Journal of the American Medical Informatics Association Volume 13 Number 3 May / Jun 2006 245

Viewpoint Paper n

The Clinical Document Architecture and the Continuity of

Care Record: A Critical Analysis

JEFFREY M. FERRANTI, MD, R. CLAYTON MUSSER, MD, MS, KENSAKU KAWAMOTO, W. ED HAMMOND, PHD

A b s t r a c t Health care provides many opportunities in which the sharing of data between independent sites is
highly desirable. Several standards are required to produce the functional and semantic interoperability necessary to
support the exchange of such data: a common reference information model, a common set of data elements, a common
terminology, common data structures, and a common transport standard. This paper addresses one component of that
set of standards: the ability to create a document that supports the exchange of structured data components. Unfor-
tunately, two different standards development organizations have produced similar standards for that purpose based
on different information models: Health Level 7 (HL7)’s Clinical Document Architecture (CDA) and The American
Society for Testing and Materials (ASTM International) Continuity of Care Record (CCR). The coexistence of both
standards might require mapping from one standard to the other, which could be accompanied by a loss of information
and functionality. This paper examines and compares the two standards, emphasizes the strengths and weaknesses of
each, and proposes a strategy of harmonization to enhance future progress. While some of the authors are members of
HL7 and/or ASTM International, the authors stress that the viewpoints represented in this paper are those of the
authors and do not represent the official viewpoints of either HL7 or of ASTM International.
j J Am Med Inform Assoc. 2006;13:245–252. DOI 10.1197/jamia.M1963.

Famous author Aldous Huxley wrote, ‘‘Technological progress emerge that may complicate the realization of this vision.
has merely provided us with more efficient means for going Differing standards and data architectures may prove to be
backwards.’’1 As we move closer to the reality of creating a the greatest obstacle of all. Unless developers and standards
truly interoperable electronic health record (EHR), these organizations strive to work together, the array of competing
words may ring true. While both clinicians and informaticians technologies could become the health care information tech-
envision an EHR that embraces semantic interoperability and nology Tower of Babel.
seamless information exchange, overlapping technologies In an ideal world, standards development organizations
(SDOs) would communicate with and learn from one another.
The result would be one standard for each purpose. It should
Affiliations of the authors: Division of Newborn Intensive Care, not be surprising, however, that two SDOs frequently find
Department of Pediatrics, Duke Health Technology Solutions (JMF), themselves working on similar standards. When that hap-
Department of Medicine (RCM), Division of Clinical Informatics pens, partial overlaps, contradictions, and competition can
(KK), Department of Community and Family Medicine and Depart- occur. In the case of the standards discussed in this paper,
ment of Biomedical Engineering (KK, WEH), Duke University Medi- the competition has been strong and counterproductive for
cal Center, Durham, NC; Fuqua School of Business (WEH), Duke
all parties involved. One organization, The American Society
University, Durham, NC.
for Testing and Materials (ASTM International), was con-
This article reflects the authors’ opinions and is biased by two of cerned that Health Level 7 (HL7) might have infringed upon
the authors’ close associations with HL7. However, the opinions
ASTM’s intellectual property rights and incorporated their
expressed here are the opinions of the authors and do not reflect
the opinions of the HL7 Board of Directors or of the HL7 work into HL7’s proposed standard. This paper attempts to
organization. define and contrast the two similar standards in an effort to
promote a better understanding and harmonization of the
Although this paper critically analyzes the work of both ASTM and
HL7 from the authors’ perspective, the authors applaud the dedica- two efforts. The comparison is made from the viewpoint of
tion and contributions of both organizations to the future of clinical persons active in HL7; however, it is important to note that
care. They are particularly impressed by the organizations’ recent the viewpoints represented are those of the authors alone.
harmonization efforts and look forward to the future promise of
true semantic interoperability. Background
Kensaku Kawamoto is a member of HL7. W. Ed Hammond, PhD, is Traditionally, medical notes have been loosely structured,
a member of the HL7 Board of Directors, is Vice Chair of the HL7 handwritten documents that vary in content by specialty
Technical Steering Committee, and is also a member of ASTM Inter- but result in a record containing pertinent medical informa-
national Committee E31. tion and facts. Although rough guidelines impose some struc-
Correspondence and reprints: Jeffrey M. Ferranti, MD, Division of ture on these documents (e.g., problem-oriented SOAP
Newborn Intensive Care, Duke University Medical Center, Box [subjective, objective, assessment, and plan] notes2), there
3179, Durham, NC 27710-0001; e-mail: <[email protected]>. are no rules per se governing the organization of paper-based
Received for review: 09/12/05; accepted for publication: 01/16/06. clinical notes. As we venture into the realm of electronic data
246 FERRANTI ET AL., CCR and CDA: A Critical Analysis

exchange, however, the importance of structure becomes a more complex architecture for exchanging electronic health
more evident. At present, several SDOs are working to create summaries. As described in the standard, version 1a uses a
a framework for representing and exchanging the contents of new object-oriented data model7 that adds a level of detail
EHRs. We examine in some detail two of the prominent med- and structure to the original CCR. The architecture of the cur-
ical record content–related standards under development. rent CCR specification appears to overlap with the CDA in
Independent of the standard to be used, generating struc- both complexity and scope. Given this conflict, there is value
tured content for EHRs is not widely accepted by practicing in examining these two approaches. The clinical informatics
clinicians as being easy to do or problem free.3 community would benefit from the two parent SDOs work-
Both the HL7 Clinical Document Architecture (CDA) and the ing collaboratively to define a common standard for medical
ASTM International Continuity of Care Record (CCR) strive to document exchange, and that cooperation appears now to be
facilitate the interchange of health care data among care pro- taking place. As Mr. Huxley implied in the opening quota-
tion, adding additional technology is sometimes not the
viders. The CDA is based on the HL7 version 3 Reference
answer. Given the framework already provided by the HL7
Information Model (RIM),4 and the CCR is a clinical frame-
Clinical Document Architecture and the proven clinical utility
work that was originally developed by health care practi-
afforded by the CCR, the authors believe that synergy could
tioners to meet the information exchange needs of primary
be achieved by working together to blend the two standards
care providers.5 Both technologies use the World Wide Web
into a single document exchange standard that retains the
Consortium standard of Extensible Markup Language
best features of each.
(XML) to facilitate the exchange of structured medical data.6
The CDA has evolved through several iterations. While CDA
release 1 (CDA R1) focused on the structured header, CDA Overview of the Continuity of Care Record
release 2 (CDA R2) introduced the concept of structured ele- ASTM International is an SDO whose mission is ‘‘To be the
ments within the document body. Similarly, the CCR is in foremost developer and provider of voluntary consensus stan-
its second revision, referred to originally as CCR version 1a dards, related technical information, and services having glob-
and currently as ASTM International standard E2369-05.7 ally recognized quality and applicability that promote public
(To maximize clarity for the reader, this article refers to the health and safety, and the overall quality of life.’’10 The ASTM
newer version of CCR [ASTM E2369-05] as ‘‘version 1a’’ CCR was created to address a very real clinical problem: phy-
and the original draft standard as ‘‘version 1.’’ The authors sicians need a way to collect a relevant nucleus of patient care
note that ASTM currently refers to E2369-05 as ‘‘version information in a format that is structured, human-readable,
1.0.’’) While version 1 of the CCR was based on a relatively and easily transferable. To that end, several high-profile med-
simple XML schema, version 1a introduced a new object- ical organizations, including the American Academy of
oriented approach to data modeling. Pediatrics, the Massachusetts Medical Society, the American
The HL7 CDA is based on a formal information model and Academy of Family Physicians (AAFP), the Health Informa-
can be used for a number of document types, including radi- tion Management and Systems Society (HIMSS), and the
ology reports, progress notes, clinical summaries, and dis- American Health Care Association, have joined forces with
charge summaries. Release 1 of the CDA became an ANSI ASTM International to create what is now known as the
standard in November 2000 and defined only a structured CCR. According to the AAFP, the CCR is ‘‘a way to create flex-
header. It permitted a unique identifier, a name for the docu- ible documents that contain the most relevant and timely core
of health information about a patient, and to send these elec-
ment, a date of creation, an author, and a place of origin. The
tronically from one care giver to another.’’11
body of the document was left unstructured and served only
as a container for narrative text. Users could provide addi- The CCR was created by health care practitioners based on
tional structure to the body using their own rules, but these their perceptions of the data they wish to share in a given cir-
were not defined as part of the initial standard. Release 2 of cumstance. Unlike many other standards, clinicians were
the CDA added structure to the document body as well as actively involved in the creation of the CCR and were integral
to the header. The CDA is a complex standard that can be to defining its form and content. It is patient focused and
challenging to implement. To address this concern, the HL7 emphasizes the data directly related to a patient’s current
technical committee responsible for the CDA specification is medical problems. Ideally, the content for any instantiation
in the midst of generating implementation manuals to facili- is defined by a provider who knows the patient well. The
tate CDA use. CCR document is then used to transmit timely and focused
information to other physicians involved in the patient’s
The initial version of the CCR had as its strengths a light-
care. ASTM International defines the CCR as a ‘‘summary
weight, easily implemented approach, and it was intended
of the patient’s health status (e.g., problems, medications,
primarily for the exchange of health summaries. This ap- allergies) and basic information about insurance, advance
proach was quite straightforward, and many organizations directives, care documentation, and care plan recommenda-
quickly developed prototype implementations of the stan- tions.’’12 Figure 1 illustrates the conceptual model of the
dard. The CCR impressed many members of the health infor- ASTM CCR version 1.13 Figure 2 provides an example of a pa-
matics community during a demonstration at the 2004 annual tient summary encoded in the original CCR format (version
conference of the Healthcare Information and Management 1). For comparison, Figure 3 displays corresponding informa-
Systems Society (HIMSS) and the 2004 Toward an Electronic tion formatted for CDA, and Figure 4 is an example of the
Patient Record conference.8,9 same patient information using the current CCR standard
The second iteration of the CCR (version 1a), which under- (version 1a). The increased complexity in going from CCR
went balloting as an ATSM standard in April 2005, provides version 1 to CCR version 1a is evident by comparison.
Journal of the American Medical Informatics Association Volume 13 Number 3 May / Jun 2006 247

F i g u r e 1 . Conceptual model of Continuity of Care Rec-

ord version 1, 02/08/2004.22 F i g u r e 3 . Sample Clinical Document Architecture family
history component. From Implementation Guide for CDA Release
2-Level 2-Care Record Summary (US realm), p. 16. Disease of
The CCR is intended to provide consulting physicians with interest altered to match examples from Continuity of Care
the information necessary to participate in a patient’s care. Record.
In relation to an EHR, the CCR can be described as a data ex-
tract. As the implementation guide explains, ‘‘the CCR repre- the CCR on their home computer to review medications for
sents the patient summary, which for many EHRs is called the drug–drug interactions or synchronize their dosing schedule
‘overview’ of the patient.’’13 In essence, the CCR pools rele- with their PDA.’’5 Several recent demonstrations of the CCR
vant information from multiple medical documents and cre- have successfully used USB memory keys as the transport
ates a ‘‘snapshot’’ of the patient.7 From that view, it appears medium for CCR documents.14
that the CCR was originally intended neither to replace the A CCR document is represented using XML, making it easy
complete birth-to-death longitudinal record nor to define in- to transport and display. At present, it is specified by an
dividually all the clinical documents that would make up XML schema and an implementation guide. The CCR sup-
such a record. However, the standard goes on to state that ports the use of coding systems such as Systematized
the CCR can be used to ‘‘facilitate the implementation’’ of Nomenclature of Medicine Clinical Terms (SNOMED CT),
use cases other than a ‘‘summary document,’’ although they Logical Observation Identifiers Names and Codes (LOINC),
are not directly supported by the standard.7 The standard RxNorm, and CPT, but it is up to the end-user to use the
does not fully indicate what the CCR use cases will entail. coded-data functionality; as the implementation guide ex-
Thus, it is possible that these use cases will overlap with plains, the CCR ‘‘strongly recommends the use of controlled
CDA templates. vocabularies but has provided a small number of ‘escape
The CCR is summarized by ASTM as ‘‘a core data set of the hatches’ for free text where deemed absolutely necessary for
most relevant administrative, demographic, and clinical in- those systems that cannot support discretely structured, tagged
formation facts about a patient’s health care, covering one and coded data.’’7 CCR-compliant XML documents will be
or more health care encounters.’’7 It is projected that the compatible with standard HL7 messages, interpretable by
CCR will help prevent medication errors, provide a basis many third-party EHRs, and human-readable using a standard
for avoiding drug–drug interactions and duplicate prescrip- Web browser. CCR documents can also be printed using a wide
tions, and reduce redundant laboratory testing. In addition, variety of tools ranging from Microsoft Word to Adobe
future applications may ‘‘empower patients to participate in Acrobat Reader. A CCR document consists of a set of data
managing their own health. For example, patients could use objects that are organized in a structured manner using XML.

F i g u r e 2 . Sample Continuity of Care Record version 1 family history component. Constructed using XMLSpyÒ based on
schema ‘‘CCR31.xsd’’ by ASTM International, used for the 2004 HIMSS demonstration.
248 FERRANTI ET AL., CCR and CDA: A Critical Analysis

Table 1 j Comparison of CCR Versions 1 and 1a

Category Version 1 Version 1a
Vendor interest Significant vendor New version employs
awareness and a more complex
interest, including data model with
use in high-profile expanded
demonstrations functionally; level
at HIMSS 2004 of vendor interest not
and TEPR 2004 known at this time
Underlying data Proprietary, Proprietary,
model document-based object-relational
data model data model
Machine Designed Provides options
interpretability primarily for for defining data in
human structured, machine-
consumption interpretable formats
Complexity Relatively simple More complex
to implement to implement
Overlap with May overlap Overlaps with CDA
CDA with HL7 CDA in general purpose
referral document and scope
CCR 5 Continuity of Care Record; CDA 5 Clinical Document Archi-
tecture; HL7 5 Health Level 7; HIMSS 5 Healthcare Information
F i g u r e 4 . Sample Continuity of Care Record version 1a and Management Systems Society; TEPR 5 Toward an Electronic
family history component. Created using the CCR Generator Patient Record.
Tool (https://www.solventus.com/aquifer/ReportContainer.
aspx?control¼CCRgeneratorform) by Solventus, accessed
February 6, 2006 via the Continuity of Care Record site document is a defined and complete information object that
(http://continuityofcarerecord.org/x6170.xml) of the American can include text, images, sounds, and other multimedia
Academy of Family Physicians. content.’’16
The CDA derives its content directly from the HL7 Reference
The CCR version 1a recently became a full ASTM standard. Information Model (RIM) and therefore is specifically designed
While the April 4, 2004, ballot of CCR version 1 received ap- to integrate with current HL7 technologies. A CDA document
proval by 95% of the ASTM Working Group members, the ‘‘can exist outside of a messaging context and/or can be a
scope of version 1a appears to have attracted more interest MIME-encoded payload within an HL7 message. Thus the
and hence a larger voting pool than the original specification. CDA complements HL7 messaging.’’17 In essence, each CDA
A critical analysis of this technology is useful because there instantiation represents a distinct clinical document, whether
are significant differences between these two versions of the a progress note, discharge summary, or radiology report.
CCR (Table 1). The CDA is basically a constrained version of the HL7 RIM,
in which RIM object classes have been assigned specific data
Although the CCR has the potential to bring substantial ben-
types and vocabularies.18 In HL7 terms, this constraint of the
efit to the practice of clinical medicine, it is important to better
RIM is called a Refined Message Information Model (R-
understand the areas of overlap between the CCR and the
MIM). The CDA document type and Universal Observation
CDA. The clarification of this relationship is critical to ven-
Identifier Names are defined with LOINC19 document codes.
dors, developers, and the informatics community in general.
Like the CCR, the CDA allows for controlled terminologies
It is essential to harmonize the efforts of the two SDOs and
such as SNOMED CT to enhance semantic interoperability be-
produce a single standard that is truly interoperable and, to
tween medical information systems. Although some contend
the greatest extent possible, ‘‘future proof.’’
that a single CDA document could in itself represent a com-
plete EHR, others have envisioned the EHR consisting of a
The Clinical Document Architecture structured collection of multiple CDA documents. The defin-
Like ASTM, HL7 is an American National Standards Institute- ing characteristics of all CDA documents are persistence, stew-
accredited SDO, whose mission is ‘‘to provide standards for ardship, wholeness, human readability, and potential for
the exchange, management and integration of data that sup- authentication.16
port clinical patient care and the management, delivery and Like the CCR, the CDA is implemented using XML. See
evaluation of health care services.’’15 As such, HL7 has been in- Figures 2, 3, and 4 for a sample section of a CDA document
tegral in the creation of the messaging and health data stan- and its analogous data formatted for CCR versions 1 and 1a
dards that currently permeate health care in the United States. by the authors. The common architecture can be adapted
Realizing that the effective communication of medical infor- for progress notes, radiology reports, discharge summaries,
mation requires both messaging standards and common data transfer notes, medications, laboratory reports, and patient
structures, HL7 developed the CDA (R1 in 200016 and R2 in summaries. Although the initial HL7 Care Record Summary
200517) to provide a common representation for clinical docu- did not pass its first ballot, HL7 does directly support a dis-
ments through ‘‘a document markup standard that specifies charge summary and a referral document. This concept raises
the structure and semantics of clinical documents. A CDA the question of whether the CCR requires a separate standard
Journal of the American Medical Informatics Association Volume 13 Number 3 May / Jun 2006 249

or could be accurately represented as a CDA document. Some Referral Form set forth by the Massachusetts Department
initial work is being performed by the Canadian company of Public Health, and it strives to collect all the data objects
e-MS using the CDA to create a clinical summary of critical relevant to a patient’s current medical condition.21
patient information.20 The authors raise several questions regarding CCR version
The CDA allows for multiple distinct ‘‘levels’’ of machine 1a. The implementation guide suggests that the CCR can be
readability to facilitate maximum compatibility. Level 1 is used for many use cases other than the original referral rec-
an ‘‘unconstrained’’ CDA and allows for free text in order ord. This statement reinforces the authors’ belief that the
to facilitate the transfer of unstructured clinical notes; this ap- new CCR may overlap in scope with the CDA. Since its incep-
proach provides maximum compatibility with older systems tion, the CDA has explicitly considered a myriad of use cases
and simplifies the implementation process from a technical and explored the application of the CDA to a multitude of
standpoint. Level 2 adds a specification for section constraints clinical scenarios. These scenarios will help define the spe-
within the CDA document in order to provide some structure cialty-specific domain constraints required for a wide variety
while still allowing for unconstrained elements within the of clinical documents. Schematron schemas can be used to
headings; e.g., one could define the section headings of sub- constrain specific use cases.
jective, objective, assessment, and plan for the classic SOAP
Both the CCR version 1a and the CDA R2 are complex. In its
note. Level 3 provides for fully structured ‘‘entry level tem-
first iteration, the CCR was perceived as more user-friendly
plates’’ and is by far the most granular, allowing for maxi-
and more easily implemented since the number of classes
mum machine readability.18 In essence, each increasing level
was smaller and the overall data structure was more intuitive.
allows for additional machine readability, but the clinical con-
Although the CDA’s object-oriented data model appears
tent of the notes should be identical in all three levels.
more complicated than that of CCR version 1, the authors be-
Currently, CDA R2 supports constraints up to level 2.17
lieve that the difference in perceived complexity stems from
CDA level 3 specifications are expected to be available in
the late appearance of its implementation guides. In contrast,
the near future. In contrast to the CDA’s incremental levels
the CCR comes with an excellent implementation guide that
of interoperability, the CCR relies on a single explicit data
defines the components of the standard. At present, the
structure and does not allow for, or require, local extensions.
CDA implementation guide only addresses section con-
straints (Level 2) (e.g., family history, social history). A
Comparison of the CDA Version 2 and Level 3 implementation guide that defines completely struc-
the CCR Version 1a tured content is due to be released by HL7. The authors antic-
While both methodologies aim to improve patient care ipate that the Level 3 implementation guide will reduce
through efficient information exchange, their approaches development times and allow for substantial progress to be
differ (Table 2). The CCR stresses the important pieces of
made in a short period of time.
data required to care for a patient, whereas the CDA serves
as a document architecture to format all clinical documents. With the release of CCR version 1a, the CCR has taken on a
Both standards aim to facilitate the exchange of medical docu- level of complexity more similar to that of the CDA. The
ments in a format that is both human readable and machine authors believe that this version of the CCR is as complex
parsable. However, the scope of the CCR is focused on the pri- as the CDA. This added complexity could facilitate richer
mary care ‘‘summary record’’ and does not explicitly support semantic representation and allow for other types of clinical
other use cases. According to ASTM, ‘‘The primary use case documents, but it may not advance the comparative advan-
for the CCR is to provide a snapshot in time. [it] does not speak tage that the original CCR held over the CDA in terms of
to other use cases or workflows but is intended to facilitate the simplicity.
implementation of use cases and workflows.’’7 While CCR ver- The authors believe that the complexity of these novel tech-
sion 1 focused clearly on this summary record, version 1a may nologies must be weighed against the future potential for se-
be expanding its scope to encompass all possible clinical mantic interoperability. Interoperability requires common or
documents. standard data elements with precise definitions, a predefined
In contrast, the CDA was conceived and specifically built to vocabulary system, and strict processing rules. Realizing this,
represent virtually any type of medical document, and it ASTM initially proposed two technical implementations for
adds complexity to cover this generality. It has been sug- the CCR: a simplified base standard that can be implemented
gested that a complete CCR ‘‘summary document’’ could be quickly and a second version that could be mapped to the
expressed as a CDA document template. Since the CCR has CDA if required to facilitate information exchange.
clear clinical utility and the CDA provides a strong structural Both the CDA and the CCR have an unclear relationship with
backbone, it seems that harmonization of these technologies a complete EHR. The CDA was designed to create a wide va-
is the best solution. Since the CDA is intimately linked to riety of individual clinical documents; thus, it should be pos-
the HL7 RIM, its components are applicable across other sible to organize and collect these documents in the context of
HL7 standards, and it could add additional functionality an EHR system. The CCR focuses on the summary record and,
and interoperability to the clinically useful CCR. as such, it could span multiple encounters and multiple health
It seems to the authors that the initial difference between the care providers. Although the initial purpose of the CCR was
two standards lay in purpose and scope. The CDA is docu- to represent a patient summary, the CCR can be used to rep-
ment centric and useful in modeling the complex structure resent a lifelong EHR if the referring physician chooses to in-
of a multitude of clinical documents. In contrast, the CCR clude that level of detail. The content of a CCR relies heavily
was designed to focus on the data elements rather than the on the opinion of the referring physician. This option may
documents. It was originally modeled on the Patient Care be viewed as either an advantage or a disadvantage.
250 FERRANTI ET AL., CCR and CDA: A Critical Analysis

Table 2 j Comparison of CCR and CDA

Category Similarities Differences Assessment
Purpose and Both provide a mechanism CCR focuses on patient Authors of this article prefer the CDA
scope for creating medical summary information. approach because of:
documents in a CDA has a much larger scope, 1. Explicit support for use in multiple
human-readable and, accommodating any kind of document exchange scenarios other
where possible, medical document. than the transport of a patient
machine-interpretable health summary
format. CCR thus does not provide a formal 2. Ability to define templates for specific
mechanism for defining specialized use cases
CCR document types (e.g., discharge 3. Use of standard components
summaries, progress notes). (e.g., data types, information models)
By contrast, a patient summary is just based on input from many different
one of many potential uses of the stakeholders from various HL7
CDA standard and may be specified committees
using a CDA ‘‘template.’’
Because CDA was created by HL7,
CDA is one of the HL7 version
3 family of standards; as such, its
components (e.g., data types,
information models) can be reused
across other HL7 version 3 standards
(e.g., messages).
Development Conducted at SDOs CCR does not explicitly consider The CCR methodology is most likely
methodology (ASTM for CCR, use cases but was developed with faster to implement. In the authors’
HL7 for CDA) direct clinician involvement. opinion, the CDA model appears more
HL7 version 3 methodology explicitly robust in its ability to handle more
considers use cases; HL7 uses a robust, complex details and extensions.
balloted, consensus-driven
development methodology.
Difficulty of Both CCR version 1a and Effort used to implement CCR version 1a HL7 approach is generally preferred
use and CDA R2 are fairly cannot be easily leveraged for meeting by the authors (compared to CCR
implementation complex (as opposed other standards-based communication version 1a), but the lack of a level 3
to CCR version 1, needs: the components used (e.g., data implementation guide for the CDA is
which was much more types, information models, vocabulary a relative weakness and adds to the
straightforward specifications) need not be standard complexity of any CDA
to understand and components, but they can be standards implementation.
implement). based (e.g., LOINC, SNOMED CT).
Both CCR version 1a and Effort used to implement CDA R2 can
CDA R2 provide detailed be leveraged for other data exchange
implementation needs, as they are based on common
guides, with validation HL7 version 3 components.
mechanisms CCR does not provide a method for
(implementation guide specifying specific document templates
for CCR; implementation based on use cases (e.g., discharge
guide plus Schematron summary, referral to cardiologist,
schemas or XSLT style patient health summary), whereas CDA
sheets for CDA). provides an explicit method for doing
this (see section below entitled ‘‘Ability
to specify and support specific use cases’’).
Since CCR was pragmatically derived by
clinicians, it is not clear which is better.
CCR provides an implementation guide that
covers its entire scope of work; CDA
provides implementation guide only up
to level 2 (section constraints), although
the CDA committee is currently working
on defining an implementation guide for
level 3 (detailed structured content level).
Extensibility Both CCR and CDA CCR makes a point of not allowing any In the authors’ opinion, the CDA
use XML syntax. user-configurable fields and thus does provides greater adaptability and
not allow for local differences in extensibility to meet the needs of local
implementation. implementations. If one adheres to
the more narrowly defined purpose
of CCR, it is uncertain how significant
this difference is.
Journal of the American Medical Informatics Association Volume 13 Number 3 May / Jun 2006 251

Table 2 j (Continued)
Category Similarities Differences Assessment
CDA is adaptable and explicitly allows
for local extensions and configurability.
Because of its broad object-oriented
approach to modeling, the HL7 CDA is
able to meet local requirements, while still
allowing mapping back to the standard.
It is not clear how detrimental the lack of
extensibility is for CCR when one adheres
to its stated purpose. HL7 has potential
to meet additional goals due to
extensibility.
Ability to specify CCR does not provide a formal method In the authors’ opinion, the HL7
and support for defining specialized document approach is preferable because
specific use templates based on use cases; it was it is widely applicable to multiple
cases derived by clinicians to meet a use cases and explicitly provides a
specific purpose. mechanism for specifying
CDA provides a concrete method for document templates. Again, if one
specifying document templates to be used adheres to the more narrow goals
for specific use cases. In the current of CCR, the advantage of HL7 may
implementation guides, the constraints not be as great.
for particular use cases can be defined
using Schematron schemas
(http://xml.ascc.net/schematron/).
Information Multitiered specification, CCR implements this concept using a It is difficult to say that one approach
modeling going from just human CodedDescriptionType, where level 1 is superior over the other; however,
approach readable to detailed, is a simple text string, level 2 is a in the authors’ opinion, the use of
unambiguous coded simple text string, and a robust reference information
machine-interpretable level 3 is a coded simple text model (RIM) makes the HL7
encoding. string plus structured representation. information modeling approach
CDA implements this concept using attractive. Furthermore, the HL7
specifications at level 1 (unconstrained RIM has been International
CDA specification), level 2 (section-level Standards Organization-approved
templates defined), and level 3 and is the basis for many
(entry-level templates defined). other approved standards.
Multiple miscellaneous differences
(e.g., how addresses are modeled, how
vocabularies are specified).
CCR 5 Continuity of Care Record; CDA 5 Clinical Document Architecture; HL7 5 Health Level 7; SDO 5 standards development organization;
R1 5 release 1; R2 5 release 2; SNOMED CT 5 Systematized Nomenclature of Medicine Clinical Terms; LOINC 5 Logical Observation Iden-
tifiers Names and Codes; ASTM 5 American Society for Testing and Materials.

As previously noted, by design, the CCR does not provide for to move data between disparate groups in a human-readable,
user-configurable fields. The implementation guide stresses summary form. Its utility as a clinical tool remains unques-
the point: ‘‘To reiterate, there are no end-user or vendor config- tioned, and it promises great advances beyond our current
urable fields in the CCR.’’7 The structure of the CCR requires paper-based systems. In the authors’ opinion, as a general-
this level of consistency in order to ensure interoperability. purpose information exchange standard for all EHR compo-
Unfortunately, in the authors’ opinion, this lack of local exten- nents, the technical implementation of the CCR falls short
sibility could make it difficult for institutions to tailor the CCR of the mark because the CCR was designed for a single pur-
to meet needs beyond the stated purpose of the CCR. In many pose. Although the CCR meets an important clinical need,
cases, if additional purposes are desired, this may force ven- users may require the enhanced interoperability offered by
dors and local centers to create proprietary solutions that devi- the CDA when other needs exist.
ate from the CCR standard. The CDA, on the other hand, is Looking ahead at the future of these standards, a major goal
quite flexible and permits local extensibility while maintaining should be to maximize their strengths and minimize their
direct mapping to the RIM. This flexibility may be viewed as weaknesses. The information contained in both formats can
an advantage or disadvantage, given the work required to be expected to improve patient care, reduce medication
create useful local representations for documents. errors, and ameliorate the financial burden of unnecessary
duplicate testing. The CCR’s usefulness was manifest in the
Conclusion simple yet robust clinical functionality provided by the initial
Overall, the CCR is a clinically useful document that has been version of the standard. The strength of the CDA, on the other
forged from the ground up to meet a specific need. Its major hand, lies in its strong framework and dynamic adaptability.
contribution is capturing the intent of providers and vendors In the authors’ opinion, with CCR version 1a, ASTM deviated
252 FERRANTI ET AL., CCR and CDA: A Critical Analysis

from the strengths of version 1 by moving CCR toward some 5. Kibbe DC, Phillips RL, Green LA. The Continuity of Care Record.
of the functionality, and thus the complexity, of the CDA. Am Fam Physician. 2004;70:1220–3.
Rather than creating an overlapping set of technologies, it is 6. World Wide Web Consortium (W3C). Extensible Markup Lan-
more prudent that the organizations collaborate and capital- guage (XML) 1.0, 3rd ed. February 4, 2004. Available from:
http://www.w3.org/TR/REC-xml/. Accessed 05/28/2005.
ize on each initiative’s strengths.
7. ASTM E31.28, E2369-05 Standard Specification for Continuity of
As clinicians and informaticians, the authors are frustrated by Care Record (CCR). ASTM International, 2005.
the conflicting technologies in health care information tech- 8. Kryptiq Corporation Press Release. Kryptiq to demonstrate tech-
nology. While the authors see substantial value in the CCR, nologies for connecting healthcare at HIMSS. February 17, 2004.
they are concerned that it does not possess the same potential Available from: http://www.kryptiq.com/News/PressReleases/
for interoperability as the CDA. Several possible solutions ex- 37.html. Accessed 12/01/05.
ist, however. One solution is to completely map the CCR into 9. Medical Records Institute Press Release. MRI announces suc-
cessful CCR interoperability demonstration project at TEPR.
CDA using XSLT transformations. This solution is only ac-
May 27, 2004. Available from: http://www.medrecinst.com/
ceptable if it can be done without data loss. If the two stan- pages/latestNews.asp?id5110. Accessed 12/01/05.
dards cannot be directly linked in this way, a second option 10. ASTM International. Mission statement. Available from: http://
might be to define a Common Data Element Set to be used www.astm.org/cgi-bin/SoftCart.exe/NEWS/Mission2.html?E1
in all clinical documents. (In this sense, data elements can mystore. Accessed 12/01/05.
be thought of as individual entries, such as fill-in-the-blanks, 11. Kibbe, David C. Unofficial Faq of the ASTM Continuity of Care
on a medical intake form.) The elements can be combined and Record (CCR) Standard. 2005 American Academy of Family
organized to accommodate a wide variety of clinical scenar- Physicians. Available from: http://continuityofcarerecord.org/
ios. Of course, special care must be taken to assign terminol- x6454.xml. Accessed 06/01/2005.
ogies to each data element. In this way, CDA documents, 12. ASTM WK4363 Draft Standard Specification for the Continuity
of Care Record, Version 1. ASTM International, 2004.
CCR records, X12N claim forms, DICOM image reports,
13. Tessier C. The Continuity of Care Record. Available from: http://
and many others might finally be able to communicate to- www.astm.org/COMMIT/E31_CCRJuly04.ppt. Accessed 05/25/05.
gether. In the end, the ideal solution is a single standard 14. SanDisk Corporation Press Release. SanDisk Demonstrates the use
using content and knowledge from both groups. of USB Flash Drives by Medical Providers for the Continuity of
Recently, after much discussion among the members of both Care Records. Available from: http://www.sandisk.com/Oem/
groups, the issues appear to be resolving. HL7 announced DocumentInfo.aspx?DocumentID51491. Accessed 12/01/05.
in November 2005 that it is creating an implementation guide 15. Health Level Seven, Inc. HL7 Faq. Available from: www.hl7.org.
Accessed 12/01/05.
for expressing the CCR data set in the CDA. This action pro-
16. Dolin RH, Alschuler L, Beebe C, Biron PV, Boyer SL, Essin D,
vides a critical step toward interoperability and builds on the Kimber E, Lincoln T, Mattison JE. The HL7 Clinical Document
strengths of both organizations. The implementation guide Architecture. J Am Med Inform Assoc. 2001;8:552–69.
will combine the CCR-defined set of data elements with the 17. Dolin RH, Alschuler L, Boyer S, Beebe C, Behlen FM, Biron PV,
CDA’s method for expressing clinical documents. To achieve Shabo Shvo A. HL7 Clinical Document Architecture, Release 2.
semantic interoperability, CCR data elements will be ex- J Am Med Inform Assoc. 2006;13:30–9.
pressed in CDA syntax and will be compatible with the 18. Health Level Seven, Inc. HL7 Clinical Document Architecture,
HL7 RIM. We must continue pursuing cooperation and col- Release 2.0. Available from: http://www.hl7.org/v3ballot/
laboration, rather than competition, to achieve our common html/cda/cda.htm. Accessed 08/30/04.
goal of improving health and saving lives. 19. McDonald CJ, Huff SM, Suico JG, Hill G, Leavelle D, Aller R,
Forrey A, Mercer K, DeMoor G, Hook J, Williams W, Case J,
Maloney P. LOINC, a universal standard for identifying labo-
ratory observations: a 5 year update. Clin Chem. 2003;49:
References j
624–33.
1. Huxley AL. Tomorrow and Tomorrow and Tomorrow (And 20. Electronic Medical Summary (e-MS). Available from: http://
Other Essays, Signet Book). New American Library; 1964. www.e-ms.ca/documentation.php. Accessed 04/18/05.
2. Weed LL. Medical records, medical education, and patient care: 21. HIMSS Standards Insight. An Analysis of Health Informa-
the problem-oriented record as a basic tool. Cleveland: Case tion Standards Development Initiatives. December 2003,
Western Reserve University Press; 1970. HIMSS. Available from: http://www.himss.org/content/files/
3. McDonald CJ. The barriers to electronic medical record systems StandardsInsight/2003/12–2003.pdf. Accessed 02/03/05.
and how to overcome them. J Am Med Inform Assoc. 1997;4:213–21. 22. ASTM E31.28, Continuity of Care Record (CCR): the concept
4. Health Level 7. HL7 data model development. Available from: paper of the CCR. Available from www.astm.org/COMMIT/
http://www.hl7.org/library/data-model/. Accessed 03/03/05. E31_ConceptPaper.doc. Accessed 12/03/05.