Many smartphone apps that contend they address hypertension make medical claims without clinical validation or FDA approval, according to a study in the Journal of the American Society of Hypertension.
“There is an urgent need for greater regulation and oversight in medical app development,” the authors conclude. “High quality, adequately powered randomized controlled trials are needed to evaluate the effectiveness of mobile-health interventions on clinical outcomes in hypertension.”
Fourteen percent of the top 107 hypertension apps in the Google Android store make medical device claims, for example, by using the smartphone's camera to measure blood pressure, the authors found.
Dr. Nilay Kumar of the Cambridge (Mass.) Health Alliance is the lead author of the study, A Content Analysis of Smartphone-Based Applications for Hypertension Management.
While preliminary studies show that cuffless methods of measuring blood pressure are potentially valid, the apps surveyed by the co-authors do not attempt to validate the blood pressure measurements against a gold standard, the authors contend.
Those medical device apps have been downloaded up to 2.4 million times, and a minimum of 900,000 times, the authors found. Having a medical device function is a significant predictor of more positive reviews, according to the authors' statistical analysis.
This study is not the first to raise concerns about smartphone apps making strong medical claims. An April 2013 study in JAMA Dermatology reviewed four apps that claimed to be able to diagnose melanoma by using statistical techniques to analyze pictures of a patients' skin. Reviewers used 188 pictures of lesions, with 60 pictures of cancerous lesions, and 128 benign control pictures.
Performance was weak. Sensitivity of the four apps ranged from 6.8% to 98.1%, and specificity from 30.4% to 93.7%.
A September 2013 guidance concerning mobile medical applications, and the development of a framework detailing how FDA, ONC and FCC would approach the health IT sector are aimed at addressing the issue of regulating such apps. The administration released a draft framework in spring 2014, but it's unclear when that effort will be completed.
FDA enforcement actions against apps making medical claims have been infrequent. The agency took action against an app, uChek, which claimed to be able to perform urinalysis. But the app had not received clearance to perform some of its tasks, such as glucose levels. The agency's original action against the app developer, Biosense Technologies, came in 2013, but the agency has continued to pursue the developer, with the most recent enforcement letter coming in June 2014.
The agency did not comment on the study in the Journal of the American Society of Hypertension.
Follow Darius Tahir on Twitter: @dariustahir