Category Archives: Medical technology
After years of deliberation, the U.S. Food and Drug Administration (FDA) has issued final guidance on the regulation of smartphone medical devices. In a nutshell, generally speaking any device used in diagnosis or treatment can’t be marketed until it’s approved by the FDA; other apps—such as calorie counters, or pedometers built into a phone—don’t need the FDA’s nod. The FDA’s criteria is how much risk an app poses for a consumer. The agency says it “intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.”
Specifically, the FDA will focus its oversight on mobile medical apps that:
- Are intended to be used as an accessory to a regulated medical device—for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet.
- Transform a mobile platform into a regulated medical device—for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine whether a patient is experiencing a heart attack.
“We have worked hard to strike the right balance, reviewing only the mobile apps that has the potential to harm consumers if they do not function properly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
While the final guidelines were only just released, FDA has cleared 100 mobile medical apps for marketing in the last few years, and 40 of those were just in the last two years.
Synim Rivers, an FDA spokesman, answered questions for NewPublicHealth about the final guidance on mobile medical apps.
May is Stroke Awareness Month, a good time to bump up the percentage of Americans who recognize the most common symptoms of a stroke from only 38 percent, according to a Centers for Disease Control and Prevention (CDC) survey. Speedily identifying stroke symptoms and calling for an ambulance is essential because people who get to an emergency room for treatment within three hours are healthier three months later than people for whom stroke care was delayed, according to the CDC.
New this year to help increase symptom awareness is a free smartphone app from the American Heart Association/American Stroke Association called F.A.S.T. The acronym stands for common stroke symptoms and a critical call to action: Face drooping; Arm weakness; Speech difficulty; and Time to call 9-1-1. The app also includes a link to additional symptoms that bystanders and caregivers can access and a 9-1-1 button to call an ambulance. Using the 9-1-1 button saves time by not having to back out of the app to dial the number manually. And using the button also generates an automatic time stamp, which gives emergency room staff a good indication of when symptoms began. Some treatments can only be given within a specific time window.
Winners of the Surgeon General’s Healthy App Challenge were announced late last week, after the challenge launched earlier this winter at the mHealth Summit. The goal of the challenge was to highlight the ability of innovative new technologies to provide health information tailored to the needs of the user, and empower the public to regularly engage in and enjoy health-promoting behaviors.
>>Read more about the value of challenges to promote innovation from HHS Chief Technology Officer, Todd Park.
"I've been delighted with the response to the challenge," said Surgeon General Regina Benjamin, MD, MPH. "The winning apps will help many Americans to have fun while getting fit and healthy."
The applications were assessed by a team of judges that included figure skater Michelle Kwan and Shellie Pfohl, Executive Director of the President’s Council on Fitness, Sports & Nutrition. Criteria used to assess the apps included:
- quality of evidence supporting the app’s approach to healthy behaviors
- ability to tailor and download personal data
- the “fun” factor
In addition, all the apps submitted for review had to be available on readily accessible platforms, free for consumer use and fully operational without the purchase of additional products.
And the winners are…