New bill would create FDA mHealth office

Would not expand FDA’s regulation, but would simplify existing rules

Rep. Michael Honda (D-Calif.) has introduced a bill that would establish an Office of Wireless Health at the Food and Drug Administration in order to coordinate with other federal agencies and industry on how to develop a consistent and reasonable approach on emerging mobile health technologies.

The Healthcare Innovation and Marketplace Technologies Act, H.R. 6626, aims to encourage more innovation in health care through market incentives, challenge grants and increased workforce training, according to the lawmaker whose district includes Silicon Valley.

The bill, introduced Dec. 3, will not expand FDA’s regulation of mobile health but simplify existing rules and establish expertise within the agency, which regulates medical devices.

Honda’s bill offers other provisions, including to:

  • Start a program at the Health and Human Services Department to help mobile app developers build their devices in line with current privacy regulations. It would offer support resources, such as a national hotline, educational website and annual report that could translate privacy guidelines into everyday language.
  • Create the Disruptive Technologies Prize Program and small innovator challenge grants that encourage risk-taking and attract outside investment to try new approaches to improve quality of care, reduce costs and be market viable.
  • Develop low-interest small business loan program for physicians purchasing health IT and a tax incentive program that enables healthcare providers to deduct costs related to non-EHR health IT.
  • Establish two-year grants to assist providers in retraining their employees into new positions that use health IT.

“Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry,” said Honda in a statement. An established market for new mobile health technologies and trained workers to use them are also lacking. “This bill begins to bridge these gaps,” he said.

While innovator challenge grants are already used in HHS in partnership with industry, legislation, if it were to pass, would provide authorization by Congress. The bill must be considered by the House Energy and Commerce, Ways and Means, and Small Business Committees.