LEGISLATIVE COUNSEL'S DIGEST


SB 482, as amended, Padilla. Healing arts: medical
practice. Biological data analysis services:
regulation.
Existing law provides for the licensure and regulation of clinical
laboratories and clinical laboratory personnel by the State
Department of Public Health and makes a violation of these provisions
a misdemeanor. Under existing law, only designated health care
personnel are authorized to perform, under specified conditions,
clinical laboratory tests or examinations that are classified as
waived, moderate complexity, or high complexity under federal law.

This bill would require an entity that provides post-CLIA
bioinformatics services, as defined, to contract with a licensed
clinical laboratory to process biological specimen collection kits,
except as specified. The bill would require an entity that provides
post-CLIA bioinformatics services to employ a specified expert for
approval of the algorithms used in the interpretation of the
biological data of a customer. The bill would further impose on an
entity that provides post-CLIA bioinformatics services specified
privacy, recordkeeping, disclosure, and audit requirements, and would
impose specified duties on the State Department of Public Health in
that regard. The bill would also subject those entities to specified
provisions of existing law prohibiting unearned rebates, refunds, and
discounts, a violation of which constitutes a crime. Because the
bill would expand the scope of a crime, the bill would impose a
state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Under existing law, the Medical Practice Act, the Medical Board of
California licenses and regulates physicians and surgeons.

This bill would make a nonsubstantive change to one of those
provisions.

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Comments/questions on SB 482 (Padilla): Biological data analysis services: regulation.