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Hipaa's Privacy Rule And State Privacy Laws: Roadblocks To Medical Organizations' Self-Policing Expert Medical Testimony, Miles J. Zaremski, Douglas M. Belofsky Jan 2019

Hipaa's Privacy Rule And State Privacy Laws: Roadblocks To Medical Organizations' Self-Policing Expert Medical Testimony, Miles J. Zaremski, Douglas M. Belofsky

Alumni Publications

As part of the wave of medical malpractice reforms over the last several decades, efforts were initiated to ensure the reliability and credibility of expert witness opinion and testimony, which is the sine qua non of necessary proof for any such claim or lawsuit. Governing bodies of professional medical organizations and societies have crafted rules and regulations for their members that wish to provide expert medical witness testimony. Where such testimony does not conform to these organizations’ standards, sanctions can be levied, including membership expulsion. Such self-policing has found favor with courts.

Before sanctions are imposed, however, necessary administrative investigations ...


What Genetic Testing Teaches About Long-Term Predictive Health Analytics Regulation, Sharona Hoffman Jan 2019

What Genetic Testing Teaches About Long-Term Predictive Health Analytics Regulation, Sharona Hoffman

Faculty Publications

The ever-growing phenomenon of predictive health analytics is generating significant excitement, hope for improved health outcomes, and potential for new revenues. Researchers are developing algorithms to predict suicide, heart disease, stroke, diabetes, cognitive decline, future opioid abuse, and other ailments. The researchers include not only medical experts, but also commercial enterprises such as Facebook and LexisNexis, who may profit from the work considerably. This Article focuses on long-term disease predictions (predictions regarding future illnesses), which have received surprisingly little attention in the legal and ethical literature. It compares the robust academic and policy debates and legal interventions that followed the ...


Portable Medical Order Sets (Polst®): Ethical And Legal Landscape, Sharona Hoffman Jan 2019

Portable Medical Order Sets (Polst®): Ethical And Legal Landscape, Sharona Hoffman

Faculty Publications

Anyone who has observed the dying of a loved one or who has thought about medical care in the final months of life may be concerned about end-of-life care. How can individuals ensure that their care fits their needs and preferences if they cannot express these because of dementia, confusion, or other frailties? Some worry that they will receive care that is painful and aggressive in the last stages of disease even though they would prefer comfort care only. By contrast, others worry that physicians will withhold therapeutic care because they assume that such care is unwanted by patients who ...


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 ...


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 ...


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.


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 ...


Modernizing The Emergency Medical Treatment & Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel Jan 2015

Modernizing The Emergency Medical Treatment & Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel

Faculty Publications

The Emergency Medical Treatment and Active Labor Act (EMTALA) is a federal statute passed almost 30 years ago which was designed to ensure equal access to emergency treatment and to halt the practice of “patient dumping.” Patient dumping is a situation where some patients—typically uninsured, disabled, and minority individuals—receive inferior emergency medical care or are denied emergency medical treatment altogether. The goal of EMTALA is to ensure that everyone coming to the emergency room will receive equal care.

Unfortunately, despite EMTALA, the practice of patient dumping has continued to this day. The most recent case in the news ...


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 ...


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.


Balancing Privacy, Autonomy, And Scientific Needs In Electronic Health Records Research, Sharona Hoffman, Andy Podgurski Jan 2012

Balancing Privacy, Autonomy, And Scientific Needs In Electronic Health Records Research, Sharona Hoffman, Andy Podgurski

Faculty Publications

The ongoing transition from paper medical files to electronic health records will provide unprecedented amounts of data for biomedical research, with the potential to catalyze significant advances in medical knowledge. But this potential can be fully realized only if the data available to researchers is representative of the patient population as a whole. Thus, allowing individual patients to exclude their health information, in keeping with traditional notions of informed consent, may compromise the research enterprise and the medical benefits it produces.

This Article analyzes the tension between realizing societal benefits from medical research and granting individual preferences for privacy. It ...


Drug-Drug Interaction Alerts: Emphasizing The Evidence, Sharona Hoffman, Andy Podgurski Jan 2012

Drug-Drug Interaction Alerts: Emphasizing The Evidence, Sharona Hoffman, Andy Podgurski

Faculty Publications

Many analysts and users of contemporary clinical decision support ("CDS") systems have expressed grave concerns about the technology’s efficacy and functionality. Alerts generated by CDS systems are often inaccurate, and an excess of alerts leads some physicians to experience "alert fatigue" and to turn off CDS altogether. This article formulates recommendations to improve drug-drug interaction (DDI) alerts.

The paper comments upon a proposal by Susan Ridgely and Michael Greenberg, who call for the development of a consensus-based "clinically significant drug-drug interaction list" that could generate limited liability protection for users. We argue that instead of creating a list of ...


The Individual Mandate And The Taxing Power, Erik M. Jensen Jan 2012

The Individual Mandate And The Taxing Power, Erik M. Jensen

Faculty Publications

This article, prepared for a symposium at the Salmon P. Chase College of Law, Northern Kentucky University, considers whether the Taxing Clause provides an alternative constitutional basis, as some have recently argued, for the individual mandate in the Patient Protection and Affordable Care Act of 21 - the requirement, going into effect in 214, that most individuals acquire satisfactory health insurance or pay a penalty. The article concludes that the Taxing Clause arguments are misguided. At best, the Clause can provide authority for the penalty, not for the mandate as a whole. Furthermore, the article questions whether the penalty will be ...


What Is The Meaning Of Health? Constitutional Implications Of Defining 'Medical Necessity' And 'Essential Health Benefits' Under The Affordable Care Act, B. Jessie Hill Jan 2012

What Is The Meaning Of Health? Constitutional Implications Of Defining 'Medical Necessity' And 'Essential Health Benefits' Under The Affordable Care Act, B. Jessie Hill

Faculty Publications

One consequence of the Affordable Care Act (ACA) is that government will come to play a more extensive role in healthcare decision-making by individuals and their providers. The ACA does not directly regulate access to health services, but by means of a system of funding, mandates, and penalties, it essentially requires many employers to provide, and most individuals to carry, a certain minimum level of health insurance. Governmental decisions about which medical services qualify as medically necessary and appropriate may take on a new and greater importance, because government officials will be required to decide what sorts of procedures must ...


Medical Decision Making By And On Behalf Of Adolescents: Reconsidering First Principles, B. Jessie Hill Jan 2012

Medical Decision Making By And On Behalf Of Adolescents: Reconsidering First Principles, B. Jessie Hill

Faculty Publications

The school nurse cannot give your teenage daughter an aspirin for her headache without your permission, but that same daughter can get an abortion without even informing you. Or can she? The obligations on medical personnel providing care to adolescents are famously indeterminate.

Two common-law presumptions have long lurked in the background, but, far from elucidating matters, those presumptions have contributed to the state of confusion. The first presumption is that, absent any special rule, children lack the legal authority to consent to medical treatment on their own. A parallel and corresponding presumption is that parents have a legal entitlement ...


Professional Power And The Standard Of Care In Medicine, Maxwell J. Mehlman Jan 2012

Professional Power And The Standard Of Care In Medicine, Maxwell J. Mehlman

Faculty Publications

Since before the founding of the Republic, American medicine has been fighting a war to control the standard of care that physicians are expected to provide to their patients. It has waged battles on two fronts: against internal disagreements within the profession over what constitutes proper care, and against attempts to delineate the standard of care by forces outside the profession, such as private health insurers, the government, and the judicial system.


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 ...


The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman Jan 2012

The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman

Faculty Publications

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend ...


All For One And One For All: Informed Consent And Public Health, Jessica Wilen Berg Jan 2012

All For One And One For All: Informed Consent And Public Health, Jessica Wilen Berg

Faculty Publications

The concept of informed consent is well established in the field of bioethics, but its application is unclear in the area of public health. The increasing prevalence of public health interventions creates a need to analyze the scope of government power as it relates to individual choice. This Article explores three different types of public health measures in which individual choice has been limited: (1) environmental interventions; (2) classic public health interventions to prevent contagious disease; and (3) public health information reporting or use. The reasons for limiting informed consent vary depending on the context, and the implications for the ...


Meaningful Use And Certification Of Health Information Technology: What About Safety?, Sharona Hoffman, Andy Podgurski Jan 2011

Meaningful Use And Certification Of Health Information Technology: What About Safety?, Sharona Hoffman, Andy Podgurski

Faculty Publications

Health information technology (HIT) is becoming increasingly prevalent in medical offices and facilities. Like President George W. Bush before him, President Obama announced a plan to computerize all Americans’ medical records by 214. Computerization is certain to transform American health care, but to ensure that its benefits outweigh its risks, the federal government must provide appropriate oversight.

President Obama’s stimulus legislation, the American Recovery and Reinvestment Act of 29 (ARRA), dedicated $27 billion to the promotion of health information technology. It provides payments of up to $44, per clinician under the Medicare incentive program and $63,75 per clinician ...


Whose Body? Whose Soul? Medical Decision-Making On Behalf Of Children And The Free Exercise Clause Before And After Employment Division V. Smith, B. Jessie Hill Jan 2011

Whose Body? Whose Soul? Medical Decision-Making On Behalf Of Children And The Free Exercise Clause Before And After Employment Division V. Smith, B. Jessie Hill

Faculty Publications

Within constitutional law, children’s rights have suffered from severe neglect. The issue of parents’ constitutional rights to deny children medical treatment based on religious belief is one area in desperate need of attention. Although the Supreme Court’s 199 decision in Employment Division v. Smith seemingly set forth a relatively clear rule regarding the availability of exemptions from generally applicable laws - such as those requiring parents to ensure that their children receive appropriate medical care - Smith has changed little in this realm, and if anything, it has only confused matters, highlighting the intractable nature of the issue. While Smith ...


Cooperation, Commandeering, Or Crowding Out? : Federal Intervention And State Choices In Health Care Policy, Jonathan H. Adler Jan 2011

Cooperation, Commandeering, Or Crowding Out? : Federal Intervention And State Choices In Health Care Policy, Jonathan H. Adler

Faculty Publications

The Patient Protection and Affordable Care Act (ACA) substantially alters the respective roles of the federal and state governments in health care policy. Beyond the individual mandate, the ACA presents many questions of federalism, both constitutional and policy-related. This paper, prepared for a symposium sponsored by the Kansas Journal of Law & Public Policy, addresses some of these federalism issues. After outlining some of the policy considerations for determining the proper federal and state balance in health care policy, it identifies constitutional limitations on the federal government’s ability to direct or even influence state policy choices, before discussing how federal ...


Improving Health Care Outcomes Through Personalized Comparisons Of Treatment Effectiveness Based On Electronic Health Records, Sharona Hoffman, Andy Podgurski Jan 2011

Improving Health Care Outcomes Through Personalized Comparisons Of Treatment Effectiveness Based On Electronic Health Records, Sharona Hoffman, Andy Podgurski

Faculty Publications

Comparative effectiveness research (CER) is one of the Patient Protection and Affordable Care Act’s significant initiatives that aims to improve treatment outcomes and lower health care costs. This Article takes CER a step further and suggests a novel clinical application for it. The Article proposes the development of a national framework to enable physicians to rapidly perform, through a computerized service, medically sound personalized comparisons of the effectiveness of possible treatments for patients’ conditions. A treatment comparison for a given patient would be based on data from electronic health records of a cohort of clinically similar patients who received ...


Litigation, Integration, And Transformation: Using Medicaid To Address Racial Inequities In Health Care, Ruqaiijah Yearby Jan 2010

Litigation, Integration, And Transformation: Using Medicaid To Address Racial Inequities In Health Care, Ruqaiijah Yearby

Faculty Publications

Using a public health policy perspective, this article examines the persistence of racial inequities in nursing homes and prescribes a solution to address these inequities. I use empirical data to prove the persistence of racial inequities in health care, analyze the government policies that allow racial inequities to continue, and provide a solution of regulatory integration. Specifically, I propose that civil rights enforcement be integrated with the nursing home enforcement system, which has been aggressively enforced and monitored. There are many strategies that may lead to the adoption of this system. One such strategy is using the Medicaid Act to ...


Employing E-Health: The Impact Of Electronic Health Records On The Workplace, Sharona Hoffman Jan 2010

Employing E-Health: The Impact Of Electronic Health Records On The Workplace, Sharona Hoffman

Faculty Publications

Electronic Health Record (HER) systems may soon become a fixture in most medical settings. President Obama’s 29 stimulus legislation includes $19 billion to promote their implementation. The sophisticated features and efficiencies of HER systems have the potential to improve health outcomes and enhance patient welfare considerably. However, this emerging technology also poses significant challenges and risks, not the least of which are its workplace impacts. This article provides a first of its kind analysis of the ramifications of HER systems for workers and employers.

The potential effects of health information computerization on the workplace are numerous. Employers may obtain ...


Finding A Cure: The Case For Regulation And Oversight Of Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski Jan 2009

Finding A Cure: The Case For Regulation And Oversight Of Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski

Faculty Publications

In the foreseeable future, it is likely that the familiar, paper-based patient medical files will become a thing of the past. On April 26, 24, President George W. Bush announced a plan to ensure that all Americans' health records are computerized within ten years and to establish a National Health Information Network. Many advocates are enthusiastically promoting the adoption of health information technology (HIT) and electronic health record (HER) systems as a means to improve U.S. health care.

HER systems often not only serve as record-keeping systems, but also have multiple capabilities, including drug ordering, decision support, alerts concerning ...


E-Health Hazards: Provider Liability And Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski Jan 2009

E-Health Hazards: Provider Liability And Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski

Faculty Publications

In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency ...