Law Commons^™

Is There A Fundamental Right To Privacy When An Educational Institution Requires A Student To Disclose Proof Of His Or Her Vaccination Status?, Mary D. Fatscher

Touro Law Review

In 2020, the coronavirus disease (“COVID-19”) dominated the world. Although the public has progressively become more informed about the disease and how to safeguard itself, challenges persist as there is still much unknown. Aside from wearing masks, social distancing, and despite its undetermined consequences, the COVID-19 vaccination has emerged as a primary solution to substantially reducing the incidence and severity of the virus in our country. Many COVID-19 vaccine mandates were initiated once three pharmaceutical and biotechnology companies including Pfizer-BioNTech, Moderna, and Johnson & Johnson received Emergency Use Authorization from the Food and Drug Administration (“FDA”).

Professional Medical Judgment And Pharmaceutical Marketing: Drawing Legal And Ethical Lines Around Conflict Of Interest, Steven R. Salbu

William & Mary Business Law Review

Pharmaceutical manufacturers develop relationships with healthcare providers for several purposes, including the marketing and sale of their products. Professional associations give guidance to physicians and companies for managing these relationships ethically. Some practices permitted by these associations entail conflicts of interest. This Article explores two of these practices: (i) company funding of external educational seminars, conferences, and continuing medical education; and (ii) company-hosted speaker programs. The conflict of interest concerns raised by the former practice are manageable, and the practice should continue to be permitted subject to appropriate safeguards; however, the conflict of interest concerns raised by the latter practice …

Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous

Saint Louis University Journal of Health Law & Policy

Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …

Reclaiming Access To Truth In Reproductive Healthcare After National Institute Of Family & Life Advocates V. Becerra, Diane Kee

Michigan Law Review

Crisis Pregnancy Centers (CPCs) are antiabortion organizations that seek to “intercept” people with unintended pregnancies to convince them to forego abortion. It is well documented that CPCs intentionally present themselves as medical professionals even when they lack licensure, while also providing medically inaccurate information on abortion. To combat the blatant deception committed by CPCs, California passed the Reproductive FACT Act in 2015. The Act required CPCs to post notices that disclosed their licensure status and informed potential clients that the state provided subsidized abortion and contraceptives. Soon after, CPCs brought First Amendment challenges to these disclosure requirements, claiming that the …

An Implied Defense: Self-Disclosure Offers A Defense To The Expanded False Claims Liability After Universal Health Services V. Escobar, Megan E. Italiano

William & Mary Law Review

No abstract provided.

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

Reconsidering Constitutional Protection For Health Information Privacy, Wendy K. Mariner

Faculty Scholarship

What kinds of health information should be reported to government for civil purposes? Several competing trends encourage efforts to reassess the scope of constitutional protection for health information: the social and commercial value of health information; the amount of data held by third parties, from health care providers to internet servers; critiques of the third party doctrine exception to Fourth Amendment protection; and concerns about the loss of privacy. This article describes a variety of civil purposes for which health information is collected today. A close analysis of cases applying the third party doctrine, administrative search principles, and the special …

Avoiding Unintended Disclosure: Representing Clients With Hiv And Aids, Lashanda Taylor Adams

Journal Articles

When the HIV/AIDS epidemic was initially recognized in the United States, many attorneys wondered what it would mean to represent a client with HIV. As the number of HIV-infected individuals grew, so did the need for attorneys to represent them. Specifically, attorneys questioned whether or not their duty of confidentiality would expose them to civil liability from failing to protect a third party.1 In response to this concern, several law review articles were written discussing the dilemma faced by attorneys bound by professional rules of conduct.2 These articles focused on the needs of the attorney and the public rather than …

Heterogeneity In Irb Policies With Regard To Disclosures About Payment For Participation In Recruitment Materials, Christopher Robertson, Megan Wright

Faculty Scholarship

Scholars have documented variation in the way local Institutional Review Boards differently adjudicate identical research proposals. It is unclear whether such heterogeneity is due to variation in positive policies, or variation in human processes of interpretation and enforcement. A particularly interesting question relates to whether investigators are allowed to provide truthful information about research opportunities to potential participants, which some IRBs seem to forbid. We investigated local IRB policies on disclosing the amount of compensation in recruitment materials by conducting a census of the top 100 institutions by receipt of NIH funding in 2012. We downloaded the relevant policies and …

Disclosure For Closure? Why The Self-Referral Disclosure Protocol Process Paired With The 60-Day Overpayment Rule Creates More Headaches Than Solutions, Peter J. Eggers

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Truman V. Thomas: The Rise Of Informed Refusal, Thomas M. O'Neil

Pepperdine Law Review

Truman v. Thomas addresses the issue of whether or not a physician must inform a patient of the possible consequences of her refusal to submit to a diagnostic test. The California Supreme Court has determined that a physician has such a duty, and the author provides an examination of this decision and a view of previous case law in the area of informed consent. Although increasing the physician's burden of disclosure, the decision can be seen as a continuation of the trend of cases allowing patients more control over the care of their own bodies.

Can Consumers Control Health-Care Costs?, Mark A. Hall, Carl E. Schneider

Articles

The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today’s health policy watchword. This article evaluates consumerism and the regulatory mechanism …

A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson

Faculty Scholarship

The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor.

Examining Timely Disclosure Of Material Information To Shareholders And The Privacy Concerns Of Executive Officers, Ufuoma Barbara Akpotaire

Ufuoma Barbara Akpotaire

On January 20, 1993, Michael Walsh, the former Chairman and CEO of Tenneco revealed to the public that he had brain cancer. This type of disclosure of health issues are arguable serious enough to affect Wall Street. Other company officials have previously made similar disclosures such as Hugh Martin, CEO of Pacific Biosciences who in October 2010 disclosed to his employees that he had cancer of the Blood (multiple myeloma), and Harry J. Pearce, the Vice President of General Motors, who disclosed in 2001 that he had leukemia.

The above public disclosures are however more the exceptions than the rule. …

Sex And Hiv Disclosure, Aziza Ahmed, Beri Hull

Faculty Scholarship

What do you consent to when you have sex with someone? What if the person is a new sexual partner from a night at a bar? What if the person is your spouse or long-term partner? In these two scenarios, people might understand both HIV risk and HIV disclosure differently. Close reflection demonstrates that a purportedly clear set of criminal laws rarely reflects the complexity of sexual interaction.

This article explores how the dynamics of HIV disclosure prior to sex contribute to an ongoing dialogue about disclosure and consent: Does a person have a right to know his or her …

Sex And Hiv Disclosure, Aziza Ahmed, Beri Hull

Aziza Ahmed

No abstract provided.

Technical Problem: How City Of Dallas V. Dallas Morning News, Lp Exposed A Major Loophole In The Texas Public Information Act Comment., Alexander J. Yoakum

St. Mary's Law Journal

The Texas Public Information Act (TPIA) grants everyone a statutory right to access records of a governmental body unless disclosure would violate the law. Generally, TPIA is construed broadly to favor disclosure, but the rise of modern technology like email and text messaging reveals how dated TPIA truly is. According to the recent City of Dallas v. Dallas Morning News, LP, a governmental body is not required to release any business-related electronic communications sent via personal devices. This means governmental employees can conduct official business via personal email or cell phone without being subject to disclosure provisions, unless the requester …

When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law., Mark A. Hall, Carl E. Schneider

Articles

The ultimate aim of health care public policy is good care at good prices. Managed care stalled at achieving this goal by trying to influence providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy are now pressuring patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's watchword. This Article evaluates this ideal type …

Double Helix, Double Standards: Private Matters And Public People, Teneille R. Brown

Journal of Health Care Law and Policy

No abstract provided.

A Comprehensive Analysis Of Mri Research Risks: In Support Of Full Disclosure, Jennifer Marshall, Toby Martin, Jocelyn Downie, Krisztina Malisza

Articles, Book Chapters, & Popular Press

Magnetic resonance imaging (MRI) procedures have been used for over 20 years. This modality is considered relatively safe and holds great promise. Yet, MRI has a number of risks. In order for MRI research to meet the Canadian standard of disclosure, the investigator must communicate and make note of all risks in their research protocols and consent forms. Those creating and reviewing research protocols and consent forms must take notice of the different circumstances under which MRI poses a risk. First, this paper will describe the current standard of disclosure in Canada for research participants. Second, the paper will provide …

Reaching Disclosure, Carl E. Schneider

Articles

It is easy to forget but crucial to remember that when lawmakers decide to regulate an activity, they must select a method. The law of bioethics particularly favors one method-requiring disclosure of information. The doctrine of informed consent obliges doctors to tell patients their treatment choices. The administrative law of research ethics insists that researchers warn subjects of the risks of experiments. The Patient Self-Determination Act compels medical institutions to remind patients about advance directives. The federal government's new privacy regulations instruct medical institutions to describe their privacy regime to patients. Not just the law of bioethics, but health law …

Confidentiality, Corporate Counsel, And Competition Law: Representing Multi-National Corporations In The European Union Third Annual Symposium On Legal Malpractice & Professional Responsibility: Symposium Presentations., Sue Bentch

St. Mary's Law Journal

Professional ethics for corporate counsel in the European Union (EU) differs from the standards required in the United States. Consequently, conflicts may arise when US corporations deal with EU countries. For instance, if an issue regarding confidentiality emerges, the company bears the burden to prove to the European Commission that a particular document is protected from disclosure. Under EU’s Regulation 17, the European Commissioner has broad powers to investigate and adjudicate suspected violations of EU competition law. The Commissioner is the equivalent of an investigator, prosecutor, judge, and jury, all rolled into one. If a communication from a company was …

What Should The Law Say About Disclosure Of Genetic Information To Relatives?, Ellen Wright Clayton

Journal of Health Care Law and Policy

No abstract provided.

Family Disclosure In Genetic Testing For Cancer Susceptibility: Determinants And Consequences, Caryn Lerman, Beth N. Peshkin, Chanita Hughes, Claudine Isaacs

Journal of Health Care Law and Policy

No abstract provided.

The Argument Against A Physician's Duty To Warn For Genetic Diseases: The Conflicts Created By Safer V. Estate Of Pack, Angela Liang

Journal of Health Care Law and Policy

No abstract provided.

Ethical Responsibilities Of Patients And Clinical Geneticists, Allen Buchanan

Journal of Health Care Law and Policy

No abstract provided.

A Study In Regulatory Method, Local Political Cultures, And Jurisprudential Voice: The Application Of Federal Confidentiality Law To Project Head Start, Richard C. Boldt

Michigan Law Review

This article focuses on one particular set of issues raised by the effort to coordinate the activities of Head Start centers with those of substance abuse treatment programs and the introduction of treatment and prevention functions into the daily interactions of Head Start staff and parents. These issues involve the disclosure of potentially damaging information about a Head Start parent's drug or alcohol abuse and the confidentiality considerations that arise when she or he has sought or received treatment for that abuse. Although it is possible to characterize these issues as technical, doctrinal questions of statutory and regulatory interpretation, it …

A Study In Regulatory Method, Local Political Cultures, And Jurisprudential Voice: The Application Of Federal Confidentiality Law To Project Head Start, Richard C. Boldt

Michigan Law Review

This article focuses on one particular set of issues raised by the effort to coordinate the activities of Head Start centers with those of substance abuse treatment programs and the introduction of treatment and prevention functions into the daily interactions of Head Start staff and parents. These issues involve the disclosure of potentially damaging information about a Head Start parent's drug or alcohol abuse and the confidentiality considerations that arise when she or he has sought or received treatment for that abuse. Although it is possible to characterize these issues as technical, doctrinal questions of statutory and regulatory interpretation, it …

Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

Articles

You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from a broader public policy perspective. We have …

A Doctor's Duty To Disclose Life Expectancy Information To Terminally Ill Patients, Denise Ann Dickerson

Cleveland State Law Review

It is the purpose of this Note to review and evaluate the benefits to making full disclosure to a terminally ill patient. It is this author's position that a patient's well-being and dignity dictate that the physician be forthright with all information regarding a patient's diagnosis and the range of treatments available, including both active and passive treatments.