A legislative showdown is brewing between Congress and the U.S. Food and Drug Administration over the right balance between promoting innovation in a fledgling mobile health industry and protecting patient safety. 2014 could be the year that several laws are passed with significant implications for health I.T., according to a HIMSS14 panel discussion on congressional affairs.
"You have the FDA rule that came out in 2013 which basically said they will regulate mobile apps as a medical device if they see fit. So, that is a cause for some concern," said Mitchell Vakerics, Legislative Counsel for Congresswoman Renee Ellmers (R-N.C.), who sits on the House Energy and Commerce Committee where she serves on the Health, Communications and Technology Subcommittee.
"What we don't want is the FDA to go too far, stifle an industry and over-regulate it," Vakerics added. "We're talking about a 1970s law that they're working with."
In late October, a bipartisan bill called the SOFTWARE Act was introduced in the House of Representatives to amend the Federal Food, Drug, and Cosmetic Act and to limit the FDA's regulatory authority over mobile medical apps. Earlier this month, a companion bill--the PROTECT Act--was introduced in the Senate. Both the SOFTWARE Act and the PROTECT Act would exempt so-called "health software" and "clinical software" from FDA oversight.
"We're very concerned about an inappropriate burden on the innovation and technology," said Stacy Cline, Director of Oversight and Investigations for the Senate Committee on Health, Education, Labor and Pensions and ranking member Senator Lamar Alexander (R-Tenn.).
Supporters of the PROTECT Act, including athenahealth, IBM, McKesson and Software & Information Industry Association, believe it provides a clearer regulatory framework for health I.T. that promotes innovation and job creation while protecting patient safety.
However, opposition to the PROTECT Act continues to mount. A Feb. 12 position paper jointly issued by the Clinical Decision Support Coalition and mHealth Regulatory Coalition argued that the proposed legislation would remove from FDA regulation high-risk clinical decision support software, mobile medical apps and other medical device functionality currently under the oversight of the regulatory agency.
In addition, the Patient, Consumer and Public Health Coalitioncomprising a dozen patient groups--sent a Feb. 14 letter to Senator Tom Harkin (D-Iowa), Chairman of the Senate Committee on Health, Education, Labor and Pensions, stating that they are "extremely concerned" that this bill will deregulate medical technology crucial to patient health, causing patients unnecessary risk.
"Rather than move rashly on legislation that could harm patients, Congress should wait for the recommendations from the HIT report and discuss them thoughtfully," stated the letter from the Patient, Consumer and Public Health Coalition.
A FDASIA-mandated report to Congress on a risk-based regulatory framework for health I.T. is expected in the first quarter of 2014 that will cover clinical decision support software, which wasn't addressed by the FDA's final guidance on mobile medical apps released in September.
In a separate legislative move, a bill was introduced in November in the House to increase the use of wireless technologies in health care in order to bring down care costs. The Health Savings Through Technology Act calls for the creation of a commission that would inventory existing data and examine any cost-savings attainable through the use of wireless health technologies. Ostensibly, the commission would devise a strategy for integrating the most successful tools into federal health care programs, including Medicare and Medicaid.
The bill has been endorsed by the American Telemedicine Association, California Healthcare Institute, and Qualcomm, among others.
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