ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build

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Requirements: RI.1.1.1 Originate/Retain Record Lifecycle Event (Function)

Active as of 2024-11-23
Statement N:

Originate and Retain Record Entry (1 instance)

Description I:

Occurs when an agent causes the system to: a) initiate capture of potential record content, and b) incorporate that content into the storage considered a permanent part of the health record.

Reference: ISO 21089-2018, Section 15.1.

Criteria N:
RI.1.1.1#01 SHALL

The system SHALL provide the ability to capture (originate) a Record Entry instance corresponding to an Action instance and context.

RI.1.1.1#02 SHALL

The system SHALL capture a unique instance identifier for each Record Entry.

RI.1.1.1#03 SHALL

The system SHALL capture the signature event (e.g., digital signature) of the origination entry Author, binding signature to Record Entry content.

RI.1.1.1#04 SHALL

The system SHALL provide the ability to capture both structured and unstructured content in Record Entries.

RI.1.1.1#05 SHALL

The system SHALL provide the ability to capture Record Entries from information recorded during system downtime.

RI.1.1.1#06 SHOULD

The system SHOULD provide the ability to integrate Record Entries from Information recorded during system downtime.

RI.1.1.1#07 SHALL

The system SHALL provide the ability to capture the date/time an Action was taken or data was collected if different than date/time of the Record Entry.

RI.1.1.1#08 SHOULD

The system SHOULD capture metadata that identifies the source of non-originated Record Entry (e.g., templated, copied, duplicated, or boilerplate information).

RI.1.1.1#09 MAY

The system MAY provide the ability to tag unstructured Record Entry content to organize it according to need, for example, in a time-related fashion or by application-specific groups (such as photographs, handwritten notes, or auditory sounds), or by order of relative importance.

RI.1.1.1#10 MAY

The system MAY capture and maintain a Record Entry encoded as a standards-based data object (e.g., HL7 Continuity of Care, other HL7 CDA R2 Document, ISO 13606 artifact).

RI.1.1.1#11 MAY

The system MAY capture and maintain a standards-based data object to mirror (be duplicate and synchronous with) internal Record Entry representation.