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The FDA and Mobile Medical Apps – Who’s Regulated? Who’s Not?

With almost 100,000 health related mobile apps (free and fee based) available from popular app stores, patient-consumers have access to information about monitoring vital signs, tracking exercise and caloric intake, and information about drug interaction and contraindications.

Physicians and technicians share real-time images from CT scans and monitor heart rhythms to diagnose and treat patients remotely. Emergency room intake staff and triage nurses use medical translation apps to overcome language barriers.

As consumers and medical professionals move toward increased dependence on mobile technology to manage health and wellness the Food and Drug Administration (FDA) is stepping up oversight on some medical apps. In a September 23, 2013 press release the FDA provides information about which applications are subject to strict review and oversight and which will remain informational only.

According to the press release, the majority of medical and health related apps available today will not require agency review. The main objective for the agency is to reduce the potential for harm, not limit technological innovation that helps consumers manage their health and medical providers deliver high-quality health care.

Medical apps are regulated with the same set of criteria as medical devices. Manufacturers that develop, build, market and distribute applications advertised and represented as a component or accessory to a medical device or as software that solely operates or transforms a mobile platform into a medical device (i.e. a smart phone or tablet) are the primary entities subject to FDA regulation and recommendations.

In simplistic terms, applications that work with medical devices designed to assist physicians make diagnostic and treatment decisions are subject to review and regulations. Apps designed to work with medical devices, such as insulin pumps and imaging technology, are included in the FDA review process. An application that converts a smart phone to an EEG or ECG machine are also subject to the guidelines that regulate all medical devices.

The FDA guidelines allow for discretionary enforcement. Consumers will not see any change to the way that apps with low risk factors are developed and marketed. Applications that pose limited potential for harm if they fail, provide inaccurate information or otherwise do not meet expectations will not be reviewed or closely monitored.

Pharmacists may see an increase in questions about medical applications from customers. Emerging technology and cloud based medical software are changing the relationship between neighborhood pharmacists and their customers.

Conversations that once focused primarily on drug side effects and interactions now include discussions surrounding mobile devices and apps. Insulin dependent diabetics may ask about applications that work with their insulin pumps and glucose meters or applications related to calculating insulin doses and food choices. Pregnant clients may ask about apps that work with perinatal activity and blood pressure monitors.