Recent guidance by an innovation-friendly Food and Drug Administration has lifted much of the regulatory cloud over the development of medical and health-related applications for mobile devices. Numerous previously gray-area uses of mHealth for patient care, consumer engagement, and health and wellness improvement now can proceed to market without a stop at the FDA.
In the risk-averse, cautious world of health care delivery, however, some experts say the adaptation and marketing of mobile solutions for information needs in complex care environments may call for app developers to get regulated by choice. Otherwise, their products might not be trusted and embraced.
In a 43-page document issued in late September 2013, and punctuated weeks later by FDA Commissioner Margaret Hamburg, M.D., in an address to an mHealth summit in Washington, D.C., the overall target was narrowed to a small subset of apps. "The guidance makes clear that if a mobile app is intended to transform a mobile platform into a medical device, or is an accessory to a medical device — for example, an app that acts as a remote control of such a device — we would continue to regulate that kind of technology if it is on a mobile platform," Hamburg explained. "The focus is on functionality, not the specific platform."
But even within that classification, FDA staff will exercise "discretion" over — meaning they will opt not to regulate — a wide swath of apps meeting the definition of a medical device. So, of the more than 100,000 health-related apps in play, "there's a tiny sliver that falls into [the classification of] medical devices, and an even smaller group that we actually actively regulate," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said during a speech at the same December 2013 summit. Hamburg said that this small regulation target constitutes apps that "can pose a significant peril" if they don't operate as intended or are designed in ways that increase risk.
The FDA approach "is a loud and clear message that they are opening the door to greater innovation in this space," says Morgan Reed, executive director of the Association for Competitive Technology, a trade group for mobile app developers. "The FDA said, 'Look, as long as there's no clear-cut example of putting a patient at immediate risk, go forth and innovate.' " That's a dramatic contrast to the "Thou shalt not" approach of the past, which provided few clues as to what developers could do and areas they could explore without submitting to FDA controls or pre-market approvals, he says.
But a hands-off FDA and further proliferation of health-related apps might not be a boon to health care delivery unless it is matched by a better fit with what health systems and their clinicians really need today, says Robert Havasy, operations manager and senior consultant at the Center for Connected Health, a unit of Partners HealthCare System in Boston. "The biggest divide that I see [between] the clinical world and the entrepreneurial mHealth world is that we are not ready for the pace of their rapid innovation, and they don't understand the plugs in the infrastructure that they need to connect to." One issue is integration into workflow [see sidebar], and another is independent confirmation of worth.
"What's going to drive these [mHealth] businesses is really who the audience is," says Robert Jarrin, senior director of government affairs for Qualcomm Inc., which has a unit that makes medical device data systems. Clinical executives, managers and practitioners are "going to be interested much more in hard and tested, qualifiable products, because that's the world that they live in." That attitude carries some apprehension of "the loosey-goosey, health-and-wellness stuff" coming at them, he adds.
Burdensome though it is for manufacturers, FDA clearance "equates to a basic level of 'OK' to clinicians," says Havasy. For patients who want to use mobile devices and share information with physicians, for example, most apps lie outside regulation and are, therefore, risky for doctors to prescribe, he says.
For that reason, there's an argument for regulation as a confidence-maker and differentiator, bringing to market a device that's more rigorously produced according to good manufacturing practices and more attractive to the medical community because of that, says Jarrin. Qualcomm's business decision to target the medical provider market rather than the direct-to-consumer sector for mHealth includes a commitment to meet FDA Class 1 general controls, he says. "It does make for a better device — we think it actually improved our device, and it improved in ways we did not perceive."
For mobile devices and apps that attract the attention of the FDA, the agency's intent is to knock down the regulatory rigor to a Class 1 level rather than a previous inclination to subject many of them to Class 3, which requires an intensive process of pre-market approval. This lighter touch, combined with plans to wave most of app development through, is "a very deregulatory and positive development for the mobile health industry," says Qualcomm's Jarrin. But still far from a breeze.
Creating and ensuring the manufacturing practices required in any regulatory class can be a tall order for app-makers, especially small vendors, he says. "You literally have to have the controls in place to know every single thing that happened in your plant or in your manufacturing facility, day after day."
That goes also for health networks that invent their own medical devices or related data systems. Partners has registered with the FDA a number of devices it has created, says Havasy of the Center for Connected Health. The registration itself "was not a heavy burden," mainly filling out forms and paying a filing fee. The quality assurance program requirement to follow good manufacturing practices "was a bit of a burden, but it was by no means arduous."
Jarrin says Qualcomm, like Partners, a large organization, was able to handle the expense — "easily more than $100,000," he estimates — to get its first Class 1 product up and running. The expense is ongoing, because controls have to evolve as the product evolves. Subsequent product submissions can piggyback on already established controls to lower the cost, Jarrin adds, but it's not small change to a small business.
At the Center for Connected Health, a big responsibility is integrating new information sources into the workaday world of clinicians in the Partners HealthCare System, a mighty challenge. Mobile devices aren't making things any easier, says Havasy. Typically, mobile apps "don't integrate with the systems that clinicians use," he says.
The center recently integrated remotely monitored data into the Partners electronic health record, where clinicians concentrate their focus from start to finish of their day. They're busy, they need to move patients through efficiently, "and anything that disrupts that workflow is difficult to embrace," he says.
With such fundamental barriers in front of them, providers may not see regulatory obstacles to mobile app innovation as a prime concern. The way Havasy sees it, "There are lots of other problems we need to overcome before we start saying, 'Hey, the regulatory environment is slowing down our ability to deal with [mHealth].' " Outside the health sector, "it's burdensome to agile, young startup companies that don't like people telling them what they can and cannot do. They want to innovate rapidly, and the FDA is the exact opposite. But from the clinical side, it's not the barrier."
Mobile apps are subject to FDA regulation if they:
Transform a mobile platform into a regulated medical device.
- Use a sensor, lead or electrode connected to a mobile platform to
measure and display heart signals.
- Take history from potential blood donor for use in determining donor
eligibility prior to collection of blood.
- Use an attachment to measure blood glucose levels.
Connect to an existing medical device to control its operation or function.
- Alter function or settings of an IV infusion pump.
- Control the inflation or deflation of a blood pressure cuff.
- Act as wireless remote control or synchronization devices for CT or X-ray machines.
Display, transfer, store or convert patient-specific medical data from a connected device.
- Connect to nursing station, display medical device data to mobile device for review.
- Connect to bedside monitors, transfer data to central station for display and monitoring.
- Connect to perinatal system, transfer fetal heart and contraction data to remote device to monitor labor progress.