As of  2002, the standards processes for the Health Informatics Content and the Implementation of EHR systems for the market have two main foci: 1) the American National Standards Institute (ANSI: http://www.ansi.org/) for the domestic US market and 2) the International Standards Organization (ISO: http:// www.iso.ch and also http://www.astm.org/COMMIT/tc215.html) also working together with the International Electrotechnical Commission (IEC) in their Joint Technical Committee 1 (JTC1: http://www.jtc1.org) for international aspects. The general information technology standards are dealt with within ANSI by several mechanisms but the Healthcare conceptual content is dealt with by the Health Informatics Standards Board (ANSI/HISB)– now in September 2005 replaced by the Health Information Technology Standards Panel (HITSP) which has Standard Developer Organization (SDO) members as well as industry representatives, professional associations,  governmental agencies and some educational institutions who are all voting members. The viewer needs to understand how the standards system  works both in the United States and internationally. International standards are primarily created to enhance international trade and thus are more closely linked to specific markets and products or to intergovernmental agreements with respect to trade issues. This influences such standards to be more general and less specific. International standards are created by national delegations and tend to be influenced by national government’s positions and policies. In a contrary fashion, standards in the United States are open and voluntary.  They are participated in by various professional disciplines and individuals in addition to participants from the various industrial segments. Informatics standards for the EHR in the United States are instances where health professional disciplines have been major participants. The objective for these participants is to give industry clear targets for functional characteristics of EHR systems through common conventions included in documents  with various scopes and specificity such as : Guides, Practices, Specifications. The standards  participants described in this segment have helped bring the EHR to its present state of affairs and this Section of the EHR Status Segment of the EHR Web site describes how the Standards Bodies have contributed to its present state.

The ANSI Health Informatics Standards Board (HISB) came to be as a result of a ten year period of work which culminated in 1996 with the formation of the Board, now replaced in September 2005 by HITSP. Largely, the beginning of work on health informatics standards started in 1972 with the formation of the ASTM Technical Committee E-31 on Healthcare Informatics, then known as “Computerized Systems”. In 1984 and early 1985 it grew from an emphasis on industrial and clinical laboratory instrumentation information systems to include health and patient care record subjects. In 1987 HL7 (Health Level Seven) was formed to deal with intra-institutional messaging and the National Electrical Manufacturers Association (NEMA) formed the Digital Imaging and Communications Standards  working group (DICOM). These groups formed a transient ad hoc group called the Health Informatics Standards Coordinating Committee (HISCC) until the American National Standards Institute (ANSI) authorized the temporary Health Informatics Standards Planning Panel (HISPP) in 1992. HISPP lasted until fall 1995 when the permanent  HISB was formed, effective in 1996. See www.ansi.org/standards_activities/standards_boards_panels/hisb/overview.aspx?menuid=3

 

Because the role of a Standards  Board is coordination of standards development rather than development of standards themselves, the development of standards is done by ANSI accredited Standards Developer Organizations (SDOs) and these organizations are members of both ANSI and ANSI HITSP and have voting  status in  HITSP along with the other members which include professional specialty organizations, industrial organizations and governmental agencies. Another HITSP role  is the dissemination of information about the availability, use and impact of the standards that have been developed. Understanding the purpose, organization and strategic objectives of ANSI HITSP will be found at its Website noted above. The range of standards work in Health Informatics is best understood by looking at the activities of the SDO members. The usage of EHR capabilities by the professional specialties, the activities, products and services of industry and their consortia and the ways that the educational programs are addressing the understanding of the EHR and its role in healthcare are both best addressed by understanding of how voluntary American National Standards for Health Informatics will shape the EHR. This requires understanding the self-defined scope of activities and the perspectives of the HITSP/HISB participants. The following is that Board’s statement in an extract from HISB Draft Strategic Plan: HISB 87 (revised) June 1999.

I. Scope:
  1. Coordinate standards development through a Health Informatics Standards Taxonomy and a coupled standards development plan for:
  1. Educate and Disseminate:

II. VARIOUS BUSINESS PERSPECTIVES OF HISB PARTICIPANTS:

ANSI HISB is an organization which provides informatics standards for health professions and businesses by means of participating ANSI Accredited Standards Developer Organizations. Its products are useful informatics standards that are used through out the healthcare sector to attain benefits from information science in carrying out its healthcare mission. The perspectives relevant to the HISB’s role and its Strategic Plan for fully exercising that role are the following:

Patient perspective:

By improving the ability of public administrations, of research centers studying medical effectiveness and of healthcare professionals to share critical information, standards in healthcare telematics and informatics can improve the health of individual patients. This will mainly be achieved by making the largely local healthcare provider organizations more effective.

Healthcare professional perspective:

Standards facilitate the interaction of healthcare professionals, between various professions, geographical areas and even cross-border. The critical capability is clinical decision support which will enable more effective and economic care of the individual patient within the immediate practice setting. Also, more and more will be seen of an emerging market for specialized assistance in interpreting the condition of an individual patient using experts from other areas. One example is for the evaluation of very rare diseases where telemedicine is employed to transfer histopathological images to a remote "super-expert" for judgment, often as a second opinion only. This capability is only one aspect of a continuum of information support for the practitioner in whatever setting he/she may practice. Healthcare professionals will need to master more of the basic underlying concepts in health informatics in order to clearly state functional requirements for ICT products and services and be an educated consumer in the market.

Healthcare provider perspective:

Healthcare services and systems are highly complex. There is much room for informatics to improve the effectiveness and efficiency of services by providing information when and where required for automation of routine tasks, support of decisions in clinical care, involvement of ancillary disciplines, elimination of delays and avoiding duplication of labor. The purpose of health informatics standards is to enable improvements in services, not to standardize healthcare delivery. Improvements in services occur through better support of Healthcare Professionals in their care for patients as well as through better management of resources. Improvements in efficiency and effectiveness will lead to lower costs for the provider and to better care and improved outcomes of care for patients.

Healthcare ICT supplier perspective:

In conventional sectors of industry, standards are well known for increasing companies' market opportunities and for lowering the cost of equipment and services to users. The same argument holds for the field of healthcare informatics. However, it also holds a major potential for effective application of scientific knowledge to the health of individuals and populations as well as better use of skills and knowledge disciplines. Agreement on common requirements for information systems will reduce the cost of healthcare information systems and open up the market through interoperability. A critical component of the healthcare information domain is common content conventions (data structures, data representations, behaviors) as well as common implementation conventions (that utilize national and international best recommended practices in engineering information systems). Internationally, as well as nationally, ICT common conventions are being applied not only to products but also process, resource and customer aspects. The supplier will benefit from all of these aspects. The complexity of healthcare information flow requires "horizontal" links between software designed to do different tasks (e.g. between GPs and hospitals). In addition, common conventions (standards) enable "vertical" links between suppliers, creating chains of added value (e.g. either through specialty supporting services such as the clinical laboratory, image management, or pharmacy or between the suppliers of software components and system integrators), based on specialization and division of labor and economies of scale. Such supplier chains are found in all "mature" industries. These are all additional aspects of the implementation of common content in healthcare.

The major changes in healthcare that have for years been evolving have only recently sparked the realization of the inadequacy of the entire healthcare information domain. The PL 104-191 (HIPAA of 1996) legislation has brought recognition that these changes are unavoidable and must occur. These changes will be a general market incentive. Generally, industry welcomes international open markets without barriers but it should be recognized that it is mainly large enterprises that can utilize the global market. Many smaller suppliers, common for instance as developers of GP information systems, only operate on a domestic market or through major suppliers but a consistent set of US National standards should serve those suppliers also. As the Computer Science and Software Engineering disciplines, and their educational and credentialing processes, address the formal recognition of their professions, recognition of that body of knowledge will improve all of the healthcare ICT suppliers’ abilities to develop and market quality products and services to the healthcare community.

Healthcare payment body perspective:

Standards for healthcare reimbursement messages have had a very large impact already. It is clear that various national legislation and market situations means that large differences exist in the way payment bodies interact with the healthcare providers. Payment bodies have a strong interest in an increased efficiency of the healthcare provider organizations, and possibly their lower costs, but little direct interest in individual and population health status issues. These, however, are the prime concern of the professional organizations whereas payment bodies are mostly concerned with resource management. There should be little doubt that in some areas of healthcare informatics there are clear benefits of national/ possibly international standards that indirectly will be much appreciated by any payment body. Only by improved population health status will the indirect interest of the healthcare payment bodies be increased through the impact of improved healthcare status on resource management.

The healthcare authority perspective:

Standards in healthcare facilitate the task of healthcare authorities to collect information for planning of healthcare services and follow up of public health as well as the advancement of the medical sciences through various research clinical and pre-clinical. Another consideration that healthcare authorities may undertake is that standardized healthcare informatics is a requirement for a possible control of quality of care that may be deemed necessary from the point of view of public safety. Mandatory control and certification of information systems may become a reality for some classes of healthcare information systems, just as we have it for pharmaceuticals and medical devices today, if the proactive use of best recommended practices in software and systems engineering is not voluntarily adopted by information systems suppliers and users.

Information and Communication Technology Research Perspective:

The President’s Information Technology Advisory Committee Interim Report, released August 1998, (http://www.nitrd.gov/pubs/pitac/pitac-hc-9feb01.pdf) noted a major deficiency in Research and Development in ITC as well as a major role for ITC in health. Health uses of ITC is one of the most complex. Incentives for innovation in industry will depend upon the results of substantive research into both the fundamental and applied aspects throughout ICT. Innovative application of these findings to ICT products and services for healthcare will depend upon such research. The development of common conventions via voluntary consensus standards reveals the ambiguous areas and suggests research needed to resolve them. This perspective will therefore be a major forcing function for creating the capabilities needed in a robust health information domain.