resolution agreement

OCR Concludes 2018 with All-Time Record Year for HIPAA EnforcementCorrective action / RA

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Corrective action / RA

Action type

Resolution agreement

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MD

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What went wrong

OCR Concludes 2018 with All-Time Record Year for HIPAA Enforcement - February7, 2019

  • Navigate to: HIPAA for Professionals Regulatory Initiatives Privacy Summary of the Privacy Rule Guidance Combined Text of All Rules HIPAA Related Links Security Security Rule NPRM Summary of the Security Rule Security Guidance Cyber Security Guidance Breach Notification Breach Reporting Guidance Reports to Congress Regulation History Compliance & Enforcement Enforcement Rule Enforcement Process En

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Navigate to: HIPAA for Professionals Regulatory Initiatives Privacy Summary of the Privacy Rule Guidance Combined Text of All Rules HIPAA Related Links Security Security Rule NPRM Summary of the Security Rule Security Guidance Cyber Security Guidance Breach Notification Breach Reporting Guidance Reports to Congress Regulation History Compliance & Enforcement Enforcement Rule Enforcement Process Enforcement Data Resolution Agreements Case Examples Audit Reports to Congress State Attorneys General Special Topics Parental Access Mental and Behavioral Health Change Healthcare Cybersecurity Incident FAQs HIPAA and COVID-19 HIPAA and Reproductive Health HIPAA and Final Rule Notice HIPAA and Telehealth HIPAA and FERPA Research Public Health Emergency Response Health Information Technology Health Apps Patient Safety Covered Entities & Business Associates Business Associate Contracts Business Associates Training & Resources FAQs for Professionals Other Administrative Simplification Rules Substance Use Disorder Confidentiality OCR Concludes 2018 with All-Time Record Year for HIPAA Enforcement OCR Concludes 2018 with All-Time Record Year for HIPAA Enforcement – February 7, 2019 OCR has concluded an all-time record year in HIPAA enforcement activity. In 2018, OCR settled 10 cases and secured one judgment, together totaling $28.7 million. This total surpassed the previous record of $23.5 million from 2016 by 22 percent. In addition, OCR also achieved the single largest individual HIPAA settlement in history of $16 million with Anthem, Inc., representing a nearly three-fold increase over the previous record settlement of $5.5 million in 2016. Read the HHS Press Release Summary of all 2018 OCR HIPAA settlements and judgements 2018 OCR HIPAA Summary: Settlements and Judgments January 2018 In January 2018, OCR settled for $100,000 with Filefax, Inc., a medical records maintenance, storage, and delivery services provider. OCR’s investigation found that Filefax impermissibly disclosed protected health information (PHI) by leaving the PHI in an unlocked truck in the Filefax parking lot, or by granting permission to an unauthorized person to remove the PHI from Filefax, and leaving the PHI unsecured outside the Filefax facility. In January 2018, OCR also settled for $3.5 million with Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure. FMCNA filed five breach reports for separate incidents occurring between February 23, 2012 and July 18, 2012, implicating the electronic protected health information (ePHI) of five FMCNA owned covered entities. OCR’s investigation revealed that FMCNA failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI. Additional potential violations included failure to implement policies and procedures and failure to implement a mechanism to encrypt and decrypt ePHI, when it was reasonable and appropriate to do so under the circumstances. June 2018 In June 2018, an HHS Administrative Law Judge ruled in favor of OCR and required The University of Texas MD Anderson Cancer Center (MD Anderson), a Texas cancer center, to pay $4.3 million in civil money penalties for HIPAA violations. OCR investigated MD Anderson following three separate data breach reports in 2012 and 2013 involving the theft of an unencrypted laptop from the residence of an MD Anderson employee and the loss of two unencrypted universal serial bus (USB) thumb drives containing the unencrypted ePHI of over 33,500 individuals. OCR’s investigation found that MD Anderson had written encryption policies going back to 2006 and that MD Anderson’s own risk analyses had found that the lack of device-level encryption posed a high risk to the security of ePHI. Despite the encryption policies and high risk findings, MD Anderson did not begin to adopt an enterprise-wide solution to encrypt ePHI until 2011, and even then it failed to encrypt its inventory of electronic devices containing ePHI between March 24, 2011 and January 25, 2013. This matter is under appeal with the HHS Departmental Appeals Board. September 2018 In September 2018, OCR announced that it has reached separate settlements totaling $999,000, with Boston Medical Center (BMC), Brigham and Women's Hospital (BWH), and Massachusetts General Hospital (MGH) for compromising the privacy of patients’ PHI by inviting film crews on premises to film an ABC television network documentary series, without first obtaining authorization from patients. In September 2018, OCR also settled with Advanced Care Hospitalists (ACH), a contractor physician group, for $500,000. ACH filed a breach report confirming that ACH patient information was viewable on a medical billing services’ website. OCR’s investigation revealed that ACH never had a business associate agreement with the individual providing medical billing services to ACH, and failed to adopt any policy requiring business associate agreements until April 2014. Although ACH had been in operation since 2005, it had not conducted a risk analysis or implemented security measures or any other written HIPAA policies or procedures before 2014. October 2018 In October 2018, OCR settled with Allergy Associates, a health care practice that specializes in treating individuals with allergies, for $125,000. In February 2015, a patient of Allergy Associates contacted a local television station to speak about a dispute that had occurred between the patient and an Allergy Associates’ doctor. OCR’s investigation found that the reporter subsequently contacted the doctor for comment and the doctor impermissibly disclosed the patient’s PHI to the reporter. In October 2018, Anthem, Inc. also paid $16 million to OCR and agreed to take substantial corrective action to settle potential violations of the HIPAA Rules after a series of cyberattacks led to the largest U.S. health data breach in history. Anthem filed a breach report after discovering cyber-attackers had gained access to their IT system via an undetected continuous and targeted cyberattack for the apparent purpose of extracting data, otherwise known as an advanced persistent threat attack. After filing their breach report, Anthem discovered cyber-attackers had infiltrated their system through spear phishing emails sent to an Anthem subsidiary after at least one employee responded to the malicious email and opened the door to further attacks. OCR’s investigation revealed that between December 2, 2014 and January 27, 2015, the cyber-attackers stole the ePHI of almost 79 million individuals, including names, social security numbers, medical identification numbers, addresses, dates of birth, email addresses, and employment information. November 2018 In November 2018, Pagosa Springs Medical Center (PSMC), a critical access hospital, paid $111,400 to OCR to resolve potential violations concerning a former PSMC employee that continued to have remote access to PSMC’s web-based scheduling calendar, which contained patients’ ePHI, after separation of employment. OCR’s investigation revealed that PSMC impermissibly disclosed the ePHI of 557 individuals to its former employee and to the web-based scheduling calendar vendor without a business associate agreement in place. December 2018 In December 2018, Cottage Health agreed to pay $3 million to OCR and to adopt a substantial corrective action plan to settle potential violations of the HIPAA Rules concerning two breach reports of unsecured ePHI affecting over 62,500 individuals. The breaches exposed unsecured ePHI over the internet including patient names, addresses, dates of birth, Social Security numbers, diagnoses, conditions, lab results and other treatment information. OCR’s investigation revealed that Cottage Health failed to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the ePHI; failed to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level; failed to implement procedures to perform periodic technical and nontechnical evaluations in response to environmental or operational changes affecting the security of ePHI; and failed to obtain a written business associate agreement with a contractor that maintained ePHI on its behalf. Date Name Amount Jan. 2018 Filefax, Inc (settlement) $100,000 Jan. 2018 Fresenius Medical Care North America (settlement) $3,500,000 June 2018 MD Anderson (judgment) $4,348,000 Aug. 2018 Boston Medical Center (settlement) $100,000 Sep. 2018 Brigham and Women’s Hospital (settlement) $384,000 Sep. 2018 Massachusetts General Hospital (settlement) $515,000 Sep. 2018 Advanced Care Hospitalists (settlement) $500,000 Oct. 2018 Allergy Associates of Hartford (settlement) $125,000 Oct. 2018 Anthem, Inc (settlement) $16,000,000 Nov. 2018 Pagosa Springs (settlement) $111,400 Dec. 2018 Cottage Health (settlement) $3,000,000 Total (settlements and judgment) $28,683,400 Content last reviewed August 3, 2022

Timeline

  • Resolution
  • Incident and investigation milestones are not consistently published by OCR in machine-readable form.

Key takeaways for your organization

  • Treat internet-facing systems and vendor-hosted environments as in-scope for HIPAA risk analysis and technical safeguards testing.
  • Maintain an actionable risk analysis tied to remediation milestones; evidence should map to Security Rule implementation specifications.
  • Align policies, procedures, and evidence with the specific CFR provisions cited in OCR resolutions affecting your entity type.
  • Run tabletop exercises for breach response, OCR inquiry handling, and privilege-preserving communications with counsel.

Related actions

Source

U.S. Department of Health and Human Services release

Source: U.S. Department of Health and Human Services, Office for Civil Rights. medcomply.ai aggregates public materials for educational use — not legal advice.