The impact of cloud computing on FDA’s regulation of medical products

Grazed from Lexology. Author: Seth A. Mailhot.

Cloud computing involves the delivery of computing as a service rather than a product. In a cloud computing solution, shared resources, software, and information are provided much like a utility, over a network to computers and other devices. Cloud computing has been embraced by the medical industry, and is used as a vital technology in electronic medical record systems and telemedicine solutions, among other products.

The U.S. Food and Drug Administration (“FDA”), which regulates the vast majority of medical products sold in the U.S., generally applies its existing regulatory scheme when facing new technologies like cloud computing. This is typified by FDA’s approach to nanotechnology that was developed in the last decade…

Cloud computing presents several challenges to FDA’s application of its existing regulatory scheme. For one, FDA, as a regulatory agency, has responsibility over medical products shipped in interstate commerce (specifically drugs, medical devices, and biologics), but lacks authority over the services provided by healthcare practitioners (i.e. “the practice of medicine”). Cloud computing involves the delivery of computing as a service rather than as a product, which complicates the analysis of how a cloud computing solution would be regulated by FDA…

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