NHSE Design and Development Approach

Change Control

This section details a change control process for use with the NHSE standard. The change control process is part of the overall configuration management.

Overview of Process

Change Control Roles

• Requester - Any individual or group/organisation requesting a change to an existing FHIR asset in the NHSE IG or requesting a new FHIR asset to be added to the NHSE IG.
• NHSE Development Team - Individuals who are involved in the NHSE FHIR assets development and/or authoring guidance contained in the NHSE Implementation Guide.
• UK FHIR Delivery Senior Leadership Team (SLT) - a group of people from the FHIR community who represent the interests of stakeholders in the NHSE.
• UK FHIR Delivery Senior Leadership Team Technical Subgroup - a group of FHIR/Interoperability and clinical subject matter experts who evaluate NHSE IG requests for change then triage and route them as appropriate.

Requesting a Change to the NHSE IG

Requests for a change to the NHSE IG must be made using the create issue option in Simplifier if its not a project or programme which is formally engaging the NHSE development team. Requests may be from an individual or group/organisation looking to use the NHSE IG for an implementation or for an issue reported by a member of the development team. The same approach is used to feedback on issues by participants in the Clinical and Technical Assurance process.

Creating a Simplifier Account

The NHSE IG uses Simplifier for issue tracking and maintenance. Although the NHSE IG is in the public domain, you will need to create an account and login to raise issues. Creating a Simplifier account is done by going to https://simplifier.net/ and using the sign-up option on the top right of the page. An email address and a chosen password are the only details needed to set up an account.

Login to Simplifier

Logging in to your Simplifier account is required to raise issues. Browse to https://simplifier.net/ and use the login option on the top right of the page, then enter the chosen credentials.

Navigation to the NHSE IG Project

The NHSE IG project is located here in Simplifier.

Change to an existing NHSE IG Asset

When the change request is for a change to an existing NHSE IG FHIR asset, the preferred approach is to raise the issue at the level of the relevant asset.

Create a Simplifier issue at NHSE IG Asset level

It is acknowledged that not everyone will have enough knowledge of FHIR Implementation Guides or Simplifier to log an issue to the correct Simplifier resource, therefore logging at the project level is allowable, if this is the case. However, issue logging at asset level is the preferred approach, as it makes triage of issues easier.

Note: Simplifier refers to everything as a resource whether it’s an image, example or FHIR profile and provides a mechanism to filter on type.

Step 1 - How to search and filter

How to search and filter in Simplifier illustration

To search for a particular asset, for example to find the Patient profile, filter by resource category "Profiles" (tick the box alongside Profiles), add the word "Patient" in the search box and hit return. This will bring up a link to the Patient profile which will take you to a page with a view of the Patient profile.

Once the required Simplifier resource page is found, the last tab on the page is the issues tab. Clicking on this will bring up a page where a new issue should be raised by clicking the New Issue button.

Step 2 - Create new issue

Create new issue illustration

This will only require a title and the details of the issue or comment. All other issues logged for this Simplifier resource will be available from this page and you can check these or find out whether this issue has already been logged, if required.

Step 3 - New issue information required

New issue information required illustration

If you cannot locate the Simplifier resource, or it is not appropriate to log an issue at the Simplifier resource level, then you should raise an issue at the project level. In this case, the title and/or issue text should identify which part of the NHSE IG Implementation is the subject of the issue being raised. See the Creating a Simplifier Issue at Project Level section for how to do this.

Requesting a new NHSE IG Asset

Issues for new NHSE IG FHIR assets can be raised at the NHSE IG project level the issue must indicate the use case or details of the requirement as to why the new asset is needed. Projects or Programmes may also raise requests for new or amended FHIR assets.

Creating a Simplifier Issue at Project Level

To create a issue at the project level, navigate to the project. Once you are in the project, click on the issues tab and then the create button to create the issue.

Issue Triage by NHSE IG Development Team

Issues will be triaged by the UK Core Development Team and any change other than a minor issue (for example a typo or a bug fix) will be referred to a Senior Technical lead from the SLT Technical Subgroup or discussed at the UK FHIR Delivery Board for further appraisal.

If the issue raised does not have a solution suggested, then the triage will include further analysis to establish a solution which may include several proposed technical options. If the requester has provided a proposed solution, this will need to be validated, which may result in alternative or other solutions being proposed.

The response time for issues to be initially triaged does not have a formal service level agreement in place but should be responded to in a timely manner. This is managed by NHS England as part of its role in the UK Core Development Team using the Interoperability Team's mailbox, which receives auto-notifications from Simplifier on a daily basis. The mailbox is monitored daily by the NHS England Interoperability Team and initial triage will be done within a day or two, except when the issue has been raised as part of the Clinical and Technical Assurance process.

Note: The triage of issues raised as part of Clinical and Technical Assurance process (which has a three-week review period) is done at the end of the Clinical and Technical Assurance process as a batch. This enables more efficient triage of issues and the identification of dependencies and issue duplication.

Triage of Non-Clinical and Technical Assurance process issues

The triage process for issues is not something that is a tightly defined process, but more of a discussion forum of SMEs where a consensus of agreement is reached about the issue and any proposed solution. The following are examples of criteria or areas that will be discussed:

• Is the reason or use case for the requested change or addition to the NHSE IG clear enough to triage the issue?
• Is the proposed change suitable for the use case, for example are the profiles that are being requested or requested to be changed the correct profiles for the use case?
• Is the use case already covered by another asset or set of assets?
• Is this a potential breaking or non-breaking change? This is only potential, as what is a breaking on non-breaking change can be very hard to quantify in some cases.
• Does the issue need to be referred to a wider audience or a special resource, for example a Clinical lead?

The Simplifier issue will be updated with any information that will inform the requester of progress, etc.

Triage of Clinical and Technical Assurance process issues

The triage process for issues raised as part of the Clinical and Technical Assurance process is done as a batch process by the NHSE IG Development team at the end of the process. The issues raised are filtered to remove duplicates or minor issues such as typos or minor technical errors. The remaining issues are taken forward to the Clinical and Technical Assurance follow up meeting for discussion, agreement and resolution.

The Simplifier issue will be updated with any information that will inform the requester of progress etc.

Approval of issue

Once a change request is accepted, the issue is added to the NHSE IG Backlog. The requester will be notified via Simplifier by update of the issue. The issue will not be closed at this point, only when the development work has been completed.

Rejection of issue

If a request for change is rejected, then the Simplifier issue is updated with all the information required to inform the requester why it was rejected. Further calls or emails may also be used to explain the reason for rejection, if required, depending on the complexity of the issue.

Development Backlog

The NHSE IG backlog is where all the development work items are recorded and tracked. The work items are maintained using a tool called JIRA. All the work items in JIRA will be traceable back to Simplifier. The development is carried out using an agile type of methodology and managed on a Kanban board. The NHSE IG backlog is an internal process which only the UK Core Development team have access to, however this information is mirrored in the Simplifier issues for consumption by the FHIR community. The requester will be emailed whenever there is an update to the Simplifier issue.

Development Cycle

Overview

The NHSE IG development is driven by requests for change which can come from many sources. The Change control section gives details about how this is managed.

NHSE IG Development Process

This diagram shows the process used to develop the NHSE IG FHIR assets.

Development Cycle

The development cycle is feed from three main sources:

1. The Clinical and Technical Assurance Process
2. Issues raised by the FHIR Community in Simplifier
3. Issues raised from HL7 UK Ballots

See the Change Control page for full details on the change control process.

Asset Types

The first part of the development cycle is to identify the type of FHIR asset(s) and any dependencies, for example if the change is to create a new profile then there will be a need to identify any related resources required such as extensions, examples, ValueSets guide pages etc. This is required to size of the development so that resources and timescales can be planned. The required changes are then added to a JIRA backlog which is used by the UK Core Development Team to schedule the development work.

Adding to a Implementation Guide

The changes will be added to either:

• The NHSE IG FHIR Assets in development Implementation Guide
• A NHSE IG C&TA Release
• A scheduled UK Core Release

Which Implementation Guide the changes appear in depends on many factors for example:

• Which release the issue was raised against
• Which process the issue was raised in (C&TA, HL7 UK Ballot etc)
• The use case that is driving the development

The Simplifier & GitHub Management page gives further information about Implementation Guide types.

Internal Review

Once the change has been done the NHSE IG Development Team will carry out an internal review and rework as necessary until the development is of the quality required. The page on Asset Design gives more information on the principles and design of FHIR assets which are used during internal review.

External Review

There is no external review until the changes are included in a release as part of the C&TA or the Ballot process but as all development is done in the public domain and therefore feedback on any change is always possible via Simplifier.

Overview of Release Cycle

The section details the NHSE IG release cycle and how the various versions are defined.

Overview Of Cycle

The diagram below illustrates how the NHSE IG Release cycle works and is an abstract view of the way it is released. This is an evolving process, and the diagram only shows one release cycle of a sequence of a repeating process.