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In 2022, the Camden Coalition Medical-Legal Partnership began providing civil and criminal legal services to substance use disorder patients at Cooper University Health Care's Center for Healing. This paper discusses early findings from the program's first year on the efficacy of the provision of criminal-legal representation, which is uncommon among MLPs and critical for this patient population. The paper concludes with takeaways for other programs providing legal services in an addiction medicine setting. [ABSTRACT FROM AUTHOR]

This paper summarizes key shifts in judicial decisions relating to public health powers during the pandemic and the implications of those decisions for public health practice. Then, it gives a preview and call for partnership in developing a legal framework for authority that guides public health to better activities, processes, and accountability in service of the public's health. [ABSTRACT FROM AUTHOR]

Medical legal partnerships address individual legal needs that can create impediments to health. Little is known about outcomes from medical legal partnerships and their relationship to access to justice. This paper reports outcomes from one medical legal partnership from the perspective of the client, with specific emphasis on impact on health and concepts related to access to justice. We suggest a conceptual model for incorporating medical legal partnerships into a broader framework about access to justice. [ABSTRACT FROM AUTHOR]

This Paper argues that to protect at-risk communities — and all Americans — from the deadly effects of environmental racism, Congress must pass the Environmental Justice for All Act. The Act is intended to "restore, reaffirm, and reconcile environmental justice and civil rights." It does so by restoring an individual's right to sue in federal court for discrimination based on race, ethnicity, or national origin regardless of intent under the Civil Rights Act of 1964, strengthening the National Environmental Policy Act, and providing economic incentives focused on environmental justice. [ABSTRACT FROM AUTHOR]

This paper challenges historically preconceived notions surrounding a minor's ability to make medical decisions, arguing that federal health law should be reformed to allow minors with capacity as young as age 12 to consent to their own Centers for Diseases Control and Prevention (CDC)-approved COVID-19 vaccinations. This proposal aligns with and expands upon current exceptions to limitations on adolescent decision-making. This analysis reviews the historic and current anti-vaccination sentiment, examines legal precedence and rationale, outlines supporting ethical arguments regarding adolescent decision-making, and offers rebuttals to anticipated ethical counterarguments. [ABSTRACT FROM AUTHOR]

Précis: Despite significant scholarship, research, and funding dedicated to implementing criminal diversion programs over the past two decades, persons with serious mental illness and substance use disorders remain substantially overrepresented in United States jails and prisons. Why are so many U.S. adults with behavioral health problems incarcerated instead of receiving treatment and other support to recover in the community? In this paper, we explore this persistent problem within the context of "relentless unmet need" in U.S. behavioral health (Alegría et al., 2021). [ABSTRACT FROM AUTHOR]

This article discusses the misalignment of the drug innovation model in the US with broader societal goals. The paper calls for a reconfiguration of this model to prioritize the common good and ensure equitable access to health innovations. The article stresses the importance of adopting a mission-oriented approach to shape the drug market, including reforming intellectual property rights. [ABSTRACT FROM AUTHOR]

Medical-legal partnerships connect legal advocates to healthcare providers and settings. Maintaining effectiveness of medical-legal partnerships and consistently identifying opportunities for innovation and adaptation takes intentionality and effort. In this paper, we discuss ways in which our use of data and quality improvement methods have facilitated advocacy at both patient (client) and population levels as we collectively pursue better, more equitable outcomes. [ABSTRACT FROM AUTHOR]

Health systems are integrating medical-legal partnerships (MLPs) into clinical care and increasingly center "complex care" patients. These patients have intersecting medical and social needs and often face systemic inequities that exacerbate their chronic health conditions. This paper describes a role for MLPs in hospital quality initiatives; examines the ethics of MLPs assisting with guardianship and institutionalization of hospital patients including marginalized groups; and advocates for MLP interventions designed to address intersectional and ethical concerns. [ABSTRACT FROM AUTHOR]

Palliative care and medical-legal partnership are complementary disciplines dedicated to integrating care to treat the whole patient and intervening before a legal or medical issue is at a crisis point. In this paper, we discuss the founding and operations of the Yale Palliative Medical Legal Partnership, give examples of typical cases, explain special considerations in this area of law, and propose areas for further research. [ABSTRACT FROM AUTHOR]

The social ecological model (SEM) is a conceptual framework that recognizes individuals function within multiple interactive systems and contextual environments that influence their health. Medical Legal Partnerships (MLPs) address the social determinants of health through partnerships between health providers and civil legal services. This paper explores how the conceptual framework of SEM can be applied to the MLP model, which also uses a multidimensional approach to address an individual's social determinants of health. [ABSTRACT FROM AUTHOR]

This paper will review the strategies and learning trajectories followed to tap the opportunities opened by the successive waves of biotechnologies: early imitators followed by late imitators in the first generation of biosimilars (erythropoietin, insulins, interferons), and then sequential entry and skipping stages during the second generation (monoclonal antibodies). [ABSTRACT FROM AUTHOR]

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow. [ABSTRACT FROM AUTHOR]

This paper aims to characterize the main actors in the Brazilian pharmaceutical industry — national companies, foreign companies and public laboratories — and analyze how they were affected and how they reacted to changes over the last 30 years in the institutional framework. The results show that national companies have been gaining prominence in the Brazilian pharmaceutical market with their internationalization movement and their strengthening of innovation strategies. [ABSTRACT FROM AUTHOR]

This paper reviews the main pricing policies in Latin American countries, discussing their shortcomings. It also gives an overview of the most common pricing and reimbursement policies in Europe and describes in detail three well-established approaches — international price referencing, value-based pricing, including setting up of health technology assessment, and generic and biosimilar policies — building on country examples. [ABSTRACT FROM AUTHOR]

This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics. [ABSTRACT FROM AUTHOR]

In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust. [ABSTRACT FROM AUTHOR]

This paper reviews common advertising claims by egg freezing companies and evaluates the medical evidence behind those claims. It then surveys legal standards for truth in advertising, including FTC and FDA regulations and the First Amendment right to free speech. Professional standards for medical advertising, such as guidelines published by the American Society for Reproductive Medicine (ASRM), the American College of Obstetricians and Gynecologists (ACOG), and the American Medical Association (AMA), are also summarized. A number of claims, many of which relate to the targeting of younger women for eOC, are found to breach legal and ethical standards for truth in advertising. The ethical implications of misleading advertising claims are also discussed, and the central narrative woven by OC ads — that egg freezing is empowering to women — is examined. The paper concludes that a more balanced approach to the risks and benefits of OC is necessary to truly respect women's autonomy. Moreover, justice requires us to look beyond a medical procedure accessible only to a minority of women in order to address inequities in the workplace. [ABSTRACT FROM AUTHOR]

This paper evaluates the existing research on Stand Your Ground (SYG) laws in terms of the extent to which it has accounted for gender. In particular, we address (a) what the available evidence suggests are the gender-based impacts of SYG laws and (b) where, how, and why considerations of gender may be missing in available studies. [ABSTRACT FROM AUTHOR]

This paper examines the lawsuits brought by state and local government entities against prescription opioid producers and sellers. It examines their potential liability as well as some of the defenses they might raise. The paper also discusses multidistrict litigation and government lawsuits in state court. It concludes that litigation is not the best solution to the opioid crisis. [ABSTRACT FROM AUTHOR]

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is "too immature" and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or limit adolescent participation, jeopardizing study findings' validity. This paper presents recommendations on when researchers and Institutional Review Boards (IRB) should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible. [ABSTRACT FROM AUTHOR]

This paper examines the legal and ethical aspects of traceback testing, a process in which patients who have been previously diagnosed with ovarian cancer are identified and offered genetic testing so that their family members can be informed of their genetic risk and can also choose to undergo testing. Specifically, this analysis examines the ethical and legal limits in implementing traceback testing in cases when the patient is deceased and can no longer consent to genetic testing. [ABSTRACT FROM AUTHOR]

This paper describes the results of a multi-country survey of governance approaches for the use of digital contact tracing (DCT) in response to the COVID-19 pandemic. We argue that the countries in our survey represent two distinct models of DCT governance, both of which are flawed. The "data protection model" emphasizes privacy protections at the expense of public health benefit, while the "emergency response model" sacrifices transparency and accountability, prompting concerns about excessive governance surveillance. The ethical and effective use of DCT in the future requires a new governance approach that is better suited to this novel use of mobile phone data to promote public health." [ABSTRACT FROM AUTHOR]

Circumvention tourism is a form of medical tourism that occurs when individuals travel abroad to receive treatments that are a prohibited in their home county but permitted in a destination country. This paper explores this question: Should individuals be punished by their home countries for engaging in circumvention tourism? Guido Pennings, Richard Huxtable, and I. Glenn Cohen have all argued for what I call "formalist accounts" of circumvention tourism. That is, they try to show that certain types of circumvention tourism should or should not be punished in principle. Against them, I show that questions about circumvention tourism's punishability cannot be answered in the abstract. Whether individuals should be punished depends too much on the prima facie morality of the treatments being performed and the prohibitions being circumvented. [ABSTRACT FROM AUTHOR]

Digital Health Technologies (DHTs) are currently the subject of much debate both in terms of their technological frontiers as well as their ethical, legal and societal implications (ELSI). Regulation of such technologies as medical devices currently lacks behind their level of adoption. Digital Twins are the next evolution step of such DHTs and provide an opportunity to anticipate and act on ELSI before adoption again leaps before the necessary review. This paper introduces the concept and use cases of digital twins in medicine, then frames the debate through the lens of related technologies, machine learning and personalized medicine, and maps ethical challenges stemming from those. Finally, we lay out how digital twins may change and challenge the future practice of medicine. [ABSTRACT FROM AUTHOR]

This paper examines the practice implications of various state policies that provide publicly funded prenatal care to undocumented immigrants for health care workers who see undocumented patients. Data were collected through in-depth interviews with purposively sampled health care workers at safety net clinics in California, Maryland, Nebraska, and New York. Health care workers were asked about the process through which undocumented patients receive prenatal care in their health center and the ethical tensions and frustrations they encounter when providing or facilitating this care under policy restrictions. Respondents discussed several professional practice norms as well as the ethical tensions they encountered when policy or institutional constraints prevented them from living up to professional norms. Using Nancy Berlinger's "workarounds" framework, this paper examines health care workers' responses to the misalignment of their professional norms and the policy restrictions in their state. These findings suggest that the prenatal policies in each state raise ethical and professional challenges for the health care workers who implement them. [ABSTRACT FROM AUTHOR]

The paper identifies common barriers and challenges to Pre-Exposure Prophylaxis (PrEP) uptake and offers considerations for state and local public health departments to address barriers and retool infrastructure to increase access to PrEP to new users. Authors identify synergistic opportunities with federal agencies and funders to advance PrEP-related HIV prevention efforts, that prioritize strategies and investments to provide PrEP to people who could benefit from the intervention but are unaware of PrEP or struggle to access it. Barriers discussed and examined include financing strategies to reduce financial burden of PrEP medication, expanding PrEP access and outreach beyond clinical settings, and increasing the network and reach of the provider community to serve people we oppress through policy choices and discourses of racial and socioeconomic inferiority. [ABSTRACT FROM AUTHOR]

This paper provides an overview of the societal impact of a rising dementia population and examines the legal and ethical implications posed by voluntary registries as a community-oriented solution to improve interactions between law enforcement and individuals with dementia. It provides a survey of active voluntary registries across the United States, with a focus on Arizona, which has the highest projected growth for individuals living with dementia in the country. [ABSTRACT FROM AUTHOR]

The "public charge" rule is a long-standing immigration policy that seeks to determine the likelihood that a prospective immigrant will become dependent on the government for subsistence. When the Trump administration sought to expand the criteria that would count against an applicant for permanent residency to include public benefits historically excluded from the calculation, thousands of commenters wrote to oppose or support the proposed changes. This paper explores the moral and practical reasons commenters provided for their position on the public charge rule and considers the value of the public comment process for immigration, health, and social policy. [ABSTRACT FROM AUTHOR]

The paper outlines the policy context and summarizes the numerous policy issues that AD raises from the more generic to the unique. It posits that strong public fears of AD and its future prevalence projections and costs, raise increasingly difficult policy dilemmas. After reviewing the costs in human lives and money and discussing the latest U.S. policy initiatives, the paper presents two policy areas as examples the demanding policy decisions we face. The first focuses on the basic regulatory function of protecting the public from those who would exploit these fears. The second centers on the well-debated issues of advance directives and euthanasia that surround AD. Although more dialogue, education and research funding are needed to best serve the interests of AD patients and families as well as society at large, this will be challenging because of the strong feelings and divisions AD engenders. [ABSTRACT FROM AUTHOR]

This paper attempts to bring to the attention of the readers a concept that broadens ethical considerations for Alzheimer's disease research. We propose we move away from the ethical paradigm that focuses on avoidance of coercion for participation in studies as well as privacy and safety to a more inclusive paradigm that will not only include the principles outlined above but will also guarantee access to new treatments for individuals that participate in research and other members of society. Specifically, if the research being performed results in a new treatment for Alzheimer's disease, would the individuals participating in the research and other members of their community have access to and benefit from these treatments, given the availability of financial and other resources in the society that will allow for the implementation of these treatments. This paper will propose a model that will facilitate the achievement of these broader ethical considerations. [ABSTRACT FROM AUTHOR]

In the wake of COVID-19, the World Health Organization established an Intergovernmental Negotiating Body to negotiate a new instrument for pandemic prevention, preparedness, and response. This special issue of the Journal of Law, Medicine & Ethics brings together multidisciplinary scholarship to address the question of whether antimicrobial resistance should be included in this new instrument. Drawing from disciplines including law, anthropology, history, public health, public policy, economics, and veterinary medicine, this special issue explores the inclusion of AMR within the Pandemic Instrument from three perspectives: first, through the lens of global AMR governance, second, from the perspective of technical governance challenges and opportunities affecting the global ability to address AMR and future pandemics, and third, from the perspective of pandemic instrument mechanisms for strengthening global AMR governance. Each paper makes a concrete recommendation with respect to the importance of including AMR within the scope of the pandemic instrument. [ABSTRACT FROM AUTHOR]

This paper examines several decision-making models that have been proposed to limit the use of CPR for COVID-19 patients. My main concern will be to assess proposals for the implementation of unilateral DNRs — i.e., orders to withhold CPR without the agreement of patients or their surrogates. [ABSTRACT FROM AUTHOR]

This article analyzes the Supreme Court's "shadow docket" Free Exercise cases relating to COVID-19. The paper highlights the decline of deference, the impact of exemptions, and the implications of the new doctrine for vaccine and other public health laws. [ABSTRACT FROM AUTHOR]

This paper explores a grey area of psychiatric practice and, as with other challenging practices, the law is called upon to navigate conflicting legal issues. In particular, this paper explores the covert administration of medication: the concealment of medication in food or drink so that it will be consumed undetected. Rights-based approaches support nuanced understanding of the practices. Few policies, protocols or guidelines govern the practice in Ontario's psychiatric settings. While covert medication is understood to have "something to do" with rights, there is confusion about how those rights play out on the ground. Institutional silences underlie and reinforce the practice. Most pressing, the covert administration of medication warrants an overt discussion, including of its impact on the rights-experience of persons in psychiatric settings. [ABSTRACT FROM AUTHOR]

Programs, policies, and technologies — particularly those concerned with health equity — are often designed with justice envisioned as the end goal. These policies or interventions, however, frequently fail to recognize how the beneficiaries have historically embodied the cumulative effects of marginalization, which undermines the effectiveness of the intended justice. These well-meaning attempts at justice are bounded by greater socio-historical constraints. Bounded justice suggests that it is impossible to attend to fairness, entitlement, and equity when the basic social and physical infrastructures underlying them have been eroded by racism and other historically entrenched isms. Using the case of Brazil's National Health Policy for the Black Population, this paper proposes that bounded justice can contribute to justice discourses by serving as a concept, a proffering to a multi-disciplinary conceptual framework, and a potential analytic for those interested in the design of policy, technology, and programmatic interventions towards health equity. [ABSTRACT FROM AUTHOR]

An introduction to the journal is presented in which the editor discusses the submitted unrelated papers within the issue and the commentaries on them that have subjects like organ donation, medical billing, and harm reduction.

This paper argues that the trends in advertising and corporatization in dentistry since the 1970s have resulted in processes of de-professionalization and de-regulation, respectively. [ABSTRACT FROM AUTHOR]

Litigation cannot solve a public health crisis. But litigation can be an effective complementary tool to regulation by increasing the salience of a public health issue, eliciting closely guarded information to move public opinion, and prompting legislative action. From tobacco to opioids, litigants have successfully turned to courts for monetary relief, to initiate systemic change, and to hold industry accountable For years, litigators have been trying to push firearm suits into their own litigation moment. But litigation against the gun industry poses special challenges. Not only has the regulatory regime failed to prevent a public safety hazard, Congress has consistently underfunded and understaffed the relevant regulatory actors. And in 2005 it legislatively immunized the gun industry from suit with the Protection of Lawful Commerce in Arms Act (PLCAA). This paper surveys the field of litigation in response to gun violence, tracking the limited successes of victims and stakeholders suing the gun industry. We find that victories remain confined to individual actors and unlike high-impact public litigations in other areas, aggregate class actions and major public litigation led by state attorneys general are noticeably absent in the firearm context. [ABSTRACT FROM AUTHOR]

In response to the continued expansion of "red flag" laws allowing broader classes of people to petition a court for the removal of firearms from individuals who exhibit dangerous conduct, this paper argues that state laws should adopt a double-filter provision that balances individual rights and government public safety interests. The main component of such a provision is a special statutory category — "reporting party" — that enables a broader social network, such as co-workers or school administrators, to request that a law enforcement officer file a petition for an Extreme Risk Protection Order (ERPO). A double-filter provision would not give reporting parties a right to file a court petition directly. Instead, parties would file a request for petition with law enforcement officers (first filter), who must seek an ERPO from the court if they find the reporting party's information credible. That information is then transmitted to the court (second filter) as a sworn affidavit of the reporting party. The goal is to facilitate a balanced policy model that (1) widens the reporting circle in order to feed more potentially life-saving information into the system, (2) mitigates the risk of erroneous deprivation of constitutionally protected due process and Second Amendment rights. [ABSTRACT FROM AUTHOR]

Supply-side interventions such as prescription drug monitoring programs, "pill mill" laws, and dispensing limits have done little to quell the burgeoning opioid crisis. An increasingly popular demand-side alternative to these measures – now adopted by 38 jurisdictions in the USA and 7 provinces in Canada — is court-mandated involuntary commitment and treatment. In Massachusetts, for example, Part I, Chapter 123, Section 35 of the state's General Laws allows physicians, spouses, relatives, and police officers to petition a court to involuntarily commit and treat a person whose alcohol or drug abuse poses a likelihood of serious harm. This paper explores the ethical underpinnings of this law as a case study for others. First, we highlight the procedural and substantive standards of Section 35 and evaluate the application of the law in practice, including the frequency with which it has been invoked and outcomes. We then use this background to inform an ethical critique of the law. Specifically, we argue that the infringement of autonomy and privacy associated with involuntary intervention under Section 35 is not currently justified on the grounds of a lack of evidenced benefits and a risk of significant of harm. Further ethical concerns also arise from a lack of standard of care provided under the Section 35 pathway. Based on this analysis, we advance four recommendations for change to mitigate these ethical shortcomings. [ABSTRACT FROM AUTHOR]

This paper examines three possible justifications for original ACMG recommendations to return incidental findings from whole exome or genome sequencing independent of patient preferences. The first two potential justifications, based on a patient's authentic values, then on harms to others, are founding lacking as a basis of justification for these recommendations. The third, grounded in analogous professional practices, might serve as a potential justification if several controversies can be avoided. However, given the nature of these controversies and the need to instill public trust in this newly emerging science, the paper finds that updated ACMG recommendations that recognize opt-out rights on behalf of patients is the most prudent, and justifiable, approach. [ABSTRACT FROM AUTHOR]

Global health is by definition and necessity a collaborative field; one that requires diverse professionals to address the clinical, biological, social, and political factors that contribute to the health of communities, regions, and nations. While much work has been done in recent years to define the field of global health and set forth discipline-specific global health competencies, less has been done in the area of interprofessional global health education. This paper documents the results of a roundtable that was convened to study the need for an interprofessional team skills competency domain for global health students. The paper sets forth a preliminary set of team competencies based on existing scholarship and the results of the roundtable. Once an agreed upon set of competencies is defined, a valuable next task will be development of a model curriculum to teach team skills to students in global health. The preliminary competencies offered in this paper represent a good first step toward ensuring that global health professionals are able to collaborate effectively to make the field as cohesive and collaborative as the mighty task of global health demands. [ABSTRACT FROM AUTHOR]

An estimated 6,500 undocumented immigrants in the United States have been diagnosed with end-stage renal disease (ESRD). These individuals are ineligible for the federal insurance program that covers dialysis and/or transplantation for citizens, and consequently are subject to local or state policies regarding the provision of healthcare. In 76% of states, undocumented immigrants are ineligible to receive scheduled outpatient dialysis treatments, and typically receive dialysis only when presenting to the emergency center with severe life-threatening symptoms. 'Emergency-only hemodialysis' (EOHD) is associated with higher healthcare costs, higher mortality, and longer hospitalizations. In this paper, we present an ethical critique of existing federal policy. We argue that EOHD represents a failure of fiduciary and professional obligations, contributes to moral distress, and undermines physician obligations to be good stewards of medical resources. We then explore potential avenues for reform based upon policies introduced at the state level. We argue that, while reform at the federal level would ultimately be a more sustainable long-term solution, state-based policy reforms can help mitigate the ethical shortcomings of EOHD. [ABSTRACT FROM AUTHOR]

Disparities exist in the health, livelihood, and opportunities for the 46-60 million people living in America's rural communities. Rural communities across the United States need a new energy and focus concentrated around health and health care that allows for the designing capturing, and spreading of existing and new innovations. This paper aims to provide a framework for policy solutions to build a healthier rural America describing both the current state of rural health policy and the policies and practices in states that could be used as a national model for positive change. [ABSTRACT FROM AUTHOR]

Patients living with chronic pain require appropriate access to opioid therapy along with improved access to pain care and additional therapeutic options. It's both medically reasonable and ethical to consider opioid therapy as a treatment option in the management of chronic, non-cancer pain for a subset of patients with severe pain that is unresponsive to other therapies (e.g., injections, other medications, integrative strategies), negatively impacts function or quality of life, and will likely outweigh the potential harms. This paper will examine opioid therapy in the setting of the opioid epidemic, why critics feel that the CDC guideline has resulted in harsh consequences for patients and their physicians, and the rationale for opioid therapy as a means of providing ethical and compassionate pain care. [ABSTRACT FROM AUTHOR]

In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is needed for this rapidly proliferating approach to health research. [ABSTRACT FROM AUTHOR]

The law applicable to genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Although there has been some empirical work in this area, this is the first paper to survey and interview key scientific and legal stakeholders in the field of genomics to help ground identification of the most important legal problems that must be solved to successfully integrate genomics into clinical care. The respondents in this study identified a wide range of interconnected issues, focusing specifically on the need for clear guidelines about how to use these data, fear of liability for those who use these data, and the need to protect patients from use of this information particularly by insurers, while endorsing data sharing. Developing legal strategies to support appropriate use of genomics now and in the future clearly will require making trade-offs, taking into account the full complexity of this legal ecosystem. [ABSTRACT FROM AUTHOR]

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law. [ABSTRACT FROM AUTHOR]

The health care industry has moved at a rapid pace away from paper records to an electronic platform across almost all sectors — much of it at the encouragement and insistence of the federal government. Such rapid expansion has increased exponentially the risk to individuals in the privacy of their data and, increasingly, to their physical well-being when medical records are inaccessible through ransomware attacks. Recognizing the unique and critical nature of medical records, the United States Congress established the Health Care Industry Cybersecurity Task Force under the Cybersecurity Information Sharing Act of 2015 for the purpose of reviewing cybersecurity risks within the health care industry and identifying who will lead and coordinate efforts to address such risks among the various agencies. The Task Force has since issued a report setting forth six high-level imperatives that the health care industry needs to achieve in order to combat cybersecurity, and, notably, many of the vulnerabilities plaguing the industry identified in the Report as requiring correction are not necessarily related to specific flaws in the current cybersecurity framework, but rather susceptibilities presented by the infrastructure and associated regulatory regime that has evolved over the last few decades over the health care industry generally. That is, the current health care infrastructure by its nature exacerbates cybersecurity risk. Between a lack of information sharing of industry threats, risks, and mitigations, disparate leadership and governance goals for cybersecurity, the confluence and contradiction of existing federal and state laws, fragmentation in the fee-for-service delivery system, lack of care coordination, and disparate resources across and among sectors, the industry suffers from heightened cyber risk. Solutions that are reactive to problems within the current infrastructure will likely have little long term impact toward reducing cybersecurity vulnerabilities because they do not address the underlying system challenges. All of these confluences causes one to wonder whether if in fact the current health care delivery infrastructure is a contributing factor to the incidents of cybersecurity attacks and the exorbitant costs associated with resolving data breaches, should Congress look not just to curb breach incidents, but to address root cause systematic challenges in the health industry infrastructure that create increased exposure of cybersecurity threats? This article argues that cybersecurity risks will continue to be heightened and more costly to the health care industry as compared to other industries unless and until some general system redesign is achieved that allows for (1) greater sharing of resources among industry participants to ensure the same protections are implemented at all levels of the industry, which can be strengthened through greater interoperability of systems across the health care industry; and (2) increased focus and attention on the importance of cybersecurity issues as a priority among system reforms. [ABSTRACT FROM AUTHOR]