This February the FDA released updated guidance on mobile medical applications for the first time since 2013. This new guidance offers insight into the agency’s plans for regulating the rapidly growing number of applications that turn smartphones and tablets into health care devices. While the agency is taking a hands off approach to consumer-focused applications, such as those that track fitness levels or weight, it will continue to closely review and regulate software that transforms mobile technology into devices for diagnosis and treatment.
From the FDA’s standpoint, for example, mobile image-viewing software transforms a smartphone or tablet into a Picture Archiving and Communications Systems (PACS). The new guidance states:
“[A] mobile app that displays radiological images for diagnosis transforms the mobile platform into a class II Picture Archiving and Communications System (PACS).”1
Any mobile or web device displaying radiology images to be used by providers for diagnosis or treatment is subject to the same regulatory requirements as any Class II medical device.
Both developers and healthcare providers pay close attention to each release of FDA guidance documents for insight into how the FDA will apply its 1976 Medical Device Amendments to regulate new technology. These amendments, which update the original 1938 law that created the FDA, established the three-level classification system for medical devices. Class I devices are considered low risk and are subject to the least regulatory control. Dental floss, for example, is a Class I device. Class II devices, such as x-rays and pumps, are considered higher risk devices and Class III devices, such as replacement heart valves, are considered the highest risk devices.
In patient care settings, ensuring that technology has FDA Class II medical device clearance is critical because providers have neither the time nor expertise to interrupt their workflow to determine whether the application on their smartphone can be safely used for diagnosis, notes Ryan Minarovich, a lawyer and consultant with the Tenzing Group which specializes in regulatory compliance for digital and mobile health products.
“The FDA’s main goal is patient safety,” explains Minarovich. “Today’s physicians have so many tools and so much information at their fingertips that it’s important to guard both doctors and patients from inappropriate use.”
Kyle Hall, telehealth coordinator for Nebraska Medicine located in Omaha, NE, is careful to acquire health IT that has FDA clearance in place. “When doctors have the information they need at their fingertips, they react by diagnosing first and think about the rest later. That’s the way they are programmed,” comments Hall.
Hall also notes that when doctors are asked to list their priorities for health IT, risk mitigation is either in last place or not on the list at all. While every hospital has a risk manager whose job it is to proactively manage situations that could result in loss or liability, risk still isn’t top of mind with doctors. “It isn’t something doctors are trained to think about,” says Hall, whose strategy is to be sure applications are cleared “before providers get their hands on it.”
This approach is particularly critical as young physicians, already comfortable with using mobile technology, get access to information with mobile medical applications. “I don’t see much hesitation from younger physicians for using mobile devices in all areas of their workflow, from image-viewing to diagnosis,” explains Hall. “They just pick up these tools and run with them.”
FDA Cleared Image-Viewer
Ultimately, finding an FDA cleared image-viewer for diagnosis requires careful attention to product functionality and features. While some image-viewers are described as providing “diagnostic quality” images, no governing body or individual regulates the term and it means nothing without the FDA imprimatur. A true diagnostic image-viewer has Class II FDA clearance, a process which is lengthy and rigorous. Another important point of consideration is clearance for both web and mobile use so that providers can be using one solution across desktops, laptops, tablets and smartphones enabling them switch between devices as needed without incurring risk. “A diagnostic image viewer that isn’t FDA cleared for diagnosis, is just a viewer that can not be used for any type of treatment decision,” comments Hall.
The FDA guidance places web-based mobile applications under the same Class II clearance umbrella as a downloadable mobile applications, making them both subject to the same regulations. The agency’s definition of a “mobile application” or “mobile app” includes applications that run on a mobile platform, with or without wireless connectivity, as well as those that run on a web-based mobile platform “tailored to be executed on a server.”
1U.S. Department of Health and Human Services, Food and Drug Administration (February 9, 2015). Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff, p. 14.