EHRs FM Profiling Tool

EHR-S FM Profile Designer Tool

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Introduction

The HL7 EHR Work Group developed the EHR-S FM from which Functional Profiles can be derived. For both the management of the Functional Model and the Functional Profiles and the development of Functional Profiles, a tool is developed: the EHR-S FM Profile Designer Tool. The tool is built as an extension to Enterprise Architect from Sparx. The tool works with the Corporate Edition of Enterprise Architect. when someone wants to develop a Functional Profile from the EHR-S FM with the use of the tool, he needs Enterprise Architect, the extension EHR-S FM Designer Tool, and the computable artifacts to do so.
The 'Read me' and 'Overview' chapters, as a deliverable of the tooling project, gives an overview of all the artifacts that were developed. Although they are outdated (versions) it still gives an overview Media:EHR_S_FM_TOOL_C0_ReadmePhase2_v1.2.pdfandEHR_S_FM_TOOL_C1_OverviewPhase2_v1.2.pdf
Sparx has several tutorials of how Enterprise Architect works. For the EHR-S FM Designer Tool several manuals were developed. These manuals and the -How-To-Guide-, this guide describes how to create a Functional Profile, can be found on this wiki.

The wiki still contains a lot of project information from the past. This content will be removed in the coming months as the wiki will get a different purpose.

Project a summary

This project, sponsored by the HL7 Tooling Workgroup and co-sponsored by the EHR Workgroup, produced a desktop tool to create EHR-S FM Functional Profiles (starting with the EHR-S FM R2), with enforced profiling rules, and exports as documents, support for and XML interchange format for reuse across profile tool instances or for use in other tools. The Project Scope Statement can be found: HL7 Project Scope Statement - EHR-S FM Profiling Tool.doc The project scope statement was approved by the EHR and Tooling Workgroups in November 2011. The tool is part of the HL7 suite of tools.

Although the project was targeted for the EHR-S FM R2, the goal is to target the PHR-S FM also beginning with the PHR-S FM R2.
The method of creating EHR-S FM Functional Profiles, using unstructured tools (spreadsheet, text processor), did not enforce moderately complex rules for creating EHR-S FM Functional Profiles leading to a very laborious manual effort that is prone to errors. Furthermore, the methods used in the past did not easily provide methods for building on top of, merging, or updating existing profiles. These challenges were proved to be significant barriers in the use and adoption of the EHR-S Functional Model.
As said in the Introduction, the EHR-S FM Profile Designer Tool is built as an extension on Enterprise Architect and works with the Corporate Edition. In the same time, a project for MAX was running. Although MAX itself was out of scope the project team decided to use MAX as export format for this work, hence facilitating publishing work group as well. The MAX extension that was built is needed for certain functionality when creating a Functional Profile with the tool. Summarized, someone needs Enterprise Architect, corporate edition, The extension EHR-S FM Profile Designer Tool and the MAX extension. At this moment (2017-07-03) both extensions and all the computable artifacts are available for HL7 members only and can be obtained by contacting the EHR WG co-chairs (http://www.hl7.org/Special/committees/ehr/leadership.cfm).
More general information on how to create Functional Profiles and the manuals for the tool can be found on this wiki.

How to create a Functional Profile

How-To Guide

The ‘How-to Guide’ offers guidance for using the EHR-S FM Profiling Designer tool to create functional profiles that conforms to the HL7 EHR-S Functional Model (denoted hereafter FM). A conforming functional profile is one that adheres to the rules specified in the FM Conformance Clause, (Section 6). Please note that the ‘How-to guide’ is not a replacement for the Conformance Clause. You are encouraged to read Section 6 carefully. For the remainder of this section, the term profile will be used as shorthand for functional profile.
The guide offers guidelines — not binding directives. It will walk you through the basic steps involved in creating a conforming functional profile, including the development of a conformance clause and conformance criteria. The How-to Guide offers a few general principles to keep in mind as you create the functional profile. Also, it provides guidance on how and why you should consider balloting the profile you created. It assumes that you are familiar with the FM and are knowledgeable about the requirements associated with a particular EHR-S healthcare delivery setting. The guide can be downloaded here Media:How-to_Guide_R2_final.pdf

Manuals

The EHR-S FM R2 standard is published as a pdf on the HL7 website and is available for everyone. The ERH-S FM is also published in html, csv, max.xml and as an eap. file, this is the file Enterprise Architect can use. As said before, these files are only available for HL7 members at this moment. How to install the extension is described in EHR_S_FM_FP_Designer_TOOL_Installing_the_extension_v04.pdf.

How to create a Functional Profile with the tool and the use of the max.xml file is described in several manuals. The manuals follow the logical steps you have to take when creating a Functional Profile.

NOTE: the extension is not tested yet with the latest version of Enterprise Architect due to current work on several functional profiles. The manuals have screenshots in it from older versions of enterprise Architect.

Browse and search

To browse and search in the EHR-S FM R2 you need the eap. file of the FM that Enterprise Architect, EA, can read. With EA you can open the EHR-S FM, you can browse through the FM and read all the components of the FM. You can do this even if you are not creating a Functional Profile with the tool. The manuals created for this functionalities are Read the EHR-S FM (Media:ReadtheEHRSFM.pdf) and Search the EHR-S FM (Media:SearchEHRSFM.pdf).

Another functionality that can be used is looking at the traceability of elements in the EHR-S FM. In the EHR-S FM there are different relationships between the elements. The Traceability window in EA enables you to quickly see how elements, headers, functions and criteria in the functional model or functional profile, are connected and how they influence each other. How to use this functionality is described in the manual: Media:TraceabilityElements.pdf

Create a Functional Profile

A new Functional Profile is based on a Base Model. This can be the EHR-S FM (started with Release 2.0) or an existing Functional Profile (based on the EHR-S FM R 2.0). From the Base Model a Profile Definition is defined. After defining the Profile Definition the new Functional Profile can be compiled. In an Introduction chapter, the design of the EHR-S FM Profile Designer Tool is described 0Introduction.pdf

In the manuals 1 to 9 the creation of a Functional Model based on the EHR-S FM is described.
1. Create a new project for a new Functional Profile

• The first step in the creation of a new Functional profile is the creation of a new project in Enterprise Architect, EA. The manual describes how to do this. Media:1CreateNewProfile.pdf

2. Load a Base Model for creation of a new Functional profile

• The first rule for Functional Profiles is the identification of the Functional Model or Functional Profile from which you want to derive the new Functional Profile. This is the called ‘Base Model’. To do so you have to select the FM or FP for that and load the FM or FP into Enterprise Architect 2LoadBaseModel.pdf. To do so you will need the MAX file of that FM or FP. Be sure that you use the latest version of the MAX file! Ask the EHR WG co-chairs for the file.

3. Create package for (compiled) Functional Profile

• The third step is the creation of a package (EA Term) for the new Functional Profile. In the 0Introduction chapter, this is represented in figure 2 and 3. 3CreatePackageforFP.pdf

4. Provide General Information

• A basic requirement of all functional profiles is to unique identify and to convey general information about the Functional Profile. This needs to be done in EA otherwise, you cannot make a Profile Definition 4ProvideGeneralInformation.pdf. However, the general information on the functional Profile is usually described in an Overview chapter that is published together with the Functional Profile itself.

5. Create UML model for the new Functional Profile

• For the Profile Definition, you need to create a UML model in where is shown how the Profile Definition, the Base Model and the actual new Functional Profile relates to each other. This needs to be done so everything you define form the Base Model is included in the Profile Definition. And of course, everything that is defined in the Profile Definition is included in the actual new Functional Profile 5CreateUMLmodelNewFP.pdf. Figure 3 in the 0Introduction chapter shows you how this UML model looks like.

6. Create the Functional Profile definition

• The base for the new Functional Profile is the Base Model, FM or FP. The Profile Definition for the new Functional Profile is based on that Base Model 6CreateProfileDefinition.pdf. In this manual is also described how to lock the Base Model to prevent you for making changes in the Base Model instead of the Profile Definition.

7. Create the Compiled Profile

• The base for the new Functional Profile is the Profile Definition 7CreateCompiledProfile.pdf.

8. Validation of Profile Definition and Compiled Profile

• All the rules for Functional Profile creation were included in the EHR-S FM FP Designer tool as validation rules. Running a validation will give you a report on errors and warnings on the work you have done on the Profile Definition or the Compiled Profile 8Validation.pdf.

9. Running Functional Model and Functional Profile Publication

• Once the Functional Profile has been created, you will want to publish the specification for others to use. For the creation of the publication, you need the Model Automated eXchange (MAX) file of the Compiled Profile. This MAX file is an output of the Enterprise Architect (EA) EHR-S FM FP Designer Tool. In this manual guidance is given on how to create the publication from the MAX file. In the process of creating the publication, different software is used. Which software and where to find it is described in the manual 9CreatePublication.pdf.

Edit the Functional Profile

The Functional Profile inherits functions and criteria from its Base Model and serves a certain purpose, e.g Domain. For this purpose the functions and criteria can be changed in a more precise description or examples applicable for that purpose can be added. Also, there can be a need for adding criteria in existing functions or even adding functions in the Functional Profile. The functionalities for this are described in the following manuals.

Adding EHR-S FM components

• This manual describes the way new components, sections, headers, functions and/ or conformance criteria can be added to a Functional Profile with the support of the EHR-S FM Profile Designer Tool AddingEHR_S_FMFPcomponents.pdf.

Working in a project on a new functional profile

• The development of a new Functional Profile is usually done in a multidisciplinary project team. Depending on the part of the Base Model, domain expert, IT experts, security experts etc, are part of the project team. Collaboration of the project team can be done with or without using Enterprise Architect HL7 EHR-S FM Extension. Several option are described in the manual CollaborationFunctionalProfile.pdf.

Moving EHR-S FM Components

• This document describes the way components, sections, headers, functions and/ or conformance criteria, of the EHR-S FM can be moved MovingEHR_S_FMFPcomponents.pdf.

Project Management

• The development of a new Functional Profile is usually done in a project in where several parties are involved. Support for the project management can be done with several tools. As a project facilitator, you can contribute to project management by using Enterprise Architect, EA. In this context, it is important to determine what of the project management is done by the project leader, in another tool then EA, and what by the project facilitator, done in EA ProjectManagement.pdf.

Tracking Changes

• During the development of the tool people with the experience of creating a new Functional Profile asked for the requirement of the possibility to track changes in the Profile Definition TrackingChanges.pdf. See for a detailed description of how to create a Profile Definition chapter 6CreateProfileDefinition.pdf.

Export during the development process

For the development of a Functional Profile, several stakeholders are involved in reviewing the EHR-S FM or an existing Functional Profile. The review can take place in several ways 1) with the tool and 2) with an export in RTF (Rich Text Format document). In the manual is described how to create an export for the use of a review ExportSection.pdf.

For the export, you need a template that can be used in Enterprise Architect. This template comes with the computable artifacts needed when you want to use the tool for the creation of a functional profile. Please contact the EHR WG co-chairs.

How to import the template in EA is described in the manual.

Frequently asked questions, FAQ

During the development of the tool, questions were asked about how the tool supports certain functionalities or how to deal with certain issues where users ran into. From these questions, we created a document with FAQ FAQ.pdf. In the answer, we will point to the chapter in the Learning Center in where a more detail description is given.

Input for tool development

during tool development: EHR-S FM R2. In May 2017 the EHR-S FM R2.0.1 is used for the development of Meaningful Use FP and the Child Health Developmental Screening FP.

Before the start of the project, the following functionalities were described.

Absolute Functionality (Top Priority)

1. Enforce profiling rules (per Conformance Chapter)
   1. Include/Exclude functions from profile
   2. Conformance Optionality
   3. Conditional Criteria
   4. Criteria Inheritance
   5. Add functions and criteria
   6. Modify functions and criteria
   7. ... (Other absolute profile rules)
2. output formats
   1. HTML
   2. PDF
   3. XML
3. Browse & Navigation of the funtional model
   1. search capabilities, filtering capabilities, keyword search, search & replace.
4. Tool is framework specific (e.g. coded to EHR WG FM framework specifications), but content in-specific (enables the import/export of different conformant models/versions (e.g. EHR-S FM 2, future PHR-S FM). (Tool is content agnostic)
5. Save profile

Needed Functionality (High priority)

1. Ability to revert to previous state (undo)
2. Simple text copy paste (text editor related)
3. Text formatting (highlight, bold, underline, font, italicize
4. Show dependencies between functions/criteria
   1. Show impact of changes
5. Undo changes
6. Capture comments regarding specific elements (i.e. comments regarding specific functions or criteria)
7. Initialize/revert to conformant base standard (clear old comments, reset to clean restart to new version activity)
8. Ability to link functional model/profile (intra/inter base standard and profile, linked to a conceptual model, bi-directionally)

Operative Functionality (Medium Priority)

1. Output format HL7 HTML publication format (i.e. to publish through HL7 Publishing)
   1. Generate publication-ready documents.
2. Attach front-matter to publication. Chapter 1 (Additional material
3. Maintain original for comparison with modified function/criteria
4. Compare to other profiles
5. Merge Functions/Criteria from separate Profiles
6. Export Sections from Master or working copy
7. Function copy paste
8. Balloting & reconciliation traceability version control
   1. Managing voting and input from reviewers.
   2. Reporting out all comments against an element.
9. Capturing institutional memory "allow for comments/notes" attached to elements.
10. converting a profile from one version to the next.
    1. If you have a profile based on R2.0, have the tool update baseline profile to R2.1 as starting point.
11. Requirements regarding tooling access (online)
    1. Support multi-user - multiple users working on same profile at the same time?
    2. User Management, access control
12. Workflow management tool (assigning activities to users)

Additional Functionality (Low Priority)

1. mobile access

• Note - will not support R1.1. Is it necessary to convert R1/R1.1 to R2?

Listserv

The EHR-S FM Profiling Tool is part of the activities of the EHR WG. To follow the developments of Functional Models, Functional Profiles and on the tool please subscribe to the EHR WG mailing list.
To subscribe to a list service, please go to the HL7 Listservices Welcome Page