PATIENT’S RIGHTS:
CONSENT AND CONFIDENTIALITY
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
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
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
CONSENT- GENETICS CONTEXT
Limited physical invasivenessCollecting genetic sample or medical exams
Invasiveness is largely informationalCollecting informationDisseminating information
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
INFORMED CONSENT
Not only is consent required for medical intervention/treatment
Consent must be informed
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
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
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
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
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
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
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?
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
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
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
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
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
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
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
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
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
PRIVACY – MANY MEANINGS Control over personal information
Right to be let alone
Control over one’s physical person
Protection of disclosed information (confidentiality)
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
PRIVACY V. CONFIDENTIALITY
Privacy is infringed by unauthorized access to information
Confidentiality infringed when person in a confidential relationship fails to protect the information
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
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
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
HIPAA Ensures patient access to medical records
Allows review and requested amendments
Covered entities mustProvide patients with information about
privacy rightsAdopt written privacy provisionsSafeguard patient records
Sets national “floor” of privacy standards
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.
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
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
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
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 provision GI must be treated as confidential Must be kept separate from employment records
as required by American with Disabilities Act
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
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
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
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
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 when Attempts to encourage patient disclosure fail Harm is serious, imminent, and foreseeable The at-risk relative is identifiable Disease is preventable Harm of not disclosing > harm of disclosing
(ASHG) Very hard to meet all of these conditions
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
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
Top Related