I don’t know about you, but when I read the FDASIA Health IT Report released by HHS on April 3, I found it to be largely quite predictable. Indeed I’ve been scanning the media coverage of the report and I haven’t seen anyone so far express shock or surprise at what was in the report. How is it that we all pretty much knew what would be in there? Quite simply the three agencies that wrote the report – FDA, ONC and FCC – studiously and carefully drew upon the prior work of a large number of organizations. They very specifically incorporated the work of the IOM Committee on Patient Safety in Health Information Technology, as well as the FDASIA working group that Congress had asked the agency to convene. Indeed the new center described in the report is actually already accounted for in the government’s fiscal 2015 budget.
So if there’s very little new in the report, is that good or bad? Yes… A bit of both. On the plus side, it shows that these federal agencies are listening to an awful lot of very smart people. They are listening to medical and other experts enlisted by the IOM, they are listening to the public’s input as obtained through the FDASIA process and they’re listening to people on Capitol Hill. More on that later.
So why am I not completely happy? Well, I suppose I wanted more. Let’s take a deeper look.
Major Features of the HHS Strategy
If you really want to understand the report, you probably ought to read the 32 pages yourself. But I’ll give you the Reader’s Digest version here.
A three-tiered system
At a high level, the report says that health information technology can be stratified into three levels. Whoever originally thought of stratifying risk into three levels – high, medium and low –probably 1,000 years ago should have trademarked it because now everybody thinks about risk that way. For example, traditional medical devices are stratified into class I, II, and III based on risk. So in the new vocabulary of the report, we divide all HIT into three risk levels as follows: Keep reading>>