SB 512: Health care practitioners: stem cell therapy.

Existing law provides for the licensure and regulation of various health care practitioners by boards and agencies within the Department of Consumer Affairs. Existing law requires a health care practitioner, as defined, to communicate to a patient his or her name, state-granted practitioner license type, and highest level of academic degree, in a specified manner.

This bill would require a licensed health care practitioner who performs a stem cell therapy that is not approved by the United States Food and Drug Administration (FDA) to communicate to his or her patient seeking stem cell therapy specified information regarding the provision of stem cell therapies on a specified notice in a prominent display in an area visible to patients in his or her office, posted conspicuously in the entrance of his or her office, and provided in writing to the patient prior to providing the initial stem cell therapy. The bill would not apply to a health care practitioner who has obtained approval for an investigational new drug or device from the FDA for the use of human cells, tissues, or cellular or tissue-based products. The bill would authorize the licensing board having jurisdiction of the health care practitioner to cite and fine the health care practitioner, not to exceed $1,000 per violation, as specified. The bill would require the Medical Board of California to indicate specific enforcement information in its annual report, commencing with the 201819 annual report, with regard to its licensees who provide stem cell therapies.