Archive for January, 2010

Invited speaker to the first IEEE-AMA Conference, found here:

http://ama-ieee.embs.org/overview/speakers/

I am into my 3rd day at a conference hosted by CONTINUA and CIMIT on medical device interoperability at the FDA. We are engaged in a 3 day communication, interaction, workshop on how to apply the existing 510(k), 513(g), IDE rules and processes to interoperable medical devices and those applications that fall into the domain of interoperability. This is a rather unique area as attributes that are affected are intended use, risks and hazard assessments. I am unsure as to outcome as of yet, but it is clear that a key purpose of the conference has been achieved: getting device manufacturers, EMR vendors, and the FDA in the same room to discuss the intended purpose. If nothing else, this is truly a feat.

So, the book continues… I have close to 40,000 words completed on my way to 92,000. I am running long, though, in terms of figures and words. Plus, I’ve included a lot of compute code that I’ve written to support the modeling practices and ideas throughout. All-in-all I am estimating a 300 page book. Target date is still June 30th, 2009. Publisher is Artech House.