2019-10-16 Dental FP PSS

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Submit template change requests to PMO@HL7.org
For Reaffirmations, please refer to the FAQ in Hl7 Project Scope Statement Instructions for a list of which sections and fields should be completed

Project Name and ID

EHR System Dental Functional Profile
Project ID:	1406
Complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative”. Forward PSS to the TSC (via tscpm@HL7.org); this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.
	TSC Notification: Informative/STU to Normative				Date: Submission date
	- or - Direct to Normative (no STU) (includes reaffirmations)
Identify ISO, IEC or ISO/IEC standard to be adopted in text box below
Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:
Includes text from ISO, IEC or ISO/IEC standard: Check here if this standard includes excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption.						Yes	No
Select the unit of measure used in the standard; if no measurements are in the standard, select N/A			N/A	U.S.		Metric	Both
	Investigative Project (aka PSS-Lite)	Date :
Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. Sections 1-Project Name, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3e-Project Objectives/Deliverables/Target Dates, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required for Investigative Project. Investigative Project specific instructions are highlighted in yellow. An investigative project must advance in two WGM cycles, requiring a full scope statement. Otherwise the project will be closed.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

Primary Sponsor/Work Group
(1 (And Only 1) Allowed)

Electronic Health Records Work Group

2.b. Co-sponsor Work Group(s)

Co-sponsor Work Group(s): (Enter co-sponsor approval dates in Section 6.d Project Approval Dates)		None
Indicate the level of involvement that the co-sponsor will have for this project
	Request formal content review prior to ballot
	Request periodic project updates. Specify period
	Other Involvement. Specify details here:

2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)	Gregory Zeller, Patrick Cannady
Other interested parties and their roles
Multi-disciplinary project team (recommended)
Modeling facilitator	Andrew Casertano
Publishing facilitator	Mark Janczewski, John Ritter
Vocabulary facilitator	Jean Narcisi
Domain expert rep	Gregory Zeller, Jean Narcisi, Patrick Cannady
Business requirement analyst
Conformance facilitator (for IG projects)
Other facilitators (SOA, etc)
Implementers (2 Mandatory for STU projects) *FHIR Project Note:* The implementer requirement will be handled by the “balloting” project. Therefore work groups do not fill out the above section. However, feel free to list implementers specific to your work group’s resources if you know of any.
1) Zack Church (Henry Schein)
2) Stacey Steinbeck (XLDent)

3. Project Definition

3.a. Project Scope

The scope of this project is the creation of a EHR System Dental Functional Profile containing a list of mandatory and optional standard functional requirements for electronic health records systems used in the practice of dentistry and its various specialties.

Per ISO 1942:2009(E/F) Dentistry is defined as the “science of preventing, diagnosing, and treating diseases and malfunctions of, and injuries to, the teeth, mouth, and jaws, and of replacing lost teeth and associated tissues and promoting of oral health.” The American Dental Association defines oral health as “…a functional, structural, aesthetic, physiologic and psychosocial state of well-being and is essential to an individual’s general health and quality of life.”*

[*Adopted by the 2014 ADA House of Delegates]

This project incorporates and revises requirements identified in ADA Standard No. 1067, which was developed in harmony with HL7 EHR-S FM R1.1 under a joint ADA-HL7 Statement of Understanding (SOU) that was in effect from 2010-2012. It will also incorporate HL7 EHR-S FM R2 criteria as are acceptable to the ADA SCDI Dental EHR Functional Model Working Group, the HL7 EHR Working Group, and interested HL7 stakeholders.

This project will be developed under the terms of the June 15, 2017, ADA-HL7 SOU, which was renewed in June of 2019. This will be a US-Realm specific work product.

The American Dental Association's ANSI-accredited Standards Committee on Dental Informatics (SCDI) is a recognized HL7 Associate SDO, per the June 2019 SOU.

3.b. Project Need

Currently, HL7's EHR System Functional Model R2 contains no dentistry-specific functional requirements and no US Realm Dental Functional Profile has ever been initiated, let alone completed a ballot process. As a result, there is no standard, computable EHR Dental Functional Profile that can be used to create RFPs, define certification criteria, or design EHR systems for the dental setting. This project will complete a much-needed oral health portion of HL7's EHR System Functional Model.

The ADA Standards Committee on Dental Informatics (SCDI), an Associate SDO per the current ADA-HL7 SOU, developed a Dental EHR System Functional Model, ADA Standard No. 1067, under the terms of a predecessor agreement or agreements in effect 2010-2012. ADA Standard 1067 incorporated relevant conformance requirements in HL7 EHR-S FM R1.1 with the addition of unique conformance requirements identified by SCDI volunteers.

In addition to a new HL7 Dental Functional Profile of the EHR System Functional Model, the ADA SCDI would like to revise Standard 1067 and bring it into harmony with EHR-S FM R2.

3.c. Security Risks

Will this project produce executable(s), for example, schemas, transforms, style sheets, executable program, etc. If so the project must review and document security risks. Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment.		Yes
	X	No
		Unknown

3.d. External Drivers

None at this time.

3.e. Project Objectives / Deliverables / Target Dates

Submit for Comment-Only Ballot	2020 Sep Ballot
Comment Reconciliation	2021 May WG Meeting
Publication of Results	2021 Sep Ballot
Submit for Informative Ballot?	2022 Jan WG Meeting?

3.f. Common Names / Keywords / Aliases

EHR-S Dental FP, Dental EHR System Functional Profile

3.g. Lineage

None

3.h. Project Dependencies

None

3.i. HL7-Managed Project Document Repository Location

Dental

3.j. Backwards Compatibility

Are the items being produced by this project backward compatible?	Yes	No	Unknown	X	N/A
If you check 'Yes' please indicate the earliest prior release and/or version to which the compatibility applies:

For V3, are you using the current data types? (Refer to TSC position statement on new projects using R2B for more information on the current V3 data types)	Yes	No	Unknown	X	N/A

If you check no, please explain the reason:

3.k. External Vocabularies

Will this project include/reference external vocabularies?	X	Yes		No		Unknown		N/A
If Yes, please enter the vocabularies: Dental Procedures Codes (CDT), Current Procedural Terminology (CPT), SNODENT (SNOMED subset), ICD-10-CM, LOINC

4. Products (check all that apply)

	Arden Syntax	V2 Messages – Administrative
	Clinical Information Modeling Initiative (CIMI)	V2 Messages - Clinical
	Clinical Context Object Workgroup (CCOW)	V2 Messages - Departmental
	Domain Analysis Model (DAM)	V2 Messages – Infrastructure
X	Electronic Health Record (EHR) Functional Profile	V3 Domain Information Model (DIM / DMIM)
	FHIR Extensions	V3 Documents – Administrative (e.g. SPL)
	FHIR Implementation Guide (enter FHIR product version below)	V3 Documents – Clinical (e.g. CDA)
	FHIR Profiles (enter FHIR product version below)	V3 Documents - Knowledge
	FHIR Resources	V3 Foundation – RIM
	Guidance (e.g. Companion Guide, Cookbook, etc)	V3 Foundation – Vocab Domains & Value Sets
	Logical Model	V3 Messages - Administrative
	New/Modified/HL7 Policy/Procedure/Process	V3 Messages - Clinical
	New Product Definition (please define below)	V3 Messages - Departmental
	New Product Family (please define below)	V3 Messages - Infrastructure
	Non Product Project - (Educ. Marketing, Elec. Services, etc.)	V3 Rules - GELLO
	White Paper	V3 Services – Java Services (ITS Work Group)
	Creating/Using a tool not listed in the HL7 Tool Inventory	V3 Services – Web Services (SOA)
X	ANSI/ADA Standard No. 1067 Electronic Dental Record System Standard Functional Requirements and also ANSI/ADA No. 1084 for Reference Core Data Set for Communication among Dental and Other Health Information Systems

5. Project Intent (check all that apply)

	Create new standard			X	Supplement to a current standard
	Revise current standard (see text box below)				Implementation Guide (IG) will be created/modified
	Reaffirmation of a standard				Project is adopting/endorsing an externally developed IG:
	New/Modified HL7 Policy/Procedure/Process				Specify external organization in Sec. 6 below;
					Externally developed IG is to be (select one):
	White Paper (select one):				Adopted - OR -	?	Endorsed
		Balloted Informative OR	Non-balloted WG White Paper		N/A (Project not directly related to an HL7 Standard)
This will be a profile of the EHR-S Functional Model + Revision to an Associate SDO Standard

If revising a current standard, indicate the following:
- Name of the standard being revised:
- Date it was published (or request for publication, or ANSI designation date)
- Rationale for revision
- The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)

5.a. Ballot Type (check all that apply)

X	Comment (aka Comment-Only)		Joint Ballot (with other SDOs)
X	Informative		N/A (project won’t go through ballot)
	STU to Normative - OR -	Normative (no STU

5.b. Joint Copyright

Check this box if you will be pursuing a joint copyright. Note that when this box is checked, a Joint Copyright Letter of Agreement must be submitted to the TSC in order for the PSS to receive TSC approval.

Joint Copyrighted Material will be produced? Covered by the existing SOU with the ADA

X

Yes

No

6. Project Logistics

6.a. External Project Collaboration

ADA Standards Committee on Dental Informatics (SCDI)
For projects that have some of their content already developed:
How much content for this project is already developed?	Difficult to say, 25-40%? Some R1.1 content already identified (in ADA SCDI Standard No.1067) for this profile that can be quickly added to an R2 profile using the HL7 EHR-S FM Profiling tool. An unknown number of unique dental requirements with no reference to either R1.1 or R2 are in ANSI/ADA Standards 1067 and 1084 and will need to be included in this dental functional profile.
Was the content externally developed ? :	*Yes and No, see above.*
Is this a hosted (externally funded) project? (not asking for amount just if funded)	X	Yes	No

6.b. Realm

	Universal	- OR -	X	Realm Specific: U.S. Realm
				Check here if this standard balloted or was previously approved as realm specific standard
US Realm

6.c. Stakeholders / Vendors / Providers

This section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballots

	Stakeholders		Vendors		Providers
	Clinical and Public Health Laboratories		Pharmaceutical		Clinical and Public Health Laboratories
	Immunization Registries	X	EHR, PHR	X	Emergency Services
X	Quality Reporting Agencies	X	Equipment	X	Local and State Departments of Health
X	Regulatory Agency	X	Health Care IT	X	Medical Imaging Service
X	Standards Development Organizations (SDOs)	X	Clinical Decision Support Systems	X	Healthcare Institutions (hospitals, long term care, home care, mental health)
X	Payors	X	Lab
X	Other (specify in text box below)	X	HIS		N/A
Private Dental Practices, Dental Schools, FQHCs with Dental Clinics, Federal Health Sector

6.d. Project Approval Dates

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

WG Approval Date

2017-12-12

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

N/A

US Realm Projects: US Realm Steering Committee Approval
(Email WG approved PSS to: tscpm@HL7.org)

USRSC Approval Date

2018-02-27

Affiliate Approval Date (for Affiliate Specific Projects):

ADA SCDI Approved

2017-10-16

Submit PSS to Steering Division after all of the above approvals are received

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date

2018-01-29

Last PBS Metrics Score:		Green		Yellow		Red
PBS Metrics Reviewed? (required for SD Approval if not green)				Yes		No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

(determined that the content did not need review)

2019-11-19

TSC Approval

If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
signed by both parties.

Yes

No

N/A

Technical Steering Committee Approval Date:
(Email SD WG approved PSS to: tscpm@HL7.org)

TSC Approval Date

2020-01-20

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