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

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


Without adequate audit systems to ensure accountability, electronic health record (EHR) systems remain vulnerable to undetected misuse, both malicious and accidental. Users could modify or delete protected health information without these actions being traceable to the modifier. According to Chuvakin and Peterson [3], “If [an organization’s information technology] isn’t accountable, the organization probably isn’t either.” Patients need to trust the privacy practices and accountability of healthcare organizations. Administering software audit mechanisms forms a basis for privacy-driven and accountability-driven policy and regulations, including government regulations<sup>[8]</sup>. The United States Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Privacy Rule states that one must implement, “mechanisms that record and examine activity in information systems that contain or use electronic protected health information”<sup>[5]</sup>.
Without adequate audit systems to ensure accountability, electronic health record (EHR) systems remain vulnerable to undetected misuse, both malicious and accidental. Users could modify or delete protected health information without these actions being traceable to the modifier. According to Chuvakin and Peterson<sup>[3]</sup, “If [an organization’s information technology] isn’t accountable, the organization probably isn’t either.” Patients need to trust the privacy practices and accountability of healthcare organizations. Administering software audit mechanisms forms a basis for privacy-driven and accountability-driven policy and regulations, including government regulations<sup>[8]</sup>. The United States Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Privacy Rule states that one must implement, “mechanisms that record and examine activity in information systems that contain or use electronic protected health information”<sup>[5]</sup>.
 
Storing an accurate history of user interaction with a software application and its underlying data helps build a sense of accountability, since a user cannot expressly deny performing certain actions that were recorded by the audit mechanism. In the case of a medical mistake, audit mechanisms can provide a record by which healthcare practitioners can exonerate themselves from legal action by demonstrating that they prescribed the correct drug at a certain time, or that a certain test result was, in fact, what they claim it was. The health informatics field needs standards that address the implementation of software audit mechanisms to monitor access and information disclosure, including details of ''what'' should be logged, ''how'' it should be logged, and ''when'' logged information should be monitored.
 
''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''. In performing this study, we investigate the following questions:
 
* R1: What events should be included in an EHR log file for non-repudiation?
* R2: What are the strengths and weaknesses of software auditing mechanisms in EHR systems?


== 2. Background ==
== 2. Background ==