1	Everything you need to know to build EHR-S Conformance Criteria Lynne S. Rosenthal National Institute of Standards and Technology lynne.rosenthal@nist.gov Chicago April 2005
2	Motivation What does it mean when someone says they conform? Profiles, EHR-S What do they actually conform to? What criteria (requirements) does it meet? Conformance Clause. How do you know if they conform or not? Test suites, test tools, testing and certification
3	Conformance Clause: Why have one? Communication: between standard developers, product developers, users/buyers Defines the meaning of a ‘conforming implementation’ – i.e., what is required Provides basis for buyers to express their purchasing requirements People will claim conformance and others will ask for it If we don’t do it someone else will Many will do it, in different ways
4	Definitions CONFORMANCE – the fulfillment of a product, process or service of specified requirements. CONFORMANCE CLAUSE - a section of a specification that defines at a high level, the requirements, criteria, or conditions to be satisfied in order to claim conformance. CONFORMANCE CRITERIA – requirements indicating the behavior, action, capability that constitutes implementation of the function. CONFORMANCE TESTING – a way to determine directly or indirectly that relevant requirements are fulfilled. VALIDATION - process necessary to perform conformance testing in accordance with a prescribed procedure and official test suite CERTIFICATION - acknowledgement that a validation was completed and the criteria established for issuing certificates (brands) was met.
5	Fitting it all together
6	Draft Conformance Clause Defines conformance to the Functional Model Concepts: Profiles conform to the Functional Model EHR-S conforms to 1 or more profiles
7	Draft Conformance Clause Conformance Criteria Every function is associated with a set of conformance criteria Conformance criteria form the basis for determining if the function has been implemented Structure of the Functional Model Headers - Id and Name Functions - Id, Name, Statement, Description, Conformance Criteria Hierarchical
8	Draft Conformance Clause Normative Language Shall: Mandatory requirement (‘is required to’) Should: Optional, recommendation (‘is encouraged’) May: Optional, permissible action (‘is permitted’) Rules for Profiles How to build conforming profiles Defines how EHR-S’s and derived profiles conform to profiles Addresses conformance criteria for profiles Adapted from Functional Model conformance criteria to match needs and priorities of profile Add conformance criteria At least 1 shall be a ‘shall’
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10	Why have Conformance Criteria? Helps answer: what does it mean to implement a function? Identifies functionality requirements and options Provides basis for articulating features of a function Improves the Functional Model Identifies problem areas – confusing terminology, inconsistencies, incompleteness, Identifies need to roll-out, split, or create new functions Other reasons Used by profiles and applications Facilitates testing and certification activities by others
11	How to create Conformance Criteria: How to Guide with Do’s and Don’t’s Help notes, not binding Presents Steps and Principles Targets Functional Model, but useful for Profiles Steps Read the Function carefully Separate into meaningful sentences: What does it mean to implement this function? Condition to hold true, behavior or actions to take Identify the actor and interaction Is this mandatory or optional? Check for dependencies and co-relationships
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13	Creating criteria
14	Example: System = Coffee Maker Function = Make Coffee Statement: Produce coffee beverage Description: Coffee is liquid drink that can be served hot, cold, or iced. Key ingredients are coffee and water. Coffee is made in various ways, e.g., perk, brew, drip, espresso. Conformance Criteria a) System should produce coffee beverage in liquid form b) At a minimum, the system should input coffee and water via at least one method c) Temperature of coffee produced should be in the range of 33°F - 211°F d) System may be electric, drip, expresso, perk e) If electric, system should be 110 or 220 v and provide correct plug
15	Principles when creating criteria Do keep each statement simple, clear, precise Do make criteria technology neutral Do not change the functionality in the FM Do not mix terminologies – be consistent Do constrain optionality and cardinality What features, values, etc need to be there? How many (0 or more, choose 1, at least one) Do state explicit dependencies and constraints Do not state how to test Do not rely on formatting or context to convey intentions Don’t count on italics or bold to convey information Use normative language (shall, should may)