On the safety of EHRs

Nov 29, 2019

The subject of EHR safety is back in the news - probably driven by the AMIA meeting last week:

“I remember internal conversations where we talked about ‘What is the equivalent of a plane crash that is going to get the attention of people?’” said Reider, who now practices family medicine in upstate New York. “‘Is it going to be a congressperson’s relative is harmed by health IT that causes the attention to shift?’ I would offer that still hasn’t happened yet, but someday it will. And gosh, wouldn’t it be a horrible thing that we have to wait for that to happen?”

from https://khn.org/news/no-safety-switch-how-lax-oversight-of-electronic-health-records-puts-patients-at-risk/

What the article doesn’t discuss - which is actually a remarkable omission - is that the issue at heart is not technology, and not even the software under question.

That’s actually evident in the two solid instances of harm offered in the article:

KHN/Fortune examined more than two dozen such cases, such as a California woman who mistakenly had most of her left leg amputated because the EHR sent another patient’s pathology report indicating cancer to her medical file. A Vermont patient died after a doctor’s order to scan her brain for an aneurysm never made it from the computer to the lab

Both of these are errors at the perimeter of the EHR - they involve not technology but information systems, interoperability, and actually sound like the heart of the problem could be lack of a common patient identifier.

That’s the thread running through through all this - the EHRs are just one cog in a fiendishly complicated system. Since they are the central system of record, any mistake anywhere in the system ends up as an error in the EHR.

Of course, there are are real errors in the large systems - there always is. And the systems are highly configurable, which is it’s own fertile source of errors. But most of the errors I’ve seen arise at the boundaries of the systems - our fragmented information systems are a natural representation of our fragmented healthcare system.

One easy knee jerk reaction to this is to regulate EHRs as a medical device:

The bipartisan law, which speeds up approvals for some medical therapies, states flatly that electronic health records are not medical devices subject to FDA scrutiny.

There’s a place for regulation, but treating systems of systems as a device, and applying language and systems meant for devices… I don’t think that’s going to help.

On the other hand, the safety of the healthcare system as a whole, as supported by it’s information systems: we need to take that seriously.

Some longtime EHR safety advocates say they have all but given up hope for consensus on any system that would investigate and share findings from adverse events, as happens in other industries, like transportation and aviation.

And collecting information and sharing findings would be a great way to start. But I’m not holding my breath.