Chapter 9: Confidentiality and Informed Consent

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Chapter 9: Confidentiality and Informed Consent


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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


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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


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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


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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


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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


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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


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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


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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)


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• 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


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• 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


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• 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



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• 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


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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


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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


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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?


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• 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


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• 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


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Informed Consent: Scope of the Doctrine


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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


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– 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?



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• 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



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• 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



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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


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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


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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)


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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


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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


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• 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)


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• 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)


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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

Documents

Chapter 9: Confidentiality and Informed Consent