical devices industry: the problem of clinical evaluation reports]. / L'industrie des dispositifs médicaux : la problématique des rapports d'évaluation clinique.

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.

Monitoring Sodium Content in Processed Foods in Argentina 2017-2018: Compliance with National Legislation and Regional Targets.

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.

Opioid discontinuation as an institutional mandate: Questions and answers on why we wrote to the Centers for Disease Control and Prevention.

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.

Pilot implementation of a monitoring and enforcement system for the International Code of Marketing of Breast-milk Substitutes in Cambodia.

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.