Patient’s Rights: Consent and Confidentiality

1. Patient’s Rights:Consent and Confidentiality Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

2. Overview of Talk • Consent • Informed Consent • Wrongful Birth/Life • Privacy and Confidentiality • Confidentiality Exceptions

3. 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

4. Legal aspects of Consent • 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

5. Consent- Genetics Context • Limited physical invasiveness • Collecting genetic sample or medical exams • Invasiveness is largely informational • Collecting information • Disseminating information

6. Consent and the law in Genetics • 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

7. INFORMED Consent • Not only is consent required for medical intervention/treatment • Consent must be informed

8. 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

9. 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 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

10. 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: • Diagnosis • Nature and purpose of treatment • Risks of treatment • Treatment alternatives • Consequences of refusal to test/treat

11. Informed Consent (NeGligence) • Physician liable if • Fail to disclose required information • (Reasonable) patient would’ve decided differently -- causation • AND patient suffered physical harm -- damages • Emphasis on physical risks/physical harms • Few cases regarding non-physical risks/harm

12. Informed Consent - Genetics • 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

13. 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

14. Informed Consent - Genetics • 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?

15. Psychosocial Risks • 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

16. Legal claim forPsychosocial risks? • Duty would be based on standard of care or materiality of information • Causation may be hard to show • Studies suggest concerns about discrimination don’t influence decisions • Exceptions: some of the psychological risks • Damages • Law is highly reluctant to allow recovery for pure emotional distress without physical harm

17. 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

18. 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 consent • Prevents coercion regarding actual decision • But prescribes manner of decision making and • Prevents access to information patient believes would help with the decision

19. 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

20. Wrongful Birth/Life Claims • 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

21. 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

22. 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

23. 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

24. Privacy – many meanings • Control over personal information • Right to be let alone • Control over one’s physical person • Protection of disclosed information (confidentiality)

25. Confidentiality • “Cousin” of Privacy • It’s relational • Protects information disclosed in confidence • Physician must not reveal sensitive information without patient’s consent • Fiduciary obligation – relationship of trust • Longstanding medical ethical obligation • Hippocratic Oath -> Code of Medical Ethics AMA

26. Privacy v. Confidentiality • Privacy is infringed by unauthorized access to information • Confidentiality infringed when person in a confidential relationship fails to protect the information

27. 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

28. State Privacy Laws • 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

29. 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

30. 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 provisions • Safeguard patient records • Sets national “floor” of privacy standards

31. 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.

32. Genetic Privacy • 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

33. 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

34. State Genetic Privacy LaWS • Some require personal access to one’s 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

35. 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

36. 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

37. 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

38. 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

39. What happens if the Patient won’t inform the relative? • Different kinds of risks from usual exceptions to confidentiality • Risk to others is not created by patient • Not contagious disease, psychopath • Patient’s refusal to share information doesn’t create risk • Genetic risk already exists • Patient actions make it difficult to warn relative • BUT relative might benefit from information

40. 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

41. 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

42. FInAL NOTes • 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