What’s New in ONC? The Office of the National Coordinator for Health Information Technology Panel: Insight into Emerging Policy Copyright 2009. All Rights Reserved.

Agenda Vision for Meaningful Use John Glaser Standards and Certification Carol Bean Policy Activities Jodi Daniel Nationwide Health Information Network – Future Direction John Glaser State Grants Kelly Cronin Health IT Extension Program Rachel Nelson Nationwide Health Information Network Ginger Price Copyright 2009. All Rights Reserved.

John Glaser, PhD Senior Advisor to the National Coordinator OFFICE OF THE NATIONAL COORDINATOR John Glaser, PhD Senior Advisor to the National Coordinator Vision for Meaningful Use Slides that follow are from a draft set of recommendations made by a Work Group of the HIT Policy Committee on June 16, 2009 3 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

Achievable Vision for 2015 Prevention, and management, of chronic diseases A million heart attacks and strokes prevented Heart disease no longer the leading cause of death in the US Medical errors 50% fewer preventable medication errors Health disparities The racial/ ethnic gap in diabetes control halved Care coordination Preventable hospitalizations and re-admissions cut by 50% Patients and families All patients have access to their own health information Patient preferences for end of life care are followed more often Public health All health departments have real-time situational awareness of outbreaks Copyright 2009. All Rights Reserved.

HIT-Enabled Health Reform Achieving Meaningful Use 2009 2011 2013 2015 HIT-Enabled Health Reform Meaningful Use Criteria HITECH Policies 2011 Meaningful Use Criteria (Capture/share data) 2013 Meaningful Use Criteria (Advanced care processes with decision support) 2015 Meaningful Use Criteria (Improved Outcomes) Copyright 2009. All Rights Reserved.

Improve Quality, Safety, Efficiency 2011 Objectives Capture data in coded format Maintain current problem list Maintain active medication list Maintain active medication allergy list Record vital signs (height, weight, blood pressure) Incorporate lab/test results into EHR Document key patient characteristics (race, ethnicity, gender, insurance type, primary language) Document progress note for each encounter (outpatient only) Use CPOE for all order types Use electronic prescribing for permissible Rx Implement drug-drug, drug-allergy, drug-formulary checks Manage populations Generate list of patients by specific conditions (outpatient only) Send patient reminders per patient preference Copyright 2009. All Rights Reserved.

Improve Care Coordination 2011 Objectives Exchange key clinical information among providers of care Perform medication reconciliation at relevant encounters Copyright 2009. All Rights Reserved.

Summary Journey to a transformed health system requires meaningful use of transformation-capable HIT Migration of HIT readiness from current situation to fully HIT-enabled ecosystem will evolve over time Proposed MU criteria for 2011 and beyond provides escalating capabilities, balancing urgent need for reform and feasibility of what is achievable Copyright 2009. All Rights Reserved.

OFFICE OF THE NATIONAL COORDINATOR Carol Bean, PhD, MLS, MPH Acting Director, Office of Interoperability and Standards Standards and Certification 9 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

HHS Interoperability Standards “Recognized” in 2007-2008 “Accepted” in January 2009 EHR Laboratory Results Reporting (IS01) Biosurveillance (IS02) Consumer Empowerment (and Access to Clinical Information via Network, IS03) Emergency Responder EHR (IS04) Consumer Empowerment and Access to Clinical Information via Network (IS05) Quality (IS06) Medication Management (IS07) Personalized Healthcare (IS08) Consultations and Transfers of Care (IS09) Immunizations and Response Management (IS10) Public Health Case Reporting (IS11) Patient-Provider Secure Messaging (IS12) Remote Monitoring (IS77) Updates to IS02, IS03, IS04, IS05 Copyright 2009. All Rights Reserved.

Eight Technology Priority Areas for HIT in ARRA Privacy and Security HIT Infrastructure Certified Health Record Disclosure Audit Improve Quality Individually Identifiable Health Information (IIHI) Unusable Demographic Data Needs of Vulnerable Source: John Halamka Copyright 2009. All Rights Reserved.

Tiger Teams Focus Areas: Business Cases vs Use Cases A new EHR Centric Interoperability Specification to meet ARRA requirements Security, Privacy & Infrastructure Quality Measures Data Architecture (Element, Template, and Value Set) Exchange Architecture and Harmonization Framework Clinical Research Tiger Team membership 232 technical experts Source: John Halamka Copyright 2009. All Rights Reserved. HITSP – enabling healthcare interoperability

New Paths to Certification: In Brief (CCHIT Concept) Certified EHR Comprehensive [EHR-C] Rigorous certification of comprehensive EHR systems that significantly exceed minimum Federal standards requirements For providers who seek maximal assurance of EHR compliance and capabilities Certified EHR Module [EHR-M] Flexible certification of Federal standards compliance for EHR, HIE, eRx, PHR, Registry and other EHR-related technologies For providers who prefer to integrate technologies from multiple certified sources Certified EHR Site [EHR-S] Simplified, low cost certification of EHR technologies in use at a specific site For providers who self-develop or assemble EHRs from noncertified sources Source: “Town Call: New Paths to Certification ©CCHIT Copyright 2009. All Rights Reserved.

Mapping Current CCHIT Programs to the New Paths (CCHIT Concept) EHR-C Ambulatory and Inpatient EHRs Child Health, Cardiovascular, Enterprise add-on EHR-M Emergency Department, other specialties and settings under development Stand-alone ePrescribing PHRs Health Information Exchanges EHR-S Ambulatory or Inpatient internally developed EHRs Source: “Town Call: New Paths to Certification ©CCHIT Copyright 2009. All Rights Reserved.

Jodi Daniel, JD, MPH Director, Office of Policy & Research OFFICE OF THE NATIONAL COORDINATOR Jodi Daniel, JD, MPH Director, Office of Policy & Research Policy Activities 15 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

American Recovery and Reinvestment Act of 2009 (ARRA) Policy Activities American Recovery and Reinvestment Act of 2009 (ARRA) Established two Federal Advisory Committees Requires the Secretary to promulgate regulations related to the electronic exchange of health information. Provides incentives to eligible providers who are meaningful users of certified EHRs. Two step process Added Privacy Protections Established two Federal Advisory Committees HIT Policy HIT Standards Requires the Secretary to promulgate regulations Standards, Certification Criteria, and Implementation Specifications Two Step Process Certified EHR (which is also qualified) and Meaningful Use Added Privacy Protections Increased HIPAA penalties Allows OCR to keep a portion of the recovery Applies penalties to Business Associates Breach Notification 16 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

Policy Activities The Nationwide Privacy & Security Framework for Electronic Exchange of Individually Identifiable Health Information Draft Model Personal Health Record (PHR) Privacy Notice & Facts-At-A-Glance Reassessing Your Security Practices in a Health IT Environment: A Guide for Small Health Care Practices HIPAA Privacy Rule Guidance Related to the Privacy and Security Framework and Health IT 17 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

Other Policy Areas Policy Activities NHIN DURSA development Consumer preferences Privacy and Security 501(c)(3) status for Health Information Organizations Anti-Fraud and health IT CLIA and the electronic exchange of laboratory data Other Policy Areas NHIN DURSA development Multiparty agreement Assumes participants in production Establishes authority for interim governance Developed as part of ongoing NHIN activities First iteration was a Test Data DURSA Applies to “test data” (not PHI) for Trial Implementations Executed by all participants in Trial Implementations in September 2008 Production DURSA Initial draft Production DURSA – December 2008 Revised draft for limited production – June 2009 Initial version of production DURSA – limited production – January 2010 Large, diverse multi-stakeholder team assembled to develop this agreement through a set of contracts and grants and with active engagement of Federal agencies. Consumer preferences NHIN Cooperative is exploring technical capabilities to support consumer preferences, and permissions. Analysis under way to identify possible approaches for consumer preferences supported through the NHIN. Privacy and Security Information is securely exchanged among participants in the NHIN – supported through the NHIN architecture and secure protocols. From a policy perspective – the NHIN Cooperative is working to establish a trust model that works within the current legal and policy framework, but that also enables and fosters health information exchange based on a nationwide basis.  In addition, the NHIN Cooperative is developing: -A white paper that articulates how the NHIN addresses the 8 principles in the HHS Privacy and Security Framework -A set of NHIN participant security requirements – to identify the types of safeguards that participants agree to support as a condition of participating in the NHIN. 501(c)(3) status for Health Information Organizations Medical Identity Theft/ Anti Fraud CLIA guidance to allow for the electronic exchange of laboratory data Copyright 2009. All Rights Reserved.

John Glaser, PhD Senior Advisor to the National Coordinator OFFICE OF THE NATIONAL COORDINATOR John Glaser, PhD Senior Advisor to the National Coordinator Nationwide Health Information Network Future Direction 19 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

Nationwide Health Information Network Future Direction The NHIN is a set of conventions that provide the foundation to the exchange of health information that supports meaningful use. The foundation includes technical, policy, data use and service level agreements and other requirements that enable data exchange, whether between two different organizations across the street or across the country. The NHIN foundation supports both the local and nationwide exchange of health information. The foundation does not distinguish between the two. Health information exchanged should be enabled for all clinical information systems including at the edge systems (EHRs, PHRs, etc.) (not quite sure of the definition of an edge system). Copyright 2009. All Rights Reserved.

Nationwide Health Information Network Future Direction ONC will maintain overall responsibility for the governance of the NHIN, the development and management of the foundation and the demonstration of new components of the foundation. ONC will identify an organization to assume operational responsibility for CONNECT and the core set of NHIN-wide infrastructure. Copyright 2009. All Rights Reserved.

Kelly Cronin Director, Office of Programs and Coordination OFFICE OF THE NATIONAL COORDINATOR Kelly Cronin Director, Office of Programs and Coordination State Grants 22 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

Section 3013: State Grants to Promote HIT A program to facilitate and expand the electronic movement and use of health information among organizations according to nationally recognized standards. Information exchange to improve the quality of health care is a requirement for the meaningful EHR use incentives. Depending on maturity of efforts re: health information exchange, a state or state designated entity will be eligible for either a Planning grant or an Implementation grant. Planning grants will assist states in developing a roadmap to implement statewide health information exchange consistent with the meaningful EHR use criteria. Implementation grants will assist states with acting on approved roadmaps to build statewide health information exchange capacity consistent with meaningful EHR use criteria. Planning and implementation should be done in coordination with Medicaid to ensure the direct relevance and support for meaningful use of EHRs. ONC intends to award grants to all states and territories that submit qualified applications. The program is in support of MU and they’ll be an expectation that HIE capacity will be developed overtime to enable information exchange among eligible professionals and providers in a way that qualifies them for Medicare and Medicaid meaningful use incentives. This makes coordination across the State grant and Medicaid programs at the state and federal level critical to success. Copyright 2009. All Rights Reserved.

Planning and Implementation Grants Planning and Implementation grants should be pursued in the public interest and be consistent with the National Coordinator’s plans. Federal – State partnership is key! Funds shall be used to facilitate and expand HIE according to nationally recognized standards and to: Enhance broad and varied participation. Assist in identifying state or local resources to support a nationwide effort. Complement other federal grants and programs. Provide technical assistance to overcome barriers to exchange. Promote effective strategies to support exchange in underserved communities. Assist patients in utilizing health information technology. Encourage clinicians to utilize Regional Extension Centers for technical assistance. Support public health agencies authorized use of and access to health information. Promote use for quality improvement, including reporting on quality measures. The Secretary shall ensure continuous improvement based on annual evaluation and implementation of lessons learned. Funding will be tied to approaches that lead towards the greatest improvement in quality of care, decrease in costs and the most effective authorized and secure HIE. Copyright 2009. All Rights Reserved.

Qualified State Designated Entities (QSDE) States may appoint a QSDE to carry out the work specified in Section 3013. A QSDE should meet the following criteria: Be designated by the state as eligible to receive awards. Be a not-for profit entity with broad stakeholder representation on its governing board. Demonstrate that one of its principal goals is to use information technology to improve health care quality and efficiency through the authorized and secure electronic exchange and use of health information. Adopt non-discrimination and conflict of interest policies that demonstrate a commitment to open, fair and non-discriminatory participation by stakeholders. A QSDE should consult with and consider the recommendations of: Health care providers Health plans Patient or consumer organizations HIT vendors Health care purchasers/employers Public health agencies Health professions schools Universities Clinical researchers Users such as clerical staff Copyright 2009. All Rights Reserved.

OFFICE OF THE NATIONAL COORDINATOR Rachel Nelson, MHA Special Assistant to the Deputy National Coordinator Health Information Technology Extension Program 26 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

Health Information Technology Extension Program National Health Information Technology Research Center (HITRC) Regional Centers Offering Direct Technical Assistance to Providers Copyright 2009. All Rights Reserved.

HITRC (National Research Center) Supports efforts to adopt, implement, and effectively use health IT: Offers Technical Assistance & Educational Resources Develops or recognizes best practices Incorporates input from Federal agencies, health IT users, others as appropriate Serves as resource and forum for knowledge and best-practices exchange Copyright 2009. All Rights Reserved.

Regional Centers Individualized technical assistance to providers seeking to adopt and effectively use health IT to exchange information within appropriate policy frameworks Technical Assistance with product selection, workflow changes toward achieving meaningful use – including helping with provider in-house work to connect to health information exchange infrastructure, and in effectively leveraging electronic health information and health information technology to improve quality of cares Copyright 2009. All Rights Reserved.

Ginger Price Program Director, Nationwide Health Information Network OFFICE OF THE NATIONAL COORDINATOR Ginger Price Program Director, Nationwide Health Information Network Nationwide Health Information Network 30 Copyright 2009. All Rights Reserved. Copyright 2009. All Rights Reserved.

The Nationwide Health Information Network NHIN RHIOs and HIEs Personal Health Records Federal Agencies Integrated Delivery Networks Community Health Centers Registries and Repositories The Nationwide Health Information Network The NHIN provides: Common legal framework for information sharing Common infrastructure necessary for network security and connectivity Specifications for interoperable services Copyright 2009. All Rights Reserved.

NHIN Architectural Principles Highly distributed: Patient health information is retained at the local health information exchange level Local autonomy: Each HIE must make their own determinations with respect to the release of patient information Focus only on inter-organizational health exchange: The NHIN does not attempt to standardize implementations of the NHIN services and interfaces, only the communications between HIEs Use public internet: The NHIN is not a separate physical network, but a set of protocols and standards that run on the existing internet infrastructure Platform neutral: The NHIN has adopted a stack (web services) that can be implemented using many operating systems and programming languages Copyright 2009. All Rights Reserved.

Nationwide Health Information Network Copyright 2009. All Rights Reserved. 33

Nationwide Health Information Network Standards and Services Messaging, Security and Privacy Foundation NHIN Services NHIN Profiles Messaging Message Transport Services Definition Security Public Key Infrastructure Encryption Digital Signature Authorization Framework Requestor Authentication Requestor Authorization Discovery Services Subject Discovery Authorized Case Follow-up Query for Documents NHIE Service Registry Information Exchange Services Retrieve Documents Query Audit Log Health Information Event Messaging Consumer Preferences Profile Store and exchange consumer preferences for sharing of personal health information Other Profiles in Development GIPSE (Biosurveillance) Profiles describe how to implement services for a specific domain like consumer preferences for information sharing or biosurveillance Services describe specific interfaces (web services) used between HIEs to discover and exchange health-related information Messaging, Security and Privacy Foundation describes the underlying protocols and capabilities necessary to send and secure messages between NHIE Copyright 2009. All Rights Reserved.

“ ” NHIN 2008 Results However beautiful the strategy, you should occasionally look at the results.. Sir Winston Churchill Demonstrated Technical Capability Created a Set of Initial Interoperable Specifications 20+ disparate organizations participating in the NHIN Cooperative Laid foundation for data usage agreements Completed Trial Implementations Started limited production pilots in 2009 We have the building blocks… . Copyright 2009. All Rights Reserved. 35

NHIN Cooperative Participants Private HIEs State-Level HIEs Provider Orgs / IDNs Federal Entities CareSpark Delaware Health Information Network Cleveland Clinic CDC Community Health Information Collaborative New York eHealth Collaborative Kaiser CMS HealthLINC (Bloomington) North Carolina Health Care Information and Communications Alliance (NCHICA)   DoD HealthBridge IHS Indiana (Regenstrief Institute) West Virginia Health Information Network (WVHIN) NCI Long Beach Network for Health NDMS Lovelace Clinic Foundation (NMHIC) SAMHSA MedVirginia SSA Wright State University VA Copyright 2009. All Rights Reserved.

Lessons Learned from the NHIN Trial Implementations More directed activities with shorten cycles for work products Created processes and teams like the Specifications Factory The testing tools must be matured and processes automated. Providing Reference Implementation and automated test tools and scripts Baseline the foundational services of the NHIN Need a stable platform that will not require retooling for 18 – 24 months Large IDNs and federal data are significant attractor for private Health Information Exchange entities SSA, VA, Kaiser Permanente, DoD An executable DURSA is needed to avoid complexity of point to point. The Data Use and Reciprocal Support Agreement (DURSA) developed by the NHIN DURSA Team and the ONC Office of Policy and Research recently entered Federal clearance. The DURSA pragmatically addresses the agreements needed to exchange health information on the NHIN under conditions that exist today. Need a governance structure for real health information to flow Governance includes strategic direction, representational oversight, and operating policies and procedures, and enforcement mechanisms Copyright 2009. All Rights Reserved.

Demonstration Projects NHIN limited production pilots are critical to the success of demonstrating how standards and specifications are implemented as working operational solutions for health information exchange. MedVirginia and SSA entered into the first limited production pilot in February, 2009. Copyright 2009. All Rights Reserved.

SSA – MedVA Pilot Results weeks Currently processing approximately 75% of predicted load Starting with one provider network (Bon Secours) in February Approximately 3200 SSA eligibility requests for Bon Secours last year In discussions with 4 more provider groups to come online in 2009 Copyright 2009. All Rights Reserved.

Demonstration Projects Other organizations planning to demonstrate health information exchange later this year: HealthBridge Indiana Health Information Exchange Kaiser Permanente Department of Veterans Affairs Department of Defense Centers for Disease and Prevention The next NHIN pilot project demonstrations will include onboarding the pilot partners into the NHIN trusted community, performing conformance testing and interoperability testing, issuing a digital certificate, and adding them into the NHIN service registry. Copyright 2009. All Rights Reserved.

NHIN and CONNECT Copyright 2009. All Rights Reserved.

To learn more about the Nationwide Health Information Network: Go to http://www.healthit.hhs.gov and look for: Nationwide Health Information Network Interested? We’d like to hear from you at nhin@hhs.gov Copyright 2009. All Rights Reserved.

CONNECT Seminar Presentations are Available for Download Online at http://www.connectopensource.org Copyright 2009. All Rights Reserved.