Health Law and Policy Commons^™

Index To The Bibliography

Journal of Health Care Law and Policy

No abstract provided.

Reproductive Genetics 1991-2002: A Selected Annotated Legal Bibliography Of Genetic Testing, Gene Transfer And Reproductive Cloning, Gail H. Javitt

Journal of Health Care Law and Policy

No abstract provided.

The Next Wave: Federal Regulatory, Intellectual Property, And Tort Liability Considerations For Medical Device Software, 2 J. Marshall Rev. Intell. Prop. L. 259 (2003), Paul A. Mathew

UIC Review of Intellectual Property Law

Counsel for the medical software technologist faces an unusually complex, ongoing, high-stakes challenge. Counsel operates in a special field of commercial, legal and regulatory forces: (1) intellectual property laws which govern the expression and protection of commercial rights derived from advances in medical science and technology; (2) existing and proposed contracts/warranty laws that govern technological commercial relationships; (3) negligence, professional liability, and product liability laws that govern the marketing of medical technologies; and, (4) a new body of regulation derived from the power of the federal government to indirectly provide for the safety, effectiveness, privacy, and security of medical technologies …

Protecting Human Research Subjects: A Jurisdictional Analysis, Jennifer Llewellyn, Jocelyn Downie, Robert Holmes

Articles, Book Chapters, & Popular Press

The most recent speech from the throne contained a pledge from the federal government to "work with provinces to implement a national system for the governance of research involving humans, including national research ethics and standards." This commitment signals a desire on the part of the federal government to address concerns about the inadequacies of the current governance of health research involving humans (RIH). To this end, Health Canada's Ethics Division is currently exploring the ways in which such a national governance system for RIH might be implemented. It is important for the federal government, as it moves toward making …

The Usage And Meaning Of "Clinical Significance" In Drug-Related Litigation, Sarah M.R. Cravens

Washington and Lee Law Review

No abstract provided.

The Medicare Anti-Kickback Statute: In Need Of Reconstructive Surgery For The Digital Age, Michael E. Paulhus

Washington and Lee Law Review

No abstract provided.

Transcript For Welcome Address , Andrew Pike

American University Law Review

No abstract provided.

Symposium: The Human Genome Project, Dna Science And The Law: The American Legal System's Response To Breakthroughs In Genetic Science: Biographies Of Participants

American University Law Review

No abstract provided.

Before It's Too Late- Addressing Fear Of Genetic Information, Karen H. Rothenberg, Sharon F. Terry

Faculty Scholarship

No abstract provided.

Cybersurgery: Innovation Or A Means To Close Community Hospitals And Displace Physicians?, 20 J. Marshall J. Computer & Info. L. 495 (2002), Thomas R. Mclean

UIC John Marshall Journal of Information Technology & Privacy Law

Cybersurgery is a surgical technique that allows a surgeon, using a telecommunication conduit connected to a robotic instrument, to operate on a remote patient. As a medical doctor, the author discusses the place of cybersurgery in the U.S. health care system of the new millennium. The author first reviews the field of cybersurgery and how the automatic surgeon will make off-line remote surgery possible. Then, he examines the global economy in health care systems and the impact of cybersurgery on closure of community hospitals and displacing physicians. Consequently, he discusses the ability of these entities to protect themselves with trade …

One Man's Trash Is Another Man's Treasure, Bioprospecting: Protecting The Rights And Interests Of Human Donors Of Genetic Material, Anne Nichols Hill

Journal of Health Care Law and Policy

No abstract provided.

Patents On Dna Sequences: Molecules And Information, Rebecca S. Eisenberg

Book Chapters

As public and private sector initiatives raced to complete the sequence of the human genome, patent issues played a prominent role in speculations about the significance of this achievement. How much of the genome would be subject to the control of patent holders, and what would this mean for future research and the development of products for the improvement of human health in a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claim, to the genome on behalf or the many sequential innovators who elucidate its sequence and …

Are You My Parent? Are You My Child? The Role Of Genetics And Race In Defining Relationships After Reproductive Technological Mistakes, 5 Depaul J. Health Care L. 15 (2002), Raizel Liebler

UIC Law Open Access Faculty Scholarship

Imagine that you are a married woman who wants to have a genetically related child with your husband. Your doctor tells you that you are infertile, and therefore you and your husband go to XYZ fertility clinic to receive in vitro treatment. You have your eggs harvested, your husband supplies sperm, and ten embryos are created. Five embryos are implanted in your uterus and five are frozen and kept by the fertility clinic for your later use. You successfully conceive and give birth to twins. You notice that the children you give birth to are of a different race than …

Two Concepts Of Immortality: Reframing Public Debate On Stem-Cell Research, Frank Pasquale

Faculty Scholarship

No abstract provided.

Disease Management And Liability In The Human Genome Era, Larry I. Palmer

Villanova Law Review (1956 - )

No abstract provided.

The Hormesis Challenge For Environmental Health Regulators, Michael S. Baram

Faculty Scholarship

The hormesis hypothesis provides that human, animal or plant exposure to a low external dose of a hazardous chemical substance or physical agent may have beneficial health outcomes'. For example, human exposure to a precisely defined, low external dose of a carcinogenic pollutant in the workplace or ambient environment may lead to an internal dose or concentration, which stimulates a dormant defense mechanism that inhibits the growth of tumors.

Nord Issues Gene Patenting Statement, Valerie Gutmann Koch

All Faculty Scholarship

No abstract provided.

Lengthening The Stem: Allowing Federally Funded Researchers To Derive Human Pluripotent Stem Cells From Embryos, Jason H. Casell

University of Michigan Journal of Law Reform

Recent developments in fetal tissue research and stem cell research have led to dramatic breakthroughs in the search for cures for Parkinson's disease, Alzheimer's disease, diabetes, and a host of neurological disorders. Because this research involves fetal tissue and stem cells from human embryos, many complicated ethical and legal implications surround it. This Note explores the history of fetal tissue research and stem cell research, examines the surrounding ethical and legal issues, looks at the current state of federal law, and concludes that Congress should allow federally funded researchers to derive stem cells from discarded human embryos obtained from in …

Self-Prescribing Medication: Regulating Prescription Drug Sales On The Internet, 20 J. Marshall J. Computer & Info. L. 57 (2001), Kristin Yoo

UIC John Marshall Journal of Information Technology & Privacy Law

"Online pharmacies, your friendly neighborhood drugstores." The Internet is not only a great telecommunication medium but also a low-cost and convenient commercial marketplace. It is no exception that online pharmacies flourished as a result, but the consequences of such development pose grave danger to the public and great challenges to regulations. The author discusses the benefits and risk of online pharmacies, the different types of online pharmacies, state governments' involvement in regulating online prescriptions and federal involvements. Despite both state and federal legislations and regulations, proliferation of online pharmacies, established inside and outside of the US, proves to be a …

Privacy Rights In Personal Information: Hipaa And The Privacy Gap Between Fundamental Privacy Rights And Medical Information, 19 J. Marshall J. Computer & Info. L. 535 (2001), Kevin B. Davis

UIC John Marshall Journal of Information Technology & Privacy Law

Advancements in computers and technology have affected nearly every aspect of health care. Although many of the effects of modern technology have benefited health care, a vast increase in the amount of people with access to medical information has led to numerous privacy concerns. In response to these new problems, and at the direction of Congress through the Health Insurance Portability & Accountability Act of 1996 (“HIPAA”), Health and Human Services (“HHS”) implemented the Privacy Rule. The Privacy Rule “protects privacy by regulating the ways in which certain medical information may be used by certain entities.” The constitutional right to …

Cybermedicine: How Computing Empowers Doctors And Patients For Better Health Care, 19 J. Marshall J. Computer & Info. L. 589 (2001), William B. Powers

UIC John Marshall Journal of Information Technology & Privacy Law

In Cybermedicine: How Computing Empowers Doctors and Patients for Better Health Care, Dr. Warner V. Slack takes the reader on an interesting journey from the advent of experimental computer usage in the early 1960s, to comprehensive, hospital-wide computing systems in the 1980s, and into the future. As a professor of medicine and psychiatry at Harvard Medical School and co-president of the Center for Clinical Computing and co-director of the Division for Clinical Computing at Beth Israel Deaconess Medical Center, Dr. Slack, who has been involved with computers in medicine for some thirty-five years, demonstrates how the use of computers can …

Book Review - Textbook Of Research Ethics: Theory And Practice, Elizabeth Pendo

Book Reviews

An intense and deeply divided debate is taking place over the testing of a short course of AZT to prevent maternal-fetal transmission of HIV in the developing world.' A long course of AZT-administered to HIV-infected pregnant women during their pregnancy and immediately before labor, and then to their newborn children for six weeks-is generally accepted in the United States as providing extensive protection against maternal-fetal transmission of HIV Given the expense and lengthy administration of the long course, American researchers in the developing world designed studies to test the efficacy of a shorter course of AZT administered during late pregnancy …

Genetic Testing For Susceptability To Disease From Exposure To Toxic Chemicals: Implications For Public And Worker Health Policies, Michael S. Baram

Faculty Scholarship

The Environmental Genome Program intends to identify "susceptibility genes" that would indicate if a person is more vulnerable to cancer or other disease as a result of exposure to certain chemicals in the workplace, the environment, foods, or other products. Research findings and the capability to test persons for such genes are likely to impugn and challenge health policies and regulatory programs that do not take genetic susceptibility into account when conferring health benefits and restricting chemical exposures. This article focuses on the Occupational Safety and Health Administration (OSHA) and discusses four options available to this agency for protecting genetically …

Doubts About Daubert: Psychiatric Anecdata As A Case Study, Christopher Slobogin

Vanderbilt Law School Faculty Publications

In Daubert v. Merrell Dow Pharmaceuticals Inc., the Supreme Court sensibly held that testimony purporting to be scientific is admissible only if it possesses sufficient indicia of scientific validity. In Kumho Tire Co. v. Carmichael, the Court more questionably held that opinion evidence based on "technical" and "specialized" knowledge must meet the same admissibility threshold as scientific testimony. This Article addresses the implications of these two decisions for opinion evidence presented by mental health professionals in criminal trials.

Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant

Faculty Scholarship

You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …

Symposium: Advances In Biomaterials And Devices, And Their Financing, Ronald A. Cass, Michael S. Baram, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King

Faculty Scholarship

My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.

Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …

Is The Clean Air Act Unconstitutional?, Cass R. Sunstein

Michigan Law Review

This Article deals with two linked questions. The first involves the future of the Clean Air Act. The particular concern is how the Environmental Protection Agency ("EPA") might be encouraged, with help from reviewing courts, to issue better ambient air quality standards, and in the process to shift from some of the anachronisms of 1970s environmentalism to a more fruitful approach to environmental protection. The second question involves the role of the nondelegation doctrine in American public law, a doctrine that shows unmistakable signs of revival. I will suggest that improved performance by EPA and agencies in general, operating in …

Neither Science Nor Shamans: Globalization Of Markets And Health In The Developing World, David Fidler

Indiana Journal of Global Legal Studies

No abstract provided.

The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher

Scholarly Works

No abstract provided.

Cloning And The Preservation Of Family Integrity, David Orentlicher

Scholarly Works

No abstract provided.