Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

General The following general screening criteria can be applied to screen available standards for implementation with within a solution.  It is assumed that the standards in use with existing systems participating in the solution will be evaluated as part of the initial screening, as well as options for resolving any differences between existing, implemented standards and those selected.

HTML
<link rel="stylesheet" href="https://maxcdn.bootstrapcdn.com/bootstrap/3.3.6/css/bootstrap.min.css">
<link rel="stylesheet" href="https://maxcdn.bootstrapcdn.com/font-awesome/4.6.1/css/font-awesome.min.css">
<script src="https://ajax.googleapis.com/ajax/libs/jquery/1.12.0/jquery.min.js"></script>
<script src="https://maxcdn.bootstrapcdn.com/bootstrap/3.3.6/js/bootstrap.min.js"></script>
<span>
	<h4><i class="fa fa-angle-right fa-2x1x" style="color:rgb(220,90,35)"></i> <b>Review <a href="#GeneralStandardsScreeningCriteria-fit#GeneralSelectionCriteria-Fit for purpose">Fit for Purpose Criteria</a></b></h4>
    <h4><i class="fa fa-angle-right fa-2x1x" style="color:rgb(220,90,35)"></i> <b>Review <a href="#steward#GeneralSelectionCriteria-steward">Stewardship Criteria</a></b></h4>
    <h4><i class="fa fa-angle-right fa-2x1x" style="color:rgb(220,90,35)"></i> <b>Review <a href="#quality#GeneralSelectionCriteria-quality">Quality Criteria</a></b> </h4>
</span>

Anchor

fit

Fit for purpose
Fit for purpose

fit

Fit for Purpose Criteria

Fit for purpose criteria is used to evaluate the appropriateness of the a standard for within the intended business, clinical and technical context by considering whether the standard: aligns .

Aligns to the

eHealth Blueprint; is an existing standard; supports the business requirements; supports the technical requirements; is likely to be adopted; and supports coded and free text content. [Office1] 

 

Table 1 - Fit for Purpose Criteria

Criteria

Description

Rationale

Alignment to the eHealth Blueprint

The purpose of this criterion is to assess whether the standard supports the exchange of information between two or more components of the EHR. The standard should also be intended to be used in a federated approach to EHR architecture where multiple organizations are expected to build, operate and/or host the various applications.

The standard supports eHealth mandate in providing a single, harmonized, coherent province-wide EHR.

Existing Standard [RB2] 

 

This criterion assesses whether the standard is adopted/adapted from existing standards, and whether it is intended for international, pan- Canadian.

 

Digital Health Blueprint

Selection of existing interoperability specifications and terminology subsets which have been deployed to support similar use cases improves compatibility between solutions, supports rapid project delivery and decreases speed to value.

Selection of standards which are health care delivery setting independent can be reused across multiple health care delivery settings.

Expand
titleAssessment Questions
  • Has the proposed standard already been deployed in Canada to support substantially similar use cases?
  • Is the standard currently in use in Canada across a range of use cases and care settings?

Reuses an Existing, Shared Standard

Reuse of widely adopted standards across different interoperability specifications or terminology subsets allows reuse of code,

Re-use of existing standards allows implementers to re-use code (i.e. in point of service /Health Information Access Layer (HIAL)

applications, conformance testing environments, etc.

). It

 This also allows reuse of existing tools/skills/knowledge sets to establish the standard.

 

Supports Business Requirements

Expand
titleAssessment Questions
  • Was the proposed Interoperability Specification or Subset adopted/adapted from a widely used standard?
  • Was the proposed Interoperability Specification or Subset developed for use in Canada?
  • Is the base standard widely used in Canada?

Business Requirement Support

Selected standards must address all in-scope business requirements or be adapted to meet project needs.

Expand
titleAssessment Questions
  • Does the proposed interoperability specification

This criterion assesses whether the standard expresses all information required by the business/clinical domain. While the exact business requirements are project specific, example questions may include:

Does the messaging standard
  • have all the messages to support the required functions for data exchange? 
  • Do the messages have the appropriate fields to express the information required for the business functions?
  • Does the document standard have all the sections to express the required business information?
  • Does the terminology subset contain all of the concepts that need to be captured?
  • If bi-lingual information needs to be exchanged, does the standard allow for English and French terms to be mapped to common codes? 
  • Are there user interface data collection/display requirements that should be considered when choosing the interoperability standard?

To ensure that the standard addresses the health care business requirements.

 

The standard should be health care delivery setting independent to enable use across multiple health care delivery settings.

Supports Technical Requirements

This criterion assesses the degree to which the standard is

Standards selected must be feasible to adopt and implement according to the technical requirements and constraints of the project.

While the exact technical requirements are project specific, example questions may include:

Expand
titleAssessment Questions
  • Can the standard be implemented in the proposed architecture? 
  • Does the conceptual architecture make any assumptions about synchronous or asynchronous communication? 
  • Does the architecture support HTTP and/or MLLP? 
  • Are there any interdependencies with other aspects of the architecture that would make it difficult to implement the standard (e.g. there are no places to express SAML bindings in HTTP without SOAP, making it difficult to integrate RESTful interfaces with the existing security system and therefore difficult to implement HL7 FHIR)?

To enable successful implementation of the standard.

Likely to be Adopted[Office3] 

Likelihood of Adoption

Standards that are adopted and incorporated into solutions, either by vendors or other implementers, have better staying power in the market and offer a greater opportunity to provide value back to implementers through future integrations.  Implementation costs associated with widely adopted standards may also be lower.

Expand
titleAssessment Questions
This criterion assesses the likelihood that the selected standard will be adopted and maintained by vendors and other implementers. Some questions that may be asked when assessing the likelihood for adoption, include: 
  • Have vendors already implemented this
? If they haven’t, will they get a return on investment if they do
  • standard? How many?
  • What is the expected return on investment for a software vendor?
  • Do vendors have the necessary expertise to implement the standard? If not, is it realistic that they can gain or acquire that expertise in time to implement?
  • Will vendors provide support for sustained use and maintenance?

To ensure success of the implementation. If the standard is not widely implemented or supported by vendors, it will result in increased time, cost, and effort. 

Appropriately supports coded, structured and free text content

Different standards support different data structures and levels of terminology coding.  These difference entail trade-offs to application developers and users. At one extreme, end users may resist using an application which forces them to enter data in too many fields, increasing their time/effort to produce documentation. At the other extreme, just capturing free text can contribute to privacy breaches and present a barrier to implementing decision support.  

Expand
titleAssessment Questions

Supports coded and free text content.

 

This criterion assesses the degree to which coded data is required.

Some questions to ask when assessing whether there is a need for coded data versus free text, may include: 
  • Does the project implementing the standard expect to support automated processing such as: data aggregation comparison within decision support or analytics applications, standardization of data used to trigger process flows (i.e. presence or absence of terms), etc
[Office4] 
  • .
[Office5] 
  • Do clinicians require assistance to exchange data/information for human readability?
  • Are there other forms of non-textual data/information (i.e. audio, video, images) that need to be exchanged?
  • Are there privacy concerns with exchanging free text?
Different standards support different levels of data granularity and coding.  However, there can be trade-offs to application developers and users to provide granular and coded data.

 

At one extreme, end users may reject using the application because it forces them to enter data in too many fields, increasing their time/effort to do so. At the other extreme, just capturing free text can cause privacy breaches and be a barrier to implementing decision support.

 

Anchor
steward
steward
Stewardship Criteria

Stewardship criteria facilitate support comparison of the standard‘s potential standard’s steward in terms of governance structure, licensing and intellectual property rights, and defined maintenance process.

 

Table 2 - Stewardship Criteria

Criteria

Description

Rationale

 These criteria are associated with total costs of ownership and the future availability of the standards selected.

Costs and Benefits of Implementation

This criterion assesses whether

Is the cost of implementation and disruption to current business

is

affordable given the expected benefits

. It

?  It is important to consider not only the initial cost but the on-going cost for maintenance as well. Cost is not only measured in currency, but can be in time or effort as well.

Some sample questions to ask when assessing the costs and benefits of implementation, include:

 

Expand
titleAssessment Questions
What is the return on investment for the vendor?
  • What is the cost of
tools
  • required tooling?
  • Will
the
  • project implementation timelines be increased due to
the
  • additional complexity
of
  • introduced by the standard?
  • Will the standards investment help reduce the cost or risk of subsequent system implementations
be reduced
  • ?
[Office1] 
  • What is the number of people required for implementation?
  • Is there any existing commercial off the shelf software vs. custom software?
  • If properly implemented, would the standard
provide
  • enable downstream system or societal benefits such as improved decision support
or
  • , clinical research

To take into consideration any cost constraints when adopting a standard, as well as initial implementation and longer-term maintenance costs. 

 

Governance Structure

The purpose of this criterion is to assess whether or not the standard is governed appropriately.  When assessing if a governance structure is in place, it is important to consider whether there are: 

  • or other data reuse?

Governance Structure

Well governed standards have processes in place for the voting, maintenance and changing of the standard amongst its various stakeholders; as well as certification and other capabilities of the standards development or maintenance organization. 

Expand
titleAssessment Questions
  • Are defined
Defined
  • processes in place to facilitate decision making and issue resolution related to both standards content and processes
.Balanced representation of communities
  • ?
  • Are the different communities who are responsible for and effected by the standard
.
  • Processes for adding and removing members on the governance committees. [Office2] 
  • To ensure proper processes are in place for the voting, maintenance and changing of the standard amongst its various stakeholders; as well as certification and other capabilities of the standards development or maintenance organization. 
    • represented in the governance process?  Is it well balanced?
    • Are processes to add and remove members from the governance committees documented and compatible with project needs?

    Intellectual Property and Licensing

    CostsThis criterion assesses whether the intellectual property and licensing terms for the standard allows the wide use of the standard. Example questions may include:

    Intellectual property policies, licencing terms and licensing costs can impact standards uptake.

    Expand
    titleAssessment Questions
    • Does the standard have licensing costs that are
    so expensive that the costs prohibits uptake of the standard?Are there network benefits or economies of scale to be realized due to previous implementations
    • significant enough to inhibit uptake of the standard?
    [Office3] 
    • Is it likely the standard licensing costs will increase over time?
    • If a standard is currently free, are there other hidden conditions?
    • Do existing implementations provide network benefits which justify costs?
    • Does use of the standard offset other costs (such as maintenance)?
    • Does the standard have licensing restrictions that prevent it from being implemented by anyone?
    • What standards are being implemented in
    neighbouring
    • neighboring regions/countries due to differing licensing costs? Will these impact expectations in our country?

     

    To ensure that the standard is vendor neutral and allows for the wide use of the standard. Openness and intellectual property policies affect the status, uptake and implementability of specifications, especially in the long term. 

    Defined Maintenance Process

    Maintenance Process

    Business requirements and technology change over time and, as such, standards need to evolve to meet changing needs.  It is therefore important to ensure the selected standard has defined maintenance processes in order to evolve.  There are also costs and benefits associated with the frequency of maintenance cycles and content changes.

    Expand
    titleAssessment Questions
    • Are there defined processes in place to effectively manage changes to the standard?
    • Are there

    This criterion assesses whether or not the standard custodian has processes in place to accept requests for change to address errors or new needs in the standard. When assessing if a maintenance process is in place, it is important to consider the following:

  • There are defined processes in place for changes to the standard?[Office4] 
  • Are
    • processes in place to manage and resolve stakeholder conflicts related to change processes?
    The
    • Are the change processes
    are
    • responsive to stakeholder needs
    .The
    • and feedback?
    • Is the frequency of updates
    should be
    • sufficiently short to accommodate the addition of new codes and repairs quickly
    , as well as extensions or temporary (
    • ?
    hot?) fixes to resolve immediate needs in between full updates.
    • Is the versioning process clearly defined, documented and compatible with business requirements?
    • Is the maintenance body responsive to requests for assistance, maintenance, etc.?

     

    Business requirements and technology change over time, as such, standards need to evolve to meet changing needs.
    •  
    It is therefore important to ensure the selected standard has defined maintenance processes in order to evolve.

     

    Anchor
    quality
    quality
    Quality Criteria

    Standard quality criteria evaluate relate to the overall calibre of the standard and are not related to the standard content itself. They must enable measure the level of interoperability, be adaptable, and stable.  Additional implementation resources must exist, adaptability, and stability provided by the standard as well as the availability of supporting resources such as training, implementation guides, and software to support development, conformance testing, and maintenance of the standard.[Office1] 

     

    Table 3 - Standard Quality Criteria

    Criteria

    Description

    Rationale

    Provides

    Implementation Support and Education

    [Office2] 

    To assess the degree to which resources are able to assist with appropriate use and implementation of the standard. Some key questions to consider when assessing this criteria are:

    Services which support implementers may help increase the rate of adoption and/or decrease the implementation and ownership costs for projects who would otherwise have to provide support services to adopters directly.  These services may be provided by the custodian or service providers for a fee or free of charge.

    Expand
    titleAssessment Questions
    • Does the standard’s custodian provide direct support to implementers?  Do others?  At what cost
    Does the standards development/maintenance organization (e.g. HL7, IHE, Infoway, etc.) provide support for implementation
    • ?
    • Is it easy to obtain education and/or training on the standard and supporting tools?  
    • Is the education or training offered in multiple formats (online training modules, books, in person, etc.)?
    If there are organizations available to provide supporting services to help implement, it will help increase the number of adopters and decrease the costs for specific implementers who would otherwise have to provide those services. 

    Enables Interoperability

    The purpose of this criterion is to assess whether the standard is complementary to

    Existing and new clinical solutions will need to exchange information in a seamless manner.  Standards which are complementary to – or strategically positioned to work with existing interoperability standards implementations

    . When assessing this criterion, the following should be considered:

    may offer greater flexibility or long term benefit.

    (Note that greater flexibility can also increase solution complexity.  It is important to consider how different components of an integrated solution will interoperate with one another and requirements for supporting services when evaluating this criterion.)

    Expand
    titleAssessment Questions
    • Is the standard backwards compatible?
    [Office3] 
    • (E.g. can implementers of previous versions keep their applications in tact in order to be compatible with a newer version?)
    • Does the standard have the ability to map to other terminology and classification standards?
  • Does the standard facilitate information exchange? 
  • Note: Consider how components of an integrated solution interact as well as any enabling services when assessing the costs, benefits and risks of the items above[Office4] .

    To enable existing and new clinical solutions and provide the capability of exchanging information in a seamless manner. To ensure that previous data and legacy systems are compatible with the standard and can be upgraded if necessary.

    Implementation and Maintenance Tools

    This criterion assesses the availability

    The existence of tools

    ,

    and code libraries

    , and/or COTS products to support implementation and maintenance of the standard. The following are questions that may be asked:

    that are easily accessible or commercially available can reduce the effort and cost required to implement and maintain a particular standard.

    Expand
    titleAssessment Questions
    • Are there any existing code libraries and examples available to support implementers or would it be necessary to write
    the
    • all base level code from scratch?
    • Are there standard design tools
    that
    • to help implementers
    to
    • extend or constrain the standard?
    • Are the standard design tools stable and usable?
    • Do the tools run on different operating systems? 
    • Are there tools that help implementers
    compare 2 or more
    • easily recognize differences between versions of the standard and/or
    localization
    • localizations?
    • Are there any application program interfaces or development sandboxes for implementers?
    The existence of tools that are easily accessible decreases the effort and cost to implement and maintain a particular standard.

    Conformance Testing Methodologies and Tools

    This criterion assesses if the standard has well defined conformance testing processes and supporting tools.  Examples questions may include:

    Conformance criteria and profiles are used to test whether a standard has been implemented correctly.  Process to measure solution conformance may already be in place and available to support the project. 

    Expand
    titleAssessment Questions
    • Are there conformance testing tools that first time implementers can easily access?
    • Can implementers re-use their conformance testing environments and processes?

     

    In order to test whether a standard has been implemented correctly, a set of conformance criteria and profiles against which a standard can be measured is important. Ideally, a process to measure conformance should be in place to publicly notify those vendors that are certified (meet testing criteria). 

    • Is there a vendor certification process in place?

    Stability

    Standards which are stable and widely implemented are more attractive for other implementers to adopt.  Less mature standards may be more volatile and fragile. 

    Expand
    titleAssessment Questions

    Proven Stability [Office5] 

    This criterion assesses the stability and level of adoption of the standard. Some key questions to consider are:
    • Has the standard been implemented and tested previously?
    Is
    • Has the standard already been implemented by the
    project‘s
    • project’s implementers?
    • Is the standard stable or
    still
    • is it in a draft
    ?

    If a standard is stable and widely implemented it is more attractive for other implementers to adopt it.

    If a standard is still in inception, it is more volatile and fragile, which will likely lead to increased risks (e.g. increased implementation costs and timeline delays) for initial implementers.

    • status and subject to change?

    Adaptability

    Different standards allow implementers different levels of flexibility to make modifications to support local needs.  

    (Note that greater flexibility can also increase solution complexity.  It is important to consider how different components of an integrated solution will interoperate with one another and requirements for supporting services when evaluating this criterion.)

    Expand
    titleAssessment Questions

    Adaptable and customizable [Office6] 

    This criterion assesses the extent to which the standard allows implementers to make modifications to meet local requirements. Example questions may include:
    • Is the standard highly flexible with lots of optionality and minimal cardinality constraints?
    • Is the standard very strict with little to no optionality and strict cardinality constraints?
    • Does the standard custodian have defined processes and tools for registering local extensions?

     

    For every interoperability standard, it is essential to describe how tightly the aspects defined in the standard constrain the options for the implementation, and which aspects are left for the implementation-specific or customer-specific conventions.

     

     

     

     

     

    •