Medical Regulation

Conversion therapies are any treatments, including individual talk therapy, behavioral (e.g. aversive stimuli), group therapy or milieu (e.g. "retreats or inpatient treatments" relying on all of the above methods) treatments, which attempt to change an individual's sexual orientation from homosexual to heterosexual. However these practices have been repudiated by major mental health organizations because of increasing evidence that they are ineffective and may cause harm to patients and their families who fail to change. At present, California, New Jersey, Oregon, Illinois, Washington, DC, and the Canadian Province of Ontario have passed legislation banning conversion therapy for minors and an increasing number of US States are considering similar bans. In April 2015, the Obama administration also called for a ban on conversion therapies for minors. The growing trend toward banning conversion therapies creates challenges for licensing boards and ethics committees, most...

Many health care systems include programs that allow patients in exceptional circumstances to access medical interventions of as yet unproven benefit. In this article we consider the ethical justifications for—and demands on—these special access programs (SAPs). SAPs have a compassionate basis: They give patients with limited options the opportunity to try interventions that are not yet approved by standard regulatory processes. But while they signal that health care systems can and will respond to individual suffering, SAPs have several disadvantages, including the potential to undermine regulatory and knowledge-generation structures that constitute significant public goods. The “balance” between these considerations depends in part on how broadly SAPs are used, but also on whether SAPs can be made to contribute to the generation of knowledge about the effects of health interventions. We argue that patients should usually be required to contribute outcome data while using SAPs.

Distributed digital manufacturing offers a solution to medical supply and technology shortages during pandemics. To prepare for the next pandemic, this study reviews the state-of-the-art for open hardware designs needed in a COVID-19-like pandemic. It evaluates the readiness of the top twenty technologies requested by the Government of India. The results show that the majority of the actual medical products have had some open source development, however, only 15% of the supporting technologies that make the open source device possible are freely available. The results show there is still considerable work needed to provide open source paths for the development of all the medical hardware needed during pandemics. Five core areas of future work are discussed that include:  i) technical development of a wide-range of open source solutions for all medical supplies and devices, ii) policies that protect the productivity of laboratories, makerspaces and fabrication facilities during a pandemic, as well as iii) streamlining the regulatory process, iv) developing Good-Samaritan laws to protect makers and designers of open medical hardware, as well as to compel those with knowledge that will save lives to share it, and v) requiring all citizen-funded research to be released with free and open source licenses.

As more Americans are burdened with chronic conditions, prominent health policy thought leaders urge a reorientation of our health care system from provision of episodic, reactive care to a “population health” focus. Some of the mechanisms proposed to achieve this would devolve certain responsibilities from physicians to other members of care teams. In particular, there is heightened interest in deploying lay health workers to reach out to the medically underserved. The Food and Drug Administration has initiated formal discussion of loosening regulatory constraints on the prescribing of medications used to treat chronic conditions. This article reviews recent efforts to transform care delivery and the regulatory barriers to realizing their full potential. It concludes that there are promising health interventions that could be implemented on a wider scale if legal barriers were lifted. It proposes a design for demonstration projects that would waive some regulatory requirements to p...

An unfinished draft on regulation of medical (and other) gases. I felt that as India (and many other countries) are currently facing an unprecedented struggle over medical air, there might be someone who would be interested to read it. The paper traces the regulatory way of air from nature to containers in medical theaters and operating rooms around the globe, while highlighting failures of this regulation in locales considered peripheral by the regulatory regime.

ABSTRACT
Objectives: The primary aim was to investigate the impact of complaints on doctors’ psychological welfare and health. The secondary aim was to assess whether doctors report exposure to a complaints process is associated with defensive medical practise.
Design: This was a cross-sectional anonymous survey study. Participants were stratified into recent/current, past, no complaints. Each group completed tailored versions of the survey.
Participants: 95 636 doctors were invited to participate. A total of 10 930(11.4%) responded, 7926 (8.3%) completed the full survey and were included in the complete analysis.
Main outcome measures: Anxiety and depression were assessed using the standardised Generalised Anxiety Disorder scale and Physical Health Questionnaire. Defensive practise was evaluated using a new measure. Single-item questions measured stress- related illnesses, complaints-related experience, attitudes towards complaints and views on improving complaints processes.
Results: 16.9% of doctors with current/recent complaints reported moderate/severe depression (relative risk (RR) 1.77 (95% CI 1.48 to 2.13) compared to doctors with no complaints (9.5%)). Fifteen per cent reported moderate/severe anxiety (RR=2.08 (95% CI 1.61 to 2.68) compared to doctors with no complaints (7.3%)). Distress increased with complaint severity, with highest levels after General Medical Council (GMC) referral (26.3% depression, 22.3% anxiety). Doctors with current/recent complaints were 2.08 (95% CI 1.61 to 2.68) times more likely to report thoughts of self- harm or suicidal ideation. Most doctors reported defensive practise: 82–89% hedging and 46–50% avoidance. Twenty per cent felt victimised after whistleblowing, 38% felt bullied, 27% spent over
1 month off work. Over 80% felt processes would improve with transparency, managerial competence, capacity to claim lost earnings and action against vexatious complainants.
Conclusions: Doctors with recent/current complaints have significant risks of moderate/severe depression, anxiety and suicidal ideation. Morbidity was greatest in cases involving the GMC. Most doctors reported practising defensively, including avoidance of procedures and high-risk patients. Many felt victimised as whistleblowers or reported bullying. Suggestions to improve complaints processes included transparency and managerial competence.

The law’s relation with medicine has ceased to be one of mutual trust, with the claims that the law is adverse to the practice of medicine. Law is accused to foster the culture of blame that has led to the increase in errors in the hands of health professionals who are constantly worried over the threat of litigation. But the standards by which law measure the conduct of doctor is set by the medical profession itself, largely with the endorsement given by the courts in Bolam. This essay will look in to the truth of these claims and argue that such claims cannot be sustained.

Risk from sub-optimal medical practice remains a perennial international problem. While regulatory efforts for improvement have been significant, new thinking and innovation is needed. In an ideal world, professional career paths would be enhanced, supported and successfully maintained from medical school to retirement. Regulatory outcomes would be made resilient to public and professional challenge. Professional development, with quality improvement at its heart, would be maximized, and concerns about medical competency would be highlighted and acted upon at an early stage -- before they become “a fitness to practice” matter. At this early stage, referred to in this paper as the “amber zone,” concerns about an individual's ability to practice medicine competently may emerge, but they are not considered of sufficient severity to warrant a referral to a fitness to practice inquiry by medical regulators. The introduction of a concept called Insightful Practice is one attempt to ad...

In 2010, the Educational Commission for Foreign Medical Graduates (ECFMG) announced that as of 2023, physicians applying to train and practice in the United States will be required to graduate from a medical school that has been accredited using criteria such as those developed by the World Federation for Medical Education. This study analyzed posts on the Student Doctor Network (SDN) online forum that refer to this accreditation requirement to investigate how it has been perceived and understood by current and prospective medical students. A keyword search of relevant terms was used to identify posts discussing the accreditation requirement on the SDN online forum, which were subjected to thematic analysis. There were a total of 83 posts from 49 distinct user accounts between May 2012 and January 2020. Seven themes were identified in total; four whose overall purpose was to seek or offer advice and three whose overall purpose was commentary. Themes relating to advice included appli...

This article reports the consensus recommendations of a working group that was convened at the end of a four-year research project funded by the National Institutes of Health that examined 280 cases of egregious ethical violations in medical practice. The group reviewed data from the parent project, as well as other research on sexual abuse of patients, criminal prescribing of controlled substances, and unnecessary invasive procedures that were prosecuted as fraud. The working group embraced the goals of making such violations significantly less frequent and, when they do occur, identifying them sooner and taking necessary steps to ensure they are not repeated. Following review of data and previously published recommendations, the working group developed 10 recommendations that provide a starting point to meet these goals. Recommendations address leadership, oversight, tracking, disciplinary actions, education of patients, partnerships with law enforcement, further research and rela...

In 2012 a new biobanking law came into effect in Finland which, according to some, is one of the most com- prehensive and broad national biobanking legislations in the world to date. The law covers both clinical and research collections and provides institutions with great flexibility in terms of transferring existing collections into a biobank. The law also includes provisions for individuals whose samples are stored in the biobank to request information regarding the studies in which the sample has been used. However, this provision also compels biobanks to provide an account of the significance of the research findings to their individual health. This legal provision has created tension between policy and practice in that most biobanks will struggle to interpret and apply this provision in practice. The relationship between the rights and needs to conduct research using biobank material and individual rights of access is sometimes unclear and fraught with interpretational challenges. The derivation of national interpretations of European Directives and Conventions gives rise to what I call interpretive regulatory dissonance. This is expected to be a challenge for harmonizing European and global biobanking activities in the future.

In 2012, medical regulation in the United Kingdom was fundamentally changed by the introduction of revalidation-a process by which all licensed doctors are required to regularly demonstrate that they are up to date and fit to practice in their chosen field and are able to provide a good level of care. This paper examines the implications of revalidation on the structure, governance, and performance management of the medical profession, as well as how it has changed the relationships between the regulator, employer organizations, and the profession. We conducted semi-structured interviews with clinical and non-clinical staff from a range of healthcare organizations. Our research suggests that organizations have become intermediaries in the relationship between the General Medical Council and doctors, enacting regulatory processes on its behalf and extending regulatory surveillance and oversight at local level. Doctors' autonomy has been reduced as they have become more accountable to and reliant on the organizations that employ them.

The 25 state medical councils and the apex body, the Medical Council of India, were set up to regulate practitioners registered
with them. However, the self-regulatory bodies themselves often made news by getting mired in corrupt activities. Taking the case of the Maharashtra Medical Council as an illustration, this article discusses how it emerged from the controversies surrounding it and also looks at how it can better its functioning.

Objective Patient safety is fundamental to high-quality patient care. Critical steps toward improving the safety of the health care system include ensuring the system is aware of its errors so effective remedies can be applied, and enhancing the trustworthiness of the health care system for patients by disclosing errors that are meaningful to them. This study aimed to construct a conceptual model of the factors that facilitate or hinder disclosure of medical errors. Methods We conducted 25 separate focus groups with attending physicians, nurses, residents, patients and hospital administrators at five academic medical centers in a university health care system. The protocol probed the ethical perceptions of participants and the details of disclosure expectations. Audiotapes of the focus groups were transcribed and analyzed using Atlas.ti software. Codes were assigned to the text in an iterative fashion. Themes were identified and assembled into a model of disclosure. Results All grou...

Within the regulatory community, there has been increasing interest in the issue of proportionality in regulation — that is, using the right amount and right types of regulatory interventions to achieve the primary mandate of the regulatory community in order to serve and to protect. The Health and Care Professions Council (HCPC) in the United Kingdom, one of the largest health-care regulatory bodies in the world, recently commissioned a study examining the disproportionately large number of complaints against paramedics in the UK and social workers in England. The objective of the study was to examine the nature of, and to better understand the reasons behind, this disproportionality, and to identify options and opportunities from a regulatory perspective that could be taken to address this issue. The study involved a systematic multi-methods research approach involving four key interrelated research elements:A systematic literature reviewA Delphi consultation with international ex...

This article reports the consensus recommendations of a working group that was convened at the end of a four-year research project funded by the National Institutes of Health that examined 280 cases of egregious ethical violations in medical practice. The group reviewed data from the parent project, as well as other research on sexual abuse of patients, criminal prescribing of controlled substances, and unnecessary invasive procedures that were prosecuted as fraud. The working group embraced the goals of making such violations significantly less frequent and, when they do occur, identifying them sooner and taking necessary steps to ensure they are not repeated. Following review of data and previously published recommendations, the working group developed 10 recommendations that provide a starting point to meet these goals. Recommendations address leadership, oversight, tracking, disciplinary actions, education of patients, partnerships with law enforcement, further research and rela...

Rapid changes in the medical practice environment pose novel ethical challenges for clinicians. As during any time of great innovation, unanticipated conflicts, problems, or ethical questions may arise, creating a “period of maladjustment” between the introduction of the innovation or technological advancement and the point at which society achieves consensus on the appropriate use of that innovation or advancement. This article reports examples of physicians and physician assistants who exercised poor judgment — often in the absence of systems or structural supports — when faced with novel ethical dilemmas involving advancements such as electronic health records, social media, medical marijuana certification, and access to an international marketplace for drugs and devices. It suggests areas for intervention for licensing boards, educators, and other oversight entities that may better equip licensees to address these novel ethical dilemmas. Finally, because the primacy of patient w...

We articulate an intellectual history and a definition, description and model of patient safety. We define patient safety as a discipline in the health care professions that applies safety science methods toward the goal of achieving a trustworthy system of health care delivery. We also define patient safety as an attribute of health care systems that minimizes the incidence and impact of adverse events and maximizes recovery from such events. Our description includes: why the field of patient safety exists (the high prevalence of avoidable adverse events); its nature; its essential focus of action (the microsystem); how patient safety works (e.g., high-reliability design, use of safety sciences, methods for causing change, including cultural change); and who its practitioners are (i.e., all health care workers, patients and advocates). Our simple and overarching model identifies four domains of patient safety (recipients of care, providers, therapeutics and methods) and the element...

- Pouvez-vous nous expliquer le fonctionnement et la coordination des urgences en France ?
- Quelle est la place du smartphone dans cette coordination ?
- Que pensez-vous de l’usage des applications mobiles  édiées à l’urgence ?
- Au-delà de l’urgence à proprement parler, le smartphone et les applis comme MedPics peuvent-elles permettent de transmettre un savoir ?

This paper discusses the information needs of regulators in the face of increasing globalization in medical education and practice, the history of information resources cataloging the world's medical education institutions, and the development of a tool that can fill an information gap concerning where and how physicians around the world are educated — the World Directory of Medical Schools. The World Directory was developed to meet the needs of medical regulators and other stakeholders who rely on specific data about medical schools and their educational programs. Its data model captures information about schools and programs as separate entities, allowing for greater flexibility and utility in the areas of regulation and workforce research.

Risk from sub-optimal medical practice remains a perennial international problem. While regulatory efforts for improvement have been significant, new thinking and innovation is needed. In an ideal world, professional career paths would be enhanced, supported and successfully maintained from medical school to retirement. Regulatory outcomes would be made resilient to public and professional challenge. Professional development, with quality improvement at its heart, would be maximized, and concerns about medical competency would be highlighted and acted upon at an early stage -- before they become “a fitness to practice” matter. At this early stage, referred to in this paper as the “amber zone,” concerns about an individual's ability to practice medicine competently may emerge, but they are not considered of sufficient severity to warrant a referral to a fitness to practice inquiry by medical regulators. The introduction of a concept called Insightful Practice is one attempt to ad...

Lifelong learning and self-assessment are tenets of medical education and health care improvement; quality and patient safety care are essential to the accreditation of organizations providing either continuing medical education (CME) or patient care; accredited CME providers must assess the learning needs of physicians: Accredited health care organizations must document physician participation in education that relates to the nature of care, treatment and services provided by the hospital. The credentialing and privileging of medical staff requires ongoing focused professional practice evaluation based on six general competencies, including compassionate care, medical knowledge, practice-based learning and improvement, effective communication, demonstrated professionalism and coordinated systems-based practice. As those charged with assessment and program evaluation are challenged to produce valid and reliable results to improve education and health care, United States licensing au...

Objectives: The introduction of medical revalidation in 2012 has been a controversial and radical change to medical regulation in the UK. It involved changes to the way organizations manage medical performance, and to the relationships between doctors, their employers and the professional regulatory body. In this paper, we explore the implementation of medical revalidation, analysing the change process and its consequences for doctors and organizations. Methods: We conducted a qualitative investigation of the implementation of revalidation in 15 case study organizations in 2016-2017, collecting documents and undertaking a total of 80 interviews with medical and non-medical staff. We used Normalization Process Theory to frame and structure the analysis. Results: Revalidation reforms were largely implemented successfully within and across our case study organizations, with evidence of growing acceptance of the purpose and processes of revalidation. There was an emergent shift from securing doctors' compliance towards the use of revalidation to strengthen clinical governance, and towards evaluating revalidation processes and seeking to make them more effective. However, there was substantial variation in the implementation and impact of revalidation; it was still not fully understood by many doctors, and revalidation processes were highly reliant on a few key individuals in each organization. The changes brought about by revalidation have had consequences for the way in which doctors construct their identity and the way they relate to the organizations in which they work. Conclusion: Despite considerable early scepticism and overt opposition in the medical profession, revalidation has become gradually accepted, embedded and even valued over time. Its impact and effectiveness are still questioned by many stakeholders, and the focus of attention has now shifted towards revising and improving the way revalidation works in practice.