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American Journal of Medical Quality, Vol. 23, No. 3, 208-214 (2008)
DOI: 10.1177/1062860608315123

Caveat Emptor: The Need for Evidence, Regulation, and Certification of Home Telehealth Systems for the Management of Chronic Conditions

Bonne Farberow, BSN, RN, CCRA, CCRP

University of Pennsylvania, Division of Heart Failure/Transplant, Philadelphia, Pennsylvania

Valerie Hatton, RN, BSN, CCRP

University of Pennsylvania, Division of Heart Failure/Transplant, Philadelphia, Pennsylvania

Cindy Leenknecht, MS, APRN, BC, CCRP

Health Telemedicine Network St Vincent Healthcare, Billings, Montana

Lee R. Goldberg, MD, MPH

Heart Failure/ Transplant Ambulatory Care Center and Heart Failure/Transplant Program, Philadelphia, Pennsylvania

Carlton A. Hornung, PHD, MPH

Department of Epidemiology and Population Health, and director of Education, Clinical and Translational Science Institute, University of Louisville, Kentucky

Bernardo Reyes, MD, CPI

Charleston Area Medical Center Health Education and Research Institute, Charleston, West Virginia, bernardo.reyes{at}camc.org

The home telehealth market is rapidly expanding. The technology and capabilities currently available have the potential to significantly affect the clinical management of an aging population, particularly, the large number with multiple coexisting disease processes. Potential benefits of home-monitoring systems for patients with heart failure range from decreased rates of mortality and improved quality of life to providing third party payers, including the federal government (ie, Centers for Medicare and Medicaid Services), with significant long-term cost savings. The current regulatory process does not provide adequate oversight and standards for these systems that transmit and process data (telehealth systems) critical for patient management. Home telehealth vendors must address the possibility that increased utilization increases their risk of liability due to patient safety issues. In all, 5 major areas need to be addressed to maximize the benefits and safety of this technology: effectiveness of patient management; evidence-based outcomes; regulation; cost, including cost effectiveness and reimbursement; and certification to ensure reliability. (Am J Med Qual 2008;23:208-214)

Key Words: home monitoring devices • home telemedicine • device reliability and safety • FDA device approval • telehealth • safety • regulation


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