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- Arizona Pathologists Protect Scope of Practice
The Arizona Society of Pathology (ASP) and the CAP successfully protected pathologists’ scope of practice by advocating to amend state legislation regulating non-medical testing. Arizona Gov. Doug Ducey signed the amended legislation on April 20. The CAP works with state pathology societies to protect pathologists and laboratories from increased regulatory burdens.
The CAP coordinated with the ASP, industry partners, and direct-to-consumer genetic testing companies to include favorable language exempting “biological samples that are obtained or genetic data that for the purposes of an individual’s medical screening, treatment or diagnosis.”
The final amended bill was primarily based on the Coalition for Genetic Data Protection (CGDP)’s model legislation after collaborative efforts between stakeholders. The legislation mandated that non-CLIA regulated, direct-to-consumer genetic testing companies must provide clear information and require consent from consumers on the collection, use, and disclosure of genetic data.
Additionally, the newly enacted law includes comprehensive consent requirements that comply with federal policy to protect human research subjects. The law also provides enhanced security program features to prevent unauthorized access, use, or disclosure of genetic data. The new law also contains the CAP’s original amendment to ensure the mandate designating genetic testing as the exclusive property of the person tested does not apply to the federal health insurance portability and accountability act of 1996. With the strong advocacy of the ASP and CAP, Arizona pathologist’s scope of practice was preserved and increased consumer safety in non-regulated medical tests.