The American Dental Association (ADA) is sponsor and secretariat of the Accredited Standards Committee (ASC) MD156 for Dental Materials, Instruments and Equipment. In 1992 there was interest in the standardization of clinical information systems. After evaluating current informatics activities, the ADA initiated several projects relating to clinical technology. A task group of the ASC MD156 was created by the Association to initiate the development of technical reports, guidelines, and standards on electronic technologies used in dental practice.
Components of the task group include five working groups for clinical information systems. The working groups were established to promote the concept of a dental computerized clinical work station and allow the integration of different software and hardware components into one system in order to provide for all of a clinician's information needs. Clinical information systems include all areas of computer-based information technologies such as digital radiography, digital intraoral video cameras, digital voice-text-image transfer, periodontal probing devices, CAD/CAMs, etc. By establishing standards for these modules, the need for several stand-alone systems in the dental office will be eliminated.
Each working group encompasses a broad spectrum of projects under a central theme. Within each working group, subcommittees are responsible for the specific projects. Each subcommittee has been researching standards already in existence to determine if they could be applicable to dentistry. Participants are also interfacing with standards groups active in medical informatics.
The ADA also sponsors participation in ANSI activities of the International Organization for Standardization (ISO) Technical Committee 106 on dentistry and acts a secretariat for ANSI for Working Group 2 of ISO/TC 106. Thus, the ADA works both nationally and internationally in the formation of standards for dentistry.
The American Dental Association has been sponsoring a standards program for dental materials, instruments and equipment since 1928. From 1928 to 1953, all specifications for dental materials, instruments and equipment were developed at the national Bureau of Standards by the federal government in cooperation with the ADA. Between 1953 and 1970, the Dental Materials Group of the International Association of Dental Research (IADR) acted as advisory to the ADA in developing specifications. In 1970, American National Standards Committee MD156 (ANSC MD156) was established by the American National Standards Institute, replacing the Dental Materials Group. In 1983, the ANSC MD156 became an accredited committee by ANSI making the committee the Accredited Standards Committee MD156 (ASC MD156).
To date, 56 specifications for dental materials, instruments and equipment have been adopted by ANSI as American National Standards. In addition, the ADA acts as proprietary sponsor on a project to handle standards for dental radiographic film. This activity is conducted under the Accredited Canvas Method of ANSI.
Name of Standard Framework, Architecture or Model: (1) Proposed ANSI/ADA Specification 1000: Standard Clinical Data Architecture for the Structure and Content of a Computer-based Patient Record. This standard is being developed for based Oral Health Record (COHR). The objective was to develop COHR features which would offered the greatest utility to the profession as a whole, addressed issues of open architecture and would be technology independent. The baseline version 1.0 of the COHR Concept Model was released in February 1996. While the process and data models described in the COHR were specific to dentistry, these models were developed with the understanding that dentistry is a microcosm representative of the entire health care environment. Early in the modeling of the COHR the ADA addressed integrated care delivery and coordinating care among the various health care professions and delivery environment. The COHR was developed as a progression of analytical models founded on clinical and public health principles. It described the health care environment, the fundamental processes of health care delivery and the data needed to support these processes. The COHR Concept Model was subsequently converted into a logical data model by the ASC MD156. The logical model was expanded and modified through input from physicians, nurses and allied health personnel. This modification evolved the COHR logical model into a generic clinical data architecture for patient health care information independent of health care profession or delivery environment.
Description of Standard Framework, Architecture or Model:
Purpose: To present an organizing framework for the specification of a clinical data architecture and components via a fully attributed logical data model.
Scope and/or environment: This specification applies to the application data interface (the conceptual interface in the Codasyl Three Tier Architecture) of computer system architecture.
A. Type: Fully attributed logical data model.
In what way will this FAM be implemented/used? To guide development of databases for patient information, clinical repositories, etc.
B. Modeling or other tools required: None.
Objectives: This specification will ultimately make healthcare information seamlessly available at the time and point of care to all authorized users, in a form best used, and with no compartmentalization by profession, specialty, discipline, or care delivery environment. Seamless data interface among system users serving private practice, academia, research, industry, and government programs will offer significant benefits to all system users.
Functions: This specification presents a generic conceptual model of the clinical process, and the data required to enable these processes. From this concept model a logical data model is developed for a clinical data architecture appropriate for use in computer-based patient records and other applications.
Healthcare domain completeness: This specification is independent of health care profession and specialty. It is appropriate for the health care supporting industries, for the educational and research establishment, and for veterinary care.
Provider/payer user environment: The specification is independent of and appropriate across the range of practice philosophy, patient management approach, and reimbursement mechanism.
Systems environment: The specification applies uniformly to flat file, x-base, relational and object-oriented data management approaches.
Systems domain focus: The specification details the architecture of the Application-Data Interface of clinical systems, and therefore provides a foundation data structure useable by standards operating at a higher level of the CODASYL architecture.
Other relevant characteristics: The specification was prepared using a formal conceptual process and data modeling, with preparation of the logical data model and data characteristics through consensus of subject matter experts, consistent with the ANSI Accredited Canvass Method.
Readiness of Standard Framework, Architecture or Model:
Implementation guides and concordances with prominent existing and emerging standards will be prepared. Clinical software intended for use in dentistry may be voluntarily submitted by the vendor for conformance evaluation by the ADA under an evaluation program similar to its seal of approval program. The specification is under development: data models are complete, first two of 18 parts have been drafted and revised from public comment. Remaining parts of the specification are being prepared for public review in 1997.
A. Has it been published? Yes, initial parts but the American Dental Association, Summer of 1996.
B. Is it a draft or a final version? Draft for public comment.
C. Has it been implemented? If so, where and when? No
D. If the FAM is under development, what portions of it are available now?
Parts 1000.0 and 1000.1 are now available.
E. What are the target dates for additional portions or versions of the FAM?
Parts 1000.2 through 1000.17 will be completed by the Summer of 1997.
F. Is the use of this FAM dependent on the availability/selection of a tool? No.
G. Is the use of the FAM dependent on an RFI, an RFP or other evaluation or selection of a tool? No.
Indicator of Market Acceptance:
A. How many copies have been requested and distributed? Over 1000 copies of the draft documents have been distributed for review. Approximately 2000 copies of the foundation concept model document in two printings were distributed for public review and comment during 1995-96.
B. Which SDO's are committed to comply with or use this FAM? American Dental Association.
C. Please not any other relevant indicators of market acceptance within the public or private sector. The specification is being coordinated with ASTM E31-19 as an implementation vehicle for ASTM E31-1384 and other standards.
Level of Specificity:
The specification applies to the middle tier of the CODASYL Three-Tier Architecture. The specification identifies the metadata for entities and attributes needed to construct a physical database containing clinical data, e.g. data name, type and length, format, values, null option, and entity data usage. The specification requires ASCII character set, and where precluded by language UNICODE is required. The specification is code set independent: the data model allows user selection of any existing code set such as CDT, ICD-9, CPT, SNOMED, etc., and user definable code sets for use in reference or look-up tables. The specification requires the use of several ANSI and ISO standards.
Relationships with other standards:
The prominent existing and emerging standards relevant to this specification are ASTM (1239, 1384, 1633, 1715, 1744, 1769, and others, along with proposed standards for the longitudinal automated record and drug therapy documentation), NCPDP, ANSI X-12, DICOM, HL7, and ISO (8601, etc.).
No overlap or conflict exists since the relevant standards apply to a higher level of the CODASYL system architecture. Relevant ISO standards are required in this specification.
Documents and data dictionaries are being assembled from the standards organizations for harmonization: identical data names are used where possible, and cross mapping will be provided where commonality is not feasible. Harmonization is currently underway between DICOM, ASTM E31.19 and ASC MD156. ASC MD156 is also participating in ASTM E31.23 modeling.
Acquisition of the specification will be through normal publication routes by ANSI or the ADA. There is no license fee associated with the specification. However, ANSI or the ADA may charge for the publication of the specification and its implementation guides and concordances. The specification is expected to reduce cost of design and development of clinical information systems by providing a database blueprint and design metadata.