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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.

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., (Crown Copyright © 2020. Published by Elsevier Ltd. All rights reserved.)

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.

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., (© 2019 The Authors. Prenatal Diagnosis Published by John Wiley & Sons Ltd.)

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., (© 2019 médecine/sciences – Inserm.)

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.

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., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

The 2018 12 th Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches. This 2018 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2018 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for PK, PD and ADA assays by hybrid LBA/LCMS and regulatory agencies' input. Part 1 (LCMS for small molecules, peptides, oligonucleotides and small molecule biomarkers) and Part 3 (LBA/cell-based assays: immunogenicity, biomarkers and PK assays) are published in volume 10 of Bioanalysis , issues 22 and 24 (2018), respectively.

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.

Endocrine disruptors commonly make the headlines of newscasts and magazines, which is not without generating questions, even anxieties, with the general public. In a recent survey, 90% of French people considered it desirable to set up regulations concerning endocrine disruptors. However, under pressure from the lobbies of the chemical industry, and also due to scientific conflicts, the European Union is slow to legislate and has even been condemned before the European Court for failing to fulfill its obligations. This article does not intend to be exhaustive on the issue of endocrine disrupters, but rather to give the reader a certain number of keys enabling him to understand why national or European regulators are slow to establish specific regulation., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

The objective of the article is to study the main theoretical and practical problems arising within the introduction of contractual regulation of legal relations between a patient and a medical institution, which is connected with the reform of the health care system in Ukraine. In the process of writing a scientific article, the authors have used general scientific, special and legal methods. For example, in July-September 2017, there was a study in Ukraine, when 1,200 people aged 18 and over were interviewed using a formalized interview method. The studies of 82% of surveyed Ukrainians confirmed that Ukrainian medicine does not properly function and needs to be reformed. The beginning of the medical reform in Ukraine was marked by the development of new bills and introduction of innovations into the current legislation, one of which is the conclusion of a declaration with a doctor for the primary medical care. Thus, the legislator tried to introduce organizational and legal ways to improve the functioning of medical workers, to raise the efficiency and development of the medical services market, and also to guarantee the protection of patients' rights. Taking into account the analysis of contractual regulation of legal relations between a doctor and a patient in other countries, the authors of the article have suggested to apply positive experience of reforming the health care system in England, which is the most optimal and effective for introduction in Ukraine. The analysis of the data, obtained results during the study of the initial stage of the medical reform shows that there are gaps in the legislation and about the need to reform the health care system in Ukraine.

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.

Background: Wearable devices offer huge potential to collect rich sources of data to provide insights into the effects of treatment interventions. Despite this, at the time of writing this report, limited regulatory guidance on the use of wearables in clinical trial programs has been published., Objectives: To present recommendations from the Critical Path Institute's Electronic Patient-Reported Outcome Consortium regarding the selection and evaluation of wearable devices and their measurements for use in regulatory trials and to support labeling claims., Methods: The evaluation group was composed of Critical Path Institute's clinical outcome assessment (COA) scientists and COA specialists from pharmaceutical trial eCOA solution providers, including COA development and validation specialists. The resulting recommendations were drawn from a broad range of backgrounds, perspectives, and expertise that enriched the development of this report. Recommendations were developed through analysis of existing regulatory guidance relating to COA development and use in clinical trials, medical device certification/clearance regulations, literature-reported best practice, and practical experience of wearable technology application in clinical trials., Results: We identify the essential properties of fit-for-purpose wearables and propose evidence needed to support their use. In addition, we overview the activities required to establish clinical endpoints derived from wearables data., Conclusions: Using this framework, we believe there is enough current understanding to promote the appropriate use of wearables in study protocols. We hope this will provide a basis for discussion among clinical trial stakeholders and catalyze the development of more robust regulatory guidance., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management., (Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Transplant medicine in Germany is regulated by mandatory guidelines of the German Medical Association, the transplant law passed in 1997 serving as the legal basis. In 2012 a comprehensive modification of the guideline procedure was initiated. Since then, all guidelines are subject to an elaborate revision process. The present contribution initially depicts relevant background information and explains the formal aspects of the guideline procedure. Subsequently, the psychologically/psychosomatically relevant contents of the guidelines for organ transplantation are presented. With regard to this matter, first of all the state of the guidelines prior to the current revisions is described. Afterwards, already adopted revisions as well as published drafts are explicated, followed by the authors' evaluation of the revisions and recommendations for further revisions to be pursued. In addition, recommendations on psychosocial aspects regarding the evaluation and follow-up in living organ donation are presented, which have been submitted in similar form to the German Medical Association for a currently drawn up guideline., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

The punitive culture continues to prevail in health care organizations that rely primarily on functional systems hierarchies based on conformity. This type of culture is recognized as a major source of an unacceptable number of medical errors. The safety culture has emerged as an imperative to improve the quality and safety of patient care, but also as a shield against the judgments targeted towards the caregivers (doctor and / or nurse) involved in an undesirable event. The safety culture allows a broader view of the error by analyzing both system failures and staff incompetence. Therefore, it places caregivers in their workplace with mutual interactions and protects them from "second victim" status. It is imperative to have a reflection on the safety culture that constitutes a proof of transparency and openness towards society about the mistake that remains taboo. This attitude will avoid the risk of "judicialization of health".

From a research perspective, the interest in biobanking continues to intensify. Governments and industry have invested heavily in biobanks, as exemplified by initiatives like the United Kingdom Biobank and United States' Precision Medicine Initiative. But despite this enthusiasm, many profound legal and ethical challenges remain unresolved. Indeed, there continues to be disagreements about how best to obtain consent and the degree and nature of control that research participants retain over donated samples and health information. Emerging social trends-including concerns about commercialization and perceived rights of continuing control ("biorights")-seem likely to intensify these issues.

Harm reduction policies and attitudes in the United States have advanced substantially in recent years but still lag behind more advanced jurisdictions in Europe and elsewhere. The Obama administration, particularly in its last years, embraced some harm reduction policies that had been rejected by previous administrations but shied away from more cutting edge interventions like supervised consumption sites and heroin-assisted treatment. The Trump administration will undermine some of the progress made to date but significant state and local control over drug policies in the US, as well as growing Republican support for pragmatic drug policies, motivated in part by the opioid crisis, ensures continuing progress for harm reduction.

Reservations in super-specialty courses have been controversial for decades. A number of practising doctors, medical students and others in society have wanted to do away with reservations in specialty and super-specialty courses, while there are others in favour of persisting with reservations. Article 15 (4) of the Constitution of India states that nothing shall prevent the State from making any special provision for the advancement of any socially and educationally backward classes of citizens or for the Scheduled Castes/Tribes. However, Article 14 of the Indian Constitution should also be considered. The judiciary, particularly, the Supreme Court of India, in its judgments has strived to strike a balance between the two constitutional provisions. The Supreme Court, on various occasions, has observed that reservations in super-specialty courses should be done away with, as such reservations would be detrimental to the advancement of medical science and research and will also not serve national interest. We present the observations of the Supreme Court of India through its various judgments, with a focus on the recent case of Dr Sandeep versus Union of India, where the honourable court stated that the government should do away with reservations in super-specialty courses.

The expanded use of electronic data retrieval systems has greatly expanded the potential sources of real-world data and presents new opportunities for evidence generation outside of the traditional research trial. These data may be used to inform trial design and interpretation as well. Externally controlled trials, such as single-arm and noninferiority designs, have long been used in regulatory decision-making despite the potential flaws based on assumptions of assay sensitivity and constancy., (Published 2017. This article is a U.S. Government work and is in the public domain in the USA.)

The US Food and Drug Administration (FDA) approved the first oncolytic viral therapy (OVT), Imlygic (talimogene laherparepvec), in October 2015 for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery, although talimogene has not been shown to improve overall survival or have an effect on visceral metastases., (Published 2017. This article is a U.S. Government work and is in the public domain in the USA.)

The number of serum 25-hydroxyvitamin D (25OHD) assays has increased tenfold in France in less than 10 years, sometimes for invalidated reasons. In 2013, the French National Authority for Health (Haute autorité de santé, or HAS) limited the indications for serum 25OHD measurements to rickets/osteomalacia, older adults with recurrent falls, monitoring of kidney transplant in adults, and surgical treatment of obesity in adults. Our aim here was to note that other indications for serum 25OHD measurements are supported by previous literature and by a number of national and international recommendations, in particular the following: any situation of bone fragility, any chronic renal failure <45 mL/min/1.73m 2 , any situation of malabsorption, clinical signs consistent with vitamin D deficiency or vitamin D overload, and calcium phosphorus evaluation. We suggest that the measurement of serum 25OHD concentration should remain reimbursed as part of these extended indications.

The application since September 2014 of the new 17 March 2013 law «reforming disability schemes and introducing a new protection status in accordance with human dignity», restates the legal approach to helping vulnerable people. The changes are complex and wide-ranging. This article describes the key elements of the reform, focusing particularly on the role of the medical doctor.

The energy of the legislator in the healthcare system was barely stoppable in 2015. Many new laws have been brought into force and legal initiatives have also been implemented. The Hospital Structure Act, the Treatment Enhancement Act, amendments of the official medical fee schedules for physicians, the Prevention Act, the E-Health Act, the Anti-corruption Act, the hospital admission guidelines and amendments of the model specialty training regulations are just some of the essential alterations that lie ahead of the medical community. This article gives a review of the most important new legislative regulations in the healthcare system and presents the fundamental consequences for the practice.

Conditional and directed deceased organ donations occur when donors (or often their next of kin) attempt to influence the allocation of their donated organs. This can include asking that the organs are given to or withheld from certain types of people, or that they are given to specified individuals. Donations of these types have raised ethical concerns, and have been prohibited in many countries, including the UK. In this article we report the findings from a qualitative study involving interviews with potential donors (n = 20), potential recipients (n = 9) and transplant staff (n = 11), and use these results as a springboard for further ethical commentary. We argue that although participants favoured unconditional donation, this preference was grounded in a false distinction between 'medical' and 'non-medical' allocation criteria. Although there are good reasons to maintain organ allocation based primarily upon the existing 'medical' criteria, it may be premature to reject all other potential criteria as being unacceptable. Part of participants' justification for allocating organs using 'medical' criteria was to make the best use of available organs and avoid wasting their potential benefit, but this can also justify accepting conditional donations in some circumstances. We draw a distinction between two types of waste - absolute and relative - and argue that accepting conditional donations may offer a balance between these forms of waste., (© 2015 The Authors. Bioethics published by John Wiley & Sons Ltd.)

Genetic testing reveals information about a patient's health status and predictions about the patient's future wellness, while also potentially disclosing health information relevant to other family members. With the increasing availability and affordability of genetic testing and the integration of genetics into mainstream medicine, the importance of clarifying the scope of confidentiality and the rules regarding disclosure of genetic findings to genetic relatives is prime. The United Nations International Declaration on Human Genetic Data urges an appreciation for principles of equality, justice, solidarity and responsibility in the context of genetic testing, including a commitment to honoring the privacy and security of the person tested. Considering this global mandate and recent professional statements in the context of a legal amendment to patient privacy policies in Australia, a fresh scrutiny of the legal history of a physician's duty to warn is warranted. This article inquiries whether there may be anything ethically or socially amiss with a potential future recommendation for health professionals or patients to universally disclose particular cancer predisposition genetic diagnosis to genetic family members. While much of the discussion remains applicable to all genetic diagnosis, the article focuses on the practice of disclosure within the context of BRCA1/2 diagnosis. An 'ethic of care' interpretation of legal tradition and current practice will serve to reconcile law and medical policy on the issue of physician disclosure of genetic results to family members without patient consent., (© 2015 John Wiley & Sons Ltd.)

The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before 28 May 2016, provides an opportunity to review the legal and political context within which this important aspect of research law and policy sits and to reflect on the implications for public health. My aim in this article is to relate the context to the key purposes and aims of EU law and policy on clinical trials in order to explain and clarify its orientation. On that basis, I argue that the CTR and the changes it introduces to the law on clinical trials are part of the EU's continued focus on market optimisation. It is this focus that orients and directs the wider pharmaceutical development pipeline, but that undermines the achievement of key public health objectives., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

The energy of the legislator in the healthcare system was barely stoppable in 2015. Many new laws have been brought into force and legal initiatives have also been implemented. The Hospital Structure Act, the Treatment Enhancement Act, amendments of the official medical fee schedules for physicians, the Prevention Act, the E-Health Act, the Anti-corruption Act, the hospital admission guidelines and amendments of the model specialty training regulations are just some of the essential alterations that lie ahead of the medical community. This article gives a review of the most important new legislative regulations in the healthcare system and presents the fundamental consequences for the practice.

Critical congenital heart disease (CCHD) screening is rapidly becoming the standard of care in the United States after being added to the Recommended Uniform Screening Panel (RUSP) in 2011. Newborn screens typically do not require affirmative parental consent. In fact, most states allow parents to exempt their baby from receiving the required screen on the basis of religious or personally held beliefs. There are many ethical considerations implicated with allowing parents to exempt their child from newborn screening for CCHD. Considerations include the treatment of religious exemptions in our current legal system, as well as medical and ethical principles in relation to the rights of infants. Although there are significant benefits to screening newborns for CCHD, when a parent refuses for religious or personal beliefs, in the case of CCHD screening, the parental decision should stand.