42 U.S.C. § 1320d — Definitions

Page 2746 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320c–20 1 So in original. Probably should be ‘‘Part’’. tions between Professional Standards Review Organiza- tions and administrative instrumentalities. Section 1320c–15, act Aug. 14, 1935, ch. 531, title XI, § 1166, as added Oct. 30, 1972, Pub. L. 92–603, title II, § 249F(b), 86 Stat. 1443; amended Oct. 25, 1977, Pub. L. 95–142, § 5(h), 91 Stat. 1189, related to general prohibi- tion against disclosure of data or information and ex- ceptions to such prohibition. See section 1320c–9 of this title. Section 1320c–16, act Aug. 14, 1935, ch. 531, title XI, § 1167, as added Oct. 30, 1972, Pub. L. 92–603, title II, § 249F(b), 86 Stat. 1443; amended Oct. 25, 1977, Pub. L. 95–142, § 5(i), (n), 91 Stat. 1190, 1191, related to limitation of liability of persons providing information to Profes- sional Standards Review Organizations and Statewide Professional Standards Review Councils. See section 1320c–6 of this title. Section 1320c–17, act Aug. 14, 1935, ch. 531, title XI, § 1168, as added Oct. 30, 1972, Pub. L. 92–603, title II, § 249F(b), 86 Stat. 1444; amended Dec. 31, 1975, Pub. L. 94–182, title I, § 112(c), 89 Stat. 1055; Oct. 25, 1977, Pub. L. 95–142, § 5(j), 91 Stat. 1190; Aug. 13, 1981, Pub. L. 97–35, title XXI, § 2113(j), 95 Stat. 795, related to authorization for use of funds for administering professional review program, transfer of moneys between funds, and pay- ments for Professional Standards Review Organiza- tions. See section 1320c–8 of this title. Section 1320c–18, act Aug. 14, 1935, ch. 531, title XI, § 1169, as added Oct. 30, 1972, Pub. L. 92–603, title II, § 249F(b), 86 Stat. 1444, related to technical assistance given to organizations desiring to be designated as Pro- fessional Standards Review Organizations. Section 1320c–19, act Aug. 14, 1935, ch. 531, title XI, § 1170, as added Oct. 30, 1972, Pub. L. 92–603, title II, § 249F(b), 86 Stat. 1445, related to exemptions of Chris- tian Science sanatoriums. See section 1320c–11 of this title. § 1320c–20. Repealed. Pub. L. 97–35, title XXI, § 2113(k), Aug. 13, 1981, 95 Stat. 795 Section, act Aug. 14, 1935, ch. 531, title XI, § 1171, as added Oct. 25, 1977, Pub. L. 95–142, § 5(d)(2)(D), 91 Stat. 1186, set forth provisions respecting Federal-State rela- tions regarding memorandum of understanding be- tween Organization and State agency. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF REPEAL Repeal applicable to agreements with Professional Standards Review Organizations entered into on or after Oct. 1, 1981, see section 2113(o) of Pub. L. 97–35, set out as an Effective Date of 1981 Amendment note under section 1396a of this title. §§ 1320c–21, 1320c–22. Omitted Editorial Notes CODIFICATION Sections 1320c–21 and 1320c–22 were omitted in the general revision of this part by Pub. L. 97–248, title I, § 143, Sept. 3, 1982, 96 Stat. 382. Section 1320c–21, act Aug. 14, 1935, ch. 531, title XI, § 1172, as added Oct. 25, 1977, Pub. L. 95–142, § 5(k), 91 Stat. 1190; amended Aug. 13, 1981, Pub. L. 97–35, title XXI, §§ 2113(l), 2193(c)(7), 95 Stat. 795, 827, related to an- nual reports submitted to Congress by Secretary. See section 1320c–10 of this title. Section 1320c–22, act Aug. 14, 1935, ch. 531, title XI, § 1173, as added Oct. 25, 1977, Pub. L. 95–142, § 5(l)(1), 91 Stat. 1191; amended Dec. 5, 1980, Pub. L. 96–499, title IX, § 923(e), 94 Stat. 2628, provided that medical officers in American Samoa, the Northern Mariana Islands, and the Trust Territory of the Pacific Islands were includ- able in program under former Part B. See section 1320c–12 of this title. PART C—ADMINISTRATIVE SIMPLIFICATION § 1320d. Definitions For purposes of this part: (1) Code set The term ‘‘code set’’ means any set of codes used for encoding data elements, such as ta- bles of terms, medical concepts, medical diag- nostic codes, or medical procedure codes. (2) Health care clearinghouse The term ‘‘health care clearinghouse’’ means a public or private entity that proc- esses or facilitates the processing of non- standard data elements of health information into standard data elements. (3) Health care provider The term ‘‘health care provider’’ includes a provider of services (as defined in section 1395x(u) of this title), a provider of medical or other health services (as defined in section 1395x(s) of this title), and any other person fur- nishing health care services or supplies. (4) Health information The term ‘‘health information’’ means any information, whether oral or recorded in any form or medium, that— (A) is created or received by a health care provider, health plan, public health author- ity, employer, life insurer, school or univer- sity, 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. (5) Health plan The term ‘‘health plan’’ means an individual or group plan that provides, or pays the cost of, medical care (as such term is defined in section 300gg–91 of this title). Such term in- cludes the following, and any combination thereof: (A) A group health plan (as defined in sec- tion 300gg–91(a) of this title), but only if the plan— (i) has 50 or more participants (as de- fined in section 1002(7) of title 29); or (ii) is administered by an entity other than the employer who established and maintains the plan. (B) A health insurance issuer (as defined in section 300gg–91(b) of this title). (C) A health maintenance organization (as defined in section 300gg–91(b) of this title). (D) Parts 1 A, B, C, or D of the Medicare program under subchapter XVIII. (E) The medicaid program under sub- chapter XIX. (F) A Medicare supplemental policy (as de- fined in section 1395ss(g)(1) of this title). (G) A long-term care policy, including a nursing home fixed indemnity policy (unless the Secretary determines that such a policy does not provide sufficiently comprehensive Page 2747 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320d–1 coverage of a benefit so that the policy should be treated as a health plan). (H) An employee welfare benefit plan or any other arrangement which is established or maintained for the purpose of offering or providing health benefits to the employees of 2 or more employers. (I) The health care program for active military personnel under title 10. (J) The veterans health care program under chapter 17 of title 38. (K) The Civilian Health and Medical Pro- gram of the Uniformed Services (CHAMPUS), as defined in section 1072(4) of title 10. (L) The Indian health service program under the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.). (M) The Federal Employees Health Benefit Plan under chapter 89 of title 5. (6) Individually identifiable health information The term ‘‘individually identifiable health information’’ means any information, includ- ing 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 rea- sonable basis to believe that the informa- tion 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 1320d–2(a)(1) of this title, means any such data element or transaction that meets each of the standards and implementation specifications adopted or established by the Secretary with respect to the data element or transaction under sections 1320d–1 through 1320d–3 of this title. (8) Standard setting organization The term ‘‘standard setting organization’’ means a standard setting organization accred- ited by the American National Standards In- stitute, including the National Council for Prescription Drug Programs, that develops standards for information transactions, data elements, or any other standard that is nec- essary to, or will facilitate, the implementa- tion of this part. (9) Operating rules The term ‘‘operating rules’’ means the nec- essary business rules and guidelines for the electronic exchange of information that are not defined by a standard or its implementa- tion specifications as adopted for purposes of this part. (Aug. 14, 1935, ch. 531, title XI, § 1171, as added Pub. L. 104–191, title II, § 262(a), Aug. 21, 1996, 110 Stat. 2021; amended Pub. L. 107–105, § 4, Dec. 27, 2001, 115 Stat. 1007; Pub. L. 111–5, div. A, title XIII, § 13102, Feb. 17, 2009, 123 Stat. 242; Pub. L. 111–148, title I, § 1104(b)(1), Mar. 23, 2010, 124 Stat. 146.) Editorial Notes REFERENCES IN TEXT The Indian Health Care Improvement Act, referred to in par. (5)(L), is Pub. L. 94–437, Sept. 30, 1976, 90 Stat. 1400, which is classified principally to chapter 18 (§ 1601 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 1601 of Title 25 and Tables. PRIOR PROVISIONS A prior section 1171 of act Aug. 14, 1935, was classified to section 1320c–20 of this title prior to repeal by Pub. L. 97–35. AMENDMENTS 2010—Par. (9). Pub. L. 111–148 added par. (9). 2009—Par. (5)(D). Pub. L. 111–5 substituted ‘‘C, or D’’ for ‘‘or C’’. 2001—Par. (5)(D). Pub. L. 107–105 substituted ‘‘Parts A, B, or C’’ for ‘‘Part A or part B’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2010 AMENDMENT Pub. L. 111–148, title I, § 1105, Mar. 23, 2010, 124 Stat. 154, provided that: ‘‘This subtitle [subtitle B (§§ 1101–1105) of title I of Pub. L. 111–148, enacting sub- chapter I of chapter 157 of this title, amending this sec- tion and sections 1320d–2 and 1395y of this title, enact- ing provisions set out as a note under section 1320d–2 of this title, and amending provisions set out as a note under this section] shall take effect on the date of en- actment of this Act [Mar. 23, 2010].’’ PURPOSE Pub. L. 104–191, title II, § 261, Aug. 21, 1996, 110 Stat. 2021, as amended by Pub. L. 111–148, title I, § 1104(a), Mar. 23, 2010, 124 Stat. 146, provided that: ‘‘It is the pur- pose of this subtitle [subtitle F (§§ 261–264) of title II of Pub. L. 104–191, enacting this part, amending sections 242k and 1395cc of this title, and enacting provisions set out as a note under section 1320d–2 of this title] to im- prove the Medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.], the med- icaid program under title XIX of such Act [42 U.S.C. 1396 et seq.], and the efficiency and effectiveness of the health care system, by encouraging the development of a health information system through the establishment of uniform standards and requirements for the elec- tronic transmission of certain health information and to reduce the clerical burden on patients, health care providers, and health plans.’’ § 1320d–1. General requirements for adoption of standards (a) Applicability Any standard adopted under this part shall apply, in whole or in part, to the following per- sons: (1) A health plan. (2) A health care clearinghouse. (3) A health care provider who transmits any health information in electronic form in con- nection with a transaction referred to in sec- tion 1320d–2(a)(1) of this title. (b) Reduction of costs Any standard adopted under this part shall be consistent with the objective of reducing the ad-