ToC+RI+Architecture+Scope

include component="page" wikiName="siframework" page="TOC Header" This wiki page provides detailed information on the scope of the ToC RI Architecture and components that will be leveraged to create a robust ToC Reference Implementation (RI). The WG has reached final consensus on this artifact.

Scope of ToC Reference Implementation Architecture
The goal of the ToC RI Architecture is to identify the layers, components, interactions and patterns that are necessary to create a reference implementation that can be used by the community. It will support the Purpose and Goals of the ToC Initiative and the ToC Use Cases by providing **open source code** to assist developers (vendors, providers, individuals, etc.) to **more efficiently create valid ToC information packages (content)**, based upon the outcomes of the following workgroups: CIM/Vocab, Standard Analysis and CDA Harmonization that can be exchanged and understood equivalently by senders and receivers, as described in the Abstract Model. It is understood that content must be secured, transported, audited, etc., but this particular ToC Initiative and its reference implementation focus is only on the **content** of the information packages.

Reference Implementation Goals

 * 1) **Create valid ToC documents as outputs, as defined in the ToC S&I Implementation Guide, using** **the Clinical Information Model (CEDD) objects as inputs.** Provide code which supports the ability of the source to "create a ToC Information Package" e.g., as required for Discharge or Consults.
 * 2) **Create an object-oriented implementation of the ToC CEDD.** Provide well-defined, straightforward API to CEDD data elements for use by client applications in processing instances of ToC documents.
 * 3) **Create valid CEDD objects as outputs using** ToC documents as inputs. Provide code that supports the ability to "decipher and validate the ToC Information Package" for incorporation of the information by a consumer.
 * 4) **Validate ToC output documents against the ToC S&I Implementation Guide.** These tools will validate that a ToC Information Package is complete and correct. These tools can validate ToC documents that are created either by the RI or any other method (e.g., ToC documents produced by vendors through their own code). These tools may be similar to tools currently provided by NIST, but will fully support any new constraints from the ToC initiative (including the CDA consolidation when it is approved), and will be offered to NIST to incorporate into their toolkit for validators.

In-Scope

 * **The RI focuses on clinical content**, consistent with the scope and charter of the ToC Initiative.
 * **RI provides tools as aids, not as "standards."** RI tools do not supersede or replace balloted standards or implementation guides (e.g., CDA is a standard, but any APIs provided by RI services are optional aids to produce standardized outputs, not to become standards in themselves).
 * **The data elements identified by the ToC Use Case Care Planning WG, and supported by the ToC CEDD, are within scope.**

Out-of-Scope

 * **In the ToC Use Case Care Planning WG, the workflow, processes and governance associated with care planning, as well as care planning data elements, not currently supported by the ToC CEDD,** **are out of scope.**
 * **Transport, Security, Privacy, Addressing, Audit, and Patient Identification are out of scope for the ToC RI.** These are all essential components from an overall system perspective. However, this ToC initiative is about content, not about transport or other infrastructure. The RI will not produce code to transport, encrypt, or otherwise "secure" the payloads from a sender to a receiver. Other projects (Direct Project, Nationwide Health Information Network Exchange and CONNECT, etc.) have produced RI open source code for transport, encryption, and other infrastructure. (include links to their source libraries). Some standards -- e.g., access control, audit log, authentication, integrity, encryption of data in rest and in transit, have already been specified by ONC in its Final Rule for EHR Standards and Certification. Other ONC S&I Framework Initiatives, such as Provider Directory and Certificate Interoperability, address gaps in standards and implementation guidance that have not been previously specified in regulations and/or standards.

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