ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build
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Sections 6.2 through 6.7 are the HL7 EHR Work Group approved Conformance Clauses. As important background on conformance, please note the following:
This Conformance Clause defines the minimum requirements for Functional Profiles claiming conformance to the EHR System Functional Model. It also identifies how EHR systems achieve conformance to the Functional Model, which is via the system’s conformance to a particular functional domain profile, multiple Functional Profiles, or combination of domain and companion profiles. This clause specifies:
While the conformance requirements for Functional Profiles can be found in this clause, they necessarily reference the Functional Model and other sources.
This Conformance Clause does not specify inspection, testing or validation procedures to assess a Functional Profile’s conformance to the Functional Model. It also does not specify inspection, testing or validation procedures to determine whether an EHR system conforms to a Functional Profile or matches the EHR System Conformance Statement.
Creating a Functional Profile is a method for defining subsets of the Functional Model. A Functional Profile is a specification which uses the Functional Model to indicate which functions are required, desired, or implemented for certain EHR systems, healthcare delivery settings, or for other purposes (e.g., the functional profile for Records Management and Evidentiary Support).
Functional Profiles can be created by healthcare community stakeholders with interest in using and/or providing a Functional Profile for an EHR system. Functional Profiles can represent the functionality required and desired for a realm (country/region), domain, care setting or service/specialty, or reflect the functionality incorporated in a vendor’s EHR system.
(NOTE: During the process of creating a Functional Profile, it may be important to discuss clinical processes, work flows and/or interaction(s) of the healthcare actors. The international standard ‘ISO 13940 System of Concepts to Support Continuity of Care’ provides an outline of key principles and processes in the provision of healthcare. We would highly recommend reviewing this standard as part of your work.)
There are two types of Functional Profiles. The Functional Domain Profile is the common type of profile used to describe an EHR system for use in one or more care settings, or to describe an EHR system for use in a selected realm (country/region) to meet the rules, regulations and standards applicable for that realm, to describe an EHR system for use by a particular service or specialty, etc. The Functional Companion Profile is a type of profile that must be paired with one or more Domain Profiles. The purpose of a Companion Profile is to add unique features to an EHR System, such as for research or for evidentiary support. For example, many EHR systems in a clinic environment do not need to support clinical research. But for a clinic that was supporting advanced research, they might want an EHR system that was both capable of all of the expected functions for routine clinic patient care activities, but also had unique features to support the needs for research reporting and clinical trials.
Once a Functional Profile is defined its functions (complying with conformance criteria) can be implemented within EHR systems or it may trigger the creation of derived Functional Profiles. A derived Functional Profile is a Functional Profile that is created from an existing Functional Profile, inheriting FP functions and conformance criteria. There are two types of derived Functional Profiles: Derived Domain FP and Derived Companion FP.
There are two types of mandatory inheritance in the EHR-S FM. All Functional Domain Profiles will inherit the full set of functions in the EHR-S FM Overarching section and their related “SHALL” criteria. All criterion listed in a parent function will be applicable to all the children of that parent function.
A formal HL7 process exists for registering and balloting Functional Profiles. Functional Profiles that are submitted to the HL7 EHR WG with an attestation of conformance to Section Conformance Clause of the HL7 EHR-S Standard and successfully complete review by the WG are designated as “Registered Functional Profiles”. Registered Functional Profiles that undergo formal public scrutiny via the HL7 consensus process as an Informative EHR TC ballot at the committee level will be designated as HL7 functional domain or companion profiles. HL7 Functional Profiles are eligible to undergo full membership ballot via the HL7 consensus process.
Conformance to the Functional Model is defined for Functional Profiles. A functional domain profile conforms either (1) directly to the base EHR-S FM or (2) to another conforming functional domain profile. NOTE: All functional domain profiles must include all the functions and “SHALL” criteria of the Overarching Chapter. An EHR system does not conform directly to the Functional Model; rather, it conforms to a functional domain profile, or to a domain profile in combination with selected companion profile(s). Thus, Functional Profiles claim conformance to the Functional Model and EHR systems claim conformance to one or more conforming domain Functional Profiles. An EHR system can also claim conformance to a domain Functional Profile, in combination with one of more companion profiles. An EHR system cannot claim conformance to only a companion profile. Figure 3 (below) illustrates this relationship.
Functional Profiles allow for added specificity and extensibility to the Functional Model with changes allowed to the base FM functions and criteria. However, Section 8.6 (following) defines rules for these changes. It is also required that any changes and additions be tracked. Two added columns in profiles accomplish this. One column will document the unique source FM row number for each item in the new profile (or source profile for a derived profile). The second column will provide codes for the type of changes from the source FM (or source profile). Together, these two traceability columns will keep track of the origins of the functions or criteria – and whether it is modified or unchanged from that within the FM or the source profile. This may be important when questions arise as to where did it come from, why was it chosen or modified, etc. It can also be helpful to have traceability back to the FM functions and criteria if and when revisions to a profile or for derived profile are needed to reflect care setting, regulatory, technology changes – or a future new release of the base EHR-S FM.
The EHR-S Functional Model (i.e., all chapters) contains normative, informative, and reference sections. In this Conformance Clause section, the normative content defines how a Functional Profile achieves conformance to the Functional Model. The following keywords (i.e., normative verbs) SHALL be used to convey conformance requirements.
Every function in the Functional Model is associated with a set of conformance criteria. These conformance criteria form the basis for determining whether the function has been implemented
Functional Profiles also have conformance criteria associated with functions in the Functional Profile. The Functional Profile’s criteria are either (1) adapted from the Functional Model conformance criteria with requirements or language specific to the purpose, care-setting, realm (country/region), domain, service or specialty focus of the Functional Profile; or otherwise (2) inherited directly from Functional Model. Functional domain and companion profiles MAY change Functional Model criteria to match the needs and priorities of the Functional Profile’s constituency, e.g., by making it more specific, or changing it from ‘may’ or ‘should’ to ‘shall’. Functional Profiles MAY change the criteria of a function to allow for alignment to realm specific nomenclature, including language distinctions and implication of non-english translations. In these cases, the International Organization for Standardization (ISO) country code (ISO 3166 Country Codes) SHALL be appended to the function ID in the Functional Profile.
The functional domain profile SHALL NOT be made less restrictive than the Functional Model by changing ‘shall’ criteria to ‘may’ or ‘should’ criteria (The functional companion profile MAY be less restrictive that the FM by ignoring ‘shall’ criterion). Functional domain and companion profiles MAY also add additional criteria.
Conformance criteria that contain the keyword ‘shall’ and a dependency on situational conditions are called ‘dependent shall’ criteria. The ‘dependent shall’ SHALL contain the phrase “in accordance with scope of practice, organizational policy, or jurisdictional law” or other appropriate grammatical tie-in words (e.g., ‘based on’ rather than ‘in accordance’). A ‘dependent shall’ criteria is used to highlight only these (i.e., scope of practice, organizational policy or jurisdictional law) conditions. A ‘dependent shall’ criterion is a mandatory criterion for Functional Profiles and situational for EHR systems. Specifically,
There is often a link between functions and their criteria with other functions and criteria. For example, a given function may depend on another function or on a specific criterion associated with another function. A criterion in the Functional Profile that references another function in the Functional Profile SHALL reference that function by indicating its name and ID, as “X.n.n (Name)”. If the referenced function is required to be implemented, then all the ‘shall’ criteria of this referenced function apply. If the referenced function is a parent with children, the reference must be explicit on whether the children are included in the reference, all or selected ones. See the examples below:
A criterion in the Functional Profile that references a specific criterion in another function SHALL reference that function by rewriting the referenced criterion as one of its own and indicating the function and criterion number from where it came (e.g. F#, CC3).
Functions MAY be contained (i.e., nested) within other functions. A nested function is a ‘child’ to its ‘parent’ (i.e., the function that contains it). A child SHALL always have a parent. A function that is not a parent to another function is considered a ‘leaf’. Figure 2 illustrates this hierarchical structure. The Functional Model is represented as a hierarchical list of functions, consisting of functional header parents, functional header children and functional leaf functions. Headers include an ID, Name and “H” in the column labeled “Type”. Parent and Child Headers MAY contain conformance criteria only if the criteria apply to all its descendent functions (i.e., children, grandchildren, and leafs). Parent, Child and Leaf functions contain at a minimum the following: ID, Name, Statement, Description, and Conformance Criteria and have a “F” in the “Type” column. Conformance criteria listed in a parent function SHALL be inherited by all its children functions. Conformance Criteria have a “C” in the “Type” column.
(Note: The numbering schema above reflects functions in the Care Provision chapter. For instance, CP.4.2 is the function ‘Manage Medication Orders.)
Functional Profiles either:
Functional Profiles SHALL NOT change the name or statement of a function except to allow for alignment to realm specific nomenclature, including language distinctions and implication of non-english translations. In these cases, the International Organization for Standardization (ISO) country code (ISO 3166 Country Codes) SHALL be appended to the function ID in the Functional Profile. It is recommended that the HL7 Affiliate for the respective realm coordinate with the profile development process to maintain a mapping of the Functional Model function name and/or statement and the realm-adjusted name and/or statement.
Functional Profiles indicate the importance and/or immediacy of a Functional Profile by associating a priority with a function. Three priorities have been defined, Essential Now, Essential Future, and Optional.
Any or all of these priorities SHALL be used in a Functional Profile. If the Essential Future priority is used, then Functional Profiles are required to define the timeframe associated with implementing functions. A timeframe MAY be a date, time allotment (e.g., year 2014 or 4 months after Functional Profile publication), or event (e.g., republication of this Functional Profile). A Functional Profile MAY define multiple timeframes for the Essential Future priority. If multiple timeframes are defined, then the timeframe SHALL be used to qualify each occurrence of the Essential Future priority (e.g., EF-2015, EF-2016).
To accommodate changes in technology as well as Functional Profiles’ needs, the Functional Model is designed for extensibility, for functions and their related criteria. Incorporation of additional functions in the Functional Profile beyond what is defined in the Functional Model is accommodated through a set of rules for adding new functions as defined in Section 8.7.2.
Incorporation of additional criterion, changing the sequence of criterion and providing greater profile-specific detail, beyond what is defined in the Functional Model, is accommodated through a set of rules for adding new criterion or changing existing criterion as defined in Section 8.7.2.
A Functional Profile claiming conformance to the Functional Model SHALL meet all requirements specified in the 8.7.1 Rules for Functional Domain Profiles or in the 8.7.5 Rules for Functional Companion Profiles.
Functional Domain Profiles SHALL claim conformance to the version of the EHR-S Functional Model from which it was derived.
Functional Profiles claiming Functional Model conformance SHALL:
Functional domain profiles claiming conformance to the Functional Model MAY:
Functional domain profiles claiming conformance to the Functional Model SHALL NOT:
If a function is not adequately specified for a Functional Profile or does not exist, the Functional Profile SHALL only create new children, the new children can be parents or leafs . Figure 5 illustrates the addition of a new child function.
The following rules specify the method for creating new functions.
If new children functions are created by a Functional Profile that is balloted or registered, these new functions will be captured by the HL7 EHR WG and tracked for review. The EHR TC WILL use these new functions and related criterion as input and candidates for changes to the Functional Model (e.g., inclusion, relaxation of conformance criteria). The EHR WG MAY maintain a file of functions and criterion reviewed and rejected for inclusion in a future version of the FM.
Function IN 4.4 is added as a new child which is a sibling to IN 4.1, IN 4.2, and IN 4.3.
Derived functional domain profiles claiming conformance to one or more base functional domain profiles SHALL:
Functional Profiles MAY want to require that a conformance statement be produced for systems claiming conformance to the profile. A Conformance Statement provides information about an EHR system, by presenting in a uniform manner the functions that have been implemented by the EHR system. A blank (i.e., yet to be completed) Conformance Statement typically takes the form of a questionnaire or checklist, to be completed for each EHR system.
A Conformance Statement provides a concise summary of a Functional Profile. It follows a standard layout, thus providing EHR system vendors and users a quick overview of the Functional Profile’s functions. Moreover, it can also be used to highlight optional functions and capabilities supported by the EHR systems as well as document any extensions (i.e., additional functionality beyond what is in the Functional Profile) or specializations that have been made. An EHR system’s Conformance Statement provides information that can be used in assessing the EHR system’s conformance to a specific Functional Profile. Additionally, organizations wishing to acquire an EHR system MAY produce a Conformance Statement to indicate the functions that are required and/or desired in an EHR system.
Functional Profiles MAY want to include a blank, to be completed, sample Conformance Statement in order to promote consistency among completed Conformance Statements. Conformance Statements can be useful in determining the chances of interoperability between two EHR systems, by comparing the functions supported by each EHR system. Additionally, for conformance testing purposes, it can be used to facilitate the selection of tests that would be applicable to a particular EHR system being tested. For example, if an EHR system did not implement functions designated as ‘Essential Future’, this would be evident in the Conformance Statement and the tests for these functions (which are unimplemented) would not be performed.
Functional Domain Profiles SHALL claim conformance to the version of the EHR-S Functional Model from which it was derived. Functional Companion Profiles will follow the section 6.7.1 Rules for Functional Domain Profiles and the section 6.7.3. Rules for Derived Functional Profiles, except for the exceptions and addition described below: Functional companion profiles claiming Functional Model conformance SHALL:
Functional companion profiles claiming conformance to the Functional Model MAY:
There are no exceptions to section 6.7.5. for Derived Functional Companion Profiles
Care setting
It is determined that a new care setting functional domain profile is needed to reflect the care setting specific requirements. To help ensure widespread use and uniformity, the Functional Profile authors elect to undergo the registration review followed by the HL7 consensus process (i.e., submitting the registered Functional Profile for an “Informative” committee level ballot). If successful, the result will be designated a HL7 Informative Functional Profile.
After looking at current list of HL7 informative Functional Profiles, the decision to create a new Functional Profile is made. Each function in the EHR System Functional Model is examined and those that are relevant to the care setting are chosen. From these functions, a small set of ‘core’ functions are selected as being essential and mandatory. For each function, conformance criteria is developed either adapting the Functional Model conformance criteria or in a few cases, using the Functional Model criteria as is. To complete the Functional Profile, a description of the Functional Profile, including its intended use and audience as well as a Conformance Clause is written. The Functional Profile is made public by publishing it on various web sites. Additionally, the Functional Profile is submitted to HL7’s EHR Work Group for registration review, comment and ballot.
Community of interest derived functional domain and companion profiles
A community of interest (e.g., regional health information exchange network) wants a functional domain profile to reflect their specific needs, and the needs of one of their members to support clinic research.
The Community of Interest doesn’t want to create a new Functional Profile from scratch. After looking at the list of Registered Functional Profiles, they find an existing Functional Profile that is very close to what they want. Using this Functional Profile as the base, they accept all the functions designated as ‘Essential Now’, reject functions designated as ‘Future’ and add several more functions. For each function, they review the conformance criteria and adapt the criteria to reflect their situational information.
For the one member of the community that needs to support research, a functional companion profile is created. The Functional Profile is only needed to address the narrow areas of operation that are specific to research. So, the group finds an existing companion profile for clinical research and modifies it to reflect the functions needed for the specific disease state implications for the research activities of their member. Now the Community of Reference can seek a vendor that can meet the needs of both the domain profile for the group and the companion profile for the unique member.
Vendor functional domain profile and overarching conformance
A vendor with an EHR system wants to claim conformance to the EHR System Functional Model. The vendor identifies and lists all the functions that are in his product. The vendor adds a description and a Conformance Clause (see samples in section 7.2). This is the vendor’s functional domain profile. If the vendor has actually implemented all the functions listed, then this is equivalent to ‘Essential Now’ and these functions are mandatory. If functions that are currently implemented and those that will be implemented in the future are listed, then the Functional Profile is comprised of ‘Essential Now’ and ‘Essential Future’ and/or optional functionality. Finally, the vendor adds conformance criteria for each function, inheriting some criteria directly (without change) from in the Functional Model. But can also add new criterion to reflect added system features. If all children of a function have the same new criterion, that criterion would be moved to the parent function as overarching, and applicable to all the children. This is appealing in that, the vendor has the opportunity to list all the current functionality and if desired, indicate future plans. In essence, this is similar to a vendor Conformance Statement (a concept most vendors are already familiar with). A vendor may create multiple Functional Profiles.
To aid Functional Profile developers in developing a Conformance Clause for their Functional Profile, as required by Section 8.1 rule #3, the following examples are offered. Note: in these examples, the keywords ‘shall’, ‘should’, and ‘may’ are capitalized and bold. This is a convention to draw attention to the keywords.
Conformance Clause for a care-setting functional domain profile
This functional domain profile defines the conformance requirements for EHR systems and derived functional domain profiles. To conform to this Functional Profile, all ‘Essential Now’ functions SHALL be implemented. ‘Essential Now’ functions are considered mandatory functions. An EHR system is conforming if it implements all the functions designated as ‘Essential Now’ and the mandatory conformance criteria associated with that function. A derived functional domain profile is conforming if it follows the Rules for Functional Profiles. Mandatory conformance criteria are indicated by the keyword ‘shall’. Optional conformance criteria are indicated by the keywords ‘should’ or ‘may’. EHR systems SHALL provide a Conformance Statement structured according to the rules and policies defined in this Functional Profile.
Conformance Clause for an application
E-Application is an application that if included in a care-setting specific system SHALL conform to this Functional Profile. E-Application is an application that has a defined set of attributes of which a minimum set of functions is required of any system claiming this e-Application functionality. Two levels of conformance are designated:
A system MAY claim conformance to either the Core or Advanced Conformance levels, if it implements all the mandatory criteria for the functions at the conformance level for which the claim is being made.
Functions designated with the priority ‘Essential Now’ indicate core functionality. These functions are required to be implemented in order to claim conformance to E-Application, regardless of the level of conformance (i.e., core or advanced) to which the claim is made.
Functions designated with the priority ‘Essential Future’ indicate advanced functionality. These functions are required to be implemented in order to claim advanced level conformance. ‘Essential Future’ functions become mandatory 18 months after publication of this Functional Profile and thus, required for immediate implementation in order to claim conformance at either the core or advanced levels.
Conformance Clause for a vendor system functional domain profile
Conformance is defined for My-EHRsystem. All functions in this Functional Profile are mandatory, are deemed as ‘essential now’, and SHALL be implemented in order to conform to this Functional Profile.
Conformance Clause for a community of interest functional companion profile
Conformance is defined for BuyMyDiabetesEHR. To conform to this functional companion profile, all functions labeled as ‘essential now’ SHALL be available and have been implemented, , and all functions labeled ‘essential now’ in the Long Term Care or Ambulatory domain profile must also be available and implemented. Functions labeled ‘essential future’ are optional, in that they are present for informational purposes only and MAY be implemented in future functional companion profiles.
Conformance criteria in the FM and those created can be structured in the simple format an Actor followed by normative verb followed by action or property. For example: The system SHALL capture demographic information as part of the patient record.
However, there are two conditional forms for which if the condition is true, then the following text must apply. One is If/Then. If condition, then Actor followed by normative verb followed by action. If the condition is not met (i.e., false) then ignore the rest of the sentence. For example, IF data is exchanged with internal or external systems, THEN the system SHALL conform to function IN 5.1 (Interchange Standards)
The other is a ‘Dependent Shall’ format. Actor followed by normative verb followed by action/interaction followed by ‘according to scope of practice, organizational policy or jurisdictional law’. For example, "The system SHALL enable EHR-S security administrators to grant authorizations to principals according to scope of practice, organizational policy, or jurisdictional law."
The following example of a Functional Model ‘dependent shall’ criterion will be used to illustrate conditional concepts throughout this section.
Functional Model criterion: The system SHALL enable EHR-S security administrators to grant authorizations to principals according to scope of practice, organizational policy, or jurisdictional laws.
The purpose of the ‘dependent shall’ is to allow Functional Profiles to constrain a Functional Model ‘shall’ criteria based on situational conditions such as policy and legal implications. Specifically, the ‘dependent shall’ criteria in the Functional Model are ‘shall’ criteria + a dependency, where the dependency is defined by:
The structure of the ‘dependent shall’ criteria in the Functional Model is the same as the ‘shall’ criteria except with the addition of the phrase “in accordance with scope of practice, organizational policy or jurisdictional law” or other appropriate grammatical tie-in words (e.g., based on rather than in accordance). Note that all three dependencies are present in the Functional Model ‘dependent shall’ criteria. It is the Functional Profile that narrows it to any one dependency or any combination of the three. Moreover, in the Functional Profile, the specific scope of practice, organizational policy, and/or jurisdictional law which necessitates evoking the ‘dependent shall’ is explicitly identified.
For example: (derived from the Functional Model criterion above)
Functional Model criterion: The system SHALL enable EHR-S security administrators to grant authorizations in accordance with HIPAA.
The difference between a ‘shall’ criterion and a ‘dependent shall’ criterion is shown in Table 3 below.
| ‘SHALL’ Criterion | ‘Dependent SHALL’ Criterion | |
|---|---|---|
| Be present in the Functional Profile | Yes, either verbatim or modified (e.g., constrained or refined) | Yes, verbatim. If dependency exists, add additional criteria reflecting the dependency. |
| Implemented by EHR systems | Yes. | Situational - only implement if the dependency exists. Specifically, EHR system does not implement the ‘dependent shall’ criterion (as copied from the FM), but does implement additional ‘shall’ criteria created to reflect the dependency. |
Table 3 Differences between 'shall' and 'dependent shall'
The reason for using a ‘dependent shall’ in the Functional Model is to highlight these criteria and bring them to the attention of the reader – both developers of Functional Profiles as well as other users. These criteria are considered to be special cases, where there are one or more dependencies that affect these criteria, across multiple care settings. Using the ‘dependent shall’ ensures that developers of all Functional Profiles address the criterion and consciously decide whether the criterion in question is applicable, based on the stated dependency. Regardless of whether a dependency exists or not, the ‘dependent shall’ is copied verbatim into the Functional Profile. The reasons for this are:
The way to interpret and apply a ‘dependent shall’ criterion in a functional domain profile is as follows:
If one or more dependencies are applicable to the Functional Profile (e.g., there are jurisdictional legal requirements), add one or more ‘shall’ criteria that refine and further constrain the ‘dependent shall’ with respect to the dependencies.
For the new criteria, add an explanation and/or citing for the dependency. For example, jurisdictional legal requirements for this Functional Profile are defined by Federal Regulations (see 45 CFR Parts 160, 162 and 164 – The HIPAA Security Rule. The explanation or citing may be in an appendix. It is likely that multiple criteria will reference the same explanation or citing.
Examples:
Functional Profile criteria
Dependency Explanation *For a U.S. realm Functional Profile, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as well as other jurisdictional legal requirements or other more stringent requirements would be applied to ‘dependent shall’ criteria in the Functional Profile.
| FM | Dependency Applicable? | Applicability | Functional Profile |
|---|---|---|---|
| Dependent SHALL | Yes | Mandatory | Copy SHALL from FM |
| Mandatory | Add additional criteria to reflect the dependencies. Use ‘shall’. | ||
| Mandatory | Add explanation or citing | ||
| Optional | Add additional criteria derived from ‘dependent shall’. Use ‘shall’, ‘should’ or ‘may’. |
If no dependency is applicable to the functional domain profile (i.e., there are no scope of practice, organizational policies or jurisdictional legal requirements that apply), then document the rationale for deciding that no dependencies apply. This explanation may be in an appendix. It is likely that this explanation will apply to multiple ‘dependent shall’ criteria.
| FM | Dependency Applicable? | Applicability | Functional Profile |
|---|---|---|---|
| Dependent SHALL | No | Mandatory | Copy SHALL from FM |
| Mandatory | Add explanation | ||
| Optional | Add additional criteria derived from ‘dependent shall’. Use ‘shall’, ‘should’ or ‘may’. |
Add additional criteria – regardless of whether a dependency exists or not.
It is always permissible for a Functional Profile to add new criteria. Add new criteria that are derived from the ‘dependent shall’. Use any keyword: ‘shall’, ‘should’ or ‘may’ (see Section 3) in these new criteria.
Examples: