A recent investigation into Epic Systems’ proprietary software algorithms underscores the critical importance of whistleblowers to protect patients as the health technology industry develops.
Concerns About Epic Systems’ AI Algorithms
STAT News reported that several artificial intelligence algorithms developed by Epic may be providing inaccurate predictions that hospitals use for patients in certain circumstances.
STAT’s investigation – based on interviews with hospital employees, data scientists, Epic’s clients and others – found significant concerns about Epic’s algorithms. The most serious concerns are about the ability of its algorithm to accurately predict sepsis, a life-threatening condition stemming from complications of serious infections. Employees of several major health systems said that Epic’s sepsis algorithm “routinely fails to identify the condition in advance, and triggers frequent false alarms.”
Impact of Inaccurate Predictions on Patient Care
Experts told STAT they have found shortcomings with some of Epic’s other models, including those used to predict patients’ length of hospital stays and the likelihood of patients becoming severely ill, as well as predict those who may fail to show up for medical appointments.
Also concerning are incentive payments made by Epic to hospital systems to encourage adoption of its software algorithms in clinical care. The Wisconsin-based company has paid some health systems up to $1 million in incentives partly based on their adoption of predictive algorithms developed by Epic, according to STAT.
Epic Systems’ Response to Allegations
In response to the issues raised, STAT said that Epic “defended its approach to testing and distributing its AI products, asserting that its incentives are designed to reward implementation of technologies — whether developed by Epic or another company — that can improve patient care. It also said that some of the published studies critical of its sepsis algorithm arise from differences in the way some institutions choose to define the onset of sepsis, rather than underlying problems with the model’s technical performance.”
Epic is the largest electronic health records software company and the largest company selling algorithms that work inside electronic health records, with more than $3.3 billion in revenue in 2020. Epic’s software holds the medical records of approximately 250 million people, according to STAT.
The Role of Whistleblowers in Healthcare IT
The accuracy and reliability of health IT products and artificial intelligence software used in healthcare have enormous consequences on the quality of patient clinical care and patient safety.
The Department of Justice and the Office of Inspector General for the Department of Health and Human Services have made fraud and kickbacks in the electronic health record industry a top enforcement priority following the 2017 settlement of a groundbreaking “qui tam” (whistleblower) case against EHR vendor eClinicalWorks brought by Phillips & Cohen LLP.
Legal Precedents and Whistleblower Cases
The eClinicalWorks case alleged violations of the False Claims Act and the Anti-Kickback Statute in many ways, including knowingly failing to correct urgent problems and bugs in its EHR software and paying hidden kickbacks to customers to recommend its products. After the US Attorney’s Office in Vermont intervened in the case, eCW paid $155 million to settle the case and entered into an innovative corporate integrity agreement, the first of its kind in the EHR industry, with HHS OIG.
Phillips & Cohen has since settled two additional qui tam lawsuits involving EHR. The first alleged that Viztek, an EHR company based in North Carolina, had cheated on certification tests to hide failure of its software to conform with federal quality and safety standards. The US Attorney’s Office in New Jersey intervened in the case. Konica Minolta Healthcare, which acquired Viztek, paid $500,000 to resolve the allegations in 2020.
Earlier this year, the US Attorney’s Office in Miami, Florida, settled a qui tam case brought against Miami-based CareCloud by another Phillips & Cohen client alleging violations of the Anti-Kickback Statute through payments to providers to recommend purchase of the EHR software to other providers without disclosure of any concerns for functionality. Further enforcement actions against healthcare IT companies and health tech firms are expected in this growing area of federal fraud enforcement.
Importance of Whistleblowers in the Health Tech Industry
Whistleblowers can help pierce the veil of secrecy behind health tech products and enforce accountability in the healthcare IT and health tech industries when patients’ well-being and quality of care are on the line.
The False Claims Act empowers whistleblowers to sue on behalf of the government anyone who is alleged to have cheated the government. This includes entities that sell defective EHR systems and health tech products to hospitals and other healthcare providers used to treat Medicare and Medicaid patients.
The government will investigate the allegations in a qui tam lawsuit and decide whether to intervene in the case. If a whistleblower’s lawsuit is successful, the whistleblower can receive a reward of 15% to 30 % of the funds recovered as a result of their case. The False Claims Act also offers whistleblowers redress against job retaliation.
If you are aware of fraud in the health tech or EHR industry and would like to discuss your options with an experienced whistleblower lawyer, contact Phillips & Cohen for a free, confidential review of your matter.
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