Legislation to call for creation of FDA Office of Mobile Health

Rep. Mike Honda (D-Calif.), a member of the House Appropriations and Budget Committees, is expected to introduce a bill this month that would establish a special Office of Mobile Health at the Food and Drug Administration to provide recommendations on mobile health application issues, according to a Sept. 26 Kaiser Health News article.

The Healthcare Innovation and Marketplace Technologies Act (HIMTA) also would create a mobile health developer support program at the U.S. Department of Health & Human Services to ensure that application developers are in compliance with privacy regulations such as HIPAA.

Honda's congressional district includes Silicon Valley, which is driving the development of the tens of thousands of mobile health applications that are available for download on smartphones and tablets. The congressman believes that his proposed legislation would help to streamline the regulatory process for technology companies looking to bring mobile health apps to market.

"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," Honda said in a statement, which was not available on Honda's website. "Why have the principles of Silicon Valley, which I represent--competition, innovation, and entrepreneurship--not fully manifested themselves in the healthcare information technology space? This bill gets us closer to that space."

The FDA is the agency charged with regulating mobile health apps. In July 2011, the FDA released a first draft of guidelines requiring application developers making medical claims to apply for agency approval.

Although final regulations have not yet been released, critics of the FDA are skeptical that the agency will be able to keep pace with the tech industry's rapid development of mobile health apps. They point out, for example, that it takes six to 20 months for the approval of medical devices, which are similarly regulated.

Joel White, executive director of the Health IT Now Coalition--which includes Intel, Medco, Verizon, Aetna and the U.S. Chamber of Commerce--would rather see the federal government create a new agency to regulate mobile health that bypasses FDA's cumbersome process.

Signed into law in July, the FDA Safety and Innovation Act creates a multi-agency commission to propose a strategy for regulating mobile health apps. The problem is that the commission's report is not due for another 16 months, which will be long after the FDA is expected to release its final regulation.

To learn more:
- read the Kaiser Health News article