UPDATE: California’s Crackdown on Consumer Genomics

Some Good News (Maybe) and Prof. Manson Issues Challenges to Regulators and Industry

Diane at Genealogy Insider reports:

Lea Brooks of the California Department of Public Health told me that “Genetic testing used for ancestor tracking or forensic purposes is not covered by California clinical laboratory law standards.”

That is in fact consistent with my initial reading of the regulations. However, seems to me that we’ll have to see if that’s the way the state and the state courts eventually interpret the regulations. And if the Department of Public Health takes this position, is the Department prepared to adopt an interpretive regulation to that effect?

On the other hand is the “personal genomics” industry prepared to adopt some “best practices” that may ease some of the regulators’ concerns? And would the Department of Public Health and the industry work with the Capital Center for Government Law & Policy and our health law and policy institute students and my administrative law students come August to come to a reasonable agreement about the issues? I’ll let you know.

OFF
Craig


June 2008
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