Connecting Health and Care
for the Nation
A Shared Nationwide
Interoperability Roadmap
DRAFT Version 1.0
Table of Contents
Letter from the National Coordinator.......................................................................
Appendix A: Background Information on Policy Levers...................................................................... ...
Letter from the National Coordinator
In June 2014, the Office of the National Coordinator for Health Information Technolog...
We are thankful to our federal, state and private sector partners who have worked with us over these past
few months to sh...
Questions on the Roadmap
As you review the Roadmap, please consider the following questions and submit your responses duri...
8. Measurement
1. 1. Does the measurement and evaluation framework cover key areas? What concepts are
missing?
2. Which co...
8
Executive Summary
Introduction
Health information technology (health IT) that facilitates the secure, efficient and effe...
collaboration and action across government, communities and the private sector. As such, the Roadmap
will enable stakehold...
10
Specifically, the Roadmap focuses on actions that will enable a majority of individuals and providers
across the care c...
externally derived electronic health information in meaningful and appropriately non-disruptive
ways.
2. Even when technol...
A Common Clinical Data Set
 Patient name
 Sex
 Date of birth
 Race
 Ethnicity
 Preferred language
 Smoking status
...
13
simple. These standards should enable sharing a common clinical data set6
Core Technical Standards and Functions
buildi...
Many organizations have misinterpreted HIPAA rules and other regulations and therefore
refrain from sharing health informa...
Figure 2: Timeline of Select High-Level Critical Actions for Near-Term Wins
Disclaimer: Timeframes noted are approximate e...
Roadmap Introduction
The Federal Health IT Strategic Plan
The draft Federal Health IT Strategic Plan 2015-2020 describes a...
Interoperability Vision for the Future
An interoperable health IT ecosystem makes the right data available
to the right pe...
Scope
For purposes of this Roadmap, interoperability is defined as
the ability of a system to exchange electronic health
i...
efficiency and patient-centeredness of care, based on the best available evidence. IOM envisioned that
a Learning Healthca...
20
Guiding Principles for Nationwide Interoperability
ONC articulated a set of guiding principles and building blocks in C...
abilities to evolve and take advantage of the best of technology and health care delivery.
Modularity creates flexibility ...
Figure 5: Stakeholder Perspectives
People who receive care or support the care of others
Individuals, consumers, patients,...
How the Roadmap is Organized: Business and Technical Requirements for
a Learning Health System
Interoperability
Roadmap Bu...
Interoperability
Roadmap Building
Blocks
LHS Requirements
Certification and
testing to support
adoption and
optimization o...
The Roadmap is based on a core set of business and functional requirements to achieve a learning
health system, organized ...
Additional Resources
While the Roadmap contains important detail on each business and functional requirement for a
learnin...
A Shared Nationwide Interoperability Roadmap
This section is organized by building blocks and then LHS requirements that f...
28
FEDERAL HEALTH IT STRATEGIC PLAN OBJECTIVES SUPPORTED
 Improve health care quality, access and experience through safe...
that regulatory action would stifle innovation and improvements in health information exchange. In
response to the industr...
Standards Development
In addition to the governance actors, there are standards development organizations (SDOs) that deve...
To implement this process, there needs to be a set of criteria for entities that facilitate electronic health
information ...
availability of patient health data.
o Promote collaboration and avoid instances where (even when permitted by law)
differ...
• Security: Data holders and entities facilitating interoperability of health information should
secure and ensure respons...
o Standards should support data portability from one health IT product to another.
o The development and implementation of...
Category
2015-2017
Send, receive, find and use a
common clinical data set to improve
health and health care quality
2018-2...
Category
2015-2017
Send, receive, find and use a
common clinical data set to improve
health and health care quality
2018-2...
Supportive Business, Clinical, Cultural and Regulatory Environments
While the Medicare and Medicaid EHR Incentive Programs...
traditionally been reimbursed (typically "fee-for-service" payment models.) Economic gains from
interoperability are reali...
Achieving greater interoperability, with common policies and standards, will require coordinated
commitments across health...
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Nationwide Interoperability Roadmap draft version 1.0

Connecting Health and Care for the Nation
Published on: Mar 3, 2016
Published in: Technology      
Source: www.slideshare.net


Transcripts - Nationwide Interoperability Roadmap draft version 1.0

  • 1. Connecting Health and Care for the Nation A Shared Nationwide Interoperability Roadmap DRAFT Version 1.0
  • 2. Table of Contents Letter from the National Coordinator...................................................................................................4 Questions on the Roadmap..................................................................................................................6 Executive Summary .............................................................................................................................8 Introduction.............................................................................................................................................. 8 Principle-Based Interoperability: Working Toward a Long-Term Vision with Near-Term Wins...............9 Current Context...................................................................................................................................... 10 Critical Actions for Near Term Wins .......................................................................................................11 Roadmap Introduction....................................................................................................................... 16 The Federal Health IT Strategic Plan.......................................................................................................16 Interoperability Vision for the Future.....................................................................................................17 Scope ...................................................................................................................................................... 18 Why a Learning Health System...............................................................................................................18 Guiding Principles for Nationwide Interoperability................................................................................20 Who is this Roadmap for? ...................................................................................................................... 21 How the Roadmap is Organized: Business and Technical Requirements for a Learning Health System.......................................................................................................................... 23 Process for Updating the Roadmap........................................................................................................25 Additional Resources.............................................................................................................................. 26 A Shared Nationwide Interoperability Roadmap ................................................................................ 27 Rules of Engagement and Governance...................................................................................................27 Supportive Business, Clinical, Cultural and Regulatory Environments...................................................37 Privacy and Security Protections for Health Information.......................................................................52 Certification and Testing to Support Adoption and Optimization of Health IT Products and Services............................................................................................................................................ 74 Core Technical Standards and Functions................................................................................................77 Tracking Progress and Measuring Success ........................................................................................ 102 Why Monitor Progress toward Success?..............................................................................................102 Call to Action on Measurement and Evaluation of Exchange and Interoperability .............................102 Measurement and Evaluation Proposed Framework: Defining Success..............................................102 Defining Success: Measurement and Evaluation Domains ..................................................................105 Gaps in Measurement ..........................................................................................................................109 Measurement Actions ..........................................................................................................................112 2
  • 3. Appendix A: Background Information on Policy Levers...................................................................... 113 Appendix B: Background Information on Efforts to Promote Individuals’ Engagement With Their Health and Health Care.................................................................................................... 120 Appendix C: Background Information on Cybersecurity and Encryption ............................................. 124 Appendix D: Background Information on Permission to Disclose Identifiable Health Information ....... 127 Appendix E: Background Information on National Information Exchange Model (NIEM)..................... 133 Appendix F: Background Information on Medication Use and Management ...................................... 135 Appendix G: Glossary ....................................................................................................................... 138 Appendix H: Priority Interoperability Use Cases ................................................................................ 163 3
  • 4. Letter from the National Coordinator In June 2014, the Office of the National Coordinator for Health Information Technology (ONC) laid out a vision for a future health IT ecosystem where electronic health information is appropriately and readily available to empower consumers, support clinical decision-making, inform population and public health and value based payment, and advance science. In Connecting Health and Care for the Nation: A 10- Year Vision to Achieve an Interoperable Health IT Infrastructure (ONC’s 10-Year Interoperability Concept Paper)1 , ONC committed to leading and collaborating with the health IT and health sector to define a shared Roadmap for achieving interoperable health IT that supports a broad scale learning health system by 2024. This Roadmap reflects the result of that collaborative work with federal, state and private partners. It lays out a plan for what needs to happen, by when, and by whom, to see that electronic health information is available when and where it matters most for those we are here to serve: the American people. In the decade since ONC began its service to the nation, the United States has experienced remarkable progress in the digitization of the health experience. There has also been significant advancement of payment reform that is driving the need for better visibility of the care experience and demand for straightforward quality measurement. Consumers are increasingly expecting their electronic health data to be available when and where it matters to them, just as their data is in other sectors. And new technology is allowing for a more accessible, affordable and innovative approach. However, barriers remain to the seamless sharing and use of electronic health information. This draft Roadmap proposes critical actions that the public and private sector need to take to advance the country towards an interoperable health IT ecosystem over the next 10 years. Achieving such an interoperable system is an essential element towards HHS Secretary Sylvia Burwell’s vision of better care through smarter spending, leading to healthier people. Achieving that better care system and better health for all will, through health IT interoperability, require work in 3 critical pathways: 1) Requiring standards; 2) Motivating the use of those standards through appropriate incentives; and 3) Creating a trusted environment for the collecting, sharing and using of electronic health information. It will require us to agree to a set of rules of engagement that will bring trust to the system for consumers and others, it will allow us to see that the privacy expectations of consumers are respected, that states are aligned in policy, that we are aligning payment and other levers to advance and sustain a durable interoperable ecosystem, to make data more portable and liquid with tools like APIs, and to have a set of standards that allow more seamless, yet appropriate, sharing of electronic health information for “small” (individual patient), “big” (population level and beyond) and “long” data (wrapping around the individual and telling their health story over time). 1 http://www.healthit.gov/sites/default/files/ONC10yearInteroperabilityConceptPaper.pdf 4
  • 5. We are thankful to our federal, state and private sector partners who have worked with us over these past few months to shape this path forward and help us to identify the most impactful actions to achieve a learning health system. To date, there have been contributions from over forty individuals and organizations, twenty-five federal partners, 90 individuals from 38 states and ONC’s Federal Advisory Committees (FACAs) whose membership includes 167 representatives from over 140 private and public organizations. The Roadmap identifies critical actions that should be taken by a wide range of stakeholders to help advance nationwide interoperability. I invite you to review the Roadmap, provide your input and choose a critical action that you are willing to commit to, or even take the lead on. It is only through everyone’s combined efforts that we will achieve a learning health system that brings real value to electronic health information as a means to better care, wiser spending, and healthier people. This Roadmap is intended to be a living document owned and guided in its evolution by all health IT stakeholders. Because the Office of the National Coordinator for Health IT (ONC) is charged with supporting the adoption of health IT and promoting nationwide health information exchange to improve health and care, it has played a major role in coordinating with a broad array of stakeholders to develop this initial draft. ONC will continue to support stakeholders by coordinating input and publishing future versions of the Roadmap. ONC is accepting public comment on this draft version of the Roadmap until 5 p.m. ET on April 3, 2015 on www.healthit.gov/interoperability. After carefully reviewing and integrating the public’s feedback, ONC will release an updated Roadmap later in 2015. ONC is also releasing an open draft of the 2015 Interoperability Standards Advisory that is an initial version of a “best available standards and implementation specifications” list for interoperability of clinical health information that enables priority learning health system functions 2 . Development of this list is identified as a critical action in the Roadmap that ONC has committed to. Please review this list and provide comments on www.healthit.gov/interoperability. While you take time out to comment on these documents, please do not slow your work to advance interoperability. Thank you for your participation in this collaborative process. And thank you in advance for your thoughtful comments and willingness to take the lead on critical actions. It is a testament to the remarkable spirit of this nation’s health IT community and our shared interest in putting the person at the center. Karen B. DeSalvo, MD, MPH, MSc National Coordinator for Health Information Technology 2 The scope of the Advisory is on clinical health information exchange, and does not reference standards related to HIPAA transactions. The priority learning health functions are the business and technical requirements for a Learning Health System that are in the Roadmap introduction. 5
  • 6. Questions on the Roadmap As you review the Roadmap, please consider the following questions and submit your responses during the public comment period. 1. General 1. Are the actions proposed in the draft interoperability Roadmap the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2. Priority Use Cases 1. Appendix H lists the priority use cases submitted to ONC through public comment, listening sessions, and federal agency discussions. The list is too lengthy and needs further prioritization. Please submit 3 priority use cases from this list that should inform priorities for the development of technical standards, policies and implementation specifications. 3. Governance 1. The draft interoperability roadmap includes a call to action for health IT stakeholders to come together to establish a coordinated governance process for nationwide interoperability. ONC would like to recognize and support this process once it is established. How can ONC best recognize and support the industry-led governance effort? 4. Supportive Business, Cultural, Clinical and Regulatory 1. How can private health plans and purchasers support providers to send, find or receive common clinical data across the care continuum through financial incentives? Should they align with federal policies that reinforce adoption of standards and certification? 5. Privacy and Security Protections for Health Information 1. What security aspects of RESTful services need to be addressed in a standardized manner? 6. Core Technical Standards and Functions 1. Which data elements in the proposed common clinical data set list need to be further standardized? And in what way? 2. Do you believe the approach proposed for Accurate Individual Data Matching will sufficiently address the industry needs and address current barriers? 7. Certification and Testing 1. In what ways can semantic interoperability be best tested? (e.g., C-CDA content and semantics) 6
  • 7. 8. Measurement 1. 1. Does the measurement and evaluation framework cover key areas? What concepts are missing? 2. Which concepts from the framework are the most important to measure? What types of measures should be included in a "core" measure set? 3. Should measurement focus on certain use cases, priority populations or at certain levels of the ecosystem (e.g., encounter, patient, provider, organization)? 4. What other types of metrics have been successfully used at the local or regional level that might be considered for nationwide use? Would stakeholders be willing to propose novel metrics and provide "test beds" to assess the potential for nationwide use? 5. What measurement gaps should be prioritized and addressed quickly? 6. What other available data sources at the national level could be leveraged to monitor progress? 7. Are the potential mechanisms for addressing gaps adequate? What are other suggestions? 8. How should data holders share information to support reporting on nationwide progress? 9. What are appropriate, even if imperfect, sources of data for measuring impact in the short term? In the long term? Is there adequate data presently to start some measurement of impact? 7
  • 8. 8 Executive Summary Introduction Health information technology (health IT) that facilitates the secure, efficient and effective sharing and use of electronic health information when and where it is needed is an important contributor to improving health outcomes, improving health care quality and lowering health care costs – the three overarching aims that the U.S. is striving to achieve. Health IT can help health care providers recommend treatments that are better tailored to an individual’s preferences, genetics and concurrent treatments; it can help individuals make better treatment decisions and health-impacting decisions outside of the care delivery system; and can help reduce care delivery redundancy and cost by allowing test results to be reused while supporting analyses to pinpoint waste. To achieve this, however, the health IT community must expand its focus beyond institutional care delivery and health care providers, to a broad view of person-centered health. This shift is critical for at least two reasons: 1. Health care is being transformed to deliver care and services in a person-centered manner and is increasingly provided through community and home-based services that are less costly and more convenient for individuals and caregivers; and 2. Most determinants of health status are social and are influenced by actions and encounters that occur outside traditional institutional health care delivery settings, such as in employment, retail, education and other settings. This shift requires a high degree of information sharing between individuals, providers and organizations and therefore a high degree of interoperability between many different types of health IT, such that systems can exchange and use electronic health information without special effort on the part of the user.3 The goal of this shift is to a nationwide learning health system—an environment that links the care delivery system with communities and societal supports in "closed loops" of electronic health information flow, at many different levels, to enable continuous learning and improved health. This kind of system allows individuals to select platforms and apps to share and use their own electronic health information to meet their needs without undue constraints. 3 Derived from the Institute of Electrical and Electronics Engineers (IEEE) definition of interoperability. 4 http://www.healthit.gov/sites/default/files/ONC10yearInteroperabilityConceptPaper.pdf This shared nationwide interoperability Roadmap describes the actions and roles of a variety of health IT stakeholders needed to achieve the vision described in ONC’s 10-Year Interoperability Concept Paper4 . This 10-year Roadmap describes barriers to interoperability across the current health IT landscape, the desired future state that the industry believes will be necessary to enable a learning health system and a suggested path for moving from the current state to the desired future state. The Roadmap lays out a path to achieving the vision in the three-, six- and ten-year time frames and a vision to catalyze
  • 9. collaboration and action across government, communities and the private sector. As such, the Roadmap will enable stakeholders to make key commitments and take actions that align with other stakeholder actions, in order for the nation to collectively move towards a learning health system. Principle-Based Interoperability: Working Toward a Long-Term Vision with Near-Term Wins An interoperable health IT ecosystem that is person-centered makes the right electronic health information available to the right people at the right time across products and organizations, in a way that can be relied upon and meaningfully used by recipients. This ecosystem should adhere to the following interoperability guiding principles (Figure 1). Figure 1: Principles of Interoperability Based on these principles, this Shared Nationwide Interoperability Roadmap identifies functional and business requirements for interoperability and lays out a foundational set of short-term and long-term critical actions for all stakeholders to work towards over the next 10 years in support of a learning health system. This vision significantly expands the types of information, information sources and information users well beyond clinical information derived from electronic health records (EHRs). 9
  • 10. 10 Specifically, the Roadmap focuses on actions that will enable a majority of individuals and providers across the care continuum to send, receive, find and use a common set of electronic clinical information at the nationwide level by the end of 2017. Although this near-term target focuses on individuals and care providers, interoperability of this core set of electronic health information will also be useful to community-based services, social services, public health and the research community. This includes standardized data elements, such as demographics, that will enable better matching and linking of electronic health information across all systems and platforms. These standardized data elements support better stratification of electronic health information when aggregated to identify and address important issues such as health disparities and also support research and evidence-based personalized medicine. The intersection of clinical and administrative electronic health information is a critical consideration, but is out of scope for the Roadmap at this particular time. Use cases, standards, technologies and tools that leverage both administrative and clinical electronic health information will be an important topic to address in future iterations. There are also many aspects of health IT beyond interoperability that are important and will be critical to a learning health system, including technology adoption,5 data quality, usability and workflow. However, these topics are out of scope for this Roadmap at this particular time and deserve separate, dedicated attention. 5 Federal Health IT Strategic Plan 2015-2020 Goal One. Given the increasing volume of mobile technology usage among consumers and across the care delivery system, approaches to enable "send, receive, find and use" in the near-term must support the flow of electronic health information across both institutional and mobile-based technologies. This means traditional approaches to health IT interoperability will need to become more agile and leverage the experience of modular consumer applications, such as those created by Facebook, Amazon and Apple. These secure, but simple architectures have enabled an ecosystem of applications that allow users to engage with electronic health information across a variety of different platforms and devices and open opportunities for entrepreneurial third parties to thrive. Current Context Many successful electronic health information-sharing arrangements currently exist in communities across the nation. These arrangements have often formed around specific geographies, networks and/or technology developers. However, several barriers continue to inhibit nationwide interoperability despite these arrangements and must be overcome rapidly to achieve a learning health system. These barriers include: 1. Electronic health information is not sufficiently structured or standardized and as a result is not fully computable when it is accessed or received. That is, a receiver’s system cannot entirely process, parse and/or present data for the user in meaningful and useable ways. It is also difficult for users to know the origin (provenance) of electronic health information received from external sources. Workflow difficulties also exist in automating the presentation of
  • 11. externally derived electronic health information in meaningful and appropriately non-disruptive ways. 2. Even when technology allows electronic health information to be shared across geographic, organizational and health IT developer boundaries, a lack of financial motives, misinterpretation of existing laws governing health information sharing and differences in relevant statutes, regulations and organizational policies often inhibit electronic health information sharing. 3. While existing electronic health information sharing arrangements and networks often enable interoperability across a select set of participants, there is no reliable and systematic method to establish and scale trust across disparate networks nationwide according to individual preferences. A variety of electronic health information sharing arrangements and networks will continue to exist for the foreseeable future, as these arrangements serve important market and clinical functions by meeting the unique needs of many different communities. In a country as large and heterogeneous as the U.S., it is not realistic to suggest that all health information needs will be met with a single electronic health information sharing approach. However, the health IT ecosystem must evolve to address each of these barriers in a lasting and meaningful way to achieve a learning health system that protects the health of all Americans and provides essential human services to all. While each electronic health information sharing arrangement may continue to use its own policies, service agreements and technical standards to support participant priorities and needs, a common set of policies and technical standards must be adopted across the ecosystem to support nationwide interoperability and transcend these disparate networks. This will provide electronic health information users the flexibility to use services with deep local electronic health information sharing functions that meet many of their day-to-day needs, while having the confidence that they can still engage in key universal transactions with any authorized users in any network. This approach is consistent with the way the Internet operates today and with the interoperability trajectory experienced in other industries, such as telephone and ATM networks. Such market-based network development is critical to the achievement of nationwide interoperability. HHS will consider where additional guidance may be needed to clarify the current legal framework, including Health Insurance Portability and Accountability Act (HIPAA) Rules, to effectively support individual privacy in a learning health system. Critical Actions for Near Term Wins The four most important actions for public and private sector stakeholders to take to enable nationwide interoperability of electronic health information through health IT in the near term are: (1) establish a coordinated governance framework and process for nationwide health IT interoperability; (2) improve technical standards and implementation guidance for sharing and using a common clinical data set; (3) enhance incentives for sharing electronic health information according to common technical standards, starting with a common clinical data set; and (4) clarify privacy and security requirements that enable interoperability. Additional actions are needed in several other areas such as clinical culture, state and 11
  • 12. A Common Clinical Data Set  Patient name  Sex  Date of birth  Race  Ethnicity  Preferred language  Smoking status  Problems  Medications  Medication allergies  Laboratory test(s)  Laboratory value(s)/result(s)  Vital signs Care plan field(s), including goals and instructions Procedures Care team members Immunizations  Unique device identifier(s) for a patient’s implantable device(s)  Notes/narrative organization-level policies; these actions are described in greater detail throughout the Roadmap. However, these four foundational actions are linchpins to achieving the near-term and long- term goals described in Connecting Health and Care for the Nation (Figure 2). Below are more detailed near-term actions for each of these high priority areas. 1. Establish a coordinated governance framework and process for nationwide health information interoperability. As described above, the proliferation of health information sharing arrangements has created many different processes and rules for interoperability among sub- components of the health IT ecosystem. To enable nationwide interoperability for a common clinical data set, there must be agreement on the policies, operations and technical standards that will enable trust and allow information to be shared appropriately across the ecosystem. To that end, ONC will ensure the establishment of (1) a governance framework with overarching rules of the road for interoperability of health IT, (2) a public/private process for addressing implementation or operational-level issues and (3) a method for recognizing the organizations that comply with the rules and hold them accountable for continuing to do so. Public and private stakeholders will need to come together through a coordinated governance process to establish more detailed policies regarding business practices (including policies for identifying and addressing bad actors) and to identify the technical standards that will enable interoperability for specific use cases. See the Governance functional requirement for more detail on coordinated governance. 2. Improve technical standards and implementation guidance for sharing and using a common clinical data set. This basic set of electronic health information must be accessible via clinical documents (for example, in a care summary) and as discrete data elements (for example to plot blood pressure over time). It is unlikely that the care delivery system will stop using clinical documents for specific purposes in the near term (or perhaps the long term) and mobile technologies and applications will need to simultaneously access specific data elements to support individuals in the near term. The purpose for which electronic health information is shared and used must drive the technical standards and methods selected for nationwide adoption through a coordinated governance process. While coordinated governance processes are established, public and private stakeholders should advance standards that are scalable, high performing and 12
  • 13. 13 simple. These standards should enable sharing a common clinical data set6 Core Technical Standards and Functions building block for more detail on technical standards actions. , further constrain implementations of the C-CDA and define standards for data provenance at the document and data element levels and implement standards in a manner that makes sharing and receiving electronic health information easy for users. See the 3. Advance incentives for sharing health information according to common technical standards, starting with a common clinical data set. While the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) have been a primary motivator for the adoption and use of health IT, these programs alone are insufficient to create economic incentives that lead to interoperability across the care continuum and, over time, a learning health system. Experience has demonstrated that current fee-for-service payment policies often deter the exchange of electronic health information, even when it is technically feasible. To ensure that individuals and providers can send, receive, find and use a common clinical data set, federal, state and commercial payers will need to evolve policy and funding levers. These levers should incentivize information sharing according to technical standards designated through ONC’s HIT Certification Program in the near term and standards identified through the coordinated governance process over the longer term. See the Supportive Business and Regulatory Environment that Encourages Interoperability requirement for more detail on payment policy actions. 4. Clarify privacy and security requirements that enable interoperability. While health IT developers can design health IT tools that support electronic health information sharing, it is important to remember that the majority of clinical information resides within and is stewarded by health care organizations. Many of these health care organizations are “covered entities” (CEs) and are governed by the HIPAA Privacy and Security Rules. In addition, “business associates” (BAs) must follow parts of the HIPAA Privacy Rule and all of the requirements in the HIPAA Security Rule. Generally, BAs are organizations that perform certain functions or services to CEs that involve the use or disclosure of individually identifiable health information. The HIPAA Privacy Rule was designed to ensure that individuals’ health information is protected while allowing the flow of health information needed to provide high quality health care. The HIPAA Security Rule was designed to protect the privacy of individuals’ electronic health information while allowing the adoption of new technologies that will improve the quality and efficiency of patient care. Therefore, it is important for CEs and BAs to have consistent understanding of these requirements aligned with guidance provided by the HHS Office for Civil Rights. 6 Vitals in particular should be expanded to include – patient’s body height, body weight measured, diastolic and systolic blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation in arterial blood by pulse oximetry, body mass index (ratio). Vitals should also include date and time of vital sign measurement or end time of vital sign measurement and the measuring- or authoring-type source of the vital sign measurement
  • 14. Many organizations have misinterpreted HIPAA rules and other regulations and therefore refrain from sharing health information, even with individuals themselves. Effectively honoring the privacy and security of identifiable health information means that CEs and BAs will never be able to “open” or release identifiable health information writ large to whomever wishes to access it; however, in order to achieve nationwide interoperability, all organizations regulated by HIPAA must understand in the same way that HIPAA, through its permitted uses and its privacy protections, actually enables interoperability. With improved understanding, CEs and BAs will be able to exchange appropriately with greater confidence. This includes ensuring that individuals can exercise their legal right under HIPAA rules to access their own health information. Federal agencies and other stakeholders should work to provide the Office for Civil Rights, which enforces and issues guidance on the HIPAA Rules, with information it needs to determine whether additional guidance is needed to support interoperability while maintaining the crucial privacy protections on which interoperability relies. See the Privacy and Security Protections for Health Information building block for more detail on privacy and security actions. See Figure 2 for a timeline of select high-level critical actions. These and other critical actions are described in detail throughout the Roadmap. The Roadmap is organization according to the following five fundamental building blocks. • Core technical standards and functions • Certification and testing to support adoption and optimization of health IT products and services • Privacy and security protections for health information • Supportive business, clinical, cultural and regulatory environments • Rules of engagement and governance Within each building block, the roadmap describes functional and business requirements for a learning health system and the associated actions for making rapid near term progress. 14
  • 15. Figure 2: Timeline of Select High-Level Critical Actions for Near-Term Wins Disclaimer: Timeframes noted are approximate estimates. 15
  • 16. Roadmap Introduction The Federal Health IT Strategic Plan The draft Federal Health IT Strategic Plan 2015-2020 describes a set of overarching goals (see Figure 3) that align with HHS’ aims of improving health care quality, lowering health care costs and improving the U.S. population’s health.7 This Nationwide Interoperability Roadmap describes a path for achieving the Strategic Plan’s second goal (advance secure and interoperable health information) which helps the entire nation realize goals three, four and five through the development of a nationwide learning health system8 . Figure 3: Federal Health IT Strategic Plan Goals 7 See http://www.ahrq.gov/workingforquality/about.htm for more information on the National Quality Strategy 8 Federal Health IT Strategic Plan 2015-2020. ONC. December 8, 2014. http://www.healthit.gov/sites/default/files/federal-healthIT-strategic-plan-2014.pdf 16
  • 17. Interoperability Vision for the Future An interoperable health IT ecosystem makes the right data available to the right people at the right time among disparate products and organizations in a way that can be relied upon and meaningfully used by recipients. By 2024, individuals, care providers, communities and researchers should have an array of interoperable health IT products and services that support continuous learning and improved health. This “learning health system” should also result in lower health care costs (by identifying and reducing waste), improved population health, truly empowered consumers and ongoing technological innovation. For example, all individuals, their families and health care providers should be able to send, receive, find and use electronic health information in a manner that is appropriate, secure, timely and reliable. Individuals should be able to securely share electronic health information with care providers and make use of the electronic health information to support their own health and wellness through informed, shared decision-making. An interoperable health IT ecosystem should support critical public health functions, such as real-time case reporting, disease surveillance and disaster response, as well as data aggregation for research and value-based payment that rewards higher quality care, rather than a higher quantity of care. Section 262 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) defines “health information” as “any information, whether oral or recorded in any form or medium, that (A) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (B) relates to the past, present, or future physical or mental health or condition of any individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.” Health information such as personally maintained dietary logs, medical device data such as blood glucose readings and many other bits of information that inform health-related decision-making (both inside and outside the care delivery system) must also be connected in reusable ways in a dynamic ecosystem supported by health IT. Across this ecosystem, electronic health information in its broadest sense is and increasingly needs to be the stuff of everyday decision-making by everyday people. Care Providers is Broadly Inclusive of the Care Continuum, Including, but not Limited to: Primary care and ambulatory providers Specialists Nurses Pharmacists Laboratories and other ancillary service providers Physical therapists and other allied care providers Hospitals Mental health and substance abuse services Long-term and post-acute care facilities such as nursing homes Home and community- based services Other support service providers Care managers Other authorized individuals and institutions 17
  • 18. Scope For purposes of this Roadmap, interoperability is defined as the ability of a system to exchange electronic health information with and use electronic health information from other systems without special effort on the part of the user.9 In simple terms, this means all individuals, their families and their health care providers have appropriate access to electronic health information that facilitates informed decision-making, supports coordinated health management, allows individuals and caregivers to be active partners and participants in their health and care and improves the overall health of the nation’s population. The intersection of clinical and administrative electronic health information is a critical consideration, but is out of scope for this version of the Roadmap. Use cases, standards, technologies and tools that leverage both administrative and clinical electronic health information will be an important topic to address in future iterations. There are also many aspects of health IT beyond interoperability that are important and will be critical to a learning health system, including technology adoption,10 data quality, documentation and data entry, usability and workflow. However, these topics are out of scope for this Roadmap and deserving of separate, dedicated attention. This Roadmap focuses on decisions, actions and actors required to establish the best minimum level of interoperability across the health IT ecosystem, starting with clinical health information, in support of a learning health system. Why a Learning Health System A learning health system was first conceptualized by the Institute of Medicine (IOM) in 2005 as a Learning Healthcare System, partially in response to its earlier findings in To Err is Human and Crossing the Quality Chasm. Both of these reports indicated a need for improvements in safety, 9 Derived from the Institute of Electrical and Electronics Engineers (IEEE) definition of interoperability. 10 Federal Health IT Strategic Plan 2015-2020 Goal One. A learning health system: Will improve the health of individuals and populations. This learning health system will accomplish this by generating information and knowledge from data captured and updated over time – as an ongoing and natural by-product of contributions by individuals, care delivery systems, public health programs and clinical research – and sharing and disseminating what is learned in timely and actionable forms that directly enable individuals, clinicians and public health entities to separately and collaboratively make informed health decisions…The proximal goal of a learning health system is to efficiently and equitably serve the learning needs of all participants, as well as the overall public good. Taken from the Learning Health Community's Preamble 18
  • 19. efficiency and patient-centeredness of care, based on the best available evidence. IOM envisioned that a Learning Healthcare System would, "generate and apply the best evidence for the collaborative health care choices of each patient and provider; drive the process of discovery as a natural outgrowth of patient care; and ensure innovation, quality, safety and value in health care."11 Since 2005, the concept of a learning healthcare system has evolved to the broader concept of a learning health system, which extends beyond the care delivery system. A learning health system is an ecosystem where all stakeholders can securely, effectively and efficiently contribute, share and analyze data and create new knowledge that can be consumed by a wide variety of electronic health information systems to support effective decision-making leading to improved health outcomes. A learning health system is characterized by continuous learning cycles at many levels of scale (see Figure 4) and includes a broad array of stakeholders that include the care delivery system, but extend beyond care delivery to public health and the research community. For example, a learning health system includes transactions for routine and emergency public health services among governmental agencies (e.g., state and local health departments, emergency responders and public safety); hospitals; health care professionals; diagnostic laboratories; researchers; and non-governmental social services, advocacy and community based organizations. A learning health system also incorporates advanced health models that increasingly leverage technology, such as telecommunications technology to deliver health and clinical services remotely, that improve access to care across clinical and non-clinical community settings. Figure 4: The Health IT Ecosystem as a Learning Health System 11 The Learning Healthcare System: Workshop Summary. Leigh Anne Olsen, Dara Aisner and J. Michael McGinnis. Institute of Medicine. March 2007. http://books.nap.edu/openbook.php?record_id=11903 http://www.learninghealth.org/about-the-community/ 19
  • 20. 20 Guiding Principles for Nationwide Interoperability ONC articulated a set of guiding principles and building blocks in Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure.12 Based on feedback from a wide range of stakeholders, ONC has updated these principles as outlined below. These principles should serve as a guidepost in directing not only the critical actions described in this Roadmap, but also as subsequent actions and strategies to advance interoperability in the future. They are intended to focus our collective efforts to make practical and valuable progress, while encouraging innovation. 12 http://www.healthit.gov/sites/default/files/ONC10yearInteroperabilityConceptPaper.pdf 13 Usability refers to how useful, usable and satisfying a system is for the intended users to accomplish goals in the work domain by performing certain sequences of tasks. Drs. Jiajie Zhang & Muhammad Walji 1. Build upon the existing health IT infrastructure. Significant investments have been made in health IT across the care delivery system and in other relevant sectors that need to exchange electronic health information with individuals and care providers. To the extent possible, we will encourage stakeholders to build from existing health IT infrastructure, increasing interoperability and functionality as needed. 2. One size does not fit all. Interoperability requires technical and policy conformance among networks, technical systems and their components. It also requires behavior and culture change on the part of users. We will strive for baseline interoperability across health IT infrastructure, while allowing innovators and technologists to vary the usability13 in order to best meet the user's needs based on the scenario at hand, technology available, workflow design, personal preferences and other factors. 3. Empower individuals. Members of the public are rapidly adopting technology, particularly mobile technology, to manage numerous aspects of their lives, including health and wellness. However, many of these innovative apps and online tools do not yet integrate electronic health information from the care delivery system. Electronic health information from the care delivery system should be easily accessible to individuals and empower them to become more active partners and participants in their health and care, just as other kinds of data are empowering them in other aspects of their lives. 4. Leverage the market. Demand for interoperability from health IT users is a powerful driver to advance our vision. As delivery system reform increasingly depends on the seamless flow of electronic clinical health information, we will work with and support these efforts. The market should encourage innovation to meet evolving demands for interoperability. 5. Simplify. Where possible, simpler solutions should be implemented first, with allowance for more complex methods in the future. 6. Maintain modularity. A large, nationwide set of complex systems that need to scale are more resilient to change when they are divided into independent components that can be connected together. Because medicine and technology will change over time, we must preserve systems'
  • 21. abilities to evolve and take advantage of the best of technology and health care delivery. Modularity creates flexibility that allows innovation and adoption of new, more efficient approaches over time without overhauling entire systems. 7. Consider the current environment and support multiple levels of advancement. Not every individual or clinical practice will incorporate health IT into their work in the next 3-10 years and not every practice will adopt health IT at the same level of sophistication. We must therefore account for a range of capabilities among information sources and information users, including EHR and non-EHR users, as we advance interoperability. Individuals and caregivers have an ongoing need to send, receive, find and use their own health information both within and outside the care delivery system. 8. Focus on value. We will strive to make sure our interoperability efforts yield the greatest value to individuals and care providers; improved health, health care and lower costs should be measurable over time and at a minimum, offset resource investment. 9. Protect privacy and security in all aspects of interoperability. It is essential to maintain public trust that health information is safe and secure. To better establish and maintain that trust, we will strive to ensure that appropriate, strong and effective safeguards for electronic health information are in place as interoperability increases across the industry. We will also support greater transparency for individuals regarding the business practices of entities that use their data, particularly those that are not covered by the HIPAA Privacy and Security Rule, while considering the preferences of individuals. 10. Scalability and Universal Access. Standards and methods for achieving interoperability must be accessible nationwide and capable of handling significant and growing volumes of electronic health information, even if implemented incrementally, to ensure no one is left on the wrong side of the digital divide. Who is this Roadmap for? A learning health system includes the broad range of people and organizations traditionally involved in the delivery of clinical care (providers, individuals, payers) and many outside the care delivery system who impact the health of individuals (e.g., community-based social and human service organizations, schools, the research community, etc.). The following list of stakeholder perspectives is used throughout the Roadmap to denote which stakeholder groups are best positioned to take on a critical action and/or will directly benefit from actions to be taken (Figure 5). In most cases, individuals, groups and organizations fit more than one stakeholder perspective. Furthermore, professional organizations that represent the interests of a particular stakeholder may identify with one or more stakeholder perspective. 21
  • 22. Figure 5: Stakeholder Perspectives People who receive care or support the care of others Individuals, consumers, patients, caregivers, family members serving in a non-professional role and professional organizations that represent these stakeholders' best interests People and organizations that deliver care and services Professional care providers who deliver care across the continuum, not limited to but including hospitals, ambulatory providers, pharmacies, laboratories, behavioral health including mental health and substance abuse services, home and community based services, nursing homes and professional organizations that represent these stakeholders' best interests Organizations that pay for care Private payers, employers and public payers that pay for programs like Medicare, Medicaid and Tricare People and organizations that support the public good Federal, state, tribal and local governments People and organizations that generate new knowledge, whether research or quality improvement Researchers, population health analytics and quality improvement knowledge curators and quality measure stewards People and organizations that provide health IT capabilities Technology developers for EHR and other health IT, including but not limited to health information exchange (HIE) technology, laboratory information systems, personal health records, pharmacy systems, mobile technology, medical device manufacturers and other technology that provides health IT capabilities and services People and organizations that govern, certify and/or have oversight Governing bodies and accreditation/certification bodies operating at local, regional, or national levels that provide a governance structure, contractual arrangements, rules of engagement, best practices, processes and/or assess compliance People and organizations that develop and maintain standards Standards development organizations (SDOs) and their communities of participants, such as technology developers, health systems, providers, government, associations, etc. 22
  • 23. How the Roadmap is Organized: Business and Technical Requirements for a Learning Health System Interoperability Roadmap Building Blocks LHS Requirements Rules of engagement and governance A. Shared governance of policy and standards that enable interoperability: Nationwide interoperability across the diverse health IT ecosystem will require stakeholders to make collective decisions between competing policies, strategies, standards in a manner that does not limit competition. Maintaining interoperability once established will also require ongoing coordination and collaborative decision-making about change Supportive business, clinical, cultural and regulatory environments B. A supportive business and regulatory environment that encourages interoperability: Rules that govern how health and care is paid for must create a context in which interoperability is not just philanthropic, but is a good business decision. C. Individuals are empowered to be active managers of their health: A learning health system is person-centered, enabling individuals to become active partners in their health by not only accessing their electronic health information, but also providing and managing electronic health information through mobile health, wearable devices and online services. D. Care providers partner with individuals to deliver high value care: Providers work together with patients to routinely assess and incorporate patient preferences and goals into care plans that achieve measurable value for the individual and the population. Privacy and security protections for health information E. Ubiquitous, secure network infrastructure: Enabling an interoperable, learning health system requires a stable, secure, widely available network capability that supports vendor-neutral protocols and a wide variety of core services. F. Verifiable identity and authentication of all participants: Legal requirements and cultural norms dictate that participants be known, so that the context and access to data and services is appropriate. This is a requirement for all individual and organizational participants in a learning health system regardless of role (individual/patient, provider, technician, hospital, health plan, etc.) G. Consistent representation of permission to collect, share, and use identifiable health information: Though legal requirements differ across the states, nationwide interoperability requires a consistent way to represent an individual's permission to share their electronic health information, including with whom and for what purpose(s). H. Consistent representation of authorization to access health information: When coupled with identity verification, this allows consistent decisions to be made by systems about access to electronic health information. 23
  • 24. Interoperability Roadmap Building Blocks LHS Requirements Certification and testing to support adoption and optimization of health IT products and services I. Stakeholder assurance that health IT is interoperable: Stakeholders that purchase and use health IT must have a reasonable assurance that what they are purchasing is interoperable with other systems. Core technical standards and functions J. Consistent Data Formats and semantics: Common formats (as few as necessary to meet the needs of learning health system participants) are the bedrock of successful interoperability. Systems that send and receive electronic health information generate these common formats themselves or with the assistance of interface engines or intermediaries (e.g., HIOs, clearinghouses, third-party services.) The meaning of electronic health information must be maintained and consistently understood as it travels from participant to participant. Systems that send and receive information may or may not store standard values natively and therefore may rely on translation services provided at various points along the way. K. Standard, secure services: Services should be modular, secure and standards-based wherever possible. L. Consistent, secure transport technique(s): Interoperability requires transport techniques that are vendor-neutral, easy to configure and widely and consistently used. The fewest number of protocols necessary to fulfill the needs of learning health system participants is most desirable. M. Accurate identity matching: Whether aggregated in a repository or linked "just in time," electronic health information from disparate sources must be accurately matched to prevent information fragmentation and erroneous consolidation. As a learning health system evolves, more than individual/patient-specific information from health records will be matched and linked, including provider identities, system identities, device identities and others to support public health and clinical research. N. Reliable resource location: The ability to rapidly locate resources, including individuals, APIs, networks, etc. by their current or historical names and descriptions will be necessary for a learning health system to operate efficiently. Achieving nationwide interoperability will take a strategic and focused effort by the private sector in collaboration with federal, state, tribal and local governments. Realizing a learning health system that securely, efficiently and effectively gets the appropriate electronic health information to the appropriate person when and where it is needed in a manner that is useful, depends in large part on health IT systems being interoperable. 24
  • 25. The Roadmap is based on a core set of business and functional requirements to achieve a learning health system, organized by five critical building blocks that support the business, policies and technical needs of a nationwide interoperable electronic health information infrastructure. These 5 building blocks are interdependent and progress must be incremental across all of them over the next decade: • Rules of engagement and governance • Supportive business, clinical, cultural and regulatory environments • Privacy and security protections for health information • Certification and testing to support adoption and optimization of health IT products and services • Core technical standards and functions A learning health system depends on an ecosystem of nationwide interoperable health IT. Understanding and defining the business and technical requirements of a learning health system helps identify key decisions, actions and actors that must be put into motion, as well as dependencies and relationships that have to be accounted for in the sequencing of activities. Basic functional and business requirements to enable a learning health system are listed below and organized by building block. This is the basic structure of the Roadmap. Throughout the Roadmap, each requirement has a description of high level historical context, current state, desired future state and critical actions across three-, six- and ten-year timeframes. Each requirement is also linked to the Federal Health IT Strategic Plan objectives it supports, as well as the main stakeholders impacted by the requirement. Process for Updating the Roadmap ONC will continue to coordinate efforts and engage with the stakeholders to publish future versions of the Shared Nationwide Interoperability Roadmap. The Roadmap is intended to be a living document that is guided in its evolution by all health and health care stakeholders. ONC has served as the coordinator for this first draft of the Roadmap and will continue to do so for future iterations; however, the owners of the Roadmap are the variety of stakeholders and public represented herein. ONC anticipates updating the Shared Nationwide Interoperability Roadmap every two years with broad input from the public, stakeholders and its federal advisory committees (the HIT Policy Committee and HIT Standards Committee). For this initial version of the Roadmap, the set of actions described are offered as a starting point. The reader will note there are many objectives that lack one or more critical actions on the road to a learning health system. As a draft, this Roadmap needs the input from knowledgeable, engaged stakeholders and, in particular, areas where important actions or milestones may be missing, we ask for that input, indicated by the words “stakeholder input requested.” 25
  • 26. Additional Resources While the Roadmap contains important detail on each business and functional requirement for a learning health system, there is a significant amount of background that sits behind this document. For more background detail on health IT, as well as learning health system business and functional requirements, please see the resources below. • Historical background and current progress on interoperability: o ONC Report to Congress: Update on the Adoption of Health Information Technology and Related Efforts to Facilitate the Electronic use and Exchange of Health Information, October 2014. o ONC Data Briefs o ONC Interoperability Portfolio • Background on ONC’s 10 year vision and the five Building Blocks: o Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure, August 2014 • Additional information on ONC's Quality Improvement 10 year vision: o Health IT Enabled Quality Improvement: A Vision to Achieve Better Health and Health Care, November 2014 • Additional information on APIs and a national architecture for interoperability: o JASON Report: A Robust Health Data Infrastructure, April 2014 o HIT Policy and HIT Standards Committees’ JASON Task Force Final Report, October 2014 o JASON Report: Data for individual health, November 2014 • Additional information on person-centered health care: o Person at the Center | HealthIT.gov • Additional information on patient generated health data: o Patient-Generated Health Data | HealthIT.gov • Additional information on governance: o Health Information Exchange | HealthIT.gov • Appendices within this Roadmap document o Appendices 26
  • 27. A Shared Nationwide Interoperability Roadmap This section is organized by building blocks and then LHS requirements that fall under each building block. These building blocks and requirements are described in more detail in the above introduction of this document. Each requirement section contains: • Information about the requirement and the related Federal Health IT Strategic Plan objectives • Background information and a summary of the current state • A ‘moving forward’ section and critical actions Rules of Engagement and Governance A critical component of interoperability is a common set of standards, services, policies and practices that facilitate appropriate electronic health information exchange nationwide. Governance helps identify common policies, operational or business practices, and standards to support services that enable interoperability. Governance can also provide a mechanism for establishing trust across electronic health information trading partners, i.e., confidence in the practices of the other people/organizations with whom electronic health information is shared. While trust can be established among specific, known groups of trading partners through local governance, data use agreements and other contractual arrangements, individuals are mobile and often seek care beyond networks of local trading partners. Thus, it is important to have mechanisms for scaling trust nationwide, which requires assurance that each data holder adheres to a minimum set of common policies, operational and/or business practices and technical standards. Trading partners must also commit to using a common set of technical standards to ensure health IT is appropriately interoperable. A governance mechanism that effectively addresses all of these issues will help advance interoperability across all the diverse entities and networks that comprise a learning health system. This will facilitate the right information getting to the right people at the right time across disparate products and organizations, in a way that can be relied upon and meaningfully used by recipients. Shared governance of policy and standards that enable interoperability LHS Requirement: A. Shared governance of policy and standards that enable interoperability: Nationwide interoperability across the diverse health IT ecosystem will require stakeholders to make collective decisions between competing policies, strategies, standards in a manner that does not limit competition. Maintaining interoperability once established will also require ongoing coordination and collaborative decision-making about change. 27
  • 28. 28 FEDERAL HEALTH IT STRATEGIC PLAN OBJECTIVES SUPPORTED  Improve health care quality, access and experience through safe, timely, effective, efficient, equitable and person-centered care  Increase the adoption and effective use of health IT products, systems and services  Identify, prioritize and advance technical standards to support secure and interoperable health information  Accelerate the development and commercialization of innovative technologies and solutions  Increase user and market confidence in the safety and safe use of health IT products, systems and services Background and Current State The need for governance arises anytime a group of people or organizations come together to accomplish an end. In general, “governance is the process by which authority is conferred on rulers, by which they make the rules and by which those rules are enforced and modified.”14 Governance generally includes setting priorities, making decisions, establishing authority(ies) and ensuring accountability. 14 Arriving at a Common Understanding of Governance. The World Bank. http://go.worldbank.org/G2CHLXX0Q0 15 AHIC worked with organizations like the Markle Foundation to develop principles and frameworks for health information exchange, none of which required adoption or participation by organizations participating in health information exchange. 16 The DURSA is a single, multi-party agreement that sets the rules by which participants would operate to exchange data. 17 SEC. 3001. OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY. (8) GOVERNANCE FOR NATIONWIDE HEALTH INFORMATION NETWORK.—The National Coordinator shall establish a governance mechanism for the nationwide health information network. 18 The RFI sought public comment on a regulatory approach to establish a governance mechanism that would create conditions for trusted exchange amongst all of these organizations and set the rules of the road for exchange. Governmental Governance to Enable Interoperability ONC has made several attempts regarding governance to enable the secure nationwide exchange of electronic health information. In 2005, ONC formed the American Health Information Community (AHIC) as a federal advisory committee to discuss how to accelerate the development and adoption of health information technology and the Nationwide Health Information Network (NwHIN).15 Over the subsequent years, stakeholders and federal agencies worked together to develop the Data Use and Reciprocal Support Agreement (DURSA) for the Nationwide Health Information Network.16 In 2008, the National eHealth Collaborative (NeHC), a public-private partnership, was established to continue that work and build on the accomplishments of AHIC. In 2009, the HITECH Act explicitly directed ONC to establish a governance mechanism for the nationwide health information network17 . In 2012 ONC released a request for information (RFI) on a proposed regulatory approach to governance, titled Nationwide Health Information Network: Conditions for Trusted Exchange.18 The industry response to the RFI indicated a general desire for ONC to refrain from formal governance activity and to allow nascent and emerging governance efforts in industry to take shape. As health information exchange was in its infancy, but growing at a fast pace, commenters were concerned
  • 29. that regulatory action would stifle innovation and improvements in health information exchange. In response to the industry's comments, ONC indicated in September 2012 that it would not move forward at that time with regulation around governance. In 2013, ONC released the Governance Framework for Trusted Health Information Exchange (HIE), which established guiding principles on HIE Governance.19 Non-Governmental Governance In response to increased electronic health information exchange requirements under the EHR Incentive Programs,20 a number of organizations have been created or enhanced to define policies, practices and standards to enable interoperability between entities in their trust communities and hold participants accountable to these guidelines. Governance organizations that seek to establish exchange across organizational boundaries have also emerged. Despite significant overlap in the founders and members of these organizations, technical and governance policies that are adopted by each are often incompatible, as are their respective business practices and policies for establishing trust.21 While the overall objective of each organization is to establish a trust community and enable interoperability, they often have differing immediate goals and differing methods or standards to achieve those goals. While some industries, like airline reservations and ATM networks, only need to support simple use cases and limited standards, the health care industry is much more complex (see Appendix H for Priority Interoperability Use Cases). Some networks that support health care depend upon legal data sharing and use agreements, while some rely on self-attestation or independent accreditation. Some operate testing programs while others do not. And most (but not all) operate some level of technical infrastructure to identify participants in the trust community. In addition to varying policies and business practices that establish additional constraints beyond applicable law and regulation, there is also significant variation in the technical standards these organizations use to support interoperability, including specifications for content, transport and security. Organizations often have overlapping regional, state or national footprints, sometimes establishing trust communities that may compete for members. Additionally, some vendors and organizations have chosen not to participate in any of these organizations due to uncertainty about the industry and ONC's direction, or due to the costs associated with participation. The result is a complex web of electronic health information sharing arrangements that create some degree of interoperability within specific geographic, organizational and vendor boundaries, but fail to produce seamless nationwide interoperability to support a learning health system.22 19 http://www.healthit.gov/sites/default/files/GovernanceFrameworkTrustedEHIE_Final.pdf 20 Criteria include a requirement that eligible hospitals, critical access hospitals and eligible professionals send electronic care summaries for transitions of care and enable their patients to transmit care summaries electronically. 21 Interoperability Workgroup Governance Subgroup Presentation. July 2014. http://healthitgov.ahrqstg.org/facas/sites/faca/files/GSG_Slides_2014-07-23%20final_0.pptx 22 Ibid. 29
  • 30. Standards Development In addition to the governance actors, there are standards development organizations (SDOs) that develop technical standards and implementation guidance for content, semantics and transport of health information.23 While these entities serve a governance role for standards, there are important differences between them and broader governance functions related to technical standards. Unlike governance organizations, which tend to address the same subject matter and focus on constraint and guidelines to enable interoperability, SDOs work toward the establishment of particular types of standards. In addition to the standards work done by SDOs, there are entities that work to establish guidelines and constraints in the use of standards developed by SDOs.24 The S&I Framework25 in particular has worked to prioritize new standards initiatives and identity needs for constraining implementation guides. In most cases, the newly developed or constrained standards have then been picked up by SDOs and managed per their normal processes. Moving Forward and Milestones While the various organizations with their varying governance methods (policy, operational and technical) described above play an important part in the governance landscape, there is no single process or mechanism to bring them all together in a coordinated manner or in a manner that can reconcile differences. Furthermore, additional networks will likely emerge as customer needs evolve. The challenge is finding a way for health information to flow between these networks with varying policies and architectures. It is important that there be a set of "rules of the road," a multi-stakeholder process to address operational issues to support the rules of the road and a mechanism for demonstrating and identifying compliance with the rules, as well as addressing non-compliance. A coordinated governance mechanism must support a transparent and inclusive process for identifying operational issues and making decisions to support electronic health information exchange for individual and population health. The process should be inclusive of public and private actors and must hold true to the principle of person-centeredness. 23 SDOs do not necessarily work on the standards that the industry, CMS, ONC and other federal agencies believe are necessary to support interoperability. SDOs are member-based organizations and those members set the priorities for which standards will be developed and refined. Each SDO has a very refined process for developing, balloting, piloting, finalizing and maintaining standards and that piece of the process is working well. However, requirements development, priority setting (meaning what standards to focus on), implementation oversight, accepting feedback and enforcing correct implementations of the standards are not necessarily aligned with the priorities of health information exchange organizations. 24 One such organization is the EHR│HIE Interoperability Work Group (IWG). Some efforts of the IWG have been considered by the responsible SDO and resulted in important updates. 25 http://wiki.siframework.org/ 30
  • 31. To implement this process, there needs to be a set of criteria for entities that facilitate electronic health information interoperability (exchange and use) to follow. The federal government has a role to play in establishing rules of the road that support consumer protection and availability of electronic health information for individual and population health and supporting these rules and any specific governance criteria or accountability mechanism through its programs and requirements. The private sector has a key role to play in coalescing behind a common coordinated governance process that will establish or refine the criteria that support interoperable health IT. The public and private sectors must work together to identify and address operational issues that currently inhibit interoperability. The public and private sectors also must establish a mechanism for compliance and accountability to governance criteria. In instances where the process has established consensus criteria that require additional reinforcement, ONC or other federal agencies will consider creating implementation specifications for the criteria that could be adopted through existing public programs. Governance Principles Governance should address three main subject matter areas: policy, operations and technical standards. There needs to be a single set of basic rules of the road to support interoperability nationwide and address consumer protection. The set of principles below represents a foundation that should endure over time. More detailed criteria that support these principles can be established to support different interoperability needs as they emerge over the next three, six and ten years. These principles are based on the Governance Framework for Trusted Electronic Health Information Exchange, fair information practice principles, established privacy and security policy, and build on the existing legal framework for health information. Policy Figure 6: Overview of Governance Principles • Access to Personal Health Information: Data holders and entities facilitating interoperability of health information shall, in accordance with applicable law and individual preferences, exchange information, including with the individual to support patient care, care coordination and other permitted purposes. Specifically: o No policy, business, operational, or technical barriers that are not required by law should be built to prevent information from appropriately flowing across geographic, health IT developer and organizational boundaries in support of patient care. o Where individuals clearly instruct a data holder to release information about them to others, the data holder should comply with that directive. o Data holders and entities that facilitate interoperability should not compete on the 31
  • 32. availability of patient health data. o Promote collaboration and avoid instances where (even when permitted by law) differences in fees, policies, services, operations or contracts would prevent individuals’ personal health information from being electronically exchanged. • Respect Policies of Other Exchange Partners: Data holders and entities facilitating interoperability of electronic health information should not establish policies or practices in excess of law that limit the availability of electronic health information by another entity that is in compliance with applicable laws and these governance principles. • Individual Choice: Data holders and entities facilitating interoperability of health information should grant individuals, consistent with existing law, the ability to exercise choice over what personal health information these organizations collect from them and how the organizations use it and share it. o An individual shall not be denied access to health care services based on whether they have documented their choice regarding electronic health information exchange. o Individuals retain the right to not disclose their information in the first instance. o Data holders and entities that facilitate the interoperability of health IT should provide clear and simple choices regarding what restrictions an individual can and cannot place on the collection, sharing, or use of that individual’s health information. These choices should be presented at times and in ways that enable individuals to make meaningful decisions about personal health information collection, use and disclosure. These choices should be presented at an appropriate level for the literacy and language preference of the individual. o Data holders and entities that facilitate the interoperability of electronic health IT should enable these choices by providing individuals with easily used and accessible electronic processes that reflect the scale, scope and legal sensitivity of the personal health information that data holders collect, use, or disclose as well as the legal sensitivity of the uses they make of the information. • Transparency: Data holders and entities facilitating electronic exchange of health information should provide easily understandable and accessible information about organizations’ data practices. Specific examples include, but are not limited to: o Data holders and entities should provide clear descriptions of what personal health information they collect, why they need the data, how they will use it, when they will delete it or de-identify it and whether and for what purposes they may share such data. o Data holders and entities should provide clear descriptions of decision tools that may be used to match individual identifying information, share individually identifiable information, or withhold individual identifying information sharing. o Data holders and entities should provide clear information to health information trading partners about technical error rates (e.g., for improper individual matching) and other information (for example results of independent audits of security controls) about information interoperability that may have diverged from expected practices. 32
  • 33. • Security: Data holders and entities facilitating interoperability of health information should secure and ensure responsible handling of personal health information in line with other examples of critical infrastructure. Specific examples include but are not limited to: o Data holders and entities should maintain reasonable safeguards to control risk, such as loss, unauthorized access, use, destruction, or modification and improper disclosure. o Data holders and entities should ensure that an individuals' personal health information is consistently and accurately matched when electronically exchanged. o Data holders and entities should take reasonable steps to ensure that personal health information is complete, accurate and up-to-date to the extent necessary for the intended purpose and has not been altered or destroyed in an unauthorized manner. • Individual Access and Correction: Data holders and entities facilitating exchange of health information should provide individuals, consistent with applicable laws, a means to exchange and obtain electronic access to personal health information and the ability to correct such information in a timely manner that is appropriate to the sensitivity of the data and the risk of adverse consequences to the individual if the data is inaccurate. Operations • Transparency: Entities facilitating interoperability of health IT should operate with transparency and openness, including making publicly available information describing their electronic exchange capacity and services, for example: number of users, the types of standards implemented, number of patient lives covered and transaction volume. • Inclusive Governance: Entities facilitating interoperability of health IT should promote inclusive participation and adequate stakeholder representation (especially among individuals and patient advocates) in the development of data policies and operations policies. • Open Exchange: There should be neutrality in the exchange of personal health information. o An entity engaged in the exchange of electronic health information shall treat all personal health information exchange requests, services and efforts in roughly the same way and not erect barriers to the authorized flow of information. For instance, a health IT developer that has health information exchange applications shall not prevent a user from using health information exchange applications developed by competitors. o Provide open access to exchange services, such as access to an organization's provider directory that would enable local, regional and/or nationwide organizations and individuals to identify with whom they can electronically exchange information and how such exchange would have to be completed, pursuant to applicable laws and regulations. Standards • Data holders and entities facilitating exchange of electronic health information should ensure standards are prioritized, developed and implemented to support the public interest, national priorities and the rights of individuals (e.g., health care delivery, privacy). o Where available and appropriate for the desired exchange of health information federal vocabulary, content, transport and security standards and associated implementation specifications are used. 33
  • 34. o Standards should support data portability from one health IT product to another. o The development and implementation of technical requirements should enable the adaptation and incremental evolution of health information exchange and technologies supporting exchange to meet current and future needs of users as standards evolve. o Standards development and adoption should not unfairly provide an advantage to one sector or one organization over others. Table 1: Critical Actions for a Coordinated Governance Framework and Process for Nationwide Health Information Interoperability Category 2015-2017 Send, receive, find and use a common clinical data set to improve health and health care quality 2018-2020 Expand interoperable health IT and users to improve health and lower cost 2021-2024 Achieve a nationwide learning health system A1. Establishment of Coordinated Governance 1. ONC will define a nationwide governance framework with common rules of the road for trust and interoperability and a mechanism for identifying compliance with common criteria. These rules will first focus on interoperability of a common clinical data set for purposes of treatment. 2. ONC will identify a mechanism for recognizing organizations that comply with the common rules of the road. 3. Call to action: Public and private sector stakeholders across the ecosystem should come together to establish a single coordinated governance process to establish more detailed policies regarding business practices, including policies for identifying and addressing bad actors and to identify the technical standards that will enable interoperability for specific use cases (see Appendix H for Priority Interoperability Use Cases). 4. Call to action: Federal agencies that provide or pay for health services should align their policies for interoperability with the nationwide governance framework. 5. ONC and stakeholders participating in the coordinated governance process should establish metrics for monitoring and assessing nationwide interoperability and methods for data collection. 6. The coordinated governance process will continue to operate and update policies for business practices/operations and technical standards to enable interoperability as needed. 7. ONC and stakeholders will use nationwide interoperability metrics to assess the success of governance activities and make or recommend changes, as needed. 8. The coordinated governance process will continue to operate and update policies for business practices/operations and technical standards to enable interoperability as needed. 9. ONC and stakeholders should continue to use nationwide interoperability metrics to assess the success of governance activities and make or recommend changes, as needed. 34
  • 35. Category 2015-2017 Send, receive, find and use a common clinical data set to improve health and health care quality 2018-2020 Expand interoperable health IT and users to improve health and lower cost 2021-2024 Achieve a nationwide learning health system A2. Policies & Operations 1. Governance entities and data holders should align their policies with the nationwide governance framework. 2. ONC, in collaboration with stakeholders, should define a policy framework for exchange of patient-generated health data and pilot it. 3. ONC will work with the established coordinated governance process to identify or modify criteria and implementation specifications to address an expanded data set and uses of health information beyond treatment, including but not limited to payment and health care operations and patient-generated health data. 4. ONC and stakeholders participating in the coordinated governance process, human service providers and health- related device overseers should define policies for interoperability of health information from non- clinical sources. 5. ONC and stakeholders participating in the coordinated governance process should define a policy framework for interoperability of clinical data to support research and big data analyses. 6. ONC will work with the coordinated governance process to identify or modify criteria and implementation specifications to address the needs of a learning health system. 7. ONC and stakeholders participating in a coordinated governance process should define criteria and implementation specifications for interoperability of clinical data to support research and big data analyses nationwide. 35
  • 36. Category 2015-2017 Send, receive, find and use a common clinical data set to improve health and health care quality 2018-2020 Expand interoperable health IT and users to improve health and lower cost 2021-2024 Achieve a nationwide learning health system A3. Standards 1. The coordinated governance process should support three main functions related to technical standards: prioritization of use cases for which standards are needed, selection of standards to support priority use cases based on ONC's Interoperability Advisories and coordination across SDOs and implementers as standards are developed and refined (see Appendix H for Priority Interoperability Use Cases). 2. The coordinated governance process should support a holistic lifecycle process for technical standards that enable care providers and individuals to send, receive, find and use a common clinical data set. This involves establishing clear feedback loops between SDOs and implementers, as well as supporting non- certification-related testing of technical standards. 3. The coordinated governance process should establish an ongoing evaluation process for the efficacy of standards and testing tools. 4. The coordinated governance process should work with SDOs to identify or develop additional standards for new learning health system priority functions as part of the holistic lifecycle process. 5. The coordinated governance process should use the standards evaluation process on an ongoing basis to coordinate the roll out of software and service changes so as not to disrupt established interoperability. 6. The coordinated governance process should continue to evaluate the efficacy of standards and testing tools. 7. The coordinated governance process should continue to use the standards evaluation process on an ongoing basis to coordinate the roll out of software and service changes so as not to disrupt established interoperability. 36
  • 37. Supportive Business, Clinical, Cultural and Regulatory Environments While the Medicare and Medicaid EHR Incentive Programs have been a primary motivator for the adoption and use of certified EHR technology, these programs alone are insufficient to overcome barriers to our vision of information sharing and interoperability as outlined above. Current policies and financial incentives often prevent such exchange, even when it is technically feasible. To ensure that individuals and care providers send, receive, find and use a basic set of essential health information across the care continuum over the next three years, we need to migrate policy and funding levers to create the business imperative and clinical demand for interoperability and electronic health information exchange. A Supportive Business and Regulatory Environment that Encourages Interoperability LHS Requirement B. A supportive business and regulatory environment that encourages interoperability: Rules that govern how health and care are paid for must create a context in which interoperability is not just a way to improve care, but is a good business decision. FEDERAL HEALTH IT STRATEGIC PLAN OBJECTIVES SUPPORTED  Improve health care quality, access and experience through safe, timely, effective, efficient, equitable and person-centered care  Support the delivery of high-value health care  Improve clinical and community services and population health  Increase access to and usability of high-quality electronic health information and services Policy and funding levers that create the business imperative for interoperability are pivotal for helping to ensure that individuals, caregivers and providers can send, receive, find and use a common clinical data set across the care continuum in the near term. Policy levers related to other learning health system stakeholders such as public health, social and human services and research communities must also be addressed. Additionally, a cultural shift at both the individual and provider levels is necessary to empower individuals to participate in their health and care. Background and Current State Despite strong agreement on the need for interoperability to enable higher quality, more efficient, person-centered care, the demand among providers, consumers and purchasers of health care has not yet translated into seamless interoperability across the health care system. Countervailing market forces and structural attributes of the health care system make it costly to move away from the status quo of fragmented care and silos of health information, inhibiting widespread adoption of interoperable systems. One key barrier to interoperability arises from the way in which health care in the U.S. has 37
  • 38. traditionally been reimbursed (typically "fee-for-service" payment models.) Economic gains from interoperability are realized in the form of greater efficiency in the delivery of health care—for instance, laboratory and imaging tests are often duplicated when an existing image that might obviate the need for a test is not available or not accessed, contributing to wasteful health care spending that could be allocated more efficiently. While the effective use of interoperable systems has the potential to address this waste by allowing providers to share test results, there are few incentives to adopt these systems under the fee-for-service system, which can actually incentivize providers to deliver a greater volume of services and disincentivize the reuse of prior lab tests. In addition, many market participants, especially those in health care markets characterized by intense competition, may be wary of how increased interoperability will impact their business strategy and competitive position. Providers are concerned about increased liability risk when they exchange health information outside their walls and they may not view the benefits associated with interoperability as outweighing the costs of ensuring that they are exchanging information in a secure fashion that adequately protects individuals’ information. Seamless interoperability could also enable individuals and their caregivers to more easily change care providers and transfer electronic health information among providers, thereby reducing providers’ competitive advantages from exclusive access to an individual’s health information. These same forces may impact health IT vendors' behavior, reinforcing a status quo characterized by high costs to switch products and services, greater lock-in and reduced data portability. The lack of economic incentives for coordinated and efficient care across the continuum has fostered a health IT market where providers have demanded tools that meet their organization’s internal care delivery needs but not tools that are person-centered in allowing interoperability across many different settings and providers of care. Moreover, providers interested in improving interoperability are in some cases limited by their vendor agreements in demanding interoperability. Experience from the REC program26 has shown small providers making purchasing or licensing decisions often lack the time and resources to keep up with emerging health IT trends and products. Furthermore, interoperability and data liquidity could enable providers to more easily change health IT vendors, increasing competition between vendors. Finally, the fragmented nature of the health care marketplace poses fundamental challenges to interoperability. Where other industries have captured efficiencies from common standards and shared infrastructure, they have often relied on the market power of a few major actors that are able to drive standardization by virtue of their size and reach. Certain care delivery organizations may be dominant in a local or regional market, but have little presence elsewhere, while large payer organizations may have national reach but only a limited presence in any given market. Within this landscape, the federal government is unique in its market reach, but is still limited in its capacity to drive standardization. 26 The Regional Extension Center (REC) program provides implementation assistance to priority practices—those with limited financial, technical and organizational resources—but the assistance is time limited. Link to study: http://www.annfammed.org/content/13/1/17.full 38
  • 39. Achieving greater interoperability, with common policies and standards, will require coordinated commitments across health care stakeholders to overcome these fragmentation challenges. Over the past several years, the public and private sector alike have made progress toward changing the way health care is paid for, laying the groundwork for a value-based and person-centered health system. Under new "value-based payment" programs, providers are reimbursed based on the quality of care delivered and the degree to which providers can keep costs low and increase efficiency. These programs strengthen the business imperative to adopt common standards and exchange information across the care continuum to provide more coordinated and effective care. With value-based payment, having up-to-date information to support individuals is critical for providing timely and necessary care and services. For example, knowing that a discharged patient with congestive heart failure is gaining weight the week after they are discharged can trigger home-based interventions that can help prevent the patient from being readmitted, saving significant costs overall and preventing negative patient outcomes. Models that emphasize shared accountability for value across different organizations, including non-traditional stakeholders such as community-based services, are also creating incentives to seamlessly share information with partners. However, paying for outcomes alone will not be sufficient to change the way providers deliver care. The transition to value-based payment is a long-term, incremental process and providers will need to master new tools and ways of working together before they are willing to take on more substantial levels of risk. Payment policy should encourage incremental steps toward interoperability and address those disincentives that stakeholders perceive as making the transition to interoperability too costly. While the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) have provided significant incentives to adopt health information technology that can share information according to common standards, further action may be needed to counter the powerful business drivers described above. In addition, the EHR Incentive Programs were not designed to include all providers across the continuum of care, such as long-term care and behavioral health providers, which are some of the most significant cost drivers in the care delivery system. As HHS continues to test and advance new models of care that reward providers for outcomes, it will help to create an environment where interoperability makes business sense. Additional policy levers across the public and private sector could also be leveraged to encourage interoperable health IT, including: 1) new incentives to adopt and use interoperable health information systems to create additional demand for interoperability; and 2) requirements/penalties that raise the costs of not moving to interoperable systems. Moving Forward and Critical Actions To achieve this vision, all stakeholders who pay for health care must explore opportunities to accelerate interoperability as a key component of broader efforts to move toward a value-based healthcare system. The following discussion focuses on ways the federal government, state governments, commercial payers 39

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