I’ve spoken at some length about my enthusiasm for the current leadership at HHS and ONC. President Obama has both directly and indirectly engaged some really gifted individuals to help us address healthcare challenges through the use of information technology --- which is awesome. In particular, folks like Aneesh Chopra, Todd Park and Farzad Mostashari have brought the Internet to healthcare (or perhaps more accurately, healthcare to the Internet), and have convened some super-effective public/private groups to collaborate on specific issues with real success. I’ve had the good fortune to participate in a few of these, and it’s been some of the most rewarding work of my career.
Truth is, I’m not used to seeing such great work out of government. So I’m a bit reluctant to throw out what could be perceived as a negative message --- but after my own two-week vacation thinking about it I’m convinced the time is right to ask ONC:
PLEASE, TAKE A BREAK!JUST STOP TALKING FOR AWHILE AND LET US IMPLEMENT STUFF.
Why stop now? I think the answer is increasingly clear. Between Meaningful Use Stage 1, the Direct Project and the Health Data Initiative, government has kicked industry out of a funk it’s been in for the previous decade, and we’re seeing a ton of really exciting and positive innovation. But nobody, and certainly not ONC, knows at a detailed level how to turn that innovation into ubiquitous market reality. What we need now is a period of implementation, competition and iteration to figure out how to deliver on the promise.
I’ll use the Direct Project as an example because it’s the one I’m most familiar with. Two really amazing things happened after the FACA hearings of late 2009:
These two actions --- constantly reinforced by the remarkable diplomacy of Arien Malec --- set the stage for the rapid development of the Direct protocols and reference implementations. Microsoft and other vendors put their resources behind this project because the government made it possible for industry to succeed where it had failed alone.
OK --- so fast forward to today. A number of Direct-based pilots are underway implementing the “stories” we used as our guideposts, primarily provider-to-provider referrals and delivery of visit summary information to patients. National groups like the AAFP are creating web-based utility services that will be available to small providers, and states like Rhode Island are crafting the scalable policies necessary to sign up large and small organizations in a regional circle of trust. But even more exciting are the unexpected ways in which Direct is being leveraged:
The point is, there are a ton of ideas and trials --- all bound by and compliant with existing regulation --- happening in all corners of the industry. Some will work and some will fall by the wayside, and that’s OK, because we’ve escaped the funk and are making progress again. It’s an incredible success story for guided capitalism.
So then, what am I whining about?
As Todd says, people come and go but government process is forever. Sometimes that’s a good thing, but often it isn’t. If people keep meeting, they have to keep doing something, right? For example, the Privacy and Security Tiger Team is still out there, so ONC asks them to make recommendations on stuff. Most recently it was to recommend policies for how the federal agencies should manage certificates for Direct (certificates are technical doohickeys that help us ensure that only the right people receive and can read information using Direct).
Well, they did exactly what they were asked and made a recommendation. Unfortunately they didn’t have all the right context and information to make the decision. Really, right now nobody does --- remember, separating the policy problem from the technical problem was one of the key enablers that made Direct happen! And as it turns out, the recommendation they made doesn’t work very well, and really raises more questions than it answers, and so people are getting scared to experiment… uh oh.
The same pattern is playing out in a bunch of initiatives --- there are now more “health challenges” than I can count or keep track of, we’re clearly stuck on MU stage 2, and (in my opinion) the S&I Framework initiative has taken on too many projects for industry volunteers to sustain. Excepting folks that deal only in policy issues, the consistent message I hear now is “stop the world --- I want to get off.”
What we need now is time for the system to work, partnerships to form, software to be upgraded in production systems, ideas to be tested, consumers to choose what to buy and what not to buy.
I’m not asking for the pace of innovation to slow down --- capitalism takes care of that just fine (even in healthcare, when the conditions are right). I’m asking for the government to slow down … recognize that ONC has found an incredible recipe to guide progress, but that it will only keep working if used strategically.
When you see a funk, take action as you did with Direct. But when things are moving --- monitor and evangelize --- don’t overstep. It’s a tough balance, and I don’t claim to know exactly how to manage it better than anybody else. But I am in the trenches enough to know when it’s working and when it isn’t … and right now we’re on the edge.
ONC, you’ve done great … as a citizen and as a vendor I’m really thankful. Now it’s time to step back for awhile and be national cheerleaders for what you’ve set in motion. We’re getting there!
Re: "What we need now is a period of implementation, competition and iteration to figure out how to deliver on the promise."
I find this attitude a bit psychopathic, as while we're "figuring out how to deliver on the promise", patients will be injured and/or will die due to IT-related errors.
FDA CDRH has confirmed that these HIT systems are medical devices. We don't treat stents, defibrillators, and other devices this way; we don't tell pharma to put drugs on the market without extensive pre-marketing and post-marketing studies.
What is actually needed is a period of intense controlled clinical trials of health IT under informed consent, testing for safety and efficacy, before they are unleashed on a public who are not asked for informed consent.
Perhaps they could shift into more of a national Health IT cheerleader role since so much of the investment is going into public health, community health centers, etc? Identify the gaps.. Reach out to other government agencies HRSA, VA, SSA, etc to ensure we are all moving in the same direction by highlighting what is working. Share more stories of success in both the public and private sectors? Educate and engage consumers (I expect to see this happen shortly). Other ideas?
Personally I love the health challenges but then again I am one of those people who also love to start companies from scratch for fun over a weekend. (Startup Weekend)
SS --- I thought a lot about how to respond to your comment, this being the first time I've been actually called psychopathic, at least in an online context! :) My conclusion is that you must just not understand the ONC work that I'm referring to, because running full trials for that work would be akin to doing so for every fax machine on the market, or perhaps those new envelopes that you don't need to lick to seal. It's a ridiculous concept and not one I'm able to take seriously.
However --- if you really think I'm missing something, I'd love to have a conversation about that --- you can reach me directly at sean.nolan AT microsoft.com. Thanks!
Sherry --- I actually love the challenges too, and especially the innovation that has come out of many of them (HDI in particular has been really fruitful). The issue I have is that the market can't get these ideas into the hands of real providers fast enough to prove them out, and so we're increasingly at risk of things being written into regulation that won't work in the real world.
I think that idea of "national cheerleader" is exactly right --- push us all to take that innovation to market and find out which really are the great ideas and which ones aren't.