Interoperability 101: The Past, Present, and Future

Session PE4, March 9, 2020 Steve Lane, MD, MPH, FAAFP Clinical Informatics Director, Privacy, Information Security & Interoperability, Sutter Health Mariann Yeager, MBA Chief Executive Officer, The Sequoia Project

DISCLAIMER: The views, opinions and images expressed in this are those of the author and do not necessarily represent official policy or position of HIMSS. 1 Meet Our Speakers

Dr. Steven Lane Mariann Yeager Clinical Informatics Director, Privacy, Information Security & Interoperability Sutter Health

2 Conflict of Interest

Steven Lane, MD, MPH, FAAFP has no real or apparent conflicts of interest to report.

Mariann Yeager, MBA has no real or apparent conflicts of interest to report.

3 Agenda

• Health Information Exchange: a history

• Sutter Health: a present-day case study

• Trusted Exchange Framework and Common Agreement: the future of exchange

• Physicians Engagement: the role of providers in shaping health information exchange today and tomorrow

4 Learning Objectives

• Describe the multitude of health information exchange options available today

• Outline the scope of TEFCA based on the draft published by the ONC

• Identify opportunities for physician engagement in the development and finalization of the Common Agreement and the implementation of the Trusted Exchange Framework

5 Health Information Exchange: A history

6 Perspective

• Primary care family physician and EHR user x > 30 years

• Clinical informaticist x 25 years

• Interoperability focus x 10 years • The Sequoia Project – Board • Carequality – Steering Committee • DirectTrust – Clinicians Steering Workgroup • HL7 Da Vinci Project – Clinical Advisory Council • HIMSS – Interoperability & HIE Committee • HHS/ONC – Health Information Technology Advisory Committee 8 Interoperability Definitions

• 21st Century Cures Act • HIMSS

Health information technology that enables • Foundational Interoperability: the secure exchange of electronic health System connectivity > Exchange data information with and use of electronic health information from, other health information • Structural Interoperability: technology without special effort on the part Field level formatting, syntax > Exchange information of the user; allows for complete access, exchange, and use of all electronically • Semantic Interoperability: Codification of data accessible health information for authorized > Meaning, interpretation use under applicable State or Federal law; • Organizational Interoperability: does not constitute information blocking Policy, workflow, functional > Utility, benefit, outcomes

9 Interoperability Standards

• 1982 – Accredited Standards Committee (ASC) X12 Version 1 • Electronic Data Interchange (EDI) for financial / administrative transactions • Named in HIPAA as required standard for specific transactions, e.g., prior auth • 1987 – (HL7) Version 2 • Point-to-point connectivity • Intra-operability – connecting applications within institutions • 2005 – HL7 Clinical Document Architecture (CDA) • Human readable XML documents • Scalable for cross organizational use • 2011 – HL7 Fast Healthcare Interoperability Resources (FHIR®) • Modern, flexible, purpose-built for healthcare • 2019 – First normative release (R4)

10 Interoperability Promise

• Holistic care • Patient safety • Care coordination • Value – e.g. avoiding duplicate services • Public health • Medical research • Innovation – Care models, services • Patient engagement, empowerment, control of data, choice

11 Interoperability Successes

• HIE/HIOs – Regional/state, proprietary • Central data repository and access • Connectivity and messaging – multiple stakeholders, uses • Services – e.g., event notification • Networks • Nationwide Health Information Network • Direct Project > DirectTrust • eHealth Exchange > The Sequoia Project • Vendor-based Networks: CommonWell, Epic Care Everywhere, etc. • Trusted Exchange Framework: Carequality > TEFCA

12 Interoperability Challenges

• Everyone agrees that data access and liquidity is critical to support optimized coordinated care and population health management • BUT…

• Significant challenges: • Clinicians drowning in data • Discrete data integration, reconciliation and use • Concerns about privacy and risk • Incentivizing data access, use, curation, and exchange • Changing federal rules and requirements

13 Drowning in Data

• Due to: • EHR implementation • System Integration • Interoperability • New data sources • Patient-generated data • Multiple “-omics” • Claims data • Social determinants of health

14 Standards-based Document Exchange

• Direct interoperability (push) • Query-based document exchange (pull)

15 Direct Interoperability

• Direct Project: launched in 2010 as part of the Nationwide Health Information Network (NwHIN) • Goal: simple, secure, standards-based method for sending health information to trusted recipients via the Internet • Included in 2014 EHR certification criteria • Required by Meaningful Use Stage 2

• HISPs accredited through DirectTrust represent more than: • 2.3M Direct Addresses • 238K organizations • 299K patients/consumers

16 Direct – Current State

• All ONC certified EHRs have the ability to send and receive transition of care documents via the Direct Standard • Many providers have not routinely implemented this functionality • Use cases: • Transitions of care – ambulatory, inpatient, post-acute, EMS • Closed loop referrals • Care coordination messaging • Push notifications – Event notification, reporting

• 67M transactions / month

17 eHealth Exchange

• Four Federal Agencies • Veterans Affairs • Department of Defense • Social Security Administration • CMS • 75% of US hospitals • 70,000 medical groups • >50% of regional/state HIEs • 16M documents exchanged / month

18 Epic Care Everywhere

• 367 Epic customer organizations • 2,032 hospitals; 45,830 clinics

• 1,689 connections to 110 unique vendors’ systems • via eHealth Exchange, Carequality, Direct

• 150M records exchanged / month

19 CommonWell

• Core services: • Patient ID and record location • Document exchange • 15K provider sites • 66M patient records • 60M monthly XCPD patient discovery / record locator transactions

• 60M documents exchanged / month

20 Carequality Framework

• Policy framework and technical standards for networks and other implementers to exchange with each other • CommonWell, Epic Care Everywhere, eHealth Exchange, HIT vendors • 600,000 Physicians, 40,000 Clinics, 1,700 hospitals • Working with The Sequoia Project in its role as the Recognized Coordinating Entity (RCE) to implement the national Trusted Exchange Framework & Common Agreement (TEFCA)

• 90M documents exchanged / month

21 Standards-based Document Exchange Volume

22 Application Programming Interfaces (APIs)

* in healthcare

23 Fast Healthcare Interoperability Resources (FHIR®)

• Purpose-built for healthcare • Supports exchange of targeted data via APIs • A user/application may request just the data (resources) of interest in a well-defined format • Modern web-base data structure, transport and security • Rapid development

24 Evolving FHIR Use Cases

• EHR applications • SMART – Substitutable Medical Apps, Reusable Technology (>75 apps) • Argonaut Project – clinical notes, assessments, bulk data access • Individual / Patient Access • CMS Blue Button 2.0 – Medicare claims data • Apple Health Records, etc. – EHR and Laboratory data • Payer-Provider Exchange • CMS Beneficiary Claims Data API (BCDA) and Data at the Point of Care (DPC) • Da Vinci Project • FHIR Accelerator Projects • Social Determinants of Health – Gravity Project • Post-Acute Care Interoperability – PACIO

25 Individual / Patient Access via APIs

• Based on HIPAA individual right of access to health data • Early successes: • Blue Button 2.0 – CMS claims available to Medicare beneficiaries via API • Apple Health Records • Common Health for Android

26 Apple Health Records

• FHIR® API-based access to health data from multiple vendors • EHRs: • Allscripts • Epic • • MEDITECH • • VA • Laboratories: • LabCorp • Quest • 454 organizations/practices participating a/o 01/27/2020 • Health records data securely stored on user iPhones • Individuals can choose to allow apps to access health records data stored in HealthKit

27 Sutter Health: A present-day case study

28 Patient Records Exchanged Monthly

29 Unique Trading Partners

30 Patient Access via APIs – 2019

API Calls / month • 18,813 patients 15 Million have requested

their data using ~3,000 patient SIX patient- requests / day facing apps Trusted Exchange Framework and Common Agreement (TEFCA): The future of exchange

32 This project is supported by the Office of the National Coordinator for Health Information Technology (ONC) of the U.S. Department of Health and Human Services (HHS) under 90AX0026/01-00 Trusted Exchange Framework and Common Agreement (TEFCA) Recognized Coordinating Entity (RCE) Cooperative Agreement. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by ONC, HHS or the U.S. Government.

© All rights reserved. Why Do We Need a Trusted Exchange Framework and Common Agreement (TEFCA)?

COMPLEXITY OF CURRENT PROLIFERATION OF AGREEMENTS

Many organizations have to join multiple Health Information Networks (HINs), and most HINs do not share data with each other.

Trusted exchange must be simplified in order to scale.

© All rights reserved. 21st Century Cures Act – Section 4003(b)

“[T]he National Coordinator shall convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks.” [emphasis added]

© All rights reserved. 35 TEFCA Goals

GOAL 1 GOAL 2 GOAL 3

Provide a single Electronic Health Support “on-ramp” to Information (EHI) nationwide nationwide securely follows scalability connectivity you when and where it is needed

© All rights reserved. 36 How Will the Common Agreement Work?

RCE provides oversight and governance for QHINs.

QHINs connect directly to each other to facilitate nationwide interoperability.

Each QHIN represents a variety of Participants that they PARTICIPANTS connect together, serving a wide range of Participant

PARTICIPANT MEMBERS AND INDIVIDUAL USERS Members and Individual Users.

© All rights reserved. 37 Recognized Coordinating Entity (RCE)

• Develop, update, implement, and maintain the Common Agreement.

• Identify, designate, and monitor Qualified Health Information Networks (QHINs).

• Modify and update the QHIN Technical Framework.

• Virtually convene public stakeholder feedback sessions.

• Develop and maintain a process for adjudicating QHIN noncompliance.

• Propose strategies to sustain the Common Agreement at a national level after the initial cooperative agreement period.

© All rights reserved. Structure of a Qualified Health Information Network (QHIN)

A QHIN is an entity with the technical capabilities to connect health information networks on a nationwide scale. Participant A natural person or entity that has entered into a Participant-QHIN QHIN Agreement to participate in a QHIN.

Participant Member A natural person or entity that has entered into a Participant Member Agreement to use the services of a Participant to send and/or receive EHI.

Individual User An Individual who exercises their right to Individual Access Services using the services of a QHIN, a Participant, or a Participant Member.

© All rights reserved. What is The Common Agreement?

The Common Agreement will provide the governance necessary to scale a functioning system of connected HINs that will grow over time to meet the Common demands of individuals, clinicians, and Agreement payers. Minimum Required The Common Agreement will be a legal Terms & Conditions document that QHINs sign. Some provisions of the Common Agreement will flow down to other entities Additional Required (including providers) via contracts. Terms & Conditions

Stakeholders will be able to comment QHIN Technical Framework on the draft Common Agreement.

© All rights reserved. Provider Considerations • Provider organizations will generally • Providers will have to meet flow- be either a participant or a down requirements participant member

© All rights reserved. What Kinds of Exchange Will be Supported?

Initial Exchange Modalities: • Broadcast query (ask all) • Targeted query (ask a few) • Message delivery (push) Potential Future Additions: • Population-level data exchange • FHIR-based exchange Exchange Purposes Data Exchanged: • Available electronic health information in the US Core Dataset for Interoperability (USCDI)

© All rights reserved. Physician Engagement: Help shape interoperable health information exchange for the future

43 Upcoming Events

• March 10, 2020 – 3:30 – 4:30 pm • Public Stakeholder Session with Providers Across the Continuum •

• March 11, 2020 – 2:30-3:30 pm • Breaking Down Barriers to Interoperability •

• March 11, 2020 – 4:30-5:30 pm • HIMSS20 Journey to Trusted Exchange •

• Stay in touch! https://rce.sequoiaproject.org/contact/

44 Questions

Dr. Steven Lane Mariann Yeager @EMRDoc1

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