The U.S. Food and Drug Administration recently issued its final guidance on mobile health apps, ending a two-year wait for developers.
The FDA, which issued a draft guidance in July 2011, said it intends to exercise its enforcement discretion and not regulate apps except for those that present a risk to patients if they do not work as intended.
While some industry groups were happy the FDA made good on its promise to release the document before the end of fiscal year 2013, others say the FDA should have waited a little longer.
The agency said it will focus its enforcement on two types of apps:
- Those intended as an accessory to a regulated medical device, such as those that would allow a doctor to make a diagnosis by viewing a medical image on their smartphone.
- Those that would transform the smartphone into a regulated medical device, such as an app that turn the phone into an electrocardiography machine to detect abnormal heart rhythms.
"Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation," said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a prepared statement.
A summary of the 42-page-long guidance prepared by mHIMSS, the subsidiary of the Healthcare Information and Management Systems Society that represents the mobile health industry, identified two areas that were missing. It said the guidance did not address apps that use patient-specific analysis to aid or support clinical decision-making. The document also failed to address the FDA’s general approach to medical device accessories, according to mHIMSS.
A few weeks before the guidance was issued, it appeared the FDA may have been waiting on the Health IT Regulatory Framework to be finalized before it issued its final guidance.
In August, a federal workgroup that included members of the FDA, issued final recommendations for the framework, which is expected to be released in 2014. A group of 129 industry leaders and medical societies sent the FDA a letter in June asking it to hold off on issuing the mobile app guidance until the framework was complete.
The Health IT Now Coalition, a health IT advocacy and educational group, issued a statement saying that by releasing the final guidance, the 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 [Dept. of Health and Human Services] report with recommendations on a new framework for health IT regulation,” the coalition said in a statement.
The FDA made clear the document only describes the agency’s thinking on the topic and does not establish legally enforceable responsibilities. The approval process is voluntary but the agency has the authority to pull certain apps off the market if it thinks they require approval.
The agency has cleared more than 100 mobile medical apps over the past decade, about 40 of those in the past two years. The regulatory process can be lengthy and expensive, running into the tens of thousands of dollars. The agency is encouraging app developers to contact the FDA if they are developing a new type of app and aren’t sure if regulations will apply.
