There's been intense effort over the past several years to try to determine the best regulatory approach when it comes to mHealth technology. Thousands of hours have been spent in meetings, conferences, hearings and conversations, all in a quest to figure out how best to protect patients, foster innovation among developers and creators, and not hurt a burgeoning industry that could potentially be greater than the PC revolution.
Much of it has been focused on figuring out how to wedge mHealth tools into regulatory parameters already in place within the U.S. Food and Drug Administration, the Federal Trade Commission, and dozens of other federal and state agencies tasked with making sure what's in the market doesn't hurt the consumer, protecting data privacy and securing information.
But what if we stopped trying to wedge and just started from scratch in crafting a regulatory body specifically for mHealth? I, as I think most Americans, am not too thrilled with increasing governmental layers and layering on more red tape in any form unless it's absolutely necessary. It's not a startling declaration to say there's a great deal of redundancy that needs to be cleared out of the government oversight process.
But it could be the best approach in this particular case, given the constant stream of new innovative technologies that likely will touch every citizen in the U.S. It might just be the most efficient, easiest and ultimately best approach.
Creating and crafting an oversight agency that purely focuses on mHealth offers a tremendous opportunity to deliver on the goals of protecting consumers and patients, providing clear regulatory directive and rules to payers and providers and attaining the nimbleness necessary to adjust and change as mHealth tech is a fast moving industry.
Will it be more costly? Yes. Will it be easier? I think so.
Will it ignite a political battle and stem the ongoing regulatory discussion and debate currently going on? Yes, that's extremely possible.
Yet, I think it's one of those situations where the end justifies the means. And most importantly, it will allow for all the needed voices to play a role in creating the best regulatory approach.
No one wants to stifle mHealth innovation, and the many moving parts in the mHealth industry and technology realm require intense focus. In developing a brand-new regulatory entity, there's no getting mired down in 'this is how we do it,' and other change management hurdles.
The one thing everyone involved in the ongoing regulatory and oversight discussion can agree on is that it needs to get done fast and not be compromised by trying to wedge a square peg into a round hole. - Judy (@JudyMottl and @FierceHealthIT)