Data Access Framework (DAF) All Community Meeting July 24, 2013

Meeting Etiquette Remember: If you are not speaking keep your phone on mute Do not put your phone on hold – if you need to take a call, hang up and dial in again when finished with your other call – Hold = Elevator Music = very frustrated speakers and participants This meeting, like all of our meeting is being recorded – Another reason to keep your phone on mute when not speaking Feel free to use the “Chat” feature for questions, comments or any items you would like the moderator or participants to know. NOTE: This meeting is being recorded and will be posted on the Meeting Minutes Wiki page after the meeting From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute 2

Agenda TopicTime Allotted General Announcements5 minutes Review of DAF Project Charter45 Minutes Next Steps/Questions10 Minutes 3

General Announcements The Data Access Framework (DAF) All Hands Community meets every Wednesday from 12:00-1:00 PM EDT – To participate please see the “Weekly Meetings” Section of the DAF Wiki Homepage: Note: Please check the meeting schedule weekly to get the most up-to-date meeting information 4

Join the Initiative We encourage all members to “sign up” or join the initiative. By joining this ensures you stay up-to-date with the work being done, communications and any initiative activities. Simply complete the Join Form on the Join Wiki Page: org/Data+Access+Fra mework+Join+the+Initi ative org/Data+Access+Fra mework+Join+the+Initi ative 5

S&I Framework Phases & Data Access Framework Activities 6 We are Here

DAF Project Charter-Challenge Challenge… The wide deployment of Electronic Health Records (EHRs) has created unique opportunities as well as challenges for Providers, Care Managers and Organizations etc. to access and use the patient data that is already collected during clinical workflows. Who is accessing the data, why are they accessing the data and what are the challenges faced in accessing the data? – Providers, Caregivers etc. want to access data within their own organization so that they can use additional care management tools appropriate for the patient. And to access their own data allows for the use innovative and new applications that can improve patient engagement and care. – Providers, Caregivers etc. want to access data from external organizations visited by patients for specific healthcare needs. Accessing data from an external organization requires the appropriate authentication and authorization before data can be made available. 7

DAF Project Charter-Challenge Challenge Continued Again, who is accessing the data, why are they accessing the data and what are the challenges faced in accessing the data? – Applications within an organization integrated into various clinical workflows require the ability to access the data from an EHR using Application Program Interfaces (API’s) that are consistent across vendors. – Currently there is no uniform way of accessing data within an organization or from an external organization. This presents a huge challenge for providers who are using data in combination with external 3rd party applications to improve their patient’s health. What are the types of data accesses that need to be supported? While there are a large spectrum of data granularity required based on the business requirements they can be abstracted using example dimensions represented in the table found on the next slide. – Note: The Data Access mechanism dimension can keep extending depending on the types of information that provider is trying to access, one example is accessing decision support information within a clinical workflow. 8

DAF Project Charter-Challenge Challenge Example The challenge is to select appropriate mechanisms to access the data described in the above table in a uniform way both within an organization and from an external organization. – While query concepts can be used to access the data, standardizing query mechanisms for the variety of data access needs presents a significant technical challenge. 9 Data Access Mechanism (Query) Formats Document based access Data element based access Data Access using quality measures Granularity of Data being accessed Patient Level Data Get me the latest C- CDA or lab result for a patient so that I can check if their HbA1c > 9% Retrieve dates where the patients HbA1c > 9% Get patient data for patients between 18 to 75 with HbA1c > 9% during a time frame. Population Level Data Get me the latest C- CDA’s for all patients. Identify and retrieve patients age >=65 who are due for annual Influenza immunization. Use Quality Measure to retrieve the percentage of diabetic patients with HbA1c > 9% from the population of all diabetics.

DAF Project Charter-Challenge Real World Challenge… To add to the above challenges, Interoperable Implementation of DAF in the real-world will require selection of multiple standards across multiple layers. These standards can be visualized as a Query stack (Draft). The Query stack identifies the various layers for which standards would have to be selected and implemented. An example of an existing Data Access Framework using IHE XCA Query stack is also shown to aid the reader. The DAF Initiative recognizes that solving the various challenges outlined above requires a Query stack that is composed of Modular and Substitutable standards. 10

DAF Project Charter-Challenge Real World Challenge … Modularity is the ability to keep the various layers of standards independent of each other. – e.g. Transport Layer standards should be independent of query structure standards which should be independent of query result standards. Substitutability is the ability to replace a particular standard without affecting the other layers of the query stack. – e.g. depending on the business requirements the query structure might be best represented using ebRIM/ebRS or HL7 FHIR or HL7 HQMF. 11

DAF Project Charter-Challenge Real World Challenge Continued The goal for the initiative is to modularize the query stack into modular layers (transport, query structure, query results, authentication etc.) and allow for substitutability at each layer of the query stack. The Initiative will leverage existing industry standards to create a framework that demonstrates modularity and substitutability for a limited set of combinations based on identified business requirements of the community 12

DAF Project Charter-Scope Scope Statement The Data Access Framework will be built incrementally by first focusing on Local Access via Intra-Organization query, Targeted Access via Inter- Organization query, and finally Multiple Data Source Access via Distributed Queries. This incremental path and focus areas are shown on the next slide. 13

DAF Project Charter-Scope Scope Statement – In Scope The initiative will be completed in 2 phases : Phase 1: focused on Local Access via Intra Organization Query Phase 2:focused on Targeted Access via Inter Organization Query The following capabilities are In-Scope: Define the modular layers for Data Access Framework to support identified business and functional requirements. Identify the existing standards that can be used for each layer of the Data Access Framework including guidance for substitutability of standards for both Local Access and Targeted Access. Define Implementation Guides leveraging existing standards where necessary to structure queries and query results for identified business and functional requirements. Identify standardized API’s that allow applications to query data in a consistent manner across EHRs. 14

DAF Project Charter-Scope Scope Statement- Out of Scope The following capabilities are Out-of-Scope: Policy aspects that allow queries to be executed within an organization or across organizations. Policies include Trust establishment between organizations, any governance required, data use agreements, privacy laws, authorization rules to disclose data. Patient Matching to identify patients and related records for query purposes. Patient consent aspects for query purposes which varies from organization to organization. Data Source capabilities including Information Models, terminologies and vocabulary definitions required to support the selected standards are out of scope. Discovery of Query Service end points are out of scope. 15

DAF Project Charter-Value Value Statement… The value of the DAF in the real world is the ability to use multiple modular and substitutable standards as necessary to implement sample scenarios listed in the table below. Note - The Multiple Data Source Access scenarios in the table found on the next slide are examples of work done in the Query Health Initiative and are out of scope. These are just examples to demonstrate the applicability of Data Access Framework. 16

DAF Project Charter-Value Value Statement Continued The above table is for example purposes only and does not convey actual work products. Appropriate Scenarios and User Stories to support this initiative will be further detailed during the Use Case and functional requirements phase with assistance from the community. 17 Local Access via Intra-Organization Query Targeted Access via Inter - Organization Query between two organizations Multiple Data Source Access via Distributed Queries – Out of Scope Access a Patient’s latest Clinical data using demographic information. Access a Patient’s latest Clinical data from an external organization using demographic information. Access a Patient’s latest Clinical data from multiple organizations using demographic information. Access the list of all patients who have hbA1C > 8% over a period of time Access lab results, medications from a recent encounter at an external organization for a patient who has hbA1C > 8%. Determine the percentage of patients who have hbA1C > 8% among all diabetics across multiple organizations. Allow clinical research/population analysis tools, 3 rd party applications to function alongside the EHRs by accessing the necessary patient or population data from the EHR. Access an EMR for a single patient’s longitudinal clinical information (i.e.. Allergies, medications, procedures, problem list across multiple encounters) De novo queries for clinical research, quality measures, population health and analysis

DAF Project Charter-Outcomes Outcomes Empowering providers to manage their patients effectively across care settings by accessing the appropriate data required for treatment and care transitions. Improvement in provider experience and workflow for patient care and other purposes. Allow innovative applications outside of the EHR to provide value added functions to improve patient care by accessing EHR data within an organization. Ability to use the Data Access Framework standards in a consistent way for meaningful use of health information technology. Leverage existing standards from IHE, HL7 and others to compose a modular and substitutable Data Access Framework and support standards in use by eHealth Exchange, EHR vendor communities, HIO’s, RHIO’s. Establish the incremental path that builds the necessary infrastructure to scale data access nationally. 18

DAF Project Charter-Deliverables Deliverables Project Charter Use Case and Functional Requirements 1 – Local Access via Intra- Organizational Query Use Case and Functional Requirements 2 – Targeted Access via Inter-Organizational Query Project proposals to Standards Organizations Data Access Technical Framework and approach – Identify/modify standards to support Local Access via Intra- Organization query – Identify/modify standards to support Targeted Access via Inter-Organization query between organizations which may be using health information systems from same or multiple vendors. – Implementation guides to support the implementation of use cases Demonstrate implementation of both Use Cases through successful pilots and obtain Pilot Feedback 19

DAF Project Charter-Strategic Alignment Strategic Alignment The Data Access Framework will strategically align with – HITPC and HITSC guidance on queries – ONC Innovation community work – Meaningful Use Stage 2 standards where applicable – CommonWell work related to queries – eHealth Exchange standards related to queries – Existing standards from IHE and HL7 20

Proposed Timeline Kick-off (7/16) Pre-Discovery, Call for Participation Jan 2014 Nov Discovery S&I Lifecycle (Discovery  Pilot & Evaluation) 21 July 2013Sept Implementation Define Use Case & Functional Requirements Standards Gap Analysis Harmonized Specifications Technology Evaluations Technical Project Outline (11/14) Use Case 1 Consented 10/22 UC 1: Local Data Access : Intra- Organizational Query UC 2: Targeted Data Access : Inter- Organizational Query Discovery Define Use Case & Functional Requirements Implementation Standards Gap Analysis Use Case 2 Consented 11/29 Charter Review & Consensus

DAF Project Charter- Principles Guiding Principles To guide the Initiative across various S&I Framework phases we will: – Leverage existing intellectual property, technology, and standards to create the Data Access Framework – Allow Data Access Framework to be used and integrated into clinical workflows using APIs for Local Queries. Leverage internet technologies to enable national scale and performance Make decisions to promote modularity and substitutability while balancing complexity Leverage data captured during the routine course of patient care without adding new workflows or data capture requirements on the provider Align with other applicable S&I Initiatives for standards across each of the Data Access Framework layers 22

DAF Project Charter-Standards Relevant Standards The following are a list of candidate standards that have been identified for consideration across the various Data Access Framework layers. Other standards, as they are identified, will be included as part of the candidate standards analysis: 23 NOTE: In addition to these standards the HL7 FHIR will be analyzed to support API’s for Local Queries

DAF Project Charter-Stakeholders Relevant Stakeholders 24 Individual ProvidersProvider Organizations Query Thought Leaders Government Agencies Standards Organizations HIE/HIO HIT Vendors- EHR/EMR/PHR Other Healthcare Vendors Privacy and Security Experts PatientsPatient AdvocatesBeacon Communities Federal Agencies

DAF Project Charter-Risks Potential Risks, Issues and Obstacles… Risk #1: Trying to address several interoperability problems in a single Initiative – Mitigation: Constrain the use cases and requirements within a manageable scope so that readily available standards are leveraged. Risk #2: Projected timeline may not be achievable due to various reasons such as lack of community input, delays in achieving consensus on artifacts, and unavailability of relevant experts – Mitigation: Work with community to refine timeline as the initiative progresses and adjust timelines as needed. Risk #3: EHR vendors have already implemented some query standards and may not have the availability to participate due to other priorities such as Meaningful Use – Mitigation: Include support for existing standards so that vendors can reuse existing implementations. 25

DAF Project Charter-Risks Potential Risks, Issues and Obstacles Continued Risk #4: Modularity and Substitutability identifies too many combinations of how to access data many of which may not be used in the real-world. – Mitigation: Identify the combinations based on the existing use cases and existing standards that are most likely to be adopted and implemented in the real-world. Risk #5: Ensuring potential Pilot Sites are identified and engaged throughout the initiative, so that the standards can be pilot tested in the real world. – Mitigation: Perform outreach and frequent communication, identify tangible Data Access Framework benefits to the potential pilot organization 26

Providing DAF Charter Comments 1.Review the DAF Project Charter – ata+Access+Framework+Charter +and+Members ata+Access+Framework+Charter +and+Members 2.Scroll ½ way down the page and fill out the comment form – All four fields are required 3.Submit your comments 4.A Message is displayed verifying your comment was submitted 27

Comment Evaluation Section of Project Charter: Scope Statement Comment: “I question whether it is practical to classify as "out of scope" the following: “Patient Matching to identify patients and related records for query purposes.“ While it is not necessary to specify the patient matching algorithms (probabilistic, deterministic, etc.), it seems impossible to implement the targeted inter-organizational query use case without some provision for patient matching, since separate organizations will not necessarily use the same patient identifier, and a universal patient identifier does not currently exist. I suggest that a "substitutable, modular" element of the stack at least be optional if not required. The HIT SC in 2011 published recommendations on patient identity matching. Even if existing standards have gaps, that is no different than many other areas in S&I Framework where standards have gaps, but that doesn't mean they should be ruled out-of-scope before starting” Section of Project Charter: General Statement Comment: Public health is also a stakeholder in this project and should be included in the listing. Public health agencies both provide data and use data from multiple sources. Draft Disposition: Discussion: 28

Next Steps Provide comments on DAF Charter Attend weekly “DAF All Hands Community Meetings” taking place every Wednesday from 12:00-1:00 PM EDT – Next Meeting July 31, 2013 Visit DAF Wiki page – All Announcements, Meeting Schedules, Agendas, Minutes, Reference Materials, Project Charter and General Data Access Framework information will be posted on the DAF Wiki page located at: NOTE: Please be sure to check the DAF wiki homepage for the most up- to-date meeting information

Initiative Support Leads For questions, please feel free to contact your support leads: – Initiative Coordinator: John Feikema – ONC Sponsors: Mera Choi – Support Team: Project Management: – Jamie Parker Technical Support: – Dragon (Nagesh) Bashyam Use Case Development: – Presha Patel Vocabulary and Terminology Subject Matter Expert: – Mark Roche Project Support – Gayathri Jayawardena 30

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Data Access Framework (DAF) Resources DAF Wiki Homepage – Become a Community Member – tive tive DAF Charter – embers embers Standards and Interoperability(S&I) Framework – S & I Calendar of Events –