Compliance Considerations for Entities Providing Hybrid Clinical Trial Services

• Published in: Journal of Health Care Compliance 2022-03, Vol.24 (2), p.23-30
• Main Author: Faget, Kyle Y
• Format: Article
• Language: English
• Subjects: Associations; Capital stock; Clinical trials; Coronaviruses; COVID-19; Licenses; Medical education; Medical research; Medicine; Physicians; Professionals; Professions; State laws; Stockholders; Telemedicine
• ISSN: 1520-8303

Not surprisingly, institutions began implementing telehealth into clinical trials. Since the beginning of COVID-19, clinical trials have been leveraging the powerful tool of telehealth, which promises to effectively blow the doors off of the geographic barriers that have long plagued clinical trial enrollment. The physician on a full-time basis is engaged in diagnosing, treating or offering to treat any mental or physical disease or disorder or any physical deformity or injury or performing such actions with respect to individual patients for compensation and shall include clinical medical research, the practice of clinical investigative medicine, the supervision and training of medical students or residents in a teaching facility or program approved by the Liaison Committee on Medical Education of the American Medical Association, the American Osteopathic Association or the Accreditation Council for Graduate Medical Education, and professional managerial, administrative, or supervisory activities related to the practice of medicine or the delivery of health care services. Texas, therefore, explicitly includes "clinical medical research" in its definition of the practice of medicine, as well as "professional managerial, administrative, or supervisory activities related to the practice of medicine or the delivery of health care services." Code 165.156 states that a "person, partnership, trust, association, or corporation commits an offense if the person, partnership, trust, association, or corporation, through the use of any letters, words, or terms affixed on stationery or on advertisements, or in any other manner," indicates that such person, corporation, or other entity is entitled to practice medicine if such person or entity is not licensed to do so.2 Arizona case law generally prohibits corporations and other non-professional business entities from employing health care practitioners to render professional services.3 Arizona Title 32, ch. 13, Art. 1 defines a "Doctor of Medicine" as a "natural person holding a license, registration or permit to practice medicine pursuant to this chapter.