LRI+-+Use+Case+Assumptions

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6.0 Use Case Assumptions

 * Providers securely access clinical information through an EHR system.
 * Appropriate security and transport protocols; patient identification methodology; requisition (order) identification methodology; consent; privacy and security procedures; coding, vocabulary and normalization standards have been agreed to by all relevant participants.
 * This Use Case only addresses the exchange of laboratory results that are associated with the In Scope laboratory tests.
 * All relevant parties have agreed on a structured laboratory test results message format.
 * This Use Case covers all CLIA reporting requirements, including but not limited to: result reports statuses; preliminary, final, appended, corrected and/or amended.
 * For the specimen collection process the data included in the dataset considerations table are assumed to be available and reported in the result.
 * Legal and governance issues regarding data access authorizations, data ownership, and data use are in effect.
 * Established network and policy infrastructure to enable consistent, appropriate, and accurate information exchange across provider systems, data repositories and locator services. This includes, but is not limited to:
 * Methods to identify and authenticate users;
 * Methods to identify and determine Providers of care;
 * Methods to enforce data access authorization policies;
 * Methods to ensure the veracity of data.
 * Detailed audit trails are kept as necessary by all participating systems.
 * Security and privacy policies, procedures and practices are commonly implemented to support acceptable levels of patient privacy and security; i.e. HIPAA, HITECH and EHR certification criteria
 * Laboratory Information Systems will be the sender of laboratory test results while Electronic Health Record Systems will be the receiver
 * The transport mechanism will provide guaranteed delivery and error handling
 * This Use Case acknowledges the variations in requirements for reporting across local, state, tribal, and territorial boundaries as well as voluntary versus mandatory requirements.
 * All Federal, State & local regulations are being supported.

//Appendix ** XX (this will be updated once we finalize the appendices) ** provides more details on Privacy and Security assumptions.//

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