Medical Jurisprudence Commons^™

Law Enforcement, Reproductive Health Information, And The Hipaa Privacy Rule, Stacey A. Tovino

Faculty Articles

On April 26, 2024, the federal Department of Health and Human Services (HHS) promulgated a final rule (Final Rule) amending the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The Final Rule prohibits HIPAA covered entities and business associates from using and disclosing protected health information (PHI) to conduct criminal, civil, or administrative investigations into an individual for the mere act of seeking, obtaining, providing, or facilitating lawful reproductive health care. The Final Rule also prohibits HIPAA covered entities and business associates from using and disclosing PHI to impose criminal, civil, and administrative liability on any individual, or to …

Genetic Property Rhetoric And The Public Domain, David Fagundes

Faculty Articles

Among the many themes that illuminate Jorge Contreras’s The Genome Defense, this Essay focuses on property. It considers the rhetorical role played by property in convincing both courts and the public that patenting genetic data was legally and ethically objectionable. This Essay begins by locating property—and public property—as a major theme in the dialogue surrounding the Myriad litigation. It then situates this rhetorical move in the context of property-talk generally, highlighting the distinctiveness of leveraging public rather than private ownership as a means of accessing moral intuitions. Finally, this Essay reflects on what the use of public property rhetoric …

Customary Corruption, Ani B. Satz, Liza Vertinsky

Faculty Articles

For over a hundred years, it has been well-accepted among tort scholars that physicians—as one of the legally recognized professions— determine their own customary practices. Within tort law, and medical malpractice more specifically, customary practice establishes whether physicians breach or uphold the required standard of care toward their patients. The results of our hand-coded examination of decided cases and statutes show a more complex picture. While some states have endeavored to shift the standard away from professional custom, it continues to play a critical, and in many cases a determinative, role in establishing physician liability in most states.

Using illustrative …

Dialing In Or Dialing Out? The Relationships Between State Telemedicine Law And Access To Buprenorphine, Stacey A. Tovino

Faculty Articles

This Article begins by reporting the results of a comprehensive 50-state survey assessing state laws and other state sources governing the telemedicine induction (“tele-induction”) and subsequent telemedicine prescription (“tele-prescription”) of buprenorphine for the treatment of opioid use disorder (“OUD”) following the expiration of the COVID-19 public health emergency (“PHE”). Original, concrete findings include: (1) the glaring patchwork of state law governing the tele-induction and subsequent tele-prescription of buprenorphine for the treatment of OUD in the United States; (2) the variety of primary authorities and secondary sources that house relevant permissions, prohibitions, and affiliated requirements; (3) the number of primary authorities …

Confidentiality Over Privacy, Stacey A. Tovino

Faculty Articles

No abstract provided.

Stigma In The Statute: When The Language Of The Law Injures, Stacey A. Tovino

Faculty Articles

Jurists frequently consider the extent to which a writer’s or speaker’s harmful statements may be actionable under the law. But what should be done when the law itself contains harmful language? Consider the case of individuals with alcohol use disorder (AUD). Hundreds of federal and state statutes refer to these individuals as “addicts,” “abusers,” “alcoholics,” “drunkards,” “inebriates,” and “intemperates.” These statutes exist notwithstanding research showing that these words provoke negative thinking by others, including thinking that individuals with AUD are more deserving of punishment and less deserving of treatment. These laws persist in the face of research showing that these …

Distilling The Language Of The Law, Stacey A. Tovino

Faculty Articles

No abstract provided.

Privacy For Student-Patients: A Call To Action, Stacey A. Tovino

Faculty Articles

Consider a law student who has a mental or reproductive health issue that the student wishes to keep private. If the student seeks care at an off-campus health clinic that is not affiliated with the student’s law school or university, the student typically has a number of federally enforceable privacy rights. For example, the federal HIPAA Privacy Rule will typically apply and prohibit the clinic from disclosing the student’s protected health information to professors, parents, and other third parties without the student’s prior written authorization. The law student also will have the right to receive a notice of privacy practices, …

Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu

Faculty Articles

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …

Assessing Legal Protection Of Biometric Data In China: Gaps, Principles, And Policy Recommendations, Qian Li, Jianyu Zhou, Jennifer S. Stevenson

Faculty Articles

The legal protection of biometric data is becoming an increasingly important issue in the information society. China attaches importance to the legal protection of biometric data. Over the past decades, the rapid development of digital technology has profoundly influenced Chinese information society. However, digital technology may also trigger substantial risks. In this article, we provide an in-depth examination of existing Chinese laws protecting biometric data. We explore general laws and facial recognition laws, administrative regulations, sector-based rules, judicial interpretations, regulatory documents, policy documents, and (draft) national standards. We find gaps in laws in China. Building on this analysis, we elaborate …

Disclosing Deviations: Using Guidelines To Nudge And Empower Physician-Patient Decision Making, Melissa Ballengee Alexander

Faculty Articles

Americans fail to receive recommended care roughly half the time, reflecting poor decision making that threatens their health. This Article offers an innovative solution: require physicians to disclose clinical practice guideline recommendations to patients during informed consent. Behavioral economics suggest that insisting physicians and patients discuss guidelines, before deviating from them, could be surprisingly effective at nudging more rational care choices. At the same time, such disclosure should also educate and empower patients, serving autonomy.

Previous scholarship on unwarranted variances in care has focused primarily on malpractice reforms, largely ignoring the role of cognitive bias and the importance of patients …

Giving Thanks: The Ethics Of Grateful Patient Fundraising, Stacey A. Tovino

Faculty Articles

Grateful patient fundraising, defined as the solicitation of philanthropic donations by health care providers from current and former patients, raises a number of legal and ethical issues. Elsewhere, I detailed the confidentiality issues raised by the use and disclosure of patient identifiable information by hospital development officers, major gifts officers, institutionally-related foundations, and commercial fundraisers, and proposed corrections to federal health information confidentiality regulations to better balance the competing aims of health care philanthropy and health information confidentiality. In this Article, I analyze several outstanding issues raised by physician involvement in grateful patient fundraising. That is, physicians who solicit philanthropic …

The Dsm-5: Implications For Health Law, Stacey A. Tovino

Faculty Articles

In May 2013, the American Psychiatric Association released the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders ("DSM-5"). Among other changes, the DSM-5 includes new entries for hoarding disorder and premenstrual dysphoric disorder as well as a reclassified entry for gambling disorder. Using these changes as examples, this Article examines the implications of the DSM-5 for key issues in health law, including health insurance coverage, public and private disability benefit eligibility, and disability discrimination protection. As a descriptive matter, this Article illustrates how the addition of new disorders and the reclassification of existing disorders in the DSM-5 …

Will Neuroscience Redefine Mental Injury?: Disability Benefit Law, Mental Health Parity Law, And Disability Discrimination Law, Stacey A. Tovino

Faculty Articles

No abstract provided.

Silence Is Golden ... Except In Health Care Philanthropy, Stacey A. Tovino

Faculty Articles

No abstract provided.

Uncovering The Silent Victims Of The American Medical Liability System, Joanna Shepherd

Faculty Articles

A frequently overlooked problem with the current medical liability system is the vast number of medical errors that go uncompensated. Although studies indicate that 1% of hospital patients are victims of medical negligence, fewer than 2% of these injured patients file claims. In this Article, I explain that many victims of medical malpractice do not file claims because they are unable to find attorneys willing to take their cases.

I conducted the first national survey of attorneys to explore medical malpractice victims' access to the civil justice system. The results from the survey indicate that the economic reality of litigation …

A "Common" Proposal, Stacey A. Tovino

Faculty Articles

The Federal Policy for the Protection of Human Subjects (the "Common Rule") is codified in separate regulations by seventeen federal departments and agencies, including the Department of Health and Human Services (HHS). HHS’s version of the Common Rule currently contains a basic policy for the protection of all human subjects, codified at Subpart A of the Common Rule, as well as special provisions governing human subjects research involving three sets of vulnerable populations, including pregnant women, fetuses, and neonates (Subpart B); prisoners (Subpart C); and children (Subpart D). This Article proposes that HHS amend the Common Rule to add a …

All Illnesses Are (Not) Created Equal: Reforming Federal Mental Health Insurance Law, Stacey A. Tovino

Faculty Articles

This article is the second, and most important, installment in a three-part series that presents a comprehensive challenge to lingering legal distinctions between physical and mental illness. The basic impetus for this historical, medical, and legal project is a belief that there exists no rational or consistent method of distinguishing physical and mental illness in the context of health insurance law. The first installment in this series narrowly inquired as to whether a particular set of disorders, the postpartum mood disorders, are or should be classified as physical or mental illnesses in a range of health law contexts. This second …

Further Support For Mental Health Parity Law And Mandatory Mental Health And Substance Use Disorder Benefits, Stacey A. Tovino

Faculty Articles

In this Article, I provide additional support for my recent proposal (All Illnesses Are (Not) Created Equal: Reforming Federal Mental Health Insurance Law, Harvard Journal on Legislation, Vol. 49, forthcoming 2012.) to extend federal mental health parity law and mandatory mental health and substance use disorder benefits to all public healthcare program beneficiaries and private health plan members. I begin by examining health-related doctrine outside the context of mental health insurance law, including disability discrimination law, civil rights and human rights law, health information confidentiality law, healthcare reform law, and child and adult health and welfare law, and …

Reforming State Mental Health Parity Law, Stacey A. Tovino

Faculty Articles

This Article is the final installment in a three-part project that presents a comprehensive challenge to lingering legal distinctions between physical and mental illness in the context of health insurance. The first installment in this series narrowly inquired as to whether the postpartum mood disorders should be classified as physical or mental illnesses in a range of health law contexts, including the context of health insurance. The second installment was broader in scope and challenged a number of federal provisions that allow publicly- and privately-funded health care programs and plans to provide mental health insurance benefits that are less comprehensive …

A Proposal For Comprehensive And Specific Essential Mental Health And Substance Use Disorder Benefits, Stacey A. Tovino

Faculty Articles

This Article analyzes the initial efforts of the Federal Department of Health and Human Services to implement the essential mental health and substance use disorder services benefit required by section 1302(b)(1)(E) of the Affordable Care Act and proposes the adoption of a comprehensive and specific essential mental health and substance use disorder benefit set. At a minimum, the benefit set should cover medically necessary and evidence-based inpatient and outpatient mental healthcare services, inpatient substance abuse detoxification services, inpatient and outpatient substance abuse rehabilitation services, emergency mental healthcare services, prescription drugs for mental health conditions, participation in psychiatric disease management programs, …

Scientific Understandings Of Postpartum Illness: Improving Health Law And Policy?, Stacey A. Tovino

Faculty Articles

In its broadest sense, this Article examines the relationship between science and the law in the context of postpartum illness. From classical antiquity to the present day, physicians and scientists have investigated the causes, correlates, and consequences of the depressions and psychoses that develop in some women following their transition to motherhood. The scientific investigation of postpartum illness has been characterized by an open-ended search for knowledge with the recognition that scientific findings published one day are subject to revision the next. Legislators and judges also have sought to understand postpartum illness as necessary to make laws that affect and …

Neuroscience And Health Law: An Integrative Approach?, Stacey A. Tovino

Faculty Articles

Clinicians and scientists use functional magnetic resonance imaging (fMRI) to map sensory, motor, and cognitive function and to study the neural correlates of a range of physical and mental conditions, behaviors, characteristics, and preferences. Due to its move outside the clinical and research contexts, fMRI raises a number of ethical, legal, and social issues that are being examined within the overlapping fields of neuroethics and neurolaw. The early neuroethics and neurolaw scholarship focused heavily on the implications of fMRI for evidence law, criminal law, criminal procedure, and constitutional law. Little attention has been paid, however, to the implications of advances …

Neuroimaging Research Into Disorders Of Consciousness: Moral Imperative Or Ethical And Legal Failure, Stacey A. Tovino

Faculty Articles

In this article I explore the ethical and legal implications of enrolling individuals with disorders of consciousness (DOC) in neuroimaging research studies. Many scientists have strongly emphasized the need for additional neuroimaging research into DOC, characterizing the conduct of such studies as morally imperative. On the other hand, institutional review boards (IRBs) charged with approving research protocols, scientific journals deciding whether to publish study results, and federal agencies that disburse grant money have limited the conduct, publication, and funding of consciousness investigations based on ethical and legal concerns. Following a detailed examination of the risks and benefits of neuroimaging research …

Imaging Body Structure And Mapping Brain Function: A Historical Approach, Stacey A. Tovino

Faculty Articles

Now in its second decade, functional magnetic resonance imaging (fMRI) localizes changes in blood oxygenation that occur in the brain when an individual performs a mental task. Physicians and scientists use fMRI not only to map sensory, motor, and cognitive functions, but also to study the neural correlates of a range of sensitive and potentially stigmatizing conditions, behaviors, and characteristics. Poised to move outside the traditional clinical and research contexts, fMRI raises a number of ethical, legal, and social issues that are being explored within a burgeoning neuroethics literature. In this Article, I place these issues in their proper historical …

Letting Katz Out Of The Bag: Cognitive Freedom And Fourth Amendment Fidelity, Christian Halliburton

Faculty Articles

Emerging surveillance technologies now allow operators to collect information located within the brain of an individual, allow the collection of forensic evidence regarding cerebral and cognitive processes, and are even beginning to be able to predict human intentions. While science has not yet produced a mind-reading machine per se, the devices referred to as cognitive camera technologies are substantial steps in the direction of that inevitable result. One such technique, a proprietary method called Brain Fingerprinting, is used as an example of the strong trend towards increasingly invasive and ever more powerful surveillance methods, and provides an entrée to a …

Functional Neuroimaging And The Law: Trends And Directions For Future Scholarship, Stacey A. Tovino

Faculty Articles

Under the umbrella of the burgeoning neurotransdisciplines, scholars are using the principles and research methodologies of their primary and secondary fields to examine developments in neuroimaging, neuromodulation, and psychopharmacology. The path for advanced scholarship at the intersection of law and neuroscience may clear if work across the disciplines is collected and reviewed and outstanding and debated issues are identified and clarified. In this article, I organize, examine and refine a narrow class of burgeoning neurotransdiscipline scholarship; that is, scholarship at the interface of law and functional magnetic resonance imaging.

Psychiatric Restraint And Seclusion: Resisting Legislative Solution, Stacey A. Tovino

Faculty Articles

The use of restraint and seclusion in the American psychiatric setting has a rich history - rich in medical, ethical, legal, and social controversy. For centuries, mental health care providers used movement restrictions and solitary confinement to manage psychiatric patients. Superintendents of eighteenth and early nineteenth century insane asylums and other institutions of confinement believed that strait-waistcoats, "tranquilizer chairs," "maniac beds," chains, shackles, and "quiet rooms" deescalated agitation and promoted self-control. Reforms beginning in the nineteenth century helped make some psychiatric institutions more humane, in part because staff members were trained to find ways to calm potentially violent patients without …

Functional Neuroimaging Information: A Case For Neuro Exceptionalism, Stacey A. Tovino

Faculty Articles

Functional magnetic resonance imaging (fMRI) has built on a number of technologies, including electroencephalography, magnetoencephalography, positron emission tomography, and single-photon emission computed tomography, to become one of the decade's most powerful tools for mapping sensory, motor, and cognitive function. Scientists also are using fMRI to study the neural correlates of a range of conditions, characteristics, and social behaviors, including schizophrenia, addiction, racial evaluation, deception, cooperation, and sexual preferences. Now poised to move outside the research context, functional neuroimaging raises a number of confidentiality, privacy, and identity issues. In this Article, I examine whether special, or heightened, confidentiality, privacy, and informed …

My Father, John Locke, And Assisted Suicide: The Real Constitutional Right, John B. Mitchell

Faculty Articles

This article discusses the right to assisted suicide, a right not derived from anything explicit or implied in any textual provision of the Constitution. It is a right derived from the two underlying political philosophies, which form the basis of the entire U.S. Constitutional enterprise: John Locke's Social Contract and Civic Republicanism. In Part I, this article discusses Glucksberg's fundamental rights analysis. So much has been written about this case that this article will limit comments to briefly adding thoughts as to why, given the combination of the Court's motivation, both institutional and pragmatic, in approaching this case, and its …