These Standards Are Taken From The HL7 Functional Standards

These Standards Are Taken From The Hl7 Functional Standards For An Ehr

These standards are taken from the HL7 Functional Standards for an EHR document. It is important to note that the Information Infrastructure standards below represent only a small portion of the entire standards. ID Function Name Function Statement Functional Description Rationale Your Evaluation – Discuss why the EHR meets/does not meet each standard I.1 Information Infrastructure I.1.1.0 EHR Information Security Secure the EHR information. The EHRS is required to manage EHR information securely. For this, all EHRS applications must ensure the authentication, authorization of entities (e.g., user and applications) and control access to the EHR information.

Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.1.1 Entity Authentication Authenticate EHRS users and/or entities before allowing access to an EHRS. Both users and application are subject to authentication. EHRS application must provide mechanisms for users and applications to be authenticated. Users will have to be authenticate when they attempt to use the application, the applications themselves must authenticate themselves before accessing EHR information managed by other application or remote EHR Systems. Examples of entity authentication are: • Username/ password • Digital certificate • Secure token • Biometrics 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.1.5 Patient Privacy Protect the patient’s privacy according to personal, local, and national rules. Functionality allows for compliance with personal, local, and national rules. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.1.5.3 Advisement of Patient Privacy Rights Record that the patient was informed of current privacy policies practices. The EHRS will allow for the dispensing and tracking of patient education regarding current privacy policies and procedures. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.1 Information Integrity Ensure that clinical information is valid according to the healthcare-specific business rules. An important aspect of maintaining a legally sound health record is securing the record to prevent loss, tampering, or unauthorized use. The integrity of the health record may be questioned in a legal proceeding if concerns are raised about the security of paper-based or electronic records. The Rules of Evidence require an organization to have policies and procedures in place to protect against alterations, tampering, and loss. Systems and procedures should also be in place to prevent loss (such as tracking and sign-out procedures), secure record storage areas or systems, and limit access to only authorized users. For example, • Entered data must be validated based on system edit rules and valid code sets. These may be field specific (i.e., valid list of values), intra-record (i.e., date deceased) date of birth), or they may extend across multiple related records (i.e., test order must exist before test results can be recorded). • Healthcare documents must not be altered as dictated by the “Uniform Rules of Evidence” and the “Federal Rules of Evidence”. • Translations between numbering systems and written languages must not result in substantive document alterations. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.2 Document Retention Retain all clinical documents (including complex standards-based clinical documents) for the policy-designated or legally-designated time period. Each healthcare provider should develop a retention schedule for patient health information that meets the needs of its patients, physicians, researchers, and other legitimate users, and complies with legal, regulatory, and accreditation requirements. EHRS applications must conform to the current rules. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.5 Confidentiality Promote patient confidentiality by enforcing the privacy rules that apply to various parts of the EHR. This section deals with the enforcements of the privacy rules. Patients may be harmed if their privacy is invaded (including unauthorized access to Electronic Healthcare Records), or if the patient a part of their records that they must not access or view. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.6 Audit trail Track changes to EHR data to verify enforcement of business, security, and access-control rules. Most information systems benefit from the quality control offered by an audit trail. All systems that are backed up, for example, also note the date and time of the backup in an audit log. Healthcare-related information systems, however, have many additional events and controls that must be audited (tracked) due to the sensitive (personal) nature of the healthcare data itself. For example: HIPAA Security Rule Section 164.308(a)(1)(i) Security Management Process requires Information System Activity Review, which means to "Implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports." 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.6.1 Amendment history Track amendments to clinical documents. Once an clinical document receives a mark of attestation by a healthcare provider, (e.g., a signature), it becomes a legal document and must be preserved in an unaltered fashion. Sometimes, however, corrections or amendments need to be made to the document. In these cases, the EHRS must keep track of the corrections or amendments such that the integrity of the original (signed) document is still preserved. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.6.3 Information Lifecycle Access-Event audit Track who, when, and by which system an EHR record was viewed or extracted. The EHRS application must be able to record information required to determine who viewed or extracted EHR related information from that application. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.6.4 Record audit Generate an audit report for an EHR record (or for a set of EHR records). Differing care-settings benefit from being able to identity the various people or systems that viewed or altered a patient's (or set of patient's) EHR's. For example, a judge might want to know how many patients a given healthcare provider treated while the provider's license was suspended. Similarly, in some cases a report detailing all those who modified or viewed a certain patient record might be needed. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.6.6 Information-Exchange audit Retain any information exchange details along with any amendment history sent with clinical documents by an external clinical or EHR system. If EHR information is exchanged between EHRS application for viewing or other purposes, the receiving application must log information about the sender and the nature, history, and content of the information exchanged in the transaction If any translations are necessary (.e.g. vocabulary lookup) then a record of the transformation must be created by the receiving application. For example, in addition to receiving an EHR from an external system, receive the amendment history for that record, the identity of the originating system, and details about the receiving system’s reception event (including, when and by whom the EHR and its audit trail were received). 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality I.1.2.7.4 Data Availability Make clinical information readily available (as required by a clinical care setting). Not only must clinical information be available for recall, in certain care-settings the data must also be available within a proscribed period of time. For example, if the EHRS fails to present a report that it has received from a laboratory in a timely fashion, the patient may die. Depending on the care setting, the EHRS must make all or some of the EHR information available when, where, and how the users need it. 1. Support delivery of effective healthcare 2. Improve patient safety 3 Facilitate management of chronic conditions 4. Improve efficiency 5. Facilitate self-health management 6. Ensure privacy, confidentiality

Paper For Above instruction

The electronic health record (EHR) system plays a vital role in modern healthcare delivery, and adherence to standards such as those outlined by HL7 ensures that EHRs are secure, reliable, and effective in supporting patient care. This paper critically evaluates the HL7 functional standards for EHRs, particularly focusing on information security, privacy, integrity, retention, audit trails, exchange, and data availability. It discusses how these standards contribute to delivering effective healthcare, enhancing patient safety, facilitating management of chronic conditions, and upholding confidentiality and privacy.

Introduction

The implementation of an EHR system involves complex processes that require compliance with established standards to safeguard sensitive health information while supporting clinical workflows. HL7 (Health Level Seven International) has developed a comprehensive set of functional standards aimed at optimizing EHR functionalities. These standards not only address technical interoperability but also encompass critical security and privacy considerations, which are fundamental to maintaining trust, legal compliance, and effective healthcare delivery.

Security Standards and Information Infrastructure

HL7 emphasizes the importance of a robust security framework to protect EHR data from Unauthorized access, tampering, and loss. The standards specify that EHR systems must incorporate entity authentication mechanisms—such as usernames, passwords, biometric verification, and digital certificates—to verify users and applications before granting access. This ensures that only authorized personnel can view or modify sensitive health information, thereby supporting the delivery of effective healthcare and safeguarding patient safety (Cote et al., 2018).

Furthermore, the standards prioritize patient privacy, requiring systems to comply with personal, local, and national privacy rules. For example, the advisement of patient privacy rights entails documenting that patients are informed about privacy policies, which promotes transparency and supports ethical standards in healthcare (Davis & Walker, 2020). Protecting patient privacy is also crucial in preventing harm resulting from privacy invasions or unauthorized access, which could lead to stigmatization or discrimination.

Information Integrity and Document Retention

Maintaining data integrity is fundamental to legal and clinical reliability. HL7 standards mandate validation of data entries based on system edit rules and code sets, preventing errors and unauthorized alterations. Ensuring that clinical documents remain unaltered once signed is vital in legal contexts, and systems are required to track amendments meticulously (McCartney et al., 2019). The retention of documents for legally mandated periods ensures that historical data remains available for review, research, or legal proceedings, promoting accountability and quality assurance.

In addition, HL7 emphasizes the importance of audit trails and change tracking. These audit logs record details like who accessed or modified data, when, and using which system. Such transparency is essential for detecting unauthorized activities and ensuring compliance with regulations like HIPAA. The capability to generate audit reports enhances accountability and reinforces trust in the EHR system (Floridi et al., 2017).

Audit Trails and Data Exchange

HL7 standards specify comprehensive audit trail capabilities, including tracking amendments, access history, and information exchanges between systems. These features are critical in scenarios where legal or operational accountability is necessary, such as investigations or quality audits. For example, recording who viewed or extracted data enables healthcare providers and legal entities to verify adherence to privacy and security protocols (Hersh et al., 2019). Additionally, maintaining detailed exchange logs ensures that data shared across different EHR platforms retains its integrity and contextual information, supporting interoperability.

The standards also mandate that clinical information be readily available when needed—particularly in urgent care settings. Timely availability of data can be life-saving, emphasizing the importance of system reliability and performance (Kellogg et al., 2021). Systems must be designed to ensure high availability and rapid retrieval of necessary information, aligning with the clinical needs of diverse healthcare environments.

Conclusion

Adherence to HL7’s detailed standards ensures that EHR systems are secure, privacy-compliant, and reliable in managing sensitive health information. These standards foster effective healthcare delivery, enhance patient safety through robust security and audit mechanisms, and support seamless data exchange. As healthcare organizations increasingly rely on digital records, compliance with these standards remains critical to building trust, ensuring legal accountability, and delivering high-quality patient-centered care.

References

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