Software used by more than 850,000 healthcare provides to maintain medical records has proven to be substandard. The United States Department of Justice has approved the settlement of a whistleblower lawsuit against EClinical Works for $155 million, which constitutes the largest False Claims Act payout in the history of Vermont, but that may be the tip of the iceberg for the software provider. A class action suit has been filed in the Southern District of New York on behalf of millions of patients whose records may have been compromised by the software provider and that ECW lawsuit alleges damages of nearly $1 billion. According to Harmony Healthcare, the costs born by providers include “determining the level of faulty records as well as the expense to clean up the errors. Some of the errors may take a long time to uncover if they are able to be uncovered at all. There is uncertainty about the damages, even if there aren’t penalties assessed by CMS.”
There is an ongoing push in the United States to digitize all medical records under the theory that electronic records can improve public health outcomes through the sharing and pooling of collected data across multiple platforms. There are financial incentives to encourage medical providers to make the switch and to document the meaningful use of electronic records. EClinical Works is a software provider that has positioned itself as an industry leader through aggressive marketing to a wide variety of clinical professionals. The United States government has standards in place to ensure electronic medical records are secure and before software can be used by clinical providers, it must be certified by the government. The ECW lawsuit alleges the software provider falsified key information about its programs to gain certification, and then claimed to be selling a more secure and efficient product than it actually was. The settlement with the Department of Justice explicitly states that ECW misrepresented its software capability in order to gain certification from the Department of Health and Human Services, which oversees the program.
The lead plaintiff in the class action suit is the estate of a cancer victim alleging problems related to the functional capacity of ECW software made it difficult to ascertain his proper medical history via electronic methods and thereby complicated and delayed vital treatment. Specifically, the ECW lawsuit alleges it was impossible to properly assess and treat the cancer in a timely fashion. The suit claims millions of unnamed class members can no longer rely on the accuracy of their medical records due to the falsification of claims regarding the true capacity of ECW’s software products.
False Claims Act lawsuits can be brought by whistleblowers, the Department of Justice, or directly by injured plaintiffs, as in the most recent ECW lawsuit.