FCC, FDA open lines of communication

Mary Stevens, Editor

The Federal Communications Commission (FCC) has had its hands full lately. That’s just as well. There are decisions to be made that will affect everything from devices for mobile health to content delivery. The debate over what constitutes a medical device has not gone away. If anything, it’s more vital than ever to figure this out.

Recognizing this, the FDA and FCC met earlier this week to hash out regulatory questions about mobile health devices and applications. Communications devices are regulated by the FCC and medical devices are under the authority of the FDA, which has led to some confusion as communications devices are increasingly used for medical purposes.

More conferences (many more) will probably be necessary to hammer out when a smartphone is just that, and when it’s a piece of medical equipment that should be subject to FDA regulations. Meanwhile, some organizations have been urging all parties to include imaging requirements in future mHealth regulations.

The mHealth Summit in Boston last week showcased examples of what is already being done to improve care for patients with chronic disease. Three providers demonstrated that, given the opportunity to self-monitor, many patients become more engaged in their care and their outcomes improve.

Separately, a principal investigator at Nationwide Children’s Hospital has developed an iPhone application that sends customized text message treatment reminders to adolescent diabetes patients. A pilot study concluded that weekly, customized messages resulted in an increase in overall treatment adherence and improved blood glucose levels among teen diabetic patients. 

Meanwhile, as states race to adopt a variety of healthcare IT, CMS announced a $5.75 million matching grant program to fund EHR initiatives in six states and the District of Columbia state planning activities. And the Leapfrog Group weighed in with applause and concerns regarding the final rule for meaningful use: Props for including CPOE, scorn for allowing systems that officially demonstrate meaningful use without requiring confirmation that “their system actually works as intended.”

Nevertheless, others found the Stage 1 meaningful use requirements a good start, with or without CPOE checks, because they will prod facilities to get used to reporting quality measures.

In addition to another round of quarterly earnings reports and some mergers and acquisitions, this was a week of alliance announcements. Heavy hitters teamed up to deliver cloud-based CDS (IBM and ActiveHealth), telehealth tools (GE and Intel) and an online physician platform (NextGen and the AMA).

The FDA and FCC meeting may have set a good example.

Mary Stevens, editor
mstevens@trimedmedia.com