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Genetic Databases & Privacy Law 134: Law & Technology May 15, 2001 Karl Manheim Coverage Genetic Privacy What is it Why we care about it Genetic Databases What are they How are they used Protecting Genetic Privacy Existing Approaches Proposed Laws Part I: Genetic Privacy

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genetic databases privacy

Genetic Databases & Privacy

Law 134: Law & Technology

May 15, 2001

Karl Manheim

Genetic Privacy - Manheim

coverage
Coverage
  • Genetic Privacy
    • What is it
    • Why we care about it
  • Genetic Databases
    • What are they
    • How are they used
  • Protecting Genetic Privacy
    • Existing Approaches
    • Proposed Laws

Genetic Privacy - Manheim

part i genetic privacy
Part I: Genetic Privacy

Genetic Privacy - Manheim

what we mean by privacy
What We Mean by Privacy
  • Privacy of information
    • Safeguarding uniquely personal information
      • No snooping (collection of personal information)
      • Confidentiality (unauthorized disclosure)
      • Privilege (testimonial & evidentiary privileges)
  • Privacy of choice
    • Freedom to make life choices
  • Physical privacy
    • The”right to be left alone” (Brandeis formulation)
  • Proprietary privacy
    • Use/exploitation of my unique qualities

Genetic Privacy - Manheim

why we care about privacy
Why We Care About Privacy
  • Promotes sense of self
    • Boundaries of individual vs. society
    • My genetic Information is private
  • Promotes personal autonomy
    • Self-determination – control over own destiny
    • My genetic choices are private
  • Protects property rights
    • My body
    • Exclude others from my genetic material

Genetic Privacy - Manheim

what s special about genetic privacy
What’s Special about Genetic Privacy?
  • Compared to other medical records
    • DNA contains more information
      • greater predictive value - our “future diary” - affecting
        • employment, insurance, social status
      • might also apply to offspring
        • contra Corruption of Blood principle
    • Easier to store, disseminate, analyze
    • Harder to control access
  • Five “P”s of genetic information
    • personal, private, powerful, pedigree, predictive

Genetic Privacy - Manheim

why genetic privacy is an issue now
Why Genetic Privacy is an Issue Now
  • Collection
    • More and more accurate information made possible by advances in genetic research
  • Analysis
    • New diagnostic and therapeutic technologies
    • Genetic data can now be read like a "future diary"
  • Storage
    • Sequencing has enabled digital storage
    • High speed computers have facilitated analysis
  • Access & Distribution
    • Data transmission (e.g., internet) has made information more accessible & by more users

Genetic Privacy - Manheim

bionformatics and privacy
Bionformatics and Privacy

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countervailing social values
Countervailing Social Values
  • Access to genetic data aids research
    • search for genetic connections to disease
  • Keeping genetic data secret harms others
    • Preventive interventions
      • Child & kin welfare
      • Sex partners

Genetic Privacy - Manheim

competing theories of privacy
Competing Theories of Privacy
  • Consequential (outcome-based)
    • Utilitarianism
  • Deontological (rule-based)
    • Social Contract
    • Duty Ethics

Genetic Privacy - Manheim

philosophical theories of privacy
Philosophical Theories of Privacy
  • Utilitarianism
    • Jeremy Bentham (1748-1832)
      • also John Stuart Mill (1806-1873)
  • Morally correct course of action is that which produces the largest possible balance of pleasure over pain
    • greatest good for the greatest number
    • Hedonic calculus
  • Applied to genetic privacy

value of happiness from individual privacy vs.

value of medical gains from genetic research

Genetic Privacy - Manheim

philosophical theories of privacy12
Philosophical Theories of Privacy
  • Social contract
    • John Locke (1632-1704)
  • function of the state is to protect the natural rights of its citizens
    • natural right to property
    • genetic property is inviolable

Genetic Privacy - Manheim

philosophical theories of privacy13
Philosophical Theories of Privacy
  • Duty Ethics
    • Immanuel Kant (1724-1804)
  • “Categorical Imperative”
    • Universal moral law
      • welfare of each individual should be regarded as an end in itself
        • no balancing of interests
      • Act so that the maxim of your action can be willed as universal law of nature.
    • absolute right to control one’s own genetic information

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outcome of different theories
Outcome of Different Theories

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part ii genetic databases
Part II: Genetic Databases

Genetic Privacy - Manheim

genetic databases generally
Genetic Databases Generally
  • Identifiable Data
  • Non-Identifiable Data

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genetic databases generally17
Genetic Databases Generally
  • Identifiable Data
    • IIHI - Individually Identifiable Health Information
      • data that can be used to identify an individual
      • HHS Policy for Protection of Human Research Subjects [45 CFR 46.102(b)(1)]
        • Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects
      • See also Health Insurance Portability and Accountability Act of 1996 (HIPAA) [104 P.L. 191 § 1171(6)]; 45 CFR 164.501

Genetic Privacy - Manheim

genetic databases generally18
Genetic Databases Generally
  • Identifiable Data
  • Non-Identifiable Data
    • no individualized reference
      • not covered by HHS policy for protection of human research subjects [45 CFR 46.102(f)(2)]
      • no (consequentialist) privacy issues
    • Common databases
      • The Genome Database
      • GenBank
        • NIH genetic sequence database, an annotated collection of all publicly available DNA sequences

Genetic Privacy - Manheim

individually indentifiable databases
Individually Indentifiable Databases
  • Medical Records
  • DNA Banks
  • DNA Databanks

Genetic Privacy - Manheim

types of genetic databases
Types of Genetic Databases
  • Medical Records
    • Every physician and hospital keeps records on patients, diagnoses, treatments

Genetic Privacy - Manheim

types of genetic databases21
Types of Genetic Databases
  • Medical Records
  • DNA Banks
    • Tissue Archives
      • Ex: tissue samples at academic medical centers
    • Depository of DNA molecules
      • For future research & analysis
        • Example: Patent Depository

Genetic Privacy - Manheim

types of genetic databases22
Types of Genetic Databases
  • Medical Records
  • DNA Banks
  • DNA Databanks
    • Coded information derived from DNA
      • National DNA Databank: CODIS
        • COmbined DNA Index System
          • Convicted Offender / Forensic law enforcement index
      • Health Sector Database (HSD) of Iceland
        • medical records, family history and genetic blueprint of every Icelandic citizen (270,000)

Genetic Privacy - Manheim

how data gets into data banks
How Data Gets into Data Banks
  • Routine medical testing
    • Tissue or blood samples
      • even autopsies
  • Genetic testing
    • Pregnancy counseling
  • Forced testing
    • Military
    • Criminal Law

Genetic Privacy - Manheim

uses misuses of genetic data
Uses & Misuses of Genetic Data
  • Diagnosis & Prevention
  • Research
  • Identification
  • Employment
  • Risk Rating
  • Social Manipulation

Genetic Privacy - Manheim

uses misuses of genetic data25
Uses & Misuses of Genetic Data
  • Diagnosis & Prevention
    • Treatment
      • Disease prevention and therapies
      • Voluntary & compulsory
    • Counseling
      • Decision to have a child
      • In utero treatment (genetic therapies)
    • Public health
      • Prevention and control of contagion
  • Criminal justice
    • Preventive Detention

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uses misuses of genetic data26
Uses & Misuses of Genetic Data
  • Diagnosis & Prevention
  • Research
    • Correlation and causation
      • Genetic formations and disease predisposition
      • Genetic formations and traits
    • Some cautionary points
      • Contestable causal relationships
      • No simple genes for complex behaviors
        • Interaction between genetic and environmental factors
        • On many questions, research is a long ways away

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uses misuses of genetic data27
Uses & Misuses of Genetic Data
  • Diagnosis & Prevention
  • Research
  • Identification
    • Criminal law
      • In/exculpatory DNA evidence
    • Family law
      • Dis/proving paternity
    • Military & forensics
      • Victim identification

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uses misuses of genetic data28
Uses & Misuses of Genetic Data
  • Diagnosis & Prevention
  • Research
  • Identification
  • Employment
    • Discrimination in hiring
  • Ex:
  • Genotype (phenotype) discrimination long-practiced
    • Sex discirmination

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uses misuses of genetic data29
Uses & Misuses of Genetic Data
  • Diagnosis & Prevention
  • Research
  • Identification
  • Employment
  • Risk Rating
    • Life & health insurance
  • Basic theory: spread the risk
  • Counter tendency: risk rating
    • Denial of Coverage
    • Discriminatory Rates

Genetic Privacy - Manheim

uses misuses of genetic data30
Uses & Misuses of Genetic Data
  • Diagnosis & Prevention
  • Research
  • Identification
  • Employment
  • Risk Rating & Prevention
  • Social Manipulation
    • Stigmatization & stereotyping (Orwell's `1984')
    • Eugenics (Hitler's `Master race')

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part iii protecting privacy
Part III: Protecting Privacy

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approaches to protecting privacy
Approaches to Protecting Privacy
  • Laissez-faire
    • Let market determine access to genetic data
      • Individuals concerned about their genetic privacy can protect it by contract
        • Enforced by breach of contract suits
    • Self-regulation
      • Adherence to industry & professional standards to promote confidence & reliability
        • Institutional Review Boards (IRB)
        • American National Standards Institute accredits orgs that develop standards for information transactions
  • Government Regulation
    • Regime of codified laws

Genetic Privacy - Manheim

privacy laws
Privacy Laws
  • Federal
  • State
  • Foreign

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privacy laws34
Privacy Laws
  • Federal
    • 1st Amendment
    • Federal Privacy Act of 1974
      • confidentiality of federal records [42 USC § 3789g]
    • HHS Medical Privacy Requirements
      • 45 CFR 164.500, et seq.
    • EEOC Guidelines on genetic discrimination

Genetic Privacy - Manheim

privacy laws35
Privacy Laws
  • Federal
    • Federal funding restrictions
      • Condtitional grants to public and private agencies requiring adherence to privacy standards
        • Health Care Financing Administration (HCFA) (in HHS)
          • 42 CFR 457.1110
      • “Common Rule”
        • Federal Policy for Protection of Human Subjects, 1991
        • All research w/ federal funds must be reviewed by Institutional Review Boards (IRB)
          • IRB Guidebook: participation must be informed & voluntary
    • Ethical, Legal & Social Implications (ELSI) program
      • HGP

Genetic Privacy - Manheim

privacy laws36
Privacy Laws
  • Federal
  • State
    • Genetic Discrimination laws (24 states)
    • Minn. Stat. § 144.335 (Access to health records)
      • a provider shall supply to a patient complete and current information possessed by that provider concerning any diagnosis, treatment and prognosis of the patient
      • a provider, or a person who receives health records from a provider, may not release a patient's health records to a person without a signed and dated consent

Genetic Privacy - Manheim

privacy laws37
Privacy Laws
  • Federal
  • State
    • Cal Gov Code § 12940 (Unlawful employment practices)
      • It shall be an unlawful employment practice … for an employer ... to subject, directly or indirectly, any employee, applicant, or other person to a test for the presence of a genetic characteristic.
    • Cal Gov Code § 10148 (Test for genetic characteristic)
      • No insurer shall require a test for the presence of a genetic characteristic for the purpose of determining insurability other than for those policies that are contingent on review or testing for other diseases or medical conditions
    • Cal Wel & Inst Code § 5328 (Confidentiality of records)

Genetic Privacy - Manheim

privacy laws38
Privacy Laws
  • Federal
  • State
  • Foreign
    • European Union Data Privacy Directive [95/46/EC]
      • member states must comply with “framework”
    • Iceland
      • Hoffman-LaRoche access to genomic database

Genetic Privacy - Manheim

other sources of regulation
Other Sources of Regulation
  • Federal funding restrictions
    • Condtitional grants to public and private agencies requiring adherence to privacy stds
      • Health Care Financing Administration (HCFA) (HHS)
        • 42 CFR 457.1110
    • Typically requiring that individuals give specific consent for research, or it meets certain criteria, such as imposing minimal risk upon the subjects.

Genetic Privacy - Manheim

concept of informed consent
Concept of Informed Consent
  • Foundation of current research regulation
  • “Informed”
    • Uninformed consent is insufficient.
    • How much understanding is required.
  • “Consent”
    • Formality.
    • Scope.
  • Opt-out provisions
  • Opt-in provisions

Genetic Privacy - Manheim

genetic privacy act
Genetic Privacy Act
  • Proposed to protect "private genetic information"
    • Any information about an identifiable individual that is derived from the presence, absence, alteration, or mutation of a gene or genes, or the presence or absence of a specific DNA marker or markers, and which has been obtained:
      • (1) from an analysis of the individual's DNA; or
      • (2) from an analysis of the DNA of a person to whom the individual is related.
    • Genesis
      • George Annas, et al, Cold Springs Harbor Lab
      • NIH/HGP - ELSI Working Group
    • Link to proposed Act

Genetic Privacy - Manheim

proposed findings
Proposed Findings
  • The Congress finds as follows:

(1) The DNA molecule contains information about one's probable medical future, and this information is written in a code that is currently being broken at a rapid pace.

(2) Genetic information has a history of being used by governments to harm individuals.

(3) Genetic information is uniquely private and personal information that should not be collected or disclosed without the individual's authorization.

(4) The improper use and disclosure of genetic information can lead to significant harm to the individual, including stigmatization and discrimination in areas such as employment, education, health care, and insurance.

Genetic Privacy - Manheim

proposed findings43
Proposed Findings
  • The Congress finds as follows:

(5) An analysis of an individual's DNA provides information not only about an individual, but also about that individual's parents, siblings and children, thus implicating family privacy.

(6) Genetic information is uniquely tied to reproductive decisions which are among the most private and intimate decisions that an individual can make.

(7) Current legal protections for medical information, tissue samples, and DNA samples are inadequate to protect genetic privacy.

(8) Uniform rules for the collection, storage and use of identifiable DNA samples and private genetic information obtained from them are needed both to protect individual privacy and to permit legitimate genetic research.

Genetic Privacy - Manheim

basic provisions of gpa
Basic Provisions of GPA
  • § 101. COLLECTION OF DNA SAMPLES

(a) REQUIREMENT OF WRITTEN AUTHORIZATION Except as otherwise provided … no person may collect or cause to be collected an individually identifiable DNA sample for genetic analysis without the written authorization of the sample source or the sample source's representative.

  • § 102. ANALYSIS OF DNA SAMPLES

(a) ANALYSIS PROHIBITED W/O AUTHORIZATION Except as otherwise provided … genetic analysis of an individually identifiable DNA sample is prohibited unless specifically authorized in writing by the sample source or the sample source's representative.

Genetic Privacy - Manheim

remedies
Remedies
  • § 171. CIVIL REMEDIES

(a) PRIVATE RIGHT OF ACTION. -- Any person whose rights under this Act have been violated may maintain a civil action for damages or equitable relief as provided [herein]

  • § 172. CIVIL PENALTIES & INJUNCTIVE RELIEF

Whenever the AG has reason to believe that any person is using or is about to use any method, act or practice in violation of the provisions of this Act, the AG may bring an action against such person to restrain … the use of such method, act or practice… If the court finds that a person has employed any method, act or practice which he knew or should have known to be in violation of this Act, the court may require such person to pay a civil penalty of not more than $50,000 for each such violation

Genetic Privacy - Manheim