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Issues for Personalized Medicine In California’s Regulatory Environment

Issues for Personalized Medicine In California’s Regulatory Environment. Issues for Personalized Medicine In California’s Regulatory Environment. Confidentiality of Medical Information Act (CMIA) “Safe Harbor” for consented tissue and data Discrimination protections beyond GINA

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Issues for Personalized Medicine In California’s Regulatory Environment

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  1. Issues for Personalized Medicine In California’s Regulatory Environment

  2. Issues for Personalized Medicine In California’s Regulatory Environment • Confidentiality of Medical Information Act (CMIA) • “Safe Harbor” for consented tissue and data • Discrimination protections beyond GINA • State personnel certification requirements

  3. Confidential Medical Information Act • CMIA, Cal Civil Code 56 et seq, • Cumbersome • Without relevant exceptions • use and sharing of data • enable Health Information Technology • secondary use of data

  4. Safe Harbor for use of samples and consent • Current law and interpretation • Prohibits study of previously consented samples & data • Adoption of appropriate safe harbor provisions • Consent should spur research & technology advancement • Protect privacy • Allow “tracking without tracing”

  5. Discrimination Laws not broad enough • GINA prohibits discrimination • Heredity and genetic predisposition only • Fails to protect if condition is not “genetic” • California could offer broader protection • Mandate for coverage and community rating insurance

  6. Unique CA Personnel Certification Requirements • Lab testing must be by certified personnel • Significant shortfall in certified personnel • In 2001, California had 76 CLS per 100,000 • 102 nationally • CA ranked 43rd among the states • Significant shortfall of programs for certification • 2007 report CA: needed 800 new CLSs a year. • 559% increase

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