It's not often that you find mHealth vendors who are asking the FDA for more regulations. However, Alan Portela, CEO of San Antonio-based AirStrip is a rare breed of company executive in that regard. Portela brings a unique perspective to the regulatory debate surrounding mobile healthcare. As he told me last December at the 2012 mHealth Summit in Washington, AirStrip wants to be the "poster child" for the FDA and that he's "probably one of the only vendors that tells you that [he loves] the FDA."
At the time, I thought these were just the idle words of someone trying to pander to the regulatory agency. Nevertheless, more than six months later, I realized there was serious conviction behind those sound bites. During a June 27 hearing held by the House Small Business Subcommittee on Health and Technology, Portela was the only industry witness to testify that the FDA "should include many more mobile medical device apps under its jurisdiction"--standing out among mHealth software developers, who usually advocate for less, not more government regulation.
In his congressional testimony, he advocated that "all mobile medical device applications displaying near and real time medical device waveforms and parameters data need careful regulation." And, while the FDA has focused on regulating hardware devices, Portela argued that companies producing software-only medical device apps or even websites need to be regulated as well.
"Today, many websites or apps have crept into FDA-regulated territory without scrutiny by adding features or functionality that position them as clinical decision support systems," he told the House subcommittee. "For example, a website where vital signs, demographic data or physiological observations are used to power a decision flowchart that guides diagnoses can easily extend out to a mobile platform. That, in essence, creates a medical device that is conducting clinical support, and should be regulated."
Yet, Portela didn't stop there. "Accessories" to primary devices should also be evaluated, he advised members of Congress."Currently, software 'accessories' (as the FDA terms them) to primary devices do not require separate clearance by FDA," he said. "Not only could the network go down, but the mobile medical device itself could be overloaded or failing in other ways. The FDA needs to also consider these accessories and potential failure points to ensure that manufacturers have addressed those issues in their testing."
According to Portela, vendors opposing FDA involvement are more concerned about the medical device excise tax as well as the strict "Good Manufacturing Practices" than quality of patient care.
When I asked Rep. Chris Collins (R-N.Y.), chairman of the Health and Technology subcommittee, about Portela's call for increased FDA regulation, the pro-business Republican congressman exclaimed: "Well, sure. You've got to understand entrepreneurs. He's already paying the tax so he wants everyone else to pay it too."
But, unlike Collins, who has never seen a government regulation he liked, I'm not as cynical about Portela's embrace of the FDA on the regulatory front. I believe Portela ultimately has patient safety as a top priority for his company and the larger mHealth community, as opposed to many vendors who strongly criticize the FDA for stifling innovation. Of course, the ulterior motive and side benefit of his advocacy for stringent FDA regulations is that it "levels the playing field" with AirStrip's competitors. And, that's only fair. - Greg (@Slabodkin)