FDA Regulation of Mobile Medical Apps May Encourage Innovation

The FDA will only regulate the subset of medical apps that transform a mobile device into a medical device or an accessory to a regulated medical device. Examples include apps that clinicians use to manage an implanted pacemaker, and apps that turn a smartphone into an ECG machine.

Nurse and IT informaticists will need an advanced degree that supports the digitization of clinical data to lower costs and improve patient care. An online degree leverages you to support the health care industry needs. Read how the use of mobile apps have made hospitals more efficient and how they have raised concerns of how to regulate and monitor.

Patients and health care providers alike are increasing using medical apps on mobile devices like smartphones and tablets. Nurses and physicians can quickly access symptom checkers or calculate a drug dose, while patients use apps to track calories, check their heart rate during exercise, or even monitor a chronic condition like diabetes.

Yet there’s a potential downside to these mobile applications: the rapid growth of this market has increased the risk posed by apps that are not evidence-based, contain erroneous information or perform unreliably. A report published by Medscape.com in 2012 expressed the opinion that was just a matter of time before medical errors caused by malfunctioning apps emerged. As it noted, Pfizer had already “recalled” a rheumatology app used by doctors to calculate disease activity in patients with inflammatory diseases, because it was providing incorrect values. The app was removed from the market, and doctors were asked to delete it from their devices and review any medical calculations they used it for.

This past September, the Food and Drug Administration issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. The agency took a very limited, risk-based approach to its regulatory oversight – it will only regulate the subset of medical apps that transform a mobile device into a medical device or an accessory to a regulated medical device. Examples include apps that clinicians use to manage an implanted pacemaker, apps that turn a smartphone into an ECG machine, and apps that use algorithms to analyze medical images for cancerous lesions. Such apps present the greatest risk to patients if they don’t work as intended.

The FDA will not regulate apps that provide medical reference or general patient education materials, including apps that help patients manage chronic conditions like diabetes but do not provide specific treatment recommendations. Apps that allow doctors, nurses, or patients to access the EMR are also not regulated.

Rather than stifling innovation, this FDA oversight may very well serve to expand the medical app market, by adding legitimacy to apps that clinicians might otherwise avoid, due to patient safety concerns. CBS News recently reported on some of the amazing innovations that are currently in the works:

One app that has been released on the market is SpiroSmart. It uses a smartphone’s microphone to take lung measurements of breath capacity. This could help people with asthma, chronic obstructive pulmonary disease and cystic fibrosis check their stats, especially because home testing systems called spirometers can cost up to a few thousand dollars. Researchers at Seattle Children’s and the University of Washington are seeking FDA approval for the app.


Another app and device can reportedly turn a smartphone into a handheld biosensor so people can test their food for allergens. The device, which was developed at the University of Illinois at Urbana-Champaign, uses lenses and filters on a cradle mirror to detect toxins, bacteria, spot water contamination and identify allergens. The smartphone then processes the information. The additional device contains about $200 of optical parts, but may do tests as well as a $50,000 laboratory device can.

Innovative new apps sometimes come from front-line caregivers like NICU nurse Anna Wroble, who conceptualized the Baby Growth Tracker mobile app for parents of a child in the neonatal intensive care unit. Are you a tech-savvy nurse? Health care is in need of nurses who can analyze technologies from both the bedside and IT perspectives, to help create patient-centric tools. An online MSN degree in nursing informatics is the perfect way to improve your knowledge, skills, and value to your organization.