Radiation therapy: Regulatory framework and constraints.

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France.

Quality/risk management system in radiotherapy: Changes afoot.

The French sanitary and regulatory context in which radiotherapy centres are comprised is evolving. Risk and quality management systems are currently adapting to these evolutions. The French nuclear safety agency (ASN) decision of July 1st 2008 on quality assurance obligations in radiotherapy has reached 10 years of age, and the French high authority of health (HAS) certification system 20 years now. Mandatory tools needed for the improvement of quality and safety in healthcare are now well known. From now on, the focus of healthcare policies is oriented towards evaluation of efficiency of these new organisations designed following ASN and HAS nationwide guidelines.

[From virginity certificates to hymenoplasty surgery in France]. / Des « certificats de virginité ¼ aux hyménoplasties en France.

"In the Republic, it is not allowed to deliver virginity certificates, prior to marriage; in the French Republic, the laws of religion cannot prevail over the laws of the Republic" said President Emmanuel Macron in February 2020. Nevertheless, what about the religious status of these certificates? Why focusing only on virginity certificates without mentioning the concomitant practice of hymen rehabilitation? There is a whole range of revirginization surgical practices, such as nymphoplasty or vaginoplasty, among which hymenoplasty figures only incidentally?

TITLE: Des « certificats de virginité ¼ aux hyménoplasties en France. ABSTRACT: « Dans la République, on ne peut pas exiger des certificats de virginité pour se marier ; dans la République, on ne doit jamais accepter que les lois de la religion puissent être supérieures aux lois de la République ¼, telle est la déclaration en février 2020 du président Emmanuel Macron. Mais quel est donc le statut de ces certificats de virginité, est-il véritablement religieux ? Pourquoi se focaliser sur les « certificats de virginité ¼ sans jamais évoquer la pratique concomitante de la réfection d'hymen ? N'existe-t-il pas une diversité de pratiques chirurgicales participant du processus de revirginisation telle que la nymphoplastie ou la vaginoplastie ; l'hyménoplastie ne serait-elle que la pointe émergée de l'iceberg ?

Medical Oversight and Scope of Practice of Medical Spas (Med-Spas).

BACKGROUND: The regulation of medical spas (med-spas) in the United States varies considerably from state to state with important ramifications for patient safety. OBJECTIVE: To describe the current state of med-spas in the United States and degree of medical oversight in these facilities. MATERIALS AND METHODS: Descriptive study based on web search and standardized phone interviews of med-spas in the most heavily populated cities in each state of the United States. Information obtained included the following: whether medical directors were listed; if so, whether they were advertised as being on site; medical directors' training and board certification; and services offered. RESULTS: Of 247 medical spas reviewed, 72% advertised a medical director on their website, and 6.5% claimed that the director was on site. Of listed medical directors, 41% were trained in dermatology and/or plastic surgery. In phone interviews, 79% of med-spas endorsed the medical director to be board certified, and 52% stated that the medical director was on site less than 50% of the time. CONCLUSION: There is significant variation in medical directorship and oversight among medical spas in the United States. Appropriate regulation of medical directors' training and the degree of oversight provided are warranted to optimize patient safety.

[From idea to standard care-a field report]. / Der lange Weg von der Idee bis zur Erstattung ­ ein Reisebericht.

Digital health products and services have started to fundamentally change healthcare and prevention. Products intended for a medical use require CE-marking and potentially certification (ISO 13485) of the company. Startups play an important role in the development of new digital products and services. Two startups share their experience with these processes. Becoming a part of standard care and hence being reimbursed is a challenge for startups. For this reason, startups pursue alternative sources of income, too. The statutory health insurance's procedures for assessing new products and services are perceived as long. Startups are required to provide evidence of the benefit of their product at an early stage in the procedure. This requires time-consuming and costly studies. Startups would therefore appreciate support in generating this evidence, e. g. through adequate procedures for testing.

[In search of a travel guide-results from a survey of E­health startup companies]. / Reiseführer gesucht ­ Ergebnisse einer Umfrage bei E­Health-Start-ups.

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.

Revalidación de títulos médicos extranjeros: eficacia y eficiencia de un examen colaborativo y estandarizado / A collaborative objective structured clinical examination for title revalidation by foreign medical graduates in Chile

Background: Title revalidation of foreign medical graduates to practice medicine in Chile is a complex and expensive process. According to the legislation they are required to approve the Unique National Exam of Medical Knowledge (EUNACOM), which has a theoretical and a practical section. Aim: To demonstrate that a collaborative and standardized examination of the practical section of EUNACOM is more effective and efficient than traditional practical examinations. Material and Methods: The faculties of Medicine of the Catholic University of Chile, University of Chile and University of Concepción were associated to implement an examination proposal, framed in the legislation. The EUNACOM board supported and funded the initiative which consisted in the implementation of Objective Structured Clinical Examination (OSCE) for each basic specialty of medicine, applied to 40 designated candidates. This format was selected because of the wide experience and evidence at the international level in the certification of medical professionals. Results: A collaborative and standardized OSCE reduces to less than half the time spent by examiners, providing more evidence of validity, reliability and objectivity. It also allows to visualize the real costs per applicant, which proved to be higher than those currently charged by EUNACOM, but comparatively lower than the examination used in the United States. Conclusions: A collaborative OSCE responds to the ethical principle of justice by being more valid, reliable, objective and cost efficient.

[ISO 9001:2015 Certification in Quality Management]. / Zertifizierung des Qualitätsmanagements nach DIN EN ISO 9001:2015.

Quality management improves the structures, processes and results of organizations of all kinds. Many practices and clinics have their existing quality management system certified according to ISO 9001, (e.g., to check their own quality management system or to obtain a testimonial against third parties). The latest version ISO 9001:2015 contains some changes, both structurally and in terms of content. These changes can be met with reasonable efforts. An ISO 9001:2015 certification represents a value for your organization, but these advantages are often not directly measurable.

[Autopsy in oncology : Treatment validation in cancer centers and clinical cancer registries]. / Obduktion bei Tumorerkrankungen : Behandlungsstrategien in Tumorzentren und klinischen Krebsregistern.

The legal recognition of autopsy as a tool of quality assurance will strengthen its importance especially in the care of cancer patients. However, this confidence is relativized by the consideration of the assessment of the autopsy in various effective nonlegislative regulations. This consideration shows that in contrast to earlier years autopsy does not play a major role in the most important programs for the certification of cancer centers or for clinical cancer registration. If clinical autopsy is to play a more important role in the future, then in addition to improving and standardizing its quality the implementation into these systems of quality management is indispensable.

Preserving the Legitimacy of Board Certification.

OBJECTIVES: The aims of this discussion were to inform the medical community about the American Board of Cosmetic Surgery's ongoing attempts in Louisiana to achieve equivalency to American Board of Medical Specialties (ABMS) member boards so that its diplomates may use the term "board certified" in advertising and to ensure public safety by upholding the standards for medical board certification. BACKGROUND: In 2011, Louisiana passed a truth in medical advertising law, which was intended to protect the public by prohibiting the use of the term "board certified" by improperly credentialed physicians. An American Board of Cosmetic Surgery diplomate petitioned the Louisiana State Board of Medical Examiners to approve a rule that would establish a pathway to equivalency for non-ABMS member boards, whose diplomates have not completed training approved by the Accreditation Council for Graduate Medical Education (ACGME) in the specialty they are certifying. Physicians and physician organizations representing multiple specialties (facial plastic and reconstructive surgery, otolaryngology [head and neck surgery], orthopedic spine surgery, pediatric neurosurgery, dermatology, and plastic surgery) urged the Louisiana State Board of Medical Examiners to clarify its advertising policy, limiting the use of the term "board certified" to physicians who have completed ACGME-approved training in the specialty or subspecialty named in the certificate. DISCUSSION: The public equates the term "board certified" with the highest level of expertise in a medical specialty. When a certifying board does not require completion of ACGME or American Osteopathic Association (AOA)-accredited training in the specialty it certifies, the result is an unacceptable degree of variability in the education and training standards applied to its diplomates. Independent, third-party oversight of certifying boards and training programs is necessary to ensure quality standards are upheld. Any system that assesses a non-ABMS member or non-AOA-certified board for equivalency approval must ensure that the training and qualifications required by the non-ABMS or AOA board are equivalent in scope, content, and duration to those required by the ABMS and AOA. This issue must not be misconstrued as a "turf battle" between physicians of 2 competing specialties. Preserving the legitimacy of board certification is incumbent upon all medical specialties and subspecialties. This argument is a truthful, principled defense of the legitimacy of board certification.

The Strategy of Voluntary Certification in Italian Olive Oil Industry: Who and Why?

BACKGROUND: The phenomenon of asymmetric information is central in the agri-food sector, in which often there is not full information transparency about product quality. This condition is particularly complex considering the high-end products. In particular, there are specific attributes (credence attributes) that are not assessable by consumers. For these reasons, a clear information about certification can give to consumers the possibility to make a rational choice. A company can choose voluntarily to participate in certification programs that can be viewed also as a simplification of some organization issues. Often the incentives to participate in voluntary programs arise from the need to have a positive economic performance of the firm. On the one hand, the firm may have benefits from the technical assistance of the certification, which allows it to reduce costs of controlling particular sensible steps of the process. On the other hand, the firm may provide a new certification label, in order to ensure a greater transparency of its processes. METHODS: The research aims to understand the characteristics of firms oriented to use voluntary certifications as a tool to reduce information asymmetries between producers and final consumers. In particular, we want to consider two contexts of analysis: a structural one, considering some specific internal aspects and investment choices of the firms (typology, size, extraction system, storage system, material investments, immaterial investments); a second one that takes into account some decisions related to market relationships (sale to consumers, sale to HoReCa, sale to wholesalers, sale to purchasing groups, sale to GDO, export activity). The study concerns small and medium olive oil company of Southern Italy. We apply two logit models in order to show the determinants in the choice to introduce a voluntary certification. RESULTS: The results show significant values in both the two dimensions considered. Among the first one, there are significances in immaterial company investments but also in physical assets related to the olive oil process. There are several scientific developments relevant to the olive oil process and some of these patents have been reviewed in this paper. Regarding the physical assets, the storage system is a clear representation of the asset importance in the decision to participate in the certification program. Furthermore, the presence of considerable immaterial investments is important in the certification decision, which confirms the idea that voluntary certification can be viewed as a strategic tool. In the second part of analysis there are significances in some distribution channels (direct sale to final consumer, to wholesalers and to purchasing groups) as well as in the export activity. CONCLUSION: This work aims to contribute to the debate about the addressing of quality policy for a reduction of asymmetric information in the high-end products. Because of small dimensions of firms in Southern Italy, not always we can find conditions about the presence of specific assets. Indeed, the small dimensions of the companies make quality investments complicated. The incentive to invest, both in terms of control of product and in terms of immaterial investment, can help in a participation in voluntary certification programs. Further, it is important to investigate the three distribution channels resulting from the research because of their importance in terms of information asymmetry.

How concerns and experiences with medical malpractice affect dermatopathologists' perceptions of their diagnostic practices when interpreting cutaneous melanocytic lesions.

OBJECTIVE: We sought to identify characteristics associated with past malpractice lawsuits and how malpractice concerns may affect interpretive practices. METHODS: We surveyed 207 of 301 (68.8%) eligible dermatopathologists who interpret melanocytic skin lesions in 10 states. The survey assessed dermatopathologists' demographic and clinical practice characteristics, perceptions of how medical malpractice concerns could influence their interpretive practices, and past malpractice lawsuits. RESULTS: Of dermatopathologists, 33% reported past malpractice experiences. Factors associated with being sued included older age (57 vs 48 years, P < .001), lack of board certification or fellowship training in dermatopathology (76.5% vs 53.2%, P = .001), and greater number of years interpreting melanocytic lesions (>20 years: 52.9% vs 20.1%, P < .001). Of participants, 64% reported being moderately or extremely confident in their melanocytic interpretations. Although most dermatopathologists believed that malpractice concerns increased their likelihood of ordering specialized pathology tests, obtaining recuts, and seeking a second opinion, none of these practices were associated with past malpractice. Most dermatopathologists reported concerns about potential harms to patients that may result from their assessments of melanocytic lesions. LIMITATIONS: Limitations of this study include lack of validation of and details about the malpractice suits experienced by participating dermatopathologists. In addition, the study assessed perceptions of practice rather than actual practices that might be associated with malpractice incidents. CONCLUSIONS: Most dermatopathologists reported apprehension about how malpractice affects their clinical practice and are concerned about patient safety irrespective of whether they had actually experienced a medical malpractice suit.