ANSI - American National Standards Institute
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Patient Safety Legislation Supported by Voluntary Standards

Interoperability technology can be key to efficiency and safety in health care

New York, Nov 08, 2002

Thanks in large measure to the successful implementation of the National Technology Transfer and Advancement Act (NTTAA), government agencies have increasingly participated in the private-sector standards development process and relied upon private-sector voluntary standards as an alternative or supplement to regulatory rule making. A bill currently moving through the legislative process that would amend the Social Security Act to improve patient safety calls for the use of voluntary national standards to achieve its directives.

H.R. 4889, Patient Safety Improvement Act of 2002, was introduced in the House of Representatives by Rep. Nancy Johnson (R-CT) on June 6, 2002, went through the Committee on Ways and Means and the Committee on Energy and Commerce, and then was discharged October 11 to the Committee of the Whole. The bill would add a new section, "Part D - Patient Safety Improvements," to the end of Title XI of the Social Security Act to provide for voluntary reporting to the Secretary of Health and Human Services of patient safety data. In order to reduce medical errors and improve patient safety and health care quality, the bill aims to establish mechanisms to analyze patient safety data and system changes adopted by patient safety organizations and health care providers.

The bill also calls for the establishment of a Medical Information Technology Advisory Board (MITAB), which would be responsible, among other things, for documenting best practices in medical information technology and recommending methods of implementing health care information technology interoperability standards. The bill specifically states that the chairman of the Board "shall be an individual affiliated with an organization having expertise creating American National Standards Institute (ANSI) accepted standards in health care information technology."

According to Sally Seitz, ANSI program administrator and secretary of the ANSI Healthcare Informatics Standards Board (HISB), numerous organizations are working together to develop guiding principles to be used by standards development organizations in the health care sector. "The HISB provides an open, public forum for the voluntary coordination of healthcare informatics standards among all United States standard developing organizations," Seitz explained. "Included in the scope of the HISB is support of the development of standards for the interchange of healthcare data, healthcare terminology and codes, and privacy, confidentiality and security of health care information."

The Patient Safety Improvement Act also calls for the development or adoption of voluntary, national standards that promote the interoperability of health care information technology systems across all health care settings. ANSI-accredited standards developers already working in this subject area include HISB members ANSI-Accredited Standards Committee (ASC) X12, a developer of standards for cross-industry electronic exchange of business information, and HL7, an ANSI-accredited organization that develops standards for electronic patient information records.

Seitz also indicated that the Health Industry Business Communications Council (HIBCC), an ANSI member and accredited standards developer, is currently revising an American National Standard that is an example of a technology-driven solution to improvement of health care delivery. The Health Industry Bar Code (HIBC) Supplier Labeling Standard (ANSI/HIBC 2-1997) is an effort to promote interoperability by encouraging labelers or manufacturers of health care products to identify their products with consistently scannable bar code symbols in accordance with ANSI/HIBC 2-1997. The standard describes data structures and bar code symbologies for bar coding health care products and includes the HIBC-LIC data format, which is a variable length alphanumeric format for primary identification of health care products, as well as formats for secondary information such as batch number and expiration date. The standard will be periodically modified to incorporate the advantages of the new technologies as they become widely available.

Both HR 4889 and the ANSI/HIBC standard reveal how voluntary standards in the public and private sector promote and protect public interest and safety. "By looking to the private sector for voluntary standards that fit government needs, government agencies avoid duplication and the waste of valuable resources," said ANSI president and CEO Dr. Mark Hurwitz. "We are confident that ANSI's accredited standards developers in the medical technology field will continue to make valuable contributions to public health and safety."

ANSI Nanotechnology Standards Panel