§170.315. ONC certification criteria for Health IT.

(2) Enable each one of a patient's ethnicities to be recorded in accordance with, at a minimum, the standard specified in § 170.207(f)(3) and whether a patient declines to specify ethnicity.

(3) Aggregate each one of the patient's races and ethnicities recorded in accordance with paragraphs (a)(5)(i)(A)(1) and (2) of this section to the categories in the standard specified in § 170.207(f)(1).

(2) Developer of the intervention (translation from clinical research/guideline);

(3) Funding source of the intervention development technical implementation; and

(4) Release and, if applicable, revision date(s) of the intervention or reference source.

(2) The data classes expressed in the standards in § 170.213 and in accordance with § 170.205(a)(4), (6), and paragraphs (b)(1)(iii)(A)(3)(i) through (iii) of this section, and

(3) The following data classes:

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

(ii) Goals. In accordance with the “Goals Section” of the standard specified in § 170.205(a)(4).

(iii) Health concerns. In accordance with the “Health Concerns Section” of the standard specified in § 170.205(a)(4).

(iv) 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).

(1) The standard specified in § 170.207(i).

(2) At a minimum, the version of the standard specified in § 170.207(a)(1).

(1) Date of birth constraint. (i) The year, month and day of birth must be present for a date of birth. The technology must include a null value when the date of birth is unknown.

(ii) Optional. When the hour, minute, and second are associated with a date of birth the technology must demonstrate that the correct time zone offset is included.

(2) Phone number constraint. Represent phone number (home, business, cell) in accordance with the standards adopted in § 170.207(q)(1). All phone numbers must be included when multiple phone numbers are present.

(3) Sex Constraint: Represent sex with the standard adopted in § 170.207(n)(1) up to and including December 31, 2025; or with the standard adopted in § 170.207(n)(2).

(1) Medications. At a minimum, the version of the standard specified in § 170.213;

(2) Allergies and intolerance. At a minimum, the version of the standard specified in § 170.213; and

(3) Problems. At a minimum, the version of the standard specified in § 170.213.

(1) Problems;

(2) Medications;

(3) Allergies and Intolerances;

(4) At least one demographic specified in paragraph (a)(5)(i) of this section;

(5) Laboratory;

(6) Vital Signs;

(7) Unique Device Identifier(s) for a Patient's Implantable Device(s); and

(8) Procedures.

(2) Developer of the intervention (translation from clinical research or guideline);

(3) Funding source of the technical implementation for the intervention(s) development;

(4) Release and, if applicable, revision dates of the intervention or reference source;

(5) Use of race as expressed in the standards in § 170.213;

(6) Use of ethnicity as expressed in the standards in § 170.213;

(7) Use of language as expressed in the standards in § 170.213;

(8) Use of sexual orientation as expressed in the standards in § 170.213;

(9) Use of gender identity as expressed in the standards in § 170.213;

(10) Use of sex as expressed in the standards in § 170.213;

(11) Use of date of birth as expressed in the standards in § 170.213;

(12) Use of social determinants of health data as expressed in the standards in § 170.213; and

(13) Use of health status assessments data as expressed in the standards in § 170.213.

(i) Name and contact information for the intervention developer;

(ii) Funding source of the technical implementation for the intervention(s) development;

(iii) Description of value that the intervention produces as an output; and

(iv) Whether the intervention output is a prediction, classification, recommendation, evaluation, analysis, or other type of output.

(2) Purpose of the intervention, including:

(i) Intended use of the intervention;

(ii) Intended patient population(s) for the intervention's use;

(iii) Intended user(s); and

(iv) Intended decision-making role for which the intervention was designed to be used/for (e.g., informs, augments, replaces clinical management).

(3) Cautioned out-of-scope use of the intervention, including:

(i) Description of tasks, situations, or populations where a user is cautioned against applying the intervention; and

(ii) Known risks, inappropriate settings, inappropriate uses, or known limitations.

(4) Intervention development details and input features, including at a minimum:

(i) Exclusion and inclusion criteria that influenced the training data set;

(ii) Use of variables in paragraphs (b)(11)(iv)(A)(5) through (13) of this section as input features;

(iii) Description of demographic representativeness according to variables in paragraphs (b)(11)(iv)(A)(5) through (13) of this section including, at a minimum, those used as input features in the intervention;

(iv) Description of relevance of training data to intended deployed setting; and

(5) Process used to ensure fairness in development of the intervention, including:

(i) Description of the approach the intervention developer has taken to ensure that the intervention's output is fair; and

(ii) Description of approaches to manage, reduce, or eliminate bias.

(6) External validation process, including:

(i) Description of the data source, clinical setting, or environment where an intervention's validity and fairness has been assessed, other than the source of training and testing data

(ii) Party that conducted the external testing;

(iii) Description of demographic representativeness of external data according to variables in paragraph (b)(11)(iv)(A)(5)-(13) including, at a minimum, those used as input features in the intervention; and

(iv) Description of external validation process.

(7) Quantitative measures of performance, including:

(i) Validity of intervention in test data derived from the same source as the initial training data;

(ii) Fairness of intervention in test data derived from the same source as the initial training data;

(iii) Validity of intervention in data external to or from a different source than the initial training data;

(iv) Fairness of intervention in data external to or from a different source than the initial training data;

(v) References to evaluation of use of the intervention on outcomes, including, bibliographic citations or hyperlinks to evaluations of how well the intervention reduced morbidity, mortality, length of stay, or other outcomes;

(8) Ongoing maintenance of intervention implementation and use, including:

(i) Description of process and frequency by which the intervention's validity is monitored over time;

(ii) Validity of intervention in local data;

(iii) Description of the process and frequency by which the intervention's fairness is monitored over time;

(iv) Fairness of intervention in local data; and

(9) Update and continued validation or fairness assessment schedule, including:

(i) Description of process and frequency by which the intervention is updated; and

(ii) Description of frequency by which the intervention's performance is corrected when risks related to validity and fairness are identified.

(1) The data classes expressed in the standards in § 170.213 (which should be in their English (i.e., non-coded) representation if they associate with a vocabulary/code set), and in accordance with § 170.205(a)(4) and (a)(5), and paragraphs (e)(1)(i)(A)(3)(i) through (iii) of this section for the time period up to and including December 31, 2025, or

(2) The data classes expressed in the standards in § 170.213 (which should be in their English (i.e., non-coded) representation if they associate with a vocabulary/code set), and in accordance with § 170.205(a)(4) and (a)(6), and paragraphs (e)(1)(i)(A)(3)(i) through (iii) of this section.

(3) The following data classes:

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

(ii) Goals. In accordance with the “Goals Section” of the standard specified in § 170.205(a)(4).

(iii) Health concerns. In accordance with the “Health Concerns Section” of the standard specified in § 170.205(a)(4).

(iv) 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 standards specified in § 170.205(a)(4).

(4) Ambulatory setting only. Provider's name and office contact information.

(5) Inpatient setting only. Admission and discharge dates and locations; discharge instructions; and reason(s) for hospitalization.

(6) Laboratory test report(s). Laboratory test report(s), including:

(i) The information for a test report as specified all the data specified in 42 CFR 493.1291(c)(1) through (7);

(ii) The information related to reference intervals or normal values as specified in 42 CFR 493.1291(d); and

(iii) The information for corrected reports as specified in 42 CFR 493.1291(k)(2).

(7) Diagnostic image report(s).

(i) Human readable format; and

(ii) The format specified in accordance with the standard specified in § 170.205(a)(4) and (5) for the time period up to and including December 31, 2025, or § 170.205(a)(4) and (6), and following the CCD document template.

(2) When downloaded according to the standard specified in § 170.205(a)(4) through (6) following the CCD document template, the ambulatory summary or inpatient summary must include, at a minimum, the following data (which, for the human readable version, should be in their English representation if they associate with a vocabulary/code set):

(i) Ambulatory setting only. All of the data specified in paragraph (e)(1)(i)(A)(1), (2), (4), and (5) of this section.

(ii) Inpatient setting only. All of the data specified in paragraphs (e)(1)(i)(A)(1), and (3) through (5) of this section.

(3) Inpatient setting only. Patients (and their authorized representatives) must be able to download transition of care/referral summaries that were created as a result of a transition of care (pursuant to the capability expressed in the certification criterion specified in paragraph (b)(1) of this section).

(1) Transmit the ambulatory summary or inpatient summary (as applicable to the health IT setting for which certification is requested) created in paragraph (e)(1)(i)(B)(2) of this section in accordance with both of the following ways:

(i) Email transmission to any email address; and

(ii) An encrypted method of electronic transmission.

(2) Inpatient setting only. Transmit transition of care/referral summaries (as a result of a transition of care/referral as referenced by (e)(1)(i)(B)(3)) of this section selected by the patient (or their authorized representative) in both of the ways referenced (e)(1)(i)(C)(1)(i) and (ii) of this section).

(1) Select data associated with a specific date (to be viewed, downloaded, or transmitted); and

(2) Select data within an identified date range (to be viewed, downloaded, or transmitted).