ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build
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| Active as of 2024-11-23 |
Overarching criteria are those that apply to all EHR Systems.
The Overarching Section contains Conformance Criteria that apply to all EHR Systems and consequently must be included in all EHR-S FM compliant profiles. These criteria are grouped under a single Function.
| OV.1#01 | SHALL |
The system SHALL conform to function [[CP.9.1]] (Produce a Summary Record of Care). |
| OV.1#02 | SHALL |
The system SHALL conform to function [[CPS.9.3]] (Health Record Output). |
| OV.1#03 | SHALL |
The system SHALL conform to function [[CPS.9.4]] (Standard Report Generation). |
| OV.1#04 | SHALL |
The system SHALL conform to function [[RI.1.1]] (Record Lifecycle) and all child functions. |
| OV.1#05 | SHALL |
The system SHALL conform to function [[RI.1.2]] (Record Lifespan) and all child functions. |
| OV.1#06 | SHALL |
The system SHALL conform to function [[RI.2]] (Record Synchronization). |
| OV.1#07 | SHALL |
The system SHALL conform to function [[RI.3]] (Record Archive and Restore). |
| OV.1#08 | SHALL |
The system SHALL conform to function [[TI.1.1]] (Entity Authentication). |
| OV.1#09 | SHALL |
The system SHALL conform to function [[TI.1.2]] (Entity Authorization) . |
| OV.1#10 | SHALL |
The system SHALL conform to function [[TI.1.3]] (Entity Access Control). |
| OV.1#11 | SHALL |
The system SHALL conform to function [[TI.1.4]] (Patient Access Management). |
| OV.1#12 | SHALL |
The system SHALL conform to function [[TI.1.5]] (Non-Repudiation). |
| OV.1#13 | conditional SHALL |
IF the system transmits data to or receives data from a system outside of a secure network, THEN the system SHALL conform to function [[TI.1.6]] (Secure Data Exchange), to ensure that the data are protected. |
| OV.1#14 | conditional SHALL |
IF the system transmits data to or receives data from a system outside of a secure network, THEN the system SHALL conform to function [[TI.1.7]] (Secure Data Routing), to ensure that the exchange occurs only among authorized senders and receivers. |
| OV.1#15 | SHALL |
The system SHALL conform to function [[TI.1.8]] (Patient Privacy and Confidentiality). |
| OV.1#16 | SHALL |
The system SHALL conform to function [[TI.2]] (Audit) and all child functions. |
| OV.1#17 | SHOULD |
The system SHOULD conform to function [[TI.3]] (Registry and Directory Services). |
| OV.1#18 | SHALL |
The system SHALL conform to function [[TI.4]] (Standard Terminology and Terminology Services). |
| OV.1#19 | conditional SHALL |
IF the system manages data for which standard terminologies have been established, THEN the system SHALL conform to function [[TI.4.1]] (Standard Terminologies and Terminology Models) to support semantic interoperability. |
| OV.1#20 | conditional SHALL |
IF the system manages data for which standard terminologies have been established, THEN the system SHALL conform to function [[TI.4.2]] (Maintenance and Versioning of Standard Terminologies) to preserve the semantics of coded data over time. |
| OV.1#21 | conditional SHALL |
IF terminology mapping is implemented within the system, THEN the system SHALL conform to function [[TI.4.3]] (Terminology Mapping). |
| OV.1#22 | conditional SHALL |
IF the system receives or transmits data for which jurisdictionally established interchange standards exist, THEN the system SHALL conform to function [[TI.5.1]] (Application and Structured-Document Interchange Standards) and all child functions to support interoperability. |
| OV.1#23 | conditional SHALL |
IF the system receives and transmits data for which generally accepted interchange standards have been established, THEN the system SHALL conform to function [[TI.5.2]] (Interchange Standards Versioning and Maintenance), to accommodate the inevitable evolution of interchange standards. |
| OV.1#24 | SHOULD |
The system SHOULD conform to function [[TI.5.3]] (Standards-based Application Integration). |
| OV.1#25 | conditional SHALL |
IF the system receives and transmits data with other systems outside itself, THEN the system SHALL conform to function [[TI.5.4]] (Interchange Agreements), to define how the sender and receiver will exchange data. |
| OV.1#26 | SHOULD |
The system SHOULD conform to function [[TI.6]] (Business Rules Management). |
| OV.1#27 | SHOULD |
The system SHOULD conform to function [[TI.7]] (Workflow Management). |
| OV.1#28 | SHALL |
The system SHALL conform to function [[TI.8]] (Database Backup and Recovery). |
| OV.1#29 | SHALL |
The system SHALL conform to function [[CPS.10]] (Manage User Help). |
| OV.1#30 | SHALL |
The system SHALL conform to function [[TI.9]] (System Management Operations and Performance). |