FDA Regulation and Approval of Medical Devices: 1976-2020.

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

Reflexiones a raíz del Covid-19 y la Ley del juego y prevención de la ludopatía de la Comunitat Valenciana (Ley 1/2020, de 11 de junio) / Reflections on Covid-19 and the Gambling and Prevention of Compulsive Gambling Law of the Region of Valencia(Law 1/2020, of 11th June)

No disponible

"It's about how much we can do, and not how little we can get away with": Coronavirus-related legislative changes for social care in the United Kingdom.

The coronavirus pandemic, referred to here as Covid-19, has brought into sharp focus the increasing divergence of devolved legislation and its implementation in the United Kingdom. One such instance is the emergency health and social care legislation and guidance introduced by the United Kingdom Central Government and the devolved Governments of Wales, Scotland and Northern Ireland in response to this pandemic. We provide a summary, comparison and discussion of these proposed and actual changes with a particular focus on the impact on adult social care and safeguarding of the rights of citizens. To begin, a summary and comparison of the relevant changes, or potential changes, to mental health, mental capacity and adult social care law across the four jurisdictions is provided. Next, we critique the suggested and actual changes and in so doing consider the immediate and longer term implications for adult social care, including mental health and mental capacity, at the time of publication.several core themes emerged: concerns around process and scrutiny; concerns about possible changes to the workforce and last, the possible threat on the ability to safeguard human rights. It has been shown that, ordinarily, legislative provisions across the jurisdictions of the UK are different, save for Wales (which shares most of its mental health law provisions with England). Such divergence is also mirrored in the way in which the suggested emergency changes could be implemented. Aside from this, there is also a wider concern about a lack of parity of esteem between social care and health care, a concern which is common to all. What is interesting is that the introduction of CVA 2020 forced a comparison to be made between the four UK nations which also shines a spotlight on how citizens can anticipate receipt of services.

La nueva calidad / No disponible

No disponible

Autonomía y heteronomía, una alianza necesaria para el abordaje del tabaquismo. Visión de profesionales y pacientes / Autonomy and heteronomy, a necessary alliance to address smoking cessation. Views of professionals and patients

Objetivo: Explorar la percepción de profesionales y pacientes sobre las cuestiones éticas que entraña la atención al tabaquismo en las consultas de atención primaria. Método: Se diseñó un estudio cualitativo. Se realizaron entrevistas semiestructuradas a 12 profesionales y 7 pacientes, y dos grupos focales con 6 profesionales y 7 pacientes de atención primaria (32 participantes en total). Se realizó un muestreo intencional buscando perfiles de profesionales y pacientes de ambos sexos, distintas edades y experiencia en relación con el tabaquismo. El análisis de contenido siguió una estrategia analítica inductiva desde los datos hasta la creación de categorías teóricas. Resultados: Se identificaron cuatro categorías principales: 1) cuestiones éticas relativas a la responsabilidad del/de la profesional con el/la paciente fumador/a; 2) cuestiones relacionadas con la actitud que debe mostrar el/la profesional ante el/la paciente; 3) aspectos relacionados con la justicia en la distribución de recursos y con el papel de la Administración pública en el control del tabaquismo; y 4) cuestiones relativas a la autonomía de la persona fumadora con respecto al consumo y al cese del tabaquismo. Conclusiones: Es necesaria una alianza entre la ética que favorece la auténtica autonomía de la persona fumadora y la regulación heterónoma del consumo de tabaco. Sería conveniente incluir estas cuestiones en los programas de formación para el manejo del tabaquismo por parte de los/las profesionales

Objective: To explore the perception of professionals and patients with regard to ethical issues involved in addressing the habit of smoking in primary care consultations. Method: A qualitative study was designed, consisting of 12 semi-structured interviews with professionals, 7 interviews with patients and 2 focus groups with 6 professionals and 7 primary care patients (a total of 32 participants). An intentional sampling was conducted, including profiles of professionals and patients of both sexes, different ages and experience in relation to smoking. A content analysis was performed with an inductive analytical approach from data to the creation of theoretical categories. Results: Four main categories were identified: 1) ethical issues related to the responsibility of the professional when treating patients who smoke; 2) issues related to attitude to patients who smoke; 3) issues related to fair and equitable distribution of resources and to the role of the different levels of government in relation to the control of smoking; and 4) issues related to smokers' autonomy regarding their habit and smoking cessation. Conclusions: An alliance is needed between the ethics that support the autonomy of patients who smoke and the regulation of tobacco consumption. This approach should be included in clinical training programmes dealing with tobacco use, dependence and cessation

The Impact of Breast Density Notification Laws on Supplemental Breast Imaging and Breast Biopsy.

BACKGROUND: Dense breast tissue increases breast cancer risk and lowers mammography sensitivity, but the value of supplemental imaging for dense breasts remains uncertain. Since 2009, 37 states and Washington DC have passed legislation requiring patient notification about breast density. OBJECTIVE: Examine the effects of state breast density notification laws on use of supplemental breast imaging and breast biopsies. DESIGN: Difference-in-differences analysis of supplemental imaging and biopsies before and after notification laws in 12 states enacting breast density notification laws from 2009 to 2014 and 12 matched control states. Supplemental imaging/biopsy within 6 months following an index mammogram were evaluated during four time periods related to legislation: (1) 6 months before, (2) 0-6 months after, (3) 6-12 months after, and (4) 12-18 months after. PARTICIPANTS: Women ages 40-64 years receiving an initial mammogram in a state that passed a breast density notification law or a control state. INTERVENTION: Mandatory breast density notification following an index mammogram. MAIN MEASURES: Use of breast biopsies and supplemental breast imaging (breast ultrasound, tomosynthesis, magnetic resonance imaging, scintimammography, and thermography), overall and by specific test. KEY RESULTS: Supplemental breast imaging and biopsy increased modestly in states with notification laws and changed minimally in control states. Adjusted rates of supplemental imaging and biopsy within 6 months of mammography before legislation were 8.5% and 3.1%, respectively. Compared with pre-legislation in intervention and control states, legislation was associated with adjusted difference-in-differences estimates of + 1.3% (p < 0.0001) and + 0.4% (p < 0.0001) for supplemental imaging and biopsies, respectively, in the 6-12 months after the law and difference-in-differences estimates of + 3.3% (p < 0.0001) and + 0.8% (p < 0.0001) for supplemental imaging and biopsies, respectively, 12-18 months after the law. CONCLUSIONS: As breast density notification laws are considered, policymakers and clinicians should expect increases in breast imaging/biopsies. Additional research is needed on these laws' effects on cost and patient outcomes.

[A new end-of-life law? An Italian detour]. / Une nouvelle loi pour la fin de vie ? - Détour par l'Italie.

On January 31, 2018, advance directives law has come into effect in Italy. It is a law that grants the right to any individual of full age to express his or her preferences regarding treatment in anticipation of the days when he or she might be unable to do so. In France, however, two years after its entry into effect, the Claeys-Leonetti law is increasingly under attack. Some are even calling for a new end-of-life legislation altogether. A discussion of the Italian case, focused on the debates that led to the approval of this new legislation, can help us re-contextualize the French case. While there are many similarities between the two laws, their differences in terms of practices and intellectual frameworks may suggest additional avenues of thinking and help improve end-of-life conditions.

The continuing saga of patents and non-invasive prenatal testing.

OBJECTIVE: This paper examines the Intellectual Property (IP) landscape for non-invasive prenatal testing (NIPT) in three key regions: the United States; Europe, with particular focus on the United Kingdom; and Australia. METHOD: We explore the patent law issues against the commercial and healthcare environment in these regions and consider the implications for development and implementation of NIPT. RESULTS: There are many patents held by many parties internationally, with litigation over these patents ongoing in many countries. Importantly, there are significant international differences in patent law, with patents invalidated in the USA that remain valid in Europe. Despite the many patents and ongoing litigation, there are multiple providers of testing internationally, and patents do not appear to be preventing patient access to testing for those who can pay out of pocket. CONCLUSION: The patent situation in NIPT remains in a state of flux, with uncertainty about how patent rights will be conferred in different jurisdictions, and how patents might affect clinical access. However, patents are unlikely to result in a monopoly for a single provider, with several providers and testing technologies, including both public and private sector entities, likely to remain engaged in delivery of NIPT. However, the effects on access in public healthcare systems are more complex and need to be monitored.

Medical-Legal Partnership Impact on Parents' Perceived Stress: A Pilot Study.

Stress has adverse effects on health, and prolonged stress exposure is a risk factor for several mental and physical illnesses. 1 Families living in poverty face many stressors created and maintained by economic hardship and unaddressed legal and social needs. Medical-Legal Partnerships (MLPs) aim to improve health and well-being by addressing health-harming legal and social needs of patients. This pilot study examined whether MLP-involved parents perceived themselves as stressed; to what they attributed their stress; and whether they reported a reduction in stress when their MLP cases were closed. The study shows improvements in perceived stress following receipt of MLP interventions.

Análisis doctrinal y jurisprudencial de los delitos de descubrimiento y revelación de secretos en el ámbito sanitario / Doctrinal and jurisprudential analysis of the crimes of discovery and revelation of secrets in the health field

La protección de la intimidad y de los datos personales reservados es una de las bases fundamentales de la relación entre médico y paciente. A pesar de ello, en ocasiones, los facultativos transmiten a un tercero los datos contenidos en la historia clínica incurriendo en un delito perseguible desde el derecho penal. Este artículo comienza analizando los artículos 197 a 201 del Código Penal español para contextualizar la materia a tratar y otorgar una visión amplia de esta modalidad delictiva, y se centra después en el artículo 199.2 del mismo texto legal por ser el que, de manera específica, se aplica a los profesionales sanitarios obligados al sigilo que incurren en dicha conducta. Además, se hace una útil mención a aspectos prácticos como el alcance del secreto profesional del médico o las causas de exclusión del mismo. Por último, se analiza la jurisprudencia existente en relación con la cuestión, a pesar de su escasez. El presente artículo pretende servir por igual a profesionales del derecho y de la medicina para comprender más en profundidad, siempre desde la perspectiva del derecho penal, el descubrimiento y revelación de secretos en el ámbito sanitario

The protection of privacy and private personal data is one of the cornerstones of the physician-patient relationship. In spite of this, doctors sometimes transmit the data contained in the medical history to a third party, thereby committing a crime that can be prosecuted under criminal law. This article begins by analysing articles 197 to 201 of the Spanish Criminal Code in order to contextualize the matter to be dealt with and give a broad view of this type of crime. It then focuses on article 199.2 of the same legal text because it is the one which specifically applies to health professionals forced to secrecy who engage in such conduct. In addition, it includes a useful mention of practical aspects such as the scope of the physician's professional secrecy or the causes of exclusion from it. Finally, it analyses the existing jurisprudence in relation to the issue, despite its scarcity. This article aims to serve law and medicine professionals alike to understand more deeply, always from the perspective of criminal law, the discovery and disclosure of secrets in the health field

Are the Italian ethics committees ready for Europe? Commentary.

The Law of 3 January 2018 established in Italy the "National Centre for the Coordination of Regional Ethics Committees for Clinical Trials of Medicines and Medical Devices for Human Use" and reduced the number of ethics committees in the country to 40. This Act should, amongst other things, facilitate Italy's compliance with the provisions set forth in European Regulation (EU) 536/2014. Hopefully, in addition to the provisions set forth in the Law, the National Centre will strive to foster the harmonisation of ethics committee procedures, in order to reform Italian legislation on the evaluation of clinical trials and, more generally, biomedical studies.

Diminished Responsibility: Law Reform in the United Kingdom and Personal Perspective on Forensic Psychiatric Practice in Hong Kong.

This commentary discusses law reform on diminished responsibility in the United Kingdom and provides a personal perspective on forensic psychiatric practice relating to diminished responsibility in Hong Kong.

[CRIMINAL RESPONSIBILITY OF MEDICAL AND ITS CASE LAW EVOLUTION. LEGAL AND ECONOMIC PROFILES].

The article deals with the regulatory and jurisprudential evolution of medical criminal responsibility from the 70s to the Gelli-Bianco law of 2017. Subsequently it winds through the contribution of the last important judgments of the subject up to the decisions of the Supreme Court with United Sections of 2018, finally to conclude with an economic analysis on the increasement of the legal disputes registered in recent years.

DTC genetic testing and the role of science museums in building ethical and legal awareness / Pruebas genéticas directas al consumidor y el papel de los museos de ciencias en la creación de conciencia ética y legal

By focusing institutions' responsibility to create citizens mindful of their rights and of the interests involved in genomic knowledge and its exploitation, science museums are proposed as agoras where spreading scientific knowledge together with legal information and education. An original tool to engage citizens and build awareness on innovations with high ethical and legal significance is presented

Al centrarse en la responsabilidad de las instituciones para crear ciudadanos conscientes de sus derechos y de los intereses involucrados en el conocimiento genómico y su explotación, se proponen museos de ciencia como ágoras donde se difunda el conocimiento científico junto con la información legal y la educación. Se presenta una herramienta original para involucrar a los ciudadanos y crear conciencia sobre las innovaciones con gran importancia ética y legal