Science and Technology Law Commons^™

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

Yaniv Heled

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead

O. Carter Snead

The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …

Diagnostics Need Not Apply, Rebecca S. Eisenberg

Articles

Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …

The Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Harvey L. Fiser

No abstract provided.

The Buying And Selling Of Human Organs From The Living: Why Not?, Timothy M. Hartman

Akron Law Review

This article will examine the propriety of establishing a system for the sale of human organs, especially the kidney. Initially, the debilitating malady of end stage renal disease will be discussed as will the marginal "cure" of the disease via hemodialysis. Next, the superior alternative to dialysis, i.e., kidney transplantation will be discussed in two ways. First, the current procedure of using living, related donors will be examined as well as harvesting kidneys from cadaver "donors". Second, the practice of transplantation will be explored for its ramifications to society and the participants in the following areas: medicine, psychology, and the …

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …

On The Sudden Loss Of A Human Rights Activist: A Tribute To Dr. Jonathan Mann's Use Of International Human Rights Law In The Global Battle Against Aids, 32 J. Marshall L. Rev. 129 (1998), Mark E. Wojcik

Mark E. Wojcik

No abstract provided.

3-D Bioprinting: Not Allowed Or Nota Allowed?, Robert Jacobson

Chicago-Kent Law Review

In 1984, Congress passed the National Organ Transplantation Act (NOTA) to improve the supply of vital human organs. A key provision of NOTA was the prohibition of acquiring, receiving, or otherwise transferring human organs. In effect, this provision bans the purchase of human organs. However, due to recent breakthroughs in 3-D bioprinting technology, scientists are on the verge of being able to create lab-grown organs suitable for transplantation. This Note will examine the applicability of NOTA to 3-D bioprinting technology and recommend amendments to NOTA that would clarify the legality of 3-D bioprinting.

Dna Storage Banks: The Importance Of Preserving Dna Evidence To Allow For Transparency And The Preservation Of Justice, Cristina Martin

Chicago-Kent Law Review

What is the duty to preserve information in today’s society? In order for humanity to evolve, change and flourish in the future, society needs to preserve its information from the past. In the criminal justice field, preservation of evidence has special significance. DNA evidence in particular has become a helpful aid for innocent defendants who have been improperly imprisoned. Over the past twenty years, the number of exonerations of imprisoned criminal defendants has increased dramatically. With the advancement of technology, old, previously untestable or improperly tested DNA evidence will need to be retested. However, most states do not have proper …

A New Era In The Ethics Of Human Embryonic Stem Cell Research, Bernard Lo, Patricia Zettler, Marcelle I. Cedars, E. Gates, Arnold R. Kriegstein, Michelle Oberman, Renee R. Pera, Richard M. Wagner, Mary T. Wuerth, Leslie E. Wolf, Keith R. Yamamoto

Patricia J. Zettler

Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESCs for transplantation. Several issues should be addressed now, even though phase I clinical trials of hESC transplantation are still in the future. To minimize the risk of hESC transplantation, donors of materials used to derive hESC lines will need to be recontacted to update their medical history and screening. Because of privacy concerns, such recontact needs to be discussed and agreed to at the time of donation, before new hESC lines …

The Scramble To Promote Egg Donation Through A More Protective Regulatory Regime, Jacob Radecki

Chicago-Kent Law Review

Egg “donation” is a burgeoning industry in the United States. Fertility clinics capitalize on financially needy college students by advertising substantial financial benefits; particularly gifted women may receive thousands of dollars for selling their eggs. Rosy advertisements portray a well-paying procedure that also helps bring a child to a loving parent. Yet these descriptions mask significant potential harms. With respect to known problems, hormone regimens may cause ovarian hyper-stimulation syndrome, which in the most severe cases can lead to infertility. In terms of unknown risks, anecdotal evidence suggests that the long-term side effects of egg extraction may include cancer. The …

The "Uberization" Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan

Fazal Khan

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined …

Promoting “Academic Entrepreurship” In Europe And The United States: Creating An Intellectual Property Regime To Facilitate The Efficient Transfer Of Knowledge From The Lab To The Patient, Constance Bagley, Christina Tvarno

Constance E. Bagley

In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the EU needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (PPPPs) …

A New Era In The Ethics Of Human Embryonic Stem Cell Research, Bernard Lo, Patricia Zettler, Marcelle I. Cedars, E. Gates, Arnold R. Kriegstein, Michelle Oberman, Renee R. Pera, Richard M. Wagner, Mary T. Wuerth, Leslie E. Wolf, Keith R. Yamamoto

Leslie E. Wolf

Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESCs for transplantation. Several issues should be addressed now, even though phase I clinical trials of hESC transplantation are still in the future. To minimize the risk of hESC transplantation, donors of materials used to derive hESC lines will need to be recontacted to update their medical history and screening. Because of privacy concerns, such recontact needs to be discussed and agreed to at the time of donation, before new hESC lines …

Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney

University of Michigan Journal of Law Reform

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …

‘The Greatest Wealth Is Health’: Patient Protected Health Information In The Hands Of Hackers, 31 J. Marshall J. Info. Tech. & Privacy L. 657 (2015), Samantha Singer

UIC John Marshall Journal of Information Technology & Privacy Law

This comment will analyze the specific requirements and stages that EPs/EHs must comply with in order to receive its Medicare and Medicaid incentives, how EHR technologies are being implemented, how EHR technologies are affecting patients' privacy with regard to hacking a patient‟s PHI, and what EHR technology vendors and EPs/EHs should be doing to improve patient privacy and security to prevent hacking and other breaches.

Part I of this comment will address hacking of PHI. Part II will analyze the security measures that EHR vendors must currently incorporate into EHR technology and how the lack of required security measures impacts …

The Fda And The Rise Of The Empowered Patient, Lewis Grossman

Contributions to Books

No abstract provided.

Encouraging Maternal Sacrifice: How Regulations Governing The Consumption Of Pharmaceuticals During Pregnancy Prioritize Fetal Safety Over Maternal Health And Autonomy, Greer Donley

Articles

Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as “vulnerable” and thus precludes them from …

Panel 3: Chronic Pain, Psychogenic Pain, And Emotion, Robert Dinerstein

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Is The Turkey Halal? Genetically Modified Animal Feed Regulation Where East Meets West, Jennifer Spreng

Jennifer E Spreng

Turkey’s Biosafety Law (2010) imposes some of the world’s most stringent restrictions on the import, release and marketing of genetically modified foodstuffs. The Biosafety Board has not approved a single food event; the Council of State has suspended approval of MON 810; Turks have endured meat and milk price spikes; herders are going bankrupt for lack of affordable feed; and importers have been arrested and prosecuted for trace contamination with unapproved GMOs. It’s a pox an all their houses: Turks want nothing do with GM foodstuffs.

The culprit? The “precautionary principle,” which authorizes taking precautions in the face of scientific …