Page:United States Statutes at Large Volume 110 Part 3.djvu/293

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PUBLIC LAW 104-191—AUG. 21, 1996 110 STAT. 2023 "(M) The Federal Employees Health Benefit Plan under chapter 89 of title 5, United States Code. "(6) INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION. — The term 'individually identifiable health information' means £Uiy information, including demographic information collected from an individual, that— "(A) is created or received by a health care provider, health plan, employer, or health care clearinghouse; and "(B) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and— "(i) identifies the individual; or "(ii) with respect to which there is a reasonable basis to believe that the information can be used to identify the individual. "(7) STANDARD.— The term 'standard', when used with ref- erence to a data element of health information or a transaction referred to in section 1173(a)(1), means any such data element or transaction that meets each of the steuidards and implementation specifications adopted or established by the Secretary with respect to the data element or transaction under sections 1172 through 1174. "(8) STANDARD SETTING ORGANIZATION. — The term 'standard setting organization' means a standard setting organization accredited by the ii\merican Nationed Standards Institute, including the National Council for Prescription Drug Programs, that develops standards for information transactions, data elements, or any other standard that is necessary to, or will facilitate, the implementation of this part. "GENERAL REQUIREMENTS FOR ADOPTION OF STANDARDS "SEC. 1172. (a) APPLICABILITY.—Any standard adopted under 42 USC i320d-i. this part shall apply, in whole or in part, to the following persons: "(DA health plan. "(2) A health care clesuinghouse. "(3) A health care provider who transmits any health information in electronic form in connection with a transaction referred to in section 1173(a)(1). "(b) REDUCTION OF COSTS. — Any standard adopted under this part shall be consistent with the objective of reducing the administrative costs of providing and paying for health care. "(c) ROLE OF STANDARD SETTING ORGANIZATIONS. — "(1) IN GENERAL.— Except as provided in paragraph (2), any stemdard adopted under this part shall be a standard that has been developed, adopted, or modified by a standard setting organization. "(2) SPECIAL RULES. — "(A) DIFFERENT STANDARDS. —The Secretary may adopt a standard that is different from any standard developed, adopted, or modified by a standard setting organization, if— "(i) the different standard will substantially reduce administrative costs to health care providers and health pleuis compared to the alternatives; and