The many benefits that technology – and particularly information technology – provides to other industries has yet to be realized in healthcare, although it is the popular belief that the adoption and use of Healthcare Information Technology (HIT) will have a large positive effect on the clinical outcomes and the economy. Recent legislation has attempted to embrace HIT. For example, the Health Information and Technology for Economic and Clinical Health (HITECH) Act and the Affordable Care Act (ACA) both include financial incentives through Medicaid and Medicare for implementing HIT. One side effect of new legislation has been the increased interest in developing new technologies such mobile medical apps, devices regulated by the FDA. In fact it is estimated that by 2015, 500 million smartphone users will be using mobile medical apps, and by 2018, approximately 50 percent of users will have downloaded some form of a mobile health application.
Unfortunately, the regulatory landscape for mobile medical apps is still not well defined. It is clear that mobile medical apps fall under the jurisdiction of the FDA, but the FDA is still working out how it will enforce its regulatory authority. Last year, CDRH attempted to clarify their stance on medical mobile apps by issuing a guidance called “Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff.” However, FDA is still publishing information on their website to further fine tune their stance.
If you are a stakeholder in mobile medical apps, the guidance is worth a read. It clarifies where FDA gets their authority to regulate mobile medical apps, and what is considered a mobile medical app. In addition, there are numerous mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and customers. For these devices FDA exercises “enforcement discretion.” In other words, FDA will not regulate the device but may choose to do so in the future – read about the changes in LDT regulations in “New LDT Regulations on the Horizon.”
If you want to find more information on mobile medical apps, visit http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm255978.htm or contact one of our knowledge consultants at the KAS Group.
Posted by Spencer Kimber