With the financial impact to businesses suffering data breaches in 2024 now averaging nearly $5 million and the announcement by the Department of Health and Human Services Office of Civil Rights (“OCR”) two additional Health Insurance Portability & Accountability Act (“HIPAA”) “Risk Analysis Initiative” settlements in seven days, health plans, health care providers, healthcare clearinghouses (“Covered Entities”) and their business associates (collectively “Regulated Entities”) face a growing imperative to act now to promote the defensibility of their practices under the Risk Analysis and other HIPAA Privacy, Security, and Breach Notification Rule requirements. Coupled with OCR’s steady announcement of enforcement actions like those announced this month against NERAD and others under its Risk Analysis Initiative, OCR clearly health plans and other Regulated Entities to clean up and strengthen their Risk Analysis and other HIPAA Security Rule compliance.
HIPAA Risk Analysis Requirement & OCR Risk Analysis Initiative
The need for Regulated Entities to ensure their fulfillment of HIPAA’s Risk Analysis requirements to prevent and mitigate their legal, financial and operational exposures from breaches of electronic protected health information (“ePHI”) and to defend against a potential OCR Risk Analysis enforcement action or audit is demonstrated by OCR’s announcement of HIPAA Security Rule enforcement actions and settlements with Northeast Radiology, P.C. (NERAD) on April 10, 2025, and Guam Memorial Hospital Authority (“GMHA”) on April 17, 2025, the sixth and seventh under OCR’s recently announced HIPAA “Risk Analysis Initiative” .
Risk Analysis Longstanding HIPAA Requirement
The HIPAA Privacy, Security, and Breach Notification Rules Regulated Entities to meet specific standards to protect the privacy and security of protected health information. Since the HIPAA Security Rule first took effect, risk analysis is one of the four required implementation specifications Regulated Entities must meet under the Security Management Process standard in 45 CFR § 164.308.
To fulfill this Risk Analysis requirement, a Regulated Entity must conduct an “accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI” and “[i]mplement policies and procedures to prevent, detect, contain, and correct security violations.”
Additionally, in 45 CFR § 164.402 the HIPAA Breach Notification Rule requires a Regulated Entity that experiences an impermissible acquisition, access, use, or disclosure (“breach”) of unsecured ePHI to conduct a documented risk assessment to determine whether the Regulated Entity must notify affected individuals, OCR and in the case of breaches involving the ePHI of 500 or more individuals, the media. As consistently interpreted and applied by OCR, experiencing a breach or the existence of evidence putting the Regulated Entity on notice of a potential susceptibility creating a risk of a breach triggers a duty by the Regulated Entity to conduct a Risk Assessment to assess the susceptibility of its ePHI to the risk and the actions reasonably necessary to mitigate it under the Security Rule.
OCR views Risk Analysis as foundational to the protection of ePHI. As OCR Acting Director Anthony Archeval recently stated to explain OCR’s emphasis on Risk Analysis compliance and enforcement, “Ransomware and hacking are the primary cyber-threats to electronic protected health information within the health care industry. Failure to conduct a HIPAA risk analysis puts this information at risk and vulnerable to future ransomware attacks and other cyber-threats[.]” Consequently, OCR has constantly has urged Regulated Entities to fulfill their Risk Analysis obligations since the earliest days of HIPAA. To promote compliance, OCR persistently has communicated the necessity and importance of the Risk Analysis in guidance and sought to reinforce the consequences of inadequate Risk Analysis by discussing the role of Risk Analysis deficiencies in creating the circumstances leading to enforcement actions against Regulated Entitles in its civil monetary penalty assessments and HIPAA settlement announcements.
OCR Raising Risk Analysis Expectations & Enforcement
Despite OCR’s constant and ever-rising efforts to promote compliance with the Risk Analysis requirements, however, OCR consistently has found deficiencies in Regulated Entities’ Risk Analysis in its breach investigations and audit findings since these rules became effective. As the number and magnitude of reported breaches of ePHI skyrocketing and massive breaches like those experienced in 2024 by UnitedHealthcare subsidiary Change Health, Ascension and others demonstrating the serious consequences ransomware and other cyberattacks can inflict on health plan claims and payment, health care delivery, payment, and patient privacy, OCR is placing new emphasis on tightening both the requirements for Risk Analysis and its enforcement of compliance with the Risk Analysis requirements.
On December 27, 2024, for instance, OCR published a notice of proposed rulemaking that proposes to clarify and tighten significantly the Risk Analysis requirements and other elements of the HIPAA Security Rule. Along with proposing these heightened Risk Analysis requirements, OCR announced and now is zealously enforcing the current Risk Analysis requirements through its Risk Analysis Initiative to hold Regulated Entities accountable for failing to fulfill their Risk Analysis responsibilities as part of its heightened efforts to improve Regulated Entities’ fulfillment of their Risk Analysis obligations. With OCR’s announcement of the NERAD and GMHA enforcement actions on April 10 and April 17, respectively bringing to seven the number of Risk Analysis Initiative enforcement settlements in recent months, health care providers and other Regulated Entities should heed the schooling these and other similarly sanctioned organizations as a call to action to ensure their own Risk Analysis and other HIPAA Privacy, Security and Breach Rule compliance.
NERAD Enforcement Risk Analysis Initiative Enforcement Action & Settlement
The first of two Risk Analysis Initiative settlements announced in seven days in April and the sixth enforcement action and settlement specifically labeled as taken under the “Risk Analysis Initiative,” the NERAD enforcement action and settlement announced April 10, 2025 resolves liabilities for violation of the Risk Analysis Rule arising from OCR’s investigation of a breach of ePHI stored on NERAD’s Picture Archiving and Communication System (“PACS”) server for storing, retrieving, managing, and accessing radiology images.
OCR initiated its investigation of NERAD after receiving a NERAD breach report that between April 2019 and January 2020, unauthorized individuals accessed radiology images stored on NERAD’s PACS server. NERAD notified the 298,532 patients whose information was potentially accessible on the PACS server of this breach. OCR’s investigation found that NERAD had failed to conduct an accurate and thorough Risk Analysis to determine the potential risks and vulnerabilities to the ePHI in NERAD’s information systems.
To avoid potentially much greater HIPAA civil monetary penalties under the terms of the resolution agreement, NERAD paid OCR $350,000 and agreed to implement a corrective action plan that OCR will monitor for two years. Under the corrective action plan, NERAD will take steps to improve its compliance with the HIPAA Security Rule and protect the security of ePHI, including:
- Conducting an accurate and thorough Risk Analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
- Developing and implementing a risk management plan to address and mitigate security risks and vulnerabilities identified in its Risk Analysis;
- Developing and implementing a written process to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports;
- Developing, maintaining, and revising, as necessary, its written policies and procedures to comply with the HIPAA Rules; and
- Augmenting its existing HIPAA and security training program to all of its workforce members who have access to PHI.
Guam Memorial Hospital Authority Risk Assessment Initiative & Ransomware Enforcement Action
Seven days after announcing the NERAD Risk Analysis enforcement action and settlement, OCR reaffirmed its commitment to enforcement of the Risk Analysis enforcement when it announced its first HIPAA settlement under the new Trump Administration with GMHA, a public hospital on the U.S. Territory, island of Guam, on April 17, 2025.
The seventh Risk Analysis Initiative enforcement action and eleventh ransomware enforcement action announced by OCR, the GMHA settlement arose from OCR’s investigation of two complaints alleging that GMHA impermissibly allowed the disclosure of ePHI of GMHA patients. OCR originally initiated its investigation in response to a January 2019 complaint alleging that GMHA experienced a ransomware attack affecting the ePHI of approximately 5,000 individuals. During the investigation, OCR received another complaint in March 2023 alleging that hackers accessed patient records. OCR’s investigation determined that GMHA had failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to ePHI held by GMHA.
Under the terms of the resolution agreement, GMHA paid OCR $25,000 and agreed to implement a corrective action plan that OCR will monitor for three years. In the corrective action plan, GMHA must take a number of steps to ensure compliance with the HIPAA Security Rule and protect the security of ePHI, including:
- Conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
- Develop and implement a risk management plan to address and mitigate security risks and vulnerabilities identified in its risk analysis;
- Develop a written process to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports;
- Develop, maintain, and revise, as necessary, written policies and procedures to comply with the HIPAA Privacy, Security and Breach Notification Rules;
- Augment its existing HIPAA and security training program so all workforce members with access to PHI understand the HIPAA requirements and GMHA’s HIPAA policies and procedures;
- Enhance workforce security and information access management by reviewing all access credentials that have been granted access to ePHI; and
- Conduct breach risk assessments and provide evidence to OCR that all breach notification obligations have been conducted.
Required & Recommended Actions To Promote Defensibility Of Risk Analysis Compliance
With cyberattacks targeting health plan and other Regulated Entities soaring and OCR stepping up its scrutiny of Regulated Entities’ Risk Analysis compliance in audits and enforcement actions, each health plan and insurer and other Regulated Entity should review and tighten its Risk Analysis practices and documentation to reduce its susceptibility to potential breaches and to promote its ability to defend its compliance with the Risk Analysis requirements in the event of a breach investigation or audit.
Fulfill Current Risk Analysis Standards
To fulfill the “Risk Analysis” implantation specification, the Security Management Process Standard requires Regulated Entities enforce appropriate administrative, physical, and technical safeguards for the confidentiality, integrity, and security of electronic protected health information (“ePHI”) based on an up-to-date conduct of an up-to-date accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by that organization (“Risk Analysis”).
The Security Rule requires Regulated Entities to document each Risk Analysis in writing, to keep Risk Analysis documentation for six years, and to provide Risk Analysis documentation to OCR upon request.
Among other things, the Risk Analysis implementation standard requires regulated entities adequately to:
- Identify where ePHI is located in the organization, including how ePHI enters, flows through, and leaves the organization’s information systems.
- Integrate Risk Analysis and risk management into the organization’s business processes.
- Ensure that audit controls are in place to record and examine information system activity.
- Implement regular reviews of information system activity.
- Utilize mechanisms to authenticate information to ensure only authorized users are accessing ePHI.
- Encrypt ePHI in transit and at rest to guard against unauthorized access to ePHI when appropriate.
- Incorporate lessons learned from incidents into the organization’s overall security management process.
- Provide workforce members with regular HIPAA training that is specific to the organization and to the workforce members’ respective job duties.
Use Proposed Rules & Enforcement Actions For Additional Guidance To Mitigate Risks
The proposed rule published by OCR on December 27, 2024, seeks to clarify and expand the original requirements of the Risk Assessment implementation standard based on OCR’s past HIPAA Security and Breach Rule investigation and enforcement experience. Under the proposed rule, a Regulated Entity’s Risk Analysis also would be required to include:
- Require the development and revision of a technology asset inventory and a network map that illustrates the movement of ePHI throughout the regulated entity’s electronic information system(s) on an ongoing basis, at least once every 12 months and in response to a change in the regulated entity’s environment or operations that may affect ePHI.
- Require greater specificity for conducting a risk analysis, including a written assessment that contains, among other things:
- A review of the technology asset inventory and network map;
- Identification of all reasonably anticipated threats to the confidentiality, integrity, and availability of ePHI;
- Identification of potential vulnerabilities and predisposing conditions to the regulated entity’s relevant electronic information systems;
- An assessment of the risk level for each identified threat and vulnerability, based on the likelihood that each identified threat will exploit the identified vulnerabilities; and
- A review of the technology asset inventory and network map.
Other changes included in the proposed rule would further heighten the Risk Analysis and other Security Standard requirements for Regulated Entities. For instance, the proposed rule would require Regulated Entities:
- To establish written procedures to restore the loss of certain relevant electronic information systems and data within 72 hours;
- To perform an analysis of the relative criticality of their relevant electronic information systems and technology assets to determine the priority for restoration;
- To establish written security incident response plans and procedures documenting how workforce members are to report suspected or known security incidents and how the regulated entity will respond to suspected or known security incidents;
- To implement written procedures for testing and revising written security incident response plans;
- To conduct a compliance audit at least once every 12 months to ensure their compliance with the Security Rule requirements;
- To require business associates to verify at least once every 12 months for covered entities (and that business associate contractors verify at least once every 12 months for business associates) that they have deployed technical safeguards required by the Security Rule to protect ePHI through a written analysis of the business associate’s relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate;
- To encrypt ePHI at rest and in transit, with limited exceptions;
- To establish and deploy technical controls for configuring relevant electronic information systems, including workstations, in a consistent manner including deployment of anti-malware protection, removal of extraneous software, and disabling network ports in accordance with the regulated entity’s risk analysis;
- Use of multi-factor authentication, with limited exceptions;
- Vulnerability scanning at least every six months and penetration testing at least once every 12 months;
- Network segmentation;
- Separate technical controls for backup and recovery of ePHI and relevant electronic information systems;
- To review and test the effectiveness of certain security measures at least once every 12 months, in place of the current general requirement to maintain security measures;
- Business associates to notify covered entities (and subcontractors to notify business associates) upon activation of their contingency plans without unreasonable delay, but no later than 24 hours after activation;
- Group health plans to include in their plan documents requirements for their group health plan sponsors to: comply with the administrative, physical, and technical safeguards of the Security Rule; ensure that any agent to whom they provide ePHI agrees to implement the administrative, physical, and technical safeguards of the Security Rule; and notify their group health plans upon activation of their contingency plans without unreasonable delay, but no later than 24 hours after activation.
To help Regulated Entities understand and fulfill these responsibilities, OCR alone and in conjunction with the Office of the National Coordinator for Health Information Technology (“ONC”) also has published guidance like the HIPAA Security Risk Assessment (SRA) Tool. OCR guidance reflects that fulfillment of the Tool can help Regulated Entities may help defend but does not guarantee fulfillment of the Risk Assessment requirements, as the adequacy of the Risk Assessment always depends upon the unique facts and circumstances of the Regulated Entity at a particular time. This guidance confirms the importance of conducting timely and appropriate Risk Analysis in a manner that shows the Regulated Entity appropriately evaluated the risks to its e-PHI and acted reasonably in designing, administering, and updating that Risk Analysis to reasonably defend its e-PHI against breaches or other susceptibilities.
Since OCR’s guidance makes clear that the adequacy of a Regulated Entity’s Risk Analysis and other HIPAA Security compliance based on its evaluation and response to known and suspected susceptibility threats as conducted and documented pursuant to the Risk Analysis rule, health plans and other Regulated Entities should view Risk Analysis as a ongoing process. While the Security Rule does not currently dictate how frequently a regulated entity must perform Risk Analysis, a proposed rule published by OCR on December 27, 2024 seeks to amend the existing Security Rule to expand the requirement to require regulated entities to develop and revise a technology asset inventory and a network map that illustrates the movement of ePHI throughout the regulated entity’s electronic information system(s) on an ongoing basis, at least once every 12 months and in response to a change in the regulated entity’s environment or operations that may affect ePHI. Although OCR has not yet officially adopted this and other changes contained in the proposed rule, substantial evidence exists that it already regularly administers the Risk Analysis requirement with the expectation that regulated entities will perform Risk Analysis at least this frequently. For instance, current OCR resolution agreements require impacted organizations to conduct Risk Analysis to identify and address vulnerabilities at least annually, and more frequently as needed in response to signs of potential breach or susceptibility. Likewise, since OCR developed the proposed rule from its past enforcement experience, wise Regulated Entities also will recognize the value of drawing upon the changes set forth in the proposed rule for helpful insights to strengthen the security of their ePHI generally and promoting the defensibility of the adequacy of their Risk Assessments.
Suggested Process For Updating & Strengthening Risk Analysis
With the continued explosion in ransomware and other cyberthreats heightening the risk of experiencing a breach or other incident likely to draw the attention of OCR, each health plan or other Regulated Entity should take assess and confirm the adequacy of their current Risk Analysis, both to protect its ePHI and to promote its ability to defend its compliance with the HIPAA Security Rule’s Risk Analysis and other requirements in light of OCR’s heightened emphasis on Risk Analysis compliance and enforcement. For purposes of conducting this analysis, Regulated Entities generally will want to use a process like the following to structure their evaluation of their existing Risk Analysis to take advantage of the opportunity to use attorney-client privilege and other evidentiary rules to help protect discoverability of sensitive discussions about possible deficiencies in their existing Risk Analysis and discussions about potential tradeoffs considered in current or future Risk Analysis response:
- Engage legal counsel experienced with HIPAA and other cybersecurity-related risks and liabilities to advise and assist your organization in designing and administering your Risk Analysis processes and response within the scope of attorney-client privilege;
- Appoint and designate leadership and technical leadership for team responsible for design and administration of your organization’s initial and ongoing cybersecurity Risk Analysis and response (“Cyber-Risk Team”) and process for board and senior management reporting of the Cyber-Risk Team;
- Select and engage outside consulting service providers, cyber-liability insurers and other risk service providers expected to participate in the process; work with qualified legal counsel to contract with these business associates to include the business associate agreement and other reassurances required by the HIPAA Privacy, Security and Breach Notification Rule and other performances, cooperation to provide and back services in accordance with agreed-upon protocols in the contract;
- Train Cyber-Risk Team in the appropriate processes for working with internal teams, outside service providers, leadership, and designated legal counsel to conduct Risk Analysis, investigation and response using attorney-client privilege and other evidentiary tools and processes to maximize defensibility;
- Require the Cyber-Risk Team conduct an updated, document assessment of cyber-risk within scope of attorney-client privilege and work with legal counsel to develop a documented cyber-risk policy that captures analysis and determinations for your justification for the size, scope and timing of your periodic Risk Analysis and rules and processes for interim risk identification, reassessments and response in reaction to potential cyber-risk signs between periodic Risk Analysis for presentation and approval by the Board taking into account the insights from published final and proposed guidance, enforcement actions and industry standards;
- Require, oversee and enforce Cyber-Risk Team’s documented administration of the initial and subsequently required Risk Analysis and response pursuant to the adopted cyber-risk policy to identify vulnerabilities and work with legal counsel within the scope of privilege to document your analysis and justifications for addressing identified vulnerabilities and other required actions in response to identified susceptibilities or event;
- Review adequacy of incident detection and response arrangements, including reporting and response mechanisms, insurance and indemnification protection, and other critical elements for mitigation and recovery; and
- Other actions as warranted based on advice of counsel taking into account emerging threats, guidance, and risk susceptibility.
Although civil monetary penalties or settlements are the most common sanction imposed for HIPAA Security and Breach Notification rule violations, willful and certain other violations of HIPAA can trigger criminal liability subject to the Federal Sentencing Guidelines. Consequently, beyond fulfilling the specific requirements of HIPAA, an adequate Risk Assessment also can be an invaluable tool for helping mitigate Federal Sentencing Guideline exposures of a Regulated Entity and its leaders under the Federal Sentencing Guidelines Organizational Liability rules.
Beyond these specific HIPAA-associated exposures, Regulated Entities and their leaders should keep in mind that HIPAA is likely only one of many laws that define their responsibilities to secure, report, and respond to breaches of ePHI or other sensitive data. Depending on the location, nature and other circumstances, Regulated Entities and their leaders also may have additional responsibilities and liability exposures under a variety of other federal and state laws, ethical or other professional standards, and contractual obligations. For instance, health plan fiduciaries may risk fiduciary liability under the Employee Retirement Income Security Act of 1974 for failing to prudently secure and protect participate and other health plan data from improper access, use or disclosure. Inadequate data safeguards for ePHI also can trigger liability for brokers, consultants, insurers and others under the Fair and Accurate Credit Transactions Act, the Federal Trade Commission Act, and various electronic crimes statutes. The Securities and Exchange Commission rules can trigger disclosure and other obligations for publicly traded employers and insurers. Regulated Entities and their leaders generally will want to fully evaluate and manage these risks in conjunction with their compliance with the Risk Analysis and other requirements of the HIPAA Security and Breach Notification Rules.
The author of this update, Cynthia Marcotte Stamer is nationally known and celebrated for her experience providing advice and representation to employers, employer and other health plan sponsors, health plans, health plan fiduciaries and administrators, third party administrators, health care and life sciences organizations, human resources and health plan technology, and other businesses about HIPAA and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.
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We hope this update is helpful. For more information about these or other health or other employee benefits, human resources, or health care developments, please contact the author, Cynthia Marcotte Stamer, via e-mail or telephone at (214) 452-8297.
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About the Author
Cynthia Marcotte Stamer is a Martindale-Hubble AV-Preeminent (highest/top 1%) practicing attorney recognized as a “Top Woman Lawyer,” “Top Rated Lawyer,” and “LEGAL LEADER™” in Health Care Law and Labor and Employment Law; among the “Best Lawyers In Dallas” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law recognized for her experience, scholarship, thought leadership and advocacy on HIPAA and other data and technology use, security and compliance in connection with her work with health care and life sciences, employee benefits, insurance, education, technology and other highly regulated and performance-dependent clients.
Board certified in labor and employment law by the Texas Board of Legal Specialization and a Fellow in the American College of Employee Benefits Counsel, Ms. Stamer works with these and other highly regulated or data and performance reliant businesses to design, risk manage, and defend their employment and other workforce, data and technology and other operations to promote legal and operational compliance, reduce regulatory and other liability and promote other operational goals.
Along with her decades of legal and strategic consulting experience, Ms. Stamer also contributes her leadership and experience to many professional, civic and community organizations. She currently serves as Co-Chair of the ABA Real Property Trusts and Estates (“RPTE”) Section Welfare Plan Committee, Co-Chair of the ABA International Section International Employment Law Committee and its Annual Meeting Program Planning Committee, Chair Emeritus and Vice Chair of the ABA Tort Trial and Insurance (“TIPS”) Section Medicine and Law Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee.
Additionally,more her ABA involvements include than a decade of service as a Scribe for the Joint Committee on Employee Benefits (“JCEB”) annual agency meetings with the Department of Health and Human Services and JCEB Council Representative, International Section Life Sciences Committee Chair, RPTE Section Employee Benefits Group Chair and a Substantive Groups Committee Member, Health Law Section Managed Care & Insurance Interest Group Chair, as TIPS Section Medicine and Law Committee Chair and Employee Benefits Committee and Workers Compensation Committee Vice Chair, Tax Section Fringe Benefit Committee Chair, and in various other ABA leadership capacities. Ms. Stamer also is a former Southwest Benefits Association Board Member and Continuing Education Chair, SHRM National Consultant Board Chair and Region IV Chair, Dallas Bar Association Employee Benefits Committee Chair, former Texas Association of Business State, Regional and Dallas Chapter Chair, a founding board member and Past President of the Alliance for Healthcare Excellence, as well as in the leadership of many other professional, civic and community organizations. She also is recognized for her contributions to strengthening health care policy and charitable and community service resolving health care challenges performed under PROJECT COPE Coalition For Patient Empowerment initiative and many other pro bono service involvements locally, nationally and internationally.
Ms. Stamer is the author of many highly regarded works published by leading professional and business publishers, the ABA, the American Health Lawyers Association, and others. Ms. Stamer also frequently speaks and serves on the faculty and steering committee for many ABA and other professional and industry conferences and conducts leadership and industry training for a wide range of organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see http://www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
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