“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,” — 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.
Book a live interview
 To book a live or taped interview with Nathan Cortez in the SMU News Broadcast Studio call the SMU News office at 214-768-7650 or email news@smu.edu. |
Related links
- New England Journal of Medicine, citation: “FDA Regulation of Mobile Health Technologies“
- The New England Journal of Medicine, full article: “FDA Regulation of Mobile Health Technologies“
- Nathan Cortez
- Nathan Cortez research
- Dedman School of Law
More SMU Research news
Help wanted: Principals who embrace change in wake of Race to the Top
Observed by Texas telescope: Light from huge explosion 12 billion years ago reaches Earth
Low IQ students learn to read at 1st-grade level after persistent, intensive instruction
Richest marine reptile fossil bed along Africa’s South Atlantic coast is dated at 71.5 mya
Satellite view of volcanoes finds the link between ground deformation and eruptionLiveScience reporter Bahar Gholipour interviewed Cortez for the July 25 article, “Should you trust health apps on your phone?”
EXCERPT:
By Bahar Gholipour
LiveScience
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.
SMU is a nationally ranked private university in Dallas founded 100 years ago. Today, SMU enrolls nearly 11,000 students who benefit from the academic opportunities and international reach of seven degree-granting schools. For more information see www.smu.edu.
SMU Dedman School of Law was founded in 1925 and enjoys a national and international reputation of distinction, with graduates who have distinguished themselves as global leaders in law, business and government, and as prominent members of the judiciary.
SMU has an uplink facility located on campus for live TV, radio, or online interviews. To speak with an SMU expert or book an SMU guest in the studio, call SMU News & Communications at 214-768-7650.
