OCR Cybersecurity Newsletter Highlights Importance of HIPAA Sanctions Policies

The Office for Civil Rights (OCR) recently offered covered entities and business associates (regulated entities) some not-so-subtle reminders in its October 2023 Cybersecurity Information Bulletin that effective sanctions policies can encourage HIPAA compliance.

Regulated entities are required by HIPAA to implement sanctions policies in which they impose appropriate sanctions against their respective personnel who fail to comply with the Privacy Rule or Security Rule, policies and the regulated entity’s privacy procedures and/or the regulated entity’s security policies and procedures, if applicable. These sanctions policies are important administrative safeguards intended to ensure that there are objective, documented consequences for HIPAA non-compliance among staff members. The recent proliferation of social engineering attacks and the increasingly sophisticated nature of external cybersecurity threats in the healthcare industry underscore the importance for regulated entities to systematically review and enforce their sanctions policies .

Because the Privacy Rule and Security Rule provide regulated entities flexibility regarding the content of their sanctions policies, including sanctions and severity of sanctions imposed, OCR has included in the Cybersecurity Newsletter the following considerations for regulated entities when drafting or reviewing their sanctions. Strategies:

• Document or implement sanctions policies in accordance with a formal process Regulated entities must have separate written policies and procedures explaining how their sanctions policies will be applied.
• Require staff members to affirmatively acknowledge that a violation of the organization’s HIPAA policies or procedures may result in sanctions. In addition to being informed of sanction procedures, staff members must sign a declaration of adherence to the security and/or confidentiality policy and procedures.
• Document the sanction process, including the personnel involved, the procedural steps, the period, the reason for the sanction(s), and the final outcome of an investigation. As part of their HIPAA audit protocol, regulated entities will want to review personnel involved in the sanctioning process; the steps and time frame required (including notification); the reasons for the sanction; identification of sanctions applied in the event of non-compliance; and documentation of the outcome of the sanction. OCR also recommended that these records be retained for at least six years.
• Create sanctions that are (i) adapted to the nature of the violation; (ii) vary based on factors such as the severity of the breach, whether the breach was intentional or unintentional, and whether the breach indicated a pattern or practice of inappropriate use or disclosure of protected health information; and (iii) range from warning to termination The Privacy Rule requires regulated entities, where appropriate, to use a flexible sanctions approach in which they consider the specific details and severity of the violation.
• Provide examples of potential violations of policy and procedures To ensure transparency, regulated entities should consider including real-world examples of potential violations by personnel of the entity’s HIPAA policy and procedures.

OCR noted in the Cybersecurity Newsletter that it has enforced regulated entity sanctions requirements in the past, including through settlements with a Texas health system in 2017 and an allergy practice in 2018 , respectively, to resolve allegations that the entities violated the requirement of the confidentiality rules to impose. appropriate sanctions against staff members who have failed to comply with the confidentiality rule and the policies and procedures of the respective organizations.

As OCR often communicates, HIPAA policies and procedures are only as effective as how entities apply them to their organizations. Regulated entities should regularly review their sanctions policies and organizational policies and procedures to assess whether they have implemented and enforced these policies fairly and consistently across the organization, for all personnel, including management.

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