Law Commons^™

From Nucleotides To Nuanced Law: The Value Of An Incremental Approach To Experimentation In State-Level Genetic Anti-Discrimination Legislation, Katelyn Fisher

University of Massachusetts Law Review

A person’s genetic information tells a detailed story of what someone looks like, who her relatives are, and even what illnesses she may develop. This information, as enlightening as it may be, can be especially damaging when utilized in a discriminatory way. This Note explores how the protections under the Genetic Non Discrimination Act of 2008 will no longer be sufficient for protecting individuals from genetic discrimination as the use of genetic information becomes more commonplace. The questions become: Where do we start? How and where should protections that extend to circumstances not covered by GINA be created in a …

Healthy Data Protection, Lothar Determann

Michigan Technology Law Review

Modern medicine is evolving at a tremendous speed. On a daily basis, we learn about new treatments, drugs, medical devices, and diagnoses. Both established technology companies and start-ups focus on health-related products and services in competition with traditional healthcare businesses. Telemedicine and electronic health records have the potential to improve the effectiveness of treatments significantly. Progress in the medical field depends above all on data, specifically health information. Physicians, researchers, and developers need health information to help patients by improving diagnoses, customizing treatments and finding new cures.

Yet law and policymakers are currently more focused on the fact that health …

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 …

A Comment On Privacy And Accountability In Black-Box Medicine, Carl E. Schneider

Michigan Telecommunications & Technology Law Review

Human institutions and activities cannot avoid failures. Anxiety about them often provokes governments to try to prevent those failures. When that anxiety is vivid and urgent, government may do so without carefully asking whether regulation’s costs justify their benefits. Privacy and Accountability in Black Box Medicine admirably labors to bring discipline and rationality to thinking about an important development — the rise of “black-box medicine” — before it causes injuries regulation should have prevented and before it is impaired by improvident regulation. That is, Privacy and Accountability weighs the costs against the benefits of various forms of regulation across the …

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, …

Privacy And Accountability In Black-Box Medicine, Roger Allan Ford, W. Nicholson Price Ii

Michigan Telecommunications & Technology Law Review

Black-box medicine—the use of big data and sophisticated machine-learning techniques for health-care applications—could be the future of personalized medicine. Black-box medicine promises to make it easier to diagnose rare diseases and conditions, identify the most promising treatments, and allocate scarce resources among different patients. But to succeed, it must overcome two separate, but related, problems: patient privacy and algorithmic accountability. Privacy is a problem because researchers need access to huge amounts of patient health information to generate useful medical predictions. And accountability is a problem because black-box algorithms must be verified by outsiders to ensure they are accurate and unbiased, …

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

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 …

Satmed: Legal Aspects Of The Physical Layer Of Satellite Telemedicine, Stephen Rooke

Michigan Journal of International Law

In 2003, Paul Hunt, the U.N. Commission on Human Rights' Special Rapporteur on the Right to Health, presented a report on the global availability of health care. Special Rapporteur Hunt argued that states are obligated to implement a right to health. Included in this right is the obligation "to ensure that no international agreement or policy adversely impacts upon the right to health, and that .. . international organizations take due account of the right to health, as well as the obligation of international assistance and cooperation, in all policy-making matters." One area Hunt left unexplored in his report was …

Property As Control: The Case Of Information, Jane B. Baron

Michigan Telecommunications & Technology Law Review

If heath policy makers' wishes come true, by the end of the current decade the paper charts in which most of our medical information is currently recorded will be replaced by networked electronic health records ("EHRs").[...] Like all computerized records, networked EHRs are difficult to secure, and the information in EHRs is both particularly sensitive and particularly valuable for commercial purposes. Sadly, the existing federal statute meant to address this problem, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), is probably inadequate to the task.[...] Health law, privacy, and intellectual property scholars have all suggested that the river …

Harm Reduction, Human Rights, And Access To Information On Safer Abortion, Joanna Erdman

Articles, Book Chapters, & Popular Press

A harm reduction and human rights approach, grounded in the principles of neutrality, humanism, and pragmatism, supports women's access to information on the safer self-use of misoprostol in diverse legal settings. Neutrality refers to a focus on the risks and harms of abortion rather than its legal or moral status. Humanism refers to the entitlement of all women to care and concern for their lives and health, to be treated with respect, worth, and dignity, and to the empowerment of women to participate in decision-making and political action. Pragmatism accepts the historical reality that women will engage in unsafe abortion, …

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Sunshine And Accountability: The Pursuit Of Information On Quality In Medicaid Managed Care, Sarah Somers, Jane Perkins, Nhelp .

Saint Louis University Journal of Health Law & Policy

No abstract provided.

There Is A Time To Keep Silent And A Time To Speak, The Hard Part Is Knowing Which Is Which: Striking The Balance Between Privacy Protection And The Flow Of Health Care Information, Daniel J. Gilman, James C. Cooper

Michigan Telecommunications & Technology Law Review

Health information technology (HIT) has become a signal element of federal health policy, especially as the recently enacted American Recovery and Reinvestment Act of 2009 (Recovery Act or ARRA) comprises numerous provisions related to HIT and commits tens of billions of dollars to its development and adoption. These provisions charge various agencies of the federal government with both general and specific HIT-related implementation tasks including, inter alia, providing funding for HIT in various contexts: the implementation of interoperable HIT, HIT-related infrastructure, and HIT-related training and research. The Recovery Act also contains various regulatory provisions pertaining to HIT. Provisions of the …

Health Care Law, Kathleen M. Mccauley, Kristi L. Vanderlaan

University of Richmond Law Review

No abstract provided.

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 …

The Burden Of Knowledge, Christian Turner

Scholarly Works

Sometimes we are better off not knowing things. While we often hear that "ignorance is bliss," there has not been a comprehensive consideration in the legal academy of the virtues of ignorance and its regulation. Though the distribution of knowledge, like the distribution of other goods, is affected both directly and indirectly by law, several characteristics of knowledge distinguish it from other kinds of property. Much has been written about the impact of the nonrival and nonexclusive nature of knowledge on its production and distribution. This Article centers around two other attributes of knowledge that combine to create a special …

The Patient Life: Can Consumers Direct Health Care?, Carl E. Schneider, Mark A. Hall

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 …

After Autonomy, Carl E. Schneider

Articles

Bioethicists today are like Bolsheviks on the death of Lenin. They have, rather to their surprise, won the day. Their principle of autonomy is dogma. Their era of charismatic leadership is over. Their work of Weberian rationalization, of institutionalizing principle and party, has begun. The liturgy is reverently recited, but the vitality of Lenin's "What Is To Be Done?" has yielded to the vacuity of Stalin's "The Foundations of Leninism." Effort once lavished on expounding ideology is now devoted to establishing associations, organizing degree programs, installing bioethicist commissars in every hospital, and staffing IRB soviets. Not-so-secret police prowl the libraries …

Hipaa-Cracy, Carl E. Schneider

Articles

The Department of Health and Human Services has recently been exercising its authority under the (wittily named) "administrative simplification" part of the Health Insurance Portability and Accountability Act to regulate the confidentiality of medical records. I love the goal; I loathe the means. The benefits are obscure; the costs are onerous. Putatively, the regulations protect my autonomy; practically, they ensnarl me in red tape and hijack my money for services I dislike. HIPAA (a misnomer-HIPAA is the statute, not the regulations) is too lengthy, labile, complex, confused, unfinished, and unclear to be summarized intelligibly or reliably. (Brevis esse laboro, …

Family Privacy And Death: Antigone, War, And Medical Research, George J. Annas

Faculty Scholarship

Death ends the doctor–patient relationship, and legally the patient's right of privacy dies with the patient. Other privacy interests survive, the most central of which are those of the patient's family to bury the body and to prevent the disclosure of some personal information, such as medical information, about the deceased relative. Just what privacy interests encompass and when they can be overridden by other interests — such as freedom of speech or the claims of public policy or medical research — are evolving.1 Family privacy concerning a family member who has died is at the forefront of a …

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 …

Going To Pot, Carl E. Schneider

Articles

In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.

Hipaa Regulations: A New Era Of Medical-Record Privacy?, George J. Annas

Faculty Scholarship

The new privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) become effective April 14, 2003. This article outlines the implications of the new policy for practicing physicians. The regulations will affect virtually every physician, because they apply to any health care provider who conducts any business electronically, including billing. The regulations require health care providers to provide patients with a privacy notice that informs them who will have access to their records without their explicit consent and about patients' rights to inspect and amend their own records.

How Underlying Patient Beliefs Can Affect Physician-Patient Communicaion About Prostate-Specific Antigen Testing, Michael H. Farrell, Margaret Ann Murphy, Carl E. Schneider

Articles

Routine cancer screening with prostate-specific antigen (PSA) is controversial, and practice guidelines recommend that men be counseled about its risks and benefits. OBJECTIVE. To evaluate the process of decision making as men react to and use information after PSA counseling. DESIGN. Written surveys and semistructured qualitative interviews before and after a neutral PSA counseling intervention. PARTICIPANTS. Men 40 to 65 years of age in southeastern Michigan were recruited until thematic saturation—that is, the point at which no new themes emerged in interviews (n = 40). RESULTS. In a paper survey, 37 of 40 participants (93%) said that they interpreted the …

Medical Privacy And Medical Research: Judging The New Federal Regulations, George J. Annas

Faculty Scholarship

Americans support both protecting the privacy of medical records and encouraging medical research. Thus, it is not surprising that a move to change practices in these two areas has generated attention and comment. The new federal regulations, promulgated under the authority of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), were adopted to protect the privacy of medical records. They were not specifically designed to facilitate or limit medical research. Nonetheless, the regulations have prompted strong objections from the biotechnology industry and from academic medicine. The Association of American Medical Colleges and the Biotechnology Industry Organization have argued …

Gang Aft Agley, Carl E. Schneider

Articles

In my last contribution to this column (HCR, July-August 2000), I argued that the law of bioethics has repeatedly failed to achieve the hopes cherished for it. I presented evidence, for example, that most doctors breach the duty of informed consent, that advance directives do not direct patients' care, and that repeated legal attempts to increase organ donation have failed to find the success predicted for them. I closed that column by promising to try to explain this chastening experience. It would, of course, take a lifetime of columns to capture all the reasons the law of bioethics …

The Best-Laid Plans, Carl E. Schneider

Articles

It is natural to suppose law is like the centurion and can do as it will: "I say to this man, Go, and he goeth; and to another, Come, and he cometh; and to my servant, Do this, and he doeth it." But a thousand years ago, King Canute tried to disillusion his courtiers about his efficacy by commanding the waves to stop beating. And fifty years ago, Harry Truman predicted of Dwight Eisenhower, "He'll sit here, and he'll say, 'Do this! Do that!' And nothing will happen. Poor Ike-it won't be a bit like the Army. He'll find it …

Indictments And Informations In Texas: The Conduct/Evidence Pleading Conundrum., Robert R. Barton

St. Mary's Law Journal

In the prosecution of a criminal case in Texas, the State’s primary pleading is an indictment or information. In an indictment or information, there are two basic rules for the charging of an offense. First, the defendant must be given adequate notice to prepare a defense and to plead the judgment from the trial of the case in bar to a subsequent prosecution for the same offense. Second, the State is not required to plead evidentiary matters. The simplicity of these rules exists more in their statement than in their application because circumstances exist which require the State to plead …

Lawyers' Negligence Liability To Non-Clients: A Texas Viewpoint., Brian J. Davis

St. Mary's Law Journal

Courts should examine the relationship of a non-client to a negligent lawyer to determine whether a lawyer is liable to a non-client despite lack of privity. In most jurisdictions, attorneys enjoy the privity of contract requirement which limits their duty to exercise reasonable care. As a result, lawyers are normally immune to negligent malpractice actions brought by non-clients. Courts should examine the relationship between the attorney and the non-client to determine whether the requirement of privity is an overly restrictive limit on the lawyer’s scope of duty. These relationships can be classified into three categories. The first category involves plaintiffs …