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 ... 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 find this attitude to be somewhat - well, let's just say, in a somewhat negative message, psychopathic.
We're talking about real, live human patients as the subject of our "figuring."
For, during the period of implementation, competition and iteration during which "we" will be figuring out how to deliver on "the promise" of experimental health IT medical devices, we shall be putting at risk and injuring non-consenting patients with our IT lessons-learned, and burying our more serious mistakes.
A far better way to figure out "how to deliver on the promise" would be to follow the protocols and procedures used to figure out how to deliver on the promise of other medical devices. These protocols and procedures, and ethical guidelines as well (link), were developed over decades in response to abuses of the past. (The Tuskegee experiments come to mind.)
That calls for controlled clinical trials under informed consent for safety and efficacy, careful study of the results, weeding out of unproven or dangerous technologies via regulation, and all this even before wide-scale rollouts of these health IT medical devices. Even after rollout, there needs to be a robust post-marketing surveillance process.
That's how it works with other medical devices and with pharmaceuticals. HIT medical devices deserve no special accommodation for any logical or ethical reason I can think of.
A lesson here: computer people, and health IT zealots of any background, need to be kept at arm's length from clinical settings, and on very short leashes in those settings.
-- SS
Aug. 3 addendum: the "period of implementation, competition and iteration to figure out how to deliver on the promise" in the UK did not turn out very well.
