§ 170.315 (b)(1): Transitions of Care | Transition of Care Functionality | Provider identified users are able to create transitions of care, validate and display C-CDA, send and receive summaries from the Health IT module. | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | The Health IT Module must be capable of receiving and sending message via SMTP and transmission should be encrypted by TLS |
| | | | | Must have the capability to receive one or more attachments such as C-CDA documents and XDM packages. Our EHR must be able to process and recognize XDM mime types |
| | | | | Must be capable of sending/receiving XDR message with Full (XDS) metadata (IHE XDR Profile for Limited Metadata ) |
| | | | | Health IT Module must be able to validate the format correctness of C-CDA documents |
| | | | | Health IT Module must be able to render C-CDA Documents and XDM packages with support for styling via css stylesheets for human readability |
| | | | | Health IT Module must have the capability to create and send valid C-CDA documents via SMTP Edge Protocol under a TLS connection |
| | | | | Must ensures that the required Data Elements for different settings are included in generated C-CDA’s |
§ 170.315 (b)(6): Data Export | C-CDA Data Export Functionality | Provider identified users are able to successfully export user-identified client C-CDA files for user-defined date/time ranges from the Health IT module. | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | Provider identified users can create export summaries in real-time; based on a relative date and time or a specific date and time. |
| | | | | Provider identified users can set configuration options for data elements, date and time ranges, and locations when generating a C-CDA |
| | | | | Provider identified users can generate a set of C-CDAs for between one client and all clients, without generating each C-CDA individually |
| | | | | C-CDA generation is limited to those users who have the proper role or system credentials, as determined by the provider |
| | | | | Provider identified users not having proper system credentials cannot generate C-CDAs. Applies to:- Document creation configuration
- Timeframe configuration
- Location Configuration
Only authorized users can set the limits of users who can do the above. |
| | | | | C-CDAs may be exported to local or network storage, in addition to integrated transmission methods |
§ 170.315 (c)(1): Clinical Quality Measures – Record and Export | Clinical quality measures (CQM) functionality | Provider identified users are able to record and export all of the data that would be necessary to calculate each CQM | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | The Health IT Module must be able to record all of the data that would be necessary to calculate each CQM. |
| | | | | Must be able to export a data file at any time the user chooses and without subsequent developer assistance to operate:- Formatted in accordance with the standard specified in §170.205(h)(2);
- Ranging from one to multiple patients; and
- That includes all of the data captured for each and every CQM to which technology was certifiaed under paragraph (c)(1)(i) of this section.
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§ 170.315 (c)(2): Clinical quality measures import and calculate | Clinical quality measures (CQM) functionality | Provider identified users are able to import a data file and use it to calculate all of the data that would be necessary to each CQM | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | The user must be able to import a data file in accordance with the standard specified in §170.205(h)(2) for one or multiple patients and use such data to perform the capability specified in paragraph (c)(2)(ii) of this section. A user must be able to execute this capability at any time the user chooses and without subsequent developer assistance to operate |
| | | | | The Health IT Module can calculate each and every clinical quality measure for which it is presented for certification. |
§ 170.315(c)(3) Clinical quality measures report | Clinical quality measures (CQM) functionality | Provider identified users are able to generate CQM data files for transmission based on appropriate QRDA guidelines. | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | The user must be able to electronically create a data file for transmission of clinical quality measurement data: (i) In accordance with the applicable implementation specifications specified by the CMS implementation guides for Quality Reporting Document Architecture (QRDA), category I, for inpatient measures in § 170.205(h)(3) and CMS implementation guide for QRDA, category III for ambulatory measures in § 170.205 (k)(3); or (ii) In accordance with the standards specified in § 170.205(h)(2) and § 170.205(k)(1) and (2) for the period until December 31, 2022. |
§ 170.315 (g)(7) Application access – patient selection | Application access functionality | An API must be able to receive a request with sufficient data to uniquely identify a patient and return an ID or other token that can be used by an application to subsequently execute requests for that patient’s data | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | The Health IT Module will uniquely identify a patient and return an ID or other token that can be used by the application to subsequently execute requests for that patient’s data. |
§ 170.315 (g)(8) Application access – data category request | Application access functionality | Upon receipt of an ID/Token, the API will return the requested data specified in the CCDS in full and in a computable format, and respond in regard to specific date requests as well as ranged requests. | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | The Health IT Module must be able to respond to requests for patient data (using an ID or other token) for each of the individual categories listed in the Common Clinical Data Set (CCDS) and return the full set of data for that category, according to the required data standards in a computable format. |
| | | | | The Health IT Module must be able to respond to requests for patient data associated with a specific date as well as requests for patient data with a specific date range. |
§ 170.315 (g)(9) Application access – all data request | Application access functionality | Upon receipt of an ID/Token, the API will return the requested data in a summary format following CCD documentation template guidelines, or provide the CCDS, and address assessment and plan of treatment, goals, health concerns, and unique device identifiers for any implantable devices. | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | The Health IT Module must be able to respond to requests for patient data (using an ID or other token) for all of the data categories specified in the United States Core Data for Interoperability Standard (USCDI) at one time in a summary record formatted according to the Consolidated CDA Release 2.1 Continuity of Care Document (CCD) template. |
| | | | | The Health IT Module must be able to respond to requests for patient data associated with a specific date as well as with a specific date range. |
§ 170.315 (h)(1) Direct Project | Direct Project functionality | Provider identified users are able to send and receive health information | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
| | | | | The Health IT Module can electronically transmit (send and receive) health information to a 3rd party which must be formatted only as a “wrapped” message using the Applicability Statement for Secure Health Transport, Version 1.2. |
| | | | | The Health IT Module can electronically transmit (send and receive) health information to a 3rd party using Direct in accordance with the Implementation Guide (IG) for Delivery Notification in Direct, Version 1.0. |