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Genetic Databases & Privacy

Genetic Databases & Privacy

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Genetic Databases & Privacy

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  1. Genetic Databases & Privacy Law 134: Law & Technology May 15, 2001 Karl Manheim Genetic Privacy - Manheim

  2. 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

  3. Part I: Genetic Privacy Genetic Privacy - Manheim

  4. 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

  5. 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

  6. 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

  7. 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

  8. Bionformatics and Privacy Genetic Privacy - Manheim

  9. 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

  10. Competing Theories of Privacy • Consequential (outcome-based) • Utilitarianism • Deontological (rule-based) • Social Contract • Duty Ethics Genetic Privacy - Manheim

  11. 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

  12. 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

  13. 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 Genetic Privacy - Manheim

  14. Outcome of Different Theories Genetic Privacy - Manheim

  15. Part II: Genetic Databases Genetic Privacy - Manheim

  16. Genetic Databases Generally • Identifiable Data • Non-Identifiable Data Genetic Privacy - Manheim

  17. 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

  18. 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

  19. Individually Indentifiable Databases • Medical Records • DNA Banks • DNA Databanks Genetic Privacy - Manheim

  20. Types of Genetic Databases • Medical Records • Every physician and hospital keeps records on patients, diagnoses, treatments Genetic Privacy - Manheim

  21. 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

  22. 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

  23. 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

  24. Uses & Misuses of Genetic Data • Diagnosis & Prevention • Research • Identification • Employment • Risk Rating • Social Manipulation Genetic Privacy - Manheim

  25. 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 Genetic Privacy - Manheim

  26. 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 Genetic Privacy - Manheim

  27. Uses & Misuses of Genetic Data • Diagnosis & Prevention • Research • Identification • Criminal law • In/exculpatory DNA evidence • Family law • Dis/proving paternity • Military & forensics • Victim identification Genetic Privacy - Manheim

  28. Uses & Misuses of Genetic Data • Diagnosis & Prevention • Research • Identification • Employment • Discrimination in hiring • Ex: • Genotype (phenotype) discrimination long-practiced • Sex discirmination Genetic Privacy - Manheim

  29. 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

  30. 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') Genetic Privacy - Manheim

  31. Part III: Protecting Privacy Genetic Privacy - Manheim

  32. 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

  33. Privacy Laws • Federal • State • Foreign Genetic Privacy - Manheim

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. Genetic Privacy - Manheim