Monday, November 16, 2009

Sometimes I feel like a lone wolf...

I'm sitting here at the 2009 annual meeting of the American Medical Informatics Association. This is my first time at this meeting. I was disappointed to see such a sparse pathology presence here, but given my limited interaction with the organization and its website, I wasn't terribly surprised. It is a problem which needs to be corrected especially given the influence that this organization has on national policy.

Having said (written) that, the meeting has been great so far. The buzz mostly surrounds the HITECH portion of the American Recovery and Reinvestment Act (ARRA). David Blumenthal gave a keynote address, and during the question session afterwards, one gentleman whose name I unfortunately don't have, gave a wonderful analogy to a situation that I find myself struggling with on an almost daily basis. He said that HITECH should have been constructed much more like the Clean Water Act. In the Clean Water Act, those companies who are producing the pollution as a result of manufacturing are responsible for introducing measures to reduce it. Everyone who lives downstream of the water which has been polluted are not required to do anything because, while they are consuming the water (after its been treated, obviously), they are not creating the pollution. Unlike the Clean Water Act, HITECH and HIPAA puts the burden of compliance with the federal regulations on the end user of the technology rather than on the vendors producing and designing it. This is akin to requiring everyone who lives downstream of polluted water to clean it up because they are consumers of it.

I went to a talk put on by the Certification Commission for Health Information Technology (CCHIT - I think that certification for information systems sounds like a great idea. It would make it much easier for me and my institution, as consumers of these systems, to make educated choices without spending huge amounts of time doing research. CCHIT obviously has its flaws, but I think that the concept is good. However, when I checked the CCHIT website, there is no Laboratory or Pathology working group. Radiology and Pharmacy are also missing. Pathology (which, for clarification, as far as I am concerned always includes Laboratory Medicine), Pharmacy and Radiology are usually the three biggest utilizers of health information technology because of the information management demands (I like to refer to them as the Big Three). CCHIT does have medical subspecialty groups, though, because cardiovascular health and dermatology are both represented by their own working groups. If CCHIT gets deemed status, such as what the College of American Pathologists ( has for inspection and certification of laboratories under the Clinical Laboratory Improvement Act (CLIA), then I have grave concerns that the information needs of the Big Three are going to be unrealistic or insufficient. In the laboratory as in other medical areas, we have very specialized needs which CCHIT and HITECH have not yet addressed.

For example, is there any plan to require certification of middleware and instrument software? These applications house protected health information (PHI) just like electronic medical records (EMRs), but in my experience there are much less likely than laboratory information systems to be compliant with the HIPAA Final Security rule, even though that rule was in force as of April 2003. This puts me in a bit of a pickle because, in some cases, the only instrument that is available to provide the medical care that our patients need has associated software which breaks the rules. This is not an uncommon situation, and it takes quite a bit of discussion with a vendor to get them to realize that this is a problem. This is a huge time drain. Sitting between the end users in the lab who really want the instrument and the instrument vendor whose software has serious problems is not a fun place to be, and I am finding myself there more and more frequently. Simply from a time perspective, it would be nice if certification extended to these other medical applications so that I could spend my time doing things that are much more productive, like research and development of new cool tools.

I am concocting some plans to help change this situation, but if anyone has any constructive suggestions on how not to be a lone wolf crying in the darkness, I would be happy to hear them. I've gotten a few so far, one from the former National Director of Health Information Technology and others from members of the AMIA Policy Committee. All of them are sure to make me very unpopular, but when has that ever stopped me?