Sunday, October 24, 2010

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)

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. 

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

Posted by: David C. Kibbe, MD MBA | Nov 13, 2009 1:23:24 PM

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.

Posted by: bev M.D. | Nov 13, 2009 1:45:24 PM

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.

Posted by: Matthew Holt | Nov 13, 2009 2:46:07 PM

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.

Posted by: Brian Klepper | Nov 13, 2009 3:39:25 PM


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.

Posted by: Gilles Frydman | Nov 14, 2009 1:58:38 PM

Mark has worked very hard to forward the agenda of HIMSS vendors that he represents. His agenda has hurt the many EMR vendors that CCHIT has marginated. His agenda has hurt physicians who end up purchasing costlier, bloated, unusable "certified" EHR systems. His agenda has led to the HITECH Act, another cash-for-clunkers scheme which is a Federal mandate which has forced doctors to actually "significantly use" these certified clunkers or else get penalized by big government.

May he RIP, but to cast him as a friend of IT and a friend of health care is misguided. Good riddance Leavitt- go to an island far, far away.

Posted by: Al Borges MD | Nov 30, 2009 4:09:40 AM

An observation immediately jumps off this page, based on the content seen here, folks appear to be hitting the anxiolytics and SSRI's to heavily. Let's not forget there is a half life to using this stuff.

Now back to the business at hand, this page reads like a farewell to a benevolent king. How quick you are to forget that this man operated a business with an intent to make profits without a business license and with a defunct state charter, passing himself off as the panacea for ulcers caused by a lack of certifying body.

Let us think of Mark's resignation as required debridement of a nasty wound. The sugar-coated words of those who have engaged in battle with Mark Leavitt come upon us like a wet to dry dressing that is just too wet. I say tear the bandage off, and let the air at it!

Posted by: Walla Walla | Nov 30, 2009 9:30:16 PM


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