by Rick Krohn, co-editor, mHealth: From Smartphones to Smart Systems
In a blog written 16 months ago, I named four hurdles to mHealth adoption, listed below. I suggested these issues would require swift resolution, in the face of mobile’s growing momentum in healthcare. So how are we doing? Let’s look at my comments about each—from 2010 and today.
Issue 1: Business Model
Then: A number of mobile health business models are developing, including provider services, direct-to-consumer and clinical technology integration. But questions remain over who will ultimately bear the costs for mHealth solutions—payer, provider or patient?
Now: If the 2012 Annual HIMSS Conference & Exhibition is a bellwether, the gold rush is in full fury, and revenue concern is running a distant second. To borrow a Bible phrase, “…Many are called, but few are chosen.”
Issue 2: Security
Then: In a recent survey conducted by HRI, physicians cited security as their No. 1 concern about adopting mHealth solutions. To “bulletproof” sensitive information shared via wireless, mHealth suppliers may be compelled to adopt multifactor ID or security architecture akin to online banking—which could be cumbersome.
Now: In general, vendors have done yeoman-like work in imbedding encryption, auto ID and device security features into their solutions. But incredibly, despite a slew of data breaches, mobile security isn’t receiving the urgent attention it requires from IT departments.
Issue 3: Regulatory Compliance
Then: Beyond HIPAA, the Food and Drug Administration, which regulates medical devices, is developing new guidelines for mobile health applications and devices. The agency just published a report on its 510(k) approval process for medical devices. Not to be outdone, the FCC has announced a proposal to create a new medical program experimental radio license that would create test-bed facilities, where manufacturers and developers could try out new wireless medical technologies and assess their operational readiness.
Now: The FDA has produced a list of mobile medical devices that can be regulated, but many loose ends remain. The FCC is focused on the national broadband plan, mobile health must wait.
Issue 4: Standards
Then: The ever-expanding universe of mHealth innovation has spurred concerns about a set of common standards for mobile devices and applications. Ideally, open standards (outfits like Continua Health, mHealth Alliance, HIMSS and others are working on this) will head off the inclination of technology companies to offer their own standards sets that may require substantial retooling in the future.
Now: Still very much a work in progress, with disturbing echoes of the clinical data standards mess.
Then (and Now): It’s a mistake to conclude that these issues, which have had such a braking effect on the adoption of tethered solutions like the EHR, will exercise a similar influence on the evolution of the mHealth market. The evidence to date just doesn’t support any other conclusion but that mHealth is going to become foundational to healthcare—faster, better, cheaper.