45 CFR 170.550 - EHR Module certification.

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§ 170.550 EHR Module certification.
(a) When certifying EHR Module(s), an ONC-ACB must certify in accordance with the applicable certification criteria adopted by the Secretary at subpart C of this part.
(b) An ONC-ACB must provide the option for an EHR Module(s) to be certified solely to the applicable certification criteria adopted by the Secretary at subpart C of this part.
(c) Gap certification. An ONC-ACB may provide the option for and perform gap certification of previously certified EHR Module(s).
(d) An ONC-ACB may provide an updated certification to a previously certified EHR Module(s).
(e) Privacy and security certification. EHR Module(s) shall be certified to all privacy and security certification criteria adopted by the Secretary, unless the EHR Module(s) is presented for certification in one of the following manners:
(1) The EHR Modules are presented for certification as a pre-coordinated, integrated bundle of EHR Modules, which would otherwise meet the definition of and constitute a Complete EHR, and one or more of the constituent EHR Modules is demonstrably responsible for providing all of the privacy and security capabilities for the entire bundle of EHR Modules; or
(2) An EHR Module is presented for certification, and the presenter can demonstrate and provide documentation to the ONC-ACB that a privacy and security certification criterion is inapplicable or that it would be technically infeasible for the EHR Module to be certified in accordance with such certification criterion.
(f) Inherited certified status. An ONC-ACB must accept requests for a newer version of a previously certified EHR Module(s) to inherit the certified status of the previously certified EHR Module(s) without requiring the newer version to be recertified.
(1) Before granting certified status to a newer version of a previously certified EHR Module(s), an ONC-ACB must review an attestation submitted by the developer(s) of the EHR Module(s) to determine whether any change in the newer version has adversely affected the EHR Module(s)' capabilities for which certification criteria have been adopted.
(2) An ONC-ACB may grant certified status to a newer version of a previously certified EHR Module(s) if it determines that the capabilities for which certification criteria have been adopted have not been adversely affected.
§ 170.550, Nt.
Effective Date Note:
At 77 FR 54291, Sept. 4, 2012, § 170.550 was amended by revising paragraph (e), redesignating paragraph (f) as paragraph (g), and adding a new paragraph (f), effective Oct. 4, 2012. For the convenience of the user, the added and revised text is set forth as follows:
§ 170.550 EHR Module certification.
(e) Privacy and security certification. For certification to the 2011 Edition EHR certification criteria, EHR Module(s) shall be certified to all privacy and security certification criteria adopted by the Secretary, unless the EHR Module(s) is presented for certification in one of the following manners:
(1) The EHR Modules are presented for certification as a pre-coordinated, integrated bundle of EHR Modules, which would otherwise meet the definition of and constitute a Complete EHR, and one or more of the constituent EHR Modules is demonstrably responsible for providing all of the privacy and security capabilities for the entire bundle of EHR Modules; or
(2) An EHR Module is presented for certification, and the presenter can demonstrate and provide documentation to the ONC-ACB that a privacy and security certification criterion is inapplicable or that it would be technically infeasible for the EHR Module to be certified in accordance with such certification criterion.
(f) When certifying an EHR Module to the 2014 Edition EHR certification criteria, an ONC-ACB must certify the EHR Module in accordance with the certification criteria at:
(1) Section 170.314(g)(1) if the EHR Module has capabilities presented for certification that would support a meaningful use objective with a percentage-based measure;
(2) Section 170.314(g)(3) if the EHR Module is presented for certification to one or more listed certification criteria in § 170.314(g)(3); and
(3) Section 170.314(g)(4).

Title 45 published on 2013-10-01

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 2013-10-01

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