Source: https://www.healthit.gov/test-method/auditable-events-and-tamper-resistance
Timestamp: 2019-04-26 10:16:06+00:00

Document:
(d)(2)(i)(A) step 2 updated types of actions.
(d)(2)(i)(A) “changes to user privilege” was moved to be grouped with “change” to make clear that they can be separately recorded actions or that this more specific change can be labeled first as a “change” and then with more specificity as to the type of change.
Record the encryption status (enabled or disabled) of electronic health information locally stored on end-user devices by technology in accordance with the standard specified in §170.210(e)(3) unless the technology prevents electronic health information from being locally stored on end-user devices (see paragraph (d)(7) of this section).
Default setting. Technology must be set by default to perform the capabilities specified in paragraph (d)(2)(i)(A) of this section and, where applicable, paragraphs (d)(2)(i)(B) and (d)(2)(i)(C) of this section.
When disabling the audit log is permitted. For each capability specified in paragraphs (d)(2)(i)(A) through (C) of this section that technology permits to be disabled, the ability to do so must be restricted to a limited set of users.
Audit log protection. Actions and statuses recorded in accordance with paragraph (d)(2)(i) of this section must not be capable of being changed, overwritten, or deleted by the technology.
Detection. Technology must be able to detect whether the audit log has been altered.
§ 170.315(d)(7)(ii) Technology is designed to prevent electronic health information from being locally stored on end-user devices after use of the technology on those devices stops.
§ 170.210(e)(3) The audit log must record the information specified in sections 7.2 and 7.4 of the standard specified at § 170.210(h) when the encryption status of electronic health information locally stored by EHR technology on end-user devices is changed. The date and time each action occurs in accordance with the standard specified at § 170.210(g).
Clarification added around types of audit logs which should be captured with this criterion.
Clarification added around recording actions in the audit log.
Clarification added related to functionality not included in health IT.
Clarification added in (d)(2)(i)(C) related to testing (d)(2) without (d)(7).
Clarification added for “Query” actions.
Clarifications added for the application of this criterion to relied upon software and HISPs. In addition, clarified the meaning of the term “user,” the requirements for recording changes to user privileges, the timing of logging changes is dependent on Health IT design or workflow, and that either a single audit log or multiple audit logs may be used to meet the requirements of this criterion.
Clarification added for the entire criterion related to testing of “portal” products.
If the health IT does not include a capability for which an ‘‘action’’ is listed, testing and certification can proceed for the audit log process without health IT showing that it can record actions related to a non-existent capability.
Similarly, for example, a developer that is seeking to certify a Health IT Module to 170.315(h) will not necessarily have end-user device encryption features (see 170.315(d)(7)). As such, certification can proceed for the audit log process without the health IT Module demonstrating that it can record an encryption status as required by 170.315(d)(2)(i)(C).
For HISP software that does not normally store patient data, certification to (d)(2) does not create the obligation to do so. Rather, certification to (d)(2) requires that a user is able to produce a forensic reconstruction of events in the case of a security incident. At a minimum, some type of message ID, date/time, sender, receiver, confirmation of receipt, and other values may be necessary. For example, it may be helpful to consider what types of data a user would need to track misrouted or dropped messages. Additionally, the HISP software being certified may contain error queues, support dashboards, and other tools where messages containing PHI are persisted. Audit records would have to be created when actions are performed on PHI through these tools, per (d)(2).
For portal products seeking (e)(1) certification, testing the activity history log will involve much of the patient level audit recording, such as patient account login, view, download, and transmit actions. This criterion would not be applicable to the patient user. Rather, it applies to administrative functionality such as creating accounts, revoking privileges, and account disabling. It is not applicable to the activity history log for patient use of the (e)(1) functionality.
Technical outcome – The health IT records actions pertaining to electronic health information in accordance with sections 7.2 through 7.4, 7.6, and 7.7 of the ASTM E2147-01 standard when health it is in use; changes to user privileges when health IT is in use; and records the date and time in accordance with either RFC 1305 or RFC 5905.
“Copy” can encompass a variety of actions, including extracting data from the health IT.
For "Query" actions, some of the fields listed in ASTM E2147-01 may not apply, such as patient ID. To enable a forensic reconstruction of the query, the health IT should capture information about the query, such as the search the user performed, so that a security professional could identify nefarious user behavior. For example, a user performing multiple searches looking for famous individuals who may be patients in the system.
The certification criterion requires actions initiated by the user from within the health IT interface to be tracked in the audit log. The copy and paste functions of Microsoft Windows originate outside of the health IT environment and are thus outside the scope of certification. Copy actions originating from within the health IT interface (e.g., exporting or downloading a copy of electronic health information from the health IT) are required to be tracked in the audit log.
Demonstration of the ability to use NIST time servers is required for certification, however vendors are not required to use NIST servers post certification.
A "pointer to original data state" is a means of identifying original information that has been changed by a user. Similarly, a "pointer to deleted information" is a means of identifying information prior to deletion. A description of a change or deletion is acceptable as long as the type of action is specified and both the original and modified data states are able to be identified. For example, an audit log could include a link to an original document and provide a description of the modified state. Conversely, it could include a description of the original data state and provide a link to the modified document. The certification criterion is not prescriptive of how the requirement should be achieved. Demonstrating the ability to view the original document prior to a change or deletion is an acceptable method of meeting the certification requirement, however it is not required during testing.
Information related to the required actions (additions, deletions, changes, queries, print, and copy) must be recorded in the audit log, however the certification criterion is not prescriptive to the method by which this is achieved and does not place limitations on the format in which this information is presented in the audit log. Namely, the audit log should record actions in a way that assists the user in reconstructing events that occurred effecting health information. For example, a "change" action may be listed in the audit log as an "edit" event if that is the labeling the user is accustomed to using in the health IT Module for those kinds of actions.
“Changes to user privilege” are considered a type of “change.” Health IT may separately record this auditable event or may reflect an approach that records user privilege changes as a subtype or reason (description) for the change.
If the audit log reflects the privilege modification to each individual user account that was part of the group, the privilege modification may be applied as a group change.
The elements "Patient identification" and "Identification of the patient data that are accessed" are not applicable when capturing a "user privilege change" action.
The exact point in time when an action is logged may depend on the architecture/design of the Health IT Module or the workflow.
For the purposes of certification, a Health IT Module may create a single audit log file with all of the specified auditable data or it may use multiple audit log files. However, if this latter approach is used, when all of the audit log files are considered together the total content they include must represent all of the required auditable data (which would be equivalent to the single audit log file approach).
Technical outcome – The health IT records the audit log status in accordance with sections 7.2 and 7.4 of the ASTM E2147-01 standard when the audit log status is changed and records the date and time each action occurs in accordance with either RFC 1305 or RFC 5905.
This provision only applies when the technology allows the audit log to be disabled.
Technical outcome – The health IT records the information specified in sections 7.2 and 7.4, of the ASTM E2147-01 standard when the encryption status of locally stored electronic health information on end-user devices is changed and records the date and time each action occurs in accordance with either RFC 1305 or RFC 5905.
This provision does not apply when the technology prevents electronic health information from being locally stored on end-user devices.
Paragraph 170.315(d)(2)(i)(C) is NOT applicable for the privacy and security testing and certification of a Health IT Module required by § 170.550(h)(3)(iii), (v), (vii), and (viii). This specific requirement was intended to be exempted. It would only apply if § 170.315(d)(7) was also required for privacy and security testing and certification, which it is not under the aforementioned paragraphs.
Technical outcome – The health IT is set by default to record actions related to electronic health information (per provision (d)(2)(i)(A)), (where applicable) record the audit log status (per provision (d)(2)(i)(B)), and (where applicable) record the encryption status of locally stored electronic health information on end-user devices (per provision (d)(2)(i)(C)).
The default setting requirement is only applicable for recording the audit log status if the technology permits the audit log be disabled.
The developer must demonstrate that the audit log is capable of recording the details (date, time, and user identification at a minimum) related to enabling and disabling of the encryption status. However, if the health IT is designed in such a way that no users are able to enable or disable the encryption status, the vendor is permitted to submit supporting documentation to demonstrate this. Requirements related to the specific process of encrypting electronic health information locally stored on end- user devices by health IT are outside the scope of this certification criterion, but are addressed in the § 170.315(d)(7) End-user device encryption certification criterion.
Technical outcome – The health IT will restrict the ability for auditing to be disabled to a limited set of users if the technology permits auditing to be disabled.
Technical outcome – The health IT will not allow actions and status recorded related to electronic health information per provision (d)(2)(i)(A), (B), and (C) to be changed, overwritten, or deleted by the technology.
Technical outcome – The health IT must be able to detect whether the audit log has been altered.

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