Emerging mobile health technologies need FDA oversight

Smart phones and other mobile devices have the potential to transform healthcare, improving medical outcomes, reducing errors, and broadening access to healthcare. The Food and Drug Administration must continue to have jurisdiction over these “mobile health” or “mHealth” innovations to address emerging risks, according to I. Glenn Cohen, Nathan G. Cortez, and Aaron S. Kesselheim, writing in the New England Journal of Medicine.

In their July 24, 2014 article, these authors argue that new mHealth apps have tremendous potential, and are already being used effectively to, among other things, help diabetics track insulin doses with mobile phones; record electrocardiograms; provide medication reminders; and check symptoms.

Although some have argued that FDA regulation of mHealth apps will inhibit growth and innovation, Cohen, Cortez and Kesselheim assert that FDA oversight is essential. “Increasing reliance on mHealth raises questions about compromised patient privacy, the cross-jurisdictional practice of medicine, and legal liability for injuries,” they write. Mistakes with an mHealth app might affect thousands of patients at a time without mechanisms for detection and correction.

The article is called “FDA Regulation of Mobile Health Technologies.” It is available here: http://www.nejm.org/doi/full/10.1056/NEJMhle1403384

The paper stemmed from a Radcliffe Exploratory Seminar on Mobile Health.

Cohen is professor of law at Harvard Law School and faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics. He is the author most recently of “Human Subjects Research Regulation: Perspectives on the Future” (MIT Press, 2014). Cortez is associate dean for research and associate professor of law at SMU Dedman School of Law. Kesselheim is associate professor of medicine, Brigham and Women’s Hospital and Harvard Medical School.

Cohen also authored an article this week in the Journal of the American Medical Association calling for an end to the lifetime ban on blood donation by men who have sex with men (MSMs). Cohen, along with Jeremy Feigenbaum, wrote, “the current FDA policy may be perpetuating outdated homophobic perceptions. Even though well intentioned and guided by a need to protect the integrity of the national blood supply, a policy that demands permanent deferrals for sexually active MSMs raises the specter of exclusion, stigmatization, and marginalization. Given the discerning capability of contemporary behavioral assessments and the ever-improving sensitivity of modern diagnostic technology, the disproportionate share of HIV cases among sexually active MSMs can no longer support the current restrictive policy of the FDA.”

The full article is available here: http://jama.jamanetwork.com/article.aspx?articleid=1889152