45 CFR 170.102 - Definitions.

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§ 170.102 Definitions. Link to an amendment published at 79 FR 54477, Sept. 11, 2014. Link to an amendment published at 79 FR 54478, Sept. 11, 2014.
For the purposes of this part:
2011 Edition EHR certification criteria means the certification criteria at §§ 170.302, 170.304, and 170.306.
2014 Edition EHR certification criteria means the certification criteria at § 170.314.
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 at:§ 170.314(a)(1), (3), and (5) through (8); (b)(1), (2), and (7); (c)(1) through (3); (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.
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.
Certified EHR Technology means:
(1) For any Federal fiscal year (FY) or calendar year (CY) up to and including 2014:
(i) A Complete EHR that meets the requirements included in the definition of a Qualified EHR and has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary for the 2011 Edition EHR certification criteria or the equivalent 2014 Edition EHR certification criteria;
(ii) A combination of EHR Modules in which each constituent EHR Module of the combination has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary for the 2011 Edition EHR certification criteria or the equivalent 2014 Edition EHR certification criteria, and the resultant combination also meets the requirements included in the definition of a Qualified EHR; or
(iii) EHR technology that satisfies the definition for FY and CY 2015 and subsequent years specified in paragraph (2) of this definition;
(2) For FY and CY 2015 and subsequent years, the following: EHR technology certified under the ONC HIT Certification Program to the 2015 Edition EHR certification criteria that has:
(i) The capabilities required to meet the Base EHR definition; and
(ii) All other capabilities that are necessary to meet the objectives and associated measures under42 CFR 495.6 and successfully report the clinical quality measures selected by CMS in the form and manner specified by CMS (or the States, as applicable) for the stage of meaningful use that an eligible professional, eligible hospital, or critical access hospital seeks to achieve.
Common MU Data Set means the following data expressed, where indicated, according to the specified standard(s):
(1) Patient name.
(2) Sex.
(3) Date of birth.
(4) Race—the standard specified in§ 170.207(f).
(5) Ethnicity—the standard specified in§ 170.207(f).
(6) Preferred language—the standard specified in§ 170.207(g).
(7) Smoking status—the standard specified in§ 170.207(h).
(8) Problems—at a minimum, the version of the standard specified in§ 170.207(a)(3).
(9) Medications—at a minimum, the version of the standard specified in§ 170.207(d)(2).
(10) Medication allergies—at a minimum, the version of the standard specified in§ 170.207(d)(2).
(11) Laboratory test(s)—at a minimum, the version of the standard specified in§ 170.207(c)(2).
(12) Laboratory value(s)/result(s).
(13) Vital signs—height, weight, blood pressure, BMI.
(14) Care plan field(s), including goals and instructions.
(15) Procedures—
(i)
(A) At a minimum, the version of the standard specified in§ 170.207(a)(3) or § 170.207(b)(2); or
(B) For EHR technology primarily developed to record dental procedures, the standard specified in§ 170.207(b)(3).
(ii) Optional. The standard specified at § 170.207(b)(4).
(16) Care team member(s).
Complete EHR, 2011 Edition means EHR technology that has been developed to meet, at a minimum, all mandatory 2011 Edition EHR certification criteria for either an ambulatory setting or inpatient setting.
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.
Disclosure is defined as it is in 45 CFR 160.103.
EHR 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.
Implementation specification means specific requirements or instructions for implementing a standard.
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.
[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]
Effective Date Notes:
1. At 79 FR 54477, Sept. 11, 2014, § 170.102 was amended by revising the definition for “Base EHR”, effective Oct. 14, 2014. For the convenience of the user, the revised text is set forth as follows:
§ 170.102 Definitions.
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), (a)(18), (a)(19), or (a)(20);
(ii) At§ 170.314(a)(3);
(iii) At§ 170.314(a)(5) through § 170.314(a)(8);
(iv) Both§ 170.314(b)(1) and (2); or, both § 170.314(b)(8) and § 170.314(h)(1); or § 170.314(b)(1) and (2) combined with either § 170.314(b)(8) or § 170.314(h)(1), or both § 170.314(b)(8) and § 170.314(h)(1);
(v) At§ 170.314(b)(7);
(vi) At§ 170.314(c)(1) through § 170.314(c)(3);
(vii) At§ 170.314(d)(1) through § 170.314(d)(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.
Effective Date Notes:
2. At 79 FR 54478, Sept. 11, 2014, § 170.102 was amended by removing the definitions of “2011 Edition EHR certification criteria” and “Complete EHR, 2011 Edition”, effective Mar. 1, 2015.
Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 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].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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.

  • 2015-10-16; vol. 80 # 200 - Friday, October 16, 2015
    1. 80 FR 62602 - 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Final rule.
      These regulations are effective January 14, 2016, except for § 170.523(m) and (n), which are effective on April 1, 2016. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of January 14, 2016.
      45 CFR Part 170