Internet Draft G. Marshall Document: draft-marshall-security-audit-04.doc Siemens Expires: March 2004 September 2003 Security Audit and Access Accountability Message Data Definitions for Healthcare Applications Status of this Memo This document is an Internet-Draft and is in full conformance with all provisions of Section 10 of RFC2026[1]. Internet-Drafts are working documents of the Internet Engineering Task Force (IETF), its areas, and its working groups. Note that other groups may also distribute working documents as Internet- Drafts. Internet-Drafts are draft documents valid for a maximum of six months and may be updated, replaced, or obsoleted by other documents at any time. It is inappropriate to use Internet-Drafts as reference material or to cite them other than as "work in progress." The list of current Internet-Drafts can be accessed at http://www.ietf.org/ietf/1id-abstracts.txt The list of Internet-Draft Shadow Directories can be accessed at http://www.ietf.org/shadow.html. Abstract To help assure healthcare privacy and security in automated systems, usage data need to be collected. These data will be reviewed by administrative staff to verify that healthcare data is being used in accordance with the healthcare provider's data security requirements and to establish accountability for data use. This review process is called security auditing. This document defines the format of the data to be collected and minimum set of attributes that need to be captured by healthcare application systems for subsequent use by an automation-assisted review application. The data includes records of who accessed healthcare data, when, for what action, from where, and which patients' records were involved. The data definition is an XML schema to be used as a reference by healthcare standards developers and application designers. Conventions used in this document The key words "MUST", "MUST NOT", "REQUIRED", "SHALL", "SHALL NOT", "SHOULD", "SHOULD NOT", "RECOMMENDED", "MAY", and "OPTIONAL" in this document are to be interpreted as described in RFC-2119[2]. Marshall Expires - March 2003 [Page 1] Security Audit and Access Accountability Message September 2003 Table of Contents 1. Purpose.......................................................2 2. Scope.........................................................3 2.1 Data Collection...........................................3 2.2 Anticipated Data End-uses.................................4 2.3 Conformance...............................................5 3. Goals.........................................................5 3.1 Effective Data Gathering..................................5 3.2 Efficiency................................................6 4. Trigger Events................................................7 4.1 Security Administration...................................7 4.2 Audit Administration and Data Access......................8 4.3 User Access...............................................9 5. Data Definitions.............................................12 5.1 Event Identification.....................................12 5.2 Active Participant Identification........................15 5.3 Network Access Point Identification......................19 5.4 Audit Source Identification..............................20 5.5 Participant Object Identification........................23 6. XML Schema...................................................30 6.1 XML Schema Definition....................................30 6.2 XML Schema Localization..................................41 7. Security Considerations......................................42 References......................................................43 Draft Change History............................................43 Acknowledgments.................................................45 Author's Addresses..............................................45 1. Purpose The purposes the document fulfills are to: 1) Define data to be communicated for evidence of compliance with, and violations of, a healthcare enterprise's security and privacy policies and objectives. The focus of auditing in this document is to retrospectively detect and report security/privacy breaches, versus directly inhibiting access. This includes capturing data that supports individual accountability for patient record creation, access, updates, and deletions. It does not include real-time access alarm actions since there is a perception in the healthcare community that security measures that inhibit access may also inhibit effective patient care, under some circumstances. This document does not define healthcare security and privacy policies or objectives. Marshall Expires - March 2003 [Page 2] Security Audit and Access Accountability Message September 2003 2) Depict the data that would potentially reside in a common audit engine or database. Privacy and security audit data is to be collected on each hardware system, and there are likely to be separate local data stores for system-level and application-level audits. Collating these records and providing a common view - transcending hardware system boundaries - is seen as necessary for cost-effective security and privacy policy administration. The data definitions support such a collation, but the technical implementation alternatives are not covered in this document. 3) Depict data that allows useful queries against audited events. Audit data, in its raw form, reflects a sequential view of system activity. Useful inquiries for security and privacy administration need workflow, business process, organizational, role, and person-oriented views. Data definitions in this document anticipate and support creating those views and queries, but do not define them. 4) Provide a common reference standard for healthcare IT standards development organizations. This document consolidates previously disjoint viewpoints from Health Level 7 (HL7)[3], Digital Imaging and Communications in Medicine (DICOM) Working Group 14, Integrating the Healthcare Enterprise (IHE)[4], the ASTM International Healthcare Informatics Technical Committee (ASTM E31)[5], and the Joint NEMA/COCIR/JIRA Security and Privacy Committee[6]. It is intended as a reference for these groups and other healthcare standards developers. By specifying an XML schema, this document anticipates extensions to the base schema to meet requirements of healthcare standards bodies and application developers. 2. Scope 2.1 Data Collection This document specifies audit data to be collected and communicated from automated systems. It does not include non-automated processes. Data for events in the above categories may be selectively collected, based on healthcare organization policy. This document does not specify any baseline or minimal policies. Marshall Expires - March 2003 [Page 3] Security Audit and Access Accountability Message September 2003 For each audited event, this document specifies the minimal data requirements plus optional data for the following event categories: 1) Security administrative events - establishing and maintaining security policy definitions, secured object definitions, role definitions, user definitions, and the relationships among them. In general, these events are specific to the administrative applications. 2) Audit access events - reflecting special protections implemented for the audit trail itself. 3) Security-mediated events - recording entity identification and authentication, data access, function access, nonrepudiation, cryptographic operations, and data import/export for messages and reports. In general, these events are generic to all protected resources, without regard to the application data content. 4) Patient care data events - documenting what was done, by whom, using which resources, from what access points, and to whose medical data. In general, these audits are application-specific since they require knowledge of the application data content. Security subsystems found in most system infrastructures include a capability to capture system-level security relevant events like logon and security object accesses. This document does not preclude such functions being enabled to record and supply the data defined in this document, but transformation to conform to the common XML schema definition will be required. Application-level events, such as patient record access, are not captured by system-level security audits. The defined data support applications' record access auditing for healthcare institutional security and privacy assurance plus related policy administration functions. System-local data definitions for collection and storage of audit data, prior to transformation to a common schema and transmission to a common repository, are not included in this document. 2.2 Anticipated Data End-uses This document anticipates, but does not define, end-uses for the data collected. The typical healthcare IT environment contains many systems from various vendors and developers who have not implemented common or interoperable security administrative functions. This document anticipates a requirement to transmit data from several unrelated Marshall Expires - March 2003 [Page 4] Security Audit and Access Accountability Message September 2003 systems to a common repository. It also anticipates the aggregated data may then be queried and viewed an a variety of ways. There are distinctions of detail granularity, specificity, and frequency between audit data required for surveillance versus forensic purposes. While some surveillance data may be useful for forensics, the scope of this document is limited to surveillance. This document does not address access real-time policy violation alarm actions. There is a perception in the healthcare community that security measures that inhibit access may also inhibit effective patient care, under some circumstances. This document does not define any data for patient care consents or patients' permissions for data disclosure. It is conceivable that the proposed audit data could be input to such applications, however, assuming strict access controls for audit data have been established. This document does not define system-specific or application-specific data that may be collected and reported in addition to the defined elements. For example, it is conceivable that audit mechanisms may be useful for tracking financial or payroll transactions. At the same time, this document does not preclude extending the XML schema to incorporate additional data. There is a potential requirement for a set of administrative messages to be sent from a central source to each participating system to uniformly specify, control, enable, or disable audit data collection. Such messages are not included in this document. 2.3 Conformance This document does not include any definitions of conformance practices. Instead, it anticipates that standards development organizations that reference this document may specify their own conformance requirements. 3. Goals 3.1 Effective Data Gathering The process of assuring that security policies are implemented correctly is essential to information security administration. It is a set of interrelated tasks all aimed at maintaining an acceptable level of confidence that security protections are, in fact, working as intended. These tasks are assisted by data from automated instrumentation of system and application functions. Data gathered from a secured environment is used to accumulate evidence that security systems are working as intended and to detect Marshall Expires - March 2003 [Page 5] Security Audit and Access Accountability Message September 2003 incidents and patterns of misuse for further actions. Once messages have been collected, various reports may be created in support of security assurance and administration information requirements. When a site runs multiple heterogeneous applications, each application system may have its own security mechanisms - user logon, roles, access right permissions and restrictions, etc. Each application system also has its own security log file that records security relevant events, e.g., login, data access, and updates to the security policy databases. A system administrator or security auditor must examine each of these log files to find security relevant incidents. Not only is it difficult to examine each of these files separately, the format and contents of each file may be confusingly different. Resolving these issues requires a framework to: - Maximize interoperability and the meaningfulness of data across applications and sites - Minimize ambiguity among heterogeneous systems - Simplify and limit the costs of administrative audit tasks. 3.2 Efficiency One of the leading concerns about auditing is the potential volume of data gathering and its impact on application system performance. Although this document does not prescribe specific implementations or strategies, the following are meant as informative guidance for development. 1) Audits should be created for transactions or record-level data access, not for individual attribute-level changes to data. 2) This document does not discourage locally optimized gathering of audit data on each application system. Instead, it anticipates implementation-defined periodic gathering and transmission of data to a common repository. This common repository would be optimized for after-the-fact audit queries and reporting, thus unburdening each application system of those responsibilities. It is also important to keep the message size compact so that audit data will not penalize normal network operation. 3) On each application system, a variety of policy-based methods could be employed to optimize data gathering and storage, e.g., selective auditing of only events defined as important plus workload buffering and balancing. Data gathering itself should be stateless to avoid the overhead of transactional semantics. In addition, prior to transmission, some filtering, aggregation, and summarization of repeated events would reduce the number of messages. Audit data storage and integrity on each application Marshall Expires - March 2003 [Page 6] Security Audit and Access Accountability Message September 2003 system need only be scaled for relatively low-volume and short- duration requirements, yet be consistent with implementation- defined minimums for holding the data for subsequent collection. 4) Leveraging existing data collection should be considered. For example, most commercial security subsystems record events in a local common log file, so the log file data can be extracted for communication to a common repository. Also, it is common in some systems' designs to have a transaction log for data reconstruction in event of database loss, so collecting data-update audit data within this subsystem could reduce impact on application system performance. 5) A security audit repository would gather all audit message data from the different applications in one database with one standard structure. This would allow easier evaluation and querying. Once a suspicious pattern has been found in the audit log repository, investigation might proceed with more detail in the application specific audit log. The presence of a common repository also simplifies and streamlines the implementation of policies for audit data storage, integrity, retention, and destruction. 4. Trigger Events The following identifies representative trigger events for generating audit messages. This is not a normative list of trigger events. For those events arising in the security infrastructure the "minimal" and "basic" level of auditing as outlined in the Common Criteria[7] should be used as a reference standard. 4.1 Security Administration This group includes all actions that create, maintain, query, and display definitions for securing data, functions, and the associated access policies. For each trigger type, the creation, update or amendment, deletion, and activation or deactivation are auditable. 4.1.1 Data Definition This includes creation, modification, deletion, query, and display of security attributes for data sets, data groups, or classes plus their atomic data elements or attributes. 4.1.2 Function Definition This includes, for example, creation, modification, deletion, query, or display of security attributes and auditable events for the application functions used for patient management, clinical Marshall Expires - March 2003 [Page 7] Security Audit and Access Accountability Message September 2003 processes, registry of business objects and methods, program creation and maintenance, etc. 4.1.3 Domain Definition This includes all activities to create, modify, delete, query, or display security domains according to various organizational categories such as entity-wide, institutional, departmental, etc.: 4.1.4 Classification Definition This includes all activities that create, modify, delete, query or display security categories or groupings for functions and data such as patient management, nursing, clinical, etc. 4.1.5 Permission Definition This includes all activities that create, modify, delete, query or display the allowable access permissions associated with functions and data, such as create, read, update, delete, and execution of specific functional units or object access or manipulation methods. 4.1.6 Role Definition This includes all activities that create, modify, delete, query or display security roles according to various task-grouping categories such as security administration, admissions desk, nurses, physicians, clinical specialists, etc. It also includes the association of permissions with roles for role-based access control. 4.1.7 User Definition This includes all activities that create, modify, delete, query, or display user accounts. It includes password or other authentication data. It also includes the association of roles with users for role- based access control, or permissions with users for user-based access control. 4.2 Audit Administration and Data Access This category includes all actions that determine the collection and availability of audit data. 4.2.1 Auditable Event Enable or Disable This reflects a basic policy decision that an event should or should not be audited. Some, but not necessarily all, triggers or use cases must create an audit record. The selection of what to audit depends on administrative policy decisions. Note that, for integrity, this event should always be audited. Marshall Expires - March 2003 [Page 8] Security Audit and Access Accountability Message September 2003 4.2.2 Audit Data Access This includes instances where audit data is viewed or reported for any purpose. Since the audit data itself may include data protected by institutional privacy policies and expose the implementation of those policies, access to the data is highly sensitive. This event should therefore always be audited. 4.2.3 Audit Data Modify or Delete This includes instances where audit data is modified or deleted. While such operations are sometimes permitted by systems policies, modification or destruction of audit data may well be the result of unauthorized hostile systems access. Therefore, this type of event should always be audited. 4.3 User Access This category includes events of access to secured data and functions for which audit data might be collected. 4.3.1 Sign-On This includes successful and unsuccessful attempts from human users and automated system. 4.3.2 Sign-Off This includes explicit sign-off events and session abandonment timeouts from human users and automated systems. 4.3.3 Function Access This includes user invocation of application or system functions that have permission definitions associated with them. Note that in a Discretionary Access Control environment not all functions require permissions, especially if their impact is benign in relation to security policies. The following are non-normative examples of trigger events relevant to healthcare privacy. The actual triggers for institutional data access, policies for non-care functions, and support regulatory requirements need to be identified by application-domain standards developers and system implementers. Marshall Expires - March 2003 [Page 9] Security Audit and Access Accountability Message September 2003 4.3.3.1 Subject of Care Record Access This includes all functions which manipulate basic patient data: - Create, e.g., demographics or patient profile - Assign identifier, e.g., medical record number - Update, amend - Merge/unmerge, e.g., combine multiple medical records for one patient - Import/export of data from/to an external source, including printing and creation of portable media copies. - Delete, e.g., invalid creation of care record 4.3.3.2 Encounter or Visit This includes all functions which associate a subject of care with an instance of care: - Create, e.g., demographics or patient profile - Assign encounter identifier - Per-admit - Admit - Update, amend - Delete, e.g., invalid creation of encounter record, breakdown of equipment, patient did not arrive as expected 4.3.3.3 Care Protocols This includes all functions which associate care plans or similar protocols with an instance or subject of care: - Schedule, initiate - Update, amend - Complete - Cancel 4.3.3.4 Episodes or Problems This includes specific clinical episodes within an instance of care. Initiate - Update, amend - Resolve, complete - Cancel Marshall Expires - March 2003 [Page 10] Security Audit and Access Accountability Message September 2003 4.3.3.5 Orders and Order Sets This includes clinical or supplies orders within an instance or episode of care. - Initiate - Update, amend - Check for contraindications - Verify - Deliver/complete - including instructions - Cancel 4.3.3.6 Health Service Event or Act This includes various health services scheduled and performed within an instance or episode of care - Schedule, initiate - Update, amend - Check for contraindications - Verify - Perform/complete - including instructions - Cancel 4.3.3.7 Medications This includes all medication orders and administration within an instance or episode of care. - Order - Check - Check for interactions - Verify - Dispense/deliver - including administration instructions - Administer - Cancel 4.3.3.8 Staff/Participant Assignment This includes staffing or participant assignment actions relevant to an instance or episode of care. - Assignment of healthcare professionals, caregivers attending physician, residents, medical students, consultants, etc. - Change in assigned role or authorization, e.g., relative to healthcare status change. - De-assignment Marshall Expires - March 2003 [Page 11] Security Audit and Access Accountability Message September 2003 5. Data Definitions This section defines and describes the data in the XML schema. The actual XML schema definition is in section 6. The proposed data elements are grouped into these categories: 1) Event Identification - what was done 2) Active Participant Identification - by whom 3) Network Access Point Identification - initiated from where 4) Audit Source Identification - using which server 5) Participant Object Identification - to what record 5.1 Event Identification The following data identify the name, action type, time, and disposition of the audited event. There is only one set of event identification data per audited event. 5.1.1 Event ID Description Identifier for a specific audited event, e.g., a menu item, program, rule, policy, function code, or application name, or URL. It identifies the performed function. Optionality: Required Format / Values Coded value, either defined by the system implementers or as a reference to a standard vocabulary. The "code" attribute must be unambiguous and unique, at least within Audit Source ID (see section 5.4). Examples of Event IDs are program name, method name, or function name. For implementation defined coded values or references to standards, the XML schema defines these optional attributes: Attribute Value -------------- -------------------------------------------- CodeSystem OID reference CodeSystemName Name of the coding system; strongly recommended to be valued for locally-defined code-sets. DisplayName The value to be used in displays and reports OriginalText Input value that was translated to the code Marshall Expires - March 2003 [Page 12] Security Audit and Access Accountability Message September 2003 To support the requirement for unambiguous event identification, multiple values may not be specified. Rationale This identifies the audited function. For "Execute" Event Action Code audit records, this identifies the application function performed. 5.1.2 Event Action Code Description Indicator for type of action performed during the event that generated the audit. Optionality: Optional Format / Values Enumeration: Value Meaning Examples ----- --------------------- ---------------------------------- C Create Create a new database object, such as Placing an Order. R Read/View/Print/Query Display or print data, such as a Doctor Census U Update Update data, such as Revise Patient Information D Delete Delete items, such as a doctor master file record E Execute Perform a system or application function such as logon, program execution, or use of an object's method Rationale This broadly indicates what kind of action was done on the Participant Object. Notes Actions that are not enumerated above are considered an Execute of a specific function or object interface method or treated two or more distinct events. An application action, such as an authorization, is a function Execute, and the Event ID would identify the function. Marshall Expires - March 2003 [Page 13] Security Audit and Access Accountability Message September 2003 For some applications, such as radiological imaging, a Query action may only determine the presence of data but not access the data itself. Auditing need not make as fine a distinction. Compound actions, such as "Move," would be audited by creating audit data for each operation - read, create, delete - or as an Execute of a function or method. 5.1.3 Event Date/Time Description Universal coordinated time (UTC), i.e. a date/time specification that is unambiguous as to local time zones. Optionality: Required Format / Values A date/time representation that is unambiguous in conveying universal coordinated time (UTC), formatted according to the ISO 8601 standard[8] Rationale This ties an event to a specific date and time. Security audits typically require a consistent time base, e.g., UTC, to eliminate time-zone issues arising from geographical distribution. Notes In a distributed system, some sort of common time base, e.g., an NTP[9]server, is a good implementation tactic. 5.1.4 Event Outcome Indicator Description Indicates whether the event succeeded or failed. Optionality: Required Format / Values Enumeration: Value Meaning ---- ---------------------------------------------------- 0 Success 4 Minor failure; action restarted, e.g., invalid password Marshall Expires - March 2003 [Page 14] Security Audit and Access Accountability Message September 2003 with first retry 8 Serious failure; action terminated, e.g., invalid password with excess retries 12 Major failure; action made unavailable, e.g., user account disabled due to excessive invalid logon attempts Rationale Some audit events may be qualified by success or failure indicator. For example, a Logon might have this flag set to a non-zero value to indicate why a logon attempt failed. 5.1.5 Event Type Code Description Identifier for the category of event. Optionality: Optional Format / Values Coded value enumeration, either defined by the system implementers or as a reference to a standard vocabulary. For implementation defined codes or references to standards, the XML schema defines these optional attributes: Attribute Value -------------- -------------------------------------------- CodeSystem OID reference CodeSystemName Name of the coding system; strongly recommended to be valued for locally-defined code-sets. DisplayName The value to be used in displays and reports OriginalText Input value that was translated to the code Since events may be categorized in more than one way, there may be multiple values specified. Rationale This field enables queries of messages by implementation-defined event categories. 5.2 Active Participant Identification The following data identify a user for the purpose of documenting accountability for the audited event. A user may be a person, or a hardware device or software process for events that are not initiated by a person. Marshall Expires - March 2003 [Page 15] Security Audit and Access Accountability Message September 2003 Optionally, the user's network access location may be specified. There may be more than one user per event, for example, in cases of actions initiated by one user for other users, or in events that involve more than one user, hardware device, or system process. However, only one user may be the initiator/requestor for the event. 5.2.1 User ID Description Unique identifier for the user actively participating in the event Optionality: Required Format / Values User identifier text string from the authentication system. It is a unique value within the Audit Source ID (see section 5.4). Rationale This field ties an audit event to a specific user. Notes For cross-system audits, especially with long retention, this user identifier will permanently tie an audit event to a specific user via a perpetually unique key. For node-based authentication -- where only the system hardware or process, but not a human user, is identified -- User ID would be the node name. 5.2.2 Alternative User ID Description Alternative unique identifier for the user Optionality: Optional Format / Values User identifier text string from authentication system. This identifier would be one known to a common authentication system (e.g., single sign-on), if available. Marshall Expires - March 2003 [Page 16] Security Audit and Access Accountability Message September 2003 Rationale In some situations a user may authenticate with one identity but, to access a specific application system, may use a synonymous identify. For example, some "single sign on" implementations will do this. The alternative identifier would then be the original identify used for authentication, and the User ID is the one known to and used by the application. 5.2.3 User Name Description The human-meaningful name for the user Optionality: Optional Format / Values Text string Rationale The User ID and Alternative User ID may be internal or otherwise obscure values. This field assists the auditor in identifying the actual user. 5.2.4 User Is Requestor Description Indicator that the user is or is not the requestor-actor for the audit event. Optionality: Optional Format / Values Boolean, default/assumed value is "true" Rationale This value is used to distinguish between requestor-users and recipient-users. For example, one person may request a report- output to be sent to a another user. Marshall Expires - March 2003 [Page 17] Security Audit and Access Accountability Message September 2003 5.2.5 Role ID Code Description Specification of the role(s) the user plays when performing the event, as assigned in role-based access control security Optionality: Optional; multi-valued Format / Values Coded value, with attribute "code" valued with the role code or text from authorization system. More than one value may be specified. The codes may be implementation-defined or reference a standard vocabulary enumeration. For implementation defined codes or references to standards, the XML schema defines these optional attributes: Attribute Value description -------------- -------------------------------------------- CodeSystem OID reference CodeSystemName Name of the coding system; strongly recommended to be valued for locally-defined code-sets. Display Name The value to be used in displays and reports OriginalText Input value that was translated to the code Rationale This value ties an audited event to a user's role(s). It is an optional value that might be used to group events for analysis by user functional role categories. Notes Many security systems are unable to produce this data, hence it is optional. For the common message, this identifier would be the one known to a common authorization system, if available. Otherwise, it is a unique value within the Audit Source ID (see section 5.4). Consider using a globally unique identifier associated with the role to avoid ambiguity in auditing data collected from multiple systems. Role ID is not a substitute for personal accountability. Marshall Expires - March 2003 [Page 18] Security Audit and Access Accountability Message September 2003 Ambiguities arise from composite roles and users with multiple roles, i.e., which role within a composite is being used or what privilege was a user employing? 5.3 Network Access Point Identification The network access point identifies the logical network location for application activity. These data are paired 1:1 with the Active Participant Identification data. 5.3.1 Network Access Point Type Code Description An identifier for the type of network access point that originated the audit event. Optionality: Optional Format / Values Enumeration: Value Meaning ----- -------------------------------- 1 Machine Name, including DNS name 2 IP Address 3 Telephone Number Rationale This datum identifies the type of network access point identifier of the user device for the audit event. It is an optional value that may be used to group events recorded on separate servers for analysis of access according to a network access point's type. 5.3.2 Network Access Point ID Description An identifier for the network access point of the user device for the audit event. This could be a device id, IP address, or some other identifier associated with a device. Optionality: Optional Marshall Expires - March 2003 [Page 19] Security Audit and Access Accountability Message September 2003 Format / Values Text may be constrained to only valid values for the given Network Access Point Type, if specified. Recommendation is to be as specific as possible where multiple options are available. Rationale This datum identifies the user's network access point, which may be distinct from the server that performed the action. It is an optional value that may be used to group events recorded on separate servers for analysis of a specific network access point's data access across all servers. Note Network Access Point ID is not a substitute for personal accountability. Internet IP addresses, in particular, are highly volatile and may be assigned to more than one person in a short time period. Examples Network Access Point ID: SMH4WC02 Network Access Point Type: 1 = Machine Name Network Access Point ID: 10.10.203.42 Network Access Point Type: 2 = IP address Network Access Point ID: 610-555-1212 Network Access Point Type: 3 = Phone Number 5.4 Audit Source Identification The following data are required primarily for application systems and processes. Since multi-tier, distributed, or composite applications make source identification ambiguous, this collection of fields may repeat for each application or process actively involved in the event. For example, multiple value-sets can identify participating web servers, application processes, and database server threads in an n-tier distributed application. Passive event participants, e.g., low-level network transports, need not be identified. Depending on implementation strategies, it is possible that the components in a multi-tier, distributed, or composite applications may generate more than one audit message for a single application event. Various data in the audit message may be used to identify such cases, supporting subsequent data reduction. This document anticipates that the repository and reporting mechanisms will perform data reduction when required, but does not specify those mechanism. Marshall Expires - March 2003 [Page 20] Security Audit and Access Accountability Message September 2003 5.4.1 Audit Enterprise Site ID Description Logical source location within the healthcare enterprise network, e.g., a hospital or other provider location within a multi-entity provider group. Optionality: Optional Format / Values Unique identifier text string within the healthcare enterprise. Null value when the system is uniquely identified by Audit Source ID. Rationale This value differentiates among the sites in a multi-site enterprise health information system. Notes This is defined by the application that generates the audit record. It contains a unique code that identifies a business organization (owner of data) that is known to the enterprise. The value further qualifies [disambiguates] the Audit Source ID. Values may vary depending on type of business. There may be levels of differentiation within the organization. 5.4.2 Audit Source ID Description Identifier of the source where the event originated. Optionality: Required Format / Values Unique identifier text string, at least within the Audit Enterprise Site ID Rationale This field ties the event to a specific source system. It may be used to group events for analysis according to where the event occurred. Marshall Expires - March 2003 [Page 21] Security Audit and Access Accountability Message September 2003 Notes In some configurations, a load-balancing function distributes work among two or more duplicate servers. The values defined for this field thus may be considered as an source identifier for a group of servers rather than a specific source system. 5.4.3 Audit Source Type Code Description Code specifying the type of source where event originated. Optionality: Optional Format / Values Coded-value enumeration, optionally defined by system implementers or a as a reference to a standard vocabulary. Unless defined or referenced, the default values for the "code" attribute are: Value Meaning ----- ------------------------------------------ 1 End-user display device, diagnostic display 2 Data acquisition device or instrument 3 Web server process 4 Application server process 5 Database server process 6 Security server, e.g., a domain controller 7 ISO level 1-3 network component 8 ISO level 4-6 operating software 9 External source, other or unknown type For implementation defined codes or references to standards, the XML schema defines these optional attributes: Attribute Value -------------- -------------------------------------------- CodeSystem OID reference CodeSystemName Name of the coding system; strongly recommended to be valued for locally-defined code-sets. DisplayName The value to be used in displays and reports OriginalText Input value that was translated to the code Since audit sources may be categorized in more than one way, there may be multiple values specified. Marshall Expires - March 2003 [Page 22] Security Audit and Access Accountability Message September 2003 Rationale This field indicates which type of source is identified by the Audit Source ID. It is an optional value that may be used to group events for analysis according to the type of source where the event occurred. 5.5 Participant Object Identification The following data assist the auditing process by indicating specific instances of data or objects that have been accessed. These data are required unless the values for Event Identification, Active Participant Identification, and Audit Source Identification are sufficient to document the entire auditable event. Production of audit records containing these data may be enabled or suppressed, as determined by healthcare organization policy and regulatory requirements. Because events may have more than one participant object, this group can be a repeating set of values. For example, depending on institutional policies and implementation choices: - Two participant object value-sets can be used to identify access to patient data by medical record number plus the specific health care encounter or episode for the patient. - A patient participant and his authorized representative may be identified concurrently. - An attending physician and consulting referrals may be identified concurrently. - All patients identified on a worklist may be identified. - For radiological studies, a set of related participant objects identified by accession number or study number, may be identified. Note, though, that each audit message documents only a single usage instance of such participant object relationships and does not serve to document all relationships that may be present or possible. 5.5.1 Participant Object Type Code Description Code for the participant object type being audited. This value is distinct from the user's role or any user relationship to the participant object. Optionality: Optional Marshall Expires - March 2003 [Page 23] Security Audit and Access Accountability Message September 2003 Format / Values Enumeration: Value Meaning ----- ------------- 1 Person 2 System Object 3 Organization 4 Other Rationale To describe the object being acted upon. In addition to queries on the subject of the action in an auditable event, it is also important to be able to query on the object type for the action. 5.5.2 Participant Object Type Code Role Description Code representing the functional application role of Participant Object being audited Optionality: Optional Format / Values Enumeration, specific to Participant Object Type Code: Value Meaning Participant Object Type Codes ----- -------------------- ----------------------------- 1 Patient 1 - Person 2 Location 3 - Organization 3 Report 2 - System Object 4 Resource 1 - Person 3 - Organization 5 Master file 2 - System Object 6 User 1 - Person 7 List 2 - System Object 8 Doctor 1 - Person 9 Subscriber 3 - Organization 10 Guarantor 1 - Person 3 - Organization 11 Security User Entity 1 - Person 2 - System Object 12 Security User Group 2 - System Object 13 Security Resource 2 - System Object 14 Security Granularity 2 - System Object Definition Marshall Expires - March 2003 [Page 24] Security Audit and Access Accountability Message September 2003 15 Provider 1 - Person 3 - Organization 16 Data Destination 2 - System Object 17 Data Repository 2 - System Object 18 Schedule 2 - System Object 19 Customer 3 - Organization 20 Job 2 - System Object 21 Job Stream 2 - System Object 22 Table 2 - System Object 23 Routing Criteria 2 - System Object 24 Query 2 - System Object A "Security Resource" is an abstract securable object, e.g., a screen, interface, document, program, etc. -- or even an audit data set or repository. Rationale For some detailed audit analysis it may be necessary to indicate a more granular type of participant, based on the application role it serves. 5.5.3 Participant Object Data Life Cycle Description Identifier for the data life-cycle stage for the participant object. This can be used to provide an audit trail for data, over time, as it passes through the system Optionality: Optional Format/Values Enumeration: Value Meaning ----- -------------------------------------- 1 Origination / Creation 2 Import / Copy from original 3 Amendment 4 Verification 5 Translation 6 Access / Use 7 De-identification 8 Aggregation, summarization, derivation 9 Report 10 Export / Copy to target 11 Disclosure Marshall Expires - March 2003 [Page 25] Security Audit and Access Accountability Message September 2003 12 Receipt of disclosure 13 Archiving 14 Logical deletion 15 Permanent erasure / Physical destruction Rationale Institutional policies for privacy and security may optionally fall under different accountability rules based on data life cycle. This provides a differentiating value for those cases. 5.5.4 Participant Object ID Type Code Description Describes the identifier that is contained in Participant Object ID. Optionality: Required Format / Values Coded-value enumeration, specific to Participant Object Type Code, using attribute-name "code". The codes below are the default set. code Meaning Participant Object Type Codes ---- ---------------------- ----------------------------- 1 Medical Record Number 1 - Person 2 Patient Number 1 - Person 3 Encounter Number 1 - Person 4 Enrollee Number 1 - Person 5 Social Security Number 1 - Person 6 Account Number 1 - Person 3 - Organization 7 Guarantor Number 1 - Person 3 - Organization 8 Report Name 2 - System Object 9 Report Number 2 - System Object 10 Search Criteria 2 - System Object 11 User Identifier 1 - Person 2 - System Object 12 URI 2 - System Object User Identifier and URI[10] text strings are intended to be used for security administration trigger events to identify the objects being acted-upon. The codes may be the default set stated above, implementation- defined, or reference a standard vocabulary enumeration, such as HL7 version 2.4 table 207 or DICOM defined media types. For Marshall Expires - March 2003 [Page 26] Security Audit and Access Accountability Message September 2003 implementation defined codes or references to standards, the XML schema defines these optional attributes: Attribute Value -------------- -------------------------------------------- CodeSystem OID reference CodeSystemName Name of the coding system; strongly recommended to be valued for locally-defined code-sets. DisplayName The value to be used in displays and reports OriginalText Input value that was translated to the code Rationale Required to distinguish among various identifiers that may synonymously identify a participant object. 5.5.5 Participant Object Sensitivity Description Denotes policy-defined sensitivities for the Participant Object ID such as VIP, HIV status, mental health status, or similar topics. Optionality: Optional Format / Values Values are institution and implementation defined text strings. 5.5.6 Participant Object ID Description Identifies a specific instance of the participant object Optionality: Required Format / Values Text string. Value format depends on Participant Object Type Code and the Participant Object ID Type Code. Rationale This field identifies a specific instance of an object, such as a patient, to detect/track privacy and security issues. Notes Marshall Expires - March 2003 [Page 27] Security Audit and Access Accountability Message September 2003 Consider this to be the primary unique identifier key for the object, so it may be a composite data field as implemented. 5.5.7 Participant Object Name Description An instance-specific descriptor of the Participant Object ID audited, such as a person's name Optionality: Optional Format / Values Text string Rationale This field may be used in a query/report to identify audit events for a specific person, especially if multiple synonymous Participant Object IDs have been used for that person. 5.5.8 Participant Object Query Description The actual query for a query-type participant object. Optionality: Optional Format / Values Base 64 encoded data Rationale For query events it may be necessary to capture the actual query input to the query process in order to identify the specific event. Because of differences among query implementations and data encoding for them, this is a base 64 encoded data blob. It may be subsequently decoded or interpreted by downstream audit analysis processing. 5.5.9 Participant Object Detail Description Implementation-defined data about specific details of the object accessed or used Marshall Expires - March 2003 [Page 28] Security Audit and Access Accountability Message September 2003 Optionality: Optional Format Type-value pair. The "type" attribute is an implementation- defined text string. The "value" attribute is a base 64 encoded data. Rationale Specific details or values from the object accessed may be desired in specific auditing implementations. The type-value pair enables the use of implementation-defined and locally-extensible object type identifiers and values. For example, a clinical diagnostic object may contain multiple test results, and this element could document the type and number and type of results. Many possible data encodings are possible for this elements, so the value is a base 64 encoded data blob. It may be subsequently decoded or interpreted by downstream audit analysis processing. Marshall Expires - March 2003 [Page 29] Security Audit and Access Accountability Message September 2003 6. XML Schema This section contains the actual XML schema definition for the data defined in section 5. It also provides brief guidance for specifying schema localizations for implementation purposes. The XML schema specified in section 6.1 conforms with the W3C Recommendations for XML Schema structure[11] and data types[12]. 6.1 XML Schema Definition Create Marshall Expires - March 2003 [Page 30] Security Audit and Access Accountability Message September 2003 Read Update Delete Execute Success Minor failure Serious failure Major failure; action made unavailable Marshall Expires - March 2003 [Page 31] Security Audit and Access Accountability Message September 2003 End-user display device, diagnostic display Data acquisition device or instrument Web server process Application server process Database server process Security server, e.g., a domain controller ISO level 1-3 network component Marshall Expires - March 2003 [Page 32] Security Audit and Access Accountability Message September 2003 ISO level 4-6 operating software External source, other or unknown type Machine Name, including DNS name IP Address Marshall Expires - March 2003 [Page 33] Security Audit and Access Accountability Message September 2003 Telephone Number Marshall Expires - March 2003 [Page 34] Security Audit and Access Accountability Message September 2003 Marshall Expires - March 2003 [Page 35] Security Audit and Access Accountability Message September 2003 Person System object Organization Other Patient Location Report Resource Master file Marshall Expires - March 2003 [Page 36] Security Audit and Access Accountability Message September 2003 User List Doctor Subscriber Guarantor Security User Entity Security User Group Security Resource Security Granualarity Definition Provider Marshall Expires - March 2003 [Page 37] Security Audit and Access Accountability Message September 2003 Report Destination Report Library Schedule Customer Job Job Stream Table Routing Criteria Query Marshall Expires - March 2003 [Page 38] Security Audit and Access Accountability Message September 2003 Origination / Creation Import / Copy from original Amendment Verification Translation Access / Use De-identification Aggregation, summarization, derivation Report Export / Copy to target Marshall Expires - March 2003 [Page 39] Security Audit and Access Accountability Message September 2003 Disclosure Receipt of disclosure Archiving Logical deletion Permanent erasure / Physical destruction Marshall Expires - March 2003 [Page 40] Security Audit and Access Accountability Message September 2003 6.2 XML Schema Localization The schema specified in section 6.1 may be extended and restricted to meet local implementation-specific requirements. W3C Recommendation for XML Schema structure[11], section 4, is the governing standard for accomplishing this. As of the current version of this document, a public reference URI for the base schema has not been established. Local definitions reference the common audit message base schema. For example, here is a schema with a local vocabulary restriction for "Audit Enterprise Site ID" plus an extension adding a new "Audit Source Asset Number" element. Marshall Expires - March 2003 [Page 41] Security Audit and Access Accountability Message September 2003 7. Security Considerations Audit data must be secured at least to the same extent as the underlying data and activities being audited. This includes access controls as well as data integrity and recovery functions. This document acknowledges the need for, but does not specify, the policies and technical methods to accomplish this. It is conceivable that audit data might have unintended uses, e.g., tracking the frequency and nature of system use for productivity measures. ASTM standard E2147-01[5] states, in paragraph 5.3.10, "Prohibit use for other reasons than to enforce security and to detect security breaches in record health information systems, for example, the audits are not to be used to explore activity profiles or movement profiles of employees." Marshall Expires - March 2003 [Page 42] Security Audit and Access Accountability Message September 2003 References 1 Bradner, S., "The Internet Standards Process -- Revision 3," BCP 9, RFC 2026, October 1996. 2 Bradner, S., "Key words for use in RFCs to Indicate Requirement Levels," BCP 14, RFC 2119, March 1997 3 Marshall, G., and Dickinson, G., "Common Audit Message," HL7 Security and Accountability Special Interest Group, November 2001 4 "IHE Technical Framework," Volume III, HIMMS/RSNA, April 2002 5 "E2147-01 Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems," ASTM International, June 2002 6 "Security and Privacy Auditing in Health Care Information Technology," Joint NEMA/COCIR/JIRA Security and Privacy Committee, 26 June 2001 7 "ISO/IEC 15408:1999 Common Criteria for Information Technology Security Evaluation, Part 2: Security Functional Requirements," ISO, August 1999 8 "ISO 8601:2000 Data elements and interchange formats -- Information interchange -- Representation of dates and times," ISO, December, 2000 9 Mills, D., "Network Time Protocol (Version 3) Specification, Implementation," March 1992. 10 Berners-Lee, et. al., "Uniform Resource Identifiers (URI): Generic Syntax", RFC 2396, August 1998 11 W3C Recommendation "XML Schema Part 1: Structures," version 1.0, May 2001 12 W3C Recommendation "XML Schema Part 2: Datatypes," version 1.0, May 2001 Draft Change History Version Date Description 00 12/02 Original draft publication 01 02/03 1) Reword the Abstract to be more understandable to a wider audience. 2) Revise Purpose and Scope and Data definition sections for clarity, in accordance with comments from several reviewers. Marshall Expires - March 2003 [Page 43] Security Audit and Access Accountability Message September 2003 3) Document default value for Event Action Code. 4) Add Alternate User ID and User Name fields. 5) Include participant object identifier support for objects of security administration trigger events. 6) Update XML schema to agree with data definitions. 02 03/03 1) Updated schema to make the "code" attribute in CodedValueType a required value. 2) Minor wording changes to the Abstract for clarity. 3) Added reference to "Security and Privacy Auditing in Health Care Information Technology", by the Joint NEMA/COCIR/JIRA Security and Privacy Committee. 03 04/03 1) Clarified that function access detail definitions in section 4.3.3 are non-normative examples 2) Specified optionalities of data items separately from descriptions 3) Added normative reference to ISO 8601:2000 standard for date and time data format 4) Added Participant Object Detail element 5) Minor editorial changes for clarity 04 09/03 1) Added import, export, and logical deletion to the Participant Object Data Life Cycle enumeration. 2) Renamed "Participant Object ID Sensitivity" to "Participant Object Sensitivity" 3) Added "TypeValuePair" complex type to schema and changed Participant Object Detail to TypeValuePair type 5) Added "Encounter Number" to Participant Object ID Type Code enumeration 6) Added Event Type Code to Event Identification as a optional repeating Coded Value 7) Added standards references, discussion, and an example of schema localization for implementation purposes 8) Added a note that the User ID is the system or process name for node-based identification. 9) Changed Event ID to a mandatory non-repeating Coded Value 10)Changed Audit Source Type Code to an optional repeating Coded Value, added data acquisition device to the default value set, and clarified that end-user devices include diagnostic displays 11)Minor editorial changes to fix typographical errors and improve clarity. Marshall Expires - March 2003 [Page 44] Security Audit and Access Accountability Message September 2003 Acknowledgments The author gratefully acknowledges the advice and assistance of the following people during the preparation of this document: Carmela Couderc, Siemens Medical Solutions Health Services Michael Davis, SAIC Gary Dickinson, Per-Se Technologies, Inc. Robert Horn, Agfa James McAvoy, Siemens Medical Solutions Health Services Jennifer Puyenbroek, McKesson Information Solutions Angela Ray, McKesson Information Solutions Larry Tarbox, Siemens Corporate Research Author's Addresses Glen Marshall Siemens Medical Solutions Health Services 51 Valley Stream Parkway Malvern, PA 19312 USA Phone: (610) 219-3938 Email: glen.f.marshall@siemens.com Marshall Expires - March 2003 [Page 45]