Details: Bill that calls for mobile health office at FDA

By: Brian Dolan | Dec 4, 2012        

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Brian Dolan, Editor, MobiHealthNewsAs expected, Silicon Valley’s Congressman Mike Honda (D-CA) introduced a bill this week that — among other things — seeks to create an Office of Wireless Health at the Food and Drug Administration (FDA). While the bill has been talked about in the past few weeks, its specific details have only now been made public. The bill also calls for a HIPAA-focused developer support program at HHS, an X Prize-like prize program in addition to small “innovator challenge” to “stimulate new approaches”, a low interest loan program for small physician practices and clinics that want to purchase “non-EHR” health care technology, and two year grants that assist medical care providers in retraining employees on how to use health IT.

Rep. Honda proposed the bill, called Healthcare Innovation and Marketplace Technologies Act (HIMTA), Monday in the House of Representatives, so it is currently far from becoming law. In some ways the bill appears to be a mini-stimulus for digital health technologies.

“As we continue to improve our health care system, technology can and should play a prominent role in achieving better care for Americans,” Rep. Honda said in a statement. “Investments, development, and adoption of technologies remain stagnant. 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. Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry,” he continued. “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 headline-grabbing portion of the bill is that it seeks to establish an office at the FDA that specifically focuses on “wireless health” that will work with other government agencies and private companies to help the FDA Commissioner develop and maintain a “consistent, reasonable, and predictable regulatory framework” for wireless and digital health technologies. Rep. Honda’s office makes clear the bill does not aim to expand the role of the FDA, just to help it clarify and simplify existing regulations.

The secondary initiative that the bill tackles on the regulatory front is the formation of a developer support program for mobile health at the Department of Health and Human Services (HHS). The specific aim here is to help developers navigate the somewhat complicated nuances of privacy regulations like HIPAA. The support program would include a national hotline, educational website, and an annual report that translates privacy guidelines into “common English”.

While the bill aims to offer small loans to physician practices that want to adopt certain digital health technologies, it also calls for a tax deduction for practices of up to $250,000 annually but equal to the amount that practice spends on qualified health technology during the year. “Qualified health technology” is defined as: “the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, data, and knowledge for communication and decision making. Such term does not include certified EHR technology,” according to the bill.

The last part of that definition is important: Not EHRs. The small loan program has similar but different exclusions:

The small loan program is aimed at helping small practices adopt various types of information technology that focuses on patient engagement or improved workflow (and more), but does not include “information technology whose sole use is financial management, maintenance of inventory of basic supplies, or appointment scheduling.”

The program calls for upwards of $250,000 in loans to single physician practices and upwards of $500,000 in loans to group practices.

For more on the contents of the HIMTA bill, read the summary over at Rep. Honda’s site.