HIPAA News

HHS Increases Civil Monetary Penalties for HIPAA Violations in Line with Inflation

The U.S Department of Health and Human Services’ has increased the civil monetary penalties for HIPAA violations to take inflation into account, in accordance with the Inflation Adjustment Act.

The final rule was issued and took effect on Tuesday November 5, 2019. This rule increases the civil monetary penalties for HIPAA violations that occurred on or after February 18, 2019. Under the new penalty structure, the increases from 2018 to 2019 are detailed in the table below:

Penalty Tier Level of Culpability Minimum Penalty per Violation

(2018 » 2019)

Maximum Penalty per Violation

(2018 » 2019)

New Maximum Annual Penalty

(2018 » 2019)*

1 No Knowledge $114.29 » $117 $57,051 » $58,490 $1,711,533 » $1,754,698
2 Reasonable Cause $1,141 » $1,170 $57,051 » $58,490 $1,711,533 » $1,754,698
3 Willful Neglect – Corrective Action Taken $11,410 » $11,698 $57,051 » $58,490 $1,711,533 » $1,754,698
4 Willful Neglect – No Corrective Action Taken $57,051 » $58,490 $1,711,533 » $1,754,698 $1,711,533 » $1,754,698

Penalties for HIPAA violations that occurred prior to February 18, 2019 have increased to $159 per violation, with an annual cap of $39,936 per violation category.

Earlier this year, the HHS’ Office for Civil Rights announced that it had reduced the penalties for HIPAA violations in certain tiers after a review of the wording of the HITECH Act. The maximum penalty for a HIPAA violation in the highest tier remained at $1.711 million, per violation category per year. Prior to the review, the maximum HIPAA violation penalty was $1.711 million in all four penalty tiers.

*The notice of enforcement discretion, announced on April 30, 2019, capped the maximum annual penalties at $10,000 (Tier 1), $100,000 (Tier 2), $250,000 (Tier 3), and $1,711,533 (Tier 4). The notice of enforcement discretion stated that the reviewed penalty tiers would also be adjusted in line with inflation. The multiplier used by OCR to calculate the cost-of-living increases was based on the Consumer Price Index for all Urban Consumers (CPI–U) for October 2019, which was 1.02522. That would make the new maximum penalties under the notice of enforcement discretion $10,252.20 (Tier 1), $102,522 (Tier 2), $256,305 (Tier 3), and $1,754,698 (Tier 4).

While OCR’s notice of enforcement discretion states that OCR will be adopting the new, revised penalties, this has yet to be made official and is pending further rulemaking. The notification of enforcement discretion creates no legal obligations and no legal rights, so OCR could therefore legally use the above maximum penalty amount of $1,754,698 per violation category, per year across all penalty tiers.

Full details of the new penalty structures have been published in the Federal Register for all agencies, including the FDA, ACF, HRSA, AHRQ, OIG, CMS, and OCR and can be viewed here (PDF).

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Texas Health and Human Services Commission Pays $1.6 Million HIPAA Penalty

The Department of Health and Human Services’ Office for Civil Rights (OCR) has imposed a $1.6 million civil monetary penalty (CMP) on Texas Health and Human Services Commission (TX HHSC) for multiple violations of Health Insurance Portability and Accountability Act (HIPAA) Rules.

TX HHSC is a state agency that operates supported living centers, regulates nursing and childcare facilities, provides mental health and substance abuse services, and administers hundreds of state programs for people in need of assistance, such as individuals with intellectual and physical disabilities.

OCR launched an investigation following receipt of a breach report from the Department of Aging and Disability Services (DADS), a state agency that was reorganized into TX HHSC in September 2017. On June 11, 2015, DADS reported a security incident to OCR which stated that the electronic protected health information (ePHI) of 6,617 individuals had been exposed over the internet. The exposed information included names, addresses, diagnoses, treatment information, Medicaid numbers, and Social Security numbers.

The information was exposed during the migration of an internal CLASS/DBMD application from a private server to a public server. A flaw in the software of the application allowed ePHI to be accessed over the internet without any authentication. As a result of the flaw, private and highly sensitive information could be found and accessed through a Google search.

TX HHSC was unable to provide documentation to demonstrate compliance with three important provisions of HIPAA Rules. OCR determined that TX HHSC had violated four HIPAA provisions.

  • 45 C.F.R. § 164.308(a)(1 )(ii)(A) – Failure to conduct a comprehensive organization-wide risk analysis to identify all risks to the confidentiality, integrity, and availability of PHI
  • 45 C.F.R. § 164.312(a)(1) – Failure to implement access controls. Credentials were not required to access ePHI contained in its CLASS/DBMD
  • 45 C.F.R. § 164.312(b) – Failure to implement audit controls that recorded user access on the public server, which prevented TX HHSC from determining who had accessed ePHI in the application during the time it was exposed.
  • 45 C.F.R. § 164.502(a) – The above failures resulted in an impermissible disclosure of the ePHI of 6,617 individuals.

Under HIPAA, financial penalties are determined based on the level of culpability. OCR determined that the violations fell short of willful neglect and constituted reasonable cause – the second penalty tier. For each of the above classes of HIPAA violation, the minimum penalty for a violation is $1,000 up to a maximum financial penalty of $100,000 per year. The risk analysis failures, access controls failures, and audit control failures spanned from 2013 to 2017, hence the $1.6 million penalty.

“Covered entities need to know who can access protected health information in their custody at all times,” said OCR Director Roger Severino. “No one should have to worry about their private health information being discoverable through a Google search.”

We initially reported on the HIPAA penalty in March 2019 when it appeared that a settlement had been reached between TX HHSC and OCR over the HIPAA violations. The 86th Legislature of the State of Texas had voted to approve the settlement; however, it would appear that the proposed settlement was rejected. OCR issued a Notice of Proposed Determination on July 29, 2019.

TX HHSC did not contest the findings of OCR’s Notice of Proposed Determination and waived the right to a hearing. OCR imposed the CMP on TX HHSC on October 25, 2019.

This is the second HIPAA penalty to be announced by OCR this week. A few days ago, OCR announced a $3 million settlement had been reached with the University of Rochester Medical Center to resolve HIPAA violations related to the loss of unencrypted devices containing ePHI.

The TX HHSC CMP is the seventh HIPAA penalty of 2019. The latest CMP brings the total HIPAA fines for 2019 up to $9,949,000.

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Lack of Encryption Leads to $3 Million HIPAA Penalty for New York Medical Center

The University of Rochester Medical Center (URMC) has paid a $3 million HIPAA penalty for the failure to encrypt mobile devices and other HIPAA violations.

URMC is one of the largest health systems in New York State with more than 26,000 employees at the Medical Center and various other components of the health system, including Strong Memorial Hospital and the School of Dentistry.

The Department of Health and Human Services’ Office for Civil Rights (OCR) launched an investigation following receipt of two breach reports from UMRC – The loss of an unencrypted flash drive and the theft of an unencrypted laptop computer in 2013 and 2017.

This was not the first time OCR had investigated URMC. An investigation was launched in 2010 following a similar breach involving a lost flash drive. In that instance, OCR provided technical compliance assistance to URMC. The latest investigation uncovered multiple violations of HIPAA Rules, including areas of noncompliance that should have been addressed after receiving technical assistance from OCR in 2010.

Under HIPAA, data encryption is not mandatory. Following a risk analysis, as part of the risk management process, covered entities must assess whether encryption is an appropriate safeguard. An alternative safeguard can be implemented in place of encryption if it provides an equivalent level of protection.

In this case, URMC had assessed risk and determined that the lack of encryption posed a high risk to the confidentiality, integrity, and availability of ePHI, yet failed to implement encryption when it was appropriate and continued to use unencrypted mobile devices that contained ePHI, in violation of 45 C.F.R. § 164.31 2(a)(2)(iv).

OCR’s investigation confirmed that the ePHI of 43 patients was contained on the stolen laptop and as a result of the theft, that information was impermissibly disclosed – 45 C.F.R. §164.502(a). OCR also determined that URMC had failed to conduct a comprehensive, organization-wide risk analysis – 45 C.F.R. § 164.308(a)(1)(ii)(A) – that included all risks to the confidentiality, integrity, and availability of ePHI, and covered ePHI stored on the lost and stolen devices.

Risks had not been sufficiently managed and reduced to reasonable and acceptable level – 45 C.F.R. §164.308(a)(l)(ii)(B) – and policies and procedures governing the receipt and removal of hardware and electronic media in and out of its facilities had not been implemented – 45 C.F.R. § 163.310(d).

In addition to the $3,000,000 financial penalty, URMC is required to adopt a robust corrective action plan to address all aspects of noncompliance identified by OCR. URMC’s compliance efforts over the next two years will be scrutinized by OCR to ensure continuing compliance.

“Because theft and loss are constant threats, failing to encrypt mobile devices needlessly puts patient health information at risk,” said OCR Director Roger Severino. “When covered entities are warned of their deficiencies, but fail to fix the problem, they will be held fully responsible for their neglect.”

This is the sixth financial penalty of 2019 that OCR has issued to resolve violations of the Health Insurance Portability and Accountability Act and it is the fourth enforcement action to cite a risk analysis failure.

The risk analysis is one of the most important elements of HIPAA compliance and a risk analysis failure is the most common HIPAA violation cited in OCRs enforcement actions.

OCR has released a risk assessment tool to help covered entities and business associates comply with this aspect of HIPAA. Further information on the HHS risk assessment tool is available on this page.

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Roger Severino Gives Update on OCR HIPAA Enforcement Priorities

Roger Severino, Director of the HHS’ Office for Civil Rights, has given an update on OCR’s HIPAA enforcement priorities at the OCR/NIST 11th Annual HIPAA Conference in Washington D.C.

Severino confirmed that one of OCR’s top policy initiatives is still enforcing the rights of patients under the HIPAA Privacy Rule and ensuring they are given timely access to their health information at a reasonable cost.

Under HIPAA, patients have the right to view and check their medical records and obtain a copy of their health data, yet there are still healthcare organizations that are making this difficult. OCR has already agreed to settle one case this year with a HIPAA-covered entity that failed to provide a patient with a copy of her health information. OCR had to intervene before those records were provided to the patient. The entity in question, Bayfront Health St Petersburg, paid a financial penalty of $85,000 to resolve the HIPAA violation.

More financial penalties will be issued to covered entities that fail to comply with this important provision of HIPAA. Severino confirmed that Bayfront Health’s financial penalty was the first in a series of penalties for covered entities that are not providing patients with access to their health data within 30 days of the request being received.

OCR has issued guidance to help covered entities comply with this aspect of HIPAA, but now the time has come “for serious enforcement,” explained Severino.

Severino also explained that patients must be allowed to have their health data sent to health apps. The requests should only be denied if the app poses a security risk to the covered entity. Severino confirmed a covered entity is not liable for what happens to PHI after a disclosure to a health app at the patient’s request.

In many cases, patients are not being denied access to their medical records and requests for copies of medical records are being honored, but patients are being charged excessive amounts. In 2016, OCR issued guidance on the amounts that healthcare organizations can charge for providing copies of medical records and further clarification was also issued on the fee structures that can be adopted. Financial penalties for overcharging for copies of medical records can be expected.

The crackdown on patient access issues is part of the HHS Regulatory Sprint to Coordinated Care initiative and fits in with the Trump Administration’s drive to improve transparency of healthcare costs and the reduction of the cost of healthcare in the United States.

A prop is always useful for getting a point across. In this case Severino used a medical boot that he purchased to aid recovery from a torn Achilles tendon. Severino said he was advised by his doctor to purchase the boot and paid his doctor $430 for the treatment aid. He explained that he later looked online and found the exact same boot for sale on Amazon for $70, saying “This boot represents what’s wrong with price transparency.”

OCR is looking at how HIPAA can be updated to address this problem, such as requiring healthcare providers and health plans to provide information about the expected out-of-pocket costs for medical services or equipment before those items or services are provided to patients.

Contractors provide quotes for work in advance and banks provide customers with information on the costs of mortgages before providing the funds, but that doesn’t always happen in healthcare. That is something that needs to change.

Severino also touched on the issue of cybersecurity. Phishing and ransomware attacks cause a high percentage of healthcare data breaches and in many cases the attacks can be prevented by practicing good cybersecurity hygiene.

Ransomware is often installed through the exploitation of vulnerabilities in Remote Desktop Protocol. The failure to address those RDP vulnerabilities has led to several major healthcare ransomware attacks and data breaches.

Phishing attacks have been a major cause of healthcare data breaches for several years. It is not possible to prevent all attacks, but by complying with HIPAA, risk can be significantly reduced. HIPAA calls for covered entities to provide employees with training to help them identify and avoid phishing threats. Severino explained that training is critical, as is conducting phishing simulation exercises to find out how susceptible employees are to phishing.

Other cybersecurity failures that could prevent data breaches include the lack of multi-factor authentication, poor access controls, and the failure to promptly terminate access to systems when employees leave the company.

2019 may have only seen four OCR financial penalties issued to date to resolve HIPAA violations but the year is far from over. Further penalties will be announced this year, including one $2.1 million civil monetary penalty.

Severino did not confirm the reason for the penalty or provide any details, other than saying a final determination has been reached and the penalty will be announced by the department soon.

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Dental Practice Fined $10,000 for PHI Disclosures on Yelp

The Department of Health and Human Services’ Office for Civil Rights has agreed to settle a HIPAA violation case with Elite Dental Associates over the impermissible disclosure of multiple patients’ protected health information (PHI) when responding to patient reviews on the Yelp review website.

Elite Dental Associates is a Dallas, TX-based privately-owned dental practice that provides general, implant and cosmetic dentistry. On June 5, 2016, OCR received a complaint from an Elite patient about a social media HIPAA violation. The patient claimed the dental practice had responded to a review she left on Yelp and publicly disclosed some of the PHI.

When replying to the patient’s June 4, 2016 post, Elite disclosed the patient’s last name along with details of her health condition, treatment plan, insurance, and cost information.

The investigation confirmed that to be the case, but also found it was not the first time that PHI had been disclosed without authorization on the social media platform when responding to patient reviews. Further impermissible PHI disclosures were found on the Elite review page.

In addition to the impermissible disclosures of PHI, which violated 45 C.F.R. § 164.502(a), OCR determined Elite had not implemented policies and procedures relating to PHI, in particular the release of PHI on social media and other public platforms, in violation of 45 C.F.R. § 164.530(i). Elite was also discovered not to have included the minimum required content in its Notice of Privacy Practices as required by the HIPAA Privacy Rule (45 C.F.R. § 164.520(b)).

OCR agreed to a HIPAA violation fine of $10,000 and a corrective action plan (CAP) to resolve the alleged HIPAA violations and settle the case with no admission of liability. The three potential HIPAA violations could have attracted a substantially higher financial penalty; however, when considering an appropriate financial penalty, OCR took the financial position of the practice, its size, and Elite’s cooperation with the OCR investigation into account.

“Social media is not the place for providers to discuss a patient’s care,” said OCR Director, Roger Severino.  “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

This is the 4th OCR HIPAA settlement of 2019. In September, OCR fined Bayfront Health St Petersburg $85,000 for a HIPAA Right of Access failure. In May, two settlements were agreed to resolve multiple HIPAA violations at Medical Informatics Engineering ($100,000) and Touchstone Medical Imaging ($3,000,000).

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Senate Fails to Remove Ban on Funding of National Patient Identifier

The Department of Health and Human Services (HHS) is prohibited from using any of its budget to fund the development and implementation of a national patient identifier, but there was hope that the ban would finally be lifted this year.

The House of Representatives added an amendment to its Departments of Labor, Health, and Human Services, and Education, and Related Agencies Act of 2020 which removed the ban, which would allow the HHS to follow through on this requirement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

It now looks likely that the ban will remain in place for at least another year as the Senate Appropriations Subcommittee’s draft 2020 fiscal budget bill, released last Wednesday, has retained the text banning the HHS from acting on this HIPAA requirement.

The ban has been in place since 1999 and was introduced because of concerns over patient privacy. The ban has been written into the Congressional budget every year since and the proposed 2020 fiscal budget bill is no different.

The proposed fiscal budget bill includes the text, “None of the funds made available in this act may be used to promulgate or adopt any final standard under section 1173(b) of the Social Security Act providing for, or providing for the assignment of, a unique health identifier for an individual (except in an individual’s capacity as an employer or a health care provider), until legislation is enacted specifically approving the 13 standard.”

The purpose of the national patient identifier is to make it easier for patients to be efficiently matched with their health records. Regardless of where a patient receives treatment, their health data will be tied to them through their unique national patient identifier code. The new identifier would help to ensure that patient information could flow freely between different healthcare organizations and it is seen by many healthcare industry stakeholders to be essential for full interoperability. A national patient identifier could help to improve patient privacy, patient safety, and eliminate considerable waste and misspending in healthcare.

For several years, industry associations such as the College of Healthcare Information Management Executives (CHIME), the American Health Information Management Association (AHMIA), and the Health Innovation Alliance (HIA) have been calling for the ban to be lifted.

HIA Executive Director Joel White has called the ban ‘antiquated’ and said studies have suggested that patients are matched with their records as little as 50% of the time. A national patient identifier would instantly solve that problem.

Efforts to have the ban removed have stepped up in recent years, and this year 56 healthcare stakeholder groups urged the Senate to remove the ban. Significant progress was made this year when the amendment receives strong bipartisan support in the House of Representatives.

Convincing the Senate to lift the ban is proving more difficult. As long as privacy concerns remain, the ban is unlikely to be lifted. One of the main issues is a single identifier would be used to tie medical records to an individual from birth until death, and that could allow unprecedented tracking of Americans through their health records. It could also potentially facilitate the sharing, use, and analysis of patient data without patient consent.

While the draft fiscal budget bill has not had the ban removed, it is possible that an amendment could be made at a later date. AHMIA and CHIME leaders remain hopeful that the Senate will follow the House’s lead and have the ban lifted this year.

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OCR Settles First HIPAA Violation Case Under 2019 Right of Access Initiative

Earlier this year, the Department of Health and Human Services’ Office for Civil Rights (OCR) announced that one of the main areas of HIPAA enforcement in 2019 would be HIPAA right of access failures, including untimely responses to access requests and overcharging for copies of medical records.

The HIPAA right of access allows patients to obtain copies of their medical records on request. HIPAA-covered entities are required to honor those requests and provide patients with access to PHI or copies of health data contained in a ‘designated record set’ within 30 days of the request being received. A covered entity is permitted to charge a reasonable, cost-based fee for providing a copy of the individual’s PHI, which can include the cost of certain labor, supplies and postage.

HIPAA-covered entities that fail to provide copies of records in a reasonable time frame or charge excessive amounts for providing a copy of a patient’s PHI are in violation of the HIPAA Privacy Rule – See 45 CFR 164.501. Such violations can attract a sizable financial penalty.

This week, OCR has announced that the first settlement has been reached with a HIPAA-covered entity under the right of access initiative. Bayfront Health St. Petersburg, a 480-bed hospital in St. Petersburg, FL, has agreed to pay OCR $85,000 to settle the case.

OCR launched an investigation into a potential HIPAA violation at Bayfront Health following receipt of a complaint from a patient on August 14, 2018. The patient alleged that she had requested her fetal heart monitor records from Bayfront Health St. Petersburg in October 2017. At the time of the complaint, 9 months after the request was made, she had still not been provided with a full copy of her records.

OCR confirmed that the patient made the request on October 18, 2017 and was informed by Bayfront Health that the records could not be found. Two further requests were sent to Bayfront Health by the patient’s counsel on January 2, 2018 and February 12, 2018. In March 2018, Bayfront Health provided an incomplete set of records and a complete response was only received on August 23, 2018. The patient’s counsel shared the records with the patient, but it took the intervention of OCR for the fetal heart monitor records to be provided to the patient. Those records were provided directly to the patient on February 7, 2019.

OCR determined that the failure to provide access to the patient’s designated record set was a clear violation of 45 C.F.R. § 164.524 and that the HIPAA violation warranted a sizable financial penalty.

“Providing patients with their health information not only lowers costs and leads to better health outcomes, it’s the law,” said OCR Director Roger Severino.  “We aim to hold the health care industry accountable for ignoring peoples’ rights to access their medical records and those of their kids.”

In addition to the financial penalty, Bayfront Health has agreed to implement a corrective action plan and will be monitored by OCR for the following 12 months.

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32% of Healthcare Employees Have Received No Cybersecurity Training

There have been at least 200 breaches of more than 500 records reported since January and 2019 looks set to be another record-breaking year for healthcare data breaches.

The continued increase in data breaches prompted Kaspersky Lab to conduct a survey to find out more about the state of cybersecurity in healthcare. Kaspersky Lab has now published the second part of its report from the survey of 1,758 healthcare professionals in the United States and Canada.

The study provides valuable insights into why so many cyberattacks are succeeding. Almost a third of surveyed healthcare employees (32%) said they have never received cybersecurity training in the workplace.

Security awareness training for employees is essential. Without training, employees are likely to be unaware of some of the cyber threats that they will encounter on a daily basis. Employees must be trained how to identify phishing emails and told of the correct response when a threat is discovered. The failure to provide training is a violation of HIPAA.

Even when training is provided, it is often insufficient. 11% of respondents said they received cybersecurity training when they started work but had not received any training since. 38% of employees said they were given cybersecurity training each year, and a fifth (19%) of healthcare employees said they had been provided with cybersecurity training but did not feel they had been trained enough.

32% of respondents said they had been provided with a copy of their organization’s cybersecurity policy but had only read it once and 1 in 10 managers were not aware if their company had a cybersecurity policy.  40% of healthcare workers in the United States were unaware of the cybersecurity measures protecting IT devices at their organization.

Training on HIPAA also appears to be lacking. Kaspersky Lab found significant gaps in employees’ knowledge of regulatory requirements. For instance, 18% of respondents were unaware what the Security Rule meant and only 29% of respondents were able to identify the correct meaning of the HIPAA Security Rule.

Kaspersky Lab researchers recommend hiring a skilled IT team that understands the unique risks faced by healthcare organizations and has knowledge of the tools that are required to keep protected health information safe and secure.

It is also essential to address data security and regulatory knowledge gaps. IT security leaders must ensure that every member of the workforce receives regular cybersecurity training and is fully aware of the requirements of HIPAA.

It is also important to conduct regular assessments of security defenses and compliance. Companies that fail to regularly check their cyber pulse can identify and address vulnerabilities before they are exploited by hackers and cause a costly data breach.

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Allscripts Proposes $145 Million Settlement to Resolve DOJ HIPAA and HITECH Act Case

A preliminary settlement has been proposed by Allscripts Healthcare Solutions to resolve alleged violations of HIPAA, the HITECH Act’s electronic health record (EHR) incentive program, and the Anti-Kickback Statute related to the electronic health record (EHR) company Practice Fusion, which was acquired by Allscripts in 2018.

Prior to the acquisition, Practice Fusion has been investigated by the Attorney’s Office for the District of Vermont in March 2017 and had provided documentation and information. Between April 2018 and January 2019, the company received further requests for documents and information through civil investigative demands and HIPAA subpoenas.

Then in March 2019, the company received a grand jury subpoena over a Department of Justice (DOJ) investigation into the business practices of Practice Fusion, potential violations of the Anti-Kickback Statute, HIPAA, and the payments received under the HHS EHR incentive program. Scant information has been released about the nature of the alleged violations by Practice Fusion.

The proposed settlement will see Allscripts pay $145 million to the DOJ to resolve the company and Practice Fusion of all civil and criminal liability related to the investigation. Allscripts President Rick Poulton hopes the settlement will be sufficient to resolve the case. Since Practice Fusion was acquired, Allscripts has had to devote an increasing amount of resources the investigation. Poulton wants to reach an agreement as soon as possible so the company can move on.

“While the amount we have agreed to pay of $145 million is not insignificant, it is in line with other settlements in the industry, and we are happy to have reached the agreement in principle,” said Poulton. “We will work with the DOJ to finalize the details of the settlement over the coming months”.

Last year, the HHS agreed a settlement with EHR vendor eClinicalWorks over alleged false claims related to the HITECH Act EHR incentive program. eClinicalWorks paid $155 million to resolve the case.

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