For months now, I’ve called for the FDA guidance to clarify medical device regulations as they apply to mHealth. While most vendors would shy away from stricter regulations and standards, I believe that FDA regulations are necessary for mobile applications and websites to ensure patient safety and privacy in this emerging space. This week my calls were answered, with the release of the FDA final guidance for mobile medical applications.
The long-awaited final guidance is a critical milestone for mHealth, and is largely aligned with what was anticipated based on earlier released drafts. But it’s what happens now that guidance is in place that will truly shape the industry. It’s critical for payers, providers and, ultimately, consumers to ensure that they are being broadly implemented.
Traditionally, when the government comes up with the standards or guidance, technology vendors create barriers or decide the level of compliance they want to exercise. For example, standards already exist for interoperability, and vendors claim to carry the flag of collaboration and support full integration, but we all know how that is playing out. Most vendors will choose to support only standards that limit the relevance of outbound data sent and completely prevent the ability to write back into their systems. It is evident that many vendors will continue to limit the data they expose and hide the relevant data under proprietary formats that are exposed via their proprietary, expensive engines. In addition, medical device vendors will also try to leverage their FDA clearance on the primary device without seeking the same clearance for mobile access. Fortunately, it’s no longer up to the vendors alone.
We are about to experience the biggest transformation in healthcare ever with wide-spread provider consolidation and the move into patient-centric models. In large regional networks with multiple care settings, providers are becoming very powerful and need to be the force compelling vendors to adhere to these standards and guidelines. With the shift in power, providers will have the ability to pick and choose technologies that are providing the best possible services and outcomes. With so many options in the market, they simply won’t choose the vendors that aren’t meeting standards and regulations.
As consumers, the patients will in turn guide providers’ decision-making by assessing how those providers utilize the technology to better serve them. From a broader perspective, in this new era of healthcare, patients are going to judge providers by performance. Inadequacies such as lack of compliance, interoperability, substandard quality, etc., should drive patients to those healthcare systems that are taking a stand on their behalf.
It’s great news that the FDA is publishing a draft of guidance and opening this up for industry feedback. But the reality is that providers now have the real power and need to enforce those guidelines according to the needs of their markets. The enforcement of regulations and standards by providers will eventually reduce the barriers being created by technology vendors and create shared responsibility for the new ecosystem that will transform healthcare. As healthcare technology vendors, we need to become provider advocates so they, in turn, can become better patient advocates.