The new year is bringing a steady stream of insight, opinions and viewpoints on what it will take for mHealth apps and devices to take deep root this year, and it all appears to hinge on one consistent element: consumer trust.
But building, gaining and keeping trust isn't something many app developers and start-ups can do in a short period of time, and certainly won't happen without some sort of official, sanctioned and respected "stamp of approval."
After all, we aren't talking thigh masters or vitamin supplements promising weight loss. We're talking blood pressure readings, glucose monitoring and diagnostics relating to everything from heart disease and diabetes to HIV. We're talking about personal, confidential data being collected, analyzed, stored and shared.
It is very clear federal agencies are not jumping to develop new rulemaking to build such trust. The Federal Trade Commission has gone on record as not eager to create and enforce new regulations. The U.S. Food and Drug Administration, meanwhile, is taking what most would agree is a very light touch on device oversight. While the feds are acting quickly to slap back inaccurate marketing and advertising promises on mHealth related tech tools, it's an after-the-fact act at this point.
So when it comes to building trust and giving consumers qualifying mechanisms on mHealth, tech investment is not going to be a government responsibility, at least not now. But something needs to be put in place.
A while back I suggested the creation of a whole new level of regulatory oversight, a new governmental agency, but as I quickly learned from readers, no one really endorses that approach, and for good reason. One reason is that guidance for health apps is already in play. The National Institute of Standards and Technology is working on draft guidance regarding vetting of third-party software for mobile devices. Vetting is needed to ensure an app is acceptable for use in an expected situation. That's what builds trust.
So what about a compromise of sorts? Something in the realm of a Consumer Reports or Good Housekeeping stamp of approval doled out by an industry-advocate-government cooperative that could be led by a body representing trusted industry groups, consumer advocate agencies, vendor coalitions and consumers.
An ex-FDA deputy commissioner suggested a similar idea last year where tech groups would define basic technical standards while exempting most health and wellness apps from any sort of premarket review.
There is already a very good model that can be used as a foundation or best practices paltform and that's the ACT - The App Association's efforts in gaining clearer and more accessible regulatory guidance relating to the Health Insurance Portability and Accountability Act rules.
As I wrote in this column last week, the need to develop, build and maintain consumer trust isn't just confined to mHealth apps and smartphones that can process a blood test. Wearables require the same level of consumer trust to advance and innovate and are facing the same challenges of data protection, user privacy and technology verification and validation.
The good news is there are already many interested parties, even if many of them will clearly profit from mHealth tech that will build and keep consumer trust. Now it is time for one of those parties, a tech giant like Apple, a telecom leader like Verizon or even an industry leader such as ACT, to pave the way.
- Judy (@JudyMottl and @FierceHealthIT)