Modifying Without a Trace: High-level Audit Guidelines are Inadequate for Electronic Health Record Audit Mechanisms: Difference between revisions

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== Abstract ==
== Abstract ==
Without adequate audit mechanisms, electronic health record (EHR) systems remain vulnerable to undetected misuse. Users could modify or delete protected health information without these actions being traceable. ''The objective of this paper is to assess electronic health record audit mechanisms to determine the current degree of auditing for non-repudiation and determine if high-level audit guidelines adequately address non-repudiation. We qualitatively assess three open-source EHR systems''. In our high-level analysis, we derive a set of 16 non-specific auditable event types that affect non-repudiation. We find that the EHR systems audit an average of 12.5% of non-specific event types. In our lower-level analysis, we generate 58 black-box test cases based on specific auditable events derived from the Certification Commission for Health Information certification criteria. We find that only 4.02% of these test executions pass. Additionally, 20% of tests fail in all three EHR systems on actions including the modification of patient demographics, assignment of user privileges, and change of user passwords. The ambiguous nature of non-specific auditable event types may explain the overall inadequacy of auditing for non-repudiation. EHR system developers should focus on specific auditable events for managing protected health information instead of non-specific auditable event types derived from generalized guidelines.


== 1. Introduction ==
== 1. Introduction ==

Revision as of 18:38, 5 January 2014

J. King, B. Smith, L. Williams, "Modifying Without a Trace: General Audit Guidelines are Inadequate for Electronic Health Record Audit Mechanisms", Proceedings of the International Health Informatics Symposium (IHI 2012), pp. 305-314, 2012.

Abstract

Without adequate audit mechanisms, electronic health record (EHR) systems remain vulnerable to undetected misuse. Users could modify or delete protected health information without these actions being traceable. The objective of this paper is to assess electronic health record audit mechanisms to determine the current degree of auditing for non-repudiation and determine if high-level audit guidelines adequately address non-repudiation. We qualitatively assess three open-source EHR systems. In our high-level analysis, we derive a set of 16 non-specific auditable event types that affect non-repudiation. We find that the EHR systems audit an average of 12.5% of non-specific event types. In our lower-level analysis, we generate 58 black-box test cases based on specific auditable events derived from the Certification Commission for Health Information certification criteria. We find that only 4.02% of these test executions pass. Additionally, 20% of tests fail in all three EHR systems on actions including the modification of patient demographics, assignment of user privileges, and change of user passwords. The ambiguous nature of non-specific auditable event types may explain the overall inadequacy of auditing for non-repudiation. EHR system developers should focus on specific auditable events for managing protected health information instead of non-specific auditable event types derived from generalized guidelines.

1. Introduction

2. Background

3.1. Challenges in Technology

3.1.1. Limited Infrastructure Resources

3.1.2. Log File Reliability

3.2. Challenges in Policy, Regulations, and Compliance

3.2.1. Ill-defined Standards, Policies, and Regulations

3.2.2. Ineffective Log Analysis

4. Assessment Methodology

4.1 High-level Assessment using Audit Guidelines and Checklists

4.1.1 Derivation of Non-specific Auditable Events

4.1.2 High-level Assessment Methodology

4.2. Low-level Assessment using Black-box Test Cases

4.2.1 Audit Test Case Template

4.2.2 Audit Test Case Example

5. Case Studies

5.1. Open-source EHR Systems Studied

5.2. High-level User-based Non-repudiation Assessment

5.3 Low-level User-based Non-repudiation Assessment with Black-box Test Cases

6. Modifying without a Trace

7. Limitations

8. Future Work

9. Conclusion

10. Acknowledgements

11. References