Health Law and Policy Commons^™

Does The Right To Counsel On Appeal End As You Exit The Court Of Appeals?, Nancy P. Collins

Seattle Journal for Social Justice

No abstract provided.

Improving Access To Justice: Plain Language Family Law Court Forms In Washington State, Charles R. Dyer, Joan E. Fairbanks, M. Lynn Greiner, Kirsten Barron, Janet L. Skreen, Josefina Cerrillo-Ramirez, Andrew Lee, Bill Hinsee

Seattle Journal for Social Justice

No abstract provided.

Congress' Encroachment On The President's Power In Indian Law And Its Effect On Executive-Order Reservations, Mark R. Carter Jd, Phd

Seattle Journal for Social Justice

No abstract provided.

Speech As A Weapon: Planned Parenthood V. American Coalition Of Life Activists And The Need For A Reasonable Listener Standard, Alex J. Berkman

Touro Law Review

No abstract provided.

The Future Of Hipaa In The Cloud, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

This white paper examines how cloud computing generates new privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale Iii, Elizabeth A. Reilly, Jeffrey Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Law Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Grand Bargains For Big Data: The Emerging Law Of Health Information, Frank Pasquale

Maryland Law Review

No abstract provided.

Patient Awareness And Approval For An Opt-Out Genomic Biorepository, Ellen Wright Clayton, Kyle B. Brothers, Matthew J. Westbrook, M. Francis Wright, John A. Myers, Daniel R. Morrison, Jennifer L. Madison, Jill M. Pulley

Vanderbilt Law School Faculty Publications

Aim: In this study, we sought to assess patient awareness and perceptions of an opt-out biorepository. Materials & methods: We conducted exit interviews with adult patients and parents of pediatric patients having their blood drawn as part of their clinical care at Vanderbilt University Medical Center (TN, USA). Results: 32.9% of all patients and parents of pediatric patients report having heard of the opt-out biorepository, while 92.4% approve of this research effort based on a brief description. Awareness that leftover blood could be used for research increased among adult patients during the study period, from 34.3 to 50.0%. Conclusion: These …

Gone Too Far: Federal Regulation Of Health Care Attorneys, Stacey A. Tovino

Faculty Articles

Outside health care counsel frequently obtain medical records, billing records, health insurance claims records, and other records containing individually identifiable health information in the course of representing health industry clients in medical malpractice, licensure, certification, accreditation, fraud and abuse, peer review, and other civil, criminal, and administrative health law matters. This Article is the first to argue that state rules of professional conduct, not federal health information confidentiality regulations, should govern outside health care counsel’s use and disclosure of confidential client information, and that outside counsel should be excepted from direct federal regulation under the HIPAA Privacy Rule.

The Guatemala Std Inoculation Study As The Incentive To Change Modern Informed Consent Standards, Marie Constance Scheperle

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

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 …

William H. Sorrell, Attorney General Of Vermont, Et Al. V. Ims Health Inc., Et Al. - Amicus Brief In Support Of Petitioners, Kevin Outterson, David Orentlicher, Christopher T. Robertson, Frank A. Pasquale

Faculty Scholarship

On April 26, 2011, the US Supreme Court will hear oral arguments in the Vermont data mining case, Sorrell v. IMS Health Inc. Respondents claim this is the most important commercial speech case in a decade. Petitioner (the State of Vermont) argues this is the most important medical privacy case since Whalen v. Roe.

The is an amicus brief supporting Vermont, written by law professors and submitted on behalf of the New England Journal of Medicine

Patent Protection Of Medical Records—Focusing On Ethical Issues, Yūsuke Satō, Jiameng Kathy Liu

Washington International Law Journal

The following is a translation of “Patent Protection of Medical Methods—Focusing on Ethical Issues,” an article written by Professor Yūsuke Satō in the June 2007 issue of the Japanese periodical Annual of Industrial Property Law. In Japan, despite the lack of an explicit statutory prohibition, methods of medical treatment have never been patentable. The Japan Patent Office (“JPO”) has rejected patenting medical processes on ethical grounds, interpreting that they do not fulfill the statutory requirement of “industrial applicability” in the main sentence of Article 29, Section 1 of the Patent Act, and courts have been confirming this practice. In light …

In Re Miguel M., Jonathan Weinstein

NYLS Law Review

No abstract provided.

Privacy Rights And Public Families, Khiara Bridges

Faculty Scholarship

This Article is based on eighteen months of anthropological fieldwork conducted among poor, pregnant women receiving prenatal care provided by the Prenatal Care Assistance Program (“PCAP”) at a large public hospital in New York City. The Prenatal Care Assistance Program (“PCAP”) is a special program within the New York State Medicaid program that provides comprehensive prenatal care services to otherwise uninsured or underinsured women. This Article attempts to accomplish two goals. The first goal is to argue that PCAP’s compelled consultations – with social workers, health educators, nutritionists, and financial officers – function as a gross and substantial intrusion by …

Approval Of New Pharmacogenomic Tests: Is The Canadian Regulatory Process Adequate?, Yann Joly, Emma Ramos-Paque

Canadian Journal of Law and Technology

In the first part of our analysis, we will examine the impact which pharmacogenomics is expected to have on drug research and development, on the drug approval process and on post-marketing surveillance and clinical practice. This will allow us to show how pharmacogenomic testing could be beneficial to drug companies, regulatory bodies, and patients. The second part of our analysis will focus on the regulatory framework applicable to the approval of pharmacoge- nomic tests in Canada, although we are aware of the fact that most manufacturers decide to approve their tests outside of Canada. As mentioned, the applicable regu- lations …

Canadian Personal Data Protection Legislation And Electronic Health Records: Transfers Of Personal Health Information In It Outsourcing Agreements, Dara Lambie

Canadian Journal of Law and Technology

Personal data protection and privacy of personal health information in the electronic era is a broad topic that includes consent, security measures and access considerations. The focus of this article is on one component of the larger picture: data transfers of personal health information that occur in the context of informa- tion technology (“IT”) outsourcing. If the societal good envisioned by an inter-jurisdictional EHR is to be fully realized, then the necessity of outsourcing is a reality that must be addressed.

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 …

Is The Door Open Or Closed? Evaluating The Future Of The Federal Medical Peer-Review Privilege, 42 J. Marshall L. Rev. 561 (2009), Ghazal Sharifi

UIC Law Review

No abstract provided.

Comments: Privacy At Risk: Patients Use New Web Products To Store And Share Personal Health Records, Juliana Bell

University of Baltimore Law Review

No abstract provided.

Neuroscience And Health Law: An Integrative Approach?, Stacey A. Tovino

Faculty Articles

Clinicians and scientists use functional magnetic resonance imaging (fMRI) to map sensory, motor, and cognitive function and to study the neural correlates of a range of physical and mental conditions, behaviors, characteristics, and preferences. Due to its move outside the clinical and research contexts, fMRI raises a number of ethical, legal, and social issues that are being examined within the overlapping fields of neuroethics and neurolaw. The early neuroethics and neurolaw scholarship focused heavily on the implications of fMRI for evidence law, criminal law, criminal procedure, and constitutional law. Little attention has been paid, however, to the implications of advances …

"I Will Not Divulge": How To Resolve The "Mass Of Legal Confusion" Surrounding The Physician-Patient Relationship In West Virginia, Mary Claire Johnson

West Virginia Law Review

No abstract provided.

Neuroimaging Research Into Disorders Of Consciousness: Moral Imperative Or Ethical And Legal Failure, Stacey A. Tovino

Faculty Articles

In this article I explore 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 (IRBs) 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 …

Making The Plaintiff ’S Bar Earn Its Keep: Rethinking The Hospital Incident Report, Katherine Mikk

NYLS Law Review

No abstract provided.

Access To Medical Records For Research Purposes: Varying Perceptions Across Research Ethics Boards, Donald Willison, Claudia Emerson, Karen Szala-Meneok, Elaine Gibson, Lisa Schwartz, Karen Weisbaum, François Fournier, Kevin Brazil, Michael Coughlin

Articles, Book Chapters, & Popular Press

Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient …

Who's Minding The Shop? The Role Of Canadian Research Ethics Boards In The Creation And Uses Of Registries And Biobanks, Elaine Gibson, Kevin Brazil, Michael Coughlin, Claudia Emerson, François Fournier, Lisa Schwartz, Karen Szala-Meneok, Karen Weisbaum, Donald Willison

Articles, Book Chapters, & Popular Press

Background: The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks.

Methods: Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were …

Invisible Actors: Genetic Testing And Genetic Discrimination In The Workplace, Susannah Carr

University of Arkansas at Little Rock Law Review

Current federal and state law is inadequate to protect employees from employer's misuse of their genetic information. Genetic information is knowledge of a person's genome that indicates a predisposition towards an illness, disease, or medical condition, where symptoms of the condition have yet to manifest themselves. Federal law protections are insufficient, and relevant state laws vary in their scope and application. Not only are employees unevenly protected across the United States, but varying standards also make complying with the law difficult for interstate employees.

To give employees sufficient protection and to facilitate employer compliance, Congress should pass a law specifically …

Electronic Health Records: Interoperability Challenges Patients' Right To Privacy, Laura Dunlop

Washington Journal of Law, Technology & Arts

President George W. Bush's administration has outlined initial necessary steps to transform the healthcare delivery system through adoption of interoperable electronic health records ("EHRs") by the year 2014. This Article examines the nation's shift toward the use of EHR technology, which largely facilitates patient care by providing clinicians with the ability to review a more complete medical record at the time of treatment. Current legislation calls for financial support and technical standards. However, lawmakers neglect to fully address the Health Insurance Portability and Accountability Act ("HIPAA") and the need to expand its application and enforcement. In addition, healthcare provider Anti-Kickback …

Mission Creep: Public Health Surveillance And Medical Privacy, Wendy K. Mariner

Faculty Scholarship

The National Security Agency's domestic surveillance program has parallels in the growth of disease surveillance for public health purposes. This article explores whether laws requiring health providers to report to government names and identifiable information about patients with infectious or chronic diseases may be vulnerable to challenge as an invasion of privacy. A shift in the use of disease surveillance data from investigating disease outbreaks to data mining and analysis for research, budgeting, and policy planning, as well as bioterrorism, tests the boundaries of liberty and privacy. The Supreme Court has not reviewed a disease reporting law. Its few related …

Newsgathering In Light Of Hipaa, Alexander A. Boni-Saenz

All Faculty Scholarship

This short piece examines the interaction between the Health Insurance Portability and Accountability Act (HIPAA), a federal law designed to protect the privacy of individuals’ health information, and state Freedom of Information (FOI) laws, which are designed to ensure public access to government documents. It describes three recent cases from different states that addressed difficult issues about where and how to draw the line between the public’s right to know and individuals’ rights to keep their medical information secret. It concludes that questions about the interaction of state FOI laws and HIPAA should be guided by the framework suggested in …