DSHS: Investigational Stem Cell Treatment Rules Stakeholder Meeting

Regulatory
April 9, 2018
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Overview of House Bill 810 and Rule Development Process. The Department of State Health Services (DSHS) held a stakeholder meeting to accept comments as the agency develops rules to designate medical conditions that constitute a severe chronic disease or terminal illness for the purpose of access and use of an investigational stem cell treatment. House Bill 810, 85th Legislature, Regular Session, 2017, charged the Health and Human Services Commission (HHSC) with the responsibility of designating the medical conditions for which the provisions of the bill apply. Additionally, HHSC may adopt a form to document the patient’s informed consent to investigational stem cell treatment. HHSC has delegated to DSHS responsibility for developing the rules required by House Bill 810. At this time, the United States Food and Drug Administration (FDA) has an exemption that allows terminally ill patients, with their doctors' approval and after meeting certain criteria, access to unapproved drugs

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