published by the law at baltimore iow & health care

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Published by the Law & Health Care Program (L&HCP) School of Law, University of Maryland at Baltimore IOW & HEALTH CARE In this issue: Testing and Telling?: Genetic Privacy, Family Disclosure and the Law 1 Faculty Undertake New Research Projects 3 L&HCP Faculty Notes 4 In The Health Law Clinic 5 Spotlight on Health Law Practicums and Externships 7 Student Health Law Organization News 8 Testing and Telling?: Genetic Privacy, Family Disclosure and the Law P redictive genetic testing tech- niques are developing at a lightning pace. Dramatic technological advances suggest that the greatest impact in genetic testing will result from tests that predict risk for common killers such as cancer and heart disease. While testing may lead to an impressive reduction in mortality, the use of genetic testing on a scale as vast as antici- pated by the Human Genome Project will undoubtedly create complex legal and ethical problems for the courts. The L&HCP brought together a distinguished group of nationally recognized experts who presented substantive analyses on the medical, psychosocial, legal, and ethical implications of disclosure, and pro- vided consumer and judicial perspec- tives, as well. From the Director S ince the L&HCP has added two important facets to our Program-The Journal of Health Care Law & Policy and the Concentration in Health Law-we have become even more cognizant of the importance of interaction among our program components. The theme of this issue is synergy-most of the articles highlight the interdependence of selected program components and the way each enhances the other. I hope you enjoy the issue. Karen Rothenberg Presenters included Francis S. Collins, MD, PhD, director of the National Human Genome Research Institute at the National Institutes of Health, who discussed medical implica- tions of the genetic revolution and R. Alta Charo, JD, who delivered the Stuart Rome Lecture, "Genetic Essen- tialism and the Future of Law." Also presenting papers were Ellen Wright Clayton, MD, JD from Vanderbilt University, who discussed the legal implications; Allen Buchanan, PhD, from the University of Wiscon- sin, speaking on the ethical responsi- bilities of physicians and patients; Caryn E. Lerman, PhD, from the Georgetown University Medical Center (GUMC), who presented empirical data Cont. on page 2 Francis S. Collins 0 1997, University of Maryland School of Law

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Published by the Law & Health Care Program (L&HCP)School of Law, University of Maryland at Baltimore

IOW & HEALTH CARE

In this issue:

Testing and Telling?: Genetic Privacy,

Family Disclosure and the Law 1

Faculty Undertake New Research

Projects 3

L&HCP Faculty Notes 4

In The Health Law Clinic 5

Spotlight on Health Law Practicums and

Externships 7

Student Health Law Organization News 8

Testing andTelling?: GeneticPrivacy, FamilyDisclosure andthe Law

Predictive genetic testing tech-niques are developing at alightning pace. Dramatic

technological advances suggest that thegreatest impact in genetic testing willresult from tests that predict risk forcommon killers such as cancer andheart disease. While testing may lead

to animpressivereduction inmortality,the use ofgenetictesting on ascale as vastas antici-pated by theHumanGenomeProject will

undoubtedly create complex legal andethical problems for the courts.

The L&HCP brought together adistinguished group of nationallyrecognized experts who presentedsubstantive analyses on the medical,psychosocial, legal, and ethicalimplications of disclosure, and pro-vided consumer and judicial perspec-tives, as well.

From the Director

Since the L&HCP has addedtwo important facets to ourProgram-The Journal of

Health Care Law & Policy and theConcentration in Health Law-we

have become even more cognizant ofthe importance of interaction among

our program components.The theme of this issue is

synergy-most of the articleshighlight the interdependence of

selected program components andthe way each enhances the other.

I hope you enjoy the issue.

Karen Rothenberg

Presenters included Francis S.Collins, MD, PhD, director of theNational Human Genome ResearchInstitute at the National Institutes ofHealth, who discussed medical implica-tions of the genetic revolution and R.Alta Charo, JD, who delivered theStuart Rome Lecture, "Genetic Essen-tialism and the Future of Law."

Also presenting papers were EllenWright Clayton, MD, JD fromVanderbilt University, who discussedthe legal implications; Allen Buchanan,PhD, from the University of Wiscon-sin, speaking on the ethical responsi-bilities of physicians and patients;Caryn E. Lerman, PhD, from theGeorgetown University Medical Center(GUMC), who presented empirical data

Cont. on page 2

Francis S. Collins

0 1997, University of Maryland School of Law

Testing and TellingCont. from page 1

on family disclosure of genetic testresults; Beth Peshkin, MS, CGS, alsoof GUMC, who moderated a panel onconsumerperspectives; andstate JudgeRosalyn B. Bell,who discussedjudicial perspec-tives.

"Most genetics-related legalscholarship hasfocused on theuse of DNAtesting in thecriminal context, on genetic diagnostictesting in the context of new repro-ductive technologies and on concernsover privacy and confidentiality ofgenetic information in insurance andemployment contexts. The implica-tions of predictive genetic testing forlaw and society are much more farreaching, however," stated KarenRothenberg, Director of the Law& Health Care Program.

Rothenberg adds that becausepredictive genetic testing maydetermine with some specificitythe health risks faced by individu-als, as well as their blood relatives,it challenges existing legal, ethicaland practice paradigms. Theboundaries of privacy betweenhealth care professionals, patientsand family can be overrun in therush to diagnose, treat, or preventthe onset of a genetic disease.

Traditional medical ethics and legalrules need to be re-examined toaccommodate changing familial rightsand responsibilities within the geneticscontext. The paradigm of individualautonomy in health care supports anindividual ' s right to evaluate thebenefits and risks of medical testing,to decide whether to be tested andwhether to share test results. How-ever, what is the responsibility of theindividual and the provider to sharegenetic test results with other familymembers? Is the patient, in fact, theindividual or the family unit? When

sharing genetic information, how manygenerations should be included? Whatresponsibilities will there be to obtain

and share information aboutgenetic predispositions? Incertain cases, the mutationcannot be found withouttesting the affected carrier andother blood relatives. What ifsome relatives want to betested and some do not? Canfamily members keep geneticsecrets? Who in the familyshould contact family mem-bers with genetic information?What is the duty of a health

care provider to warn a family memberof genetic risk?

Two recent court cases haveconsidered the physician ' s duty towarn relatives who are at risk ofdeveloping a genetic disease. TheFlorida Supreme Court held that aphysician had a duty to tell his patientof the risk to offspring and to encour-

age thepatient toshare thisinformationwith hischildren. Thecourt clari-fied, how-ever, that thephysician hasno duty towarn familymembers,

reasoning that it would be prohibitedby disclosure laws, as well as beimpractical, difficult, and place tooheavy a burden on the physician.Rather, the court reasoned that thepatient ordinarily can be expected topass on the warning to family mem-bers.

More recently, the New JerseySuperior Court held that the physiciandid have a duty to warn and declined tohold that in all circumstances, the dutyto warn will be satisfied by informingthe patient. It predicted that if the casewent to trial, the court may have "toresolve a conflict between the

Law & Health CareNewsletter

is published by theLaw & Health Care Program

at theSchool of Law

University of Marylandat B al timo re

500 West Baltimore StreetBaltimore, MD 21201

Director:Karen Rothenberg, JD, MPA

Associate Director:Diane E. Hofmann, JD, MS

There are a number of law schoolfaculty who contribute to the

diversity of the Law & Health CareProgram through their teaching and

scholarship. Beginning with this issue,we will share some of their selected

publications, presentations, andappointments in Faculty Notes:

Taunya Lovell Banks, JDRichard Boldt, JD

Deborah S. Hellman, MA, JDStanley S. Herr, JD, DPhilDavid A. Hyman, MD, JD

Susan Leviton, JDMax Stu] Oppenheimer, JD

Joan O'Sullivan, JDRenal. Steinzor, JD

Deborah J. Weimer, JD, LLMRoger C. Wolf, JD

Adjunct Faculty (1997-1998)Ellen Callegary, JD, Callegary &

Stettin-tanJames Doherty, Jr., JD, Johns Hopkins

Health System CorporationLewis Noonberg, JD, Piper and

MarburyFrank Palumbo, PhD, JD, University of

Maryland School of PharmacyCarol Rubin, JD, Fisher & Winner

Program Coordinator/Editor:Nancy Zibron, MA

Administrative Assistant:Victoria Ndiaye

Comments and letters should beforwarded to the above address.

R. Alta Charo

Judge Rosalyn B. Bell

2 Law & Health Care Newsletter

ORDER FORM

THE JOURNAL OF HEALTH CARE LAW & POLICY

UNIVERSITY OF MARYLAND SCHOOL OF LAW

NAME

ORGANIZATION

ADDRESS

CITY, STATE, ZIP

TELEPHONE FAX EMAIL

No. Subscriptions @ $251year (includes 2 issues)

Individual Issues @ $13/issueNo. "Conducting Medical Research on the Decisionally

Impaired," January/February 1998No. "Testing and Telling?: Genetic Privacy, Family

Disclosure and the Law," Spring/Summer 1998No. "Up in Smoke: Coming to Terms with the Legacy

of Tobacco," Winter 1999

Please make checks payable to: Journal of Health CareLaw & Policy - UMB

and mail to:

The University of Maryland School of LawThe Journal of Health Care Law & Policy500 West Baltimore StreetBaltimore, MD 21201

physician's broader duty to warn andhis fidelity to an expressed preferenceof the patient that nothing be said tofamily members about the details of thedisease. "

These two cases further highlight theneed for better understanding of familyrelationships, privacy and confidential-ity concerns, and realistic expectationsin the genetics context.

The Workshop's main goal was toexpand scholarship on what the role ofthe law should be in governing thedisclosure of genetic information byhealth care professionals and individu-als to family members. Participantsincluded judges, policy makers andmembers of the genetics community,who evaluated and critiqued eachpresentation.

The papers will be published in theSpring/Summer 1998 issue of theUniversity of Maryland School ofLaw's Journal ofHealth Care Law &Policy.

Faculty UndertakeDiverse Research ProjectsMayday Scholar

In July, Professor Diane Hoffmann,received a grant from the MaydayScholars fund to conduct a study

on pain management and managedcare. She along with four otherindividuals were selected to receive thegrant by the American Society of LawMedicine & Ethics. The grant wasawarded as part of the Society ' sinitiative to "develop scholarship andexpertise in legal, regulatory andfinancing polices that affect access toeffective pain relief." The issue ofmanaged care and pain relief wasidentified by the Society as a prioritytopic. Professor Hoffmann ' s study,already underway, is being conductedin coordination with the national Blue

Cross Blue Shield Association. She willbe surveying BCBS plans to identify ordetermine (1) the level of concernamong health plans about pain controland palliative care as issues for theirinsured populations, (2) activities beingundertaken by plans to address issuesof pain control and palliative care; (3)the level of plan coverage for paincontrol and palliative care services; and(4) examples of innovative and bestpractices by plans to deal with theissues of pain control and palliativecare.

Health Insurance PreferencesProfessors Diane Hoffmann andTaunya Banks are currently conductinga major study of state employees at the

University of Maryland at Baltimoreand Coppin State to determine whichhealth insurance plans they havechosen over the past two years,whether they have changed healthinsurance plans, and, if so what factorsinfluenced their decision to changeplans. The survey also asks whetheremployees have had disputes with theirhealth plans and whether they weresatisfied with the way in which thedisputes were resolved and theirattitudes generally about managed care.The survey was distributed in October,during the State ' s Open Enrollmentseason. Hoffmann and Banks areinterested in looking at several factors

Cont. on page 6

Law & Health Care Newsletter 3

L&HCP Faculty Notes . .PROFESSOR KAREN ROTHENBERGPublications:"Genetic Accountability and PregnantWomen," 7 Women's Health Issues215 (1997)

Selected Presentations:"Predictive Genetics & Women'sHealth: Ethical, Social & PolicyChallenges," Beyond Hunt Valley:Research on Women's Health for the21st Century, National Institutes ofHealth, Bethesda, Maryland (1997)

"Predictions and Precautions: Ethical,Legal and Social Challenges, " Li-FraumeniSyndrome, 31st Patterson Symposium,Patterson Institute for Cancer Research,Manchester, England (1997)

Lecturer, "Gaps and Paradoxes:Challenges for Research Ethics, " NIHClinical Center, Bioethics Program,Bethesda, Maryland (1997)

"Risk, Regulation, and Responsibility:Genetic Testing and the Use of Infor-mation, Seminar Series on GeneticResearch and Society, " AmericanEnterprise Institute for Public PolicyResearch, Washington, D.C. (1997)

"Discrimination and Legislation,"Ethical, Legal, and Social Implications ofthe Human Genome Project, DartmouthCollege, Hanover, NH (1997)

Appointments:Coordinating Group on Bioethics and theLaw, American Bar Association (1997-)

ASSISTANT PROFESSOR

DIANE HOFFMANNPublications:"Managing the Persistent Patient withChronic Pain," Case Commentary, 9Healthcare Ethics Committee Forum 365(1997)

Selected Presentations:"Ethics Committees, Lawyers & the Law,"Federal Judicial Center Conference onHealth Care and the Legal System," PalmSprings, CA (1997)

"The Impact of the Supreme Court's De-cisions on Physician Assisted Suicide onNursing Homes," Annual Meeting, Ameri-can Association of Homes and Servicesfor the Aging, New Orleans, LA (1997)

"Pain Management and Managed Care,"Blue Cross/B lue Shield Northeast MedicalDirectors' Conference, Annapolis, MD(1997)

"Integrating Elderlaw Into the Health LawCurriculum," The 18th Annual Health LawTeachers Conference, Seton Hall Univer-sity, Newark, NJ (1997)

ASSISTANT PROFESSOR

DEBORAH S. HELLMAN

Publications:"Is Actuarially Fair Insurance PricingActually Fair?: A Case Study inInsuring Battered Women," 32 Harv.C.R.-C.L. L. Rev. 355 (1997)

Selected Presentations:"Genetic Testing: Legal and EthicalIssues," Federal Judicial CenterConference on Health Care and the LegalSystem, Palm Springs, CA (1997)

ASSOCIATE PROFESSOR

STANLEY S. HERRPublications:"Questioning the Questionnaires: BarAdmissions and Candidates withDisabilities," 42 Villanova L. Rev 501(1997)

Selected Presentations:"Aging, Rights, and Disabilities,"Keynote Speaker, Vision Conference,University of Wyoming College ofHealth Sciences (1997)

"Legal Rights and Policy Issues forAdults with Mental Retardation,"Johns Hopkins Medical Institutions,Baltimore, MD (1997)

ASSOCIATE PROFESSOR

DAVID A. HYMANPublications:"Medicaid, Managed Care and America's

Health Safety Net," (with R. Manskiand D. Peddicord) 25 J. Law Med. &Ethics 30-33 (1997)

"Consumer Protection (?), ManagedCare, and the Emergency Depart-ment," in Achieving Quality in Man-aged Care: The Role of Law 57-77(1997)

Selected Presentations:"Nonprofit or For-Profit?: HospitalConversions and Optimal SubsidyPolicy," American Public HealthAssociation Annual Meeting,Indianapolis, IN (1997)

"Consumer Protection in a ManagedCare World: Should 'ConsumersCall 911?, " Pursuing Health in an Eraof Change: Emerging Legal Issuesin Managed Care, Thirty- SecondAnnual Symposium of the VillanovaLaw Review, Villanova School ofLaw, Philadelphia, PA (1997)

VISITING ASSISTANT

PROFESSOR JOAN O' SULLIVAN

Selected Presentations:"Adult Guardianship and Alternatives,"Continuing Education, University ofMaryland School of Social Work, UMB(1997

"Long Term Managed Care in Mary-land," Families USA Regional MedicaidManaged Care Conference, GallaudetUniversity, Washington DC (1997)

"Legal Aspects of Health Care,"University of Maryland School ofMedicine, Behavioral Sciences Semi-nar, Baltimore, MD (1997)

ASSISTANT PROFESSOR

DEBORAH J. WEIMER

Book Review:"Ethical and Legal Issues in AIDSResearch," published in the Journal of

Legal Medicine, Vol. 17, p. 177 (1997)

4 Law & Health Care Newsletter

IN THE HEALTH LAW

CLINICThe law school offers, as part of itsregular curriculum, a clinical lawprogram in which .faculty memberswho are practicing attorneys superviselaw students in the representation ofactual clients. For those students witha general interest in health law, theclinic represents clients in casesinvolving health care ,for children,legal issues of the handicapped, mentalillness, AIDS and the elderly.

One engrossing aspect ofteaching health law clinicstudents is watching them

struggle to define the limits of alawyer ' s role. This is especiallydifficult when we represent older,vulnerable clients whose competency istenuous. These clients often havemultiple problems, and their legalconcerns may be by far the leastpressing. Students are often tornbetween the principles of clientcentered decision making that weteach, and their strong impulses tosolve all of a client ' s problems and toprotect their client from all harm.

Especially with our senior citizenclients, we attempt to respect theirautonomy and their right to make theirown decisions about their case, despitetheir physical and, sometimes, emo-tional fragility. However, when theclient ' s capacity is questionable, weoften wonder whether this is the righttack to take. Students are torn betweenrespect for the client ' s autonomy andpaternalism, a tension often present inworking with the elderly who haveimpairments.

A recent case demonstrated thistension clearly. We were referred anestate case in which there was sus-pected financial abuse. The client wasMr. M., an 83 year old man whosewife of 53 years had recently died. He

by Joan O'Sullivan, JD

owned his own home, and it was notlong before a distant cousin, Stan,Stan's girlfriend, and several childrenhad moved in to take care of Mr. M. Itwas the cousin who had asked for legalhelp: he wanted Mr. M. to make a will,leaving the house to him in return forhis care giving.

Mr. M. ' s daughter in Florida hadheard about this and was concerned.She also worried about Mr. M. ' sfinances. He had worked for therailroad for many years and had a goodmonthly pension, as well as someinsurance proceeds from his wife'sdeath. She suspected that Stan wasliving off this money and had asked thereferring agency for an investigation offinancial abuse and for protection forMr. M.

Mr. M. had not asked for anything.My student, Kate, and I discussed thisfact before we went to interview himat his home. We talked about how wecould determine whether Mr. M. wascompetent, and how to set up theinterview so that we could speak tohim alone. Kate was well aware thatthe request for representation had tocome from Mr. M., and that it was hewho had to sign the retainer agreement.

This first interview was verydifficult, as interviews out of thecontrolled setting of the law officeoften are. The cousin and two youngchildren were present, and otherchildren carne home from school whilewe were there. We had explained ourneed for a confidential setting, and wewere directed to the dining room tablewhile the family went out on the porch.There was very little privacy, however,as members of the household hoveredaround the open porch window and

came and went from the kitchen. Mr.M. looked around constantly to seewho was listening.

Mr. M. seemed oriented, aware ofwho we were and why we were there.When Kate asked if he wanted anylegal help, he said no. When shepointedly asked if he wanted to make awill, he said no, emphatically. He saidhe thought his daughter would get hishouse when he died. Even if he did notwrite a will, this was true. This seemedto be the end of our case. If he wascompetent and did not want our help,there was little we could do.

We called Stan in to explain this. Heblew up, outraged that we refused tohelp. He insisted that at least we helphim find out if there was any mortgagelife insurance on the life of Mr. M.'swife, since Stan had been stymied inhis attempts to do so. Mr. M. agreedthat we could do this, and he signed alimited retainer agreement.

Kate did a good job of investigatingthe situation. She collected documentsfrom Mr. M. and Stan, and soonlearned a great deal about his financialpicture. She discovered that largeamounts of money had disappearedfrom Mr. M.'s bank account since hiswife ' s death, and that his pensioncheck was being withdrawn everymonth as soon as it was deposited. Sheplanned to explain this to Mr. M. andthe results of her fruitless search formortgage insurance. She was con-vinced that when she told Mr. M.about what was happening to hismoney, he would want her to take allactions possible to protect his assets.

She talked to a worker from AdultProtective Services (APS) who wasinvestigating an anonymous complaintof abuse, and persuaded the workerthat Mr. M. did not need a guardian,but that he could appoint an agent in a

Cont. on page 6

Law & Health Care Newsletter 5

In The Health Law ClinicCont. from page 5

power of attorney or ask for a repre-sentative payee for his RailroadRetirement check. She was confidentthat he would do so. Who wouldn ' t?

Kate arranged for Mr. M. to come toour office for this next appointment.She explained to Stan that she wouldsee Mr. M. alone first, and then shewould speak to Stan if Mr. M. agreed.

I was copying some papers whenKate found me. "I can ' t get him out ofthe waiting room!" she said. "Mr.M. he won ' t budge from Stan ' s side.He refuses to come with me alone."

Mr. M. was sitting as if glued toStan ' s arm. Stan was a large imposingfigure, and was glowering at us. Mr.M. looked small and scared beside him.I asked Mr. M. if he would like tocome to the interview room with us.He looked at Stan and said no.

I tried to reassure him, explainingthat we would bring Stan in later andtell him everything we had said if hewanted that. Mr. M looked at Stan andsaid no.

I asked Mr. M. if there was some-thing he was afraid of. Mr. M. lookedat Stan and said no. Then Stan spokeup, insulted that I was implying thatStan had said or done something to Mr.M. to intimidate him. Stan said he hadjust one concern and that was hisfamily ' s security.

Kate tried again to persuade Mr. M.to come with her, but finally I inter-vened and said that if Mr. M. did notwish to talk to us, he was free to go. Iexplained that if he did not want ourrepresentation, we would close thecase. The pair rose and headed for theelevator. Kate and I headed for myoffice to debrief.

She was frustrated and upset, andpositive that Mr. M. was afraid of Stanand that something very bad washappening to him. She wanted to callthe APS worker to make certain thatshe vigorously pursued her investiga-tion, and said she was sorry that shehad dissuaded the worker from filingfor guardianship. She became evenmore frustrated when she ran into thebrick wall of client confidentiality.

Without Mr. M. ' s consent, there was

nothing Kate could tell APS. Weexamined the confidentiality rulecarefully, but reluctantly admitted thatthis situation did not fit any of theexceptions. We looked at the statutefor mandatory reporting of abuse ofvulnerable adult; lawyers were notincluded in the list of professionalswho must report. And yet, Kate couldnot accept that her role had ended. Herdesire to protect Mr. M. was over-whelming. Gone was her belief that hewas competent, and gone was herwillingness to let Mr. M. direct thecourse of the case. She felt he neededhelp and that she had to do something.

I had to admit that I felt much thesame way. Kate and I spent some timescheming about indirect ways ofreporting what we knew to APS, toprod them into investigating further.We could not think of a single way tohelp him ourselves, for each time wehad to ask, "Where would we get theauthority to act, if not from the client? "

We decided to think about theproblem overnight and meet again thenext day. During that time I wonderedhow much of my feeling was a desireto protect this client and how muchwas simply a desire to win, to preventStan, with or without Mr. M. ' scompliance, from taking advantage ofthe old man. I wondered why we werewilling to believe our client competentwhen he wanted our help, and unwill-ing to believe him competent when hedid not?

In the end, we decided there waslittle else we could do. Kate graduallycame to accept that after all we areonly lawyers, not miracle workers. Weare merely agents of our clients. Wecan employ, interpret and explain thelaw to the advantage of those clients,but we derive all our authority to actfrom the client. If the client does notwant to be saved, our hands are tied.

Before we closed the case, wedevised a careful script for Kate to usewhen returning a call to the APSworker. She told her that she could notdiscuss the case further because we nolonger represented Mr. M. and that wewere bound by the rules of confidenti-ality. Then she listened as the workertalked about her own distrust of Stanand about her next steps, which

seemed to include a petition forguardianship. Kate heard enough toallay some of her fears for Mr. M., butshe intends to keep checking the courtdocket to search for that guardianshipfiling.

Faculty Research ProjectsCont. from page 3

that may influence health plan choice.In addition to factors that have beenlooked at in other studies, e.g.. income,health status, family status, cost ofplan, premiums, deductibles, etc., theywill also be looking at race and medicalexpertise, which have not been asignificant focus of other studies onthis topic. The University ofMaryland's Baltimore Campus includesthe University ' s schools of medicine,nursing, dentistry and pharmacy andCoppin State has a predominantlyAfrican American faculty and staff.

Greenwall FoundationIn November, Professor Hoffmannreceived a planning grant from theGreenwall Foundation to determine theshortfall between the current level ofknowledge and skills of those individu-als doing bioethics consults and thoseproposed in the guidelines put forth bythe Society for Health and HumanValues Task Force on Standards forHealth Care Ethics Consultation.

The Task Force guidelines wereproposed this fall, but their "need" hasnot been empirically documented norevaluated in terms of ultimatelyimproving the effectiveness of theperformance of ethics committees.

This issue is especially relevant to thestate of Maryland which, in 1987,enacted a law requiring that all hospi-tals have "patient care advisory com-mittees" or ethics committees, as theyare more commonly called. The lawwas extended to include nursing homesin 1990. Committee quality in Mary-land is uneven and yet committees haveconsiderable authority under the state'sHealth Care Decisions Act to makehealth care recommendations affectinglife sustaining treatment and othermedical treatment decisions regardingincapacitated patients.

6 Law & Health Care Newsletter

on . • •HEALTH LAW PRACTICUMS

AND EXTERNSHIPS: The NationalInstitutes of Health

fter 17 years as a biochemist

Ain a medical school setting Iioped that law school would

bring a new focus and direction forapplying my science background.Many times in the first two years ofschool I second-guessed leaving thesecurity of the scientific research en-vironment. However, once I begantaking health law courses I started tosee the possibilities. Then, every ca-reer option seemed exciting. Handson experience helped me to definemy career goals.

My first opportunity for real worldhealth law experience was apracticum at the National Institutesof Health (NIH) Office of the Gen-eral Counsel (OGC). The OGC is re-sponsible for all the legal concerns ofall the institutes which comprise theNIH. Issues may arise that are re-lated to clinical care, to research, orto the awarding of grants to outsideinvestigators. The legal issues are asdiverse as property and employmentlaw, scientific misconduct, or patentlaw. My supervising attorney in theOGC was primarily responsible forissues relating to technology transfer,an increasingly important area in law.The goal of technology transfer is totake new technology from the labo-ratory to applications for public use.

With respect to NIH, the govern-ment is not involved in commercial-ization, so any basic research resultswhich might have public health ben-efits must be further developed byprivate entities. While in the OGC Ihad the opportunity to review a vari-ety of agreements between NIH andprivate entities for research collabo-ration and for technology transfer.

I must confess that I had little un-derstanding of the significance of theprovisions in these agreements.

by Malka Scher, 3D

To further develop my skills I partici-pated in an externship at the NationalCancer Institute (NCI) in the Technol-ogy Development and CommercializationBranch (TDCB). The TDCB is respon-sible for representing NCI scientists informing agreements with private entitiesfor transfer of materials and for researchcollaborations. Clinical trials agreementsand agreements for screening of com-pounds supplied by outside entities arealso negotiated by the TDCB. Pharma-ceutical companies and biotechnologycompanies are interested in collabora-tions and other agreements with NCI be-cause of the network of clinical testingsites that NCI has in place and becauseof the outstanding research capabilitiesof NCI scientists and physicians.

My most significant responsibilities atthe TDCB included the negotiation anddrafting of Material Transfer Agree-ments which provide for the sharing ofresearch materials between outside par-ties, generally non-profit institutions, andgovernment scientists. I was also for-tunate to be given the opportunity to ne-gotiate and draft more complex MaterialTransfer Agreement - Cooperative Re-search and Development Agreements.

While at the TDCB my understandingof the provisions in these agreements in-creased dramatically compared to thetime I was at OGC. In negotiating theseagreements I acted independently in in-teractions with the NCI scientists manyof whom are world renowned and are atthe forefront of development of new re-search or clinical methods.

Since, unlike private entities, certainprovisions in NIH agreements are gov-erned by federal statute, regulations, andNIH policy, it was necessary for me tolearn the pertinent substantive law. Withthis background and with supervisoryapproval I drafted the appropriate modi-fications to standard agreements. The

The Law & Health Care Program's

Health Law Practicum Program pro-

vides an opportunity for students

interested in health law to obtain

credit by working .for organizations

and government agencies dealing

with health care issues. Students

spend 10 to 20 hours at their place-

ment and additional hours through-

out the semester in the classroom

participating in The Health Law

Practice Workshop. Placements have

included the American Nurses Asso-

ciation; FDA; Johns Hopkins Hospi-

tal, Office of the General Counsel;

Med-Chi of Maryland; Medlantic

Healthcare Group; National Health

Law Program; NIH; US. Senate Spe-

cial Committee on Aging; University

of Maryland Medical System, Office

of the General Counsel; and the

Office of the Attorney General, Gen-

eral Litigation Unit and Medicaid

Fraud Unit.

The Program has also offered seven

full semester externships-The Na-

tional Health Law Program

externship in Washington, D.C.; The

University of Maryland externship,

located in University Hospital 's Gen-

eral Counsel's office; Blue Cross/Blue

Shield of Maryland (BCBSM), The

Federal Trade Commission, The

Health Care Access and Cost Commis-

sion; the NIH General Counsel 's Of-fice; and the Women's Legal Defense

Fund in Washington, D.C.

amount of responsibility that I wasgiven contributed immeasurably towarddeveloping proficiency in negotiationand toward evaluating transactional lawas a possible career choice.

Since I have had experiences at twodifferent NIH offices, it is possible tocompare these different legal positionswithin the framework of a single fed-eral agency. Both the nature of thelegal work and the breadth of the le-gal work differ in the two offices. Itappears to me that in the OGC NIH at-torneys spend considerable time re-searching, analyzing, and applying thelaw. Issues may arise which require thelegal staff to discuss policy changes

Cont. on page 8

Law & Health Care Newsletter 7

Student Health LawOrganization (SHLO) News

Jn early October, representatives ofthe Student Health Law Organiza-tion participated in the annual

Alzheimer's Memory Walk, earning$130.00 for the Alzheimer ' s Asso-ciation.

On November 20, 1997, SHLOsponsored a career panel at which fourattorneys presented students withdiverse views on the practice of law ina variety of settings. Attorneysparticipating in the panel included: JaneWeaver, JD, MN, FNP, RN of theAmerican Nurses Foundation; ThomasDoherty, JD, Medlantic HealthcareGroup; Roy Mason, JD, Mason,Ketterman & Morgan; and NancyTennis, JD, Assistant Attorney Generalfrom the Department of Health andMental Hygiene.

The program was organized in a"day in the life" type format and aboutthirty students attended. A receptionwas held after the event to allow thoseattending an opportunity to talkinformally.

In another area, SHLO President,Chris Coffin has information regardinga new program designed to teachelderly persons about advance direc-tives-an opportunity for SHLOmembers to perform some legal healthcare work for the community.Contact the program office or Chris [email protected] .

SHLO officers for the 1997-98academic year are: Chris Coffin,President; Dan Gaskill, Vice-President;Dan Alexander, Secretary; and MikeImber, Treasurer.

Spotlight OnCont. from page 7

with the top administrative officials atNIH. Thus, it seems the attorneys atOGC are quite influential and the ques-tions they analyze may be quite signifi-cant.

In contrast, the TDCB attorneys prac-tice transactional law and have a morenarrow focus on transactions relating totechnology transfer. The attorneyswork much more closely with individualscientists and discussions of new tech-nology are common in the office.

Even after completing the practicumand the externship. and participating inthe Health Law Practice Workshop,%am still analyzing career options. Although { once thought that a careerchoice meant,rIlowing a straight andnarrow path fo a goal set early in life, Inow see jhat for me, at J.east, definingand adj. ting. cs, g ehciieeS is a con-tinuing, UM-long process.

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8 Law & Health Care Newsletter