45 CFR 170.102 - Definitions.

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§ 170.102 Definitions.

For the purposes of this part:

2014 Edition Base EHR means an electronic record of health-related information on an individual that:

(1) Includes patient demographic and clinical health information, such as medical history and problem lists;

(2) Has the capacity:

(i) To provide clinical decision support;

(ii) To support physician order entry;

(iii) To capture and query information relevant to health care quality;

(iv) To exchange electronic health information with, and integrate such information from other sources;

(v) To protect the confidentiality, integrity, and availability of health information stored and exchanged; and

(3) Has been certified to the certification criteria adopted by the Secretary:

(i) For at least one of the four criteria adopted at § 170.314(a)(1), (18), (19), or (20);

(ii) At § 170.314(a)(3);

(iii) At § 170.314(a)(5) through (8);

(iv) Both § 170.314(b)(1) and (2); or, both § 170.314(b)(8) and (h)(1); or § 170.314(b)(1) and (2) combined with either § 170.314(b)(8) or (h)(1), or both § 170.314(b)(8) and (h)(1);

(v) At § 170.314(b)(7);

(vi) At § 170.314(c)(1) through (3);

(vii) At § 170.314(d)(1) through (8);

(4) Has been certified to the certification criteria at § 170.314(c)(1) and (2):

(i) For no fewer than 9 clinical quality measures covering at least 3 domains from the set selected by CMS for eligible professionals, including at least 6 clinical quality measures from the recommended core set identified by CMS; or

(ii) For no fewer than 16 clinical quality measures covering at least 3 domains from the set selected by CMS for eligible hospitals and critical access hospitals.

2014 Edition EHR certification criteria means the certification criteria at § 170.314.

2015 Edition Base EHR means an electronic record of health-related information on an individual that:

(1) Includes patient demographic and clinical health information, such as medical history and problem lists;

(2) Has the capacity:

(i) To provide clinical decision support;

(ii) To support physician order entry;

(iii) To capture and query information relevant to health care quality;

(iv) To exchange electronic health information with, and integrate such information from other sources; and

(3) Has been certified to the certification criteria adopted by the Secretary in § 170.315(a)(1), (2), or (3); (a)(5) through (9); (a)(11); (a)(14); (b)(1) and (6); (c)(1); (g)(7) through (9); and (h)(1) or (2);

2015 Edition health IT certification criteria means the certification criteria in § 170.315.

Certification criteria means criteria:

(1) To establish that health information technology meets applicable standards and implementation specifications adopted by the Secretary; or

(2) That are used to test and certify that health information technology includes required capabilities.

Common Clinical Data Set means the following data expressed, where indicated, according to the specified standard(s):

(1) Patient name. For certification to both the 2014 Edition EHR certification criteria and the 2015 Edition health IT certification criteria.

(2) Sex.

(i) No required standard for certification to the 2014 Edition EHR certification criteria.

(ii) The standard specified in § 170.207(n)(1) for certification to the 2015 Edition health IT certification criteria.

(3) Date of birth. For certification to both the 2014 Edition EHR certification criteria and the 2015 Edition health IT certification criteria.

(4) Race.

(i) The standard specified in § 170.207(f)(1) for certification to the 2014 Edition EHR certification criteria.

(ii) For certification to the 2015 Edition health IT certification criteria:

(A) The standard specified in § 170.207(f)(2);

(B) The standard specified in § 170.207(f)(1) for each race identified in accordance § 170.207(f)(2).

(5) Ethnicity.

(i) The standard specified in § 170.207(f)(1) for certification to the 2014 Edition EHR certification criteria.

(ii) For certification to the 2015 Edition health IT certification criteria:

(A) The standard specified in § 170.207(f)(2);

(B) The standard specified in § 170.207(f)(1) for each ethnicity identified in accordance § 170.207(f)(2).

(6) Preferred language.

(i) The standard specified in § 170.207(g)(1) for certification to the 2014 Edition EHR certification criteria.

(ii) The standard specified in § 170.207(g)(2) for certification to the 2015 Edition Health IT certification criteria.

(7) Smoking status. For certification to both the 2014 Edition EHR certification criteria and the 2015 Edition health IT certification criteria: The standard specified in § 170.207(h).

(8) Problems.

(i) At a minimum, the standard specified in § 170.207(a)(3) for certification to the 2014 Edition EHR certification criteria.

(ii) At a minimum, the standard specified in § 170.207(a)(4) for certification to the 2015 Edition Health IT certification criteria.

(9) Medications.

(i) At a minimum, the standard specified in § 170.207(d)(2) for certification to the 2014 Edition EHR certification criteria.

(ii) At a minimum, the standard specified in § 170.207(d)(3) for certification to the 2015 Edition Health IT certification criteria.

(10) Medication allergies.

(i) At a minimum, the standard specified in § 170.207(d)(2) for certification to the 2014 Edition EHR certification criteria.

(ii) At a minimum, the standard specified in § 170.207(d)(3) for certification to the 2015 Edition Health IT certification criteria.

(11) Laboratory test(s).

(i) At a minimum, the standard specified in § 170.207(c)(2) for certification to the 2014 Edition EHR certification criteria.

(ii) At a minimum, the standard specified in § 170.207(c)(3) for certification to the 2015 Edition Health IT certification criteria.

(12) Laboratory value(s)/result(s). For certification to both the 2014 Edition EHR certification criteria and the 2015 Edition health IT certification criteria.

(13) Vital signs.

(i) Height/length, weight, blood pressure, and BMI for certification to the 2014 Edition EHR certification criteria.

(ii) For certification to the 2015 Edition Health IT certification criteria:

(A) The patient's diastolic blood pressure, systolic blood pressure, body height, body weight, heart rate, respiratory rate, body temperature, pulse oximetry, and inhaled oxygen concentration must be exchanged in numerical values only; and

(B) In accordance with the standard specified in § 170.207(c)(3) and with the associated applicable unit of measure for the vital sign measurement in the standard specified in § 170.207(m)(1).

(C) Optional. The patient's BMI percentile per age and sex for youth 2-20 years of age, weight for age per length and sex for children less than 3 years of age, and head occipital-frontal circumference for children less than 3 years of age must be recorded in numerical values only in accordance with the standard specified in § 170.207(c)(3) and with the associated applicable unit of measure for the vital sign measurement in the standard specified in § 170.207(m)(1). For BMI percentile per age and sex for youth 2-20 years of age and weight for age per length and sex for children less than 3 years of age, the reference range/scale or growth curve should be included as appropriate.

(14) Care plan field(s), including goals and instructions. For certification to the 2014 Edition EHR certification criteria.

(15) Procedures - (i)(A) At a minimum, the version of the standard specified in § 170.207(a)(3) for certification to the 2014 Edition EHR certification criteria and § 170.207(a)(4) for certification to the 2015 Edition health IT certification criteria, or § 170.207(b)(2); or

(B) For technology primarily developed to record dental procedures, the standard specified in § 170.207(b)(3) for certification to both the 2014 Edition EHR certification criteria and the 2015 Edition health IT certification criteria.

(ii) Optional. The standard specified in § 170.207(b)(4) for certification to both the 2014 Edition EHR certification criteria and the 2015 Edition health IT certification criteria.

(16) Care team member(s). For certification to both the 2014 Edition EHR certification criteria and the 2015 Edition health IT certification criteria.

(17) Immunizations. In accordance with, at a minimum, the standards specified in § 170.207(e)(3) and (4) for certification to the 2015 Edition health IT certification criteria.

(18) Unique device identifier(s) for a patient's implantable device(s). In accordance with the “Product Instance” in the “Procedure Activity Procedure Section” of the standard specified in § 170.205(a)(4) for certification to the 2015 Edition health IT certification criteria.

(19) Assessment and plan of treatment. For certification to the 2015 Edition health IT certification criteria:

(i) In accordance with the “Assessment and Plan Section (V2)” of the standard specified in § 170.205(a)(4); or

(ii) In accordance with the “Assessment Section (V2)” and “Plan of Treatment Section (V2)” of the standard specified in § 170.205(a)(4).

(20) Goals. In accordance with the “Goals Section” of the standard specified in § 170.205(a)(4) for certification to the 2015 Edition health IT certification criteria.

(21) Health concerns. In accordance with the “Health Concerns Section” of the standard specified in § 170.205(a)(4) for certification to the 2015 Edition health IT certification criteria.

Complete EHR, 2014 Edition means EHR technology that meets the Base EHR definition and has been developed to meet, at a minimum, all mandatory 2014 Edition EHR certification criteria for either an ambulatory setting or inpatient setting

Device identifier is defined as it is in 21 CFR 801.3.

Disclosure is defined as it is in 45 CFR 160.103.

Global Unique Device Identification Database (GUDID) is defined as it is in 21 CFR 801.3.

Health IT Module means any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary.

Human readable format means a format that enables a human to read and easily comprehend the information presented to him or her regardless of the method of presentation.

Implantable device is defined as it is in 21 CFR 801.3.

Implementation specification means specific requirements or instructions for implementing a standard.

Production identifier is defined as it is in 21 CFR 801.3.

Qualified EHR means an electronic record of health-related information on an individual that:

(1) Includes patient demographic and clinical health information, such as medical history and problem lists; and

(2) Has the capacity:

(i) To provide clinical decision support;

(ii) To support physician order entry;

(iii) To capture and query information relevant to health care quality; and

(iv) To exchange electronic health information with, and integrate such information from other sources.

Standard means a technical, functional, or performance-based rule, condition, requirement, or specification that stipulates instructions, fields, codes, data, materials, characteristics, or actions.

Unique device identifier is defined as it is in 21 CFR 801.3.

[75 FR 2042, Jan. 13, 2010, as amended at 75 FR 36203, June 24, 2010; 75 FR 44649, July 28, 2010; 77 FR 54283, Sept. 4, 2012; 78 FR 65887, Nov. 4, 2013; 79 FR 52933, Sept. 4, 2014; 79 FR 54477, 54478, Sept. 11, 2014; 80 FR 62741, Oct. 16, 2015; 80 FR 76871, Dec. 11, 2015]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code
U.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

Title 45 published on 2015-10-01

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

  • 2016-10-19; vol. 81 # 202 - Wednesday, October 19, 2016
    1. 81 FR 72404 - ONC Health IT Certification Program: Enhanced Oversight and Accountability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Final rule.
      These regulations are effective December 19, 2016. The incorporation by reference of the publication listed in the rule is approved by the Director of the Federal Register as of December 19, 2016.
      45 CFR Part 170