Chapter 9: Confidentiality and Informed Consent

2. Chapter 9: Confidentiality and Informed Consent

3. Introduction • Balance: protect information and ensure that patient’s needs are met • Confidentiality is a modern and developing concept • Obligation to maintain patient information and protect it from dissemination or disclosure • Responsibility of providers and health information managers • Informed consent: providing information to patients needed to decide for or against treatment

4. Confidentiality • Focus: relationship between the patient and health care provider • Patient gives provider information • Provider uses data/information to diagnose/treat • Dialogue is private • information is not disseminated beyond the health care provider(s) • Obligation: Hippocratic oath set the foundation • Today: complex web of protections • Technology, growth of third-party payers, increased amount of available information

5. Confidentiality • Legal protections are based on patient’s right to privacy • Right to be left alone • Right to control personal information • Legal sources for foundation for rights • Constitutional provisions • Statutory provisions • Common law provisions

6. Confidentiality: Constitutional Basis • Right to privacy: recognized but not explicitly listed in the U.S. Constitution • U.S. Supreme Court has held that such a right exists. • Application to health information (Whalen v.Roe) : • Individual interest in avoiding disclosure • Individual interest in independent decision making • Is this individual interest outweighed by the public’s need for information? • State constitutional protections • Some states provide more protection • Examples: Alaska, Arizona, California, Florida, Hawaii

7. Confidentiality: Statutory Basis-Federal Level • Laws focus on government record keeping • Freedom of Information Act (FOIA): • Mandates access to records and disclosure upon request • Privacy Act of 1974 • Presumes certain information held by government is confidential • Individual consent needed for disclosure • Impact on health care • SSA and DHHS hold information related to research and statistical studies • Agencies must comply with statutes when releasing information; patient identifiers removed

8. Confidentiality: Statutory Basis-State Level • Open record statutes • Apply to records held by state agencies • Correspond with principles of FOIA • Privacy statutes • Correspond with federal Privacy Act • Presume certain information held by state is confidential • Patient authorization needed to disclose • Physician-patient privilege • Applies to introduction of evidence at trial • Prevents forced disclosure of information obtained during treatment • Rests with patient; provider may assert on patient’s behalf

9. Confidentiality: Common Law Basis • Common law is judge made law • Legal protections recognize the right to: • Bring lawsuit for damages against one who inappropriately discloses/uses information • Examples of lawsuits • Invasion of privacy claims • Defamation • Breach of contract

10. Confidentiality Application • Privacy and confidentiality • Separate but related concepts • Important to distinguish between • Privacy • Right belonging to patient • Looking inward: patient protecting her information • Confidentiality • Duty belonging to health care provider • Looking outward: provider does not disseminate information about another (the patient)

11. Confidentiality Application • Protected Health Information (PHI) • HIPPA privacy rule defines confidential health information as PHI • Contains identifiers by which the individual may be recognized, including • Name, address, dates (of birth, death, admission) • Phone numbers or email addresses • Social security, health record, or insurance number • Photos or other identifiers (vehicle or device) • Without authorization, information must be de-identified prior to release or disclosure

12. Confidentiality Application • Ethical obligation • Duty to protect patient privacy and confidentiality of information • Health care providers and HIM owe this duty • Increasingly difficult with increased demands • Notice of privacy practices • HIPAA requires provider to inform patients • Describes duties concerning PHI • Disclosure, safeguards, accounting, complaints • Notice is to be posted and acknowledged by patient

13. Confidentiality Application • Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information • Privacy rule provides basis for this protection • Principles • Individual access and individual choice • Correction • Openness and transparency • Collection, use, and disclosure limitations • Data quality and integrity principles • Safeguards and accountability

14. Confidentiality Application • Expanding responsibilities of HIM • EHR poses challenges to maintaining confidentiality and privacy • HIPAA requirements • Expansion of electronic exchange of PHI • Computer data security programs to address concerns • Scope of influence and responsibilities will continue to grow

15. Confidentiality Application:HIV Information • State laws may provide special protections • Restrictions on patient identification and test results • Strict limits on disclosure: • May be made only to patient, authorized representative, provider, or public health authority • Release form must permit HIV-related disclosure • Person injured by unauthorized disclosure may sue • Exceptions may exist that warrant disclosure • Court will consider public safety

16. Confidentiality Application:HIV Information and Ethical Issues • Professional guidelines to guide action • Standards of conduct issued • May be used to establish standard of care • Patient death: obligation to keep HIV information confidential does not end • Ethical guidelines from AMA • When to include HIV/AIDS information on autopsy report

17. Informed Consent: Historical Development • Basis in theory of battery • Battery is an unauthorized touching of another. • Provider liable for battery if treatment of patient without consent • Legal analysis shifted from • Did patient consent to treatment? • Did patient understand the nature and effects of treatment? • Focus moved to evaluate the quality of consent • Did the patient have sufficient information to make and informed decision?

18. Informed Consent: Historical Development • Rooted in the ethical concept of autonomy • Requires that health care providers • Disclose adequate information to patients • Ensure that patients understand information • Power placed in the competent patient to • Act voluntarily • Make decisions regarding extent of care • Traditional application of battery theory not an adequate basis for related law suits

19. Informed Consent: Historical Development • Growing recognition over time • Negligence principles were applicable • Separate legal theory needed: Doctrine of Informed Consent • Focus on duty of health care providers to • Obtain consent • Explain the nature of procedure, risks, alternatives, and expected results • Process must be documented in health record • Recognize that failure may result in liability

20. Informed Consent: Scope of the Doctrine

21. Informed Consent: Who May Consent? • Patient who is a competent adult • Substituted consent for incompetent patient • Minor • Parent or legal guardian provides substituted consent • Exceptions and special conditions to which minor may provide treatment consent include: • Pregnancy • Sexually transmitted diseases • Substance abuse and mental health care

22. Informed Consent: Who May Consent? • Emancipated minor is considered competent • State law defines • May include marriage, armed services membership, or complete self-sufficiency Does another, acting for the patient have the right to refuse treatment when the result may be death?

23. Informed Consent: Who May Consent? • Cruzan v. Missouri Dept of Health (1990) • Nancy Cruzan in vegetative state due to car accident • Family wanted to withdraw life support, hospital refused • Nancy left no written instructions prior to accident • State required clear and convincing evidence of Nancy’s wishes before allowing withdraw • U.S. Supreme Court held that Missouri’s requirement did not violate the constitution

24. Informed Consent: Who May Consent? • Patient Self Determination Act (PSDA) • Cruzan case raised concerns about end of life • Led to passage of PSDA • Goal: patient’s right to self determination should be communicated and protected • Requires that certain providers inform patients • Of state laws governing right to make advanced directives • Of providers’ policies regarding patient rights

25. Informed Consent:Advanced Directives • Patient describes wishes regarding care • Written when patient is competent • In effect only after patient becomes incompetent • Living will • Provides direction on medical care wishes • Durable power of attorney for health care decisions • Identifies health care decision maker

26. Informed Consent: Advanced Directives • Federal requirements under PSDA • Ensure health record reflects whether patient has an advanced directive • Avoid discrimination against patients • Educate and communicate • States have power to define legal rights concerning advanced directives • PSDA does not alter rights under state law

27. Informed Consent: Advanced Directives • State statutes • Address substantive legal rights • Grant permission to create and use • Living wills • Durable powers of attorney for health care • DHHS regulations expect compliance with PSDA • Accreditation standards on advanced directives (JC and DNV Healthcare)

28. Informed Consent: Emergencies • What happens if patient needs care but cannot consent due to an emergency condition? • Another is not available to give consent • Delay would result in death or serious harm • State laws protect providers from risk of liability • If emergency condition exists and patient cannot give consent, provider may act to save life or limb without informed consent

29. Informed Consent: What is Disclosed? • Did the patient receive enough information to make an informed decision? • Matter of state law • Generally, sufficient disclosure includes: • Nature of the proposed procedure/treatment • Risks • Benefits • Any available alternatives

30. Informed Consent: What is Disclosed? • State laws take different approaches • Professional disclosure standard • What would the reasonable health care provider under the same circumstances disclose? • Expert testimony needed to establish • State statute (Alabama, Florida, New Hampshire, North Carolina) • State common law (Colorado, Indiana, Kansas, South Carolina)

31. Informed Consent: What is Disclosed? • Other states approach from patient perspective • Reasonable patient standard • What material is necessary for an average patient to decide to consent or forgo treatment? • Expert testimony is not needed • State statute (Iowa, Texas, Washington) • State common law (D.C., California, Rhode Island)

32. Informed Consent: When is It Required? • Any treatment rendered requires patient consent • Implied consent sometimes enough • Voluntary consent by submitting to procedure • Risk is slight • Taking temperature or pulse, blood draw • Informed consent • Diagnostic or therapeutic procedure • Risk significant and/or not readily apparent • Surgery, radiologic therapies • Procedure that may change body structure • Strict requirements for research/experiments