ARM 37.106.3304. DEFINITIONS

(1) "Administrator" means the person designated on the center application or by written notice to the department as the person responsible for the daily operation of the center and for the daily patient care provided in the center. (2) "Change of ownership" means the transfer of ownership of an experimental treatment center to any person or entity other than the person or entity to whom the experimental treatment center's license was issued, including the transfer of ownership to an entity that is wholly owned by the person or entity to whom the experimental treatment center's license was issued. (3) "Department" means the Department of Public Health and Human Services. (4) “Experimental treatment review board” means a board that examines and evaluates patient safety and treatment results pursuant to ARM 37.106.3316. (5) An “inpatient experimental treatment center” offers experimental treatment services to patients who are admitted to or reside at the facility for 24 hours or more. (6) “Investigational medical device” means any device, including devices with health-tracking or data monitoring functions, falling under the definition of “experimental treatment” as defined in 50-12-102(1), MCA. (7) "License" means the document issued by the department that authorizes a person or entity to provide experimental treatments in the center in which the license is issued. (8) "Licensed health care professional" means a licensed physician, physician assistant-certified, advanced practice registered nurse, or registered nurse who is practicing within the scope of the license issued by the appropriate licensing board at the Montana Department of Labor and Industry. (9) "Medical director" means a physician licensed by the Montana Board of Medical Examiners who has the responsibilities outlined in ARM 37.106.3308 and who is the head of the experimental treatment center’s Quality Assurance and Performance Improvement (QAPI) and infection control programs. (10) An “outpatient experimental treatment center” offers experimental treatment services to patients who reside there for 23 hours and 59 minutes or less per day. (11) "Practitioner" means an individual licensed by the Montana Department of Labor and Industry who has assessment, admission, and prescription authority. (12) “Qualified medical institution” means an institution that has generated documented clinical evidence supporting the safety of a medical intervention equivalent to that required for successful completion of a phase 1 clinical trial, and operates under one of the following frameworks: (a) oversight by a regulatory authority recognized by international standards; or (b) oversight by a regulatory authority that demonstrates substantially equivalent standards for data quality, monitoring, and patient protection. (13) "Treatment" means a medication, modality, product, device, or dietary supplement used to maintain well-being or to diagnose, assess, alleviate, or prevent a disability, injury, illness, disease, or other similar condition.