Section
A section is a logical way to organise the content and guide the reader and in some sections group together the data items to make up a single record e.g. for a medication. It does not describe how it should be displayed in a user interface. Sections are also in most cases reusable components such as medications and allergies.

Element
An element is a data item.

Record entry
A record entry within a section is used where a set of information is required to describe the item (e.g. a medication). For example, for each medication there is a medication name and dose.

Conformance (MRO)
Conformance describes whether the element is Mandatory (MUST be recorded or shared), required (SHOULD be recorded or shared if available) or optional (MAY be recorded or shared). These rules apply to the person recording or sharing the information.

Value Sets
The valid values for the element e.g. SNOMED CT, free text, number. The PRSB works with expert terminologists to agree the codes to be used to record information within specific ‘elements’ (or data items) helping to ensure that coding is used consistently throughout the health and care system.

Implementation guidance
This provides guidance on how the sections and elements should be used.

Information type
The information type of the record entry determines the required provenance information. There are two information types used: “Record” and “Event.Record”. For “Record” entries, the provenance data includes the person (or device) recording the data, and the time it was recorded. For “Event.Record” entries, details of the performer of the event, the location, and the time the event happened are also included in the provenance data.

Cardinality
This is how many of the record entries, sections or elements are valid – 0, 1 or more than 1.

PRSB standards give the user the ‘best practice’ set of information that should be recorded or shared.

The information model sets out which data items are:

• Mandatory (MUST be recorded or shared)
• Required (SHOULD be recorded or shared if available)
• Optional (MAY be recorded or shared).

These rules apply to the person recording or sharing the information.

For example, information about allergies must always be included (even if there are no known allergies). If an allergy is recorded, the causative agent MUST be recorded. This is “mandatory” information. Other information SHOULD be recorded if it is known, like the date the allergy was first experienced and evidence for the allergy. This is “required” information. Other information is “optional” which means that organisations can decide whether the information can be recorded. This is typically used for additional comments.

The standard should be implemented in full, but we recognise that it will take time for implementers to achieve 100% implementation therefore we have devised a system to define a minimum level of implementation allowable now, with an agreed timeframe for full implementation.

To achieve the minimum implementation level that is required for the safe and effective use of the standard a percentage of the standard’s data items and business rules (requirements related to implementation of the standard so that it can be used effectively) must be implemented correctly in the system. This includes any data items and business rules that are identified as ‘MUST HAVES’.  The PRSB has developed a robust conformance process which works with you to assess your implementation of the standard, and the process includes conformance with the MUST HAVES, awarding the PRSB quality mark where conformance is achieved. If you are procuring a system utilise the PRSB quality mark to ensure the system is conformant with the standard. 

The presentation of the data in the information model can be determined locally based on user requirements – for example the information could be graphed or summarised with the ability to drill down to more detail. However, the conformance requirements of the standard and implementation guidance should be followed.

The provider organisation is responsible for ensuring that their system supplier has implemented the information model correctly with at least the minimum requirements.

Supporting materials published with a PRSB standard include:

• General implementation guidance – this sets out how to read and use the PRSB standards. This should be read by anyone implementing the standard.
• Final report – this describes the project approach and sets out findings and recommendations from the consultation and provides background information and context to the standard.
• Survey report – this is a separate report including detailed analysis from the survey (part of the consultation process).
• Clinical safety case report – this report addresses the requirements of DCB 0129 V4.2 Clinical Risk Management: it’s Application in the Manufacture of Health IT Systems. The report is necessarily limited in its scope because it is neither directly related to software development nor to deployment. Suppliers developing software to implement these standards are therefore still expected to fully apply DCB0129. Organisations involved in the deployment of such software are still expected to fully apply DCB0160. This should be read by anyone implementing the standard as it identifies clinical safety risks transferred to implementation.
• Hazard log – this table lists the hazards identified through consultation and clinical safety workshops. This should be read by anyone implementing the standard as it will identify some hazards related to implementation, but it is expected that further hazards and mitigations are identified as clinical risk assessments and safety cases are developed by systems suppliers and sites during implementation.
• Business rules – these are requirements of the clinical system aimed at reducing clinical risk or supporting or enabling interoperability when using the standard. The ‘MUST HAVE’ business rules is the minimum set of business rules that should be implemented for safe and effective use of the standard. These should be read by anyone implementing the standard and considering an assessment of conformance.
• The ‘MUST HAVE’ data items – these are the minimum set of data items that should be implemented in a system to support safe and effective use of the standard. These should be read by anyone implementing the standard and considering an assessment of conformance.