Lesson 2



Please read your lesson below and then proceed to assignment two.  After reading this lesson you will understand why standards in healthcare are important, what organizations are active in the development of standards, and what aspects of medical information management are supported today by standards.

      Standards in Medical Informatics


A standard comprises of a set of rules and definitions that specify how to carry out a process or produce a product.  Standards were created and used to make things or processes work more easily or sometimes to work at all.  Hardware and software components depend on standards for exchanging information. 

The first computers were built without standards; however, hardware and software standards quickly became a necessity.  The first standard computer language, COBOL, was written to simplify program development but it was also adopted as a way to allow sharing of code and development of software components that could be integrated.  As a result, COBOL was given official standard status by the American National Standards Institute.  

The Need for Standards in Informatics

Historically healthcare facilities consisted of loosely connected independent units.  In the various independent units/ancillary departments, patients are treated across primary, secondary, and tertiary care settings, with little bi-directional communication and coordination among services.  Patients are also cared for by primary care physicians, as well as by specialists.  Within the clinical setting ancillary departments such as radiology, laboratory, pharmacy, etc. functioned as detached units, performing their tasks as separate service units.  Reimbursement requires patient information that is often derived through a different process, based on fragmented data collected in the patients medical record and abstracted for billing purposes.  The resulting set of diagnosis and procedure codes are often incorrect/does not correspond to the patient's original information.

The goal of healthcare organizations is an integrated delivery system; however, to meet this goal standardized identifiers for individuals, healthcare providers, health plans, and employers must be put into place so that such participants can be recognized across systems.  Unfortunately, choosing an identifier is a complicated task.  However, the Healthcare Financing Administration has defined a National Provider Identifier (NPI) that will likely become the national standard.  This number is a seven-character alphanumeric base identifier with a one-character check digit.  Each number is unique and it is never reissued.   

There is also a need for standards for encoding data about patients that are collected by one system and used by another.  For example a pharmacy records information about patients, allergies to medication, a laboratory system records information with regards to patient kidney function tests, and a radiology system records the x-ray requested by a doctor.  Systems need ways to store this data to present the data to clinical users, to send warnings about possible disease-drug interactions, etc.  The coding of clinical knowledge using an accepted standard would allow many people and institutions to share the work done by others.  

The Process of developing Standards

There are four ways to develop a standard:

1.  Consensus Method

2.  Government-mandate method

3.  Ad hoc method

4.  De facto method

Consensus Method - A group of volunteers representing interested parties works in an open process to create a standard.  Most healthcare standards use this method.  An example of a standard created using this process is the Health Level 7 (HL7) standard used for clinical data interchange.

Government-mandate method - A government agency such as the National Institute for Standards and Technology (NIST).  The NIST creates standards and also legislates its use.  An example of a standard created using this method would be HCFA's UB92 insurance-claim form.

Ad hoc method - A group of people and organizations (laboratory system and hospital system vendors) that agree on a standard specification.  The standards created using this method are informal and accepted as standards through mutual agreement of the  participating groups.  An example of a standard produced using this method would be the American College of Radiology/National Electrical Manufacturers Association DICOM standard for medical imaging. 

De facto method - When a vendor dominates the market and makes its product the market standard.  An example of a standard produced using this method would be Microsoft's Windows.

Organizations that develop standards

American National Standards Institute - A private nonprofit organization founded in 1918 that is responsible for approving official American National Standards (ANSI).  ANSI membership includes companies, government agencies, professionals, technical, trade, labor, and consumer organizations.  ANSI assists standard developers and user from the private sector and from government to reach consensus on the need for standards.  ANSI is the only government recognized system for establishing standardization.  

ISO Technical Committee 215 - Was created in January 1998 by the International Standards Committee. This committee was created to create standards in the filed of informatics to achieve compatibility and interoperability between independent systems.  This committee will also address issues required to ensure compatibility of data for comparative statistical purposes and to reduce duplication of effort and redundancies.

CEN Technical Committee 251 - Established by a European Committee for Standardization for the development of standards for healthcare informatics.  The purpose for this committee is to develop standards for communication among independent medical information systems so that clinical and management data produced by one system can be transmitted to another system.  This committee also works parallel in the United States through various working groups.  These groups deal with data interchange standards; medical-record standards; code and vocabulary standards; imaging standards; privacy, security, and confidentiality standards.  Standards that these groups are currently working on are: standards for interfacing reference laboratory systems to healthcare settings; for the transmission of electronic documents; and a message standard developed by Project Team 007 for transmitting content of electrocardiogram carts to computers.

Healthcare Informatics Standards Board - Established by ANSI in January 1992 to coordinate the work of the message standards group for healthcare data interchange and healthcare informatics to achieve the evolution of a unified set of non-redundant, non-conflicting standards.  In addition, a sub-committee was formed to interact with and to provide input to CEN TC 251  and to explore avenues of international standards development.


The Health Insurance Portability and Accountability Act of 1996.   Please click link to read about HIPAA :



Assignment 2