Wednesday, May 27, 2015

First, We Sue All the EHRs

There appears to be a new tactic in medical malpractice suits: blame the EHR.  Oh, great; something else we can try to make their fault.

Evidence for this trend is, at this point, more directional than statistically significant.  An analysis by The Doctors Company, a large medical malpractice insurer, found that EHRs were a contributing factor in less than 1% of suits from 2007 - 1H 2014, but that the rate had doubled in the last few months of the study.

Experts suggest that the percentages are still small because EHR adoption did not really pick up until after HITECH passed in 2009, and that malpractice cases usually take several years to work themselves through the legal system.  So what we're seeing now may be the tip of the iceberg.

Other research is mixed.  A 2015 review of the literature by RTI International for HHS on health IT's impact on patient safety concluded that it most definitely can help, including lowering the risk for malpractice claims.  A study by CRICO, another malpractice insurer, found that EHRs offer new types of risks -- some user error, some system-based.   Half of the cases they found resulted in "severe injury."  Incorrect information accounted for 20% of errors, although a variety of system failures were responsible for even more.

Fair enough to say that if EHRs work as intended, and if they are are used properly, then they can help reduce risks and improve patient outcomes...but both those "ifs" are not certainties by any means.  Thus the risk for malpractice and other legal risks.

The issue became visible last fall during the U.S Ebola scare, when the hospital with patient zero initially blamed its EHR for missing key information that would have helped them spot the proper diagnosis earlier, only to be firmly rebutted by Epic, the EHR vendor.  The facts appear to be that the problem was not the EHR itself but the workflow and how information in the EHR got viewed by whom (e.g., nurses notes were not readily visible to doctors).

I'll bet Epic felt it dodged a bullet, but they shouldn't be too complacent.  EHR vendors represent deeper pockets than most providers, which makes them a tempting target for lawsuits.  As Computerworld put it in an article last month, Lawyers smell blood in electronic medical records.

The article cited Keith Klein, a professor of medicine at UCLA, as describing four cases where the judgments were over $7.5 million because the data in the EHR couldn't be trusted.  Dr. Klein told Computerworld: "There are attorneys now looking for a clean case to sue the vendor.  This is reality. It is not theoretical."

Deep pockets, here we come.

In a related post, Dr. Jeffrey Guterman, another professor at UCLA, criticizes the push for meaningful use, suggesting that "meaningful users" are more important.  Dr. Guterman believes that once HITECH passed, EHR vendors made a land grab for market share, with the unintended consequence of diverting resources devoted to R&D and technology advancement.

Dr. Guterman further says that most EHR systems were built from billing platforms and/or use database structures that are well over thirty years old.  These lead directly to the interoperability issues that I've written about before, and which helps explain the EHR vendors' thirst for market share: once they get a customer, they know how difficult it will be for them to ever leave.

"Information blocking" is the new term being used for this intentional desire to confine patient information to a specific EHR platform.  ONC recently released a requested report on the topic to Congress, acknowledging that the practice is happening.  ONC also detailed the actions that it is already taking, or proposing to take, to address the practice, while noting that "many types of information blocking are beyond the reach of current federal law and programs to address."

A Health Affairs blog post by Julia Adler-Milstein notes both that "ONC makes plain that this behavior will no longer be tolerated," and that the criteria used to define what constitutes information blocking will be very difficult to prove, as the conduct has to be "objectively unreasonable in light of public policy."  As she says, "There is no question that the CEO of a large electronic health record vendor would have quite a different definition of “reasonable” than would our National Coordinator for Health IT."  Or a hospital CEO.

While ONC, many providers, and even some EHR vendors see a problem, Epic continues to deny there is one.  An Epic vice-president told The New York Times, "We do not participate in any activities that could be described as information blocking. To our knowledge, these activities are very rare, if they exist at all."

I'll bet he even said it with a straight face.

Congress inadvertently created the problem, and it can (in theory) pass all the laws ONC suggests to address it, but the truth is that information blocking is likely to continue until information sharing is a financial advantage to providers.  That may end up being true within an ACO (although many health systems are trying to accomplish this by making affiliated providers get on their EHR platform), but otherwise there is not much incentive to share.

As Dr. Adler-Milstein concluded, "When the C-suite truly believes that they can be most successful by competing on the basis of sharing and using data, rather than hoarding and controlling data, we will know that we have succeeded."  It's just hard to think of too many industries where companies compete by sharing their data.

I keep thinking of a recent Fortune article by Kentaro Toyama,   Professor Toyama throws cold water on the hope that technology will help control health costs.  His "Law of Amplification" asserts that:
Technology’s primary effect is to amplify, not necessarily to improve upon, underlying human inclinations.
That makes me think about those built-on-billing-systems EHRs that Dr. Guterman warned about, and suddenly the issues with EHRs are all too easy to understand.  They're not about the patients -- or, at least, not primarily for their benefit -- and their main focus is not assuring better care.  The vendors and even their customers would probably disagree with both assertions, but providers are buying the EHRs more to get the federal incentives and to help protect their revenue stream than to improve care.  And that is the problem.

Many readers probably recognized that my title referenced Shakespeare's "The first thing we do, let's kill all the lawyers" from Henry VI.  I have to admit that, until I looked it up, I assumed it was referring to venial or corrupt lawyers.  In fact, it means the opposite: it was spoken by a character trying to overthrow the government and the rule of law.

So it is with EHRs.  We shouldn't get caught up in blaming them for their perceived shortcomings and hamstringing their development with more rules.  Instead, we should do a better job of creating the appropriate environment for them to rapidly evolve to help improve care.

For previous thoughts on how to do that, try hereherehere, and here.

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