Why the eClinicalWorks settlement may rattle the industry

Users are likely to gain additional clout in pointing out shortcomings with EHRs, perhaps spurring needed improvements in products.

The legal settlement between the Department of Justice and eClinicalWorks is a jolt to the system for vendors of electronic health records systems.

Granted, the announcement Wednesday afternoon just applied to the terms of the settlement between the federal agency and that one specific vendor. But the impact can be felt more widely, as developers of these systems now see they could be held similarly accountable.

It's important to underscore that, in the settlement, eClinicalWorks has denied any wrongdoing in agreeing to the terms, and that the claims "settled by the agreement are allegations only, and there has been no determination of liability." The company settled to "avoid the cost and uncertainty inherent in protracted litigation."

Still, the path to this case and the way in which it was brought should be of concern for vendors. The landmark case perhaps may provide the impetus to ensure that vendors’ EHR functionality is “as advertised,” and it lends significant credence to the importance of user experiences.

The suit was filed by Brendan Delaney, an IT staff worker for New York City who was implementing the eClinicalWorks system at Rikers Island jail; he contends he found problems with the coding of the software that affected its functionality, as did other users of the application. Those problems jeopardized patient care and could put patient lives at risk, Delaney contended in his suit.

Interestingly, the worker filed suit under the False Claims Act, a federal law that allows people who are not affiliated with the government to file actions against federal contractors, using the legal action to claim that fraud has been perpetrated against the government.

Such whistleblowing activity has occurred in other industries, but this is a first for healthcare IT. And it provides an interesting and powerful way for the government to enlist help in ensuring that HIT vendors are truthful and honest in how they achieve certification for software that's intended to help providers achieve meaningful use of EHR systems.

There's been some distrust of the incentive program, which has provided about $35 billion in federal funds to provider organizations so they can implement electronic records systems. Some have questioned who's really making sure that products can truly deliver needed functionality. The certification process for clinical records systems has not received the attention in recent years that it received early on.

Now, all that's changed, and in a big way. Delaney says other users of the eClinicalWorks system for the jail’s new system played a big role in identifying alleged shortcomings in its system, and problems with its design were highlighted as having the potential to cause patient safety risks.

Suddenly, this adds a whole new level of accountability for system vendors. Users can spot problems with systems as they train on them and use them daily, and usability and design issues now may become hot buttons that carry even more weight with vendors to listen to user concerns.

And it's hard not to notice that the IT staff worker who brought the whistleblower suit could stand to receive as much as $30 million from bringing the suit. Dollar amounts of that magnitude may incentivize others to pursue action in cases where they believe vendors might be defrauding the federal government.

Beyond that, there's nothing like a case such as this to throw the fear of God (and legal action) into an industry.

The $155 million in fines are only a small part of the penalty that eClinicalWorks faces. The settlement includes a requirement that the company enter a complex and thorough corporate integrity agreement that will provide oversight for how the company operates. That agreement also places requirements on the company to assist its customers, even so far as helping them transition to other EHR vendor systems.

At many levels, the announced settlement shows that EHR vendors have entered a period of increased scrutiny, with users now enabled to play a role in ensuring that systems can actually do what their developers say they can do.

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