Data Access Framework (DAF) Kickoff 7/16/2013 July 16 th, 2013 Doug Fridsma, MD, PhD, FACP, FACMI Chief Science Officer & Director, Office of Science & Technology John Feikema – Initiative Coordinator Mera Choi – ONC Lead 1

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Opening Remarks - Doug Fridsma, MD, PhD Director, Office of Standards and Technology, ONC The Standards & Interoperability Framework Initiative Introduction Data Access Framework Initiative o History o Importance o Scope o Expected Outcomes o Timeline Next Steps/Call for Participation Questions & Answers Resources Agenda 3

Office of Science and Technology(OST) Promote compliance with validated information exchange standards, services and policies to assure interoperability between validated systems 4

S&I Framework Overview Specific health interoperability initiatives guide the design and development of a fully integrated and connected health information system. An S&I Initiative focuses on a single challenge with a set of value-creating goals and outcomes, and the development of content, technical specifications and reusable tools and services. Call for Participation: The overall success of the S&I Framework is dependent upon volunteer experts from the healthcare industry and we welcome any interested party to get involved in S&I Framework Initiatives, participate in discussions and provide comments and feedback by joining the Wiki: 5

S&I Framework Coordination 6 ONC Programs & Grantees Community S&I Framework FACAs SDOs State HIE Program & CoPs SHARP Program REC Program & CoPs Beacon Program Technology Vendors System Integrators Government Agencies Industry Associations Other Experts HL7 IHE CDISC NCPDP ASC X12 ASTM WEDI HIT Standards Committee HIT Policy Committee Tiger Team ISO/TC 215 IHTSDO NLM NQF Regenstrief Other health IT standards related organizations

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. 7 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

S&I Framework Phases & Data Access Framework (DAF)Activities 8 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 Vocabulary Implementation  Creation of aligned specification  Documentation of relevant specifications and reference implementations such as guides, design documents, etc.  Validation of Vocabulary  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

A Brief History of the Data Access Framework (DAF) BlueButton initiatives enabled patients to access to their own data DAF is a similar concept, except it is focused on enabling providers to access their patient’s data both within and across organizations –Current industry standards are not modular enough to allow the different types of data access desired by Providers –NwHIN targeted and distributed queries –Multiple ONC initiatives Query Health, Innovation projects identified multiple data access challenges within and across organizations 9

Data Access Framework Problems to Solve Data Portability –Patient moving from one provider to a new provider Quality Improvement –A need for customized “small data analytics” for quality improvement –NwHIN/Targeted Query Remote “chart pulls” Public Health –Common framework needed 10

DAF will identify/create/modify standards to solve basic data access issues faced by providers within their own organization and across organizations in a modular and substitutable fashion. DAF is focused on enabling providers, their tools and applications to access their patient’s data Through new or modified standards DAF will allow providers to use new and innovative applications improve and fill gaps (such as medication tracking, long term care needs) in patient care What is DAF 11

DAF - Example Real World Scenarios A provider wants to access data about a particular population within his/her practice using quality measures For example the provider wants to know all diabetic patients with HbA1c > 8% within their organization A provider wants to access the complete medical history of a patient to improve care and use new tools and applications to improve care Tools include predictive modeling, comparison with existing data sets etc. Enable applications such as Medication Adherence and Tracking to be used by patients and care givers. Enable social workers and other care givers to consume the patient information and determine the next steps in providing care. These may include determining what kind of long term care facility best suits the patient based on their demographics, diagnosis, medications etc. Build an Extraction capability (such as an API) from EMRs 12

DAF – Challenge… Data Access Framework has to support a wide variety of user stories (sample illustrated in table below) 13 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 – Challenges Cont’d To support the various user stories and access mechanisms there is a need to create a modular and substitutable framework that can be evolve with the industry over time –Modular framework can be best visualized as a stack of standards with multiple layers independent of each other –Substitutable standards will provide the ability to replace standards for a single layer and reuse standards from the other layers Basic Transport Protocols Application Transport Protocols Query Structure Query Vocabularies and Value Sets Authentication/Autho rization Result Structure Result Vocabularies and Value Sets Information Models Transport Layer Security Layer Query Structure Query Results Data Model to support queries Data Access Framework 14

Basic Transport Protocols Application Transport Protocols Query Structure Query Vocabularies and Value Sets Authentication/Autho rization Result Structure Result Vocabularies and Value Sets Information Models DAF – Modularity and Substitutability Challenge Transport Layer Security Layer Query Structure Query Results Data Model to support queries Data Access FrameworkInitial Candidate Standards HTTP SMTP SOAP (IHE SOAP) SOAP (IHE SOAP) RESTful (IHE mHealth) RESTful (IHE mHealth) Direct TLS+SAML TLS+OAuth2 S/MIME ebRIM/ebRS HL7 FHIR HL7 HQMF C-CDA HL7 v2.5.1 QRDA I, II, III MU2 ModSpec RTM 15

Data Access Framework Local Access via Intra-Organization Query Targeted Access via Inter-Organization Query Multiple Data Source Access via Distributed Query (Query Health) – Completed Initiative Standards based approach to enable access at all levels: Local, Targeted, and Distributed Create and disseminate queries internal to organization Query Structure Layer APIs Receive standardized responses Query Results Layer Create and disseminate queries internal to organization Query Structure Layer APIs Receive standardized responses Query Results Layer Create and disseminate queries to external organization Query Structure Layer Transport Layer Authentication/Authorization Layer Receive standardized responses from external orgs Query Results Layer Create and disseminate queries to external organization Query Structure Layer Transport Layer Authentication/Authorization Layer Receive standardized responses from external orgs Query Results Layer Create and disseminate queries to multiple orgs Governed by a network Receive aggregated or de-identified responses Focus on Information Model for the network and leverage standards from earlier phases. Create and disseminate queries to multiple orgs Governed by a network Receive aggregated or de-identified responses Focus on Information Model for the network and leverage standards from earlier phases. Data Source Data Source Data Source Query Request Query Response X Hospital System Y Hospital System DAF – Overall Context 16

DAF - Scope The work of this initiative will be done in 2 phases: Phase 1 is focused on Local Access via Intra Organization Query Phase 2 is 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 APIs that allow applications to query data in a consistent manner across EHRs. We will work with FACA and OPP to coordinate policy issues 17

Organization Entity A Sends: Data Query Receives: Patient(s) Data or Document Information Requester Internal Information System Scenario Example: Information Requester sends a data query to his/her Internal Information System requesting information about one or more patient(s). The Internal Information System returns the requested patient data or document to the Information Requester. DAF - Local Data Access Workstream via Intra-Organizational Query 18

Firewall DAF - Targeted Data Access Workstream via Inter-Organizational Query Organization Entity A Originating Request System Data Source System Sends: Data Query Receives: Patient(s) Data or Document Organization Entity B Scenario Example: Originating Request System from Org A sends a data query to a known external organization requesting information for a known patient to Data Source System from Org B. The Data Source System from Org B returns the requested patient data or document to the Originating Request System in Org A. 19

Notional Project Timeline Kick-off (7/16) Pre-Discovery, Call for Participation Jan 2014 Nov Discovery S&I Lifecycle (Discovery  Pilot & Evaluation) 20 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

Logistics We will be meeting as a community every week on Wednesdays This will be a 60 minute meeting Community Meeting Time Wednesdays 12:00-1:00 EST All Announcements, Meeting Schedules, Agendas, Minutes, Reference Materials, Use Case, Project Charter and General Data Access Framework information will be posted on the Data Access Framework Wiki page Join us for our next meeting July 24th, 2013 See the wiki page for the meeting updates 21

Data Access Framework Wiki Page Data Access Framework Wiki Page 22

Next Steps – Sign Up The ONC Data Access Framework Initiative is open for anyone to join. This community will meet frequently by webinar and teleconference We use Wiki pages to facilitate discussion. Information on how to join the Community can be found on the Data Access Framework Sign Up Wiki: ative ative In order to ensure the success of our initiative and the subsequent pilot, we encourage broad and diverse participation from the community. This is your chance to have an impact on the creation and implementation of a pilot program in this important area of health IT development. 23

Next Steps – Getting Started Details on the Data Access Framework launch including this presentation are posted on the wiki: Please feel to review and comment on the Proposed Project Charter To review the Data Access Framework Project Charter go to the Charter wiki page: mbers mbers Complete the Data Access Framework Project Charter Comment Form: mbers (you will need to select the “Click Here to Provide Comments” in the Project Charter Comments Section) mbers Join us for our next meeting July 24 th, 2013 from 12-1 pm EST All meeting updates, call in number and web meeting details can be found here:

Resources and Questions Please feel free to reach out to any member of the Data Access Framework Initiative team: Initiative Coordinator: John Feikema: ONC Sponsors Mera Choi: Support Team: Project Management: Jamie Parker and Gayathri Jayawardena Technical Support: Dragon (Nagesh) Bashyam Use Case Development: Presha Patel Vocabulary and Terminology Subject Matter Expert: Mark Roche 25