You know all that debate that’s been simmering for a while now about how the U.S. Food and Drug Administration should regulate mobile health and what that might look like? Congressman Mike Honda, a Democrat from California whose 15th Congressional District includes the Silicon Valley, is taking the initiative with a new bill that seeks to introduce standards and simplify existing regulations.
It wouldn’t include electronic medical records, but it would provide a sense of order in a sector commonly referred to as the Wild West in reference to its lack of uniform regulation.
“Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry,” Honda said in a statement. “There is also a lack of an established marketplace for new technologies and a lack of trained workers to handle the implementation and use of these technologies. This bill begins to bridge these gaps.”
The Healthcare Innovation & Marketplace Technologies Act seeks to accomplish a few things:
- Create an Office of Wireless Health at the FDA that would provide a “consistent, reasonable and predictable regulatory framework on wireless health issues.”
- Create a tax incentive program to allow providers to deduct costs related to non-EHR healthcare information technology.
- Familiarize healthcare staff with the technology using two-year training grants.
- Stimulate innovation by identifying three areas of health IT that don’t have “enough” innovation and creating an innovation challenge like the X-Prize Foundation competition for private-manned space flight.
- To address privacy concerns, it would set up an mhealth developer support program at the Department of Health and Human Services to help mobile application developers build their devices to agree with current privacy regulations.
But is it a case of too little, too late, or better late than never? That depends on your perspective. Research scientists and physicians who advocate submitting even noninvasive apps to studies to ensure their safety and efficacy should welcome the proposal. Those in support of self-regulation, or at least an industry-adopted certification program defining criteria that makes a good app or mobile device tool like the program under development at Happtique, would welcome several aspects of a proposal like the tax incentive, training and innovation challenge. But they might be a bit more tempered in their response to the rest of it.
It will be interesting to see how the legislation evolves over the coming months and the kind of debate it sparks. I think the deficit concerns could diminish the training grants and money for an innovation challenge. The issue of data privacy and ownership came up a lot at the mHealth Summit in Washington, D.C. this week and is likely to generate a lot more discussion going forward.