FDA mulls the role of screening apps, devices

By: Brian Dolan | Mar 20, 2012        

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Brian Dolan, Editor, MobiHealthNewsThis week the US Food and Drug Administration (FDA) is holding a hearing about using innovative technologies and other mechanisms to expand the number of medications that can administered over the counter. A report in the San Diego Union Tribune recognizes that some of the innovations that the FDA has in mind are mobile health apps and devices.

“FDA is aware that industry is developing new technologies that consumers could use to self-screen for a particular disease or condition and determine whether a particular medication is appropriate for them,” the agency wrote in the Federal Register last month. “For example, kiosks or other technological aids in pharmacies or on the Internet could lead consumers through an algorithm for a particular drug product. Such an algorithm could consist of a series of questions that help consumers properly self-diagnose certain medical conditions, or determine whether specific medication warnings contraindicate their use of a drug product.”

Last year the FDA listed a number of example mobile medical apps that were diagnostic in intent, for example:

> Apps that connect to a home use diagnostic medical device such as a blood pressure meter, body composition analyzer, or blood glucose meter to collect historical data or to receive, transmit, store, analyze, and display measurements from connected devices.

> Apps that use the built-in accelerometer or other similar sensors in a mobile platform to monitor the user’s movement to determine conditions such as sleep apnea, sleep phase, fall detection, or detect motion related to other conditions or diseases or to measure heart rate.

> Apps that use a mobile platform to record response time and accuracy of patients completing a cognitive task and/or automatically score or interpret cognitive testing results.

> Apps that use a mobile platform to upload electroencephalograph (EEG) recordings and automatically detect seizures.

These are just a few of the mobile medical apps that the FDA outlined in its proposed guidelines for medical app regulation last year. There are many more examples of new diagnostic apps and devices.

According to the Federal Register posting, the FDA is considering OTC status under certain conditions for drugs that treat: asthma, diabetes, high blood pressure, high cholesterol, and migraines. Which apps might be used by pharmacists to make these OTC recommendations? Which mobile health screening apps might be safe for patients to use at home to determine a need for OTC meds or other treatments?

These questions should lead to an interesting discussion this Thursday and Friday at the FDA.

Importantly, here’s the core reason for this discussion, based on the FDA’s notice in the Federal Register: “Eliminating or reducing the number of routine visits could free up prescribers to spend time with more seriously ill patients, reduce the burdens on the already overburdened health care system, and reduce health care costs.”

  • https://identify.us.com IdentifyUS

    Mobile apps hold great potential for improving various facets of the healthcare process, however, as with any great upside potential there’s also the downside risk that a few bad apples will spoil things for others. Let’s hope for a balanced, coordinated and well thought-out approach to how such apps are evaluated and judged. At first blush, it seems the term “diagnostic” will likely become the crux of the matter. Clearly we want to provide people with new technology that enables them to do more for themselves and at less cost without over-legislating protection to the detriment of innovation. Yet we don’t want to see consumer nightmares either where people are taken advantage of either financially or via some modern, updated form of snake-oil salesman. Can the market decide this on it’s own?

  • HoyaZoya

    Thanks for this helpful information.   By any chance do you know if the hearings will be recorded, and when the transcription will be available online?