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Full-Text Articles in Health Law and Policy
Access To Health Care: What A Difference Shades Of Color Make, Gwendolyn Roberts Majette
Access To Health Care: What A Difference Shades Of Color Make, Gwendolyn Roberts Majette
Annals of Health Law and Life Sciences
Professor Majette's timely article examines an age-old problem: the effect of race and ethnicity on a patient's receipt of health care. Her article analyzes some of the major health care access issues, with a focus on barriers confronting African Americans, Asians, Hispanics, and Native Americans. Some of the barriers include inability to pay, cultural insensitivity, a shortage of health care providers, and discrimination. She also examines some of the unsuccessful legal solutions and remedies designed to eliminate these barriers. Given the complexity of the access barriers encountered by people of color, Professor Majette concludes that only an interdisciplinary approach can …
Time Is Running Out - The Burdens And Challenges Of Hipaa Compliance: A Look At Preemption Analysis, The Minimum Necessary Standard, And The Notice Of Privacy Practices, Jennifer Guthrie
Annals of Health Law and Life Sciences
Ms. Guthrie's paper involves the final Privacy Regulations promulgated by the Department of Health and Human Services pursuant to HIPAA. Her thesis highlights three burdensome requirements which remain significant obstacles to the compliance date of April 14, 2003: (1) the need to undertake thorough preemption analyses, (2) lack of clarity surrounding the "Minimum Necessary Standard," and (3) confusion regarding the "Notice of Privacy Practices." Ms. Guthrie provides a close analysis of these three areas and offers several viable and persuasive alternatives to the associated burdens. She concludes that HHS must make several integral modifications and provide substantial and continuing guidance …
Table Of Contents, Annals Of Health Law
Table Of Contents, Annals Of Health Law
Annals of Health Law and Life Sciences
No abstract provided.
Quality Assurance And Hospital Structure: How The Physician-Hospital Relationship Affects Quality Measures, Ronald G. Spaeth, Kelley C. Pickering, Shannon M. Webb
Quality Assurance And Hospital Structure: How The Physician-Hospital Relationship Affects Quality Measures, Ronald G. Spaeth, Kelley C. Pickering, Shannon M. Webb
Annals of Health Law and Life Sciences
Mr. Spaeth writes about the relationship between hospital administration and the physician, and how that relationship affects the quality of medical care delivered to the patient. The article focuses on the differences between the employment structure in an academic teaching hospital, and the open, independent contractor medical staff typical of a traditionally smaller community hospitals. The individual traits and nuances of these structures and how they can be distinguished from one another create dynamic differences in the approach for quality care. Peer review, credentialing, and management of adverse outcomes are just a few of the ways in which hospitals continue …
The Hospital Board At Risk And The Need To Restructure The Relationship With The Medical Staff: Bylaws, Peer Review And Related Solutions, John P. Marren, G. Landon Feazell, Michael W. Paddock
The Hospital Board At Risk And The Need To Restructure The Relationship With The Medical Staff: Bylaws, Peer Review And Related Solutions, John P. Marren, G. Landon Feazell, Michael W. Paddock
Annals of Health Law and Life Sciences
This article argues that the current structure of the hospital governing board and medical staff relationship does not support and promote quality and patient-centered care. The fundamental flaw in the current structure is the interdependent, yet independent and discordant relationships between hospital governing boards and medical staffs. These relationships are described as cultures and fit into three types of "silos": organizational (the "structural silo"); professional (the "professional silo", including the "culture of blame"); and the fragmented quality information silo (the "informational silo"). While case law, statutory requirements and regulatory expectations clearly state that governing boards are ultimately responsible for quality …
Proposed Changes To The Hospital-Medical Staff Relationship To Improve Quality Of Care, Elizabeth A. Snelson
Proposed Changes To The Hospital-Medical Staff Relationship To Improve Quality Of Care, Elizabeth A. Snelson
Annals of Health Law and Life Sciences
Medical staff attorney Snelson answers the Colloquium's charge, "What exactly has to change in the hospital-medical staff relationship for health care quality to be improved?" Her response emphasizes the logic of having clinicians vested with authority to establish policies concerning the clinical decision-making. The article discusses the cases defining the medical staff bylaws as contractual in nature, and the problem of hospital attorneys demanding unilateral amendments to bylaws. Bylaw clauses that would chill medical opinion and communication or denigrate clinical recommendations are discussed. Ms. Snelson advocates for the inclusion of the medical staff organization in exclusive contract and other clinical …
Off-Label Or Out Of Bounds? Prescriber And Marketer Liability For Unapproved Uses Of Fda-Approved Drugs, James O'Reilly, Amy Dalal
Off-Label Or Out Of Bounds? Prescriber And Marketer Liability For Unapproved Uses Of Fda-Approved Drugs, James O'Reilly, Amy Dalal
Annals of Health Law and Life Sciences
Professor O'Reilly's study of recent drug review legislation applies a historical and holistic view of promotion practices for unapproved uses of prescription drugs. He faults Congress for moving public health protections away from a strictly protective mode and toward assistance to drug marketers. He argues that the adverse health consequences of "off-label" promotion of drugs are not well understood, and that the 1997 amendments disserved the public health interest while expanding pharmaceutical company profits.
Fda's Proposed Rules On Patent Listing Requirements For New Drug And 30-Month Stays On Anda Approval (Proposed Oct. 24, 2002), Yuk Fung Hui
Fda's Proposed Rules On Patent Listing Requirements For New Drug And 30-Month Stays On Anda Approval (Proposed Oct. 24, 2002), Yuk Fung Hui
Annals of Health Law and Life Sciences
In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui …
Making The Health Insurance Flexibility And Accountability (Hifa) Waiver Work Through Collaborative Governance, Barbara J. Zabawa
Making The Health Insurance Flexibility And Accountability (Hifa) Waiver Work Through Collaborative Governance, Barbara J. Zabawa
Annals of Health Law and Life Sciences
This paper argues that collaborative governance should be an essential component in any HIFA waiver proposal, due to the fact that the health care system is moving away from a federal and hierarchical program design and implementation towards a more local, collaborative approach. As several current collaborative projects demonstrate, collaboration may overcome barriers to health expansion program success, such as stakeholder buy-in, notice, and state access to private health coverage information. Furthermore, collaboration within the context of the HIFA waiver process may maximize the strengths of current collaborations, such as providing: (a) access to greater and more stable funding sources; …
Medical Restrictive Covenants In Illinois: At The Crossroads Of Carter-Shields And Prairie Eye Center, Stuart Gimbel, Miles J. Zaremski
Medical Restrictive Covenants In Illinois: At The Crossroads Of Carter-Shields And Prairie Eye Center, Stuart Gimbel, Miles J. Zaremski
Annals of Health Law and Life Sciences
This article examines the history, development and treatment by Illinois courts of medical restrictive covenants. The authors highlight two recent cases from Illinois, one from the Supreme Court and the other authored by an appellate court panel. The article concludes by providing not only a forecast of how such covenants should be treated by Illinois state courts in the future, but also a pathway for the expectations of health care practitioners who wish to use restrictive covenants in their employment relationships with their colleagues.
The Medical Staff Structure - Its Role In The 21st Century, Gerald M. Eisenberg
The Medical Staff Structure - Its Role In The 21st Century, Gerald M. Eisenberg
Annals of Health Law and Life Sciences
Dr. Eisenberg's paper presents a vision of the medical staff from the point of view of a practicing physician and medical staff leader. Dr. Eisenberg focuses on ways the medical staff, as an independent entity, may use the collective clinical knowledge and experience of its physician membership to enhance quality. This paper also presents Dr. Eisenberg's unique insights regarding the interplay and conflict between hospitals and their associated medical staff in today's complex health care delivery system. He provides several suggestions to increase cooperation between these two important components of inpatient care.
No More Kidding Around: Restructuring Non-Medical Childhood Immunization Exemptions To Ensure Public Health Protection, Ross D. Silverman
No More Kidding Around: Restructuring Non-Medical Childhood Immunization Exemptions To Ensure Public Health Protection, Ross D. Silverman
Annals of Health Law and Life Sciences
Professor Silverman's article examines the complex challenges faced by U.S. policymakers attempting to balance the public health protections of mandatory childhood immunization programs with the legal, religious, philosophical, and practical concerns raised by permitting non-medical exemptions under the programs. The article begins with a discussion of the history of childhood immunization programs, and continues by describing the inconsistency of enforcement of state immunization laws and exemptions. The author analyzes recent cases from New York, Wyoming, and Arkansas, and discusses how these decisions both pose threats to these programs' public health protections, while also offering insight into potential problems for other …
When Self-Regulation, Market Forces, And Private Legal Actions Fail: Appropriate Government Regulation And Oversight Is Necessary To Ensure Minimum Standards Of Quality In Long-Term Health Care, Alexander D. Eremia
Annals of Health Law and Life Sciences
Mr. Eremia's paper discusses market forces, professional self-regulation, and private litigation individually and collectively as methods of maintaining and improving quality of care. He determines that whether separately or in conjunction, these three paradigms have not been successful agents in this regard. By analyzing the regulatory framework and oversight provided by the federal government in the long-term care industry, Mr. Eremia argues persuasively that despite its occasional inadequacies, regular and consistent oversight and regulation by the government is imperative in order to effect meaningful and systemic improvements in the provision of quality care.
Table Of Contents, Annals Of Health Law
Table Of Contents, Annals Of Health Law
Annals of Health Law and Life Sciences
No abstract provided.
Foreword, Susan Danial, Billy Thomas
Foreword, Susan Danial, Billy Thomas
Annals of Health Law and Life Sciences
No abstract provided.
The Government's Role In Health Care Delivery, Linda Reneé Baker
The Government's Role In Health Care Delivery, Linda Reneé Baker
Annals of Health Law and Life Sciences
As Secretary of Illinois' largest agency, the Department of Human Services, Secretary Baker provides a thorough overview of the role her agency plays in the ongoing health and welfare of the citizens of Illinois. Her contention that government should play a critical role in health care delivery is buttressed by the DHS' role as a funding agent, its contributions of staff and systems, and the direct role it plays in the pursuit of truly public health care. Secretary Baker effectively demonstrates the complexities and disparities that still exist in health care by discussing an inter-generational study of one poor family …
Taking A Closer Look At The Managed Care Class Actions: Impact Litigation As An Assist To The Market, Kathy L. Cerminara
Taking A Closer Look At The Managed Care Class Actions: Impact Litigation As An Assist To The Market, Kathy L. Cerminara
Annals of Health Law and Life Sciences
Professor Cerminara examines the use of class action lawsuits to empower individuals to challenge health care decision-making. The article begins by noting the benefits of class actions which provide strength in numbers and a far-ranging impact by challenging policy decisions and encouraging corporate responsiveness. Professor Cerminara concludes that class actions are but one step in the process of empowering individuals and decreasing their resentment of the lack of process currently within the health care system.
Competition Law's Role In Health Care Quality, John V. Jacobi
Competition Law's Role In Health Care Quality, John V. Jacobi
Annals of Health Law and Life Sciences
Professor Jacobi's essay analyzes the various regulatory responses that are available to the government when crises in quality of care occur. These responses range from complete government involvement, i.e. "command and control" regulation, to a limited caretaker role in maximizing market forces. In responding to the recent IOM Report on human error in medical care, Professor Jacobi looks back to the 1986 IOM Report that revealed the crisis of care going on in nursing homes as well as the more recent controversy involving managed care. Following his analysis of the varied governmental approaches to these issues, Professor Jacobi concludes that …
Paradigms Revised: Intersex Children, Bioethics & The Law, Laura Hermer
Paradigms Revised: Intersex Children, Bioethics & The Law, Laura Hermer
Annals of Health Law and Life Sciences
Ms. Hermer explores the controversy surrounding the management of intersex infants and children in America. Her focus on the areas of medical malpractice and informed consent leads her to the conclusion that contrary to some recommendations, a moratorium on cosmetic genital and sex assignment surgeries for infants and children is not warranted. Rather, providers should focus on offering parents with complete information, referrals to support groups and forthright discussions on the dearth of information available.
Health Care Quality Information Liability & Privilege, Sharon King Donohue
Health Care Quality Information Liability & Privilege, Sharon King Donohue
Annals of Health Law and Life Sciences
As the General Counsel for the National Committee for Quality Assurance, which accredits health plans and measures outcome performance, Ms. Donohue is in a unique position to comment on the use of such data in litigation against health plans and providers. After reviewing the growing tide of class-action lawsuits in this area, she argues that such information should be protected under the common law privilege of self-critical analysis, extended to third parties, because such privilege would protect and encourage quality assessment. Ms. Donohue further argues that the sharing and reporting of this information on a system-wide level will allow plans …
The Business Associate Brain Teaser: A Look At Problems Involving The Business Associate Regulations Under The Health Insurance Portability And Accountability Act Of 1996, Randi Heitzman
Annals of Health Law and Life Sciences
Ms. Heitzman addresses in her article the impact of the Administration Simplification statute of the Health Insurance Portability and Accountability Act of 1996 on the protection of health information by third parties to health care transactions. These regulations were enacted, in part, to increase consumers' trust in the health care system. However, their impact on business associates that come into contact with the health care entities has been a source of contention and confusion since they were drafted. This article concludes that the current regulations are too ambiguous and complex to achieve the goals of protection of privacy and Congress' …
Information Is The Key To Patient Empowerment, Robert John Kane
Information Is The Key To Patient Empowerment, Robert John Kane
Annals of Health Law and Life Sciences
Mr. Kane's paper examines the role of patients to ensure that they have both the knowledge and power to direct their health care choices. The evolving health care market place is discussed to emphasize the increased importance of individual involvement in health decision making. A checklist sets forth questions which a patient should ask of herself and of her provider before entering into health care decisions.
The Legal Liability Regime: How Well Is It Doing In Assuring Quality, Accounting For Costs, And Coping With An Evolving Reality In The Health Care Marketplace?, James F. Blumstein
The Legal Liability Regime: How Well Is It Doing In Assuring Quality, Accounting For Costs, And Coping With An Evolving Reality In The Health Care Marketplace?, James F. Blumstein
Annals of Health Law and Life Sciences
Professor Blumstein's timely article deals with two competing paradigms that provide the poles in the spectrum of legal liability regimes. The "professional" or "scientific" model of liability assumes a rigidly normative approach to medical practice while the second more recent paradigm reflects the principles of marketplace economics in considering cost and resource availability to determine quality of care standards. Professor Blumstein concludes that the traditional approach to determining legal liability is being eroded by both the economics of managed care and the recent emphasis on systemic management of health care to promote patient safety, and that the traditional regime will …
Regulation Of Online Pharmacies: A Case For Cooperative Federalism, Sara E. Zeman
Regulation Of Online Pharmacies: A Case For Cooperative Federalism, Sara E. Zeman
Annals of Health Law and Life Sciences
Ms. Zeman examines the regulatory challenges and responses arising from online pharmacies. In particular, Ms. Zeman discusses the roles taken by the States' attorney general offices, the States' legislatures, and the pharmaceutical industry itself, to ensure protection for those consumers seeking health care via the Internet.
Striving For A Secure Environment: A Closer Look At Hospital Security Issues Following The Infant Abduction At Loyola University Medical Center, Amy Baum Goodwin
Striving For A Secure Environment: A Closer Look At Hospital Security Issues Following The Infant Abduction At Loyola University Medical Center, Amy Baum Goodwin
Annals of Health Law and Life Sciences
Ms. Goodwin discusses the need for heightened hospital security in light of the infant abduction at the Loyola University Medical Center in May, 2000. The article first discusses general security issues endemic to the hospital environment; it then explores protective measures enacted by legislative agencies to reduce the likelihood of violence in hospitals. The article then points to recent litigation arising out of a failure to create a safe hospital environment. Finally, Ms. Goodwin considers the consequences that hospitals and society must face when the hospitals fail to comply with safety procedures.
Foreword, John Blum, Joan Krause, Larry Singer
Foreword, John Blum, Joan Krause, Larry Singer
Annals of Health Law and Life Sciences
No abstract provided.
Table Of Contents, Annals Of Health Law
Table Of Contents, Annals Of Health Law
Annals of Health Law and Life Sciences
No abstract provided.
Recovery Of Medicare And Medicaid Overpayments In Bankruptcy, Peter R. Roest
Recovery Of Medicare And Medicaid Overpayments In Bankruptcy, Peter R. Roest
Annals of Health Law and Life Sciences
Mr. Roest argues in favor of the Third Circuit's decision in University Medical Center v. Sullivan to advance the proposition that the Doctrine of Recoupment should be applied narrowly in health care bankruptcy cases. The article begins by introducing key provisions of the Medicare Act and Bankruptcy Code, and by distinguishing between recoupment and setoff. The article then focuses on the Third Circuit's decision, giving both a sketch of the court's decision and a commentary on the holding. The article concludes with a discussion of recoupment-related issues left open by the University Medical Center decision.
The Changing Role Of Pharmacy Practice - A Clinical Perspective, Jannet M. Carmichael, Janice A. Cichowlas
The Changing Role Of Pharmacy Practice - A Clinical Perspective, Jannet M. Carmichael, Janice A. Cichowlas
Annals of Health Law and Life Sciences
Professor Carmichael and Dr. Cichowlas argue for the reexamination of the pharmacist's role in the current health care system. Reexamination is necessitated due to changing complexities of the health care system as evidenced by increased economic demands and pharmaceutical surpluses. The authors advocate for Collaborative Drug Therapy Management, in which physicians and pharmacists maximize patient care by pooling their areas of expertise together.
Internet Prescribing Limitations And Alternatives, Kara M. Friedman
Internet Prescribing Limitations And Alternatives, Kara M. Friedman
Annals of Health Law and Life Sciences
Ms. Friedman discusses the legal limitations placed on the consumer's ability to obtain drug prescriptions via the Internet. The article focuses on current legislative policies and regulations used to restrict access to prescription drugs over the Internet in the absence of a well-founded physician/patient relationship. The article argues that regulators might be able to satisfy the policy objective of ensuring that a learned intermediary is involved in prescription drug therapy by expanding the prescriptive authority of licensed pharmacists.