recommended reading

Regulatory headache? There’s an app for that


The Food and Drug Administration is stymying innovation in the field of mobile medical applications with superfluous regulation, industry leaders said at a conservative think tank Wednesday.   

“We need regulatory structure 2.0 to deal with emerging technology,” said Joel White, president of Health IT Now. “It has to match the innovation and speed of the industry. Science fiction is moving to science fact.”

The American Enterprise Institute panel pointed to the 2011 Draft Guidance on Mobile Medical Applications released by the FDA as the impetus behind a convoluted and overbearing regulatory framework. The guidance identifies apps -- such as those found on an iPhone or iPad -- as medical devices that, under FDA’s purview, should be regulated.

The difficulty, according to the panel, is where to draw the line. Sixty-two percent of doctors are using tablets in some way to treat patients, according to White, and an increasing number of patients are using apps to clarify instructions, to make amateur diagnoses or simply to educate themselves on medical information. The panel contended an app that allows a patient to play checkers in order to keep his mind clear at the recommendation of a doctor should not be regulated in the same way as an app that helps a doctor read a CT scan.  

Jon Potter, president of the Applications Developers Alliance, said uncertainty in what will be regulated is driving away potential backers of new technologies.

“Investors are looking at regulatory challenges as impeding their interest in investing,” he said.
Erica Jefferson, an FDA spokeswoman, said “only a subset” of mobile medical applications will be regulated.

“[FDA] will continue to promote innovation in this new and expanding field,” she said. “FDA oversight would generally be limited to apps that present the greatest risk.”

White and Potter argued for a new structure for regulating these apps should involve independent software experts who verify that a program does what it is intended to do, rather than medical professionals who examine the medical value.

“It’s about 1s and 0s,” White said.

They also said the regulatory structure must be inexpensive, as the often free applications do not generate the revenue to support additional fees. White said developers will “make [the next] Angry Birds instead of a glucose app that helps diabetic patients,” because that’s where the money will be.

(Image via watcharakun /

Threatwatch Alert

Thousands of cyber attacks occur each day

See the latest threats


Close [ x ] More from Nextgov

Thank you for subscribing to newsletters from
We think these reports might interest you:

  • Modernizing IT for Mission Success

    Surveying Federal and Defense Leaders on Priorities and Challenges at the Tactical Edge

  • Communicating Innovation in Federal Government

    Federal Government spending on ‘obsolete technology’ continues to increase. Supporting the twin pillars of improved digital service delivery for citizens on the one hand, and the increasingly optimized and flexible working practices for federal employees on the other, are neither easy nor inexpensive tasks. This whitepaper explores how federal agencies can leverage the value of existing agency technology assets while offering IT leaders the ability to implement the kind of employee productivity, citizen service improvements and security demanded by federal oversight.

  • Effective Ransomware Response

    This whitepaper provides an overview and understanding of ransomware and how to successfully combat it.

  • Forecasting Cloud's Future

    Conversations with Federal, State, and Local Technology Leaders on Cloud-Driven Digital Transformation

  • IT Transformation Trends: Flash Storage as a Strategic IT Asset

    MIT Technology Review: Flash Storage As a Strategic IT Asset For the first time in decades, IT leaders now consider all-flash storage as a strategic IT asset. IT has become a new operating model that enables self-service with high performance, density and resiliency. It also offers the self-service agility of the public cloud combined with the security, performance, and cost-effectiveness of a private cloud. Download this MIT Technology Review paper to learn more about how all-flash storage is transforming the data center.


When you download a report, your information may be shared with the underwriters of that document.