More Mobile Medical Apps Have FDA Approval
Over 165,000 mobile health apps are estimated to be on the market. Despite their popularity, few physicians recommend them to patients because they question their reliability and suspect many of being little more than digital snake oil. One survey suggests that only 15% of doctors encourage patients to use health apps.
The same cannot be said of mobile apps for physicians, which are used by many clinicians to accomplish a variety of clinical and practice management tasks. Eighty-six percent of healthcare professionals say that mobile apps will improve their efficiency in providing patient care, and 59% use smartphones to access medical research.
Despite the popularity of these apps, clinicians still face the challenge of separating the wheat from the chaff. The guidelines on mobile medical apps issued by the US Food and Drug Administration (FDA) can help them make an informed choice.
The agency has established a risk-based approach to regulating medical apps to ensure their safety and effectiveness.[4,5] Class I apps are deemed to be low-risk. Class II apps pose a moderate risk. Certain apps are labeled class III if they pose a high risk for harm when poorly developed.
The agency is focusing most of its attention on a subset of mobile apps that meet the regulatory definition of medical devices, which "are intended to be used as an accessory to a regulated medical device" or "transform a mobile platform into a regulated medical device."
Popular Apps Among Physicians
Apps from several companies that have met FDA standards are worth considering. AirStrip Technologies, for example, has received FDA clearance for its remote patient monitoring mobile app. The app, which is intended for professional use only, allows physicians to see patient data on bedside monitors, ECG machines, and a facility's electronic medical record (EHR) from virtually anywhere in the world, assuming a reliable wireless Internet connection is available. The mobile app lets clinicians review patients' vital signs, cardiac waveforms, labs, medications, intakes and outputs, and allergies, among other essentials.
Withings, a division of Nokia, has developed a smart body scale and a blood pressure device that are accompanied by mobile apps. Both have the FDA seal of approval, and both can be prescribed by a physician, knowing that they have met safety and effectiveness standards. These digital tools enable a patient with congestive heart failure to track dangerous changes in body weight, or alert the patient to hypertensive spikes.
WellDoc has also gained traction among physicians with a FDA-cleared mobile app called BlueStar, the first diabetes monitoring system that requires a prescription. When patients input blood glucose readings from their meter into the system, the software wirelessly sends clinicians summarized statistics and analytics to help them personalize the advice they give to patients.
But many medical apps that may meet the FDA's regulatory definition of a medical device pose little or no risk to the public. Apps that automate simple tasks for a clinician is one such category. So are mobile apps that let providers interact more easily with an EHR. Some apps help clinicians track or manage patient immunizations by assessing the need for immunization and providing a consent form and immunization lot numbers.
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Cite this: Paul Cerrato. 12 Apps That Could Help Your Practice - Medscape - Nov 08, 2017.