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Personal Health Records As A Tool For Transparency In Health Care (Draft), Sharona Hoffman Jan 2018

Personal Health Records As A Tool For Transparency In Health Care (Draft), Sharona Hoffman

Faculty Publications

This chapter explores the benefits and limitations of personal health records (PHRs) as a tool to promote transparency in health care. A PHR can be defined as “an electronic application through which individuals can access, manage and share their health information . . . in a private, secure, and confidential environment.” PHRs can enhance efficiency, communication, data accuracy, and health outcomes. At the same time, they can disrupt the physician-patient relationship and raise liability concerns. For example, PHRs may induce patients and physicians to rely on electronic communication when office visits would be far more appropriate. The chapter analyzes the impact of PHRs ...


Step Therapy: Legal And Ethical Implications Of A Cost-Cutting Measure, Sharona Hoffman Jan 2018

Step Therapy: Legal And Ethical Implications Of A Cost-Cutting Measure, Sharona Hoffman

Faculty Publications

The very high and ever-increasing costs of medical care in the United States are well-recognized and much discussed. Health insurers have employed a variety of strategies in an effort to control their expenditures, including one that is common but has received relatively little attention: step therapy. Step therapy programs require patients to try less expensive treatments and find them to be ineffective or otherwise problematic before the insurer will approve a more high-priced option. This Article is the first law journal piece dedicated to analyzing this important cost control measure.

The Article explores the strengths and weaknesses of step therapy ...


Big Data Analytics: What Can Go Wrong, Sharona Hoffman Jan 2018

Big Data Analytics: What Can Go Wrong, Sharona Hoffman

Faculty Publications

It is not uncommon to read that long-held beliefs about medical treatments have been dislodged by new studies. For example, there is now doubt as to whether women should undergo annual mammograms, previously a cornerstone of cancer screening. Hormone replacement therapy for menopausal women, once considered highly suspect in light of worrisome research findings, is now being reconsidered as a beneficial therapy. These reversals trouble and confuse many Americans.

This Article explores why medical research findings can be erroneous and what can go wrong in the process of designing and conducting research studies. It provides readers with essential analytical tools ...


Services And Resources For People Living With Hiv/Aids In The Southcoast Of Massachusetts: “Can’T Get There From Here!”, Jason Potter Burda, Margaret B. Drew, Caitlin M. Stover Jan 2017

Services And Resources For People Living With Hiv/Aids In The Southcoast Of Massachusetts: “Can’T Get There From Here!”, Jason Potter Burda, Margaret B. Drew, Caitlin M. Stover

Faculty Publications

Fall River and New Bedford, two diverse and economically challenged cities in the Southcoast region of Massachusetts, are areas of substantial concern in the effort to reduce HIV incidence and to provide effective services for people living with HIV/AIDS in the Commonwealth. In these two communities, HIV disparately impacts marginalized populations, with particularly high infection and prevalence rates among men who have sex with men and injection drug users in comparison to other Massachusetts localities. This project used community engaged research principles to conduct a community assessment guided by the social determinants of health. The primary goal of this ...


A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer Jan 2017

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

No abstract provided.


Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin Jan 2017

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety ...


Introduction, Trudo Lemmens, Andrew Flavelle Martin Jan 2017

Introduction, Trudo Lemmens, Andrew Flavelle Martin

Faculty Publications

In 2004, Canada's Parliament passed the Assisted Human Reproduction Act. Fully in force by 2007, the act was intended to safeguard and promote the health, safety, dignity, and rights of Canadians. However, a 2010 Supreme Court of Canada decision ruled that key parts of the act were invalid. Regulating Creation is a collection of essays built around various components of the 2010 ruling. Featuring contributions by Canadian and international scholars, it offers a variety of perspectives on the role of law in dealing with the legal, ethical, and policy issues surrounding changing reproductive technologies. The book is divided in ...


Big Data And The Americans With Disabilities Act, Sharona Hoffman Jan 2017

Big Data And The Americans With Disabilities Act, Sharona Hoffman

Faculty Publications

While big data offers society many potential benefits, it also comes with serious risks. This Essay focuses on the concern that big data will lead to increased employment discrimination. It develops the novel argument that the Americans with Disabilities Act (ADA) should be amended in response to the big data phenomenon in order to protect individuals who are perceived as likely to develop physical or mental impairments in the future. Employers can obtain medical data about employees not only through the traditional means of medical examinations and inquiries, but also through the non-traditional mechanisms of social media, wellness programs, and ...


Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah Yearby Jan 2017

Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah Yearby

Faculty Publications

No abstract provided.


Preventing Neonatal Abstinence Syndrome Within The Opioid Epidemic: A Uniform Facilitative Policy, Jeremiah A. Ho Sep 2016

Preventing Neonatal Abstinence Syndrome Within The Opioid Epidemic: A Uniform Facilitative Policy, Jeremiah A. Ho

Faculty Publications

The United States is currently in the midst of an opioid epidemic that has hit states in the southern New England regions particularly hard — with Massachusetts as one primary example. One of the many unfortunate results of the epidemic is a dramatic upsurge in cases of opioid dependency by expectant women that result in children born with Neonatal Abstinence Syndrome (NAS). NAS is a clinical syndrome that occurs when a newborn suffers withdrawal symptoms as a consequence of abrupt discontinuation of prenatal substance exposure. The expenses of treating and rehabilitating these drug-dependent newborns, predominantly shouldered by state taxpayers, are extremely ...


Prep And Our Youth: Implications In Law And Policy, Jason Potter Burda Jan 2016

Prep And Our Youth: Implications In Law And Policy, Jason Potter Burda

Faculty Publications

Truvada®, an antiretroviral medication originally approved to treat HIV, is the first drug to receive FDA approval for use by HIV-negative individuals to actually prevent infection. The prophylactic use of an antiretroviral such as Truvada is a pharmacological prevention method called “HIV pre-exposure prophylaxis” (or “PrEP”). With an efficacy of over ninety percent when used as prescribed, Truvada as PrEP has been embraced by the public health community, and implementation is under way across the United States. Truvada as PrEP is currently indicated for adult use only, but it may also be prescribed off-label to at-risk youth. In this Article ...


The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi Jan 2016

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi

Faculty Publications

The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the ...


Collective Corporate Knowledge, The Federal False Claims Act, And The Future Of Federal Health Programs, Sam F. Halabi Jan 2016

Collective Corporate Knowledge, The Federal False Claims Act, And The Future Of Federal Health Programs, Sam F. Halabi

Faculty Publications

While recent U.S. Supreme Court decisions have drawn focus to whether what corporations “say” is protected by the First Amendment or what they “believe” is protected by the federal Religious Freedom Restoration Act, the more relevant inquiry for a wide range of statutory and regulatory regimes is what corporations “know.” At the core of that question is what guides information relevant for legal compliance (including product safety, employee welfare, and material risks considered by investors) from its source to any given point in the firm, including decision-makers. This Article analyzes the federal False Claims Act as an underexploited resource ...


The Adoption Of Mandatory Gunshot Wound Reporting Legislation In Canada: A Decade Of Tension In Lawmaking At The Intersection Of Law Enforcement And Public Health, Andrew Flavelle Martin Jan 2016

The Adoption Of Mandatory Gunshot Wound Reporting Legislation In Canada: A Decade Of Tension In Lawmaking At The Intersection Of Law Enforcement And Public Health, Andrew Flavelle Martin

Faculty Publications

In 2005, Ontario adopted the Mandatory Gunshot Wounds Reporting Act. Over the following decade, seven other provinces and one territory adopted largely identical legislation. While these statutes require health facilities to report gunshot wounds to the police, they are mostly silent on what purpose this reporting is intended to achieve and how police are to use the reports to achieve it. This paper analyzes the legislative history across these nine jurisdictions to identify these features. It demonstrates that the statutes embody an unresolved tension between the purposes of public health and safety, on the one hand, and law enforcement on ...


Electronic Health Records And Medical Big Data: Law And Policy, Sharona Hoffman Jan 2016

Electronic Health Records And Medical Big Data: Law And Policy, Sharona Hoffman

Faculty Publications

This book helps readers gain an in-depth understanding of electronic health record (EHR) systems, medical big data, and the regulations that govern them. It is useful both as a primer for students and as a resource for knowledgeable professionals. The book analyzes the shortcomings and benefits of EHR systems, explores the law's response to the technology’s adoption, highlights gaps in the current legal framework, and develops detailed recommendations for regulatory, policy, and technological improvements. Electronic Health Records and Medical Big Data addresses not only privacy and security concerns, but also other important challenges, such as those related to ...


Dangerous Diagnoses, Risky Assumptions, And The Failed Experiment Of "Sexually Violent Predator" Commitment, Deirdre M. Smith Jul 2015

Dangerous Diagnoses, Risky Assumptions, And The Failed Experiment Of "Sexually Violent Predator" Commitment, Deirdre M. Smith

Faculty Publications

In its 1997 opinion, Kansas v. Hendricks, the U.S. Supreme Court upheld a law that reflected a new model of civil commitment. The targets of this new commitment law were dubbed “Sexually Violent Predators” (SVPs), and the Court upheld indefinite detention of these individuals on the assumption that there is a psychiatrically distinct class of individuals who, unlike typical recidivists, have a mental condition that impairs their ability to refrain from violent sexual behavior. And, more specifically, the Court assumed that the justice system could reliably identify the true “predators,” those for whom this unusual and extraordinary deprivation of ...


Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan Jan 2015

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are ...


Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan Jan 2015

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other ...


When Condoms Fail: Making Room Under The Aca Blanket For Prep Hiv Prevention, Jason Potter Burda Jan 2015

When Condoms Fail: Making Room Under The Aca Blanket For Prep Hiv Prevention, Jason Potter Burda

Faculty Publications

Given the alarming upward trend in HIV infection rates and the downward trend in condom usage, we need a new approach to HIV prevention in the United States. One such approach, HIV Pre-Exposure Prophylaxis (commonly known as “PrEP”), has the potential to significantly reduce HIV incidence. The FDA recently approved a daily dose of Truvada® — an antiretroviral drug that suppresses the virus in HIV-positive individuals — for daily use by high-risk HIV-negative individuals to prevent infection. Despite an effectiveness above ninety percent and significant regulatory momentum, this pharmacological prevention modality has proven difficult to implement. In this Article, I address the ...


Multipolarity, Intellectual Property And The Internationalization Of Public Health Law, Sam F. Halabi Jul 2014

Multipolarity, Intellectual Property And The Internationalization Of Public Health Law, Sam F. Halabi

Faculty Publications

This Article critically examines the proliferation of international legal agreements addressing global health threats like the outbreak of infectious diseases, tobacco use and lack of access to affordable medicines. The conventional wisdom behind this trend is that a global normative shift has occurred which has caused states to regard health as “special” and less subject to the normal rules of international law making because health threats endanger all of humanity. This Article challenges that thesis, arguing that at the same time the number and scope of international health law treaties has grown, developed states have subordinated health law to intellectual ...


Liberty Without Capacity: Why States Should Ban Adolescent Driving, Vivian E. Hamilton Jul 2014

Liberty Without Capacity: Why States Should Ban Adolescent Driving, Vivian E. Hamilton

Faculty Publications

No abstract provided.


Mental Illness And Danger To Self, Cynthia V. Ward Apr 2014

Mental Illness And Danger To Self, Cynthia V. Ward

Faculty Publications

No abstract provided.


Selling Hospice, Sam F. Halabi Jan 2014

Selling Hospice, Sam F. Halabi

Faculty Publications

Americans are increasingly turning to hospice services to provide them with medical care, pain management, and emotional support at the end of life. The increase in the rates of hospice utilization is explained by a number of factors including a “hospice movement” dating to the 1970s which emphasized hospice as a tool to promote dignity for the terminally ill; coverage of hospice services by Medicare beginning in 1983; and, the market for hospice services provision, sustained almost entirely by governmental reimbursement. On the one hand, the growing acceptance of hospice may be seen as a sign of trends giving substance ...


The Use And Misuse Of Biomedical Data: Is Bigger Really Better?”, Sharona Hoffman, Andy Podgurski Jan 2013

The Use And Misuse Of Biomedical Data: Is Bigger Really Better?”, Sharona Hoffman, Andy Podgurski

Faculty Publications

Very large biomedical research databases, containing electronic health records (HER) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is “big data” necessarily better data?

This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons ...


Taxation Without Representation: The Illegal Irs Rule To Expand Tax Credits Under The Ppaca, Jonathan H. Adler, Michael F. Cannon Jan 2013

Taxation Without Representation: The Illegal Irs Rule To Expand Tax Credits Under The Ppaca, Jonathan H. Adler, Michael F. Cannon

Faculty Publications

The Patient Protection and Affordable Care Act (PPACA) provides tax credits and subsidies for the purchase of qualifying health insurance plans on state-run insurance exchanges. Contrary to expectations, many states are refusing or otherwise failing to create such exchanges. An Internal Revenue Service (IRS) rule purports to extend these tax credits and subsidies to the purchase of health insurance in federal exchanges created in states without exchanges of their own. This rule lacks statutory authority. The text, structure, and history of the Act show that tax credits and subsidies are not available in federally run exchanges. The IRS rule is ...


Reducing The Discount Rate, Ben L. Trachtenberg Oct 2012

Reducing The Discount Rate, Ben L. Trachtenberg

Faculty Publications

This article presents two arguments against the “discounting” of future human lives as part of cost benefit analysis, or CBA. Our first argument is that because CBA has thus far ignored evidence of rising health care expenditures, it underestimates the “willingness to pay” for health and safety that future citizens will likely exhibit, thereby undervaluing their lives. Our second argument is that until recently CBA has ignored the trend of improved material conditions in developed countries, and most agencies continue to ignore it entirely. As time advances, residents of rich countries tend to live better and spend more, meaning that ...


Party Polarization And Judicial Review: Lessons From The Affordable Care Act, Neal Devins Oct 2012

Party Polarization And Judicial Review: Lessons From The Affordable Care Act, Neal Devins

Faculty Publications

Congress paid nearly no attention to the Constitution when enacting the Affordable Care Act (ACA) in 2010. Legislative hearings and committee reports ignored the Constitution altogether; legislative debates largely did the same. This Essay both highlights Congress’s indifference to the Constitution when enacting the ACA and examines the reasons behind this legislative failure. In particular, this Essay advances three explanations. First, Congress is generally uninterested in “public goods” like constitutional interpretation. Second, the polarization of Democrats and Republicans in Congress further depresses Congress’s interest in thinking about the Constitution; instead, the majority party seeks to limit opportunities for ...


Why Congress Did Not Think About The Constitution When Enacting The Affordable Care Act, Neal Devins Mar 2012

Why Congress Did Not Think About The Constitution When Enacting The Affordable Care Act, Neal Devins

Faculty Publications

No abstract provided.


Breaking The Cycle Of ‘Unequal Treatment’ With Health Care Reform: Acknowledging And Addressing The Continuation Of Racial Bias, Ruqaiijah Yearby Jan 2012

Breaking The Cycle Of ‘Unequal Treatment’ With Health Care Reform: Acknowledging And Addressing The Continuation Of Racial Bias, Ruqaiijah Yearby

Faculty Publications

Since the Civil War access to health care in the United States has been racially unequal. This racially unequal access to health care remains even after the passage of Title VI of the Civil Rights Act of 1964 ("Title VI") and the election of an African-American President. Both of these events held the promise of equality, yet the promise has never been fulfilled. Now, many hail the passage of the Patient Protection and Affordable Health Care Act ("ACA") as the biggest governmental step in equalizing access to health care because it has the potential to increase minority access to health ...


Introduction - Symposium Issue On Health Data Security Systems, Sharona Hoffman Jan 2012

Introduction - Symposium Issue On Health Data Security Systems, Sharona Hoffman

Faculty Publications

Introduction to the Health Data Security System symposium 2012 Huston, TX.