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.

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.

[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.

Foods Distributed During Federal Disaster Relief Response in Puerto Rico After Hurricane María Did Not Fully Meet Federal Nutrition Recommendations.

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.

[Legal limits of (online) marketing for doctors]. / Rechtliche Grenzen des (Online-) Marketings für Ärzte.

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.

Health Insurance Portability and Accountability Act Noncompliance in Patient Photograph Management in Plastic Surgery.

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.

No evidence of "weaponized Title IX" here: An empirical assessment of sexual misconduct reporting, case processing, and outcomes.

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).

Legal duties, professional obligations or notional guidelines? Screening, treatment and referral of domestic violence cases in primary health care settings in South Africa.

BACKGROUND: Since 2013, approximately 4400 women have been murdered by their partners in South Africa. This is five times higher than the per capita global average. Domestic violence is known to be cyclical, endemic and frequently involves multiple victims. It also becomes progressively more dangerous over time and may lead to fatalities. In 2012, the Health Professions Council of South Africa released a domestic violence protocol for emergency service providers. This protocol, or screening guidelines, includes assessing future risk to domestic violence, providing physical and psychosocial care, documentation of evidence of abuse and informing patients of their rights and the services available to them. The extent to which these guidelines have been circulated and implemented, particularly by general health care practitioners (HCPs), is unknown. AIM: We review international treaties to which South Africa is a signatory, as well as national legislation and policies that reinforce the right to care for victims of domestic violence, to delineate the implication of these laws and policies for HCPs. METHOD: We reviewed literature and analysed national and international legislation and policies. RESULTS: The 'norms' contained in existing guidelines and currently practiced in an ad hoc manner are not only compatible with existing statutory duties of HCPs but are in fact a natural extension of them. CONCLUSION: Proactive interventions such as the use of guidelines for working with victims of domestic violence enable suspected cases of domestic violence to be systematically identified, appropriately managed, properly referred, and should be adopted by all South African HCPs.

Assessment of US Hospital Compliance With Regulations for Patients' Requests for Medical Records.

Importance: Although federal law has long promoted patients' access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process. Objective: To evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access. Design, Setting, and Participants: A cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017 US News & World Report Best Hospitals National Rankings. Exposures: Scripted interview with medical records departments in a single-blind, simulated patient experience. Main Outcomes and Measures: Requestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments. Results: Among the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for processing times. Conclusions and Relevance: The study revealed that there are discrepancies in the information provided to patients regarding the medical records release processes and noncompliance with federal and state regulations and recommendations. Policies focused on improving patient access may require stricter enforcement to ensure more transparent and less burdensome medical records request processes for patients.

Guidelines Regarding §16 of the German Transplantation Act - Initial Experiences with Structured Reporting.

Purpose To transfer the report sheet from the guidelines regarding the German Transplantation Act to a standards-compliant report template and to evaluate it in the clinical routine. Materials and Methods The template was developed using the freely available software brackets.io. It was implemented in the clinical routine using a reporting platform developed in-house. Interfaces to the department RIS and PACS allowed for integration into the usual reporting workflow. The evaluation period was 70 days. Results Developing the template for implementation of the guidelines was possible without any difficulties. The content of the report sheet provided in the guidelines was transferred one to one. Additionally, a text field was included to allow for further remarks. In the period under review, 7 radiologists performed 44 evaluations in line with §â€Š16 of the German Transplantation Act. Users of the template, referring physicians and the employees of the transplantation office reported a high degree of satisfaction. Conclusion Implementing report sheets that are required by law (e. g. in the guidelines regarding §â€Š16 of the German Transplantation Act) in the clinical routine electronically is easy and achieves a high degree of acceptance. The standard supported by the German Radiological Society (IHE - "Management of radiology report templates") allows for a quick response to the growing demand for structured and standardized reporting. Key Points · Report sheets as required by law can easily be incorporated electronically into the clinical routine.. · Templates for structured reporting as supported by the German Radiological Society allow for a quick response to the growing demand for standardized reporting.. · Radiologists as well as referring physicians report a high degree of satisfaction with the electronic version of the report sheet.. Citation Format · Pinto dos Santos D, Arnhold G, Mildenberger P et al. Guidelines Regarding §16 of the German Transplantation Act - Initial Experiences with Structured Reporting. Fortschr Röntgenstr 2017; 189: 1145 - 1151.

Effect of enhanced feedback to hospitals that are part of an emerging clinical information network on uptake of revised childhood pneumonia treatment policy: study protocol for a cluster randomized trial.

BACKGROUND: The national pneumonia treatment guidelines in Kenya changed in February 2016 but such guideline changes are often characterized by prolonged delays in affecting practice. We designed an enhanced feedback intervention, delivered within an ongoing clinical network that provides a general form of feedback, aimed at improving and sustaining uptake of the revised pneumonia treatment policy. The objective was to determine whether an enhanced feedback intervention will improve correctness of classification and treatment of childhood pneumonia, compared to an existing approach to feedback, after nationwide treatment policy change and within an existing hospital network. METHODS/DESIGN: A pragmatic, cluster randomized trial conducted within a clinical network of 12 Kenyan county referral hospitals providing inpatient pediatric care to children (aged 2-59 months) with acute medical conditions between March and November 2016. The intervention comprised enhanced feedback (monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators) and this was compared to standard feedback (2-monthly written feedback on multiple quality of pediatric care indicators) both delivered within a clinical network promoting clinical leadership linked to mentorship and peer-to-peer support, and improved use of health information on service delivery. The 12 hospitals were randomized to receive either enhanced feedback (n = 6) or standard feedback (n = 6) delivered over a 9-month period following nationwide pneumonia treatment policy change. The primary outcome is the proportion of all admitted patients with pneumonia (fulfilling criteria for treatment with orally administered amoxicillin) who are correctly classified and treated in the first 24 h. The secondary outcome will be measured over the course of the admission as any change in treatment for pneumonia after the first 24 h. DISCUSSION: This trial protocol employs a pragmatic trial design during a period of nationwide change in treatment guidelines to address two high-priority areas within implementation research: promoting adoption of health policies and optimizing effectiveness of feedback. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02817971 . Registered retrospectively on 27 June 2016.

Increased minimum legal age for the sale of alcohol in the Netherlands as of 2014: The effect on alcohol sellers' compliance after one and two years.

BACKGROUND: As of January 2014, the Dutch minimum legal age for the sale and purchase of all alcoholic beverages has increased from 16 to 18 years of age. The effectiveness of a minimum legal age policy in controlling the availability of alcohol for adolescents depends on the extent to which this minimum legal age is complied with in the field. The main aim of the current study is to investigate, for a country with a West-European drinking culture, whether raising the minimum legal age for the sale of alcohol has influenced compliance rates among Dutch alcohol vendors. METHODS: A total of 1770 alcohol purchase attempts by 15-year-old mystery shoppers were conducted in three independent Dutch representative samples of on- and off-premise alcohol outlets in 2013 (T0), 2014 (T1), and 2016 (T2). The effect of the policy change was estimated controlling for gender and age of the vendor. RESULTS: Mean alcohol sellers' compliance rates significantly increased for 15-year-olds from 46.5% before to 55.7% one year and to 73.9% two years after the policy change. Two years after the policy change, alcohol vendors were up to 3 times more likely to comply with the alcohol age limit policy. CONCLUSION: After the policy change, mean alcohol compliance rates significantly increased when 15-year-olds attempted to purchase alcohol, an effect which seems to increase over time. Nevertheless, a rise in the compliance rate was already present in the years preceding the introduction of the new minimum legal age. This perhaps signifies a process in which a lowering in the general acceptability of juvenile drinking already started before the increased minimum legal age was introduced and alcohol vendors might have been anticipating this formal legal change.