FDA gets thumbs up on mobile apps regs
mHealth advocates are giving good early reviews to the U.S. Food and Drug Administration's final guidance document on the regulation of mobile medical apps, with one expert calling it "an expansive document that truly seeks to deregulate our nimble and innovative industry, while ensuring patient safety."
[See also: FDA releases final rules on mobile apps.]
"The guidance goes much further than I thought it would," said Robert Jarrin, senior director of government affairs for Qualcomm, who noted that the agency has taken a new and novel approach in launching a consumer-facing website with an adjoining list of regulated apps that may be updated on a regular basis. In addition, he said, the FDA is creating a team that will be tasked with answering public inquiries about mobile medical apps submitted through firstname.lastname@example.org.
"We are obviously delighted that after all of the debate this summer, FDA chose to go forward with publishing the guidance," said Bradley Merrill Thompson, an attorney with the Washington D.C.-based Epstein Becker Green law firm and legal counsel for the mHealth Regulatory Coalition. "I think this shows both courage and a genuine desire to help innovation."
[See also: Leaders urge FDA to keep up with mHealth.]
The American Telemedicine Association also expressed its support.
"The FDA has chosen wisely to target its strict regulatory efforts on mobile applications that could pose a significant risk to consumers if used improperly." said Jonathan Linkous, the ATA's chief executive officer, in a release. “Their regulation will help reassure patients and consumers that mobile health applications are not only convenient, but safe.”
“This regulation is critical to the growth in the use of wireless devices and software. Providing the FDA's stamp of approval will provide needed assurance to providers and consumers that telemedicine can help improve quality, access and affordability of care,” he added.
Others aren't so sure. In a statement, the Health IT Now Coalition said more work is needed to bring mHealth legislation up to date.
“We don’t want to lose sight of the longer term goal, which is rationalizing the regulatory framework so that innovation and patient safety are protected, and duplication and regulatory burdens are reduced," said Joel White, the coalition's executive director, in the statement. "By issuing the final guidance, FDA has endorsed an old framework. We think the Administration and Congress ought to work together on updating the 1970s era law to meet the needs of the 2013 and beyond mobile health economy. So we look forward to the HHS report with recommendations on a new framework for health IT regulation.”
In praising the regulations, Thompson pointed out that the FDA took a long time between the initial release of proposed guidelines in June 2011 and this week to come up with a final document.
"Their approach to the comments in this case is quite different than normal. The usual situation with FDA is a dozen or so institutions file comments, and FDA changes a few words before finalizing the guidance document. In this case, FDA made massive changes to the guidance document in response to the comments. They really showed that they cared about the comments they received," he said.
"However, this does create an interesting problem," he added. "An awful lot of the language in the final guidance document is new, which means it has not been publicly vetted before. While much of it is carefully written, some of it is subject to interpretation and a bit confusing. I’m sure these issues will get worked out; they don’t seem to be very fundamental."
The release of the final guidance document caps a tumultuous year that saw different mHealth interests lobbying for and against the FDA. In June, the mHealth Regulatory Coalition asked federal officials to pressure the FDA to release the document, saying it would help foster innovation in the mHealth space and curb fears that the regulations would be too restrictive.