Special
Section -- Information and Communication Technology in Health Care
Thornburgh Will Present
Gardere Wynne Sewell & Riggs Lecture 2000:
"The Americans with Disabilities
Act: A Retrospective"
Governor
Dick Thornburgh, former Attorney General for the Bush and Reagan Administrations,
will present "The Americans with Disabilities Act: A Retrospective" on
February 24, 2000 as the Gardere Wynne Sewell & Riggs Lecture. Mr.
Thornburgh was U.S. Attorney General when the ADA was signed into law ten
years ago.
Thornburgh obtained a degree in engineering at Yale University and a J.D. at the University of Pittsburgh School of Law. He takes a special interest in the needs of persons with disabilities because one of his four sons is mentally retarded.
He is Chairman of the State Science and Technology Institute and Vice Chairman of the World Committee on Disability. He chairs the Legal Policy Advisory Board of the Washington Legal Foundation. He has served as Director of the Institute of Politics at Harvard's John F. Kennedy School of Government and as a visiting lecturer at the George Washington University Law School.
The lecture, underwritten by the law firm of Gardere Wynne Sewell & Riggs L.L.P., will be held on February 24, 2000 at 9:00 a.m. at The Houstonian Hotel. A panel will discuss the policy implications of Mr. Thornburgh’s remarks. The panel discussion features: Becky Ogle, Executive Director, Presidential Task Force on Employment; and Patrisha Wright, Director, Governmental Affairs, Disability Rights Education and Defense Fund. The presentation is open to the public, and admission is free. One hour of participatory CLE credit is offered.
A luncheon sponsored by TIRR and Continental Airlines will follow the panel discussion. Gordon Bethune, Chief Executive Officer of Continental Airlines, is the featured luncheon speaker. Former President George Bush will attend the luncheon and present the Bush Medals of Honor for contributions to the advancement of individuals with disabilities. The recipients will be: Elizabeth Boggs, Founder of the Arc (formerly the Association for Retired Citizens); Justin Dart, Disability Rights Advocate, and Founder of Justice for All; Evan Kemp, former Chairperson of the U.S. Equal Employment Opportunity Commission; Joshua Malinga, President of Disabled Peoples International; Dick Thorburgh; and Patrisha Wright, Director, Governmental Affairs, Disability Rights Education and Defense Fund. The luncheon is $100. Contact the Health Law & Policy Institute at 713-743-2101or healthlaw@uh.edu for information.
Out-of-State Students May Pay In-State Tuition for Health Law LL.M.
The University of Houston Law Center's Health Law LL.M. Program has been added to the Academic Common Market effective immediately. The Academic Common Market is an interstate agreement for sharing academic programs by opening programs to students across state lines. Students gain access to programs not available in their home states without having to pay out-of state tuition.
Students accepted from any participating state are eligible to pay in-state tuition for the Health Law LL.M. Program at the University of Houston Law Center. The participating states are: Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, Oklahoma, South Carolina, Tennessee, Virginia, and West Virginia.
Institute Adds New Advisory
Board Members
Mark Coffin |
Patricia Gray |
Susan Harris |
Bernard Levin |
Jane Nelson |
Dalton Tomlin |
Furrow Will Teach Intersession Course
Visiting Professor of Law Barry R. Furrow will teach Medical Malpractice at the University of Houston Law Center during the Intersession from January 3 - 13, 2000. Professor Furrow is Dean of Faculty, Director of the Health Law Institute, and Professor of Law at Widener University School of Law.
Professor Furrow received his B.A. in 1967 from Harvard College and his J.D. in 1971 from Harvard University. He has authored and co-authored a number of books, including Health Law: Cases, Materials, and Problems (with Johnson, Jost, and Schwartz) and Hornbook on Health Law (with Greaney, Johnson, Jost, and Schwartz).
Rothstein Named to HHS Committee
Mark A. Rothstein, director of the Health Law & Policy Institute, has been appointed to the National Committee on Vital and Health Statistics (NCVHS) by Secretary of Health and Human Services (HHS) Donna Shalala. The NCVHS serves as the statutory public advisory body to the HHS Secretary in the area of health data and statistics. The committee advises and assists HHS and serves as a forum for private sector groups interested in a variety of important health data issues. Among other things, the NCVHS will advise Secretary Shalala on measures to protect the confidentiality of medical records.
The NCVHS is composed of 18 private citizens who have distinguished themselves in the various health fields. The HHS Secretary appoints 16 members to 4-year terms. Congress appoints the remaining two. Meeting minutes and transcripts are available on the Web, and most public meetings of the NCVHS are broadcast live on the Internet. The NCVHS Web site is located at http://www.ncvhs.hhs.gov.
FOCUS ON AN ADJUNCT PROFESSOR
T. Howard Stone
T.
Howard Stone, J.D., LL.M., has been teaching health law courses at the
University of Houston Law Center since 1997. He has been teaching Correctional
Health Law since 1997, and in 1999, he began teaching Regulation of Biomedical
Research.
Presently, Mr. Stone serves as Assistant Professor (N/T-Research), School of Medicine Department of Preventive Medicine & Community Health, Adjunct Member, The Institute for the Medical Humanities, Research Director, Program for Legal and Ethical Issues in Correctional Health, and Adjunct Instructor, School of Medicine Department of Internal Medicine, The University of Texas Medical Branch.
Since 1997, Mr. Stone has been a member of the faculty of the Open Gates Teletraining Institute, Stillwater, Oklahoma. In 1995, he served as a consultant for the World Health Organization's Regional Office for the Western Pacific, Manila, Philippines. Mr. Stone has also been a Legal Analyst, Health Law & Policy Institute, Legal Assistant/Legal Intern, Department of Health, Division of Correctional Health Services, City of New York Health Services Research Program, New York, N.Y., and Administrative Director, Santa Monica-U.C.L.A. Medical Center, Santa Monica, California.
In 1995, Mr. Stone received his LL.M. in Health Law at the University of Houston Law Center. He received his J.D. in 1994 at the New York Law School, New York, New York. He received is B.A. in Political Science in May 1991 at the University of California at Los Angeles.
HLO Sponsors Numerous Events
On October 13, 1999, Scott Hendler of the Hendler Law Firm in Austin, Texas spoke to University of Houston Law Center students on "The Good, the Bad, and the Ugly: Why Being a Plaintiff's Lawyer is One of the Most Honorable of Professions." The event was sponsored by the Health Law Organization (HLO), the Employment and Labor Law Society, and the International Law Society. His firm represents victims and their families in toxic injury litigation, including asbestos disease cases. His firm also represents labor unions and their members from Guatemala, Panama, and Ecuador, and human rights groups and child advocacy organizations in Costa Rica, El Salvador, and Nicaragua in toxic injury litigation.
On October 21, 1999, many
students turned out for the first informational meeting for the Houston
Journal of Health Law & Policy. Jennifer Jasper, Rujul Desai, Amy McGuire,
and Melanie Dolgoff comprise the Houston Journal of Health Law & Policy
Executive Planning Committee.
| On October 28, 1999, HLO
held a Halloween Bake Sale.
On November 3, 1999, at its Annual Alumni Breakfast, HLO honored State Representative Debra Danburg with the Alumni Recognition Award for her invaluable contributions to the Law Center and the community. In attendance at the award presentation were Dean Stephen Zamora, HLO President Amanda Snowden, J. Richard Cheney, General Counsel of Methodist Health Care System, George Eugene McDavid, former President of the Houston Chronicle and member of the UH Board of Regents, and Professor Laura Rothstein. On November 10, 1999, HLO held a Taquito Breakfast sale to benefit the MLK Center. On November 16, 1999, HLO held an informational meeting on Health Law Clinics and Clerkships. |
Dean Stephen Zamora, HLO President Amanda Snowden, Rep. Debra Danburg, J. Richard Cheney, General Counsel of Methodist Health Care System, George Eugene McDavid, former President of the Houston Chronicle and member of the UH Board of Regents, and Professor Laura Rothstein |
FROM THE WEB
The following articles were
added to Health Law Perspectives, which can be found on the Health Law & Policy Institute's Web site at
http://www.law.uh.edu/healthlawperspectives,
between August 1 and October 31, 1999:
| Victims of Domestic Violence
Deserve Safe Shelters
Legislating Nurse-to-Patient Ratios: California Legislation Falls Short Federal Government Funds National Campaign to Eliminate Syphilis Are Medical Directors Performing Utilization Review "Practicing Medicine"? Sterilization Program Not All It’s C.R.A.C.K.ed Up to Be Uninsured Rate Soars Amid Prosperity Paying for Pills: The Challenge Posed by Escalating Prescription Drug Costs New Round in the Battle Against the Superbugs Surgeon General Promotes Health of the Nation: Unlocking Health Care for the Uninsured, Underserved, Underrepresented, Uninspired, and Uninformed Discipline of Oregon Physician for Undertreating Pain is an Appropriate Response to a Serious Problem Physician Disciplined for Undertreating Pain |
No Duty to Warn of Threats
of Violence: Dispelling the Myth in Texas Jurisprudence
Web Ethics: Another Challenge to Reliability of Health Information on the Internet Human Infection from "Mad Cow Disease" in the U.S.?: A Precautionary Ban on Blood Donations Limiting the Intrusiveness of Forensic DNA Sampling Should FDA Limit Interstate Shipment of Compounded Pharmaceuticals? Epilepsy and the ADA: The Fallout of Sutton Begins Drug Manufacturer Liability in Direct-to-Consumer Marketing Cases New Rules on Access to Research Data Excite Controversy End-of-Life Decision-making for Pregnant Women New Texas Law Authorizes Disciplinary Action Against Health Care Providers Who Fail to Effectuate Advance Directives Are States Spending Tobacco Settlement Funds Wisely? Smallpox and Bioterrorism: A Growing Threat |
PUBLICATIONS
Mary R. Anderlik
Research Letter: Informed Consent for Tissue Research, 282 JAMA 1625 (November 3, 1999)(with Rebecca D. Pentz et al.)
Laura F. Rothstein
SPECIAL EDUCATION LAW (Longman 3d ed. 1999) and INSTRUCTOR'S MANUAL
Mark A. Rothstein
The Impact of Behavioral Genetics on the Law and the Courts, 83 JUDICATURE No. 3 (Nov.-Dec.1999)
Genetic Testing, Genetic Medicine, and Managed Care, 34 WAKE FOREST L. REV. 849 (1999)(with Sharona Hoffman)
Privacy in Genetic Research, 285 SCIENCE 1359 (1999)(with Barbara Fuller et al.)
Why Treating Genetic Information Separately is a Bad Idea, 4 TEX. REV. L. & POLITICS 33 (1999)
GENETIC SECRETS: PROTECTING PRIVACY AND CONFIDENTIALITY IN THE GENETIC ERA (Yale University Press 1999)(Paperback edition)
Ronald Turner
Comparing Title VII's and Section 1983's Regulatory Regimes, 31 URBAN LAWYER 503 (1999)
William J. Winslade
CONFRONTING TRAUMATIC BRAIN INJURY: DEVASTATION, HOPE, AND HEALING (Yale University Press 1999)(Paperback edition)
PRESENTATIONS
Mary Anne Bobinski
"Health Care Access Issues," 100 Years of Women, SUNY, Buffalo, New York, October 22, 1999
Laura F. Rothstein
"Post-Tenure Review and Disability Discrimination for College Faculty," "How to Appropriately Manage Student with Psychological Disabilities," and "The ADA: Recent Trends and Decisions," Legal Issues in Higher Education 9th Annual National Conference, University of Vermont, Burlington, Vermont, October 4, 1999
"Current Issues for Disabled Persons on College and University Campuses, North Harris County Community College, Houston, Texas, October 14, 1999
"Legal Issues Regarding Public School Students with Disabilities," Special Education Update, Advocacy, Inc., Houston, Texas, October 15, 1999
"Affirmative Action--The Impact of Hopwood," American Council on Education Annual Meeting, Albuquerque, New Mexico, October 29, 1999
"The Appropriate Use of the LSAT" (on behalf of the Law School Admissions Council), Texas Southern University Law School, Houston, Texas, November 17, 1999
"The Appropriate Use of the LSAT" (on behalf of the Law School Admissions Council), University of New Mexico Law School, Albuquerque, New Mexico, November 19, 1999
Mark A. Rothstein
"Privacy of Genetic Information in Litigation," American Law Institute/American Bar Association, Washington, D.C., October 15, 1999
"The Use of Genetic Information in the Workplace," American College of Occupational and Environmental Medicine, San Antonio, Texas, October 17, 1999
"Medical Privacy Issues in Liability Insurance," Chartered Property and Casualty Underwriters Society, Bloomington, Illinois, November 5, 1999
"Ethical and Legal Issues in Genetic Testing for Cancer Susceptibility," American Society of Clinical Oncology, San Francisco, California, November 6, 1999
"Genetic Predisposition to Cancer: Health Care and Other Uses," M.D. Anderson Cancer Center, Houston, Texas, December 10, 1999
William J. Winslade
"Confronting Traumatic Brain Injury: Devastation, Hope, and Healing," Grand Rounds," CME Program, Baylor College of Medicine, August 13, 1999
"Ethical Guidance for Difficult Situations," Ethical Struggles: Clarifying Options... Supporting Choices Conference, City of Hope, Nursing Research and Education, National Medical Center and Beckman Research Institute, Duarte, California, September 24, 1999
"Patients' Rights: Past, Present, and Future," Medical Grand Rounds, Henry Ford Health Sciences Center, Detroit, Michigan, October 14, 1999
FACULTY NOTES
Laura F. Rothstein was the subject of a feature article, "Staying Sharp: Professor Laura F. Rothstein on the Finer Points of Disability Law, Diversity, and Needlepoint," in the Texas Lawyer in October 1999.
Laura F. Rothstein has been appointed Chair of the Dean Search Committee for the University of Houston College of Education.
Mark A. Rothstein has been named to a two-year term as chair of the Social Issues Committee of the American Society of Human Genetics.
FOCUS ON OUR GRADUATES
Pedro Martin (J.D. '89) is pursuing a Masters of Public Health at the University of Texas HHSC School of Public Health's El Paso satellite campus.
Jennifer Soffer (J.D. '98) is Staff Attorney at the Texas State Board of Medical Examiners.
BOOK REVIEW
Managing Healthcare Compliance
By: Scott C. Withrow
Health Administration Press,
Chicago, Illinois, 1999
Reviewed by: Ronald L. Scott,
J.D., LL.M.
Research Professor
Health Law & Policy Institute
University of Houston Law
Center
Compliance programs provide affirmative steps toward promoting ethical and lawful corporate conduct. Specifically, compliance programs promote prevention, detection and resolution of instances of conduct that do not conform to federal and state law, health care program requirements, and the health care provider’s ethical and business policies. Under federal sentencing guidelines and agency practice, the Department of Justice and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) look to see if an entity guilty of misconduct has exerted reasonable efforts to avoid and detect any misbehavior that occurs within its operations. The existence of an effective compliance program may determine the level of sanctions, penalties and exclusions that will be imposed on the health care provider.
For health care providers in the process of establishing (or maintaining) a compliance program, Managing Healthcare Compliance is an extremely worthwhile "how-to" and reference guide. Author Scott C. Withrow has packed an amazing quantity of information into his 219 page book. Also, he has written and organized the material to suit a variety of audiences. Although the subject matter is necessarily somewhat dry, the book is written in a style that is understandable to the non-lawyer, yet contains footnotes, citations, and appendices that will please a lawyer wishing to verify sources or obtain further information.
Health care compliance programs address risk areas such as billing for items or services not actually rendered, providing medically unnecessary services, upcoding, "DRG creep," teaching physician and resident requirements for teaching hospitals, duplicate billing, and false cost reports. Depending on the nature of the health care provider (e.g., hospital, home health agency, health maintenance organization) compliance efforts may also address the Stark physician self-referral law, knowing failure to provide covered services or necessary care to members of an HMO, patient dumping, and antitrust issues. Withrow addresses each of these substantive areas of law in chapters 13-15. Included are several useful appendices comparing, for example, overlapping anti-kickback safe harbors and Stark general exceptions.
Creators of compliance programs have one difficult choice from the outset. Compliance programs are complex, and sometimes an attorney seems a logical choice as compliance officer. OIG suggests that the compliance officer be a high-level official with direct access to the health care provider’s Chief Executive Officer and governing body. In chapter 5, Withrow examines the benefits and pitfalls of choosing an attorney, including OIG’s hostility towards attorneys as compliance officers and issues of attorney-client privilege. Withrow points out that designating an in-house counsel as compliance officer can result in loss of the attorney-client privilege in some circumstances. Nonetheless, Withrow believes that in-house counsel can be a good choice as compliance officer, provided the attorney is familiar with likely compliance concerns such as documentation and coding issues. For those organizations choosing a non-attorney as compliance officer (Withrow suggests some candidates), Withrow’s book is a must. By simply reading this short work, a newly designated compliance officer is given an overview of the history, purpose and mechanics of creating and maintaining an effective program.
OIG has promoted voluntary compliance programs for the health care industry since 1997, when OIG first issued a compliance model for clinical laboratories, followed by its model compliance program guidance for hospitals in 1998. Even if a hospital, clinical laboratory, or other health care provider already has a compliance program, the OIG model program should be reviewed against the existing program to ensure that the health care provider has knowledge of the elements the government relies upon in making judgments as to the effectiveness of compliance programs. Withrow provides a critical analysis of OIG’s compliance guidance. He notes that many of OIG’s provisions were derived from "corporate integrity agreements" crafted by prosecutors and imposed on offending providers in settlement of an OIG prosecution. In chapters 4 through 10, Withrow examines each of the elements suggested by OIG, and offers suggestions on where health care providers may reasonably decide not to follow OIG's guidance.
In chapter 16, Withrow offers a little-mentioned suggestion for health care compliance programs. Too often, such programs only focus on legal issues specifically related to delivery of health care, leaving other issues of legal compliance either not addressed at all, or relegated to human resources and the dreaded personnel manual. Withrow proposes that organizations first address the areas of most risk, i.e., billing, anti-kickback, Stark, and antitrust. Next, he suggests that issues such as end-of-life decision making, informed consent, and confidentiality of medical records be addressed. Finally, he advocates that the compliance program may be expanded to deal with issues such as political lobbying, trade secret and software piracy, equal opportunity, affirmative action, and sexual harassment. This approach makes a great deal of sense for both large and small health care providers. Otherwise, particularly in a large hospital, employees and contractors will have to deal with a variety of sometimes inconsistent requirements set forth in risk management policy manuals, personnel handbooks, human resources policy statements, and compliance programs. There is no logical reason for an organization to approach compliance with the Americans with Disabilities Act or the Occupational Safety and Health Act differently from Stark compliance. Chapter 16 concludes with a three page, 44-item checklist summarizing the steps required to establish a compliance program. Withrow even provides a sample "form" compliance program for hospitals in Appendix A.
This book will be very useful to attorneys involved in establishing or maintaining a compliance program and to non-attorneys designated as compliance managers. It would also be a good resource for CPAs involved in audits of compliance. Finally, its summaries of anti-kickback, antitrust, and other health care laws alone make the book a worthwhile purchase for physicians and other individual health care practitioners.
Introduction
Beyond Y2K: Technology Issues Abound in Health Care
Y2K has been a hot topic in the news for well over a year now. Unless you have not seen a newspaper or heard a television or radio news broadcast, you are aware that the date change to January 1, 2000 could cause problems in all manner of equipment and computers because they may malfunction as a result of the change from 1999 to 2000. In the health care arena, government agencies, hospitals, insurers, and others have been testing their equipment in hopes of ensuring that the equipment upon which they rely will be Y2K compliant by year end.
The good news is that Y2K will be behind us shortly. With January 1, 2000 fast-approaching, the extent of the problems resulting from Y2K will soon be known, and attention can be focused on other aspects of information and communication technology for health care. The Internet is one example.
An enormous quantity of health-related material is available on the Internet. According to the Federal Trade Commission, approximately 22.3 million Americans sought health and medical information online as of December 1998. The Internet is not merely a research tools. Consumers are purchasing health-related items, including prescriptions, over the Internet. Also, providers are using the Internet to communicate more effectively with insurers.
Along with the Internet, telemedicine, biotechnology, and software advances are changing many aspects of health care. For example, they are changing the manner in which medicine is practiced, the manner in which prescription drugs are marketed, and the manner in which medical records are used, stored, and distributed. With these changes, complex issues of law and ethics arise. Many concepts of health law are based on the traditional practice of medicine. As technology changes the manner in which medicine is practiced, the law must also change. The articles in this Special Section examine some such changes.
Bruce Fried and Jason Zuckerman examine the FDA's role in regulating medical software. Pat Kuszler looks into the application of medical malpractice to telemedicine. Nicholas Terry discusses the learned intermediary doctrine as it is changed by the Internet. Tom Paul and David Fox consider the biotechnology issue of whether one should be able to patent the discovery of part of a gene. Lisa Dahm examines electronic medical records privacy under the Health Insurance Portability and Accountability Act.
Telemedicine and the Changing Face of the Doctor-Patient Relationship
Patricia Kuszler, M.D., J.D.
Associate Professor of Law
University of Washington
Telemedicine
is increasingly hailed as a means by which the limited resources in our
struggling health care system can be economically stretched to provide
better, more timely, access to health care. The ever-greater capacity for
electronic interaction presents risk as well as benefit for both patients
and physicians. One significant downside of telemedicine is the alteration,
perhaps even ablation, of the personal interaction between doctor and patient.
This brief article will focus on how this changing face of the physician-patient
interaction in telemedicine is likely to blur and alter the traditional
concept of duty and complicate analysis of this element in traditional
malpractice negligence actions.
Telemedicine allows patients to electronically connect with ever more information and access a greater variety and larger universe of providers. In some instances, the patient may "talk" to a physician in a distant city and even receive advice over the internet. A recent study reported that when a fictitious "patient" solicited e-mail advice from 58 physicians about a skin complaint, 50% responded and 59% of these explicitly suggested a diagnosis to the patient. Telecommunications also facilitate collaborative consultation between providers. This will increase the number of providers -- and the universe of potential defendants.
In the traditional malpractice case, the alleged negligence occurs firmly within the temporal boundaries of an episode of care delivered by an identified physician. Specialty consultations occur in a sequential pattern, each occupying a distinct quantum of patient and provider time. However, in a telemedicine intervention, the temporal boundaries are more fluid. Moreover, the intervention may involve multiple physicians and consultants simultaneously, or involve stored-and-forwarded images and data that are reviewed by the provider or secondary providers at a later, undefined time. Thus, telemedicine presents the opportunity for the courts to recast the provider-patient relationship, and the duty that flows from it, in a more elastic fashion.
It is likely that the courts will turn to two lines of cases involving nuances of the provider-patient relationship in order to accommodate the challenges raised by telemedicine. The first are cases involving telephone calls between the provider and patient which have allegedly resulted in harm to the patient. The second are those cases involving a consultant or secondary health care provider whose advice has resulted in, or contributed to, the allegedly negligent care.
In the former, the content of a telephone consultation between the physician and patient is pivotal in determining whether there is, in fact, a relationship and a physician duty to the patient. For such a duty to exist, the physician must agree to undertake care of the patient. Absent such agreement, the physician has assumed no duty toward the patient. In order for a physician-patient relationship to have formed on the basis of a mere telephone contact, a number of factors must be present. There must be an assent by the physician to see or counsel the patient, although this may be indirect. See, e.g.,Bovara v. St. Francis Hospital, 700 N.E. 2d 143 (Ill. 1998). The content of the interaction must include some evaluation, even if only a rudimentary one, by the physician of the patient's complaint. See, e.g.,Weaver v. University of Michigan Board of Regents, 506 N.W. 2d 264 (Mich. 1993). Finally, the patient must rely upon physician's determination, however preliminary that evaluation might have been. See, e.g.,Lyons v. Grether, 239 S.E.2d 103 (Va. 1977).
Thus, it seems likely that when a physician enters into a dialogue with a patient using telecommunication technologies, complies with a patient's request for evaluation and proffers medical advice or recommendations which then are relied upon by the patient, a provider-patient relationship, replete with duties and responsibilities, will have been formed. Such would be the case, for example, in an e-mail consultation which generated a physician response with advice that is relied upon. Moreover, if the diagnosis was in error or falsely reassuring, and, as a result, the patient sustains harm, the patient would likely have a viable negligence action against their e-mail physician.
Telemedicine transactions are by nature and design not limited to the traditional attending physician-single patient model of care. Rather, there are morasses of interactions among a variety of providers, who may have linkages to the patient that are variable at best, and undiscernible at worst. The virtual world has an unlimited supply of consultants.
Existing case law provides substantial clues as to the potential liability of telemedicine consultants. In a telemedicine encounter, several consultants may be involved in a case, communicating among themselves, with the primary physician, and the patient. The question then is, what factors will determine which consultations confer a cognizable duty upon the consulted provider? Once again, parallels can be drawn to existing case law.
Specialty consultation falls into two general categories. The first of these are consultations in which the patient and/or the patient's record is referred to the consultant by the primary attending physician for review and advice. The primary attending physician generally is seeking specialty guidance as to diagnosis or management of the patient and usually will be disposed to follow received advice. In this category of interactions, the patient is aware of, and consents to the consultation, and usually is billed for the service. In such consultations, the consultant has established a relationship with the patient and has a duty to that patient, even if the consultant and patient have never met in a face-to-face encounter.
In the second common type of consultation, the consultation is more informal. These "curbside" consultations include a vast array of interactions between physicians discussing management of patient complaints and illnesses. Typically, there is a presentation of the patient's history, recitation of the diagnostic test results obtained to date, and discussion of potential avenues of treatment for this patient and others with similar symptom complexes. In such cases, the identity of the patient may be unknown, the consultation is transparent to the patient, and the specialist colleague does not bill for his advice.
Discerning between these two types of consultations may be problematic, even without the complications of modern telemedicine. For example, in Reynolds v. Decatur Memorial Hospital, 660 N.E. 2d 235 (Ill. 1996), a young pediatrician, in the midst of examining a child, telephoned a second, more senior, physician at home and asked for his advice. The second physician suggested that a certain test be performed. The examining physician proceeded to complete the evaluation of the child, including the test suggested by the second physician. Nevertheless, the examining pediatrician misdiagnosed the child. In this case, because the second physician had given only an informal opinion, had not been asked to see the patient, did not review tests, directly order laboratory or other studies, and did not bill the patient, the court held that the consultation amounted to a mere inquiry from a colleague.
Telemedicine will exponentially increase the opportunity for both the informal and the formal categories of consultations. Moreover, the distinction between the informal consultation, where no physician-patient relationship is formed, and the more substantive consultation will be increasingly difficult to draw. With the enhanced ability to transmit records and diagnostic images and to engage in interactive videoconferencing, barriers of time and distance will be removed. This will facilitate easy transmission of more information to consultants, prompting more formal consultations and decreasing the likelihood of the casual, informal "curbside consult." For example, the young pediatrician in the Reynolds case might well have asked her older colleague to observe the sick child had videoconferencing been available; she probably would also have had the laboratory transmit the test results to him as well as herself. Either of these telemedicine techniques might have alerted the senior physician to the correct diagnosis. Either probably also would have increased the likelihood of the court finding that the consultant had formed a relationship with the patient and did indeed have a duty.
Although telemedicine offers patients a brave new world of information, some time-honored norms in medical practice necessarily will be sacrificed. One of these is the classical physician-patient relationship, which is characterized by personal interaction. The concept of duty will become more elastic and less concrete resulting in increased exposure to medical malpractice liability.
FDA Regulation of Medical Software
Bruce Merlin Fried, Esq.
Chair, Health Law Group,
Shaw Pittman
Jason Mark Zuckerman, J.D.
2000
University of Virginia School
of Law
Bruce Fried |
Jason Zuckerman |
For more than 20 years, the U.S. Food and Drug Administration ("FDA") has grappled with the issue of how to regulate medical software. Since the passage of the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act ("FFDCA"), the medical software industry has experienced uncertainty and confusion concerning FDA regulation of its products. In a draft guidance on medical software issued by the FDA in 1989, the FDA indicated that it considers most unclassified medical software a "medical device" and therefore subject to FDA regulation under the FFDCA. While it is not surprising that the FDA plays a role in regulating the use of medical devices where the software is a component or accessory of the device, a more perplexing issue is what role, if any, the FDA should play in regulating stand-alone software, which is neither a component of nor an accessory to a medical device and which typically receives medical data input and relays the results to a health care practitioner. |
Examples of stand-alone software include hospital information systems, computerized patient record systems, and expert systems which assist practitioners in making diagnostic and treatment decisions. Although stand-alone software generally poses a low risk to patients, as patient care becomes increasingly dependent on medical software, the FDA has endeavored to provide assurance that these products are safe and effective.
The 1976 Medical Device Amendments to the FFDCA define medical device very broadly with a definition expansive enough in its plain meaning to subject stand-alone software products to FDA regulation as medical devices. In 1989, the FDA issued a draft guidance policy memorandum ("1989 Guidance") which indicated that the FDA deemed unclassified medical software products as medical devices and therefore subject to FDA regulation. The 1989 Guidance exempted from FDA’s medical device regulations: (1) computer products intended only for use as traditional ‘library’ functions such as storage, retrieval, and dissemination of medical information; (2) computer products intended only for use as general accounting or communication functions; and (3) computer products intended solely for educational purposes rather than to diagnose or treat patients.
In addition, the 1989 Guidance indicated that the FDA intended to exempt from active regulation computer products, if a practitioner could interpret and override the software’s recommendation. This "competent human intervention" exemption was misconstrued by the industry in a manner which exempted most medical software products from FDA regulation. Manufacturers did not realize that the exemption applied only to unclassified software and not to accessories of classified devices and sought to avoid section 510(k) premarket notification requirements by utilizing the exemption.
Medical software products that did not fit into the exemptions in the 1989 Guidance were classified into two regulatory schemes. Manufacturers of computer products falling under existing regulatory exceptions, including (i) general purpose articles whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses, (ii) computer products manufactured by licensed practitioners solely for use in their practice, and (iii) computer products used in teaching and non-clinical research, would continue to be subject to the general prohibition against adulteration and misbranding. Manufacturers of computer products that are substantially equivalent to a Class III device, such as blood bank systems, would be subject to all applicable requirements of the FFDCA, including establishment registration, device listing, premarket notification and approval, and good manufacturing practices rules.
Therefore, the current state of FDA regulation of medical software is that while the FDA cannot legally exempt a device until it has been classified, if a software device appears to be one that would have been classified into class I, using the principles contained in the 1989 draft policy, then the FDA exercises regulatory discretion and does not require submission of a premarket notification. However, the FDA reserves the right to invoke that requirement at a later date once the device is classified.
The FDA sought to clarify the 1989 Guidance in subsequent years, culminating in a Software Policy Workshop held on September 3-4, 1996 (the "1996 Software Policy Workshop"), sponsored by the FDA’s Center for Devices and Radiological Health and the National Library of Medicine. The FDA issued a briefing paper (the "1996 Workshop Background Paper") in connection with the conference, which signaled the FDA’s intention to move away from the standard of competent human intervention to a classification of medical software based on:
The FDA has worked with the industry to formulate a comprehensive regulatory scheme, which will likely be published for public comment in the coming months. A good indication of the shape of the forthcoming FDA software regulations is the following guiding principles for such a policy set forth in an article by the leading FDA regulators of medical software:
The AMIA proposal recommends that FDA regulation exempt most clinical software systems and focus on those systems posing highest clinical risk, with limited opportunities for competent human intervention. In addition, AMIA proposes "four categories of clinical system risks and four classes of measured monitoring and regulatory actions that can be applied strategically based on the level of risk in a given setting . . . [and] local oversight of clinical software systems, and adoption by healthcare information system developers of a code of good business practices."
Manufacturers and vendors of medical software are concerned that FDA regulation of their products will significantly delay the development and introduction of new products because the FDA will be unable to devise design and quality standards fast enough to keep up with changes in technology and because the FDA lacks the resources and expertise to regulate their products effectively. Moreover, unlike pharmaceuticals, software is updated frequently and each upgrade would be subject to FDA review, thereby delaying the introduction of new products.
However, FDA regulation might not be as cumbersome as the industry fears for several reasons. First, the FDA might rely on SQAs in lieu of filings under section 510(k). Second, even if section 510(k) notices are required, the FDA might perform a less stringent review on software in comparison to the review conducted for traditional medical devices. Third, with the current political climate the FDA faces on Capitol Hill, coupled with the opposition of the software industry, the FDA is likely to proceed with caution.
As medical software becomes increasingly prevalent and important in modern health care delivery, the FDA is likely to exercise its authority under the FFDCA to assure safety and effectiveness. Innovations in telemedicine and medical informatics have yielded significant improvements in the quality and decreases in the cost of health care, and the imposition of cumbersome regulatory requirements on the industry would slow the development and introduction of medical software products. For now, manufacturers and vendors of medical software will need to pay close attention to the FDA’s forthcoming regulations and devise appropriate regulatory strategies to comply with them.
The full text of this article will appear in vol.33, no.1 of the Journal of Health Law.
Has Health Care Marketing Defeated Risk Management?
Nicolas P. Terry (terry@slu.edu)
Professor of Law
Center for Health Law Studies
Saint Louis University
The
graffiti has been on the doctrinal wall for some time; health industry
marketing departments are increasingly ignoring the sage advice of their
risk managers. That advice has been simple: do not disturb a judicial conception
of the health care industry that is 25 years out of date.
Why have risk managers been so keen not to rock this particular boat? The answer is that the courts have created some quite dubious legal doctrine sadly reflective of their view of the industry. No doubt amazed at their good fortune, industry risk managers have been happy to propagate two key myths. First, individual physicians do not provide medical services. Second, drug companies have no contact with patients and so conveying warnings is the sole responsibility of physicians.
Law professors (though, I suspect, not their students) have reveled in the intricate legal structures erected to give operational effect to these misconceptions. In malpractice courses generations of students have been taught that the doctor not the health care institution is the primary defendant in a case of substandard medical care practiced on the institution’s patient. Their teachers, having alluded to the decline of charitable immunity and the growth of facilities liability, then proudly present an ad nauseam collage of exceptional cases based on ostensible agency, the right to control, estoppel, apparent authority and non-delegable duty. Leaving aside the intellectual (and highly examinable) niceties, we have tolerated a provider liability doctrinal structure totally oblivious to the business models that it regulates.
Products liability features a similar doctrinal black hole. Nationwide, courts have nurtured the expansion of products liability for failure to provide adequate warnings. Yet, the application of that doctrine to the paradigm health care situation, the supply of a prescription drug, has been subjected to a deliciously misconceived exception, the so-called "learned intermediary" doctrine. This rule is something of a backhanded compliment to the prescribing physicians left holding the liability bag. Although subject to arcane exceptions, the learned intermediary rule essentially immunizes the pharmaceutical manufacturer in most failure to warn cases. With the manufacturer only under a duty to provide warnings to the physician the active liability scenario metamorphoses into a physician’s duty to procure informed consent.
Lately, however, injured patients have discovered some unlikely allies; MBA-clad marketing denizens of the health care industry’s advertising departments. Fiercely competitive MCOs have instructed their once dormant marketers to fill the billboards and radio waves. The resulting marketing for the purveyors of industrialized medicine has been replete with full service, holistic images of the services offered; the message has been one of MCO branding with physician individuality fully repressed.
A related phenomenon is dominating the world of prescription drugs. Pharmaceutical companies have been searching for some kind of leverage against MCOs and their restrictive lists of approved drugs. Traditionally, drug companies have marketed through doctors. However, the compressed space that MCOs allocate to the physician-patient dialogue now limits the effectiveness of marketing budgets spent on detail men and advertising to doctors. In fact, drug companies realize that they can promote their drugs far more effectively by working against their physician-distributors rather than with them. Eager to please, the FDA has chimed in with tolerance of direct-to-consumer (DTC) marketing (FDA/CDER, Guidance for Industry, Consumer-Directed Broadcast Advertisements, August 1999, http://www.fda.gov/cder/guidance/1804fnl.htm). As a result TV and the Web are now flooded with advertising designed to lead patients to demand specific drug brands from MCOs.
Abandoned in this marketing-driven frenzy has been the advice of the industry risk managers about preserving judicial ignorance of the true nature of industrialized medicine. As a result, it now appears that the courts are beginning to figure out the commercial realities behind the relationships in today’s health care marketplace. Both limited MCO liability and the relative immunity afforded drug companies by the learned intermediary rule must now be considered on the endangered species list.
One of the first indications of imminent demise was contained in the case of Kashishian v. Port, 481 N.W.2d 277, 282 (Wis. 1992). The Supreme Court of Wisconsin was faced with the classic MCO liability issue, was a hospital liable on an apparent agency basis for the allegedly negligent acts of an independent contractor cardiologist? The court reversed a defense summary judgment refusing to limit the apparent agency rule to emergency room physicians. Central to its decision was the court’s reflection on the business model it was observing to the effect that "[m]odern hospitals have spent billions of dollars marketing themselves, nurturing the image with the consuming public that they are full-care modern health facilities." A growing line of cases seems to be based on this sentiment, notably the recent decision of the Supreme Court of Indiana in Sword v. NKC Hospitals, Inc., 714 N.E.2d 142 (Ind. 1999) (hospital could be liable for negligence of independent contractor obstetrician on apparent agency theory).
Now the other liability shoe seems to be dropping. In Perez v. Wyeth Laboratories, Inc., 1999 WL 591438 (N.J. Aug. 9, 1999), the New Jersey Supreme Court examined the potential liability of the manufacturer of Norplant (levonorgestrel capsules). The court began its analysis with the ominous phrase: "[o]ur medical-legal jurisprudence is based on images of health care that no longer exist." The manufacturer had looked to rely on the learned intermediary doctrine. The court did not go so far as to abandon learned intermediary. But it did open a large window of vulnerability; in cases where there has been DTC marketing, "patients deprived of reliable medical information [may] establish that the misinformation was a substantial factor contributing to their use of a defective pharmaceutical product."
Needless to say, billboard advertising for hospital conglomerates and the incongruous sight of an ex-Senator shilling for sildenafil citrate are only the first signs that marketing departments now hold sway over health industry risk managers. The next major shift in the development of e-commerce will be the rapid deployment of services, particularly professional services. Thus, it will be on the Web that the true nature of the modern relationship between patient and provider will be exposed (see generally Nicolas P. Terry, Cyber-Malpractice: Legal Exposure for Cybermedicine, 25 Am. J. Law & Med. 327-66 (1999)). Given what has been learned from two or three decades of malpractice and products litigation, maybe this time around the courts will be less gullible.
© 1999 Nicolas P. Terry. All Rights Reserved
The "EST" Dilemma: Should the Discovery of a Part of a Gene Lead to a Patent that Could Cover the Entire Gene Once Discovered?
David L. Fox, Ph.D., J.D.
Fulbright & Jaworski
L.L.P.
Houston, Texas
Thomas D. Paul, Ph.D., J.D.
Fulbright & Jaworski
L.L.P.
Houston, Texas
David Fox |
Thomas Paul |
Imagine the discovery of only a fragment of a gene, with no knowledge of the complete structure or function of the gene. Should a patent based on the fragment cover the complete gene and its use once discovered? What if the gene is a human gene? The United States Patent and Trademark Office (USPTO), as well as other patent offices throughout the world, are currently debating this issue. The outcome of this debate may affect future developments in genetics and medicine. |
On one extreme, the USPTO could determine that ESTs are not patentable. This probably would not benefit society since it encourages the discoverers of ESTs to keep them secret, thus hiding access to these important tools for scientific and medical research. The other extreme is that ESTs are patentable with broad coverage of not just the fragment, but the entire gene and its uses. This probably does not benefit society since it decreases the incentive to further develop genetically-based tests and treatments. A middle ground is that ESTs are patentable, but the scope of patent protection is limited to only the EST and its uses. This last scenario has the potential to benefit society by providing an incentive to disclose ESTs as important tools, while not inhibiting the incentive to develop further genetically-based tools and treatments.
It is well established in the United States that a gene is patentable when the complete sequence and a function of the gene is discovered. However, ESTs face patentability issues due to the fact that they are only fragments of genes, and the sequence and function of the complete genes are usually not known.
Patentability in the United States requires that patentable subject matter have "utility." A discovery has utility if it is "useful." Utility is an issue for ESTs since the function (use) of the complete gene associated with the EST is usually not known. The USPTO has not finally determined whether ESTs have utility when the sequence and/or function of the complete genes are not known. The USPTO could refuse to grant patents to ESTs based upon lack of utility. However, the USPTO could accept a minimal utility for ESTs, for example an EST is useful as a tag for identifying the complete gene.
If ESTs have utility and are patentable, then the issue becomes the scope of patent protection available. The scope of EST patent protection will determine whether an EST patent covers only the EST, or the complete gene corresponding to the EST. Narrow coverage would extend only to the specific EST sequence and its specific use claimed in the patent. Broad coverage, on the other hand, would extend to any sequence or use of a sequence that contains the EST sequence.
The future for patentability of ESTs is unknown. However, the issuance of narrow EST patents covering only ESTs and their specific use, and not complete genes, is consistent with the policy behind patent law, i.e., to reward the discoverer and to encourage future research and discoveries to benefit society. This would give EST discoveries patent protection, but not extend the protection to entire genes. Denying patentability to ESTs could adversely affect the patentability genetic sequences and discourage invention. Issuing broad EST patents could be harmful to society by granting patent rights that cover entire genes based upon the discovery of only portions of genes.
The implications of the EST debate are very important to medical research and treatment. For instance, denying patent protection to ESTs would encourage their discoverers to keep them secret, thus denying medical science the use of important tools. On the other hand, providing broad patent protection to ESTs could stymie medical research and therapy and result in multiple royalty fees. Providing a less broad scope of patent protection for ESTs would benefit society by encouraging both disclosure of ESTs, and their use for scientific and medical advancements.
The views expressed in this article are those of the authors and do not necessarily reflect the views and opinions of Fulbright & Jaworski L.L.P., its attorneys or its clients.
The Health Insurance Portability and Accountability Act of 1996 and Electronic Medical Records
Lisa L. Dahm, J.D.
Deloitte & Touche, L.L.P.
When
the Health Insurance Portability and Accountability Act (HIPAA) became
effective in 1996, many hospitals and physicians mistakenly assumed that
the HIPAA provisions did not apply to them. In reality, however, Title
II of HIPAA deals specifically with security and privacy of patient health
information that is stored or collected by or transmitted between health
care providers, health care plans, or health care clearinghouses. In fact,
some industry experts believe HIPAA to be the most sweeping health care
legislation in the last thirty years, and project it will have a similarly
significant impact on the use of information technology within the industry.
According to these experts, enforcement of HIPAA will either stifle the
use of information technology in the industry or it will accelerate the
development and implementation of electronic medical records systems and
foster widespread adoption and integration of Internet technology and usage.
Under HIPAA, health care providers must maintain "reasonable and appropriate administrative, technical and physical safeguards" to insure the integrity and confidentiality of health information, to protect against its unauthorized uses or disclosures, and to guard against any reasonably anticipated threats to security or integrity of the health information within the health care provider’s control. On November 3, 1999, the Secretary of Health and Human Services published proposed regulations for electronic medical records. Once finalized, most health care providers will have only two years to design and implement the technology required to comply with them. (Health care providers with revenues of less than $10 million will have three years to implement the HIPAA requirements.) Unfortunately, few, if any, health care information systems were designed to address security in the manner required under the HIPAA proposed security standards. Technical security safeguards for health information involve access, audit and authorization controls, and the means to authenticate data and identify entities that request it. Such safeguards are intended to be "technologically neutral;" that is, no specific technologies are dictated. Health care providers may implement the security standards in any number of ways depending on unique security needs and the level of the provider’s technological sophistication.
Penalties for non-compliance with HIPAA can be quite severe. While general penalties under HIPAA provide for fines of $100 per violation up to a maximum of $25,000 per calendar year, wrongful disclosure of health information may be penalized by fines of $50,000 to $250,000 and/or imprisonment for one to ten years. Yet despite the anticipated impact of the HIPAA security standards on health care organizations, HIPAA represents a strategic opportunity to develop, implement, and use electronic medical records and other advanced technologies to greater advantage.
Under HIPAA, information is recognized as an asset – a view that the health care industry has been slow to adopt. While advanced technology is routine in some facets of the industry (telemedicine, medical devices, robotics, etc.), the technology employed for storage of individually identifiable health information is woefully antiquated, for several reasons. Neither the components of nor the documentation requirements for a patient’s health information is standardized across the industry; only one individual at a time can access a patient’s record, and keeping track of or locating a patient’s record when needed can be difficult at best.
HIPAA will ultimately force health care providers to standardize the components of and documentation in a patient’s record so that any caregiver who accesses the record will be able to rapidly assess and understand the patient’s treatment plan and progress. The Evaluation/Management Guidelines are not the industry’s first attempt towards such standardization, but they have the greatest potential for success. Once the industry agrees on a standard format and content, electronic storage of the patient’s record will allow controlled and simultaneous access by any number of caregivers at any time of day. Consulting physicians who are authorized to review a patient’s record will be able to access it at their convenience from wherever they are rather than having to wait their turn at the hospital to review pertinent information. In addition, eliminating paper records in favor of electronic storage will minimize storage requirements for a health care organization while allowing for unlimited and immediate access to a patient’s records. With today’s technology, loss of an electronically stored computer record is rare, and HIPAA is likely to contribute to tighter programming controls which help to eliminate even those rare occurrences. Finally, sharing health information between and among health care providers and organizations is likely to become even more necessary. The successful health care organization will incorporate the power of the Internet to achieve true connectivity with its patients, caregivers, associates, and the community while assuring the standardization, privacy and security of health information.