1. Data Provenance –Use Case (Discovery) Ahsin Azim– Use Case Lead Presha Patel – Use Case Lead 1

2. ONC Standards and Interoperability (S&I) Framework Lifecycle Our Missions » Promote a sustainable ecosystem that drives increasing interoperability and standards adoption » Create a collaborative, coordinated, incremental standards process that is led by the industry in solving real world problems » Leverage “government as a platform” – provide tools, coordination, and harmonization that will support interested parties as they develop solutions to interoperability and standards adoption. Tools and Services Use Case Development and Functional Requirements Standards Development Support Standards Development Support Certification and Testing Harmonization of Core Concepts Implementation Specifications Pilot Demonstration Projects Reference Implementation Architecture Refinement and Management 2

3. S&I Framework Phases outlined for Data Provenance PhasePlanned Activities Pre-Discovery  Development of Initiative Synopsis  Development of Initiative Charter  Definition of Goals & Initiative Outcomes Discovery  Creation/Validation of Use Cases, User Stories & Functional Requirements  Identification of interoperability gaps, barriers, obstacles and costs  Review of Candidate Standards Implementation  Creation of aligned specification  Documentation of relevant specifications and reference implementations such as guides, design documents, etc.  Development of testing tools and reference implementation tools Pilot  Validation of aligned specifications, testing tools, and reference implementation tools  Revision of documentation and tools Evaluation  Measurement of initiative success against goals and outcomes  Identification of best practices and lessons learned from pilots for wider scale deployment  Identification of hard and soft policy tools that could be considered for wider scale deployments 3

4. Use Case Development Objectives Engage Stakeholders as Committed Members, Invite Experts, or Interested Parties in the creation of a Use Case  This is you all! Identify Scenarios and User Stories that address real-world problems Keep it simple Focus on the business and functional requirements: Focus on “what” the requirements should be rather than “how” Create a finalized Use Case that demonstrates value and supports the proposed goals and success criteria for the Initiative Publish a finalized Use Case that contains necessary content, supported by artifacts, to enable Harmonization and subsequent S&I Framework efforts to occur 4

5. 1.0 Preface and Introduction 2.0 Initiative Overview – 2.1 Initiative Challenge Statement** 3.0 Use Case Scope – 3.1 Background** – 3.2 In Scope – 3.2 Out of Scope – 3.3 Communities of Interest (Stakeholders)** 4.0 Value Statement** 5.0 Use Case Assumptions 6.0 Pre-Conditions 7.0 Post Conditions 8.0 Actors and Roles 9.0 Use Case Diagram Use Case Outline Tailored for each Initiative 10.0 Scenario: Workflow – 10.1 User Story 1, 2, x, … – 10.2 Activity Diagram o 10.2.1 Base Flow o 10.2.2 Alternate Flow (if needed) – 10.3 Functional Requirements o 10.3.1 Information Interchange Requirements o 10.3.2 System Requirements – 10.4 Sequence Diagram 11.0 Dataset Requirements 12.0 Risks, Issues and Obstacles Appendices – Related Use Cases – Previous Work Efforts – References ** Leverage content from Charter 5

6. Assumptions Outlines what needs to be in place to meet or realize the requirements of the Use Case These points are more functional in nature and state the broad overarching concepts related to the Initiative The Use Case assumptions will serve as a starting point for subsequent harmonization activities Pre Conditions Describes the state of the system, from a technical perspective, that must be true before an operation, process, activity or task can be executed It lists what needs to be in place before executing the information exchange as described by the Functional Requirements and Dataset requirements Post Conditions Describes the state of the system, from a technical perspective, that will result after the execution of the operation, process activity or task Review of Key Use Case Sections Assumptions, Pre-conditions and Post-conditions 6

7. Review of Key Use Case Sections Use Case Diagrams Conceptually represents the Business Actors interacting with the Use Case and the User Stories Provides a pictorial representation of the environment where the exchange takes place Characterizes the types of interactions that an actor has with a specific system Shows the association and interaction between the business actors and the Use Case It provides an overview of the actors (users or external systems) and the interactions between them Example: Transitions of Care 7

8. Review of Key Use Case Sections Defining the Actors This section of the Use Case outlines the business actors that are participants in the information exchange requirements for each scenario. A business actor is a person or organization that directly participates in a scenario. The business actor must use a system to perform the functions and to participate in the information interchange. The system or system actor has roles (send, receive, publish, subscribe or in some cases display) and actions which involve exchanging content. Please see the table below for an example of these designations. ActorSystemRole PCPEHR SystemSender SpecialistEHR SystemReceiver PatientPHR SystemReceiver Example 8

9. Review of Key Use Case Sections Scenarios The scenario is a comprehensive description of the actors, interactions, activities, and requirements associated with the information exchange Scenarios pertain to supporting the health information exchange and describing key flows, and they are supplemented by User Stories Example: Specialist requests a patient’s Clinical Care Summary from Primary Care Provider (PCP) Scenario 1 User Story 1 User Story 2 Scenario 2 User Story 1User Story 2 9

10. Review of Key Use Case Sections User Story User Stories describe the real world application as an example or instantiation of the Scenario User Stories summarize the interaction between the actors of the Use Case, and specify what information is exchanged from a contextual perspective These interactions are further described in subsequent sections. Historically, user stories have been utilized to provide clinical context Example Scenario (from previous slide): Specialist requests a patient’s Clinical Care Summary from Primary Care Provider (PCP) Example User Story: A Specialist receives a referral and requires more information to treat the patient properly at the point of care. Using an EHR System, the Specialist sends a request to the PCP for the patient’s Clinical Care Summary. The PCP successfully receives the requests, understands the requests, and sends the patient’s Clinical Care Summary back to the Specialist via the EHR System. The Specialist successfully receives the patient information, understands it, and makes an informed decision that can provide better quality of care to the patient. 10

11. Review of Key Use Case Sections Activity Diagram An Activity Diagram is a special form of a state transition diagram in which all or most of the states are activity states or action states The Activity Diagram illustrates the Use Case flows graphically, and represents the flow of events and information between the actors – It also displays the main events/actions that are required for the data exchange and the role of each system in supporting the change 11

12. Review of Key Use Case Sections Functional Requirements Functional Requirements identify the capabilities a system in a role must have in order to enable interoperable exchange of the healthcare data of interest – They provide a detailed breakdown of the requirements in terms of the intended functional behaviors of the application The Functional Requirements include: – Information Interchange Requirements – System Requirements The Information Interchange Requirements define the system’s name and role. They also specify the actions associated with the actual transport of content from the sending system to the receiving system System Requirements include the requirements internal to the system necessary to participate successfully in the transaction. System requirements may also detail a required workflow that is essential to the Use Case 12

13. A Sequence Diagram is primarily used to show the interactions between objects in the sequential order that they occur – This representation can make it easy to communicate how the exchange works by displaying how the different components interact – The primary use of the diagram is in the transition from requirements expressed as use cases to the next and more formal level of refinement Note: Horizontal lines are used to identify the specific activity between the systems Review of Key Use Case Sections Sequence Diagram 13

14. Dataset Requirements Include the data elements and data element sets that will be available within the message or document. Each data element included is necessary for some aspect of the Use Case; however, the requirements do not specify exactly how they may be used together. All data element sets may contain multiple data elements unless otherwise stated. The identification of data elements forms the foundation for harmonization activities. The data elements identified in the Use Case set constraints on the contents of documents and messages. Issues Risks and Obstacles Lists the concerns that might interfere with meeting the requirements of the Use Case Note: This list takes into consideration risks outlined in the Charter Review of Key Use Case Sections Dataset Requirements & Issues, Risks & Obstacles 14

15. S&I Community Enabling Toolkit (CET) Use Case Overview 15

16. Proposed Use Case & Functional Requirements Development Timeline 16 Week Target Date (2014) All Hands WG Meeting Tasks Review & Comments from Community via Wiki page due following Tuesday by 8 P.M. Eastern 16/12 Use Case Kick-Off & UC Process Overview Introduce: In/Out of Scope & Assumptions Review: In/Out of Scope & Assumptions 26/19 Review: In/Out of Scope & Assumptions Introduce: Context Diagram & User Stories Review: Context Diagram & User Stories 36/26Review: Context Diagram & User StoriesReview: Continue Review of User Stories 47/3 Review: Finalize User Stories Introduce: Pre/Post Conditions Review: Pre/Post Conditions 57/10 Review: Pre/Post Conditions Introduce: Activity Diagram & Base Flow Review: Activity Diagram & Base Flow 67/17 Review: Activity Diagram & Base Flow Introduce: Functional Requirements & Sequence Diagram Review: Functional Requirements & Sequence Diagram 77/24 Review: Functional Requirements & Sequence Diagram Introduce: Data Requirements Review: Data Requirements 87/31 Review: Finalize Data Requirements Introduce: Risks & Issues Review: Risks & Issues 98/7 Review: Risks and Issues Begin End-to-End Review End-to-End Review by community 108/14End-to-End Comments Review & dispositionEnd-to-End Review ends 118/21Finalize End-to-End Review Comments & Begin ConsensusBegin casting consensus vote 128/28Consensus Vote*Conclude consensus voting

17. In/Out Scope Items 17 In Scope 1.To identify and define guidance on use of standards to facilitate provenance capabilities by specifying the following: *** 1.Standards for the provenance (e.g. origin, source, custodian(s), FHIR resources, CDA, etc.) 2.Supportive standards (e.g. integrity, non-repudiation) 3.Vocabulary standard metadata tags for data provenance 4.Variance in granularity to which data provenance can be collected, the way it is encoded, and how that provenance is communicated to consuming systems 2.Define system requirements that allow applications to generate, persist and retrieve provenance data and maintain associations with the target record 3.Ensure sufficient granularity to support chain of custody Out of Scope 1.Patient identity matching*** 2.Third party mechanisms for checking patient consent and the relative merits of existing policies or regulations (such as privacy policies or jurisdictional considerations)*** 3.Policy-based decisions (such as records management based policies on record retention) 4.Non-clinical data (such as environmental data) *** Leveraged from Charter

18. Assumptions 18 1.Clinical information that already exists within the EHR system (without the use of the CDA artifact) is found at the level appropriate for the implementation

19. Draft Use Case Context Diagram 19 End Point (EHR) End Point (EHR) True Source (EHR) True Source (Lab) Aggregator (EHR, HIE, other systems) Aggregator (EHR, HIE, other systems) True Source (Other)

20. A look ahead: Data Provenance Next Week 20 June 16 th, 2014 – Tiger Team (3-4 pm ET) June 19 th, 2014 – All Hands Community Meeting (2:30- 3:30) – Review In/Out Scope and Assumptions

21. Support Team and Questions Please feel free to reach out to any member of the Data Provenance Support Team: Initiative Coordinator: Johnathan Coleman: jc@securityrs.comjc@securityrs.com OCPO Sponsor: Julie Chua: julie.chua@hhs.govjulie.chua@hhs.gov OST Sponsor: Mera Choi: mera.choi@hhs.govmera.choi@hhs.gov Subject Matter Experts: Kathleen Conner: klc@securityrs.com and Bob Yencha: bobyencha@maine.rr.comklc@securityrs.combobyencha@maine.rr.com Support Team: – Project Management: Jamie Parker: jamie.parker@esacinc.comjamie.parker@esacinc.com – Use Case Development: Presha Patel: presha.patel@accenture.com and Ahsin Azim: ahsin.azim@accenturefederal.compresha.patel@accenture.comahsin.azim@accenturefederal.com – Harmonization: Rita Torkzadeh: rtorkzadeh@jbsinternational.comrtorkzadeh@jbsinternational.com – Standards Development Support: Amanda Nash: amanda.j.nash@accenturefederal.com amanda.j.nash@accenturefederal.com – Support: Lynette Elliott: lynette.elliott@esacinc.comlynette.elliott@esacinc.com 21