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

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

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Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University Slide 2 Consent Informed Consent Wrongful Birth/Life Privacy and Confidentiality Confidentiality Exceptions Slide 3 Medical treatment requires patients 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 ones physical space Autonomy/Self-Determination Right to make decisions for and about oneself Response to paternalism Slide 4 Battery A claim for touching without consent or legal justification Long common law tradition Medical corollary Medical treatment requires consent Right to refuse medical treatment Inferred/assumed constitutional liberty interest Slide 5 Limited physical invasiveness Collecting genetic sample or medical exams Invasiveness is largely informational Collecting information Disseminating information Slide 6 Common law requires consent for invasive procedures: testing, exams, etc. State statutes require consent for Collection of DNA samples Genetic analysis Retention of genetic information/samples Uses of genetic information Disclosure of genetic information to 3d parties Slide 7 Not only is consent required for medical intervention/treatment Consent must be informed Slide 8 Autonomy and self-determination Fosters Rational Decision Making Encourages physicians to think carefully about medical recommendations Moves from paternalism to shared decision making Slide 9 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 treatments No physical injury necessary Few defenses if no consent Movement to Negligence (vast majority) Broader range of disclosure requirements Causation more difficult to prove Usually must show physical injury Slide 10 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: Diagnosis Nature and purpose of treatment Risks of treatment Treatment alternatives Consequences of refusal to test/treat Slide 11 Physician liable if Fail to disclose required information (Reasonable) patient wouldve decided differently -- causation AND patient suffered physical harm -- damages Emphasis on physical risks/physical harms Few cases regarding non-physical risks/harm Slide 12 Not traditional risks of invasive treatment Exceptions: reproductive testing Invasiveness, physical risks Risks are largely psychosocial Anxiety, altered self-image Altered family relationships Social/group stigmatization Discrimination Impact on privacy and confidentiality Slide 13 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 wouldnt know) -- MI Some statutes for disclosure and retention Slide 14 Clear ethical/legal duty to obtain consent for any genetic test, physical examination Legal duty to disclose range of information Diagnosis/Genetic Risk Testing options Nature and purpose of genetic tests Physical risks Consequences of not testing What about psychosocial risks? Slide 15 Uncertainty about degree of risk Limited data on psychological stress, effect on family dynamics, risks of discrimination Risks depend on numerous variables Penetrance/expressivity/severity/nature of disease Unclear reach of legal obligations Statutes that mandate disclosure of implications of genetic testing are vague Common law focuses on physical risks Slide 16 Duty would be based on standard of care or materiality of information Causation may be hard to show Studies suggest concerns about discrimination dont influence decisions Exceptions: some of the psychological risks Damages Law is highly reluctant to allow recovery for pure emotional distress without physical harm Slide 17 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 Slide 18 Nondirectiveness avoids prescriptiveness At the extreme, may not answer question what would you do? Extreme nondirectiveness may conflict with self-determination and informed consent Prevents coercion regarding actual decision But prescribes manner of decision making and Prevents access to information patient believes would help with the decision Slide 19 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 Slide 20 Wrongful birth claims widely recognized Fewer than 10 states prohibit these claims Usual damages: Extraordinary costs/costs of delivery Less typical damages Emotional distress, ordinary costs of raising the child Wrongful life claims rarely recognized Only 4 states: NJ, CA, WA, ME Damages limited to extraordinary costs Slide 21 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 Slide 22 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 Slide 23 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 Slide 24 Control over personal information Right to be let alone Control over ones physical person Protection of disclosed information (confidentiality) Slide 25 Cousin of Privacy Its relational Protects information disclosed in confidence Physician must not reveal sensitive information without patients consent Fiduciary obligation relationship of trust Longstanding medical ethical obligation Hippocratic Oath -> Code of Medical Ethics AMA Slide 26 Privacy is infringed by unauthorized access to information Confidentiality infringed when person in a confidential relationship fails to protect the information Slide 27 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 Slide 28 Every state safeguards medical records Tend to protect privacy by entity Protections depend largely on who possesses info Few state laws are intended to be comprehensive Lots of Variation Slide 29 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 Slide 30 Ensures patient access to medical records Allows review and requested amendments Covered entities must Provide patients with information about privacy rights Adopt written privacy provisions Safeguard patient records Sets national floor of privacy standards Slide 31 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. Slide 32 Genetic information is personal/intimate Influences physical, psychological traits Reveals information about family members Much of it is hidden Potentially sensitive information May predict susceptibility to disease Can be misunderstood/ history of abuse Can be basis of discrimination or stigmatization Fear of discrimination can undermine health care and research Slide 33 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 Slide 34 Some require personal access to ones info Require (written and/or informed) consent To obtain genetic information To 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 Slide 35 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 Slide 36 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 Slide 37 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 wont disclose genetic risk to relative Slide 38 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 patients female cousins Risks of prenatal abnormalities E.g., inherited balanced translocation 50% risk sibs will have translocation Slide 39 Different kinds of risks from usual exceptions to confidentiality Risk to others is not created by patient Not contagious disease, psychopath Patients refusal to share information doesnt create risk Genetic risk already exists Patient actions make it difficult to warn relative BUT relative might benefit from information Slide 40 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 Slide 41 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 Slide 42 Many norms of genetic counseling consistent with legal obligations Consent, Informed consent Privacy and Confidentiality generally Unresolved area: confidentiality concerns v. risks to uninformed relatives Professional guidelines might conflict with legal obligations (discretion v. duty to warn) Education, discussion with patient goes long way toward dissolving dilemma