Source: https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title42-chapter7-subchapter11-partC&saved=%7CKHRpdGxlOjQyIHNlY3Rpb246MTMyMGQtMSBlZGl0aW9uOnByZWxpbSk%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim
Timestamp: 2020-08-14 15:01:13
Document Index: 329914559

Matched Legal Cases: ['§1171', '§262', '§4', '§13102', '§1104', '§1601', '§1105', '§1101', '§261', '§1104', '§261', '§1173', '§262', '§1104', '§10109', '§10109', '§3224', '§1015', '§2063', 'art 164', 'art 164', 'art 160', 'art 164', 'art 164', 'art 164', 'art 164', '§11003', '§11004', '§212', '§1104', '§10109', '§264', '§1174', '§262', '§1176', '§262', '§13410', '§13410', '§13410', '§1180', '§105', '§105', '§105']

[USC02] 42 USC CHAPTER 7, SUBCHAPTER XI, Part C: Administrative Simplification
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42 USC CHAPTER 7, SUBCHAPTER XI, Part C: Administrative Simplification
The term "health information" means any information, whether oral or recorded in any form or medium, that—
(A) A group health plan (as defined in section 300gg–91(a) of this title), but only if the plan—
The term "individually identifiable health information" means any information, including demographic information collected from an individual, that—
(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.)
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.
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".
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 subchapter I of chapter 157 of this title, amending this section and sections 1320d–2 and 1395y of this title, enacting 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 enactment of this Act [Mar. 23, 2010]."
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 purpose 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 improve the Medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.], the medicaid 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 electronic transmission of certain health information and to reduce the clerical burden on patients, health care providers, and health plans."
Each person described in section 1320d–1(a) of this title who maintains or transmits health information shall maintain reasonable and appropriate administrative, technical, and physical safeguards—
For the purposes of this subsection, the term "review committee' means a committee chartered by or within the Department of Health and Human services that has been designated by the Secretary to carry out this subsection, including—
(Aug. 14, 1935, ch. 531, title XI, §1173, as added Pub. L. 104–191, title II, §262(a), Aug. 21, 1996, 110 Stat. 2024; amended Pub. L. 111–148, title I, §1104(b)(2), title X, §10109(a), Mar. 23, 2010, 124 Stat. 147, 915.)
2010—Subsec. (a)(1)(B). Pub. L. 111–148, §10109(a)(1)(A), inserted before period at end ", and subject to the requirements under paragraph (5)".
Pub. L. 116–136, div. A, title III, §3224, Mar. 27, 2020, 134 Stat. 380, provided that: "Not later than 180 days after the date of enactment of this Act [Mar. 27, 2020], the Secretary of Health and Human Services shall issue guidance on the sharing of patients' protected health information pursuant to section 160.103 of title 45, Code of Federal Regulations (or any successor regulations) during the public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, during the emergency involving Federal primary responsibility determined to exist by the President under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5191(b)) with respect to COVID–19, and during the national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et seq.) with respect to COVID–19. Such guidance shall include information on compliance with the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note) and applicable policies, including such policies that may come into effect during such emergencies."
Pub. L. 115–271, title I, §1015(b), Oct. 24, 2018, 132 Stat. 3922, provided that:
"(1) In general.—The Secretary [probably means the Secretary of Health and Human Services] shall publish in the Federal Register a system of records notice for the data specified in paragraph (2) for the Transformed Medicaid Statistical Information System, in accordance with section 552a(e)(4) of title 5, United States Code. The notice shall outline policies that protect the security and privacy of the data that, at a minimum, meet the security and privacy policies of SORN 09–70–0541 for the Medicaid Statistical Information System.
"(2) Required data.—The data covered by the systems of records notice required under paragraph (1) shall be sufficient for researchers and States to analyze the prevalence of substance use disorders in the Medicaid beneficiary population and the treatment of substance use disorders under Medicaid across all States (including the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), forms of treatment, and treatment settings.
"(3) Initiation of data-sharing activities.—Not later than January 1, 2019, the Secretary shall initiate the data-sharing activities outlined in the notice required under paragraph (1)."
Pub. L. 114–255, div. A, title II, §2063, Dec. 13, 2016, 130 Stat. 1080, provided that:
"(a) Guidance Related to Remote Access.—Not later than 1 year after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall issue guidance clarifying that subparagraph (B) of section 164.512(i)(1)(ii) of part 164 of the Rule (prohibiting the removal of protected health information by a researcher) does not prohibit remote access to health information by a researcher for such purposes as described in section 164.512(i)(1)(ii) of part 164 of the Rule so long as—
"(b) Guidance Related to Streamlining Authorization.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance on the following:
"(1) Authorization for use and disclosure of health information.—Clarification of the circumstances under which the authorization for the use or disclosure of protected health information, with respect to an individual, for future research purposes contains a sufficient description of the purpose of the use or disclosure, such as if the authorization—
"(2) Reminder of the right to revoke.—Clarification of the circumstances under which it is appropriate to provide an individual with an annual notice or reminder that the individual has the right to revoke such authorization.
"(3) Revocation of authorization.—Clarification of appropriate mechanisms by which an individual may revoke an authorization for future research purposes, such as described in paragraph (1)(C).
"(c) Working Group on Protected Health Information for Research.—
"(1) Establishment.—Not later than 1 year after the date of enactment of this Act [Dec. 13, 2016], the Secretary shall convene a working group to study and report on the uses and disclosures of protected health information for research purposes, under the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191) [see Tables for classification].
"(2) Members.—The working group shall include representatives of—
"(3) Report.—Not later than 1 year after the date on which the working group is convened under paragraph (1), the working group shall conduct a review and submit a report to the Secretary containing recommendations on whether the uses and disclosures of protected health information for research purposes should be modified to allow protected health information to be available, as appropriate, for research purposes, including studies to obtain generalizable knowledge, while protecting individuals' privacy rights. In conducting the review and making recommendations, the working group shall—
"(A) address, at a minimum—
"(B) consider, at a minimum—
"(4) Report submission.—The Secretary shall submit the report under paragraph (3) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and shall post such report on the appropriate Internet website of the Department of Health and Human Services.
"(5) Termination.—The working group convened under paragraph (1) shall terminate the day after the report under paragraph (3) is submitted to Congress and made public in accordance with paragraph (4).
"(1) The rule.—References to 'the Rule' refer to part 160 or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation).
"(2) Part 164.—References to a specified section of 'part 164', refer to such specified section of part 164 of title 45, Code of Federal Regulations (or any successor section)."
Pub. L. 114–255, div. B, title XI, §11003, Dec. 13, 2016, 130 Stat. 1270, provided that:
"(a) In General.—The Secretary [of Health and Human Services], acting through the Director of the Office for Civil Rights, shall ensure that health care providers, professionals, patients and their families, and others involved in mental or substance use disorder treatment have adequate, accessible, and easily comprehensible resources relating to appropriate uses and disclosures of protected health information under the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 [Pub. L. 104–191] (42 U.S.C. 1320d–2 note).
"(b) Guidance.—
"(1) Issuance.—In carrying out subsection (a), not later than 1 year after the date of enactment of this section [Dec. 13, 2016], the Secretary shall issue guidance clarifying the circumstances under which, consistent with regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, a health care provider or covered entity may use or disclose protected health information.
"(2) Circumstances addressed.—The guidance issued under this section shall address circumstances including those that—
"(3) Communication with family members and caregivers.—In addressing the circumstances described in paragraph (2), the guidance issued under this section shall clarify permitted uses or disclosures of protected health information for purposes of—
Pub. L. 114–255, div. B, title XI, §11004, Dec. 13, 2016, 130 Stat. 1271, provided that:
"(a) Initial Programs and Materials.—Not later than 1 year after the date of the enactment of this Act [Dec. 13, 2016], the Secretary [of Health and Human Services], in consultation with appropriate experts, shall identify the following model programs and materials, or (in the case that no such programs or materials exist) recognize private or public entities to develop and disseminate each of the following:
"(b) Periodic Updates.—The Secretary shall—
"(c) Coordination.—The Secretary shall carry out this section in coordination with the Director of the Office for Civil Rights within the Department of Health and Human Services, the Assistant Secretary for Mental Health and Substance Use, the Administrator of the Health Resources and Services Administration, and the heads of other relevant agencies within the Department of Health and Human Services.
"(d) Input of Certain Entities.—In identifying, reviewing, or updating the model programs and materials under subsections (a) and (b), the Secretary shall solicit the input of relevant national, State, and local associations; medical societies; licensing boards; providers of mental and substance use disorder treatment; organizations with expertise on domestic violence, sexual assault, elder abuse, and child abuse; and organizations representing patients and consumers and the families of patients and consumers.
"(e) Funding.—There are authorized to be appropriated to carry out this section—
Pub. L. 113–93, title II, §212, Apr. 1, 2014, 128 Stat. 1047, provided that: "The Secretary of Health and Human Services may not, prior to October 1, 2015, adopt ICD–10 code sets as the standard for code sets under section 1173(c) of the Social Security Act (42 U.S.C. 1320d–2(c)) and section 162.1002 of title 45, Code of Federal Regulations."
Pub. L. 111–148, title I, §1104(c), Mar. 23, 2010, 124 Stat. 153, provided that:
"(1) Unique health plan identifier.—The Secretary [of Health and Human Services] shall promulgate a final rule to establish a unique health plan identifier (as described in section 1173(b) of the Social Security Act (42 U.S.C. 1320d–2(b))) based on the input of the National Committee on Vital and Health Statistics. The Secretary may do so on an interim final basis and such rule shall be effective not later than October 1, 2012.
"(2) Electronic funds transfer.—The Secretary shall promulgate a final rule to establish a standard for electronic funds transfers (as described in section 1173(a)(2)(J) of the Social Security Act, as added by subsection (b)(2)(A)). The Secretary may do so on an interim final basis and shall adopt such standard not later than January 1, 2012, in a manner ensuring that such standard is effective not later than January 1, 2014.
"(3) Health claims attachments.—The Secretary shall promulgate a final rule to establish a transaction standard and a single set of associated operating rules for health claims attachments (as described in section 1173(a)(2)(B) of the Social Security Act (42 U.S.C. 1320d–2(a)(2)(B))) that is consistent with the X12 Version 5010 transaction standards. The Secretary may do so on an interim final basis and shall adopt a transaction standard and a single set of associated operating rules not later than January 1, 2014, in a manner ensuring that such standard is effective not later than January 1, 2016."
Pub. L. 111–148, title X, §10109(b), (c), Mar. 23, 2010, 124 Stat. 916, provided that:
"(b) Activities and Items for Initial Consideration.—For purposes of section 1173(a)(5) of the Social Security Act [42 U.S.C. 1320d–2(a)(5)], as added by subsection (a), the Secretary of Health and Human Services (in this section referred to as the 'Secretary') shall, not later than January 1, 2012, seek input on activities and items relating to the following areas:
"(c) ICD Coding Crosswalks.—
"(1) ICD–9 to icd–10 crosswalk.—The Secretary shall task the ICD–9–CM Coordination and Maintenance Committee to convene a meeting, not later than January 1, 2011, to receive input from appropriate stakeholders (including health plans, health care providers, and clinicians) regarding the crosswalk between the Ninth and Tenth Revisions of the International Classification of Diseases (ICD–9 and ICD–10, respectively) that is posted on the website of the Centers for Medicare & Medicaid Services, and make recommendations about appropriate revisions to such crosswalk.
"(2) Revision of crosswalk.—For purposes of the crosswalk described in paragraph (1), the Secretary shall make appropriate revisions and post any such revised crosswalk on the website of the Centers for Medicare & Medicaid Services.
"(3) Use of revised crosswalk.—For purposes of paragraph (2), any revised crosswalk shall be treated as a code set for which a standard has been adopted by the Secretary for purposes of section 1173(c)(1)(B) of the Social Security Act (42 U.S.C. 1320d–2(c)(1)(B)).
"(4) Subsequent crosswalks.—For subsequent revisions of the International Classification of Diseases that are adopted by the Secretary as a standard code set under section 1173(c) of the Social Security Act (42 U.S.C. 1320d–2(c)), the Secretary shall, after consultation with the appropriate stakeholders, post on the website of the Centers for Medicare & Medicaid Services a crosswalk between the previous and subsequent version of the International Classification of Diseases not later than the date of implementation of such subsequent revision."
Pub. L. 104–191, title II, §264, Aug. 21, 1996, 110 Stat. 2033, provided that:
"(a) In General.—Not later than the date that is 12 months after the date of the enactment of this Act [Aug. 21, 1996], the Secretary of Health and Human Services shall submit to the Committee on Labor and Human Resources and the Committee on Finance of the Senate and the Committee on Commerce and the Committee on Ways and Means of the House of Representatives detailed recommendations on standards with respect to the privacy of individually identifiable health information.
"(b) Subjects for Recommendations.—The recommendations under subsection (a) shall address at least the following:
"(1) In general.—If legislation governing standards with respect to the privacy of individually identifiable health information transmitted in connection with the transactions described in section 1173(a) of the Social Security Act [42 U.S.C. 1320d–2(a)] (as added by section 262) is not enacted by the date that is 36 months after the date of the enactment of this Act [Aug. 21, 1996], the Secretary of Health and Human Services shall promulgate final regulations containing such standards not later than the date that is 42 months after the date of the enactment of this Act. Such regulations shall address at least the subjects described in subsection (b).
"(2) Preemption.—A regulation promulgated under paragraph (1) shall not supercede a contrary provision of State law, if the provision of State law imposes requirements, standards, or implementation specifications that are more stringent than the requirements, standards, or implementation specifications imposed under the regulation.
"(d) Consultation.—In carrying out this section, the Secretary of Health and Human Services shall consult with—
(Aug. 14, 1935, ch. 531, title XI, §1174, as added Pub. L. 104–191, title II, §262(a), Aug. 21, 1996, 110 Stat. 2026.)
Except as provided in subsection (b), the Secretary shall impose on any person who violates a provision of this part—
(Aug. 14, 1935, ch. 531, title XI, §1176, as added Pub. L. 104–191, title II, §262(a), Aug. 21, 1996, 110 Stat. 2028; amended Pub. L. 111–5, div. A, title XIII, §13410(a)(1), (d)(1)–(3), (e)(1), (2), (f), Feb. 17, 2009, 123 Stat. 271–276.)
2009—Subsec. (a)(1). Pub. L. 111–5, §13410(d)(1), substituted "who violates a provision of this part—" for "who violates a provision of this part a penalty of not more than $100 for each such violation, except that the total amount imposed on the person for all violations of an identical requirement or prohibition during a calendar year may not exceed $25,000.", added subpars. (A) to (C), and inserted concluding provisions.
Pub. L. 111–5, §13410(d)(3)(B)(i), substituted "in subparagraph (B) or subsection (a)(1)(C), a penalty may not be imposed under subsection (a) if the failure to comply is corrected" for "in subparagraph (B), a penalty may not be imposed under subsection (a) of this section if—
The term "underwriting purposes" means, with respect to a group health plan, health insurance coverage, or a medicare supplemental policy—
(Aug. 14, 1935, ch. 531, title XI, §1180, as added Pub. L. 110–233, title I, §105(a), May 21, 2008, 122 Stat. 903.)
Pub. L. 110–233, title I, §105(b)(2), May 21, 2008, 122 Stat. 905, provided that: "The amendment made by subsection (a) [enacting this section] shall take effect on the date that is 1 year after the date of the enactment of this Act [May 21, 2008]."
Pub. L. 110–233, title I, §105(b)(1), May 21, 2008, 122 Stat. 905, provided that: "Not later than 12 months after the date of the enactment of this Act [May 21, 2008], the Secretary of Health and Human Services shall issue final regulations to carry out the revision required by section 1180(a) of the Social Security Act [42 U.S.C. 1320d–9(a)], as added by subsection (a). The Secretary has the sole authority to promulgate such regulations, but shall promulgate such regulations in consultation with the Secretaries of Labor and the Treasury."