Conspiracy theory Friday (FDA & CCHIT related)


Two fun things—First, Mark Leavitt says he’s quitting CCHIT in March. He says that he’ll be 60 then and wants to go do other stuff. Of course the cynics among you will say that he’s had enough of being beaten up by David Kibbe and Brian Klepper, and that CCHIT’s role as arbiter of meaningful use has been downgraded by David Blumenthal. Leavitt says in his outgoing email (not on any website I can find but I have a copy)

Given the current high-strung health IT news environment, the media may seek to conjure up some sensation-worthy driver of this decision, but the fact is that I am simply keeping a promise I made to my family and myself to retire from full-time work within a certain window of time”

It also happens that this announcement comes the day after Blumenthal sends out an email to the Health IT world that Vince Kuraitis (at the very least) sees as a direct shot at large health IT vendors whose products don’t play nice with others (i.e. aren’t too interoperable) yet are already CCHIT certified. Here’s Vince’s take on who should have got that email.

Second, the twittersphere has been abuzz with a series of hearings where the FDA has been taking opinions on how and why they should regulate Pharma advertising in social media. this is a non-trivial issue for both sides. Pharma wants to reach patients, patients want those social media players to exist, and the sites need money (which will have to come from Pharma, unless something changes in the space time continuum). I don’t pretend to know the outcome except to remind you all (via Bill Silberg) that a similar meeting was held more than a decade ago and the result was….nothing. no guidance, no policy.

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5 replies »

  1. 1.Too bad! I won’t have any more opportunities to write posts like David Kibbe & Mark Leavitt : Openness vs. Opacity.
    2. The FDA meeting offered some very interesting presentations and was much more interesting than what I originally expected. I would be very surprised if the new FDA does not come up with recommendations, within the normal DC timeframe (<25 yrs). After announcing originally that there would be no cell phone reception and no WiFi at the hearing on social media (!) , and after blocking CNBC from bringing a camera inside the hearing room, the FDA finally provided real time video streaming of the entire meeting. Extra kudos to @skypen who gave one the very best presentations and created http://fdasm.com where anyone interested in this topic can find all they need.

  2. Agreed. Mark has worked very hard to move things forward in Health IT. I hope he’ll find another venue where he can put his considerable talents and positive intentions to good use for us all.

  3. And I should have said that, while poking fun from the sidelines, I dont think that anyone has ever suggested that Mark was not working for the betterment of health care delivery via Health IT. And a leader with his skills and experience will continue to make a contribution somewhere.

  4. Do not underestimate the importance of the FDA’s new leadership. For one thing, the FDA has lacked a long term, permanent leader for years and years, making it difficult to form and execute coherent policy. For another, the new Comish and deputy are well liked by the employees, from my inside contacts, and are savvy, activist people. My hopes for them are higher than they have been in a long time.
    As for CCHIT, perhaps this is an example of the power of the people after all. I still think the FDA should regulate, at least in general terms, all health-related IT system functions other than simple data storage. There are too many bad, large vendor-driven systems out there which, besides not being interoperable, can be outright dangerous.

  5. Matthew: I wish Mark all the best in his next position, where ever life takes him. He’s a very smart and competent person, who I have known for almost 20 years, and who has always had tremendous energy and resolve. I’m sure he’ll continue to do well. Regards, DCK