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OCR Nails Second HIPAA Covered For Allowing Ransomware Breach

February 23, 2024

Health care providers, health plans, health care clearinghouses and their business associates (covered entities) that fail to appropriately safeguard their protected health information and systems against randomware and other malware threats as required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) should expect to pay hefty amounts to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) if an attack occurs. That is the clear message sent by OCR’s February 22, 2022 announcement of its second ransomware settlement since October, 2023.

Duty To Guard Against Malware

OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules, which sets forth the requirements that HIPAA covered entities (most health care providers, health plans, and health care clearinghouses) and their business associates must follow to protect the privacy and security of protected health information.

Ransomware and hacking are the primary cyber-threats in health care. A type of malware (malicious software) designed to deny access to a user’s data, usually by encrypting the data with a key known only to the hacker who deployed the malware, until a ransom is paid, OCR has seen large breaches affecting more than 500 individuals reported to OCR involving hacking increase 256% and those from ransomware increase 264% increase over the past five years,

In 2023, hacking accounted for 79% of the large breaches reported to OCR. The large breaches reported in 2023 affected over 134 million individuals, a 141% increase from 2022.

In light of the growing threat, OCR is prioritizing enforcement, education and compliance outreach to HIPAA covered entities.

OCR’s February 22, 2024 announcement of its second ever and second settlement of a malware related enforcement action in less than five months demonstrates OCR’s readiness to hold covered entities accountable for failing to fulfill this responsibility.

Green Ridge Ransomeware Breach

OCR’s February 22, 2022 announcement of its second ever ransomware related resolution agreement and corrective action plan reaffirms OCR’s readiness to hold covered entities accountable for failing to guard against ransomware and other cyber risks.

Green Ridge Behavioral Health, LLC, (Green Ridge), a Maryland-based practice that provides psychiatric evaluations, medication management, and psychotherapy. This marks the second settlement that OCR has reached with a HIPAA regulated entity for potential violations identified during an investigation following a ransomware attack.

The settlement resolves an investigation following a ransomware attack that affected the protected health information of more than 14,000 individuals.

OCR learned of the breach after Green Ridge filed a breach report with OCR in February 2019 that stated that its network server had been infected with ransomware resulting in the encryption of company files and the electronic health records of all patients.

In keeping with its policy of investigating all breaches affecting more that 500 individuals (large breaches), OCR opened an investigation in April, 2019.

OCR’s investigation of the breach found evidence of potential violations of the HIPAA Privacy and Security Rules leading up to and at the time of the breach. Other findings included that Green Ridge Behavioral Health failed to:

Have in place an accurate and through analysis to determine the potential risks and vulnerabilities to electronic protected health information;
Implement security measures to reduce risks and vulnerabilities to a reasonable and appropriate level; and
Have sufficient monitoring of its health information systems’ activity to protect against a cyber-attack.

Under the terms of the settlement, Green Ridge agreed to pay $40,000 and implement a corrective action plan that will be monitored by OCR for three years to avoid exposure to potentially much greater HIPAA monetary penalties.

The plan also requires Green Ridge to take many actions to resolve potential HIPAA violations and to protect electronic protected health information, including:

Conducting a comprehensive and thorough analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information;
Designing a Risk Management Plan to address and mitigate security risks and vulnerabilities found in the Risk Analysis;
Reviewing, and as necessary, developing, or revising its written policies and procedures to comply with the HIPAA Rules;
Providing workforce training on HIPAA policies and procedures;
Conducting an audit of all third-party arrangements to ensure appropriate business associate agreements are in place, where applicable; and
Reporting to OCR when workforce members fail to comply with HIPAA.

First Malware Settlement

Prior to this week’s announcement of the Green Ridge resolution agreement, OCR already had announced its first ever malware related resolution agreement on October 31, 2023.

That $100,000 settlement resolved a potentially much greater HIPAA liability business associate Doctors’ Management Services (DMS) could have faced for alleged HIPAA violations OCR found investigating a large breach report DMS filed on April 22, 2019.

The DMS breach report disclosed that a ransomware attack affected DMS’ network server with GandCrab ransomware beginning with an initial unauthorized access to the network that occurred on April 1, 2017; however, DMS did not detect the intrusion until December 24, 2018, Once the DNS system was accessed, ransomware was used to encrypt their files. The attack affected the electronic protected health information of 206,695 individuals

OCR’s investigation of the DNS breach found evidence of potential failures by DMS to have in place an analysis to determine the potential risks and vulnerabilities to electronic protected health information across the organization. Other findings included insufficient monitoring of its health information systems’ activity to protect against a cyber-attack, and a lack of policies and procedures in place to implement the requirements of the HIPAA Security Rule to protect the confidentiality, integrity, and availability of electronic protected health information.

Under the terms of the DMS settlement agreement paid $100,000 to OCR and agreed to implement a corrective action plan that requires:

DMS to submit to OCR monitoring for three years to ensure compliance with HIPAA
Review and update its Risk Analysis to identify the potential risks and vulnerabilities to Doctor’s Management Services data to protect the confidentiality, integrity, and availability of electronic protected health information.
Update its enterprise-wide Risk Management Plan (strategy to protect the confidentiality, integrity, and availability of ePHI) to address and mitigate any security risks and vulnerabilities found in the updated Risk Analysis.
Review and revise, if necessary, its written policies and procedures to comply with the Privacy and Security Rules.
Provide workforce training on HIPAA policies and procedures.

Warning To All Covered Entities

Along with announcing the two recent resolution agreements, OCR also is warning all covered entities to tighten their malware and ransomware safeguards.

OCR’s announcement of the Green Ridge resolution agreement, for instance, quotes OCR Director Melanie Fontes Rainer as stating, “Health care providers need to understand the seriousness of these attacks and must have practices in place to ensure patients’ protected health information is not subjected to cyber-attacks such as ransomware.”

To assist covered entities to meet this responsibility, OCR has developed Fact Sheet guidance that recommends covered entities to take at least the following steps to guard against breaches from ransomware and other malware attacks:

Review all vendor and contractor relationships to ensure business associate agreements are in place as appropriate and address breach/security incident obligations.
Risk analysis and risk management should be integrated into business processes; conducted regularly and when new technologies and business operations are planned.
Ensure audit controls are in place to record and examine information system activity.
Implement regular review of information system activity.
Utilize multi-factor authentication to ensure only authorized users are accessing ePHI.
Encrypt ePHI to guard against unauthorized access to ePHI.
Incorporate lessons learned from incidents into the overall security management process.
Provide training specific to organization and job responsibilities and on regular basis; reinforce workforce members’ critical role in protecting privacy and security.
two recent resolutions agreements and other guidance and enforcement actions make clear that all covered entities should ensure their ability to demonstrate their completion of these and other actions a risk analysis shows are needed to defend against a ransomware or other malware threats. This guidance also alerts covered entities to stay vigilant and update risk assessments and safeguards in response as to evolving threats.

Covered entities should not assume the relatively modest settlement amounts collected in the two new ransomware settlements compared to exponentially greater resolution settlements like the $4.75 million settlement payment New York based Montefiore Medical Center made last year reflect greater tolerance for ransomware related threats versus internal or external hacking. To the contrary, the Montefiore Medical Center resolution makes clear the randomware threat is one of a multitude of internal and external threats covered entities must defend their protected health information against to comply with HIPAA.

Moreover, covered entities and their leaders also should take steps to understand and fully address all other statutory, ethical, contractual or other privacy or confidentiality requirements beyond those imposed by HIPAA. For example, health care providers, health plans and their fiduciaries, brokers, administrators and insurers also may bear responsibilities under the Employee Retirement Income Security Act fiduciary responsibility rules, the Fair and Accurate Credit Transactions Act, federal and state electronic crimes, privacy data security, artificial intelligence, workforce, tax, and other laws.

Publicly traded organizations and their leaders also may face responsibilities and liability under new Securities and Exchange Commission regulations, clawback rules and other laws arising from the occurrence or bungled response to a breach.

Likewise, got businesses sponsoring or administering employment-based health plans, Employee Benefit Security Administration considers managing cybersecurity risks a part of the fiduciary obligations of fiduciaries of employment-based health plans. Meanwhile, health care providers, insurance organizations and brokers, third party administrators, government contractors, attorneys and other advisors and others also may be subject to medical confidentiality and other data privacy and security obligations under federal and state electronic crimes, identity theft, ethics, professional licensure, contractual, common law privacy and other statutory and common laws. Since HIPAA and many of these other laws involve potential criminal as well as civil liability, organizations and leaders in covered entities generally should ensure their HIPAA and other cybersecurity compliance efforts are included in and administered according to their Federal Sentencing Guidelines Compliance program.

While it commonly is necessary or advisable to involve consulting or other technical support in the conduct of these activities, HIPAA entities should keep in mind the likelihood that their analysis and review is likely to uncover and prompt discussion of potentially legally or politically sensitive information. For this reason, HIPAA entities and their leaders generally will want to engage experienced legal counsel for assistance in structuring and executing these activities to maximize their ability to claim attorney-client privilege or other evidentiary protections against discovery or disclosure of certain aspects of these activities.

In planning for an implementing these procedures, Covered Entities also are reminded that the effectiveness of these efforts requires that the Covered Entities incorporate appropriate processes and policies for monitoring and investigating compliance with the policies and procedures implemented to comply with HIPAA. Conducting this monitoring and investigation by necessity is likely to involve surveillance, investigation and cooperation of employees, contractors, vendors and others for which Fair Credit Reporting Act background check notification and consent and other procedures are necessary or advisable.

Finally, HIPAA entities should keep in mind that HIPAA and other cybersecurity compliance and risk management is an ongoing process requiring constant awareness and diligence. Consequently, HIPAA entities should both monitor OCR and other regulatory and enforcement developments as well as exercise ongoing vigilance to monitor and maintain compliance within their organizations.

For More Informational

We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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About the Author

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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Posted by Cynthia Marcotte Stamer

Hospital System Pays $4.75 Million HIPAA Breach Settlement

February 8, 2024

The $4.75 million settlement payment New York based Montefiore Medical Center is paying to settle charges by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) Health Insurance Portability and Accountability Act (HIPAA) that multiple breaches of HIPAA’s Security Rule allowed a former employee to steal and sell more than 12,000 patients’ electronic personal health care information (EPHI) warns other health care providers, health plans, health care clearinghouses and their business associates (Covered Entities) to ensure their HIPAA compliance efforts incorporate adequate safeguards to protect their organizations’ EPHI against insider theft or other misuse as well as against external actors.

HIPAA Requirement To Protect Protected Health Information

The HIPAA Privacy, Security, and Breach Notification Rules require health care providers, health plans and insurers and others take steps to protect the privacy and security of patients’ protected health information. The HIPAA Security Rule requires Covered Entities to protect electronic protected health information and other protected health information against use, access, disclosure or destruction by third parties except under the conditions allowed by HIPAA. These requirements include the requirements of the Security Rule to conduct and document comprehensive security assessments of risks to sensitive data systems, to implement and enforce detailed security safeguards to protect EPHI and the systems containing that data against these threats, to train and enforce compliance with these safeguards, and other requirements. Meanwhile, the HIPAA Breach Notification Rule requires Covered Entities to report most breaches of unsecured EPHI to individuals whose data is affected, OCR, and in the case of breaches of EPHI affecting more than 500 individuals, to the media.

Despite these Rules and the expanded audit and enforcement efforts by OCR, cybersecurity threats and breaches continue to present significant threats to the privacy and security of protected health information possessed by Covered Entities. OCR’s breach reports reflect that EPHI breaches affecting more than 500 individuals (large breaches) remain common. These breach reports reveal that more than 134 million individuals were affected by large breaches in 2023, compared to the not insignificant 55 million individuals affected in 2022. In response to this continuing threat, HHS released a Department-wide Cybersecurity strategy for the health care sector in December of 2023, and released voluntary performance goals to enhance cybersecurity across the health sector just last week. The enforcement action and settlement with Montefiore Medical Center is the latest of the growing list of investigations and resulting high dollar settlements obtained by OCR in its efforts to enhance the security of EPHI through enforcement of the Security Rule.

Montefiore Medical Center $4.75 Million Settlement

The $4.75 million monetary settlement agreement and corrective action plan resolves Montefiore Medical Center’s exposure to potentially much greater penalties that OCR could impose for multiple Security Rule violations OCR reports finding while investigating a Montefiore Medical Center data breach report of the theft and sale of personal health information by an employee.

Montefiore Medical Center learned of the data theft while investigating a report from the New York Police Department of evidence of theft of a specific patient’s medical information in 2015. The internal investigation revealed two years previously a Montefiore Medical Center employee stole the electronic records containing patient’s name, address, SSN, next of kin, and health insurance information, of 12,517 patients from its electronic medical record system and then sold patient information to an identity theft ring. OCR learned of the breach when Montefiore Medical Center filed the breach report about the theft with OCR to comply with the HIPAA Breach Notification Rule.

In accordance with its policy of investigating all breach reports involving the personal health information of more than 500 individuals (a large breach), OCR conducted an investigation of the breach reported in the Montefiore Medical Center breach notification report. According to OCR, that investigation revealed the breach and theft of the Montefiore patients’ EPHI was made possible by multiple potential violations of the HIPAA Security Rule, including failures by Montefiore Medical Center:

To analyze and identify potential risks and vulnerabilities to protected health information,
To monitor and safeguard its health information systems’ activity, and
To implement policies and procedures that record and examine activity in information systems containing or using protected health information.

OCR concluded without these safeguards in place, Montefiore Medical Center was unable to prevent the cyberattack or even detect the attack had happened until years later.

Under the terms of the settlement, Montefiore Medical Center will pay $4,750,000 to OCR and implement a corrective action plan that identifies certain steps toward protecting and securing the security of protected health information. These actions include:

Conducting an accurate and thorough assessment of the potential security risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information;
Developing a written risk management plan to address and mitigate security risks and vulnerabilities identified in the Risk Analysis;
Developing a plan to implement hardware, software, and/or other procedural mechanisms that record and examine activity in all information systems that contain or use electronic protected health information;
Reviewing and revising, if necessary, written policies and procedures to comply with the HIPAA Privacy and Security Rules;
Providing training to its workforce on HIPAA policies and procedures; and
Submit to monitoring of its compliance by OCR for two years.

Covered Entities Urged To Protect EPHI From Internal & External Security Threats

The Montefiore breach illustrates both how cyber criminals and thieves frequently target EPHI held by Covered Entities for criminal purposes and reminds Covered Entities that these breaches often are committed or facilitated by employees or other insiders of their own or a business associate’s organization. The $4,750,000 settlement paid by Montefiore Medical Center demonstrates the significant financial consequences that a Covered Entity is likely to incur if it experiences a breach as a result of its failure to adequately comply with HIPAA Security Rules from both external and internal threats.

To mitigate these risks, Covered Entities must be prepared to demonstrate their efforts to implement safeguards to mitigate or prevent cyber threats in accordance with the HIPAA Security Rule. In conducting these activities, Covered Entities should heed the clear warning from the Montefiore Medical Center breach and settlement that the Security Rule requires the protection of EPHI from a broad range of ever-evolving internal and external threats. While theft by a malicious insider definitely is one of these risks, cyberthreat and breach experiences within the health care and other industries as well as OCR’s enforcement, investigation and other guidance demonstrate that Covered Entities must be vigilant to monitor and manage a multitude of ever-changing risks. Covered Entities and their leaders must be prepared to demonstrate the adequacy of their ongoing efforts to identify and manage these risks in compliance with the Security Rule.

As part of these efforts, OCR recommends that Covered Entities HIPAA Security and other cybersecurity defenses include, but not be limited to:

Reviewing all vendor and contractor relationships to ensure business associate agreements are in place as appropriate and address breach/security incident reporting obligations.
Integrating risk analysis and risk management into business processes; and ensuring that they are conducted regularly, especially when new technologies and business operations are planned. Ensuring audit controls are in place to record and examine information system activity.
Implementing regular review of information system activity.
Utilizing multi-factor authentication to ensure only authorized users are accessing protected health information.
Encrypting protected health information to guard against unauthorized access.
Incorporating lessons learned from previous incidents into the overall security management process.
Providing training specific to organization and job responsibilities and on regular basis; and reinforcing workforce members’ critical role in protecting privacy and security.

Additionally, HIPAA entities and their leaders also should take steps to understand and fully address all other statutory, ethical, contractual or other privacy or confidentiality requirements beyond those imposed by HIPAA. For example, health care providers, health plans and their fiduciaries, brokers, administrators and insurers also may bear responsibilities under the Employee Retirement Income Security Act fiduciary responsibility rules, the Fair and Accurate Credit Transactions Act, federal and state electronic crimes and privacy laws. Publicly traded organizations and their leaders may face responsibilities and liability under new Securities and Exchange Commission regulations. The Employee Benefit Security Administration considers managing cybersecurity risks a part of the fiduciary obligations of fiduciaries of employment-based health plans. Meanwhile, health care providers, insurance organizations and brokers, third party administrators, government contractors, attorneys and other advisors and others also may be subject to medical confidentiality and other data privacy and security obligations under federal and state electronic crimes, identity theft, ethics, professional licensure, contractual, common law privacy and other statutory and common laws.

For More Information