sonia m. suter, m.s., j.d. assoc. prof. of law george washington university

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PATIENT’S RIGHTS: CONSENT AND CONFIDENTIALITY Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

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Page 1: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

PATIENT’S RIGHTS:

CONSENT AND CONFIDENTIALITY

Sonia M. Suter, M.S., J.D.

Assoc. Prof. of Law

George Washington University

Page 2: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

OVERVIEW OF TALK Consent

Informed Consent

Wrongful Birth/Life

Privacy and Confidentiality

Confidentiality Exceptions

Page 3: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

ETHICS OF CONSENT Medical treatment requires patient’s

consent“Every adult human of adult years and

sound mind has a right to determine what shall be done with his own body.” (Cardozo, 1914)

Ethical Underpinnings Bodily Integrity:

Right to control access to one’s physical space

Autonomy/Self-Determination Right to make decisions for and about oneself Response to paternalism

Page 4: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

LEGAL ASPECTS OF CONSENT Battery

A claim for touching without consent or legal justification

Long common law tradition

Medical corollaryMedical treatment requires consent Right to refuse medical treatment“Inferred/assumed” constitutional liberty

interest

Page 5: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

CONSENT- GENETICS CONTEXT

Limited physical invasivenessCollecting genetic sample or medical exams

Invasiveness is largely informationalCollecting informationDisseminating information

Page 6: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

CONSENT AND THE LAW IN GENETICS Common law requires consent for

invasive procedures: testing, exams, etc.

State statutes require consent forCollection of DNA samplesGenetic analysisRetention of genetic information/samplesUses of genetic informationDisclosure of genetic information to 3d

parties

Page 7: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

INFORMED CONSENT

Not only is consent required for medical intervention/treatment

Consent must be informed

Page 8: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

INFORMED CONSENT - ETHICS Autonomy and self-determination

Fosters Rational Decision Making

Encourages physicians to think carefully about medical recommendations

Moves from paternalism to shared decision making

Page 9: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

INFORMED CONSENT - LAW Duty to inform patients about procedure

Duty to “satisfy the vital informational needs of the patient” (Canterbury v. Spence, 1972)

Origins in Battery Requires limited disclosure: proposed

treatmentsNo physical injury necessaryFew defenses if no consent

Movement to Negligence (vast majority)Broader range of disclosure requirementsCausation more difficult to proveUsually must show physical injury

Page 10: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

INFORMED CONSENT (NEGLIGENCE) Information to disclose (2 approaches)

Professional Standard What a reasonable practitioner would disclose

Patient-based standard: Information material to reasonable patient

Typical information to disclose:DiagnosisNature and purpose of treatmentRisks of treatmentTreatment alternativesConsequences of refusal to test/treat

Page 11: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

INFORMED CONSENT (NEGLIGENCE) Physician liable if

Fail to disclose required information (Reasonable) patient would’ve decided

differently -- causationAND patient suffered physical harm --

damages

Emphasis on physical risks/physical harms

Few cases regarding non-physical risks/harm

Page 12: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

INFORMED CONSENT - GENETICS Not traditional risks of invasive

treatmentExceptions: reproductive testing

Invasiveness, physical risks

Risks are largely psychosocialAnxiety, altered self-imageAltered family relationshipsSocial/group stigmatizationDiscrimination Impact on privacy and confidentiality

Page 13: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

INFORMED CONSENT LAWS FOR GENETICS Several state statutes require informed consent

for genetic testing

Handful describe information to disclose for (presymptomatic/predictive) testing Nature and purpose of test Effectiveness and limitations of test Implications of taking test Meaning of test results Procedure of providing test results (no information reasonable doc wouldn’t know) -- MI

Some statutes for disclosure and retention

Page 14: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

INFORMED CONSENT - GENETICS Clear ethical/legal duty to obtain

consent for any genetic test, physical examination

Legal duty to disclose range of informationDiagnosis/Genetic RiskTesting optionsNature and purpose of genetic testsPhysical risksConsequences of not testing

What about psychosocial risks?

Page 15: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

PSYCHOSOCIAL RISKS Uncertainty about degree of risk

Limited data on psychological stress, effect on family dynamics, risks of discrimination

Risks depend on numerous variablesPenetrance/expressivity/severity/nature of

disease

Unclear reach of legal obligationsStatutes that mandate disclosure of

“implications of genetic testing” are vagueCommon law focuses on physical risks

Page 16: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

LEGAL CLAIM FORPSYCHOSOCIAL RISKS? Duty would be based on standard of

care or materiality of information

Causation may be hard to showStudies suggest concerns about

discrimination don’t influence decisions Exceptions: some of the psychological risks

DamagesLaw is highly reluctant to allow recovery for

pure emotional distress without physical harm

Page 17: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

GENETIC COUNSELING AND IC Goals of Genetic Counseling

Enable “clients to make informed independent decisions, free of coercion, by providing or illuminating the necessary facts and clarifying the alternatives and anticipated consequences.” (NSGC Code of Ethics)

Decisions based on personal values and life plans

Emphasizes informed decision making Emphasizes independent decision

making Nondirectiveness: goes beyond IC

Page 18: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

NONDIRECTIVENESS AND IC Nondirectiveness avoids

prescriptiveness

At the extreme, may not answer question “what would you do?”

Extreme nondirectiveness may conflict with self-determination and informed consentPrevents coercion regarding actual decisionBut prescribes manner of decision making

andPrevents access to information patient

believes would help with the decision

Page 19: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

WRONGFUL BIRTH/LIFE CLAIMS “Cousins” of Informed Consent

Claim for failure to disclose reproductive risks, which limits reproductive options

Wrongful birth: parents sue for lost chance to avoid birth of child

Wrongful life: child sues for lost chance to have birth prevented

Liability if Breach of standard of care by not providing

information about reproductive risks and Lack of information prevents patients from avoiding

conception or terminating pregnancy

Page 20: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

WRONGFUL BIRTH/LIFE CLAIMS Wrongful birth claims widely recognized

Fewer than 10 states prohibit these claimsUsual damages:

Extraordinary costs/costs of deliveryLess typical damages

Emotional distress, ordinary costs of raising the child

Wrongful life claims rarely recognizedOnly 4 states: NJ, CA, WA, ME Damages limited to extraordinary costs

Page 21: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

WRONGFUL TERMINATION?? Claim for termination based on

inaccurate diagnosis of abnormality

Subject of only a handful of judicial opinions

Far less likely basis of lawsuit than wrongful birth claim

Page 22: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

LAWS EFFECT ON INCENTIVES? Failing to identify prenatal conditions can lead

to wrongful birth claims

Incorrectly diagnosing a condition that leads to a termination is not likely to result in a wrongful termination claim

Best defense against wrongful birth claim is not only to offer a test, but TO test

.:. Strong incentive to PUSH prenatal testing But inconsistent with goals of genetic

counseling

Page 23: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

PRIVACY AND CONFIDENTIALITY Different from (informed) consent

But based on overlapping concerns and interests of autonomy and self-determination

Privacy and confidentiality are not precisely the same, overlapping rights

Page 24: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

PRIVACY – MANY MEANINGS Control over personal information

Right to be let alone

Control over one’s physical person

Protection of disclosed information (confidentiality)

Page 25: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

CONFIDENTIALITY “Cousin” of Privacy

It’s relational Protects information disclosed in confidence

Physician must not reveal sensitive information without patient’s consentFiduciary obligation – relationship of trust

Longstanding medical ethical obligationHippocratic Oath -> Code of Medical Ethics

AMA

Page 26: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

PRIVACY V. CONFIDENTIALITY

Privacy is infringed by unauthorized access to information

Confidentiality infringed when person in a confidential relationship fails to protect the information

Page 27: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

VALUE OF PRIVACY AND CONFIDENTIALITY Good in its own right Protects autonomy Space to develop and maintain

self/identity Prevents us from being misunderstood

Limits shame/stigmatization/discrimination

Necessary for intimacy Builds trust in medical care Encourages participation in research

Page 28: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

STATE PRIVACY LAWS Every state safeguards medical records

Tend to protect privacy by entityProtections depend largely on who

possesses info

Few state laws are intended to be comprehensive

Lots of Variation

Page 29: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

HEALTH INSURANCE PORTABILITY & ACCOUNTABILITY ACT (“HIPAA”) Protects individually identifiable health

information, in any form, electronic or non-electronic, held or transmitted by covered entity

Individually identifiable information relates to physical/mental health or condition Provision of or payment of health care Includes genetic information

Covered entities Health plans Health care clearinghouses And health care providers

Page 30: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

HIPAA Ensures patient access to medical

records Allows review and requested amendments

Covered entities must Provide patients with information about

privacy rights Adopt written privacy provisionsSafeguard patient records

Sets national “floor” of privacy standards

Page 31: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

CONFIDENTIALITY – COMMON LAW Most courts recognize legal duty to

preserve patient confidentiality

Some base on invasion of privacy (tort) Others distinguish where obligation of

secrecy, a fiduciary duty

Additional bases for duty: Testimonial privilege licensing statutes implied K Etc.

Page 32: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

GENETIC PRIVACY Genetic information is personal/intimate

Influences physical, psychological traitsReveals information about family membersMuch of it is hidden

Potentially sensitive information May predict susceptibility to diseaseCan be misunderstood/ history of abuseCan be basis of discrimination or

stigmatizationFear of discrimination can undermine health

care and research

Page 33: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

STATE GENETIC PRIVACY LAWS Over 30 states address the issue

Great variation

Tend to focus on information, as opposed to specific entity or use

Protect information at different stages:From information gathering to

dissemination

Page 34: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

STATE GENETIC PRIVACY LAWS Some require personal access to one’s

info

Require (written and/or informed) consentTo obtain genetic informationTo retain genetic sample or information

Description of information retained Potential uses and limitations

For disclosure of genetic info to 3d party Purpose for which information being requested Information to be disclosed Individuals/entities making disclosure To whom disclosure made

Page 35: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

GENETIC INFORMATION NONDISCRIMINATION ACT (“GINA”) Broad definition of genetic information (GI):

Genetic information about individual and family Genetic information shall be treated as health

information as described in HIPPA

Focus is primarily on nondiscrimination

Confidentiality provisionGI must be treated as confidential Must be kept separate from employment

records as required by American with Disabilities Act

Page 36: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

LIMITS OF CONFIDENTIALITY AND PRIVACY GENERALLY Confidentiality is not absolute principle

Exceptions where “necessary to protect the welfare of the individual or of the community.”

(AMA Code of Ethics)

Legal duty is not absolute May breach without liability (discretion to warn)

To protect public health/ family members Contagious diseases

Sometimes duty to breach confidentiality Duty to report communicable diseases, gunshot

wounds, evidence child neglect/abuse, etc. Duty to warn identifiable 3d party of risk of

psychopath

Page 37: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

LIMITS OF CONFIDENTIALITY AND PRIVACY -- GENETICS Legislative exceptions to privacy

protections: Diagnosis, treatment Newborn screening Law enforcement Court order Paternity testing Anonymized research Etc.

Exceptions to confidentiality within doctor- patient relationship? Patient won’t disclose genetic risk to relative

Page 38: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

CONFIDENTIALITY CHALLENGES IN GENETICS Client has gene for late-onset condition

E.g., Huntington disease gene, inherited thyroid carcinoma

50% risk children will inherit condition

Existing condition, hidden genetic component E.g., testicular feminization syndrome 25% risk to patient’s female cousins

Risks of prenatal abnormalities E.g., inherited balanced translocation 50% risk sibs will have translocation

Page 39: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

WHAT HAPPENS IF THE PATIENT WON’T INFORM THE RELATIVE? Different kinds of risks from usual

exceptions to confidentialityRisk to others is not created by patientNot contagious disease, psychopath

Patient’s refusal to share information doesn’t create riskGenetic risk already exists Patient actions make it difficult to warn

relative

BUT relative might benefit from information

Page 40: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

PROFESSIONAL GUIDELINES Strong bias in favor of confidentiality

Right and responsibility of patient to determine who shall access his/her information (NSGC)

Privilege but no duty to warn relatives whenAttempts to encourage patient disclosure failHarm is serious, imminent, and foreseeableThe at-risk relative is identifiableDisease is preventableHarm of not disclosing > harm of disclosing

(ASHG)

Very hard to meet all of these conditions

Page 41: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

VERY LITTLE CASE LAW Pate v. Threlkel (1995- Florida)

Duty to daughter of patient – AD thyroid cancer Foreseeable risk and benefit of knowledge

BUT duty fulfilled by informing patient of risk NO duty to seek out and warn relatives

Safer v. Pack (1996 – NJ App.) Duty to daughter of patient with colon cancer

Immediate family, avertable risk Refused to decide limits of duty Requires reasonable steps to insure info reaches

those at risk Tension: duty to warn and confidentiality

Page 42: Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

FINAL NOTES Many norms of genetic counseling

consistent with legal obligationsConsent, Informed consentPrivacy and Confidentiality generally

Unresolved area: confidentiality concerns v. risks to uninformed relativesProfessional guidelines might conflict with

legal obligations (discretion v. duty to warn)Education, discussion with patient goes long

way toward dissolving dilemma