Transcript Pfizer International Collaboration Issues

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
 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