2/16/2018
Why Application Programming Interfaces Are Key for Healthcare
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FEATURES
Why Application Programming Interfaces Are Key for Healthcare
Application programming interfaces (APIs) are gaining traction in healthcare as developers seek simple, standards-based solutions
for their interoperability problems.
(https://hitinfrastructure.com/images/site/features/_large/ThinkstockPhotos-101765995.jpg)
Source: Thinkstock
Healthcare organizations seeking to create interoperability between internal apps, EHRs, and other data exchange tools, are increasingly turning
to application programming interfaces (APIs) to manage the flow of information between disparate systems.
As the ongoing transition to value-based care, population health management, and care coordination creates an imperative for actionable
insights at the point of care, APIs can ensure the electronic health record data is accessible to the right internal and external users while
remaining protected from malware and outside threats.
“We’re moving out of the era of EHR implementation and adoption and into the era of interoperability,” Bob Robke, Vice President of
Interoperability at Cerner Corporation told (https://ehrintelligence.com/news/future-of-ehrs-interoperability-population-healthand-the-cloud) EHRIntelligence.com.
“Now that we’ve automated the health record, the next phase is connecting all of the information in the EHR. We need interoperability and open
platforms to accomplish this.”
Healthcare stakeholders have started to invest in APIs to facilitate this vision
(http://healthitinteroperability.com/features/potential-for-healthcare-apis-to-revolutionize-the-industry) of open data
exchange. But what are APIs exactly, and what interoperability challenges do they help healthcare organizations overcome?
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Why Application Programming Interfaces Are Key for Healthcare
Solutions for Addressing Health Information Exchange Challenges (http://healthitinteroperability.com/features/solutionsfor-addressing-health-information-exchange-challenges)
Breakdown of Health IT Interoperability Standards, Organizations
(http://healthitinteroperability.com/features/breakdown-of-health-it-interoperability-concepts-organizations)
WHAT IS AN APPLICATION PROGRAMMING INTERFACE?
An API is an interface that allows unrelated software programs to communicate with one another. They act as bridges between two applications,
allowing data to flow regardless of how each application was originally designed.
For applications that function by pulling a constant stream of data from one or more sources, an API is especially important to decrease
development time, save storage space on endpoint devices, and overcome any differences in the standards or programming languages used to
create the data that lives at either end of the bridge.
For example, third-party travel planning sites like Expedia or Kayak don’t generate data on their own to deliver comparisons of flight prices from
ten or twelve different airlines.
They simply use the API provided by each individual airline to plug into the flight scheduling software for each company and pull information
into a single view for the end-user.
“We’re moving out of the era of EHR implementation and adoption and into the era of
interoperability.”
Because the API is a standardized gateway to the airline’s schedule and pricing data, Expedia or Kayak doesn’t have to develop a dozen different
methodologies tailored to each airline before they can establish communications.
This eliminates the need for the travel comparison site to duplicate every dataset, create new data, or hold the data itself in order to function.
APIs function similarly in enterprise environments, making building applications and accessing data quicker, more efficient, and less prone to
duplication or security errors.
Getting a Handle on APIs and Health IT Interoperability (http://healthitinteroperability.com/news/getting-a-handle-onapis-and-health-it-interoperability)
Open APIs, Use Cases Driving Interoperability at Allscripts (http://healthitinteroperability.com/news/open-apis-use-casesdriving-interoperability-at-allscripts)
WHY APIS ARE CRITICAL FOR HEALTH IT DEVELOPMENT
Healthcare organizations face challenges accessing and sharing data, especially as healthcare IT infrastructure migrates
(http://hitinfrastructure.com/news/healthcare-cloud-becomes-it-infrastructure-necessity) to the cloud, and digital information
becomes an industry standard. Different data sets use different formats, making interoperability between apps challenging.
“There’s no such thing as one set of data that gives you everything you need in one single format,” Dr. Nicholas Marko, Chief Data Officer at
Geisinger Health told (http://healthitanalytics.com/features/a-fhir-future-burns-brightly-for-population-health-management)
HealthITAnalytics.com. “There will always be information coming from a number of different places, and there will always be a need to work
with systems that handle that.”
Because APIs are the points of communication between systems, they are being developed to simplify interoperability to provide healthcare
professionals and users data more efficiently.
HL7 is currently developing (http://healthitinteroperability.com/news/how-health-it-standards-enable-patient-access-tohealth-data) the Fast Healthcare Interoperability Resource (FHIR) data standard, which provides a standardized way to aggregate and merge
patient health data from separate data sources.
“There’s no such thing as one set of data that gives you everything you need in one single
format.”
FHIR creates (https://www.hl7.org/fhir/overview.html) a standard to make it easier for healthcare professionals to use and share
clinical data by restructuring healthcare data from different sources into a compatible format for easier interoperability.
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“Healthcare records are increasingly becoming digitized,” official FHIR documentation states. “As patients move around the healthcare
ecosystem, their electronic health records must be available, discoverable, and understandable. Further, to support automated clinical decision
support and other machine-based processing, the data must also be structured and standardized.”
While FHIR is not yet as widely used (http://healthitinteroperability.com/news/how-health-it-standards-enable-patientaccess-to-health-data) in healthcare as it could be, the importance of APIs is a high priority for the ONC, which has included the technology in
its most recent EHR certification criteria.
The ONC’s proposed rule for 2015 Edition Certified EHR Technology (CEHRT) outlines (https://s3.amazonaws.com/publicinspection.federalregister.gov/2015-06612.pdf) three technical outcomes for APIs that vendor products need to meet:
Security: The API needs to include a means for the establishment of a trusted connection with the application that requests patient data. This
would need to include a means for the requesting application to register with the data source, be authorized to request data, and log all
interactions between the application and the data source.
Patient selection: The API would need to include a means for the application to query for an ID or other token of a patient’s record in order to
subsequently execute data requests for that record.
Data requests, response scope, and return format: The API would need to support two types of data requests and responses: “by data
category” and “all.” In both cases, while the scope required for certification is limited to the data specified in the Common Clinical Data Set,
additional data is permitted and encouraged.
The ONC 2015 CEHRT regulations encourage developers to custom design APIs that work for their institution while outlining requirements to
ensure security and data integration.
Can FHIR Spark Health Information Exchange, Interoperability? (http://healthitanalytics.com/news/can-fhir-spark-healthinformation-exchange-interoperability)
HHS Releases 2015 CEHRT, Meaningful Use Flexibility Rules (http://healthitanalytics.com/news/hhs-releases-2015-cehrtmeaningful-use-flexibility-rules)
(https://hitinfrastructure.com/images/site/features/_large/ThinkstockPhotos-177201924.jpg)
Source: Thinkstock
THE QUESTION OF API SECURITY
The ONC 2015 Edition CEHRT specifically calls for organizations to secure their API connections to ensure that unauthorized users do not gain
access to the healthcare API.
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Why Application Programming Interfaces Are Key for Healthcare
Organizations are tasked with implementing security measures and protocols to protect their network and data from malicious attacks or leaked
information, both of which could have serious implications for patients.
The Health IT Policy and Standards Committee formed the API Task Force (https://www.healthit.gov/facas/health-it-policycommittee/hitpc-workgroups/api-task-force) to “identify perceived security concerns and real security risks that are barriers to the
widespread adoption of open APIs in healthcare.”
A report (https://www.healthit.gov/archive/archive_files/HIT%20Joint%20Committee/2016/API%20Task%20Force/201604-26/SingleSourceofTruth-APITFRecommendations.pdf) released earlier this year by the API Task Force, along with the Health IT
Policy and Standards Committee, outlines security concerns APIs bring to healthcare.
“There are fears that APIs may open new security vulnerabilities, with apps accessing patient records ‘for evil’, and without receiving proper
patient authorization,” stated the report. “There are also fears that APIs could provide a possible ‘fire hose’ of data, as opposed to the ‘one sip at a
time’ access that a web site or email interface may provide.”
Considering how public, consumer-facing APIs function, the concerns raised by the report are valid. There is the risk of users gaining access to
too much data instead of just the data they need.
Even if the user is not “evil,” authorized users accessing a wealth of data they do not need is still a security risk and may violate HIPAA privacy
regulations.
The report found that when properly secured and managed, the benefits of APIs outweigh the risks. Several organizations testified their properly
managed APIs provided better security than legacy or proprietary integration technology.
Well-managed healthcare API exchanges usually include authentication, authorization, encryption, and signatures to ensure secure connections.
Authentication (http://healthitsecurity.com/news/controlling-healthcare-authentication-and-authorizations) and
authorization are used to reliably determine a user’s identity and what resources they can access, usually through usernames and passwords.
Security software certificates and hardware keys may also be used for extra security.
Encryption (http://hitinfrastructure.com/news/health-data-encryption-grows-with-technology-advancements) hides data
from unauthorized users and acts as a failsafe in the event the clinical data is stolen. Signatures are also used to validate API requests and ensure
the data did not experience interference during transit.
The API Task Force report touches on APIs and HIPAA regulations, particularly focusing on patient-directed API technology. While managed
APIs are secure, the risk factor rises when patients are accessing PHI without being familiar with the HIPAA Notice of Privacy Practices for
Protected Health Information.
If patients do not understand the value their personal health data has to hackers seeking to steal their identity, they are more likely to carelessly
share it with a third party app and expose themselves to privacy breaches.
The Task Force also recognizes the potential risk of patients accessing HIPAA-approved APIs and sharing the information with an app that is not
regulated under HIPAA, such as a commercial fitness tracker app.
The API Task Force recommends that the The Office of the National Coordinator for Health Information Technology (ONC) coordinates a
program to define the basics of privacy literacy and educate patients to understand basic privacy information needs to make appropriate
decisions regarding sharing personal health data with unauthorized apps.
Healthcare Authentication Factors: Breaking Down HIPAA (http://healthitsecurity.com/news/healthcare-authenticationfactors-breaking-down-hipaa)
Health IT Task Force Synthesizes Open API Themes (http://healthitinteroperability.com/news/health-it-task-forcesynthesizes-open-api-themes)
USING APIS FOR DATA INTEGRATION
The biggest hangup facing data integration in healthcare is the lack of consistency in data formats among disparate organizations,especially when
it comes to EHRs.
The Regenstrief Institute is one of several organizations seeking to merge patient health data from separate data sources to create an industry
data standard using HL7’s FHIR.
“We can really stitch together information in various sources using FHIR in a way that is user-centered and would be accepted by physicians and
patients,” Regenstrief Institute investigator Titus Schleyer, MD, PhD, told (http://healthitinteroperability.com/news/longstanding-itchallenges-still-limit-potential-of-fhir) HealthITInteorperability.com.
The Regenstrief Institute aims to leverage the FHIR standard and API technology to assemble health information from different EHR systems.
The Institute deployed a use case between between an Epic EHR using the open.epic API and the Indiana Network for Patient Care (INPC) using
a previous version of FHIR.
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“We can really stitch together information in various sources using FHIR in a way that is usercentered.”
Although this use-case was not a full implementation, the Regenstrief Institute was able to give INPC proof of concept that their data could be
integrated.
The Argonaut Project is another organization with close ties to FHIR. The group is working to develop
(http://argonautwiki.hl7.org/images/e/ec/Argonaut_UseCasesV1-1.pdf) a FHIR-based API and Core Data Services to expand the
sharing of electronic health information.
The goal of the Argonaut Project is to “enable interested vendors and providers to develop and implement a focused but complete FHIR API
specification, and accompanying security implementation.”
Argonaut members encourage prepared entities to move more quickly towards data standardization and API adoption than current regulatory
processes require in order to lead the industry by example.
“I’ve seen a lot more progress when groups of provider organizations and technology developers get together and say, ‘We’re going to go at the
quickest pace we can, regardless of whether the whole market travels at the same speed,’” Arien Malec, Vice President of Data Platform and
Acquisition Tools at RelayHealth told (http://healthitanalytics.com/news/health-data-interoperability-requires-patiencepersistence) HealthITAnalytics.com.
“Clearly, I’m proud of my work in the CommonWell Health Alliance and in being part of the Argonaut Project, which I think are both good
representations of that attitude that says, ‘We’re going to get together and drive interoperability independently of the certification program.’”
“We’re going to go at the quickest pace we can, regardless of whether the whole market travels at
the same speed.”
The Argonaut Project aims to introduce specifications for a new architectural pattern and style for healthcare organizations to access data and
services, and more flexible and open methods for authorized access to health information.
While these projects have yet to be fully realized, the potential for APIs in health data integration for secure and efficient access is promising.
Will FHIR, APIs Help or Hinder Health Information Exchanges? (http://healthitinteroperability.com/news/will-fhir-apishelp-or-hinder-health-information-exchanges)
Addressing HIPAA as an Obstacle to Health Data Exchange (http://healthitinteroperability.com/news/addressing-hipaa-asan-obstacle-to-health-data-exchange)
LOOKING TOWARDS THE FUTURE OF APIS IN HEALTHCARE
Support for APIs in healthcare is growing as government organizations encourage the use of APIs in health IT infrastructure.
The Centers for Medicare & Medicaid Services (CMS) recently called (http://healthitinteroperability.com/news/how-health-itstandards-enable-patient-access-to-health-data) for the use of APIs to help providers meet requirements for electronic patient access to
health information by giving consumers tools to easily interact with their personal health data.
ONC also recognized the importance of FHIR and APIs by hosting a pair of industry challenges (http://healthitanalytics.com/news/onclaunches-two-fhir-interoperability-app-challenges) and a funding opportunity to address several interoperability issues in healthcare
including: helping patients access their data, improving the provider user experience of EHRs and other health IT tools, and coordinating the
development of app-based solutions across the industry.
The support CMS and the ONC have for FHIR and APIs speaks to the future of the technology and its potential impact on healthcare
interoperability.
“The FHIR standard is still quite new,” said (http://healthitanalytics.com/features/a-fhir-future-burns-brightly-for-populationhealth-management) DR. David McCallie, Jr., Senior Vice President of Informatics at Cerner. “It’s not even a formal standard yet – it’s still in
draft status.”
“And vendors who are implementing it are feeling their way forward to make sure they understand it, and to discover if there are any gaps or
bugs, or if the specification is not actually specific enough.”
As API development continues, the importance of creating a standard for healthcare application communication is a priority for vendors and
organizations.
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Why Application Programming Interfaces Are Key for Healthcare
“As an industry, we have to come together to solve the problem of access to our own healthcare information,” said
(http://healthitanalytics.com/features/a-fhir-future-burns-brightly-for-population-health-management) Cerner Corporation
President Zane Burke.
“Patients deserve access to their data no matter where they are in the country, and no matter where their record primarily resides. They should
have the ability to provide consent to have a clinician be able to pull those records whether they’re on a Cerner system or a competitor’s solution.
Ultimately, that’s what we need to deliver.”
As interoperability efforts such as The Argonaut Project and The Regenstrief Institute continue to develop a data standard that can be
implemented universally, across healthcare organizations, APIs will be able to easily request and retrieve data from multiple EHR solutions
across multiple healthcare organizations and arrange them in a clear usable format.
“Patients deserve access to their data no matter where they are in the country, and no matter
where their record primarily resides.”
As API development continues, healthcare organizations can prepare their IT infrastructure by implementing app development and cloud
solutions (http://hitinfrastructure.com/news/healthcare-cloud-becoming-critical-it-infrastructure-tool) where necessary and
improving wireless network (http://hitinfrastructure.com/news/increased-cloud-demands-calls-for-health-it-wan-evolution)
speed and capacity to support faster and more efficient data exchange between applications and sources.
Organizations looking to embrace better interoperability – and have the IT infrastructure to support it – may benefit from bringing more
developers onto their IT staff to develop APIs for standardized data to increase organization operations and prepare for a future of shared data.
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Connecting Health
and Care for the Nation
A Shared Nationwide
Interoperability Roadmap
FINAL Version 1.0
Contents
Letter from the National Coordinator…………………………………………………………………………………………….. iv
Executive Summary…………………………………………………………………………………………………………………. vi
Roadmap Introduction………………………………………………………………………………………………………………. ix
Shared Nationwide Interoperability Roadmap…………………………………………………………………………………. 1
Drivers………………………………………………………………………………………………………………………………….1
A. A Supportive Payment and Regulatory Environment……………………………………………………………………………… 1
Background and Current State………………………………………………………………………………………………………. 1
Moving Forward and Critical Actions ………………………………………………………………………………………………. 2
Policy and Technical Components ………………………………………………………………………………………………4
B. Shared Decision-Making, Rules of Engagement and Accountability………………………………………………………….. 4
Background and Current State………………………………………………………………………………………………………. 4
Moving Forward and Milestones……………………………………………………………………………………………………… 6
C. Ubiquitous, Secure Network Infrastructure…………………………………………………………………………………………. 8
Background and Current State………………………………………………………………………………………………………. 8
Moving Forward and Milestones……………………………………………………………………………………………………… 9
D. Verifiable Identity and Authentication of All Participants …………………………………………………………………….. 11
Background and Current State…………………………………………………………………………………………………….. 11
Moving Forward and Milestones……………………………………………………………………………………………………. 13
E. Consistent Representation of Authorization to Access Electronic Health Information…………………………………… 15
Background and Current State…………………………………………………………………………………………………….. 15
Moving Forward and Milestones……………………………………………………………………………………………………. 15
F. Consistent Understanding and Technical Representation of Permission to Collect, Share and Use Identifiable
Electronic Health Information ………………………………………………………………………………………………………….. 17
Background and Current State…………………………………………………………………………………………………….. 17
Moving Forward and Milestones……………………………………………………………………………………………………. 19
G. An Industry-wide Testing and Certification Infrastructure ……………………………………………………………………. 21
Background and Current State…………………………………………………………………………………………………….. 21
Moving Forward and Milestones……………………………………………………………………………………………………. 21
Standards and Functions Overview……………………………………………………………………………………………….. 23
ii
TA B L E O F C O N T E N T S
H. Consistent Data Semantics…………………………………………………………………………………………………………… 25
Background and Current State…………………………………………………………………………………………………….. 25
Moving Forward and Milestones …………………………………………………………………………………………………… 26
I. Consistent Data Formats………………………………………………………………………………………………………………. 28
Background and Current State…………………………………………………………………………………………………….. 28
Moving Forward and Milestones……………………………………………………………………………………………………. 29
J. Secure, Standard Services: ………………………………………………………………………………………………………….. 31
Background and Current State…………………………………………………………………………………………………….. 31
Moving Forward and Milestones …………………………………………………………………………………………………… 32
K. Consistent, Secure Transport Techniques…………………………………………………………………………………………. 34
Background and Current State…………………………………………………………………………………………………….. 34
Moving Forward and Milestones……………………………………………………………………………………………………. 34
L. Accurate Individual Data Matching…………………………………………………………………………………………………. 36
Background and Current State…………………………………………………………………………………………………….. 36
Moving Forward and Milestones……………………………………………………………………………………………………. 37
M. Health Care Directories and Resource Location…………………………………………………………………………………. 39
Background and Current State…………………………………………………………………………………………………….. 39
Moving Forward and Milestones……………………………………………………………………………………………………. 40
Outcomes……………………………………………………………………………………………………………………………43
N. Individuals Have Access to Longitudinal Electronic Health Information, Can Contribute to that Information, and
Can Direct It to Any Electronic Location ……………………………………………………………………………………………… 43
Background and Current State…………………………………………………………………………………………………….. 43
Moving Forward and Milestones……………………………………………………………………………………………………. 44
O. Provider Workflows and Practices Include Consistent Sharing and Use of Patient Information from All Available
and Relevant Sources……………………………………………………………………………………………………………………… 46
Background and Current State…………………………………………………………………………………………………….. 46
Moving Forward and Milestones……………………………………………………………………………………………………. 46
P. Tracking Progress and Measuring Success………………………………………………………………………………………… 48
Core Aspects of Interoperability Measurement: Defining Success…………………………………………………………. 48
Measuring Success Through 2017……………………………………………………………………………………………….. 49
Measuring Success through 2018 and Beyond………………………………………………………………………………… 50
Complete Milestones, Calls to Action and Commitments …………………………………………………………………. 52
iii
Letter from the National Coordinator
We live in an exciting moment for health information technology (health IT).
Today, rapid advancements in the field have led to new opportunities – everything from precision medicine to
accountable care organizations. Best of all, improved health IT systems have led to newly engaged, empowered, and
educated consumers.
But we know that not everyone in this country has access to the health IT they need to support high quality,
personalized care. Our long-term goal is simple: to build a strong foundation of health IT in our health care system,
equipping every person with a long-term, digital picture of their health over their lifespan.
We are closer than ever before. The exciting successes of today – and the bright future of tomorrow – are the result
of more than a decade’s worth of work by the private and public sector, bolstered by investment under the Health
Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Today, electronic health record
adoption is the highest it has ever been, meaning that we are moving towards realizing the goal of every American
having an electronic health record.
Exchange of information between health systems is flowing faster than ever before, and new technology innovations are
bringing more usable digital health information to the bedside and beyond. We must build upon this success to create
an open, person-centered health IT infrastructure – one that can support our neighbors not just as engaged patients,
but as healthy citizens across their lifespan.
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, we described our vision for how interoperability is necessary for a
“learning health system” in which health information flows seamlessly and is available to the right people, at the right
place, at the right time. Our vision: to better inform decision making to improve individual health, community health,
and population health.
To complete this vision, I am pleased to issue the Final Version of the Shared Nationwide Interoperability Roadmap
(the Roadmap). The Roadmap was informed by stakeholders nationwide to coordinate our collective efforts around
health IT interoperability. And it describes the policy and technical actions needed to realize our vision of a seamless
data system.
1
http://www.healthit.gov/sites/default/files/ONC10yearInteroperabilityConceptPaper.pdf
iv
L E T T E R F R O M T H E N AT I O N A L C O O R D I N AT O R
Public and private stakeholders will need to do more than just address our policies and technical approaches to
achieve real, meaningful, seamless interoperability – we will need to change our culture. We will all need to commit
to actions that will define how we work together on behalf of the American public to empower them to improve their
health. We are committed to helping consumers easily and securely access their electronic health information when
and where they need it most; to enabling individual health information to be shared with other providers and refrain
from information blocking; and to implementing federally recognized, national interoperability standards and policies
so that we are no longer competing between standards, but rather innovating on a set of core standards. We hope the
private sector will join us in this pledge.
ONC is thankful to the individuals and organizations who shared their expertise and time to provide the feedback
that was used to improve the Roadmap. We read and listened to public comments from over 250 organizations on
the draft Roadmap, including our federal partners, states, and ONC’s Federal Advisory Committees (FACAs). Each
of the milestones, calls to action, and commitments in this roadmap were informed and prioritized according to your
feedback. Now it is time for all of us to bring these commitments to life by working together toward realizing a true
learning health system by achieving the Roadmap’s milestones – especially the foundational milestones that need to be
accomplished by the end of 2017.
The Roadmap is a living document, and we intend to evolve it in partnership with the public and private sectors as
technology and policy require. Thank you all in advance for your continued dedication and work on the advancement
of nationwide interoperability as a means of creating an open, connected community, best able to serve the health
needs of all Americans.
Karen B. DeSalvo, MD, MPH, MSc
National Coordinator for Health Information Technology
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Executive Summary
The nation needs an interoperable health system that empowers
INTEROPERABILITY
PROGRESS
individuals to use their electronic health information to the fullest extent;
enables providers and communities to deliver smarter, safer, and more
efficient care; and promotes innovation at all levels. While the Health
Information Technology for Economic and Clinical Health (HITECH) Act
stimulated significant health information technology (health IT) adoption
2004
• Decade of Health IT: Delivering
Consumer-centric and Informationrich Health Care: Framework for
Strategic Action released
and exchange of electronic health information with the goal of every
American having access to their electronic health information, 2015’s
interoperability experience remains a work in progress. The vision is a
• Stark exception and anti-kickback
safe harbor enable donations of
health IT products and services
learning health system where individuals are at the center of their care;
where providers have a seamless ability to securely access and use
• American Health Information
Community (AHIC) formed
health information from different sources; where an individual’s health
• Health Information Technology
Standards Panel (HITSP) formed
information is not limited to what is stored in electronic health records
(EHRs), but includes information from many different sources (including
technologies that individuals use) and portrays a longitudinal picture of
• National Coordinator for Health IT
position created via Executive
Order 13335
2005
to
2008
• Nationwide Health Information
Network (NHIN) develops
prototypes for exchange
repeated when necessary, because the information is readily available;
• Certification Commission for Health
Information Technology (CCHIT
EHR certification program begins
and where public health agencies and researchers can rapidly learn,
• ONC-Coordinated Federal Health
IT Strategic Plan 2008-2012
their health, not just episodes of care; where diagnostic tests are only
develop, and deliver cutting edge treatments.
• Health Information Security and
Privacy Collaboration formed
across 42 states and territories
If we steadily and aggressively advance our progress we can make it a
• State Alliance for e-Health
reality. We must focus our collective efforts around making standardized,
• HITECH Act Passed
electronic health information securely available to those who need it and in
2009
• 16% of hospitals and 21% of
providers adopted basic EHRs
ways that maximize the ease with which it can be useful and used.
• Data Use and Reciprocal Support
Agreement signed – enables
exchange with federal agencies
The Office of the National Coordinator for Health IT (ONC) is committed to
• State Health Information
Exchange (HIE) Cooperative
Agreement Program begins
advancing this vision expeditiously, systematically and in a sustainable
fashion. We first laid out this vision in Connecting Health and Care for the
Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure
and followed with a draft Shared Nationwide Interoperability Roadmap and
Interoperability Standards Advisory. Working collaboratively with federal
partners, states, consumers, and the private sector, we developed this
shared, comprehensive interoperability agenda and action plan described in
2010
• First ONC rule making for Health
IT Certification program
• Blue Button Initiative, a tool that
provides patients with access to
their electronic health information,
is launched
• Direct Project launched to enable
a secure, standards-based way
to electronically send health
information to known, trusted
recipients over the Internet
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EXECUTIVE SUMMARY
detail in the Shared Nationwide Interoperability Roadmap (the Roadmap). It is
INTEROPERABILITY
PROGRESS
meant to build upon and shore up the existing foundation of health IT, move
quickly to short-term success, and also lay out a longer term set of drivers and
policy and technical components that will achieve the outcomes necessary to
• Federal Health Information
Technology Strategic Plan
2011-2015
achieve the vision. ONC will continue to work with our partners as we
coordinate the Roadmap’s implementation, which is also a critical part of
achieving the Federal Health IT Strategic Plan’s vision of high-quality care,
• Meaningful Use Stage 1 begins
2011
lower costs, healthy population, and engaged people.
• Blue Button Initiative Pledges from
the Private Sector begin 2012
The Roadmap identifies near-term (i.e., by the end of 2017) actions and
roles that health IT stakeholders should perform to make immediate progress
2012
and impacts with respect to interoperability. It also emphasizes that we
while continuing to seek out ways to support innovation and move beyond
2013
range of health information technologies used by individuals, providers,
and researchers. The Roadmap’s three high-level goals for health IT
a learning health system by 2024. Consequently, the short-term goal is
that we can have an immediate impact on the care and health of individuals.
2014
• 80% of hospitals can electronically
query other organizations for health
information
2018-2020: Expand data sources and users in the interoperable
health IT ecosystem to improve health and lower costs.
•
• Meaningful Use Stage 2
attestations began
2021-2024: Achieve nationwide interoperability to enable a
learning health system, with the person at the center of a system that
can continuously improve care, public health, and science through
real-time data access.
The Roadmap focuses deeply on the first priority goal and its
accompanying milestones, critical action items, and commitments. To
address current challenges, the Roadmap identifies four critical pathways
• The Argonaut project is launched
to develop a first-generation
Fast Healthcare Interoperability
Resources (FHIR) based application
programming interface and core
data specification
• A 10-Year Vision to Achieve
an Interoperable Health IT
Infrastructure released
2015-2017: Send, receive, find and use priority data domains to
improve health care quality and outcomes.
•
• 51% of hospitals can electronically
query other organizations for health
information
• Carequality, a public-private
collaborative, is formed
focused on sending, receiving, finding, and using priority data domains, so
•
• CommonWell, an industry-led
Network Service Provider, is
launched
• The Department of Health and
Human Services (HHS) HIE
Acceleration Strategy Released
interoperability each reflect the progress we need to make in order to achieve
The goals are:
• The Consolidated Clinical Document
Architecture (CDA), a unified
standard for summary care records
is created
• Healtheway is launched
should use and build on the technology and investments made to date,
EHRs as the sole data source for electronic health information to a wide
• 27% of hospitals and 34% of
providers adopted EHRs
• The Draft Shared Nationwide
Interoperability Roadmap 1.0
released for public comment
2015
• Additional State HIE Cooperative
Agreement funds awarded for
breakthrough innovations
• Federal Health IT Strategic Plan
2015-2020 released
• The 2015 Interoperability Standards
Advisory released
that health IT stakeholders should focus on now in order to create a
foundation for long-term success:
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EXECUTIVE SUMMARY
•
Improve technical standards and implementation guidance for priority data domains and associated elements.
In the near-term, the Roadmap focuses on using commonly available standards, while pushing for greater
implementation consistency and innovation associated with new standards and technology approaches, such as
the use of APIs.
•
Rapidly shift and align federal, state, and commercial payment policies from fee-for-service to value-based
models to stimulate the demand for interoperability.
•
Clarify and align federal and state privacy and security requirements that enable interoperability.
•
Coordinate among stakeholders to promote and align consistent policies and business practices that support
interoperability and address those that impede interoperability.
The Roadmap is organized into three sections starting first with “Drivers,” which are the mechanisms that can propel
development of a supportive payment and regulatory environment that relies on and deepens interoperability. The
next section addresses “Policy and Technical Components,” which are essential items stakeholders will need to
implement in similar or compatible ways in order to enable interoperability, such as shared standards and
expectations around privacy and security. The last section addresses “Outcomes,” which serve as the metrics by
which stakeholders will measure our collective progress on implementing the Roadmap. Each section includes
specific milestones, calls to action, and commitments that will support the development of a nationwide, interoperable
health IT infrastructure.
The Roadmap is intended to be a living document. As we move forward to create a learning health system, the
Roadmap will be updated and new versions will be created when milestones are met and new challenges emerge.
Future Roadmap versions will continue to be informed by and incorporate stakeholder feedback. ONC’s website will
list calls to actions and commitments mapped out by stakeholder group so that all stakeholders can identify and do
their part.
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Roadmap Introduction
Interoperability: 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.2
Purpose of the Roadmap
In 2014, the Office of the National Coordinator for Health Information
Technology (ONC) published Connecting Health and Care for
the Nation: A 10-Year Vision to Achieve an Interoperable Health
Figure 1: Federal Health IT Strategic Plan:
Vision, Mission and Goals
IT Infrastructure,3 which described a vision for the improvement
of health information technology (health IT) interoperability in
three-, six- and 10-year time increments. A Shared Nationwide
Interoperability Roadmap version 1.0 (Roadmap), the second
paper in the Connecting Health and Care for the Nation series,
uses the same three-, six- and 10-year increments to clearly guide
stakeholder focus in the near- and long-term and to catalyze
collaboration among public and private stakeholders to achieve the
vision. The Roadmap lays out a clear path for stakeholders who are
going to build and use the health IT infrastructure.
In April 2015, Congress declared it, “…a national objective to
achieve widespread exchange of health information through
interoperable certified EHR technology nationwide by December
31, 2018.”4 The milestones, calls to action and commitments to be
achieved by 2017 support this objective. In addition, the Roadmap’s
implementation is a critical part of the Federal Health IT Strategic
Plan 2015-2020 (Strategic Plan),5 specifically Goal 4 (see Figure 1).
The Roadmap directly aligns with the Plan’s mission of improving the
health and well-being of individuals and communities through the
2
http://www.ieee.org/education careers/education/standards/standards glossary.html
3
http://www.healthit.gov/sites/default/files/ONC10yearInteroperabilityConceptPaper.pdf
4
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (P.L. 114-10 Sec 106)
5
http://www.healthit.gov/policy-researchers-implementers/health-it-strategic-planning
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ROADMAP INTRODUCTION
use of technology and health information that is accessible when and where it matters most. The Strategic Plan focuses
on federal actions and strategies to broaden and modernize the Nation’s health IT infrastructure to support each of
the four goals. While the Plan focuses on federal efforts, the Roadmap details the policy, technology and behavioral
changes that public and private stakeholders must make to achieve nationwide interoperability.
Current State
While the adoption of electronic health record (EHR) systems has seen a dramatic increase in the last five years, the
nation has yet to see widespread interoperability between those systems. Health information exchange, however, is
occurring in many pockets of the country. Today, approximately 41 percent of hospitals nationwide routinely have
electronic access to necessary clinical information from outside providers or sources when treating an individual.
Last year, approximately 78 percent of hospitals electronically sent a summary of care document and 56 percent
received a summary of care document. However, less than half of hospitals are integrating the data they receive into
an individual’s record.6 Additionally, as of 2013, only 14 percent of ambulatory providers shared electronic health
information with providers outside of their organization.7 While progress has been made over the last few years, there is
still significant work for stakeholders to undertake to build nationwide interoperability.
Interoperability Vision for the Future
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.8 This means that 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 to support the
health and wellness of individuals through informed, shared decision-making. With the right information available
at the right time, individuals and caregivers can be active partners and participants in their health and care. An
interoperable health IT ecosystem should support critical public health functions, including real-time case reporting,
disease surveillance and disaster response. Additionally, interoperability can support data aggregation for research,
which can lead to improved clinical guidelines and practices. Over time, interoperability will also need to support the
combining of administrative9 and clinical data to enhance transparency and enable value-based payment. The work
|
6
Charles D, Swain M Patel V. (July 2015) Interoperability among U.S. Non-federal Acute Care Hospitals. ONC Data Brief, no.28. Office of the
National Coordinator for Health Information Technology: Washington DC.
7
Despite Substantial Progress in EHR Adoption, Health Information Exchange and Patient Engagement Remain Low In Office Settings. Michael
F. Furukawa, Jennifer King, Vaishali Patel, Chun-Ju Hsiao, Julia Adler-Milstein and Ashish K. Jha. Health Affairs, 33, no.9 (2014):1672-1679.
10.1377/hlthaff.2014.0445
8
Derived from the Institute of Electrical and Electronics Engineers (IEEE) definition of interoperability.
http://www.ieee.org/education careers/education/standards/standards glossary.html
9
Administrative data includes data related to payment, eligibility and benefits.
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ROADMAP INTRODUCTION
and collaborative efforts of all stakeholders over the next 10 years will yield interoperability achievements in a variety
of areas that, in turn, will advance the industry toward a learning health system.
A learning health system is an ecosystem where all stakeholders can securely, effectively and efficiently contribute,
share and analyze data. A learning health system is characterized by continuous learning cycles, which encourage
the creation of new knowledge that can be consumed by a wide variety of electronic health information systems. This
knowledge can support effective decision-making and lead to improved health outcomes. A learning health system
includes a broad array of stakeholders that extend beyond the clinical care delivery system. This could include
routine and emergency transactions from public health services among governmental agencies such as state and
local health departments, emergency responders and public safety; hospitals; health care professionals; diagnostic
laboratories; researchers; non-governmental human services; advocacy and community based organizations. A
learning health system also incorporates advanced health models that increasingly leverage technology. For example,
telecommunications technology can be used to remotely deliver health and health care services and improve access
to care across clinical and non-clinical community settings; and medical device data, which represents the largest
source of objective biometric and clinical data can improve real-time diagnostics and treatment of the critically ill.
Interoperability provides the underpinning infrastructure that is fundamental to enabling a learning health system.
Figure 2: A Learning Health System
A Learning Health System:
“…will improve the health of individuals and populations. The 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 the 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
Scope
The Roadmap is intended for health IT stakeholders who will build the infrastructure necessary for interoperability and
for those who will use that infrastructure. This iteration of the Roadmap focuses primarily on actions that will enable a
majority of individuals and providers across the care continuum to send, receive, find and use priority data domains
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at the nationwide level by the end of 2017 (see figure 7 in H. Consistent Data Semantics). Although the near-term
target focuses on individuals and care providers, it is important to ensure the priority data domains are standardized
to support community-based services, human services, public health and the research community. Also in-scope for
the Roadmap is the ability to use data to support better stratification across populations of aggregated electronic health
information to identify and address health disparities, support research and evidence-based precision medicine.
The interaction between clinical and administrative electronic health information is a critical concern, but not every
facet of interoperability can be handled in this iteration of the Roadmap. While administrative data is out of scope for
the Roadmap at this time, it is clear that a learning health system must eventually encompass both administrative and
clinical health information. 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 of the Roadmap and the health IT
ecosystem should experiment in this area.
There are also many aspects of health IT beyond interoperability that are important and will be critical to supporting
a learning health system, including technology adoption, data quality, usability and workflow. In an attempt to draw
a boundary around “interoperability,” many aspects of these topics are out of scope for this Roadmap. For example,
the capability of an EHR to accept and parse a standard clinical document is “in scope” for the Roadmap because
it is critical to interoperability. However, the user’s experience in interacting with that clinical document or its data
within the EHR – while critically important – falls outside the boundary of interoperability in the Roadmap’s context.
Similarly, while clinical decision support (CDS) algorithms and alerts that a user might experience within an EHR are
out of scope, the application programming interfaces (APIs) and data transport techniques that may be called by a
CDS service are in scope. Though this boundary is not hard and fixed and may evolve over future iterations of the
Roadmap, it is important that the initial scope be manageable. Where appropriate, stakeholders should address some
of these out-of-scope items within their own priorities and capabilities and should broadly share results and progress in
public forums.
Stakeholders Involved in Interoperability
A broad range of people and organizations traditionally involved in clinical care delivery and many outside the clinical
care delivery system who impact the health of individuals are all pivotal to achieving interoperability among a broad range
of needs. The Roadmap denotes the stakeholder groups who are best positioned to take on a critical action or that directly
benefit from actions to be taken. In most cases, individuals, groups and organizations will 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. The following list is an effort to identify those who in some way can affect (or
are affected by) interoperability. The term “stakeholder” will be used throughout the Roadmap to reference this broader
category. The term “health IT stakeholder” will be used to reference those who directly affect interoperability.
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•
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 use disorder treatment 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 (governmental) 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,
telecommunications and technologies to enable telehealth, and other technology that provides health IT
capabilities and services, which includes health information exchange organizations (HIOs) and clearinghouses.
•
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.
Guiding Principles for Nationwide Interoperability
ONC originally 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.10 Based on feedback from a wide range
of stakeholders, ONC has updated these principles as listed below. The principles guide the development of critical
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. These principles align with the Plan principles (listed
first below), and expand upon them with principles that are specific to interoperability rather than the broader scope of
health IT advancement.
10
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1. Focus on value. 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.
2. Be person-centered. 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.
3. Protect privacy and security in all aspects of interoperability and respect individual preferences. It
is essential to maintain public trust that health information is safe and secure. To better establish and maintain
that trust, stakeholders will strive to ensure that appropriate, strong and effective safeguards for electronic health
information are in place as interoperability increases across the industry. Stakeholders 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 Rules, while considering the preferences of individuals.
4. Build a culture of electronic access and use. Standards and methods for achieving interoperability
must be accessible nationwide and capable of handling significant and growing volumes of electronic health
information, to ensure no one is left on the wrong side of the digital divide.
5. Encourage innovation and competition. Demand for interoperability from health IT users is a powerful driver
to advance our vision. The market should encourage innovation to meet evolving demands for interoperability.
6. 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, stakeholders should build from existing
health IT infrastructure, increasing interoperability and functionality as needed.
7. One size does not fit all. Although interoperability requires technical and policy conformance among
networks, technical systems and their components, it does not require that each stakeholder implement
exactly the same technology. Stakeholders will strive for baseline interoperability across health IT
infrastructure, while encouraging innovation that improves usability.
8. Simplify. Where possible, simpler solutions should be implemented first, with allowance for more complex
functionality in the future.
9. Maintain modularity. A large, nationwide set of complex, scalable systems 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, stakeholders must preserve systems’ 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.
10. 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. Stakeholders must therefore account for a range
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of capabilities among information sources and information users, including EHR and non-EHR users, as
stakeholders 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.
How the Roadmap is Organized
Figure 3: How the Roadmap is Organized
The Roadmap is organized into three main sections as shown above: drivers, policy and technical components and
outcomes that should be met and measured as we achieve interoperability for many different needs (Figure 3). The
drivers are the incentives that promote interoperability. Policy and technical components are the items that must be in
place to enable interoperability. Consistent and compatible policy and technical components must be implemented by
stakeholders to achieve interoperability nationwide. Additionally, the policy and technical components are all essential and
each one must be achieved to enable interoperability. Lastly, as we achieve interoperability for different needs, we need
to do so with a measurement framework that focuses on measuring improved outcomes for all stakeholders involved,
especially individuals and providers. Note that the section list below is not meant to be a prioritization. Rather, the letters
are used as a key for readers to quickly identify milestones, calls to action and commitments associated with each section.
Drivers
A. A supportive payment and regulatory environment
Policy and Technical Components
B. Shared decision-making, rules of engagement and accountability
C. Ubiquitous, secure network infrastructure
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D. Verifiable identity and authentication of all participants
E. Consistent representation of authorization to access electronic health information
F. Consistent understanding and technical representation of permission to collect, share and use identifiable
health information
G. Industry-wide testing and certification infrastructure
H. Consistent data semantics
I.
Consistent data formats
J. Standard, secure services
K. Consistent, secure transport technique(s)
Figure 4: Milestones, Calls to Action
L. Accurate individual data matching
and Commitments
M. Health care directories and resource location
•
Milestones are indicators that
help us see if we are on track
to reach interoperability. For
example, the milestones listed
in each section in the 20152017 timeframe align to the first
timeframe goal of send, receive,
find and use priority data
elements to improve health and
health care.
•
Calls to action are opportunities
where stakeholders can take
the lead in and commit to as
participants. Calls-to-action are
prioritized actions that support
achievement of the milestones.
•
Commitments are prioritized
actions that stakeholders
have publicly committed to
fulfilling. Commitments support
achievement of the milestones.
Outcomes
N. Individuals have access to longitudinal electronic health
information, can contribute to that information, and can direct it to
any electronic location
O. Provider workflows and practices include consistent sharing and
use of patient information from all available and relevant sources
Achieving nationwide interoperability that enables a learning health system
will take a strategic and focused effort by the private sector in collaboration
with federal, state, tribal and local governments. Throughout the Roadmap,
each section includes high-level historical context, a current state and a
desired future state. Each section also includes milestones for each
timeframe, indicating what should be achieved by when. Each section has
a table associated with it at the end of the document that lists milestones
by timeframe (reiterated from the main body), priority calls to action and
priority commitments across three-, six- and 10-year timeframes (See
Complete Set of Calls to Action and Commitments by section). The calls to
action and commitments support achievement of the milestone for each
timeframe, and ultimately, each milestone supports the overarching goal of
each timeframe.
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Process for Updating the Roadmap
The Roadmap is intended to be a living document that is guided in its evolution by all health and health care
stakeholders. ONC will continue to coordinate efforts and engage with stakeholders to publish future iterations.
However, the owners of the Roadmap are the stakeholders represented herein. We have considered and included
feedback from the many stakeholders who commented on the draft version of the Roadmap that was published for
public comment in January 2015. The final version 1.0 of the Roadmap was revised using that feedback to more
clearly describe the actions needed to achieve our collective interoperability goals. ONC anticipates updating the
Roadmap every two years with broad input from the public, stakeholders and its federal advisory committees (FACAs),
the HIT Policy Committee (HITPC) and HIT Standards Committee (HITSC).
Additional Resources
While the Roadmap contains important details on each business and functional requirement for nationwide
interoperability to enable 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 the drivers, policy and technical components and
outcomes, please see the Supplemental Materials document that accompanies the Roadmap.
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Drivers
A. A Supportive Payment and Regulatory Environment
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.
Background and Current State
Shifting payment models to those that pay for quality versus quantity is pivotal to creating the business imperative
for interoperability. While the Medicare and Medicaid EHR Incentive Programs have been a primary motivator for
the adoption and use of certified EHR technology among specific groups of clinicians,11 these programs alone are
insufficient to overcome barriers to the Roadmap’s vision for information sharing and interoperability. The current
business environment does not adequately reward, and often inhibits exchange of electronic health information, even
when it is technically feasible. History has shown that without the right financial incentives in place, systems and
technology components are built and not used.
While important progress is being made today, the health care landscape continues to be dominated by fragmentation
in care delivery and payment models that are largely based on the volume of services delivered, rather than the delivery
of efficient, high-quality care and better patient outcomes. When providers are rewarded for value, interoperability can
be a significant tool to help them meet such requirements, but broad demand for interoperability has lagged and been
insufficient to drive connectivity across health care providers. Providers that are increasingly accountable for patient
outcomes and total cost of care, regardless of where else that individual has received care, will increasingly demand
access to an individual’s complete clinical record, laboratory results, broader health-related information (human service
and other community-based information) and total cost of care required to effectively manage the person’s health.
As models that reward quality over quantity continue to expand, providers are more likely to see a business case for
making the time and cost investments to incorporate use of interoperable health information into how they deliver care.
This, in turn, will increase the demand for interoperable technology.
The Medicare Access and CHIP Reauthorization Act (MACRA), signed by the President in April 2015, will take
important steps toward streamlining and expanding the use of value-based payment and quality reporting programs.
Set to phase in over a number of years, MACRA will consolidate current physician reporting programs, including the
Medicare and Medicaid EHR Incentive Program, into a unified Merit-Based Incentive Payment System (MIPS).
11
Many care settings and care providers are not eligible for the Medicare and Medicaid EHR Incentive Programs
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MACRA also creates a new bonus framework for providers that participate in certain Alternative Payment Models
(APMs) outside of traditional fee-for-service Medicare (beginning in 2021, APMs established by commercial payers will
also contribute to the threshold providers must meet.) Under the law, eligible APMs will need to include a downside
risk feature and a quality measurement framework and will also require participating providers to utilize certified health
IT as part of the model. Through its health IT provision, MACRA will reinforce the link between value-based payment
and the use of certified technology to coordinate care. As these programs integrate providers across care settings,
these requirements are likely to reach a provider base that includes critical providers ineligible for the Medicare
and Medicaid EHR Incentive Program, such as many post-acute care providers. In addition, the link to value-based
payment promises to incentivize providers to invest in resolving interoperability challenges in their communities.
Movement to alternative payment models will naturally stimulate demand for interoperability. In addition, a supportive
payment and regulatory environment must lower real and perceived costs of interoperability. Today, many providers
may choose not to share data for a variety of reasons beyond technology capabilities, including concerns around the
increased liability risk of exchanging data, competing technology priorities or a lack of ready trading partners. In other
cases, providers may believe interoperability will jeopardize competitive advantages they gain from exclusive access to
patients’ health information. Likewise, technology developers may contribute to high interoperability costs by making it
challenging for providers to extract and share data, for instance, in order to prevent providers from easily switching to a
competitor’s product.
Moving Forward and Critical Actions
To create a payment and regulatory environment that drives providers to value interoperability, all stakeholders who
pay for health and health care must explore opportunities to accelerate interoperability because it is a key supporter of
broader efforts to move toward a value-based health care system. While the transition to new ways of paying for care
will ultimately stimulate demand for interoperability in the long run, there are many actions that stakeholders can take
in the short and medium term to accelerate interoperable exchange of electronic health information.
As the nation’s largest purchaser of health care, the federal government can exercise considerable leverage across the
care delivery system by linking payment with the use of electronic health information exchange and certified health
IT. As described in the 2013 statement, “Principles and Strategy for Accelerating Health Information Exchange,” HHS
is committed to a natural lifecycle of policies to drive interoperability beginning with incentives, followed by payment
adjustments and then conditions of participation in Medicare and Medicaid programs.12 For instance, HHS will explore
opportunities to promote interoperability through increasing participation in value-based payment. In January 2015,
HHS Secretary Burwell announced a set of delivery system reform goals to tie payment to how well providers care for
their patients, instead of how much care they provide. A key goal of this initiative is to have 85 percent of all Medicare
fee-for-service payments tied to quality or value by 2016, and 90 percent by 2018. Another key target is to have 30
12
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See http://healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf
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percent of Medicare payments tied to alternative payment models by the end of 2018 and 50 percent of payments by
the end of 2016.13
In addition to the federal government, states, private payers and purchasers of insurance also play a significant role
in shifting the payment and regulatory environment through incentives, payment reform initiatives, and contracting
processes. States have considerable opportunities to support interoperability, especially through the administration of
state Medicaid programs and their ability to direct how Medicaid funds are spent. CMS has identified a number of ways
that states can use Medicaid funds to develop care coordination capacity among their Medicaid providers, and several
states have already begun to use Medicaid Managed Care contracts to advance interoperability.14 Health plans can
also promote interoperability among provider networks. In parallel with public sector efforts over the past several years,
commercial health plans have developed and deployed a wide range of value-based payment programs within their
provider networks that offer new opportunities to focus attention on and generate demand for interoperability. Finally,
private purchasers of health care, including large employers, can use their market power to advance interoperability by
working with and encouraging health plans to adopt these initiatives within their own geographic regions.
The following includes milestones for a Supportive Payment and Regulatory Environment. Please see the Complete Set
of Calls to Action and Commitments by Roadmap Section at the end of this document for the critical actions that need
to take place to advance nationwide interoperability.
Milestones for a Supportive Payment and Regulatory Environment
2015-2017
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2018-2020
Send, receive, find and use priority
data domains to improve health and
health care quality
Expand interoperable health IT
and users to improve health and
lower cost
A1.1 CMS will aim to administer 30% of
all Medicare payments to providers
through alternative payment models that
reward quality and value, and encourage
interoperability, by the end of 2016.
A1.2 CMS will administer 50% of all
Medicare payments to providers through
alternative payment models that reward
quality and value by the end of 2018.
2021-2024
A learning health system enabled
by nationwide interoperability
A1.3 The federal government will use
value-based payment models as the
dominant mode of payment for providers.
13
http://www.hhs.gov/blog/2015/01/26/progress-towards-better-care-smarter-spending-healthier-people.html
14
http://innovation.cms.gov/
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Policy and Technical Components
B. Shared Decision-Making, Rules of Engagement and Accountability
Nationwide interoperability across the diverse health IT ecosystem will require stakeholders to agree to and follow a
common set of standards, services, policies and practices that facilitate the appropriate exchange and use of health
information nationwide and do not limit competition. Once established, maintaining interoperability will also require
ongoing coordination and collaborative decision-making about future change.
Background and Current State
Establishing a common set of standards, services, policies and practices is best accomplished through an inclusive and
transparent process that sets priorities, makes decisions, establishes authorities and rules of engagement and ensures
accountability. This activity is often referred to as “governance.” Governance processes also help establish trust between
disparate data trading partners and build confidence in the practices of the other people or organizations with whom
electronic health information is shared. The term “governance” has often been misinterpreted in the context of electronic
health information interoperability, thus we use it sparingly in this and other sections of the Roadmap.
Individuals are not stationary – they change jobs and thus health insurance networks, relocate to different states
and seek care from providers beyond defined technical networks.15 Therefore, electronic health information must
flow across technology developer, geographical and organizational boundaries in a manner that supports individuals’
health and care. It must also support individuals’ access to their information and their ability to share that information
with other individuals and entities. Consequently, the processes by which trust is established must be scalable and
extensible over time.
Electronic Health Information Sharing Arrangements
A number of electronic health information sharing arrangements, such as health information exchanges (HIE),
networks and trust communities currently exist. Electronic health information sharing arrangements are used to
enable interoperability between otherwise unaffiliated organizations or parties. These arrangements typically include
single or multiple agreements between parties on rules of engagement for information sharing (how information will
be shared, purposes for which it can be used, baseline security practices, etc.) and how those rules can be changed.
They also describe accountability mechanisms that make parties comfortable sharing information (such as surveillance
mechanisms, audit logs and recourse when the rules are not followed) or providing access to their technical systems
and agreement on the standards that will be used. These electronic health information sharing arrangements often
have overlapping regional, state or national footprints, and all have contributed to a significant increase in the exchange
of electronic health information. For example, CommonWell Health Alliance is, “creating and executing a vendor-
15
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Note that technology is not stationary either.
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neutral platform that breaks down the technological and process barriers that currently inhibit effective health data
exchange. And…[is] committed to defining and promoting a national infrastructure with common standards and
policies.”16 The Sequoia Project (formerly Healtheway) manages the Carequality initiative which is developing common
rules of the road, technical specifications, and a participant directory to enable cross-network exchange.17 The Sequoia
Project also manages eHealth Exchange, which is working to, “improve patient care, streamline disability benefit
claims, and improve public health reporting through secure, trusted, and interoperable health information exchange.”18
DirectTrust is working to, “develop, promote and, as necessary, help enforce the rules and best practices necessary to
maintain security and trust within the Direct community, and to foster widespread public confidence in the Directed
exchange of health information.”19
Despite the potential and intention of existing electronic health information sharing arrangements, they differ from
each other in fundamental ways that make it difficult for them to work together. They often have differing immediate
goals and differing methods or standards to achieve those goals. Some networks that support health care, implement
information sharing arrangements through formal contracts or legal data sharing and use agreements,20 while some
rely on self-attestation or independent accreditation.21 Some operate technical testing programs while others do not.
And most, but not all, operate some level of technical infrastructure. The result can be a complex web of electronic
health information sharing arrangements that creates some degree of interoperability within specific geographic
regions, organizational and technology developer boundaries, but fail to produce seamless nationwide interoperability
to support a learning health system.22 These existing arrangements, that are often one-to-one contracts or data use
agreements, are unlikely to scale nationwide and may not be extensible to new, novel data uses that support health.
Efforts to Bridge Electronic Health Information Sharing Arrangements
Moving forward successfully with shared decision-making, rules of engagement and accountability requires an
understanding of what has been tried in the past. ONC has made several attempts to overcome variation across
existing electronic health information sharing arrangements to enable nationwide interoperability, but with limited
success. Efforts to promote the adoption of common standards, policies and practices nationwide to advance shared
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16

17
http://sequoiaproject.org/carequality/what-we-do/
18
http://sequoiaproject.org/ehealth-exchange/
19
http://www.directtrust.org/about-us/
20
As an example, the Data Use and Reciprocal Support Agreement (DURSA) is a single, multi-party agreement that sets the rules by which
participants operate to exchange data. It is used today primarily by the Sequoia Project for participation in the eHealth Exchange network.
21
As an example, DirectTrust works with the Electronic Healthcare Network Accreditation Commission to independently accredit HISPs as Direct
Trusted Agents.
22
Interoperability Workgroup Governance Subgroup Presentation. July 2014. https://www.healthit.gov/facas/calendar/2014/07/23/policygovernance-subgroup
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decision making and rules of engagement were attempted through both the American Health Information Community
(AHIC)23 and the National eHealth Collaborative (NeHC). However, neither effort had the ability to compel participation
in nor to enforce compliance with their decisions, rules or accountability mechanisms. Without this ability, electronic
health information sharing arrangements cannot advance interoperability.
The HITECH Act24 directed ONC to establish a governance mechanism for the nationwide health information network
(NwHIN).25 Industry response to ONC’s request for information (RFI)26 on the topic indicated a general desire for ONC
to refrain from formal governance activity at that time and to allow nascent and emerging governance efforts in industry
to take shape. In lieu of any regulatory action on NwHIN governance, ONC pursued a variety of initiatives to build
consensus among a broad range of stakeholders through collaborative efforts. This included issuing the Governance
Framework for Trusted Health Information Exchange (HIE),27 which established guiding principles on HIE governance
and collaborating with states28 and existing HIE governance entities.29 While these collaborative efforts advanced
some aspects of interoperability, they have not yielded nationwide interoperability. In some cases the projects were
experimental and in other cases, such as the governance framework, there was nothing to compel or incent its use.
Moving Forward and Milestones
ONC continues to believe that the electronic health information sharing arrangements described above are valuable
tools to promote interoperability among unaffiliated organizations. However, there are evident gaps, overlaps and
conflicting approaches among and between the various organizations that prevent the sharing of electronic health
information. Reaching the near- and long-term nationwide interoperability goals will require existing arrangements to
be able to share information across their respective boundaries, even between competitors, and should focus on the
Roadmap’s near term goal of sending, receiving, finding and using priority data domains.30
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23
As a federal advisory committee focused on accelerating the development and adoption of health information technology and the Nationwide
Health Information Network (NwHIN), 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.
24
American Recovery and Reinvestment Act of 2009. 111th Congress. January 2009. http://www.gpo.gov/fdsys/pkg/BILLS-111hr1enr/pdf/BILLS111hr1enr.pdf
25
Section 3001(c)(8) of the Public Health Service Act, HITECH SEC. 3001. Office of the National Coordinator for Health IT. (8) Governance
for Nationwide Health Information Network.—The National Coordinator shall establish a governance mechanism for the nationwide health
information network.42 U.S.C. § 300jj-11.
26
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.
27
http://www.healthit.gov/sites/default/files/GovernanceFrameworkTrustedEHIE Final.pdf
28
http://www.healthit.gov/sites/default/files/wscfinalreport.pdf
29
http://www.healthit.gov/policy-researchers-implementers/exemplar-hie-governance-entities-program
30
The priority data domains are clinical to begin with, but should expand over time to cover many other types of information, including social
determinants of health.
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In a country as large and heterogeneous as the U.S., it is not realistic to suggest that all electronic health information
needs will be met with a single electronic health information sharing arrangement. Therefore, a variety of electronic
health information sharing arrangements will continue to exist as they serve important market and clinical functions
that meet the unique needs of many different communities. 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
bridge disparate arrangements and support nationwide interoperability. 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. Along with the flexibility described above, nationwide interoperability will require more
than has been done to date to support shared decision making, rules of engagement and accountability to enable trust.
In addition to the shared decision-making process, an enduring set of principles to align practices across all electronic
health information sharing arrangements and a method of knowing who abides by those principles must be created.
Public and private sector stakeholders should use policy guidance issued by ONC as a starting point for these efforts.
These stakeholders will also need to work together to establish a common shared decision-making process where
operational level issues related to standards, services, policies and business practices that inhibit the achievement of
interoperability across existing and new electronic health information sharing arrangements can be resolved. This process
should address mechanisms for accountability, including identifying and addressing those who are out of compliance with
policies and practices. The process should be inclusive and balance the participation of all stakeholders.
The following includes milestones for Shared Decision-Making, Rules of Engagement and Accountability to Enable
Interoperability. Please see the Complete Set of Calls to Action and Commitments by Roadmap Section at the end of
this document for the critical actions that need to take place to advance nationwide interoperability.
Milestones for Shared Decision-Making, Rules of Engagement and Accountability
2015-2017
|
2018-2020
Send, receive, find and use priority
data domains to improve health and
health care quality
Expand interoperable health IT
and users to improve health and
lower cost
B1.1 At least 50% of electronic health
information sharing arrangements (as
defined above), including health information
service providers (HISPs), adhere to
recommended policies and business
practices such that electronic health
information can be exchanged by participants
across organizational boundaries.
B1.2 100% of electronic health information
sharing arrangements (as defined above),
including HISPs, adhere to recommended
policies and business practices such that
electronic health information can be
exchanged by participants across
organizational boundaries.
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A learning health system enabled
by nationwide interoperability
B1.3 Non-healthcare stakeholders, such
as human services, community-based
services, and researchers are included in
electronic health information sharing
arrangements in support of a learning
health system.
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C. Ubiquitous, Secure Network Infrastructure
Enabling an interoperable, learning health system requires a stable, trusted, secure, widely available network capability
that supports technology developer-neutral protocols and a wide variety of core services.
Background and Current State
The security of network infrastructure is pivotal to ensuring the success of nationwide interoperability to enable a
learning health system. It serves as the basis for trust by ensuring that electronic health information can be shared in
a secure and private manner and not altered in an unauthorized or unintended way, while still making the information
available when needed by those authorized to access it. The security of health IT systems and their underlying security
infrastructure will continuously evolve as necessary to maintain its secure state as critical infrastructure.31
As health IT systems have become increasingly connected to each other, cyber threats have concurrently increased
at a significant rate.32 In an interoperable, interconnected health IT ecosystem, an intrusion in one system could
allow intrusions in multiple other systems. Additionally, there is high variability in the capabilities and resources that
health care organizations have at their disposal to prevent cyberattacks. Large organizations often have the resource…
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