ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
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Requirements: OV.1 Overarching Criteria (Function)

Active as of 2024-11-26
Statement N:

Overarching criteria are those that apply to all EHR Systems.

Description I:

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.

Criteria N:
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).