Domain Expert Working Session

1. Domain Expert Working Session caEHR Analysis Team August 18, 2010

2. caBIG® Clinical Information Suite John Speakman National Cancer Institute

3. Several capabilities, needs and trends are converging: Vast and growing amount of molecular information Ability to aggregate and process clinical information on an unprecedented scale $44+ Billion U.S. investment in Electronic Health Records Unsustainable cost of new drug development Defining Moment in Biomedicine…

4. The Dream of 21st Century Biomedicine • Personalized, Predictive, Preemptive, Participatory…… • Unifies discovery, clinical research, and clinical care (bench-bedside-bench) into a seamless continuum • Results in improved clinical outcomes • Accelerates the time from discovery to patient benefit • Enables a health care system, not a disparate “sector” • Empowers consumers in managing their health over a lifetime

5. Reality: Still Fighting a War on Cancer • We know “how cancer works” • BUT: • Estimated US cancer deaths 2010: 569,490 (American Cancer Society) • Estimated new US cancer cases 2010: 1,529,560 (American Cancer Society) • Cost of cancer deaths: $960.7 billion in 2000, estimated $1,472.5 billion in 2020 (Journal of the National Cancer Institute, Dec. 9, 2008)

6. Biomedicine is Decades Behind the “Knowledge Economy” Curve Translational research and personalized medicine require integration of multiple modalities and dimensions of data (clinical care / clinical trials / pathology / imaging / gene expression / population data, etc.) This integration is currently achieved by custom-built point solutions, if at all As a result, the data is often locked away in incompatible formats and systems Research studies are artisanal, handcrafted from one-of-a-kind components; clinical trials take too long to initiate, too long to accrue patients and too long to report outcomes Access to, and maturity of, informatics tools within the research community is inconsistent

7. 2004: NCI launched the Cancer Biomedical Informatics Grid (caBIG®) • caBIG® Vision: • A virtual web of interconnected data, individuals, and organizations that redefines how research is conducted, care is provided, and patients/participants interact with the biomedical enterprise. • caBIG® Mission: • Connect the cancer research community through a shareable, interoperable infrastructure • Deploy and extend standard rules and a common language to more easily share information • Build or adapt tools for collecting, analyzing, integrating and disseminating information associated with cancer research and care

8. 20th Century Biomedical Paradigm Discovery Outcomes & Surveillance • Product launch • Clinical adoption • Reporting of serious/fatal ADRs • Re-labeling (or recall) as needed • Additional indications as warranted • Candidate selection and Optimization • Pre-clinical testing • Phase I, II, III • New Drug application and Approval • Biological pathways • Target identification and validation Clinical Care Product Development

10. 21th Century Biomedical Paradigm: a Learning Health System Analysis and Learning Discovery Outcomes & Surveillance Clinical Care Product Development

11. caBIG® Act 1: Modular Applications, Vocabularies, Common Data Elements • Community driven: Public resources • Dynamic implementation: Built to be upgraded as standards “harden” and domains expand Common Data Elements Controlled vocabulary

12. caBIG made modular applications available, but unfulfilled demand for tight integration between them, e.g.: When a patient is registered in the registry application, we need to pass the patient’s identifier to the clinical data management system, initiate a patient calendar in the calendar application, get their baseline labs from the lab system, and so on Requirement for messaging - a common means of communicating between applications e.g., an enterprise service bus Requirement for common model of the meaning (i.e., semantics) of the information stored in the applications Interoperability doesn’t just happen; there is no free lunch Harmonization is much harder on the back end caBIG® Act 2: Transactional integration: Messages and Models

13. caBIG® Act 3: Enterprise Architecture, Shared Sources of Record • Vendors, Cancer Centers also exploring service integration caBIG® Clinical Trials Suite ca- AERS PSC C3PR Lab Viewer NCI Clinical Trials Reporting Program … Integration Hub / caGrid Correlation Organizations People Protocol Abstraction …

14. Are we there yet? caBIG® has aimed to: Be iterative and incremental, deliver things quickly Listen to the community, change things when they aren’t working Avoid over-engineering things, only adding extra process when we’ve tried without and come up short Harmonize with what others are doing, work with standards groups and not make our own standards (e.g., HL7 SAIF, DoD, VA, MDACC, Canada Health Infoway, Australia National E-Health Transition Authority) Look for an architecture that scales; not be shy if it doesn’t cut it Are we there yet? So far so good If we are to connect discovery, development and delivery of effective therapies for cancer and beyond on a national and a global scale, we need an architecture that we can bet the farm on

15. Oncology-Extended EHR (caEHR) The National Cancer Institute (NCI), through its Cancer Biomedical Informatics Grid (caBIG®) program, is leveraging the nation’s $44 billion investment in Healthcare Information Technology to fuel research in the following way: NCI has collaborated with the American Society of Clinical Oncology (ASCO) and other professional societies to develop specifications for an “oncology-extended Electronic Health Record” to fill a gap in existing Electronic Health Record (EHR) functionality for practicing ambulatory oncologists This NCI/ASCO project is called Clinical Oncology Requirements for the Electronic Health Record (CORE)

16. caBIG® Clinical Information Suite • NCI is developing a series of software modules (service and application modules, also referred to as “capabilities”) collectively known as the caBIG® Clinical Information Suite: • This Suite is based on the CORE specifications, and the expressed needs of the NCI community • This Suite will support the specific oncology-related data collection needs of practicing oncologists, and build the “bridge” between clinical care and research

17. caBIG® Clinical Information Suite The caBIG® Clinical Information Suite can be used in conjunction with any EHR platform (proprietary or open source) to furnish an end-to-end EHR suitable for ambulatory oncology NCI will select an open-source EHR platform with which to integrate the caBIG® Clinical Information Suite and thus deliver an end-to-end, deployable EHR as a Reference Implementation Selected National Community Cancer Center Program (NCCCP) sites intend to deploy the caBIG® Clinical Information Suite, either as a series of modules in conjunction with their existing EHR, or as the full open source reference implementation, beginning in the fall of 2010

18. caBIG® Clinical Information Suite Provides support for the workflow of practicing oncologists, and for their collection and management of data specific to the treatment of cancer Supports the oncology clinical care community by accelerating “knowledge turns” – the speed by which hypotheses can be validated in the clinical environment Supports NCI’s research community by delivering much needed clinical outcomes data to the research community for rapid validation of hypotheses Connects with, and expands, existing caBIG® clinical resources and leverages NCI’s investment in a scalable services-based infrastructure (developed by NCI to support the caBIG® program) to finally deliver a flexible, agile, comprehensive bidirectional link between research and care

19. caBIG® Clinical Information Suite Integration and Usage • Updated versions of the reference implementation with increased functionality will be released, iteratively and incrementally, over the lifecycle of the project • NCI expects there will be a wide variety of approaches to integration including, but not limited to: • Collaboration with EHR vendors and providers to implement the specifications • Incorporation of NCI’s source code and/or specification adaptation by open-source and/or commercial vendors • Deployment of the full reference implementation by healthcare providers

20. caBIG® Clinical Information Suite and NCI’s Semantic Services-Oriented Architecture • NCI will use a modular approach to enable the extension of the substantial existing EHR base (commercial and open-source) • The modules being developed will use NCI’s Semantic Services-Oriented Architecture and are intended to be leveraged by the entire community, especially EHR vendors. NCI believes that this will: • Enhance the ability of ambulatory oncology providers to fully leverage electronic health records • Allow a new level of ability to connect research and care. • Give providers a variety of options to incorporate NCI-defined ambulatory oncology functionality with minimum disruption • Give vendors a variety of options for leveraging this functionality • Leverage existing work by NCI and others

21. caBIG® Clinical Information Suite Capabilities • The caBIG® Clinical Information Suite will deliver: • Specific functionality, currently missing in existing EHRs, to facilitate ambulatory oncology practice • When implemented with an EHR platform, compliance with “meaningful use” rules established by the Center for Medicare and Medicaid Services (CMS), US Department of Health and Human Services, required to qualify for incentive payments • Facilitation of clinical trials recruitment and conduct via compliance with existing HL7 standards for integration of clinical trials capability within EHRs • Interoperability and health information exchange based on recognized, established standards • An integrated "ultra-light oncology EHR“ (effectively an electronic clinical outcomes case report form), including a minimum of information needed to identify a patient, capture their disease state, capture the intervention performed, and the result of the delivered treatment

22. “Ultra Light EHRs”(aka Patient Outcomes Data Service - PODS)… caBIG® has developed an “ultra-light Electronic Health Record” capability….effectively an electronic case report form, not limited to clinical trials, for recording and aggregating, on a large scale, clinical outcomes data for decision support (plus secondary use of data for research) Can be used to collect and aggregate this data from: Information supplied voluntarily by patients (via advocacy groups and others) Providers using EHRs that leverage the caBIG Clinical Information Suite (subject to patient authorization) Providers who may not currently have access to an Electronic Health Records but who wish to benefit from large-scale data aggregation for decision-making

23. Oncology-Extended Electronic Health Records Oncology-extended EHRs enable tracking of cancer diagnostic and staging information, treatment plans, and patient outcomes Oncology-extended EHR Chemotherapy drugs

24. 101010101 BRCA 1 Chemotherapy drugs Personal Genomics Tumor genetic profile Family Health History Integrating Consumer Input into Electronic Health Records Web-based tools enable consumers/patients to record their personal information and treatment responses, linked into their EHRs Patient-Reported Outcomes-enhanced EHR FHH

25. 10101010101 FHH BRCA 1 Chemotherapy drugs Tumor genetic profile Using EHRs to Empower Survivors Conversely, survivors can request that clinical information from EHRs is made accessible to their Personal Health Records Personal Health Record Smart EHR

26. 10101010101 FHH BRCA 1 Chemotherapy drugs Tumor genetic profile Using EHRs to Facilitate Clinical Trials For patients on trials, clinical information from EHRs can be accessed by electronic Case Report Forms Smart EHR eCRF

27. 010101010101010101 010101010101 10101010101 0101010101 This Service enables submission of outcome data allows permits queries for longitudinal follow-up or aggregate outcomes patterns. Utilizing “Smart” Electronic Health Create a Learning Health System With appropriate authorization, data on patient encounters can be electronically fed into the Patient Outcomes Data Service Patient Outcomes Data Service DataRepository

28. Notes on stakeholders and analysis There will be multiple stakeholder groups You NCCCP clinical and IT “customers” Overarching clinical review groups Technology integration groups in NCI Analysis is a defined part of the caBIG® process It is a vocation, not an avocation It is intentionally separate from the software development process

29. Summary: caBIG® Clinical Information Suite Deliverables caBIG®-developed deliverables will include: A detailed, industry-validated requirements document (CORE, developed with ASCO) A set of structured use cases and application/service specifications documents, usable to guide development A number of capabilities, i.e., software modules including both clinical (collecting data) and administrative (managing the trial) functionality, all available under a non-viral license for use by vendors and others in the community A fully functional reference implementation of the EHR based on an existing open-source EHR platform that may be deployed to sites as needed An HL7 (Health Level 7) validated functional profile for ambulatory oncology based on the ASCO/NCI CORE requirements document and the HL7 EHR functional model

30. RoadMap/Building Blocks

31. Major Streams of Work • Roadmap includes the following major categories of development: • Prototype – Ultra-Lite EHR (a.k.a. PODS 2.0) • Tolven Architectural and Business Gap Analysis • Architectural Proof-of-Concepts (POCs) • Service Development* • Reference Implementation (Tolven + Ambulatory Oncology Extensions)* * Focus of Analysis/Requirements Gathering activities

32. Business Building Blocks Outcomes

33. Scope: High-level Components • Administrative • Referral Management • Diagnostics • Tumor Staging • Therapeutics • Chemotherapy Planning, Ordering, Scheduling and Administration • Medication List Management • Patient Trial Finder

34. Scope: High-level Components (2) • Disease Response to Treatment • Response to Treatment • Patient-Reported • Functional Assessment • Financial/Cost

35. Project Plan

36. Project Themes

37. Project Themes

38. Project Themes

39. Key Analysis Milestones • Project Scope and Vision (includes final list of business capabilities) will be finalized • Project Road Map – this is the timeline for getting the business capabilities completed • EHR Platform to support business capabilities will be determined • Continue work on the following topics: • Diagnostics • Therapeutics • Patient Reported and Functional Assessments

40. Glossary • Artifacts – this concepts includes all products or deliverables developed by the caEHR project team. Examples include, but are not limited to: documents, models, notes, spreadsheets, discussion forums, technical specifications and any other format which aims to provide the stakeholders with evidence of the business capabilities and/or requirements are adequately documented for the caEHR project • AO-FP – Ambulatory Oncology Functional Profile, which is the artifact that provides requirements for an Ambulatory Oncology Electronic Health Record (i.e., extensions to an EHR)

41. Glossary • Attestation – TBD • CCB – Change Control Board, which is the governance body responsible for reviewing change requests for the caEHR project. • EHR – Electronic Health Record • HITECH - Health InformationTechnology for Economic and Clinical Health • MU – Meaningful Use