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Comp 9 - Unit 7 - Supporting Standards

Covering items and entities involved in dealing with supporting standards of EHR applications.
HL7 CCOW Standard
CCOW: Clinical Context Object Workgroup: an HL7 standard protocol designed to enable disparate applications to synchronize in real-time, and at the user-interface level. It is vendor independent and allows applications to present information at the desktop and/or portal level in a unified way.

- is a VIM. Current version of CCOW is v1.5

- CCOW Provides two discrete functions: Facilitates a process called context management that links subjects to applications, and provides single sign on that enables secure access of disparate applications by a user.
Clinical Decision Support: applying knowledge to data to provide information to the user. With CDS, we apply information technology to address, in a systematic manner, questions (and other information needs) that arise during patient care and clinical research.
Clinical Decision Support System
Types of CDSSs
- Arden Syntax, GELLO: knowledge reference framework and knowledge representation

- GLIF, GEM, ASTM: Clinical guidelines

- Infobutton (HL7)

- Disease Management Protocols

- Evidence-Based Care Plans
Arden Syntax
CDSS that arose from the need to make medical knowledge available for decision-making at the point-of-care; to make the knowledge and logic explicit; to allow sharing within and between institutions; and to standardize the way medical knowledge is integrated into health information systems.

- name adopted from Arden House, an estate originally owned by E.H.Harriman in Orange County, New York.

- moved to ASTM in 1992; transferred to HL7 in 1999. Current version is 2.7 and uses XML.

- The Arden Syntax is a guideline representation model that easy to use and has considerable power.

- One of the complaints of Arden Syntax is that it does not handle complex expressions, particularly those involving timing such as intervals after other events
American Society for Testing and Materials: an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. The organization's headquarters is in West Conshohocken, Pennsylvania.
Medical Logic Module: an Arden Syntax text document identifying appropriate data elements engaged in the logic, the logic expressions, and the actions to be taken during a given event. MLMs are called by an event monitor when the condition they are written to help occurs.
- Arden Syntax container for MLM statement storage as ASCII files.

- Slots are made up of a slotname and slotbody.

- Slots are grouped into three categories: Maintenance, Library and Knowledge. Maintenance identifies the MLM, versions, authors, etc.; Library includes purpose, name and keywords; and Knowledge holds a logic algorithm by which the knowledge is expressed.
Example of a Maintenance Slot
• Title Contrast CT study in patient with renal failure
• MLM Name: ct_contr.mlm;;
• Arden syntax version: 1.00;;
• Institution: Duke Medical Center;;
• Author: Dr. John Doe, M.D.;;
• Specialist: Dr; John Doe, M.D.;;
• Date: 2010-09-11;;
• Validation: testing;;

Note the syntax of the slot. Name tags are terminated by a colon (:) and contents are terminated by double semicolons (;;).
Example of a Library Slot
• Purpose: To alert the health care provider of new or worsening serum creatinine level;;
• Explanation: If the creatinine is at or above a threshold (1.35 mg/dl), then an alert... ;;
• Priority (optional) - not included in this example;;
• Keywords: renal insufficiency; renal failure ;;
• Citations: Proceedings of the Fifteenth Annual Symposium on Computer Applications in Medical Care; 1991 Nov 17-20; Washington, D.C. New York: IEEE Computer Society Press, 1991.
• Links: URL "NLM Web Page",

Note the syntax of the slot. Name tags are terminated by a colon (:) and contents are terminated by double semicolons (;;).
About Knowledge Slots
The knowledge slot contains:

Type - coded and required. Presently only data-driven type is defined. This type requires these additional slots be defined:
• Data - structured,
• Priority - coded, optional,
• Evoke - structured,
• Logic - structured,
• Action - structured, and
• Urgency - structured.

Action is an action produced when the logic slot concludes true.
About Data Slots
- The data slot identifies what data is involved in the logic and decision-making, and must be matched to the terms contained within the application database.

- The required data elements are identified within a set of "curly brackets" ({}), causing a major problem for Arden Syntax with semantic interoperability.

- a read command is used to obtain a value for the identified data element.
Read commands
- a read command is used to obtain a value for the identified data element inside a data slot.

- A read statement without an operator will contain a list of data elements that obtains a list of all values for that data element from the database.
The read statement with an operator returns a single value.

- Typical operators include first, last, minimum, maximum, count, average and sum.
About Evoked Slots
The evoked slot will trigger the logic operation of an MLM.

Examples of triggers include:
• The occurrence of an event.
• Timed execution after an event,
• Periodic repetition after an event, and
• Direct call from another MLM.

In short, the alarm clock/trigger for events to occur.
About Logic Slots
- contains a logic expression and ends with a conclude statement. The logic slot specifies the medical criteria by using a logical algorithm, and ends with a conclude statement. (e.g.: IF...THEN, DO...WHILE, FOR loops like FOR...WHILE...DO)
Call Statements
Call Statements (found in Action Slots) permit linking to other MLMs including passing parameters.

Examples of Call Statements are:
var1 := call my_mlm with param1, param2;
var1 := call my_event with param1, param2;
var1 := call my_interface_function with param1, param2;
About Action Slots
The action slot defines the action to be taken. Examples include:

Write message to screen;
Store a message in a file; and
Call another medical logic module (MLM).
About Urgency Slots
The urgency slot defines the importance of the action. The urgency may trigger different paths for the message - i.e. a page, a call, or an e-mail.
About Clinical Practice Guidelines (with regard to EHRs)
- Clinical practice guidelines serve to reduce inappropriate variations in practice, to improve patient safety, to improve health care, and to reduce costs.

- the importance of guidelines is well-accepted, but the use of guidelines is still limited. Guidelines are a part of meaningful use.

- Benefits of guidelines include the ability to provide automatic decision support that can be applied to individual patients, and to perform retrospective analysis to test if patients were treated appropriately.

- Guidelines must show the underlying logic when queried. This explanation is most often expressed as a block diagram, or flow diagram, showing data requirements and decision points.

- Guidelines are based on an expressive decision model. Inputs and outputs must be clear in specifying the work to be accomplished. Actions must be expressive, complete, and clear. Data must be interpreted correctly. Guidelines are also used to generate alerts and reminders.

-Guidelines must include the authoritative source for the decision logic - a literature reference, the guideline expert source, or other authority.
Challenges of sharing Guidelines
- Local adaptation of guidelines including
Availability of resources and expertise,
Local workflow issues, and Practice preferences.

- Integration with local information systems by matching patient data from EHR to GL, and by matching recommendations in guideline to actions in order-entry systems (or matching of data elements identified in the shared guideline and the local setting).

- Dissemination formats.

- Overcoming the stigma of "cookbook medicine."
Virtual Medical Record: extracted data from a local system into a mapped data position defined by a guideline.

- there is a risk of loss of information using vMRs.
National Guideline Clearing House (or NGC - Nat'l Guideline Clearinghouse): is a public resource for evidence-based clinical practice guidelines.

- sponsored by AHRQ (Agency for Healthcare Research and Quality), which is part of the U.S. Department of Health and Human Services (HHS).

- AHRQ currently supports two major projects in developing guidelines, in representing knowledge in guidelines, and in distributing guidelines.
Types of Guideline Representation Models
Arden Syntax
A guideline representation model that represents guidelines as a set of protocols within which actions are encoded.

Uses state transition for decision-making. Somewhat similar to Asbru's condition-preference model.
A guideline representation model that uses activities, actions and provides advice as a patient scenario and discusses activity states.

Uses decision steps like GLIF for decision-making, but is also somewhat similar to PROforma, GUIDE, and PRODIGY's decision model.
A guideline representation model that uses an enquiry action for information collection.

Uses decisions like GUIDE and PRODIGY.
Are all guideline representation models CDSSs?
Not exactly. CDSSs use integrated guideline representation models and models can be built up into CDSSs but the terms aren't quite synonymous.
A guideline representation model that represents guidelines as a set of protocols within which actions are encoded.

Uses condition-preference for decision-making. Somewhat similar to DILEMMA's state-transition model.
A guideline representation model that has a wait action as its knowledge representation is in the form of Petri nets.

Uses decisions like PROforma and PRODIGY.
A guideline representation model that uses activities, actions and provides advice as a patient scenario and discusses activity states.

Uses decisions like PROforma and GUIDE, but is also somewhat similar to EON and GLIF's decision steps model.
- GuideLine Interchange Format: a popular format for sharing clinical guidelines independent of platforms and systems.

- based on an object-oriented logical model of concepts, and uses XML syntax. It is an executable model.

- developed by Dr. Bob Greenes and colleagues.

-Attempts to promote GLIF as a guideline executable standard failed because of the inability to get agreement among several models. GLIF serves only as a model today. Further development has been discontinued.

- The GLIF model, similar to Arden Syntax, identifies the title of the guideline and the author. Also similar to Arden Syntax, the model includes decision steps, action steps, branch steps, synchronization steps, and a patient sleep step.
GuideLine or GuideLines
Clinical Decision Support Work Group: HL7 group that group supports the HL7 mission to create and promote its standards by working on issues related to single-patient-focused health care decision support messaging.
Health Level 7: a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services.

- "Level Seven" refers to the seventh level of the International Organization for Standardization (ISO) seven-layer communications model for Open Systems Interconnection (OSI) - the application level.
American National Standards Institute: ANSI is the official U.S. representative to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC). ANSI is also a member of the International Accreditation Forum (IAF)
- a popular class-based object-oriented programming language and a relative of the Object Constraint Language (OCL).

-GELLO creates the potential for many decision support options, as the full array of atomic patient data is greatly accessible to complement better, safer clinical decision making by health professionals.

- Standardization of GELLO it has made this language compatible with the HL7 version 3.0 Reference Information Model (RIM). GELLO uses an abstract "virtual medical record" (vMR) so that the same GELLO code can run on multiple systems accessing data stored in different formats. The vMR is a simplified view of the HL7 RIM.

- GELLO Release 2 was completed and approved by ANSI in June 2010. The GELLO specifications have been developed in coordination with the HL7 Clinical Decision Support TC (CDSTC)

• A declarative language,
• Extensible,
• Vendor independent,
• Platform independent,
• Object-oriented and compatible with vMR,
• Easy to read/write,
• Side-effect free, and
• Flexible.

- GELLO uses the basic data types: Boolean, real, integer and string.
Guideline Elements Model: developed at Yale University, Center for Medical Informatics, by Dr. Rick Shiffman. It is now an ASTM standard and has continued to be developed.

- uses XML and an XML editor called the GEM cutter.

- is defined as a DTD (Document Type Definition)
Document Type Definition: defines the legal building blocks of an XML document. It defines the document structure, with a list of legal elements and attributes. A DTD can be declared inline inside an XML document, or as an external reference.
Object Constraint Language: a well-developed constraint language that makes it an attractive use as an expression language.

- developed by the Object Management Group (OMG).
Refined Message Information Model: views or diagrams which are designed to capture all required information for the efficient processing and review of regulatory submissions and to explain what each message consists of.

- Used in GELLO expression language
Reference Information Model (ISO HL7 21731): the cornerstone of the HL7 Version 3 development process and an essential part of the HL7 V3 development methodology.
Backus-Naur Form syntax: syntax used in GELLO expression language.
Context-aware knowledge retrieval tool for clinical information systems (CIS), such as electronic health record (EHR) and personal health record (PHR) systems.

- used to help answer patient questions; On the average, physicians will have two questions for every three patients seen. These questions deal with treatment for specific problems, related to a diagnoses, related to a medication, or other. About 50% of these questions go unanswered.

- a key standard, originally developed at Columbia University, by Dr. Jim Cimino and others, and now being developed as an HL7 standard. Infobuttons are also being implemented by vendors.

- implementations are XML or URL based for the HL7 Infobutton. Standard languages supported include: RxNorm, LOINC, SNOMED CT, and MeSH. The URL can be automatically derived from the XML message. Free text is an option.
Service-Oriented Architecture: a set of principles and methodologies for designing and developing software in the form of interoperable services.
Simple Object Access Protocol, is a protocol specification for exchanging structured information in the implementation of Web Services in computer networks. It relies on Extensible Markup Language (XML) for its message format, and usually relies on other Application Layer protocols, most notably Hypertext Transfer Protocol (HTTP) and Simple Mail Transfer Protocol (SMTP), for message negotiation and transmission.
Computer Physician Order Entry: the process of electronic entry of medical practitioner instructions for the treatment of patients under the clinician's care. These orders are communicated over a computer network to the medical staff or to the departments (pharmacy, laboratory, or radiology) responsible for fulfilling the order.

- CPOE systems need to be patient specific, considering patient demographics (age, gender, other), site specific, disease specific, and event specific.

- CPOE systems often include healthcare plans to influence what tests are ordered and what treatments are given.
- becoming prevalent in developed countries.
a CPOE system continuously developed by Department of Biomedical Informatics (DBMI) faculty working with Informatics Center Staff and trainees at Vanderbilt University Medical Center (VUMC) since 1994.
Decision trees
- popular ways of using statistics and probabilities to guide decision making.

- Decision nodes are represented by a box; chance outcomes by a circle.

- The tree shows the set of possible outcomes, each of which would have an assigned value. The tree would lead to an action that selected the highest outcome value.
Patient Preference
- an important factor when selecting a course of clinical action.

- only the patient can make these decisions, hopefully after being informed and educated about the possible decisions. e.g.: Some people would select length of life over quality of life; others would do the opposite.
Evidence-based practice
- results from clinical trials, data mining and expert opinions documented in the literature.

- evidence-based medicine are traditional conceptualizations based on research utilization, clinical trials-based, and clinical practice guidelines.
17 years
Clinically, the length of time from the discovery of new knowledge to routine bed-side use.
Clinical Translational Science Act (or Award; sometimes CTSI, I= Initiative): program(s) that attempt to speed up the 17 years clinical delay between discovery and bed-side use.
Cochrane Database of Systematic Reviews
a popular source of (web) information that can be linked through the Infobutton.
RCRIM Work Group
Regulated Clinical Research Information Management Working Group: supports the HL7 mission to create and promote HL7 standards by developing standards to improve or enhance information management during preclinical research, clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.

- The Work Group defines messages, document structures, terminology and semantics to support the systems and processes used in the collection, storage, distribution, integration and analysis of such information.

- Members of this group include CDC (Center for Disease Control), FDA (Food & Drug Administration), EMEA (European Medicines Agency), ICH (International Conference on Harmonisation) as well as the usual set of stakeholders in HL7.
Regulatory and Regulated Standards
- Domain: Public Health: Individual Case Safety Report (ICSR) & Generic Incident Notification (GIN)

- Domain: Regulated Products: Structured Product Labeling (SPL), Regulated Product Submission (RPS), & Common Product Model (CPM)

- Domain Regulated Studies: Annotated ECG (aECG), Clinical Trial Laboratory (CT Lab), & Stability Study
- Web site that provides high quality information about marketed drugs. This information includes FDA labels (package inserts).

- is a national repository of the National Library of Medicine (NLM)

- DailyMed serves as the official source of approved labelling for prescribing physicians, patients and healthcare providers and is based on HL7 Clinical Document Architecture (CDA) and is computer readable
Structured Product Labeling: standard in which the US HHS Directive means to develop a standard for communicating the content of drug product labeling in both a human and machine-readable format to serve as the basis of a national repository and to create a national repository of all current approved labeling on National Library of Medicine DailyMed website .

- notes potential adverse effects in drugs.

- SPL version 3 complies with new FDA Physician Labelling Rule, and includes an encoded highlights section, among other features.

- SPL v3 is mandatory in the US for all new indications and efficacy supplements (with multi-year phase-in for remaining types of labelling applications).
Regulated Product Submission: standard is for conveying product information to regulatory authorities.

- It is used globally (developed by HL7 and ISO) with input from ICH. RPS can carry an ICH Common Technical Document (CTD) submission and other submission types for drugs, device, veterinary products, food additives and other regulated products.
Common Product Model: this domain information model is a HL7 generic standard for dealing with a variety of (non-standardized) products.
Visual Integration Messages: an interoperability specification for visual integration of applications that allows users to experience an integrated computer-user session on the desktop.

- CCOW is a VIM.
Context Management
- uses subjects of interest, such as user, patient, clinical encounter, image, lab report, charge item, etc. to virtually link applications so that an end-user sees them operate in a unified, cohesive way.

- context management is valuable for both client server and web based applications.

- used in CCOW.
Single Sign On
- works closely with content management to enable the user to identify a subject, i.e. a patient, and have access to all applications containing information about the selected subject to which the user has access.

- Single Sign On eliminates the user from having to log on to multiple systems, enter patient ID and request certain information. The end result is an aggregated view of all patient information across disparate applications.
Areas where Standards are being implemented
- Entity Identification (to manage and maintain identities within and across domains, localities, or products)

- Record Location & Retrieval (to discover, retrieve, and update records in distributed environments)

- Decision Support Services (to support evaluation processes such as clinical decision support)

- Terminology Service (to retrieve, maintain, and navigate [clinical] terminologies and ontologies)
Ontology (as used in information science)
- An ontology formally represents knowledge as a set of concepts within a domain, and the relationships between those concepts. It can be used to reason about the entities within that domain and may be used to describe the domain.

- Ontologies are the structural frameworks for organizing information and are used in artificial intelligence, the Semantic Web, systems engineering, software engineering, biomedical informatics, library science, enterprise bookmarking, and information architecture as a form of knowledge representation about the world or some part of it.

- The creation of domain ontologies is also fundamental to the definition and use of an enterprise architecture framework.
New specifications (or standards) can be used in...
- Inter-Enterprise (such as NHIN, RHIOs)
By functionally specifying behavior, roles between applications and products are clarified, and the technologies supporting them can be profiled and sharpened.

- Intra-Enterprise
Standardization on functionality allows for better integration of off-the-shelf and custom development environments, and promotes more of a "plug and play" environment.

- Intra-Product
Facilitates vendors' ability to integrate third-party value-add components and speed up the design phase with higher confidence.

- Custom-Implementation
Affords organizations wishing to custom-develop the opportunity to later integrate off-the-shelf.
Nationwide Health Information Network: an initiative for the exchange of healthcare information being developed under the auspices of the ONC.
The Office of the National Coordinator for Health Information Technology: a staff division of the Office of the Secretary, within the U.S. Department of Health and Human Services. It is primarily focused on coordination of nationwide efforts to implement and use health information technology and the electronic exchange of health information.

The position of National Coordinator was created in 2004, through an Executive Order, and legislatively mandated in the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009.
Health Information Technology for Economic and Clinical Health Act: enacted as part of the American Recovery and Reinvestment Act of 2009, (Subtitle D) addresses the privacy and security concerns associated with the electronic transmission of health information. The HITECH Act requires HIPAA covered entities to report data breaches affecting 500 or more individuals to HHS and the media, in addition to notifying the affected individuals.
Health Insurance Portability and Accountability Act of 1996: enacted by the United States Congress and signed by President Bill Clinton in 1996. Title I of HIPAA protects health insurance coverage for workers and their families when they change or lose their jobs. Title II of HIPAA, known as the Administrative Simplification (AS) provisions, requires the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers.
American Recovery and Reinvestment Act of 2009: commonly referred to as the Stimulus or The Recovery Act, is an economic stimulus package enacted by the 111th United States Congress in February 2009 and signed into law on February 17, 2009, by President Barack Obama.

To respond to the late-2000s recession, the primary objective for ARRA was to save and create jobs almost immediately. Secondary objectives were to provide temporary relief programs for those most impacted by the recession and invest in infrastructure, education, health, and 'green' energy. The approximate cost of the economic stimulus package was estimated to be $787 billion at the time of passage, later revised to $831 billion between 2009 and 2019.[citation needed] The Act included direct spending in infrastructure, education, health, and energy, federal tax incentives, and expansion of unemployment benefits and other social welfare provisions. The Act also included many items not directly related to economic recovery such as long-term spending projects (e.g., a study of the effectiveness of medical treatments) and other items specifically included by Congress (e.g., a limitation on executive compensation in federally aided banks added by Senator Dodd and Rep. Frank).
Regional Health Information Organization: also called a Health Information Exchange Organization, is a multi-stake holder organization created to facilitate HIE among stakeholders of that region's healthcare system. The ultimate objective is to improve the safety, quality, and efficiency of healthcare as well as access to healthcare through the efficient application of health information technology.

- RHIOs are also intended to support secondary use of clinical data for research as well as institution/provider quality assessment and improvement.

- RHIO stakeholders include smaller clinics, hosptials, medical societies, major employers and payers.

- RHIOs are intended to be key to the proposed US Nationwide Health Information Network (NHIN).
Health Information Exchange: the transfer of healthcare information electronically across organizations.
Types of Entity Identifiers (standardized items used to identify specific entities)
- Person Identifier
- Provider Identifier (National Provider Identifier [HIPAA][NPI] & ISO)
- Facility Identifier
- Employer Identifier
- Health Plans Identifier
- Master Patient Index (local, regional, & national)
- Record Locator Service
Types of Patient Identifiers
• Social Security Number,
• Medical Record Number,
• Patient Surname,
• Patient Given Name,
• Gender,
• Telephone Number,
• Zip Code,
• City,
• Date of Birth year, month, day,
• Next of Kin Surname, Given Name, and
• Physician Surname, Given Name.
Master Patient Index: Index systems that are necessary to locate a patient, particularly if the patient has multiple numbers across many systems. A clinic may assign one number, the hospital another number, an employer another number, and the insurance plan another number. The MPI links all of these numbers together.

The MPI contains required data to identify and distinguish the patient across healthcare facilities and levels; includes some patient demographic data; may include multiple identifiers the patient is assigned across various facilities; and has a primary identifier.

The MPI may also provide a linkage to other family members. Issues of privacy and security are factors in designing and accessing MPIs.
Clinical Genomic Work Group
This group supports the HL7 mission to create and promote its standards by enabling the communication between interested parties of the clinical and personalized genomic data. The focus of clinical genomics work is the personalization (differences in individual's genome) of the genomic data and the linking to relevant clinical information.

This Work Group will facilitate the development of common standards for clinical research information management across a variety of organizations -- including national and international government agencies and regulatory bodies, private research efforts, and sponsored research -- and thus the availability of safe and effective therapies by improving the processes and efficiencies associated with regulated clinical research.
R-MIMs, D-MIMs, and RIMs
Refined Message Information Models (R-MIMs) are used to model specific case scenarios within the HL7 V3 standard.

The Domain Message Information Model (D-MIM) is a subset of the HL7 V3 RIM model, and is used to create messages for a particular domain. It includes a fully expanded set of class clones, attributes and relationships.

The HL7 Reference Information Model (RIM) represents a static model of healthcare workflows as viewed by the HL7 standards development group. The RIM is the ultimate source from which all HL7 version 3 standards draw their information-related content. Its structure is both flexible and extensible, and it can be readily mapped to the HL7 2.x message standard and other healthcare dataset specifications.

-Each R-MIM is a subset of the D-MIM, and a D-MIM is a subset of the RIM.

- The R-MIM contains only those classes, attributes, and associations required to compose the specific set of messages or documents.

The HL7 V3 rules require that all information structures in derived models be traceable back to the RIM. Their semantic and related business rules should not conflict with those specified in the RIM. The RIM therefore is the ultimate source for all information content in HL7 V3 standards. D-MIMs and R-MIMs are simply constraints on the RIM.
- CDISC Study Data Tabulation Model: defines a standard structure for human clinical trial (study) data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).

- SDTM is used by the Clinical Genomics Work Group.

- v1.3 of SDTM will soon be released.

- The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
- Common Model Element Types (CMETs) are part of the HL7 standard and apply to projects using the HL7 Development Framework (HDF).

- CMETs are derived from a Serializable Information Model at the Logical Perspective.

- A CMET is a reusable model and design pattern.

- used by the Clinical Genomics Work Group and the Clinical Genomics Standard.