Rep. Marsha Blackburn (R-Tenn.), vice chair of the House Energy and Commerce Committee, plans to introduce a bill to Congress regarding health-related mobile apps, according to a report this week from The Hill's Hillicon Valley technology blog.
The bill, which has been in draft form for about a month, "will provide the [U.S. Food and Drug Administration] with the tools it needs to effectively protect consumers from the high-risk technologies" without subjecting lower-risk technologies to unnecessary oversight, Blackburn said at a Telecommunications Industry Association event this week, according to the post.
As a result, lower-risk technologies can "continue to be innovated upon without being caught in that massive web of expense and time that is the FDA approval process," she said. She added that her bill "will encourage the development of new technologies to improve healthcare ... and create new jobs."
A comment posted in response to the blog post questioned the need for Blackburn's bill, given the fact that the FDA, last month, issued its final guidance on mobile medical applications; the guidance emphasizes that the regulatory agency will focus on a "small subset" of the app market and only those apps that present the greatest risk to patients. "Another Congressman out to lunch?" the comment said.
However, Blackburn's proposed legislative action fits with her stated public position that the FDA, in its regulation of mobile medical apps, must be subservient to the will of Congress. In a March hearing, Blackburn told the Subcommittee on Health: "I don't think it's up to the FDA to provide that certainty" in clarifying its position on certain types of low-risk devices, but rather "it's up to Congress to decide what FDA's role should be."
In April 2012, Blackburn and five other Republican House members sent a letter to the FDA and the Federal Communications Commission expressing their concern that the "complex regulatory framework" between the various agencies could "inhibit future growth and innovation in the market, and could preclude tools that help patients better manage their care," and allow healthcare providers to reduce costs.
To learn more:
- read the post