Issues for Personalized Medicine In Californias Regulatory Environment

Confidentiality of Medical Information Act (CMIA) Safe Harbor for consented tissue and data Discrimination protections beyond GINA State personnel certification requirements

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

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

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

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