Privacy Groups Challenge Calif. Bill
A California bill seeking to create a new regulatory framework for consumer genomics firms that interpret genomic data but do not analyze samples at an in-house laboratory has raised red flags within the personalized medicine community and among privacy advocates.
California state Senator Alex Padilla (D-San Fernando Valley) earlier this year introduced SB 482, a bill that would amend the California Business and Professions Code to distinguish so-called “post-CLIA bioinformatics services” from entities providing laboratory services.
The bill, amended on April 14 and sponsored by California-based 23andMe, would exempt such business from certain requirements that clinical laboratory service providers have to meet under the Clinical Laboratory Improvement Amendment. However, the bill does define regulations specifically for “post-CLIA bioinformatics services,” such as algorithm approval processes, and requires that such services use a licensed clinical laboratory.[…]
… the American Civil Liberties Union and several other privacy groups do not agree that the bill protects patient privacy, and have sent letters to Padilla recommending more stringent privacy provisions and requirements ensuring the accuracy of data analysis.
Read more on genomeweb.