Neuroimaging Research into Disorders of Consciousness: Moral Imperative or Ethical and Legal Failure?

This article explores 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 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 involving individuals with DOC, the author urges IRBs, scientific journals, and funding agencies to no longer stall the conduct, publication, and funding of neuroimaging research into DOC if certain criteria designed to protect the health and safety of individuals with DOC are satisfied

Substance Use Disorder Insurance Benefits: A Survey of State Benchmark Plans

Professor Tovino presents the results of a survey of state benchmark health plan coverage of substance use disorder treatments and services, including treatments and services for opioid use disorder

Going Rogue: Mobile Research Applications and the Right to Privacy

This Article investigates whether nonsectoral state laws may serve as a viable source of privacy and security standards for mobile health research participants and other health data subjects until new federal laws are created or enforced. In particular, this Article (1) catalogues and analyzes the nonsectoral data privacy, security, and breach notification statutes of all fifty states and the District of Columbia; (2) applies these statutes to mobile-app-mediated health research conducted by independent scientists, citizen scientists, and patient researchers; and (3) proposes substantive amendments to state law that could help protect the privacy and security of all health data subjects, including mobile-app-mediated health research participants

Complying with the HIPAA Privacy Rule: Problems and Perspectives

Twenty years ago, President Clinton signed the Health Insurance Portability and Accountability Act of 1996 (HIPAA) into law. Over the past two decades, the federal Department of Health and Human Services (HHS) has published several sets of rules implementing the Administrative Simplification provisions within HIPAA as well as the Health Information Technology for Economic and Clinical (HITECH) Act within the American Recovery and Reinvestment Act (ARRA). These rules include a final rule governing the use and disclosure of protected health information by covered entities and their business associates (Privacy Rule). This Article addresses the question of what it means for covered entities and business associates to comply with the Privacy Rule. In particular, this Article will examine the challenges covered entities and business associates face in attempting to comply with the Privacy Rule while delivering and supporting the delivery of health care in an administratively responsible and financially feasible manner. Part I of the Article summarizes the history of the Privacy Rule, including the many proposed rules, interim final rules, final rules, guidance documents, and resolution agreements published by HHS. Part II reviews the Privacy Rule’s theory of and approach to health information confidentiality. Part III identifies three themes relating to Privacy Rule compliance

Privacy for Student-Patients: A Call to Action

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, the right to request further privacy restrictions, the right to obtain paper and electronic copies of medical records, the right to amend incorrect medical record entries, the right to receive an accounting of medical record disclosures, the right to ask privacy-related questions of an institutional privacy officer, and the right not to be intimidated, threatened, coerced, or discriminated against for exercising these rights. The HIPAA Security Rule also will typically apply, requiring the clinic to implement administrative, physical, and technical safeguards designed to protect the confidentiality, integrity, and availability of the student’s electronic protected health information. Finally, if the off-campus clinic discovers a breach of the student’s unsecured protected health information, the HIPAA Breach Notification Rule will typically apply, requiring the clinic to report the breach to the student, the federal government and, in certain cases, prominent media outlets serving the jurisdiction. If the law student seeks care at a health center affiliated with the student’s university, however, the story will be completely different. This is because the medical records that result from the student’s encounter with the student health center—called student treatment records—are excepted from the definition of protected health information under the HIPAA Privacy, Security, and Breach Notification Rules. Student treatment records also are excepted from the definition of education records under the Family Educational Rights and Privacy Act of 1974 (FERPA), the major federal statute that requires federally funded academic institutions to protect the privacy of such records. These exceptions exist because Congress, in late 1974, expressed its intent that student treatment records be protected only by state law. Unfortunately, state law provides minimal protections for student treatment records. This Article responds to the need for greater privacy, security, and breach notification protections for student treatment records. After reviewing a number of privacy and security breaches involving colleges and universities and the patchwork of federal and state law that fails to adequately protect student treatment records, this Article shows that many student health centers provide students with confusing information (at best) and misleading or incorrect information (at worst) regarding their privacy, security, and breach notification protections. After providing several practical, political, and health policy justifications for amending federal law, this Article re-writes relevant statutory and regulatory provisions in FERPA and HIPAA. If the proposals set forth in this Article are implemented by the federal government, student treatment records will receive the maximum privacy, security, and breach notification protections available currently available under the law

Of Mice and Men: On the Seclusion of Immigration Detainees and Hospital Patients

With a special focus on federal provisions strictly regulating Medicare-participating hospitals\u27 use of seclusion, this Article uses developments in health law as a lens through which the uses and abuses of seclusion in immigration detention centers might be assessed and through which the standards governing detention centers might be improved. In particular, this Article argues that the unenforceable standards governing seclusion in immigration detention, including the most recent version of ICE\u27s Performance-Based National Detention Standards, were incorrectly modeled on correctional standards developed for use in jails and prisons with respect to convicted criminals. This Article asserts that correctional standards are inappropriate guidelines for use in the immigration detention context. Borrowing the philosophy behind legally enforceable federal patients\u27 rights laws that govern the use of seclusion in hospitals, this Article proposes to reform the unenforceable standards governing the use of seclusion in immigration detention centers. It takes a novel approach by proposing to correct the abuse of the seclusion intervention in immigration detention by drawing on established frameworks in health law and bioethics. Specifically, this Article highlights the philosophical differences between federal health laws that are designed to protect the health, safety, and welfare of hospital patients and ICE\u27s unenforceable standards that fail to protect immigration detainees. It offers nine specific recommendations that, if promulgated by the Department of Homeland Security into federal regulations, would improve the health, safety, and welfare of immigration detainees

On Health, Law, and Religion

The Supreme Court recently decided a number of cases involving health, law, and religion, including Whole Woman\u27s Health v. Hellerstedt, Zubik v. Burwell, and Burwell v. Hobby Lobby Stores, Inc. These cases were important for understanding constitutional undue burden limitations and the boundaries of religious exercise during the Obama Administration. Unfortunately, the Supreme Court\u27s recent opinions addressing health, law, and religion have little value for many health law professors and most practicing health care attorneys. These individuals, tasked with teaching and applying the thousands of federal and state statutes, regulations, and government guidance documents that address a wide variety of health care access, quality, liability, organization, and finance issues, do not deal with constitutional undue burden limitations and the boundaries of religious exercise on a regular basis. Instead, these individuals focus on practical legal questions raised by the day-to-day delivery of health care. This Article seeks to remedy the lack of judicial and academic attention to practical issues that lie at the intersection of health, law, and religion. Drawing guidance from fields as wide ranging as constitutional law, transportation law, utilities law, criminal law, contract law, tax law, and trusts and estates law, this Article proposes new federal regulations and agency guidance in four illustrative contexts that implicate health, law, and religion. These contexts include religious nonmedical health care, home health care, hospice care, and health information confidentiality. If adopted by the federal Department of Health and Human Services, the proposals set forth in this Article will improve the counsel provided by regulatory health care attorneys as well as the public\u27s understanding of issues that lie at the intersection of health, law, and religion

A Right to Care

In this Article, Professor Stacey Tovino examines the right to care through a personal and historical lens, then attempts to fill a scholarly gap in legal literature surrounding the right to skilled care and rehabilitation for patients with group or commercial insurance. Professor Tovino first recounts the history of Medicare coverage for skilled care and rehabilitation, then she examines the limitations of group and commercial insurance, finally concluding by asserting a right to care