45 CFR 170.304 - Specific certification criteria for Complete EHRs or EHR Modules designed for an ambulatory setting.

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§ 170.304 Specific certification criteria for Complete EHRs or EHR Modules designed for an ambulatory setting.
The Secretary adopts the following certification criteria for Complete EHRs or EHR Modules designed to be used in an ambulatory setting. Complete EHRs or EHR Modules must include the capability to perform the following functions electronically and in accordance with all applicable standards and implementation specifications adopted in this part:
(a) Computerized provider order entry. Enable a user to electronically record, store, retrieve, and modify, at a minimum, the following order types:
(1) Medications;
(2) Laboratory; and
(3) Radiology/imaging.
(b) Electronic prescribing. Enable a user to electronically generate and transmit prescriptions and prescription-related information in accordance with:
(1) The standard specified in § 170.205(b)(1) or § 170.205(b)(2); and
(2) The standard specified in § 170.207(d).
(c) Record demographics. Enable a user to electronically record, modify, and retrieve patient demographic data including preferred language, gender, race, ethnicity, and date of birth. Enable race and ethnicity to be recorded in accordance with the standard specified at § 170.207(f).
(d) Patient reminders. Enable a user to electronically generate a patient reminder list for preventive or follow-up care according to patient preferences based on, at a minimum, the data elements included in:
(1) Problem list;
(2) Medication list;
(3) Medication allergy list;
(4) Demographics; and
(5) Laboratory test results.
(e) Clinical decision support—
(1) Implement rules. Implement automated, electronic clinical decision support rules (in addition to drug-drug and drug-allergy contraindication checking) based on the data elements included in: problem list; medication list; demographics; and laboratory test results.
(2) Notifications. Automatically and electronically generate and indicate in real-time, notifications and care suggestions based upon clinical decision support rules.
(f) Electronic copy of health information. Enable a user to create an electronic copy of a patient's clinical information, including, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list in:
(1) Human readable format; and
(2) On electronic media or through some other electronic means in accordance with:
(i) The standard (and applicable implementation specifications) specified in § 170.205(a)(1) or § 170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A) Problems. The standard specified in § 170.207(a)(1) or, at a minimum, the version of the standard specified in § 170.207(a)(2);
(B) Laboratory test results. At a minimum, the version of the standard specified in § 170.207(c); and
(C) Medications. The standard specified in § 170.207(d).
(g) Timely access. Enable a user to provide patients with online access to their clinical information, including, at a minimum, lab test results, problem list, medication list, and medication allergy list.
(h) Clinical summaries. Enable a user to provide clinical summaries to patients for each office visit that include, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list. If the clinical summary is provided electronically it must be:
(1) Provided in human readable format; and
(2) Provided on electronic media or through some other electronic means in accordance with:
(i) The standard (and applicable implementation specifications) specified in § 170.205(a)(1) or § 170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A) Problems. The standard specified in § 170.207(a)(1) or, at a minimum, the version of the standard specified in § 170.207(a)(2);
(B) Laboratory test results. At a minimum, the version of the standard specified in § 170.207(c); and
(C) Medications. The standard specified in § 170.207(d).
(i) Exchange clinical information and patient summary record—
(1) Electronically receive and display. Electronically receive and display a patient's summary record, from other providers and organizations including, at a minimum, diagnostic tests results, problem list, medication list, and medication allergy list in accordance with the standard (and applicable implementation specifications) specified in § 170.205(a)(1) or § 170.205(a)(2). Upon receipt of a patient summary record formatted according to the alternative standard, display it in human readable format.
(2) Electronically transmit. Enable a user to electronically transmit a patient summary record to other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list in accordance with:
(i) The standard (and applicable implementation specifications) specified in § 170.205(a)(1) or § 170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A) Problems. The standard specified in § 170.207(a)(1) or, at a minimum, the version of the standard specified in § 170.207(a)(2);
(B) Laboratory test results. At a minimum, the version of the standard specified in § 170.207(c); and
(C) Medications. The standard specified in § 170.207(d).
(j) Calculate and submit clinical quality measures—
(1) Calculate (i) Electronically calculate all of the core clinical measures specified by CMS for eligible professionals.
(ii) Electronically calculate, at a minimum, three clinical quality measures specified by CMS for eligible professionals, in addition to those clinical quality measures specified in paragraph (1)(i).
(2) Submission. Enable a user to electronically submit calculated clinical quality measures in accordance with the standard and implementation specifications specified in § 170.205(f).

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