1. The Elusive Search for Interoperability W. Ed Hammond. Ph.D., FACMI, FAIMBE, FIMIA, FHL7 Director, Duke Center for Health Informatics. DTMI Secretary, HL7 International Chair, US Realm Chair Emeritus, HL7 International Nothing to Disclose

2. What’s in a Word? 2 INTEROPERABILITY It means interfacing two or more “things” that work together without further effort. We encounter it everyday from when we screw in a light bulb to when we make toast for breakfast.

3. Motivation 3 Office of the National Coordinator for Health Information Technology; Medicare Access and CHIP Reauthorization Act of 2015; Request for Information Regarding Assessing Interoperability for MACRA AGENCY: Office of the National Coordinator for Health IT (ONC), HHS. ONC is issuing this RFI is to solicit input on the following three topics, which are described in the comments section (Section II) of the RFI: (1) Measurement population and key components of interoperability that should be measured; (2) Current data sources and potential metrics that address section 106(b)(1) of the MACRA; and (3) Other data sources and metrics ONC should consider with respect to section 106(b)(1) of the MACRA or interoperability measurement more broadly.

4. Meeting Interoperability 4 When did you first encounter the need for interoperability? How do you measure success?

5. Making it personal (1) We created our first computerized medical record in 1970 (The Medical Record) … for primary care, obstetrics, and nephrology. Requirement – transferring lab data into TMR from multiple labs Solution – creating a data transfer standard (MAPS) Problem – terminology and synchronization … interoperability? 5

6. Making it personal (2) 1985 – moving TMR into Surgical Intensive Care Unit Requirement – capturing data from bedside devices Solution – connecting data stream into TMR Problem – bit stream issues; data stream turned itself off … interoperability? 6

7. Making it personal (3) 1992 – Needed to synchronize two independent EHRs: Family Medicine and Obstetrics Requirements – record encounter data bi- directionally between two similar systems Solution – mapping between two different vocabulary and data element sets Issues – synchronization and corrections of entered data … interoperability? 7

8. Definition - IEEE The IEEE Standard Computer Dictionary defines interoperability as “the ability of two or more systems or components to exchange information and to use the information that has been exchanged.” IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries (New York, NY: 1990). 8

9. Interoperability Ability to exchange patient health information among disparate clinicians and other authorized entities in real time and under stringent security, privacy and other considerations. Necessary for compiling complete experience of patient’s care, for maintaining a person’s health record, and for ensuring that complete health info is accessible to clinicians as patient moves through various health settings Need for clinicians to make fact-based decisions so medical errors and redundant tests can be reduced Critical to cost-effective and timely data collection for biosurveillance, quality measurement and clinical research 2004

10. 31 Oct 2008eHammond10 Interoperability requires … Connectivity infrastructure –Land lines –Cable –Wireless –Satellites Governance infrastructure –Decisions made and enforced Standards Knowledge Process –Ideally proper decisions made by experts and mandated by governments. Interoperability is difficult without government involvement, but should be a partnership between public and private.

11. 31 Oct 2008eHammond11 Stakeholder Interoperability Security/ Privacy Interoperability Functional Interoperability Semantic Interoperability Business Interoperability Communications Interoperability eHealth Systemic Interoperability Technical Interoperability Legal, ethical and societal Interoperability Human/computer Interface Interoperability Environmental Interoperability

12. Definition - HIMSS Interoperability describes the extent to which systems and devices can exchange data, and interpret that shared data. For two systems to be interoperable, they must be able to exchange data and subsequently present that data such that it can be understood by a user. There are three levels of health information technology interoperability: 1) Foundational; 2) Structural; and 3) Semantic. 12

13. Definition - Wikipedia Interoperability is a characteristic of a product or system, whose interfaces are completely understood, to work with other products or systems, present or future, in either implementation or access, without any restrictions. Syntactic –If two or more systems are capable of communicating with each other, they exhibit syntactic interoperability Semantic – To achieve semantic interoperability, both sides must refer to a common information exchange reference model. The content of the information exchange requests are unambiguously defined: what is sent is the same as what is understood. Cross-domain –Multiple social, organizational, political, legal entities working together for a common interest and/or information exchange 13

14. Making it personal (4) 2015 – Patient-Centered Outcomes Research Institute (PCORI). Duke and Harvard Coordinating Center. PCORnet seeks to improve the nation’s capacity to conduct clinical research by creating a large, highly representative, national patient-centered network that supports more efficient clinical trials and observational studies. 14

15. PCORnet Structure 15

16. 33 CDRN (13) and PPRN (20) awardees that include patient and systems in every state 16

17. Distributed Research Network An approach to multi-site research that allows secure analysis of separate data resources held by data partners behind their firewalls. In a DRN, there is no central data warehouse. Each data resource held locally consists of data collected, captured, or otherwise obtained by the local health system. 17

18. Issues Patient Identification Terminology Value Sets Definitions – inpatient, e.g. Structured and unstructured data Mapping Time Interoperability? 18

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20. Making it personal (6) 2015 – Participated in a SMART on FHIR project Requirements – transfer data from wearable sensors through iPhone to EPIC EHR and make available to Personal Care Provider Issues – alerts and scalability 20

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22. 22 So, when we start to create a standard in HL7 International, how do we think about interoperability? Do we know what is required?

23. Creating version 2.n We knew the use case – create an inpatient hospital information system from best of breed components. We mostly knew what data we needed and the work flow. (mostly) We permitted optionality and Z segments for individualization of standard. We talked about “plug and play”, not interoperability. 23

24. Version 2.n Did and does it work? 98% of hospitals in U.S. still use version 2.n What is the level of interoperability that version 2.n provides? “Managed interoperability”? 24

25. Version 3 Version 3 message has little take-up in U.S. due to use of v2 and v3 complexity CDA and CCD based on v3 with RIM data model has reasonable international use Why has this standard not solved the problem of interoperability? 25

26. And along came FHIR Why is FHIR seen as the hope for interoperability? What problems in previous HL7 standards does FHIR address? How does FHIR move from hype to reality? What issues might FHIR encounter that limits its success? How can we make FHIR “The Last Frontier”? 26

27. Why is interoperability so difficult? Momentum of what exists Lack of motivation to change Cost of change Lack of clear ROI Unclear solutions 27

28. Obstacles (Insurmountable?) Understanding data representation Solving connectivity issues Defining what data to exchange Deal with inconsistent units, data types Provenance and synchronization of data flows Proprietary vs open systems Trust and quality 28

29. Looking at the future Why do we spend so much time finding work-arounds rather than addressing and fixing the problem? Mapping among the terminologies is an example. IDMP is an example. Patient locator algorithms are examples. 29

30. Paradigm shift Create the vision of what we want to do with no constraints or limitations. Select what standards that exist and apply to make that vision work. Identify what is missing and create those standards? 30

31. 31 Government & Policy MACRA gives healthcare a fresh start for EHR interoperability, AMA President Steven Stack says The American Medical Association and the American Hospital Association call on ONC to rethink how it measures interoperability. Rather than simply gauging data exchange, they contend, ONC should focus on better care coordination. June 13, 2016 "The lack of interoperability is one of the major reasons why the promise of electronic health records has not been fulfilled," AMA President Steven Stack, MD, wrote in a statement. "Vendors have been incentivized to meet the flawed benchmarks under the Meaningful Use program. We need to replace those benchmarks with ones that focus on better coordinated care. MACRA offers that opportunity and we need to take advantage of it." Instead of using data exchange as the metric for measuring interoperability, Stack urges CMS to focus on usefulness, timeliness, correctness and completeness of data, as well as the ease and cost of information access. Stack explained that approach would benefit patients more than counting how many times voluminous documents are sent back and forth.

32. 32 Interoperability is a complex task for which a few guiding principles should be adopted, they asserted, recommending the following: measures should not add administrative burden to clinicians or their practices, and multiple data sources should be utilized to measure interoperability. American Academy of Family Physicians

33. What is the future of interoperability? Is searching for interoperability like looking for the pot of gold at the end of the rainbow? –Target changes with perspective Is it a focus on a word by academicians and less important to real world people? Are we willing to make the changes necessary to approach interoperability? Will we always settle for less? How much does it really matter? 33