Bill provides guidance on FDA mobile medical apps regulation

A bipartisan group of House members--three Democrats and three Republicans--has introduced a bill to "provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records and other healthcare related software," according to an announcement.

The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act seeks to amend Section 201 of the Federal Food, Drug, and Cosmetic Act to regulate medical software and to provide guidance to the FDA about mobile medical app regulations. Late last month, the FDA issued its own final guidance on mobile medical apps.

"By building on the guidance recently released by the FDA and codifying their risk-based regulatory approach this important legislation provides the regulatory certainty that technology companies need in order to continue to drive innovation and ensure patient safety," according to the announcement.

"Estimates indicate that the number of consumers using medical apps on their smart phones will grow to 500 million by 2015. But today the FDA lacks the necessary tools to appropriately oversee these innovative products without overstepping their authority and stifling innovation," argue the members of Congress in their statement. "Under current law, the FDA could use its definition of a medical device to assert broad regulatory authority over a wide array of software.The SOFTWARE Act tailors their authority to the realities of the 21st century by focusing their authority onto the products that pose a potential risk to human health."

The SOFTWARE Act defines three classification levels of software--clinical software, health software and medical software.

''Clinical software and health software shall not be subject to regulation under this Act,'' states the full text of the SOFTWARE Act bill. "The President and the Congress should work together to develop and enact legislation that establishes a risk-based regulatory framework for such clinical software and health software that reduces regulatory burdens, promotes patient safety, and fosters innovation."

The bill's co-sponsors include Representatives Marsha Blackburn (pictured right) (R-TN), G. K. Butterfield (D-N.C.), Diana DeGette (D-Colo.), Phil Gingrey, M.D. (R-Ga.), Gene Green (D-Texas), and Greg Walden (R-Ore.).

Earlier this year, Congresswoman Blackburn drafted a similar bill to amend Section 201 of the Federal Food, Drug and Cosmetic Act. However, after reviewing the proposed legislation, the mHealth Regulatory Coalition (MRC) raised questions about the proposed approach and the use of new terminology in the draft.

Blackburn's earlier proposed bill included language that created a new category of "medical health technology," a definition that referred to both hardware and software. "We believe that these terms are too generic to meaningfully distinguish 'medical health technology' from traditional medical devices," wrote Bradley Merrill Thompson, the MRC's general counsel, in a July 12 letter to Blackburn.

"A pacemaker is hardware, and software includes firmware that resides in the pacemaker. It would not be logical for a pacemaker or firmware within a pacemaker to now be reclassified as 'medical health technology.'"

If a product is labeled, promoted or used in a manner that meets the definition in Section 201 of the Federal Food, Drug and Cosmetic Act, it is regulated by the FDA as a medical device and is subject to pre-marketing and post-marketing regulatory controls.

Medical devices "face a long and costly pre-market approval process at the FDA," said Congressman Walden in a written statement regarding the SOFTWARE Act. "We all want to ensure patient safety, but why would we treat mobile applications the same as a dialysis machine? Our common-sense legislation gives regulatory clarity to this innovative industry while focusing efforts on potential risks to human health."

To learn more:
- read the announcement
- read the full text of bill

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