DE SB38

Allows terminally ill patients with a prognosis of death within 12 months to access investigational drugs, biological products, or devices that have completed Phase One clinical trials but lack FDA approval.

Requires eligible patients to obtain written informed consent signed by treating physician and a witness, disclosing approved treatments, potential outcomes, insurance coverage limitations, and patient liability for all expenses.

Prohibits state agencies and regulatory boards from revoking or taking action against physicians' licenses based solely on recommending or prescribing investigational treatments to eligible patients.

Provides liability protection for manufacturers, distributors, prescribers, and administrators of investigational drugs or devices except in cases of gross negligence or willful misconduct.

Does not obligate manufacturers to provide investigational drugs or devices or require health insurance providers to cover costs associated with their use.