February 28, 2014|Categories: Healthcare Policy and Reform
Now that another HIMSS conference is in the books, here are a few things that occurred to me as I wandered the vast expanse of the Orange County Convention Center (West), in no particular order:
Regulators are from Mars… My colleagues and I had a lot of conversations about regulatory oversight of health IT, both actual and possible, including talks with no small number of government officials. (For relevant background on this important issue, see this Boston Globe article and this one from VentureBeat. Or geek out and dive into this comprehensive report from the Bipartisan Policy Center). My major takeaway: Regulators are from Mars, and innovators are from Venus. When it comes to the crucially important issue of appropriate oversight of low-risk health IT, we are talking directly past each other. There are a number of reasons for this, none of which presumes nefarious intent on anyone’s part:
- First, as reinforced during HIMSS, it is impossible to rationally discuss the possible harm of over-regulation with a regulator. The level of regulation will forever be that which the regulator deems appropriate; ergo, there can be no over-regulation. Res ipsa loquitur. The very real possibility of innovation-killing regulatory overreach is simply beyond the regulator’s ken. Doesn’t compute. No hablan.
- Second, regulators expect the rest of us to put unreasonable stock in the purity of their intentions. They repeatedly say they have no intention of stifling innovation. To the contrary! They have no present intention to over-burden health IT with heavy-handed regulation, but they want desperately to preserve the right to change their minds (much more on this in our recent whitepaper that unpacks the primary criticisms of the PROTECT Act).
This is great, but at a certain point intentions don’t matter. The FDA is simply ill-equipped to regulate gently, and lacks both the expertise and infrastructure to regulate software and a basic understanding of the crucially important differences between health information technology and their traditional areas of jurisdiction. Hence: the ill-advised present effort to shove the round peg of health IT in the square regulatory hole of FDA’s medical devices framework. Your friendly municipal firefighter may earnestly intend to water your houseplants, but if you invite him in to complete the task and his only tool is a fire hose you’d better hope your homeowners’ policy covers flood damage.
- Finally, on crucially important sub-issues, regulators and innovators may as well exist in separate realities. The FDA’s Bakul Patel recently sought to quell concerns about the implications of FDA regulation of software by noting that, in 80 percent of cases, the agency “met the statutory 90-day timeframe” in 2013 for review of mobile medical apps. He intended this as reassurance! Ninety days, I have no doubt, is light speed in the context of device approval. But in the brave new world of information technology—and the obstructions it can help bypass—90 days might as well be eternity.
Orlando is not New Orleans. The logistics and vibe of last year’s HIMSS conference in New Orleans were awesome. Orlando is not New Orleans. The visitor version of Orlando is magical when you are a kid. Kids don’t attend HIMSS. If HIMMS organizers are taking votes, mine is to go back to the Big Easy.
Finally wise to the game? The bestest-best news to come out of HIMSS 2014 from a policy perspective, and maybe even an industry perspective, was the Centers for Medicare & Medicaid Services’ (CMS) dual announcement that there will be no further delays for either Meaningful Use Stage 2 or ICD-10 implementation. Despite the short-term upheaval that both deadlines will almost certainly cause for any providers (and their patients) whose vendors have fallen short of expectations, moving ahead will benefit the overall system in the long term. athenahealth’s clients understand why.
We’ve consistently argued against repeated calls for delay and lowered standards in the Meaningful Use program. And we are the only health IT service to guarantee ICD-10 readiness. Meanwhile, many other companies are expending tremendous time and money to slow down and dumb down these programs, in part because their legacy software systems are simply not up to the demands of the 21st century information economy—and because delays prolong their abilities to sell their systems and collect government subsidies. They can’t keep up? Then, clients should not be penalized for those failings.
Compared to the rest of our economy, health IT lags years behind information technology in routine use. That is unacceptable. And we won’t catch up by slowing down.
Could the CMS’s announcements illustrate that DC policymakers are finally wise to the delay-and-subsidize game? Here’s hoping. That news alone would make this trip to Orlando worthwhile.