Since at least the creation of the Office of the National Coordinator for Health Information Technology, it’s been quite clear that the federal government was going to play a major role in the evolution of health IT across the country.
Now, at least one observer is predicting that, particularly when it comes to the matter of regulating new technology, the federal role is going to get even larger.
As he puts it, “FDA’s exemption for EHRs seems headed the way of the dodo bird.” Two “opposing” trends, he notes, will ultimately be responsible for the Food & Drug Administration’s full-scale entry into the arena of EHR regulation.
The first, ironically, is something many providers have been clamoring for, ever “greater functionality for EHRs”. On the other side,however, there’s “the trend toward greater FDA regulation of any software functionality that can impact patients.”
Needless to say, he thinks “industry needs to start planning its response now. And when I say industry, I’m including not only traditional software vendors, but those users that potentially cross the line of FDA jurisdiction by modifying what they purchase.”
That response, he suggests, “can include a wide range of activities from advocacy to ensure the agency understands the importance of a light touch in some areas of software development where speed and agility are essential, to preparing for FDA regulation for those types of software that clearly and directly impact patient care.”
We’ll leave it to readers to mine the details of his position. We’re wondering about an angle not addressed in his argument. To put it mildly, the introduction of another regulatory process into the HIT transition is bound to slow things down a bit. This may or may not be a necessary additional layer of process, but it seems reasonable to suspect that at some point the decision to regulate – or, to put it in more neutral terms, the desire to shape ultimate outcomes – is bound to run into the desire to move the country quickly across the HIT frontier.
So what’s the proper balance between making sure we move forward quickly and ensuring that we do so safely?
