Health Level Seven®, International
2013.1 Project Scope Statement
1. Project Name and ID
CDA Section for Digital Signatures and Delegation of Rights
TSC Notification Informative/DSTU to Normative
Date :
Project ID:
2. Sponsoring Group(s) / Project Team
Primary Sponsor/Work Group (1 Mandatory)
Co-sponsor Work Group(s)
Structured Documents
Security, Attachments
Project Team:
Project facilitator (1 Mandatory)
Other interested parties and their roles
Multi-disciplinary project team (recommended)
Modeling facilitator
Publishing facilitator
Vocabulary facilitator
Domain expert rep
Business requirement analyst
Conformance facilitator (for IG projects)
Other facilitators (SOA, SAIF)
Robert Dieterle (rdieterle@enablecare.us)
Daniel Kalwa (Daniel.Kalwa@cms.hhs.gov)
Electronic Submission of Medical Documentation
(esMD) Initiative – CMS
Standards and Interoperability Framework – ONC
HL7 EHR-S and Evidentiary Support Workgroup
S&I Longitudinal Coordination of Care
Initiative
Zachary May
TBD
Zachary May
Robert Dieterle
Bob Yencha
Johnathan Coleman
Zachary May
Implementers (2 Mandatory for DSTU projects):
1) Centers for Medicare & Medicaid Services (CMS)
2) Medical Electronic Attachment(MEA) / National Electronic Attachment (NEA)
3. Project Definition
3.a. Project Scope
This project proposes an effort to identify the means to apply a digital signature
— and where appropriate, delegation of rights artifacts — to a CDA document to
satisfy requirements for provenance of the document for administrative purposes. In
particular, reimbursement policies for Medicare and Medicaid Services require the
ability to establish authorship of medical documentation to support benefit
coverage determination.
3.b. Project Need
This solution will allow CMS and other Health Plans/Payers to determine provenance
of medical documentation submitted in support of benefit coverage determination .
3.c. Success Criteria
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Health Level Seven®, International
2013.1 Project Scope Statement
Successfully ballot and publish an update to CDA/C-CDA that incorporates support as
indicated above.
3.d. Project Objectives / Deliverables / Target Dates
Define and seek approval of project scope
Analysis, design and draft specifications (regular meetings)
Submit Project Scope Statement
Submit notice of intent to ballot
Submit Draft content
Submit for DTSU ballot
Submit Examples
Ballot period
Present Ballot at HL7
Reconcile Ballot comments
May 2013
May 2013
May 19, 2013
July 7, 2013
July 14, 2013
August 4, 2013
August 19, 2013
August 12 –
September 16, 2013
September 22-27,
2013
September 30 –
December 31, 2013
3.e. Project Requirements
1. Digital signature on documents for administrative provenance
a. Meets requirement for encapsulated non-repudiation (such that
validation of system configuration and validation of audit log review
is not required)
2. The signature should be applied at the time of document creation,
modification, review, or in any case based on payer policy.
3. Support multiple signatures on the same document
4. The certificate must be validated at the time it is used (via OCSP or CRL)
5. Support for a validated delegation of rights assertion
6. The signature and delegation of rights must travel with the document
7. The signature is bound to the signed document for the lifetime of document
8. Supports the transition from unsigned to signed documents over time
3.f. Project Risks
Risk Description
Impact Description
Probability:
Mitigation Plan
Risk Description
Impact Description
Probability:
Mitigation Plan
Inability to agree on the appropriate scope of C-CDA signed or
standard for inclusion of the digital signature.
This is a significant issue. It will delay or prevent the
completion of the Project.
High
Medium
Low
High
Medium
Low
Severity:
Prior conversations and coordination with Security, Structured
Documents and Attachments workgroups – do not expect this to be an
issue
Inability to complete material for ballot in time
May require delay of the ballot.
High
Medium
Low
High
Medium
Low
Severity:
Complete material and delay the ballot to January 2014 or request
an out-of-cycle ballot
3.g. Project Dependencies
1) Coordination with and review by structured documents and security workgroup
2) Availability of resource to create IG for digital signature
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2013.1 Project Scope Statement
3.h. Project Document Repository Location
http://wiki.siframework.org/esMD+Harmonization+of+Author+of+Record+Level+2
3.i. Backwards Compatibility
Are the items being produced by this project backward compatible?
Yes
No
Don’t Know
N/A
4. Products
Non Product Project- (Educ. Marketing, Elec. Services, etc.)
Arden Syntax
Clinical Context Object Workgroup (CCOW)
Domain Analysis Model (DAM)
Electronic Health Record (EHR)
Functional Profile
V2 Messages – Administrative
V2 Messages - Clinical
V2 Messages - Departmental
V2 Messages – Infrastructure
V3 Documents – Administrative (e.g. SPL)
V3 Documents – Clinical (e.g. CDA)
V3 Documents - Knowledge
V3 Foundation – RIM
V3 Foundation – Vocab Domains & Value Sets
V3 Messages - Administrative
V3 Messages - Clinical
V3 Messages - Departmental
V3 Messages - Infrastructure
V3 Rules - GELLO
V3 Services – Java Services (ITS Work Group)
V3 Services – Web Services
- New Product Definition - New/Modified HL7 Policy/Procedure/Process -
5. Project Intent (check all that apply)
.
Create new standard
Revise current standard (see text box below)
Reaffirmation of a standard
New/Modified HL7 Policy/Procedure/Process
Withdraw an Informative Document
N/A (Project not directly related to an HL7 Standard)
Supplement to a current standard
Implementation Guide (IG) will be created/modified
Project is adopting/endorsing an externally developed IG
(specify external organization in Sec. 6 below)
Externally developed IG is to be Adopted
Externally developed IG is to be Endorsed
Revision of CDA/C-CDA (R2) -- HL7 Implementation Guide for CDA Release 2: IHE
Health Story Consolidation, Release 1.1 - US Realm
5.a. Ballot Type (check all that apply)
Comment Only
Informative
DSTU to Normative
Normative (no DSTU)
Joint Ballot (with other SDOs or HL7 Work Groups)
N/A (project won’t go through ballot)
5.b. Joint Copyright
Joint Copyrighted Material will be produced
6. Project Approval Dates
2013-05-16
Sponsoring Group Approval Date
SD Approval Date CCYY-MM-DD
Steering Division Approval Date
PBS Metrics and Work Group Health Reviewed? (required for SD Approval)
Yes
No
TSC Approval Date CCYY-MM-DD
Technical Steering Committee Approval Date
Joint Copyright Letter of Agreement received? (req'd for Joint Copyrighted material)
Yes
No
7. External Project Collaboration
CMS esMD Community
CMS
S&I Framework – Longitudinal Coordination of Care
7.a. Stakeholders / Vendors / Providers
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Health Level Seven®, International
2013.1 Project Scope Statement
Stakeholders
Clinical and Public Health Laboratories
Immunization Registries
Quality Reporting Agencies
Regulatory Agency
Standards Development Organizations
(SDOs)
Payors
Other (specify in text box below)
N/A
Vendors
Pharmaceutical
EHR, PHR
Equipment
Health Care IT
Clinical Decision Support
Systems
Lab
HIS
Other (specify below)
N/A
Providers
Clinical and Public Health Laboratories
Emergency Services
Local and State Departments of Health
Medical Imaging Service
Healthcare Institutions (hospitals, long term
care, home care, mental health)
Other (specify in text box below)
N/A
Payer contractors, certificate authorities, registration authorities, licensing
and certification organizations, operating rule authoring entities, federal
agencies, healthcare clearinghouses and Business Associate as defined by HIPAA,
health information handlers, health information exchanges, health information
organizations
7.b. Synchronization With Other SDOs / Profilers
Check all SDO / Profilers which your project deliverable(s) are associated with.
ASC X12
AHIP
ASTM
BioPharma Association (SAFE)
CEN/TC 251
CHCF
CLSI
CHA
DICOM
GS1
IEEE
IHE
IHTSDO
ISO
LOINC
NCPDP
NAACCR
Object Management Group (OMG)
The Health Story Project
WEDI
Other (specify below)
OASIS, W3C
8. Realm
Universal
Realm Specific
Check here if this standard balloted or was previously approved as realm specific standard
U.S.
9. Strategic Initiative Reference – For PMO/TSC Use Only
This section used only for Strategic Initiative Projects.
1.
2.
3.
HL7 Recognition
HL7 Internal Processes
HL7 Implementation
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