§170.204. Functional standards. — Inbound Citations

(i) Patients (and their authorized representatives) must be able to use internet-based technology to view, download, and transmit their health information to a 3rd party in the manner specified below. Such access must be consistent and in accordance with the standard adopted in § 170.204(a)(1) and may alternatively be demonstrated in accordance with the standard specified in § 170.204(a)(2).

(A) Patients (and their authorized representatives) must be able to use health IT to view, at a minimum, the following data:

(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).

(B) (1) Patients (and their authorized representatives) must be able to use technology to download an ambulatory summary or inpatient summary (as applicable to the health IT setting for which certification is requested) in the following formats:

(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).

(C) Patients (and their authorized representatives) must be able to:

(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).

(D) With respect to the data available to view, download, and transmit as referenced paragraphs (e)(1)(i)(A), (B), and (C) of this section, patients (and their authorized representatives) must be able to:

(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).

(i) Patients (and their authorized representatives) must be able to use internet-based technology to view, download, and transmit their health information to a 3rd party in the manner specified below. Such access must be consistent and in accordance with the standard adopted in § 170.204(a)(1) and may alternatively be demonstrated in accordance with the standard specified in § 170.204(a)(2).

(A) Patients (and their authorized representatives) must be able to use health IT to view, at a minimum, the following data:

(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).

(B) (1) Patients (and their authorized representatives) must be able to use technology to download an ambulatory summary or inpatient summary (as applicable to the health IT setting for which certification is requested) in the following formats:

(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).

(C) Patients (and their authorized representatives) must be able to:

(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).

(D) With respect to the data available to view, download, and transmit as referenced paragraphs (e)(1)(i)(A), (B), and (C) of this section, patients (and their authorized representatives) must be able to:

(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).