[most likely] under FDA’s jurisdiction,” — Nathan Cortez
LiveScience covered the research of SMU health law expert Nathan Cortez, an associate professor of law at Southern Methodist University’s Dedman School of Law.
In a report published in The New England Journal of Medicine, Cortez and his co-authors note that smart phones and mobile devices are on the cusp of revolutionizing health care, armed with mobile health apps capable of providing everything from cardiac measurements to sonograms.
LiveScience reporter Bahar Gholipour interviewed Cortez for the July 25 article, “Should you trust health apps on your phone?”
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By Bahar Gholipour
Personal health is becoming increasingly mobile, and there are now thousands of apps aiming to address everything from lifestyle issues to chronic diseases. But can you trust these apps, the same way you trust your prescribed drugs and medical devices?
Medical devices are generally regulated by the U.S. Food and Drug Administration, and although the FDA reviews some apps, experts say the agency’s power and efforts aren’t nearly enough to cover the 97,000 and counting health apps out there that are transforming consumer health.
“The FDA is woefully understaffed and under-resourced to oversee these things, particularly given the number of the thousands of apps that are [most likely] under FDA’s jurisdiction,” said health law expert Nathan Cortez, an associate professor of law at Southern Methodist University Dedman School of Law in Dallas, Texas.
In an editorial published in The New England Journal of Medicine on Thursday (July 24), Cortez and his colleagues argued that health and medical apps hold the promise of improving health, reducing medical errors, avoiding costly interventions, and broadening access to care. But to reach their potential, these products have to be safe and effective, they said.
A large number of health apps, such as those that help you track your exercise or the calories in your meals, likely don’t pose a concerning risk to consumers. But in more ambitious apps, such as an app to manage insulin doses for diabetic patients, any mistake, bug or misinformation could simultaneously affect thousands of patients, and emerging evidence reveals many products do not work as claimed, or the products make mistakes.
“Early studies evaluating whether these apps work or not tend to paint a pretty dim picture of them. The results aren’t that promising,” Cortez told Live Science.
Which apps need to be regulated?
In September 2013, the FDA gave its position on what types of products and technologies would fall under its jurisdiction. Currently, the agency has a pre-market review process for some apps, meaning that the app developer submits information to the agency to get the FDA’s blessing, Cortez said. The agency also sometimes takes enforcement actions by issuing a public reprimand to a company if its products violate FDA’s rules and regulations.
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