Legislative Changes

Charlie's Law (Texas HB 810)

PROVISION OF INVESTIGATIONAL STEM CELL TREATMENTS TO PATIENTS WITH CERTAIN SEVERE CHRONIC DISEASES OR TERMINAL ILLNESSES

 

(1)  "Investigational stem cell treatment" means an adult stem cell treatment that:

 (A)  is under investigation in a clinical trial and being administered to human participants in that trial; and

 (B)  has not yet been approved for general use by the United States Food and Drug Administration

 

(2)  "Severe chronic disease" means a condition, injury, or illness that:

                      (A)  may be treated;

                      (B)  is never cured or eliminated; and

                      (C)  entails significant functional impairment or severe pain.

 

(3)  "Terminal illness" means an advanced stage of a disease with an unfavorable prognosis that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.

         

The executive commissioner shall adopt rules designating the medical conditions that constitute a severe chronic disease or terminal illness for purposes of this subchapter.

Institutional Review Board Requirements

Section 1003.055 (e): “The Texas Medical Board may adopt rules regarding institutional review boards as necessary to implement this section.”

 

Data Collection is a requirement of HB 810.

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