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Mobile Medical Apps and Product Liability
As mobile medical applications (MMAs), or apps, become central to medical care, litigation is inevitable. A threshold issue in such litigation is likely to be whether or not a mobile app is, in the first instance, an MMA subject to FDA regulation. The U.S. Food and Drug Administration's (FDA's) Feb. 9, 2015, guidance, Mobile Medical Applications: Guidance for Food and Drug Administration Staff (the Guidance), provides a laundry list of mobile apps that it deems not to be MMAs, but the agency makes clear that its lists are not exhaustive and will evolve over time.
Potential Defendants
Who has potential exposure when an MMA malfunctions, causing or contributing to an injury? Look for both the MMA manufacturer and health-care provider to be named as defendants in what used to be a garden-variety medical-malpractice case. See Pam Baker, “Mobile Health Apps, Part 4: Life, Death and Lawsuits (TechNewsWorld, May 5, 2011). The Guidance defines a “mobile medical app manufacturer” as any person or entity who “initiates specifications, designs, labels, or creates a software system or applications for a regulated medical device in whole or from multiple software components.”
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