On March 18, a bipartisan group of senators sent a letter to FDA Commissioner Margaret Hamburg urging greater regulatory transparency for mobile medical applications (apps) in order "to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated." The letter expresses support for the FDA's "risk-based approach" to defining mobile apps, but requests clarification of other aspects, including whether minor software updates require FDA review and how FDA determines whether to regulate novel functions not previously classified by the agency.
Although FDA has authority to regulate mobile apps, the agency has not issued final guidance on how it will regulate apps. A recent article in the Journal of the American Medical Association argues that, in the absence of FDA activity, private entities should develop independent certification and review processes to give assurance to health care providers prescribing these apps. Most reviews of mobile apps by outside organizations "have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security." However, other types of health software have undergone evidence-based reviews, and the article notes these could serve as a model for testing mobile apps.
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