45 CFR 170.300 - Applicability.

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§ 170.300 Applicability.
(a) The certification criteria adopted in this subpart apply to the testing and certification of Complete EHRs and EHR Modules.
(b) When a certification criterion refers to two or more standards as alternatives, use of at least one of the alternative standards will be considered compliant.
(c) Complete EHRs and EHR Modules are not required to be compliant with certification criteria that are designated as optional.
§ 170.300, Nt.
Effective Date Note:
At 77 FR 54286, Sept. 4, 2012, § 170.300 was amended by revising paragraph (c) and add paragraph (d), effective Oct. 4, 2012. For the convenience of the user, the added and revised text is set forth as follows:
§ 170.300 Applicability.
(a) The certification criteria adopted in this subpart apply to the testing and certification of Complete EHRs and EHR Modules.
(b) When a certification criterion refers to two or more standards as alternatives, the use of at least one of the alternative standards will be considered compliant.
(c) Complete EHRs and EHR Modules are not required to be compliant with certification criteria or capabilities specified within a certification criterion that are designated as optional.
(d) In § 170.314, all certification criteria and all capabilities specified within a certification criterion have general applicability (i.e., apply to both ambulatory and inpatient settings) unless designated as “inpatient setting only” or “ambulatory setting only.”
(1) “Inpatient setting only” means that the criterion or capability within the criterion is only required for certification of EHR technology designed for use in an inpatient setting.
(2) “Ambulatory setting only” means that the criterion or capability within the criterion is only required for certification of EHR technology designed for use in an ambulatory setting.

Title 45 published on 2012-10-01

The following are only the Rules published in the Federal Register after the published date of Title 45.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-11; vol. 79 # 176 - Thursday, September 11, 2014
    1. 79 FR 54430 - 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Final rule.
      This rule is effective October 14, 2014, except for the amendments to the amendatory instruction number 3 amendment to § 170.102, the amendments to §§ 170.205, 170.207, 170.210, 170.302, 170.304, 170.306, and the amendatory instruction number 18 amendment to § 170.550, which are effective on March 1, 2015. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 14, 2014.
      45 CFR Part 170

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United States Code

Title 45 published on 2012-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 45 CFR 170 after this date.

  • 2014-09-11; vol. 79 # 176 - Thursday, September 11, 2014
    1. 79 FR 54430 - 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Final rule.
      This rule is effective October 14, 2014, except for the amendments to the amendatory instruction number 3 amendment to § 170.102, the amendments to §§ 170.205, 170.207, 170.210, 170.302, 170.304, 170.306, and the amendatory instruction number 18 amendment to § 170.550, which are effective on March 1, 2015. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 14, 2014.
      45 CFR Part 170