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Allowing Fda Regulation Of Communications Software Used In Telemedicine: A Potentially Fatal Misdiagnosis?, Ann K. Schooley

Federal Communications Law Journal

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 …