HealthLawProf Blog

The 510(K) Third Party Review Program: Promise and Potential

Brian Miller (Johns Hopkins University), William Blanks (West Virginia University), Brian Yagi (Johns Hopkins University), The 510(K) Third Party Review Program: Promise and Potential (2023):

Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing via the 510(k) pathway. These constitute 99% of all devices approved for human use and includes the premarket review of many devices incorporating newer technology such as artificial intelligence (AI), machine learning (ML), and other software. As the complexity of these novel technologies and the number of applications is expected to increase in the coming years, statutory changes such as the 2016 21st Century Cures Act, regulations, and guidance documents have increased both the volume and complexity of device review. Thus, the ability to streamline the review of less complex, low-to-moderate risk devices through the 510(k) pathway will maximize the FDA’s capability to address other important, future-oriented regulatory questions. For over twenty five years, third party review organizations have served a defined function to assist with the review of 510(k) applications for a set of enumerated device classes. This paper reviews the history of FDA device regulation, the evolution of the 510(k) review pathway, and the recent history of the 510(k) third party review program. Finally, the paper addresses policy concerns from all stakeholders – including the FDA – along with policy suggestions to improve the third party review program and FDA device regulation writ large.

 

 

Love, Liberalism, Substituted Judgment

James Toomey (Pace University), Love, Liberalism, Substituted Judgment, 99 Ind. L. J. (Forthcoming):

Under the doctrine of substituted judgment, decision-makers for adults without legal capacity are to make the decision the person in their care would have made. In cases involving irreversible cognitive decline—where substituted judgment is most frequently applied—scholars have struggled to explain it, resorting to mysterious metaphysical claims. These philosophical acrobatics seem necessary because the person for whom the decision is made cannot appreciate it, and, philosophically, they may not be the same person they had been.

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Ella P. Stewart And The Benefits Of Owning A Neighborhood Pharmacy

Randall K. Johnson (University of Missouri, Kansas City), Ella P. Stewart And The Benefits Of Owning A Neighborhood Pharmacy, 7 Admin. L. Rev. Accord (2023):

This essay answers several open questions about one of the first Black women to earn a doctorate in Pharmaceutical Chemistry, Ella P. Stewart. For example, why did Stewart go beyond her narrow charge as a pharmacist, i.e., to sell goods and to fill prescriptions, in an attempt to generate additional benefits for her mostly African American customers? And why did this pharmacist choose to do that specific supplemental work, which included providing on-site lodging, meals and other support services, especially during a time and in a place that was particularly hostile to Black people? Particularly in cases wherein providing any such benefits to her largely African American customers came at a relatively high cost in terms of Stewart’s time, money and energy?

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Impact of Climate Change: Why Health Matters

Naveen Sukumaran (Cochin University), Impact of Climate Change: Why Health Matters (2022):

The effects of climate change on human health and lives of billions of people are already being felt throughout the world. Global warming alters various natural systems causing shifting rain patterns and distribution, glacial melting, and changes in the behavior and ecology of species and ecosystems. Such changes have resulted in rising sea levels, droughts, floods, and heat waves, and changes in the distribution and behavior of vectors and pathogens causing direct and indirect impact on human health. Physical trauma represents only a fraction of the health impact of climate change, most of the impact is due to non-traumatic conditions such as cardiovascular, respiratory, kidney, and vector-borne diseases, mental illness and psychosocial problems. Scientific studies have well established the unequivocal link between climate change, meteorological risks, and health. The capacity of health care systems to respond productively to the direct and indirect health effects of climate change is a challenge worldwide, especially among many of the least developed and developing countries, which suffer from unorganised, incompetent and insufficient health care resources. Climate change affects the most basic rights to health including right to clear air, safe water, sufficient food and adequate shelter. Health inequity and inequality, manifested through poverty, low education levels, food security, and other factors, play a major role in determining the extent of those health impacts. There is noticeable increase in research output on climate change and health in recent years. This paper attempts to analyze various health impacts associated with climate change and policies and strategies adopted to overcome them.

The Alternative Smoke-Free 2030 Plan

Christopher Snowdon (Independent), The Alternative Smoke-Free 2030 Plan (2022):

This year, Dr Javed Khan, former CEO of Barnardo’s, was commissioned by the Department of Health to draw up a plan to make England ‘smoke-free’ by 2030, a pledge made during Theresa May’s administration.

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Strengthening Policies and Structures to Combat Illicit Tobacco Trade in the Philippines

John Rafael Arda (Ateneo School of Government), Alen Josef Santiago (Ateneo School of Government), Strengthening Policies and Structures to Combat Illicit Tobacco Trade in the Philippines (2023):

The Philippines has been seeing an increase in illicit tobacco trade in recent years, undermining the impacts of legal measures such as tobacco products’ taxation and regulation due to circumvention of established avenues and costing the government its revenue. Currently, the country has twelve policies related to the prevention of illicit tobacco trade with gaps identified in its lack of licensing systems for tobacco retailers and policies on law enforcement cooperation, which manifests in the country being fully compliant to only 5 of the 16 articles under the World Health Organization's Illicit Tobacco Trade Protocol. It is recommended that the country establish a national agency or framework specifically for illicit tobacco trade to address its gaps under Tracking and Tracing, Due Diligence, and Unlawful Conduct.

COVID-19 Surveillance in India: A Bridge Too Far

Vrinda Bhandari (Independent), COVID-19 Surveillance in India: A Bridge Too Far, in Private and Controversial: When Public Health and Privacy Meet in India (Parsheera ed., Harper Collins, New Delhi) (2022):

This chapter evaluates the surveillance measures undertaken by the Central Govt. and various state governments in India during the Covid-19 pandemic. It presents a comprehensive mapping of the different types of physical and digital surveillance measures adopted by the state and by certain private actors to deal with the COVID situation. The chapter classifies these measures based on the underlying functions of symptom tracking, mobility and density mapping, quarantine enforcement, contact tracing, travel passes, and vaccination. Similar to the experience globally, India’s response to the pandemic has largely been a tech-centric one. But this has been done without a legal framework on data protection or sufficient focus on the utility, reliability, accuracy and security of many of the interventions. India’s legal response to the pandemic has hinged on its classification as a disaster, although the ‘long tail’ of the pandemic makes it very different from other types of disasters that are often of a finite and limited duration. The use of extraordinary technological measures to deal with the crises, therefore, comes with the fear of certain types of surveillance being normalized in the long run.

Systematizing Safety: The Urgent Need for Integrated Safety Management Systems in Healthcare

Carl Macrae (University of Nottingham), Systematizing Safety: The Urgent Need for Integrated Safety Management Systems in Healthcare (2022):

Patient safety remains a difficult and persistent challenge for healthcare organizations around the world. Despite enormous effort and considerable investment over the past several decades, frustrations are rising at the limited progress that has been made. One of the most striking features of the past few decades of effort to improve patient safety is the isolated and individuated character of much of this work: the field has blossomed with separate interventions, stand-alone programmes, discrete processes, individual roles, and distinct policies. This blooming of a thousand flowers across the field is indicative of the creativity and experimentalism that has been brought to bear on the problem of patient safety. But it is also indicative of something much more troublesome: fragmentation and—in its most literal sense—disintegration characterise many approaches to patient safety, both within individual healthcare organizations and across entire healthcare systems. What has long been missing—and what healthcare organizations and regulators urgently need to develop—are carefully structured and reliably implemented safety management systems in which all safety-relevant functions, activities, priorities and accountabilities are tightly integrated, properly resourced and coherently organized so that every potential source of harm and risk (and all sources of safety and resilience) can be proactively managed in each care setting across a healthcare system. This paper explores the challenge of what integrated systems of safety management should look like in healthcare and how we should get there. Three areas help point the way: other safety-critical sectors that have travelled this path before; emerging thinking and exploration in healthcare organisations; and the policy and legislative context that frames this journey. Each is considered in turn.

Innovate Food Law Workshops’ Proposals Workshop 1: Deliberative Mini-Publics for Benefits’ Assessment of Gene Edited Products Workshop 2: Making the Novel Food Regulation More Innovation-Friendly

Alexandra Molitorisová (University of Bayreuth), Alessandro Monaco (University of Bayreuth), Kai Purnhagen (University of Bayreuth), Innovate Food Law Workshops’ Proposals Workshop 1: Deliberative Mini-Publics for Benefits’ Assessment of Gene Edited Products Workshop 2: Making the Novel Food Regulation More Innovation-Friendly (2023):

This document contains a detailed methodology for 2 workshops to be held at the mid-term Innovate Food Law project meeting (http://innovatefoodlaw.eu) and will be open for observations by invited project partners and other interested parties. The 2 workshops consist of Workshop 1: Deliberative Mini-Publics for Benefits’ Assessment of Gene Edited Products and Workshop 2: Making the Novel Food Regulation More Innovation-Friendly. Workshop 1 and Workshop 2 will be running in parallel.

Sociotechnical Sources of Risk and Resilience in Autonomous and Intelligent Systems: Exploring Safety in the Implementation of Clinical Artificial Intelligence

Carl Macrae (University of Nottingham), Sociotechnical Sources of Risk and Resilience in Autonomous and Intelligent Systems: Exploring Safety in the Implementation of Clinical Artificial Intelligence (2023):

Autonomous and intelligent systems (AIS) are being developed and deployed across a wide range of sectors and encompass a variety of technologies designed to engage in different forms of independent reasoning and self-directed behaviour. AIS may bring considerable benefits to society but implementing these technologies poses a range of risk management challenges, particularly in safety-critical sectors where complex interactions between human, social and technical processes underpin safety and resilience. Healthcare is one safety-critical sector that is at the forefront of efforts to implement AIS, primarily through clinical artificial intelligence systems intended to support or replace key aspects of clinical work such as reading medical images to identify signs of pathology and make referral decisions. This paper develops a detailed qualitative analysis of the sociotechnical sources of risk and resilience associated with implementing clinical artificial intelligence in healthcare. The analysis draws on 40 in-depth interviews with participants actively involved in the implementation and regulation of clinical artificial intelligence. Qualitative template analysis is used to examine the sociotechnical sources of risk and resilience in the specific setting of healthcare, drawing on and elaborating Macrae's (2022) SOTEC framework that integrates structural, organisational, technological, epistemic and cultural sources of sociotechnical risk in AIS. This analysis characterises and contextualises the sociotechnical sources of risk associated with implementing AIS in healthcare and identifies an array of sociotechnical patterns of resilience that may counter those risks. Through this analysis, the paper extends the SOTEC framework to encompass new patterns of sociotechnical risk and explores the duality of risk and resilience in the management of safety.

The Law-Medicine Center at Case Western Reserve University School of Law Will Be Hosting a Talk Entitled: Prescribing Algorithmic Discrimination

Prescribing Algorithmic Discrimination, Wednesday, April 5^th 2023 at 12:00 PM- 1:00 PM

The talk will discuss the rise of federally-funded, state-operated prescription drug monitoring programs (PDMPs), the algorithmic risk scores they generate, the lack of validity of those scores, and their potential to discriminate against various protected classes, including women, racial minorities, and individuals with disabilities and, thereby, provoke poor health outcomes.  The talk will conclude with proposed legal and policy solutions intend to mitigate the potential discriminatory impacts of PDMP algorithmic risk scoring.

 

Our Presenter

Jennifer Oliva

Professor of Law, University of California Hastings College of Law

Register now for the April 5^th event!

Legal Considerations for Offering Metaverse-Based Education

Jon Garon (Nova Southeastern University), Legal Considerations for Offering Metaverse-Based Education (2023):

Although the metaverse is still in its early stages, those emerging metaverse platforms such as Roblox and Fortnite have over 400 million monthly active users, the majority of which are 13 or younger. A generation of learners and future citizens are emerging from a future that is not evenly distributed or well understood by the parents, educators, and policy makers who provide resources and establish educational policy.

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Legal Ableism: A Systematic Review of State Termination of Parental Rights Laws

Robyn Powell (University of Oklahoma), Legal Ableism: A Systematic Review of State Termination of Parental Rights Laws, Washington U. L. Rev. (Forthcoming):

Although the fundamental right to raise a family is among our m ost cherished, it is not equally afforded to everyone. Indeed, the United States has an appalling and enduring history of policing parenthood among people with disabilities. In recent years, the rights of parents with disabilities and their children have garnered unprecedented attention from activists, scholars, legal professionals, and policymakers. Nevertheless, the number of disabled parents who have their parental rights terminated is substantial and growing. As such, the roots of these ongoing injustices must be investigated. To that end, because the family policing system, including termination of parental rights, is primarily governed by state statutes, such an interrogation must begin there.

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“Just Do Something,” But Not that: The Structural Harms of Providing Mental Health Services Through the Bipartisan Safer Communities Act

Heather Swadley (Swarthmore College), “Just Do Something,” But Not that: The Structural Harms of Providing Mental Health Services Through the Bipartisan Safer Communities Act, Nebraska L. Rev. (Forthcoming):

Many have proclaimed that the Bipartisan Safer Communities Act is most sweeping gun control legislation to be passed in decades. However, the bill is not primarily a gun control bill—instead, much of the Act seeks to improve mental health services in hopes of preempting gun violence. Such a move is not rooted in established evidence, which finds little predictive value in knowing a someone’s mental health history. In fact, people with mental health disabilities are more likely to be victims of violent crimes than perpetrators. The Act therefore shifts the debate about gun reform from one about easy access to guns to one about improving mental health services. This is not without consequence.

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Older Persons and Climate Action

Alan S. Gutterman (Independent), Older Persons and Climate Action (2022):

Despite arguments, and some polling evidence, to the contrary, older adults are just as concerned as younger people about climate change; however, uncertainty remains about the optimal strategies for leveraging the resources that older people can bring to the debate surrounding climate change. One big problem is misconceptions about the physical and mental capabilities of older persons and their ability to contribute to climate action and there have been calls for a reframing of the general aging narrative in US society to emphasize that older adults represent a precious form of human capital with the potential to contribute creatively and constructively solving urgent societal problems, including those associated with climate change. The UN High Commissioner for Human Rights has argued that older persons possess enormous knowledge, experience, skills and resilience that give them the capacity to be key contributors in global efforts to mitigate and adapt to the negative impacts of climate change. The OHCHR emphasized the various ways in which older persons bring unique and important contributions to climate action, including supporting their families and communities financially and through informal care work, contributing to decision-making and conflict resolution, imparting important knowledge of science, history, tradition and culture and wielding significant voting and economic power that can be mobilized for effective climate policy. This chapter explores how older people can be involved in climate action as volunteers, voters, consumers and active participants in setting priorities and policies for addressing climate change.

A Look at the Current Status of the CRISPR Patent Interferences Involving Broad Institute, University of California and University of Vienna, ToolGen, and Sigma-Aldrich

Christopher M. Holman (University of Missouri), A Look at the Current Status of the CRISPR Patent Interferences Involving Broad Institute, University of California and University of Vienna, ToolGen, and Sigma-Aldrich, 41 Biotechnology L. Rep. 169 (2022):

This article reports on recent developments in patent interference proceedings relating to use of CRISPR-Cas9 for gene editing in a eukaryotic environment. The article begins with a brief overview of some substantive and procedural aspects of patent interference law of particular relevance to these proceedings, followed by a summary of the status of the interferences at the time this article was written, based primarily on information gleaned from the declarations of interference and motions filed by the various parties. It concludes with some thoughts on how things might ultimately settle out in the fight to control the patents in this important technological space.

Conjuring the Flag: The Problem of Implied Government Endorsements

Michael Mattioli (Indiana University), Conjuring the Flag: The Problem of Implied Government Endorsements, 83 Maryland L. Rev. (2024):

This Article exposes a prevalent and harmful form of advertising that exploits government actions like patent issuances, FDA authorizations, and trademark registrations. By calling upon the symbolic power of such regulatory approvals—i.e., “conjuring the flag”—marketers deceive consumers, distort competition, and undermine administrative agencies. Using machine-learning techniques to analyze thousands of ads across multiple media formats, this Article offers the first empirical study of this pervasive practice. The study reveals that it is especially prevalent in industry settings where consumers are likely to seek reassurance that a product is safe and effective. Specifically, the data shows that patents are mentioned most frequently in ads for supplements, cleansers, cosmetics, insect sprays, and hair products. It also shows that the USPTO contributes to the problem by registering trademarks that incorporate regulatory references. Consumer protection laws and regulations have failed to curb this practice, as advertisers have found subtle and legally permissible ways to manipulate consumer perception. This Article proposes two legal reforms to empower the FTC to address this issue more effectively. This Article thus sheds light on a crucial intersection of intellectual property, consumer protection, and administrative law.

The Rise and Fall of the Mental Health Inquiry for Bar Admission

Colin M. Black (Suffolk University), The Rise and Fall of the Mental Health Inquiry for Bar Admission, 50 Capital U. L. Rev. (2022):

For millennia, legal advocates have been expected to have good moral character. There can be no doubt that effective lawyering requires honesty and integrity. Over the years, how character is defined for practitioners has changed. In the 1970’s, the American Bar Association began evaluating bar applicant mental health as part of the good character evaluation. Ostensibly, this was done to protect the public and the administration of justice. In 2017, the American Bar Association recommended the elimination of the mental health questions on the character and fitness portion of the application to the bar. Notwithstanding, many jurisdictions continue to inquire into an applicant’s mental health status as a prerequisite to admission. Recently, however, the growing concern for lawyer well-being has highlighted the criticisms of this prophylactic inquiry. There is little evidence of a causal connection between mental health issues and unethical lawyering. Additionally, meritorious disability discrimination claims have warranted a reexamination of the practice of inquiring about the mental health of bar applicants. To be sure, the American Bar Association, bar authorities, law schools, and local bar organizations have all implemented various programs addressing the symptoms of the profession’s mental health crisis, including changes, and in some cases, the complete elimination of the mental health inquiry of the character and fitness evaluation portion of the bar application. All of these actions lead the author to conclude that the practice of inquiring about a bar applicant’s mental health serves no apt purpose nor predicts the ultimate elimination of the inquiry completely.

Evaluating the Carceral Kitchen: A Qualitative-Abductive Approach

Robb Elton (National University), Evaluating the Carceral Kitchen: A Qualitative-Abductive Approach (2022):

The U.S. criminal justice industrial complex (CJIC) consumes goods and services from industries ranging from health care, textiles, wood, metal to many products and proprietary strategies related to security, including specific architectural engineering designs. There are unfortunately millions of prisoners at any given time throughout facilities operated by numerous jurisdictions across the United States. The prisoners must be clothed, have access to health care, and they maintain a number of other rights under the U.S. Constitution. Prisoners must also be fed, thus, the CJIC also demands adequate food services, related staffing levels, including adequately trained and vetted personnel. Related to the CJIC are the policies, procedures, and laws governing limitations and carceral activities which affect logistics. The rationale for these rules must be understood by non-prisoners and potential employees of the CJIC alike, specific to the prison kitchen (carceral kitchen). The purpose of this article is to extrapolate reasons for the disparate absence of managerial, administrative literature from this sector, and perhaps that answer can be found in the ways and manner these environs (carceral kitchens) likely differ from commercial kitchens. The research draws upon author observation and experiences from commercial and carceral kitchens. The findings from this research are hopefully informative for future students/graduates in related fields in that it infers opportunities and skills applicable for applying culinary arts and food service in carceral kitchen systems. The findings suggest that geography/security strategy inhibits access to professional/academic opportunities. Additionally, however this niche can be a place for advancement and opportunity for entry level workers while at the same time demand creativity and managerial prowess/people skills.

Corrupt or Charitable? Patient Assistance Programs and the Case for Narrowing the Breadth of the Federal Anti-Kickback Statute

Isaac Strauss (Yeshiva University), Corrupt or Charitable? Patient Assistance Programs and the Case for Narrowing the Breadth of the Federal Anti-Kickback Statute, 44 Cardozo L. Rev. 2 (2022):

This Note surveys how the Federal Anti-Kickback Statute serves to penalize helpful healthcare arrangements in which pharmaceutical companies seek to assist patients with their cost-sharing obligations under Medicare Part D.

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