Office of Mobile Health to Speed Up Medical App Approval
- By BSTQ Staff
The U.S. House of Representatives has introduced a bill that intends to clarify and shorten the U.S. Food and Drug Administration’s (FDA’s) assessment process of mobile health apps. The Healthcare Innovation and Marketplace Technologies Act (HIMTA) would form a unique Office of Mobile Health at the FDA to give suggestions on mobile health app issues. The act also would create a mobile health app developer support program at the U.S. Department of Health and Human Services to help ensure that app developers are operating within privacy regulations.
In 2011, the FDA began regulating a small number of medical apps and released a first draft of guidelines that require mobile health app developers making medical claims apply for FDA approval. But because the FDA is taking between six and 20 months to approve other medical devices, medical app developers are concerned that the approval process for their apps will be delayed.
By 2015, 500 million smartphone users are expected to employ mobile medical apps to do everything from track illness and weight to logging a healthier diet and exercise routine. With the HIMTA bill, it is hoped that the new Office of Mobile Health will be able to keep up with an ever-growing sector of mobile health.
