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Think Locally, Connect Nationally Didi Davis Director of Testing www.sequoiaproject.org 1 2017 The Sequoia Project. All rights reserved.

The Sequoia Project s Role The Sequoia Project is a trusted, independent convener of industry and government. We work to address the challenges of secure, interoperable nationwide health information exchange (HIE). SECURE INTEROPERABLE NATIONWIDE 2 2017 The Sequoia Project. All rights reserved.

Current Sequoia Project Initiatives The ehealth Exchange is the first and largest public-private health data sharing network in the U.S. Carequality is a national-level interoperability framework to inter-connect networks. RSNA Image Share Validation Program is an interoperability testing program to enable sharing of medical images and reports. 3 2017 The Sequoia Project. All rights reserved.

4 2017 The Sequoia Project. All rights reserved.

ehealth Exchange Objectives Establish multi-use framework for information exchange Across communities Between private sector and government Agree upon a common set of policies to engender trust Standardize interfaces Test once: exchange with many 5 2017 The Sequoia Project. All rights reserved. An initiative of

Patients Are Mobile, Their Data Should Be To Henry s doctor electronically requests and receives medical records from Virginia. Notes he is diabetic. Henry Tucker Alexandria, VA Age: 62 Diabetic Destination: San Francisco, CA During a Trip to San Francisco, Henry broke his arm 6 2017 The Sequoia Project. All Rights Reserved. An initiative of

Health Data Sharing Networks Power Exchange Destination: Alexandria, VA When he returns home, his doctors have electronic access to his medical records from California. 7 2017 The Sequoia Project. All Rights Reserved. An initiative of

ehealth Exchange is Largest Public-Private Health Data Sharing Network Supporting More Than 109 Million Patients Across: All 50 states 50,000 medical groups Four federal agencies (DoD, VA, HHS including CMS, and SSA) 3,200 dialysis centers ~65% U.S. hospitals 8,300 pharmacies Shared Governance and Trust Agreement Common Standards, Specifications & Policies 8 2017 The Sequoia Project. All rights reserved. An initiative of

National Use Cases and Standards Supported http://sequoiaproject.org/resources/exchange-specifications/ Specifications & Standards Query: SOAP / SAML + IHE Push: Direct, Document Submission / Admin Distribution Content: HL7 CDA, CCDA, quality measures HL7 FHIR Imaging Exchange Integrating the Healthcare Enterprise (IHE) - XDS-I, XCA-I Others added in 2016 VPN (transport) HL7 v2 (content) NCPDP, PMIX, SCRIPT 9 2017 The Sequoia Project. All rights reserved. An initiative of

ehealth Exchange Query Workflow (one of several supported) ehealth Exchange Participant Gateway Patient Discovery (IHE XCPD) Query for Documents (IHE XCA) Retrieve Documents (IHE XCA) (Acting as an Initiator) ehealth Exchange Participant Gateway Found patient Lists zero or more found documents Returns zero or more documents (Acting as a Responder) Searches for patients Searches for Document(s) Transmits Document(s) 10 2017 The Sequoia Project. All rights reserved. An initiative of

Broad Range of Patient-centric Use Cases Treatment / Care Coordination Social Security Benefits Determination Immunization Authorized Release of Information Consumer Access to Health Information Syndromic Surveillance Encounter Alerts Authorized Release of Information Life Insurance Prescription Drug Monitoring Program (PDMP) Electronic Lab Reporting (in support of public health) Image Share Use Case 11 2017 The Sequoia Project. All rights reserved. An initiative of

Supporting Active Duty Military, Retirees, their Families, & Veterans Sample Federal Use Cases DoD and VA: Support active servicemen and veterans throughout their care by making it possible for medical records to follow the patient, providing caregivers with up-to-date medical histories. Social Security Administration: Requests claimant s records electronically to make disability determinations. Cut down claims processes from months to days. CMS: CMS End Stage Renal Disease (ESRD) program is able to receive quality reporting data from dialysis centers to assure that individuals with ESRD receive the highest quality care. 12 2017 The Sequoia Project. All rights reserved. An initiative of

Social Security Administration Disability Determinations Use Case A Closer Look Manual Process (Mail, Fax, Scan) Application Filing Request for Medical Records Weeks to Months Waiting for Medical Records Electronic Process (ehealth Exchange) Application Filing Request for Medical Records Seconds to Minutes Waiting for Medical Records Receipt & Review of Medical Records Decision Receipt & Review of Medical Records Decision Benefits for Patients Faster disability claim determinations Quicker access to monthly cash benefits Earlier access to medical insurance coverage Social Security Disability Programs As of November, 2015, SSA is interoperating with nearly 100 ehealth Exchange partners and tens of thousands of sites 13 2017 The Sequoia Project. All rights reserved. An initiative of

Supports Alternative Payment Models Intel Connected Care Intel Corporation created an incentivized health insurance/care management program, Connected Care Piloted in New Mexico Rolled out to 20,000 beneficiaries in Portland, OR Launching in other markets Beneficiaries receive care from on-campus clinic and contracted providers in Portland Value-based payment model where providers measured by customer satisfaction, quality, cost and interoperability Progress is measured Alternative payment models drive the need for health data sharing and will be the catalyst for change Intel s Connected Care Program Value-based care model designed to improve overall health and wellness of Intel s employees by providing information exchange and real-time care analytics for optimal care 14 2017 The Sequoia Project. All rights reserved. An initiative of

ehealth Exchange Validated Products Vendor Validated Product Vendor Validated Product Benefits of Validation: New participants leveraging an ehealth Exchange Validated Product reduce effort and cost in onboarding ehealth Exchange Gateway 1.0 Jiva HIE Connect http://sequoiaproject.org/rsna/validated-products/ 15 2017 The Sequoia Project. All Rights Reserved. An initiative of Resonance

16 2017 The Sequoia Project. All rights reserved. In collaboration with In collaboration with

The Situation Communities of data sharing partners have formed, brought together by specific needs. Some are geographically based, but other types of data sharing communities also exist. 17 The Sequoia Project 2017

The Challenge What if you had a cell phone plan that only allowed you to call other customers of your carrier? The communities have common use cases and a need to connect their members that has not previously been met in a systematic way. 18 The Sequoia Project 2017

The Solution Carequality creates a standardized, national-level interoperability framework to link all data sharing networks. Carequality is creating a web of interconnected communities. 19 The Sequoia Project 2017

Carequality s Role Carequality is not competitive with existing data sharing networks and programs but rather adds more value to their offerings. We bring to the table a wide array of stakeholder views at all points in our publicprivate consensus process. 20 The Sequoia Project 2017

Carequality Members 21 2017 Copyright The Sequoia Project. All rights reserved.

Essential Elements Common rules of the road: In order for the varied participants to trust each other with health information, everyone needs to have a legal obligation to abide by the same rules. Well-defined technical specs: Shared rules are not enough; clear standards must be laid out in an implementation guide that all implementers can follow. A participant directory: To connect using the common standards, systems must know the addresses and roles of each participant. 22 The Sequoia Project 2017

Carequality Implementers HIEs Technology Vendors Service Providers PHRs 23 2017 Copyright The Sequoia Project. All rights reserved.

Accelerating Health Data Sharing in America 25,000+ Clinics 1,000+ Hospitals 580K+ Providers 2M Clinical Documents Exchanged Monthly 24 2017 Copyright The Sequoia Project. All rights reserved.

25 2017 The Sequoia Project. All rights reserved. In collaboration with In collaboration with

Why Image Sharing Matters Enables Patient Access/Workflows Benefit of historical exam during interpretation Concerns about cost of imaging over-utilization Redundant exams ordered when recent exams are not accessible Radiation exposure Reduce unnecessary patient risk due to redundant exams Quality Better, more efficient care through easy availability of imaging examinations 26 2017 The Sequoia Project. All rights reserved.

What is the RSNA Image Share Validation? The Image Share Validation Program provides a conformity assessment program that sets the standard for consistency in the marketplace. The Image Share Validation Program tests the compliance of vendor systems using quality standards determined most effective for accurate and efficient exchange of medical images. The RSNA Image Share Validation Program benefits patients and providers with improved efficiency, reduced costs, enhanced quality of care, and standards-based interoperability to spur innovation. 27 2017 The Sequoia Project. All rights reserved.

RSNA Image Share Validation Program Fills a national Standards Gap Product conformity assessment testing IHE profiles provide specifications for testing Modular Standards/Specifications/Test Cases Cross-Enterprise Document Sharing for Imaging (XDS-I) Document Source and Document Consumer Registry and Repository Cross-Community Access for Imaging (XCA-I) Initiating Gateway Responding Gateway RSNA Image Share PHR 28 2017 The Sequoia Project. All rights reserved.

Foundational Standards for Image Sharing and Validation Ontologies - RadLex, SNOMED-CT DICOM medical imaging standards HL7 messaging and FHIR (Fast Healthcare Interoperability Resources) IHE-Integrating the Healthcare Enterprise Radiology Technical Framework Organizes the existing standards into practical, efficient workflows https://www.hhs.gov/about/news/2016/12/20/2017-interoperability-standards-advisory-released.html https://www.healthit.gov/sites/default/files/2017_isa_reference_edition-final.pdf 29 2017 The Sequoia Project. All rights reserved.

RSNA/IHE Image Share Architecture Hospital/ Imaging Center RIS Edge Server HIE or Image Clearinghouse Personal Health Record Reports Report db Image/ Document Repository Patientcontrolled Image and Report Storage Images PACS 30 2017 The Sequoia Project. All rights reserved.

Who Should Participate: Providers of imaging systems such as Reporting Systems, RIS and PACS that wish to enable those systems to connect to networks for sharing images with providers and patients Providers of health information exchange systems that wish to enhance their systems to exchange medical images and reports 31 2017 The Sequoia Project. All rights reserved. 11

Benefits of Validation to Patients and Providers Improved efficiency Reduced costs Standards-based interoperability to spur innovation Reduce radiation exposure Stop duplicative procedures International IHE Conformity Assessment program Enhanced quality of care! 32 2017 The Sequoia Project. All rights reserved. 12

Participants Awarded Validation Seals 14 2017 The Sequoia Project. All rights reserved.

Lessons Learned Nationwide Data Sharing Network 18 2017 The Sequoia Project. All rights reserved.

#1: Essential Building Blocks Highly constrained specifications Transport, security, web services Payload (e.g. clinical documents, images, etc.) Robust Testing Well-defined test cases and automated tools that focus on known interoperability issues and security Product testing to assure capabilities are baked in Implementation-level testing of production configuration of system used in exchange Work flow and best practices Patient matching Consent High-value use cases that drive adoption Meaningful use a start Other high-value transactions essential to realize value from connectivity Alternative payment models Interoperability policies that work across networks Minimize barriers to exchange and foster trust Need for clearly articulated responsibilities of parties to exchange Interoperability eco-system and governance Accountability measures to promote and maintain compliance Consequences for non-compliance 19 2017 The Sequoia Project. All Rights Reserved.

#2:Testing is Key Multi-level testing Profile-level testing Product testing and validation Production-level testing to assure production configuration interoperates Automated, self-service approach Tightly constrained tests Focus on known interoperability issues and security, as well as negative tests Implementation-level testing essential to catch interoperability issues introduced by systems configurations Testing eco-system with feedback loop into tightly constrained implementation specifications 20 2017 The Sequoia Project. All Rights Reserved.

#3: Interoperability is an ongoing, evolving process Technology available and in the hands of providers Health IT systems tested and validated as conformant and interoperable (tightly constrained transport, security, policy, content, clinical work flow incorporates HIE) Health IT systems utilized and records populated with data HIE capabilities implemented at scale to enable connectivity High-value transactions and use cases implemented Transmissions work reliably Content sufficiently specified to assure consistency, value, and semantic interoperability to both sender and receiver Living process to refine and improve capabilities over time 21 2017 The Sequoia Project. All Rights Reserved.

Opportunities Abound for Interoperable Exchange Leverage the growing connectivity footprint in the US and expand to include image exchange Inform development of PHR profile that will be deployed nationwide and reflect requirements for image exchange Be part of growing movement to broaden connectivity to support care management and population health 22 2017 The Sequoia Project. All Rights Reserved.

Interoperability for the Future 23 2017 The Sequoia Project. All rights reserved.

2018 Sequoia Priorities Specificity & Testing of Clinical Documents Provider Directory Patient Matching Consumer Access to Health Information 40 2017 The Sequoia Project. All rights reserved.

Thank You! Convene Collaborate Interoperate 25 2017 The Sequoia Project. All rights reserved.