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.

[The latest best practice guidelines relating to seclusion and restraint]. / Les dernières recommandations de bonnes pratiques sur l'isolement et la contention.

Several measures relating to seclusion and restraint are included in the French public health code. The best practice guidelines of the French National Health Authority, published in 2017, define these two notions and advise on the behaviour to adopt with regard to their implementation and monitoring. Likewise, informing and supporting the patient when these measures are lifted are critical moments which the teams must also be able to manage correctly.

Cardiovascular Clearance for Sports Participation.

Sudden cardiac death (SCD) in a young athlete is a rare but tragic occurrence. The goal of this article is to provide information about the risks of sudden cardiac death in athletes by reviewing the epidemiology and describing the current screening recommendations of the American Heart Association/American College of Cardiology. 1 The specifics of and reasons for differences between screening guidelines in the United States and the screening guidelines in Europe are highlighted. Electrocardiogram (ECG) changes that can be expected in the setting of conditioning vs pathology are described. Intrinsic cardiac pathologies and disorders, with related cardiac findings, are reviewed, including prevalence and inheritance patterns. Also included is a brief medical-legal discussion about physician liability in the course of making sports clearance decisions. In an area in which there is no single national standard but in which there is an expectation by almost all states for a clearance examination, this article aims to help physicians make thoughtful decisions when evaluating a seemingly healthy patient in order to detect those rare athletes who may be at increased risk of succumbing to a sudden cardiac death during sports participation. 21.

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.

Knowledge, opinions and compliance related to the 100% smoke-free law in hospitality venues in Kampala, Uganda: cross-sectional results from the KOMPLY Project.

OBJECTIVE: This study evaluated knowledge, opinions and compliance related to Uganda's comprehensive smoke-free law among hospitality venues in Kampala Uganda. DESIGN: This multi-method study presents cross-sectional findings of the extent of compliance in the early phase of Uganda's comprehensive smoke-free law (2 months postimplementation; pre-enforcement). SETTING: Bars, pubs and restaurants in Kampala Uganda. PROCEDURE AND PARTICIPANTS: A two-stage stratified cluster sampling procedure was used to select hospitality sites stratified by all five divisions in Kampala. A total of 222 establishments were selected for the study. One hospitality representative from each of the visited sites agreed to take part in a face-to-face administered questionnaire. A subsample of hospitality venues were randomly selected for tobacco air quality testing (n=108). Data were collected between June and August 2016. OUTCOME MEASURES: Knowledge and opinions of the smoke-free law among hospitality venue staff and owners. The level of compliance with the smoke-free law in hospitality venues through: (1) systematic objective observations (eg, active smoking, the presence of designated smoking areas, 'no smoking' signage) and (2) air quality by measuring the levels of tobacco particulate matter (PM2.5) in both indoor and outdoor venues. RESULTS: Active smoking was observed in 18% of venues, 31% had visible 'no smoking' signage and 47% had visible cigarette remains. Among interviewed respondents, 57% agreed that they had not been adequately informed about the smoke-free law; however, 90% were supportive of the ban. Nearly all respondents (97%) agreed that the law will protect workers' health, but 32% believed that the law would cause financial losses at their establishment. Indoor PM2.5 levels were hazardous (267.6 µg/m3) in venues that allowed smoking and moderate (29.6 µg/m3) in smoke-free establishments. CONCLUSIONS: In the early phase of Uganda's smoke-free law, the level of compliance in hospitality venues settings in Kampala was suboptimal. Civil society and the media have strong potential to inform and educate the hospitality industry and smokers of the benefits and requirements of the smoke-free law.

The attitudes of IVF patients treated in the Czech Republic towards informing children born after gamete donation.

BACKGROUND: In recent decades gamete donation has received growing attention. Data from the Czech National Registry of Assisted Reproduction show that the number of cycles using donated oocytes has been increasing every year. According to Czech law, gamete donation is anonymous. Since 2011, some members of the Czech parliament have repeatedly made requests to revoke the anonymity but anonymity is one of the preconditions for such donation in this country. The aim of this study was to find out how the gamete recipients feel towards informing their child about the circumstances of their conception and their access to the identity of the donor. METHODS: A total of 195 recipients (122 women undergoing treatment - 43 Czechs, 79 foreigners (Western Europe and the USA) and 73 male partners - 28 Czechs, 45 foreigners) participated in this survey. The data were obtained by anonymous questionnaire. RESULTS: A significant difference between the attitude of the future Czech and foreign parents regarding disclosing the mode of conception was found (P = 0.003). The vast majority of Czechs were against disclosure. The foreign recipients were somewhat more divided. Regarding the donor's identity, there was no difference in atttitude between the groups. Recipients rarely consider that the knowledge of the donor's identity will be important for their child. The recipients overall, were convinced that the psychological aspects of parenting are far more important to the child than genetics, and see no reasons for disclosing the donor´s identity. CONCLUSION: While the the foreign recipients were less adamant about non-disclosure, the overall finding was in accord with the current Czech law on anonymity and not in agreement with the proposed abolition. The recipient's attitudes towards disclosing were also culturally determined. The fact that some countries have revised their rules towards open idendity is not a rationale for such change in the Czech Republic.

[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]. / Rahmenbedingungen zur Sammlung von "Real-Life"-Daten am Beispiel der Augenklinik der Universität München.

Background The importance of evaluating real-life data is constantly increasing. Currently available computer systems better allow for analyses of data, as more and more data is available in a digital form. Before a project for real-life data analyses is started, technical considerations and staff, legal, and data protection procedures need to be addressed. In this manuscript, experiences made at the University Eye Hospital in Munich will be shared. Materials and Methods Legal requirements, as found in laws and guidelines governing documentation and data privacy, are highlighted. Technical requirements for information technology infrastructure and software are defined. A survey conducted by the German Ophthalmological Society, among German eye hospitals investigating the current state of digitalization, was conducted. Also, staff requirements are outlined. Results A database comprising results of 330,801 patients was set up. It includes all diagnoses, procedures, clinical findings and results from diagnostic devices. This database was approved by the local data protection officer. In less than half of German eye hospitals (n = 21) that participated in the survey (n = 54), a complete electronic documentation is done. Fourteen institutions are completely paper-based, and the remainder of the hospitals used a mixed system. Conclusion In this work, we examined the framework that is required to develop a comprehensive database containing real-life data from clinics. In future, these databases will become increasingly important as more and more innovation are made in decision support systems. The base for this is comprehensive and well-curated databases.

Assessing the effects of changes in care commissioning guidelines at a tertiary centre in London on the provision of NHS-funded procedures of limited clinical effectiveness: an 11-year retrospective database analysis.

OBJECTIVES: The main objective of this study was to assess the impact of changes in care commissioning policies on National Health Service (NHS)-funded cosmetic procedures over an 11-year period at our centre. SETTING: The setting was a tertiary care hospital in London regulated by the North Central London Hospitals NHS Trust care commissioning group. PARTICIPANTS: We included all patients logged on to our database at the time of the study which was 2087 but later excluded 61 from analysis due to insufficient information. PRIMARY AND SECONDARY OUTCOME MEASURES: The main outcome measures were the results of tribunal assessment for different cosmetic surgeries which were either accepted, rejected or inconclusive based on the panel meeting. RESULTS: There were a total of 2087 patient requests considered between 2004 and 2015, of which 715 (34%) were accepted, 1311 (63%) were declined and 61 (3%) had inconclusive results. The implementation of local care commissioning guidelines has reduced access to cosmetic surgeries. Within this period, the proportion of procedures accepted has fallen from 36% in 2004 to 21% in 2015 (χ2; p<0.05, 95% CI). CONCLUSION: Local guidance on procedures of limited clinical effectiveness is a useful, although not evidence-based selection process to reduce access to cosmetic surgery in line with increasing financial constraints. However, patients with a physical impairment may not receive treatment in comparison to previous years, and this can have a negative impact on their quality of life.

[Joint pilot project of the German higher federal authorities and ethics committees on implementing the EU Regulation on clinical trials]. / Gemeinsames Pilotprojekt von Bundesoberbehörden und Ethikkommissionen zur Umsetzung der EU-Verordnung zu klinischen Prüfungen.

BACKGROUND: The European Clinical Trials Regulation 536/2014 and the corresponding national legal transitions will require close cooperation between the federal higher authorities and ethics committees in the assessment of clinical trial applications involving medicinal products in humans. In preparation for this, a pilot project was launched to simulate the future processes of the regulation in line with current legal requirements and in order to give applicants, authorities and ethics committees the opportunity to familiarise themselves with the new procedures. OBJECTIVES: The aim of this paper is to examine all pilot project procedures of the first year since starting the pilot project at the end of 2015. MATERIALS AND METHODS: All 20 pilot projects completed in the first year were analysed for adherence to deadlines and results of the assessments. RESULTS: Within the time limits specified in the EU regulation, 17 of 20 procedures were fully completed. In two cases, the sponsors slightly exceeded the additional delivery period. In one case, the sponsor withdrew the application within the pilot procedure. All 20 applications were processed jointly by the federal authorities and ethics committees, and in all cases a coordinated assessment report was successfully compiled on time. All 20 applications were approved, five of which were subject to suspensive conditions. CONCLUSIONS: Compliance with the deadlines set by federal authorities and ethics committee shows that the technical infrastructures and processes established in the pilot procedure are fully functional. The cooperation between the federal higher authorities and ethics committees was very successful from the perspective of the parties involved.

[Principles of the EU Clinical Trials Regulation No 536/2014 : What will change?] / Grundzüge der EU-Verordnung 536/2014 : Was wird sich ändern?

The new Regulation (EU) No. 536/2014 for clinical trials of medicinal products for human use will replace the still valid European Directive 2001/20/EC in the future. The new regulation aims to further harmonise authorisation and reporting procedures for clinical trials and introduces of a joint European assessment for multinational clinical trials in the EU. Despite the joint assessment administered by a reporting member state, each member state continues to authorise clinical trial applications nationally. In the future, applications and any communication will be submitted paperlessly via a new electronic EU portal, which is still being developed. The regulation provides detailed information on the implementation of multinational clinical trials. In particular, the complex processing procedures and shorter time limits are to be stressed in comparison to the previously valid regulations. This is a major challenge for all stakeholders, but on the other hand it should contribute to the future role of the EU in the development of innovative medicines.

NHSLA litigation in hip fractures: Lessons learnt from NHSLA data.

Hip fractures are a major cause of trauma related death, usually occurring in vulnerable elderly patients. There are an estimated 70,000 hip fractures in the UK per year with numbers set to rise. The estimated annual cost to the healthcare economy is in the region of £2 billion. A 17-year review examining litigation related to hip fractures was undertaken. Under a freedom of information request, data was obtained relating to all orthopaedic claims made to the NHS Litigation Authority (NHSLA) between 1995 and 2012. Data was filtered to identify cases involving hip fractures examining litigation trends related to this specific area. 10263 NHSLA orthopaedic cases were identified, of which 13.3% (n=1364) cases related to the hip and femur. Hip fractures made up 16.7% (n=229). The total cost of hip fracture litigation was over £7 million with an average cost per case of £32,700. The commonest reasons for litigation were diagnostic errors (30.6%), issues with care (24.9%) alleged incompetent surgery (15.7%) and development of pressure sores (5.7%). This study highlights the main causes of litigation in patients sustaining hip fractures, with diagnosis in the emergency department and ward presenting a significant problem. In addition, the data identifies a range of care related issues, as well as several surgical factors and highlights the importance of pressure area care. We discuss these and make suggestions on how to improve practice in this area with the aim of improving patient care and reducing litigation.