50 Federal Communications Law Journal 731 (1998)
Communications technology is changing and improving the way that health care services are delivered to patients. Telemedicine, or the use of communications technology to provide medical care, allows doctors to treat patients in rural areas who otherwise would not have access to medical services. With the development and use of telemedicine, however, comes the burden of government regulation. The Food and Drug Administration (FDA) is just beginning to assert its jurisdiction over telemedicine, seeking to regulate telemedicine systems as medical devices under 21 U.S.C. § 321(h). Should the FDA strongly assert its jurisdiction, it has the ability to regulate entire telemedicine systems, including all of the communications technology used in such systems. Potential regulation by the FDA poses serious problems for the telecommunications industry, and may have a deleterious effect in the research and use of telemedicine. The jurisdiction of the FDA to regulate communications technology used in telemedicine should be limited in order to encourage the widespread development of telemedicine.
Schooley, Ann K.
"Allowing FDA Regulation of Communications Software Used in Telemedicine: A Potentially Fatal Misdiagnosis?,"
Federal Communications Law Journal:
3, Article 10.
Available at: http://www.repository.law.indiana.edu/fclj/vol50/iss3/10