FDA Regulations Require Approval of Medical Apps Prior to Release

A recent article published by Kaiser Health News in USA Today reported the presence of approximately 40,000 medical apps available for download on a smartphone or tablet. The Food and Drug Administration (FDA) is in the process of creating regulations for medical apps developers, in the same way creators of medical devices must adhere to regulations.

The FDA began creating a first draft of regulations last year; it requires developers to apply for approval to confirm their app is both safe and effective. For app creators, the regulations threaten to reduce the freedom and flexibility that comes with the modern tech industry. According to Joel White, the executive director of the Health IT Now Coalition, "The FDA's current regulatory process was created when the floppy disk was around.” 

White claims that the FDA can take up to 20 months to approve a new product, a time period that he feels would put a delay on tech device innovation. Alain Labrique, director of mobile health at John Hopkins University, agrees that the turnover period for app approval is lengthy, but feels it is necessary to ensure customer safety. Developers of health apps stated that they agree with the FDA regulations, but also feel that the approval process doesn’t fit the rapidly changing industry.

According to Orrin Franko, an orthopedic surgery resident at the University of California San Diego, the regulations will help to sort out the medically accurate apps from those that aren’t (e.g., healthy eating apps shouldn’t be considered for approval unless they contain medical claims). While the FDA continues to develop its regulations, doctors like Franko are trying to determine which of the available apps are useful in making medical decisions.

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