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FDA mobile medical app guidelines on the way

Guidelines on how certain mobile medical apps will be governed by the U.S. Food and Drug Administration may be released as soon as the end of the year.

The FDA's path was cleared this past week when President Barack Obama signed the bipartisan Food and Drug Administration Safety and Innovation Act (S. 3187), which was approved by Congress last month after some wrangling. The law allows the FDA to move ahead with plans to regulate mobile medical apps while the Department of Health and Human Services develops a report on an "appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regular duplication."

An earlier version of the bill would have stalled or even stopped the FDA's actions on mobile medical apps while HHS drafted its report, but legislators agreed to amend the bill to allow the FDA to proceed independent of HHS action.

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[See also: Path opens up for FDA regulation of mobile medical apps.]

The law also reauthorizes user fees that the FDA collects from the drug and medical device industries (an action that must be taken every five years) and creates a new fee for generic drug sellers. It also amends FDA policy to speed up the approval of potentially life-saving products and improves the agency's oversight of safety regulations.

The law has support in the San Diego-based independent non-profit West Wireless Health Institute, which issued a joint press release on July 9 with BIOCOM and CONNECT, two other southern California-based life sciences advocacy groups.

“The entire mobile health ecosystem is developing inherently low-risk technologies to extend care beyond offices and hospitals, and these novel, low-risk devices and integrated solutions can be expedited via these changes to the FDA’s de novo pathway,” said Joseph Smith, the WWHI's chief medical and science officer, in a press release. “It’s great to see our region’s healthcare innovation community work together with our elected officials on this legislation that speeds medical device innovation and lowers costs in the healthcare system, benefitting patients through common sense policies that safely expedite approvals.”

“Many BIOCOM member companies have one thing in common: Their fate is dependent on the FDA. Without FDA approval during each step of the commercialization process, nothing else matters,” added Joe Panetta, BIOCOM's president and CEO. “During the course of the debate, BIOCOM weighed in with Congress by communicating the importance of specific parts of the legislation. BIOCOM praises Congress for addressing industry concerns and is pleased with the final outcome. The FDA reforms help create a more predictable, safe and effective regulatory process that encourages the immense investment to get a concept from discovery to commercialization, giving patients access to high quality products in a timely fashion.”

“As a leading voice representing startup and emerging companies, we applaud the FDA reforms included in the bill because they will help spur young companies to grow, create jobs and continue to revolutionize life-changing medical care," added Duane Roth, CEO of CONNECT. "In a time when gridlock is more common on Capitol Hill, it is heartening to see Congress act in a bipartisan manner to ensure that our life science innovators in San Diego and throughout the U.S. can stay focused on developing breakthroughs that save lives and improve health.”

But not everyone approved of the amended legislation.

The Health IT Now Coalition had lobbied to stop the FDA from issuing its guidelines, at least until the HHS report comes out. “There are a lot of agencies that have at least some regulatory jurisdiction here: FDA, FCC, FTC, CMS, ONC all have a little piece of the pie,” said Joel White, executive director of Health IT Now, in a story on "For example, the Office of the National Coordinator for Health IT is pushing for electronic medical record standards, while the Center for Medicare & Medicaid Services is developing accountable care organization standards. Simultaneously, the Federal Communications Commission is creating requirements for enforcing communications requirements between mobile phones."

As for mobile medical apps, said White, “Congress should have a role in helping develop a framework that makes sense for mobile health technologies as they exist today, but is flexible enough to evolve with the market.”

In a recent interview with NPR's Rob Stein, Jeffrey Shuren, who leads the FDA's Center for Devices and Radiological Health, cautioned that the FDA doesn't want to regulate all apps – just those that act as medical devices or contribute to the clinical decision-making process. Health and wellness apps or apps that help users manage medical conditions won't fall under the FDA's purview, he said.