Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article on the FDA’s possible oversight of health information technology (HIT).
The article, “FDA Discusses Oversight, Regulation of HIT At ONC Workgroup Hearing on Patient Safety,” reported that in testimony, Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said that under the Federal Food, Drug, and Cosmetic Act, health information technology software is a “medical device.”
Thompson said that the FDA official’s position on health IT being a regulated device “has enormous potential” impact on the industry. The regulatory impact could be felt on the health IT software itself and on items used in tandem with the regulated product.
Shuren’s comments will start a dialogue with industry, Thompson said, before any formal regulatory decisions are made. “This cannot be done quickly” due to the magnitude of the potential impact on industry, he added.