Conduct an appropriate risk analysis and take the required steps to protect your electronic health records from phishing and other hacking threats by conducting a thorough risk analysis and otherwise cleaning up your Health Insurance Portability and Accountability Act of 1996 compliance!  That’s the clear message to the Department of Health and Human Services Office of Civil Rights (“OCR”) warns health plans and insurers, health care providers, health care clearinghouses (“Covered Entities”) and their business associates (collectively “Regulated Entities”) to learn from the $600,000 HIPAA Privacy, Security, and Breach Notification Rules (“HIPAA Rules”) settlement with Southern California health care network PIH Health, Inc. (“PIH”) the Department of Health & Human Services Office of Civil Rights (“OCR”) announced on April 23, 2025 and the deluge of other ongoing hacking-related HIPAA investigations OCR still is working to resolve.

Phishing & Other Hacking Events Common Cause of Health Plan Breaches

Hacking incidents present a significant cybersecurity threat to health plans and other Regulated Entities’ electronic health and other data.  Phishing and other hacking attacks are among the most common types of large breaches reported to OCR every year. Over the past five years, there has been a 256% increase in large breaches reported to OCR involving hacking and a 264% increase in ransomware. In 2023, hacking accounted for 79% of the large breaches reported to OCR. 

Phishing and other hacking-related breaches regularly result in OCR’s collection of high-dollar settlements and other costly enforcement actions against health plans and other Regulated Entities. See e.g., HHS Office for Civil Rights Settles with L.A. Care Health Plan Over Potential HIPAA Security Rule Violations (September 11, 2023); Voluntary Resolution Agreement Between The United States Department of Health and Human Services, Office for Civil Rights (“HHS”) and UnitedHealthcare Insurance Company (August 24, 2023); Aetna Pays $1,000,000 to Settle Three HIPAA Breaches (October 28, 2020); Health Insurer Pays $6.85 Million to Settle Data Breach Affecting Over 10.4 Million People (September 25, 2020); nthem pays OCR $16 Million in record HIPAA settlement following largest health data breach in history (October 15, 2018).

The breach and enforcement actions are continuing in 2025. OCR already has announced numerous hacking-related settlements in the first quarter of 2025. See HHS Office for Civil Rights Settles HIPAA Ransomware Cybersecurity Investigation with Public Hospital (April 17, 2025); HHS Office for Civil Rights Settles HIPAA Security Rule Investigation with Northeast Radiology (April 4, 2025); HHS’ Office for Civil Rights Settles HIPAA Security Rule Investigation with Health Fitness Corporation (March 21, 2025); HHS Office for Civil Rights Imposes a $200,000 Penalty Against Oregon Health & Science University; HHS Office for Civil Rights Imposes a $1,500,000 Civil Money Penalty Against Warby Parker in HIPAA Cybersecurity Hacking Investigation (February 20, 2025); HHS Office for Civil Rights Settles HIPAA Phishing Cybersecurity Investigation with Solara Medical Supplies, LLC for $3,000,000 (January 14, 2025); HHS Office for Civil Rights Settles 9th Ransomware Investigation with Virtual Private Network Solutions (January 7, 2025).

Look for more of these enforcement actions to emerge soon. Between January 1 and April 23, 2025 alone, OCR received 161 hacking-related breach reports from Regulated Entities. OCR’s Breach Portal indicates that on April 23, 2025, OCR had a total of 554 open hacking-related breach investigations, 506 involving health care providers, 47 involving health plans, and one involving a health care clearinghouse.

Health plans and other Regulated Entities will want to take appropriate actions to avoid becoming subject to breaches subjecting them to these investigations and enforcement actions, particularly with OCR Acting Director Anthony Archeval warninghealth plans and other Regulated Entities:

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[.]

Duty To Analyze & Manage Hacking & Other Susceptibilities

The HIPAA Privacy, Security, and Breach Notification Rules require Regulated Entities to take specific actions as warranted by their threat susceptibility to protect the privacy and security of electronic protected health information (“ePHI”) from hacking and other improper access, destruction, or disclosure. At the heart of these requirements is the requirement that health plans and other Regulated Entities conduct documented risk analyses of their assessment of the susceptibility information of their ePHI to hacking and other threats. As reflected in the following table of current HIPAA sanctions, violation of these HIPAA requirements exposes a Regulated Entity to significant civil monetary penalties or criminal sanctions.

The HIPAA Security Rule requires a Regulated Entity to 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.” Meanwhile, the HIPAA Breach Notification Rule requires in 45 CFR § 164.402 that 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. OCR interprets these Rules together also to require Regulated Entities experiencing a breach of ePHI or having evidence putting the Regulated Entity on notice of a potential susceptibility creating a risk of a breach as triggering 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. Consequently, OCR constantly has urged Regulated Entities to fulfill their Risk Analysis obligations since the earliest days of HIPAA in its guidance and educational outreach, as well as by regularly discussing the requirement and 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.

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 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.

Look for OCR both to continue zealously to enforce the Risk Analysis and other HIPAA Security Rule compliance and to tighten thesed 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. Prior to its announcement of the PIH settlement, OCR in recent months announced seven Risk Analysis Initiative settlements, including three in April. 

Breaches & Other Security Rule Violations Carry Substantial Liability Risks

Tier	Civil Penalties[1]	Criminal Penalties
1	Lack of Knowledge: $141 – $71,162 per violation	Reasonable Cause or No Knowledge of Violation: Up to 1 year imprisonment
2	Reasonable Cause: $1,424 – $71,162 per violation	PHI Obtained Under False Pretenses: Up to 5 years imprisonment
3	Willful Neglect (corrected within 30 days): $14,232 – $71,162 per violation	PHI Obtained for Personal Gain or with Malicious Intent: Up to 10 years imprisonment
4	Willful Neglect (not corrected within 30 days): $71,162 – $2,134,831 per violation

Most Regulated Entities that OCR accused of violating the HIPAA requirements avoid paying the full amount of authorized civil monetary penalties by accepting OCR settlement offers. As the $600,000 PIH and other settlements demonstrate, however, settlement with OCR allows Regulated Entities to avoid much greater potential civil monetary penalties by paying a much smaller, but still generally significant, settlement amount. As significant as these penalties and settlement costs are, they typically reflect only a small portion of the true cost organizations suffer from a breach. With the average financial consequences suffered by organizations that experience a data breach now approaching $5 million, costs of investigation and recovery from a breach and the associated operational and business disruptions experienced inflict a heavy toll even where OCR allows the health plan or other Regulated Entity to resolve its exposures with no financial settlement or penalty.

Breaches & Other Security Rule Violations Create Substantial Liability For Plans & Their Fiduciaries

While health plan breach notifications generally have lagged far behind provider notifications in number, reported health plan breaches generally have resulted the largest civil monetary penalty or resolution payments largely due to the massive number of individuals affected by these breaches. See e.g., HHS Office for Civil Rights Settles with L.A. Care Health Plan Over Potential HIPAA Security Rule Violations (September 11, 2023); Voluntary Resolution Agreement Between The United States Department of Health and Human Services, Office for Civil Rights (“HHS”) and UnitedHealthcare Insurance Company (August 24, 2023);  Health Insurer Pays $5.1 Million to Settle Data Breach Affecting Over 9.3 Million People (January 15, 2021); Aetna Pays $1,000,000 to Settle Three HIPAA Breaches (October 28, 2020); Health Insurer Pays $6.85 Million to Settle Data Breach Affecting Over 10.4 Million People (September 25, 2020); Health Insurer Pays $6.85 Million to Settle Data Breach Affecting Over 10.4 Million People (September 25, 2020); HIPAA Business Associate Pays $2.3 Million to Settle Breach Affecting Protected Health Information of Over 6 million Individual (September 23, 2020); Anthem pays OCR $16 Million in record HIPAA settlement following largest health data breach in history (October 15, 2018);  Record $16M Anthem HIPAA Settlement Signals Need To Tighten HIPAA Compliance & Risk Management. 

PIH Third Hacking Settlement In April

Although OCR’s PIH settlement announcement does not label the settlement as a Risk Analysis Initiative, OCR’s discussion makes clear OCR considered PIH’s failure to fulfill the Risk Analysis requirements a core failure contributing to the breach. The PIH settlement resolves an investigation that OCR conducted after receiving a breach report from PIH in January 2020 about a June 2019 phishing attack.  The report stated the attack compromised forty-five of its employees’ email accounts, resulting in the breach of 189,763 individuals’ unsecured ePHI. PIH reported that the ePHI disclosed in the phishing attack included affected individuals’ names, addresses, dates of birth, driver’s license numbers, Social Security numbers, diagnoses, lab results, medications, treatment and claims information, and financial information.

OCR’s investigation found multiple potential violations of the HIPAA Rules, including:

• Failure to use or disclose protected health information only as permitted or required by the HIPAA Privacy Rule.
• Failure to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by PIH.
• Failure to notify affected individuals, the HHS Secretary, and the media of a breach of unsecured protected health information within 60 days of its discovery.

Under the terms of the resolution agreement, PIH has agreed to implement a corrective action plan that OCR will monitor for two years and pay a $600,000 settlement to OCR. Under the corrective action plan, PIH is obligated to take definitive steps toward resolving potential violations of the HIPAA Rules, including:

• Conducting an accurate and thorough risk analysis of 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, maintaining, and revising, as necessary, its written policies and procedures to comply with the HIPAA Rules.
• Training its workforce members who have access to PHI on its HIPAA policies and procedures.

The findings of deficiencies in PIH’s risk analysis and requirements that PIH conduct an accurate and thorough risk analysis and implement a risk management plan to address and mitigate identified security risks and vulnerabilities are a recurrent theme in OCR breach investigations.   OCR’s recent addition of a Risk Analysis Initiative to its compliance and enforcement priorities heightens the significance of OCR’s inclusion of these findings and requirements in the PIH settlement.

Previous Health Plan Enforcement Actions Confirms Health Plan Face Similar HIPAA Exposures

In January 2021, for instance, OCR announced New York health insurer, Excellus Health Plan, Inc., would pay $5.1 million to settle potential HIPAA violations related to a breach affecting over 9.3 million people.  The settlement resulted from OCR’s investigation of a September 9, 2015, breach report that cyber-attackers gained unauthorized access to its information technology systems.  Excellus Health Plan reported that the breach began on or before December 23, 2013, and ended on May 11, 2015.  The hackers installed malware and conducted reconnaissance activities that ultimately resulted in the impermissible disclosure of the protected health information of more than 9.3 million individuals, including their names, addresses, dates of birth, email addresses, Social Security numbers, bank account information, health plan claims, and clinical treatment information. The resolution payment is the second largest collected by OCR to date.

In October, 2020, OCR announced a resolution agreement with Aetna Life Insurance Company and affiliated covered entity (Aetna) where Aetna paid a $1 million resolution payment to settle potential HIPAA violations that arose from Aetna’s filing of hacking related breach reports in 2017 and OCR’s September 2021 announcement of a resolution agreement where Premera Blue Cross (PBC) agreed to pay $6.85 million to OCR (the second largest in OCR history) to settle potential HIPAA violations related to a breach affecting over 10.4 million people. This resolution represents the third largest payment to resolve a HIPAA investigation in OCR history.

In each of these and all subsequent breach enforcement announcements and other guidance, OCR also persistently urges health plans and other regulated entities to perform the required documented risk assessments and take the required actions necessary to guard their ePHI from hackers and other susceptibilities.

Required & Recommended Actions To Promote Defensibility Of Risk Analysis Compliance  

With cyberattacks targeting health care and other Regulated Entities soaring and OCR stepping up its scrutiny of Regulated Entities’ Risk Analysis compliance in audits and enforcement actions, each health care provider 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.

Follow Proposed Rules & Enforcement Actions 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 care providers and other Regulated Entities should view Risk Analysis as an 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 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.

Additional Responsibilities & Risks For Health Plan Fiduciaries & Sponsors

Along side the OCR warnings, employment and union sponsored health plans, their sponsors, insurers, business associates and fiduciaries also now face additional pressure to take appropriate steps to security health plan data and timely investigate and report breaches.

prudent steps to secure their health plans’ protected health information and electronic data systems against improper use, access, destruction or disclosure under April, 2021 Employee Benefit Security Administration (“EBSA”) guidance package that for the first time officially recognizes cybersecurity as included in the fiduciary responsibilities of employee benefit plan fiduciaries under the Employee Retirement Income Security Act (“ERISA”) and addition of cybersecurity to its plan audits. As a result, in addition to complying with HIPAA, ERISA-covered health plan fiduciaries and sponsors also should be prepared to demonstrate that plan fiduciaries have taken the steps prudently necessary to guard health and other employee benefit plan data and systems against cybersecurity threats. In light of this guidance health plan fiduciaries and sponsors generally will want to ensure that at minimum, they can demonstrate that the health plan and health plan vendor cybersecurity safeguard meet or exceed the recommendations included in the following guidance materials published by EBSA as part of this cybersecurity announcement and any other steps that are prudent to guard against cybersecurity threats:

• Tips for Hiring a Service Provider: Helps plan sponsors and fiduciaries prudently select a service provider with strong cybersecurity practices and monitor their activities, as ERISA requires.
• Cybersecurity Program Best Practices: Assists plan fiduciaries and record-keepers in their responsibilities to manage cybersecurity risks.
• Online Security Tips: Offers plan participants and beneficiaries who check their retirement accounts online basic rules to reduce the risk of fraud and loss.

In light of this OCR and EBSA guidance, health plan sponsors, fiduciaries and vendors and other HIPAA covered entities and business associates are urged to take documented steps to audit and strengthen as needed their safeguards against hacking and other cybersecurity threats including:

• In the case of any health plan or health plan vendor, taking well documented steps to assess and tighten as necessary their health plan systems and data security to meet or exceed the recommendation outlined in the EBSA cybersecurity guidance or otherwise necessary to prudently guard their plans and plan data and systems against cybersecurity threats.
• Reviewing and monitoring on a documented, ongoing basis the adequacy and susceptibilities of existing practices, policies, safeguards of their own organizations, as well as their business associates and their vendors within the scope of attorney-client privilege taking into consideration data available from OCR, data regarding known or potential susceptibilities within their own operations as well as in the media, and other developments to determine if additional steps are necessary or advisable.
• Updating policies, privacy and other notices, practices, procedures, training and other practices as needed to promote compliance and defensibility.
• Renegotiating and enhancing service provider agreements to detail the specific compliance, audit, oversight and reporting rights, workforce and vendor credentialing and access control, indemnification, insurance, cooperation and other rights and responsibilities of all entities and individuals that use, access or disclose, or provide systems, software or other services or tools that could impact on security; to clarify the respective rights, procedures and responsibilities of each party in regards to compliance audits, investigation, breach reporting, and mitigation; and other relevant matters.
• Verifying and tightening technological and other tracking, documentation and safeguards and controls to the use, access and disclosure of protected health information and systems.
• Conducting well-documented training as necessary to ensure that members of the workforce of each covered entity and business associate understand and are prepared to comply with the expanded requirements of HIPAA, understand their responsibilities and appropriate procedures for reporting and investigating potential breaches or other compliance concerns, and understand as well as are prepared to follow appropriate procedures for reporting and responding to suspected
  violations or other indicia of potential security concerns.
• Tracking and reviewing on a systemized, well-documented basis actual and near miss security threats to evaluate, document decision-making and make timely adjustments to policies, practices, training, safeguards and other compliance components as necessary to identify and resolve risks.
• Establishing and providing well-documented monitoring of compliance that includes board level oversight and reporting at least quarterly and sooner in response to potential threat indicators.
• Establishing and providing well-documented timely investigation and redress of reported
  violations or other compliance concerns.
• Establishing contingency plans for responding in the event of a breach. 
• Establishing a well-documented process for monitoring and updating policies, practices and other efforts in response to changes in risks, practices and requirements.
• Preparing and maintaining a well-documented record of compliance, risk, investigation and other security activities.
• Pursuing other appropriate strategies to enhance the covered entity’s ability to demonstrate its compliance commitment both on paper and in operation.

Because susceptibilities in systems, software and other vendors of business associates, covered entities and their business associates should use care to assess and manage business associate and other vendor associated risks and compliance as well as tighten business associate and other service agreements to promote the improved cooperation, coordination, management and oversight required to comply with the new breach notification and other HIPAA requirements by specifically mapping out these details.

Leaders of covered entities or their business associates also are cautioned that while HIPAA itself does not generally create any private right of action for victims of breach under HIPAA, breaches may create substantial liability for their organizations or increasingly, organizational leaders under state data privacy and breach, negligence or other statutory or common laws.  In addition, physicians and other licensed parties may face professional discipline or other professional liability for breaches violating statutory or ethical standards.  Meanwhile, the Securities and Exchange Commission has indicated that it plans to pursue enforcement against leaders of public health care or other companies that fail to use appropriate care to ensure their organizations comply with privacy and data security obligations and the Employee Benefit Security Administration recently has issued guidance recognizing prudent data security practicces as part of the fiduciary obligations of health plans and their fiduciaries.  

Appropriate Processes Can Prevent Breaches & Enhance Defensibility

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 in addition to those imposed under HIPAA and ERISA. For instance, inadequate data safeguards for ePHI also can trigger liability 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 hospital or other health care providers, insurers, or their business associates. Health care providers, payers and others are likely to face specific additional health care or insurance-specific licensing and ethics rules, as well as other confidential information privacy, cybersecurity and breach reporting obligations and liability under various state statutes and regulations. 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.

Finally, health plans and other Regulated Entities are reminded that appropriate strategic planning, ongoing diligence in monitoring and responding to security events and susceptibility, and timely and appropriate use of appropriate evidentiary and procedural tools can critically impact the defensibility of pre-breach, breach investigation and post-breach investigation and decision-making. Because HIPAA, EBSA and other rules typically require prompt investigation and response to known or suspected hacking or other cybersecurity threats, health plans and other covered entities or business associates should seek the assistance of experienced legal counsel to advise and assist in these activities to understand the potential availability and proper use of these and other evidentiary rules as part of the compliance planning process as well as to prepare for appropriate use in the event of a known or suspected incident to avoid unintentional compromise of these protections.

The author of this update, Cynthia Marcotte Stamer is nationally known and celebrated for her experience providing advice and representation to health care providers, health insurers, employers and other health plan sponsors, health plans, health plan fiduciaries and administrators, third party administrators, 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.

For More Information Or Help

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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NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or admission. Solutions Law Press and its authors reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. Solutions Law Press and its authors disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2025 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press.™ For information about licensing for republication, please contact the author directly. All other rights reserved.

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[1] The civil monetary penalty amounts are adjusted annually for inflation.  OCR has not yet published the 2025 inflation adjusted amounts.