Answer:

45 CFR § 164.304 defines security incident as the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system. The Security Incident Procedures standard at § 164.308(a)(6)(i) requires a covered entity to implement policies and procedures to address security incidents. The associated implementation specification for response and reporting at § 164.308(a)(6)(ii) requires a covered entity to identify and respond to suspected or known security incidents, mitigate, to the extent practicable, harmful effects of security incidents that are known to the covered entity, and document security incidents and their outcomes.

In order to maintain a flexible, scalable and technology neutral approach to the Security Rule, no single method is identified for addressing security incidents that will apply to all covered entities. As stated in the preamble to the Security Rule, 68 Fed. Reg. 8350, an entity should be able to rely upon the information gathered in complying with the other security standards, for example, its risk assessment and risk management procedures and the Privacy Rule standards, to determine what constitutes a security incident in the context of its business operations.

In addressing the security incident procedures standard, a covered entity may consider some of the following questions: what specific actions would be considered security incidents; how will incidents be documented and reported; what information should be contained in the documentation; how often and to whom should incidents be reported; what are the appropriate responses to certain incidents; and whether identifying patterns of attempted security incidents is reasonable and appropriate.

When taking into consideration the requirements of §§ 164.306(a) and (b), and its risk analysis, the covered entity may decide that certain types of attempted or successful security incidents or patterns of attempted or successful incidents warrant different actions. For example, a covered entity may decide that a “ping” (a request-response utility used to determine whether a specific Internet Protocol (IP) address, or host, exists or is accessible) on the communications network initiated from an external source would require the following actions to comply with the standard; (1) minimal, if any, response; (2) no mitigation actions since no harmful effects were caused by the incident; and (3) brief documentation of the security incident and outcome, such as, a recording of aggregate statistical information. Based on its analysis, the entity may also determine that other types of incidents, such as suspicious patterns of “pings” on the communications network initiated from an external source or a specific malicious security incident would require a more detailed response, mitigation steps, and more detailed documentation of the incident and outcome.

While internal reporting of security incidents is an inherent part of security incident policies and procedures, the Security Rule generally does not require a covered entity to report incidents to outside entities. However, 45 CFR §§ 164.314(a)(2)(i)(C) and 164.314(b)(2)(iv) require contracts between a covered entity and a business associate, and plan documents of a group health plans, respectively, to include provisions that require business associates and plan sponsors to report to the covered entity any security incidents of which they become aware. (Note that in certain circumstances a group health plan may not be required to amend its plan documents. See § 164.314(b)(1).)