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A Clinical Informaticist Shares Why FHIR Won’t Extinguish HL7, At Least Not in the Near-Term

June 30, 2016
by Heather Landi
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Russell Leftwich, M.D., a clinical informaticist and an HL7 International board member, discusses the promise of FHIR in healthcare and the near-term “hybrid" world that healthcare organizations will be operating in.
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Within the healthcare industry, there is much discussion about the promise of Health Level Seven’s (HL7) Fast Healthcare Interoperability Resource (FHIR) standard and the role it will play in health IT’s future to improve interoperability and data exchange. Transitioning to FHIR, and enabling the use of web technology to manipulate data within the framework of FHIR, will transform healthcare organizations, essentially making it easier for providers to share health data, according to Russell Leftwich, M.D., adjunct assistant professor of biomedical informatics at Vanderbilt University and senior clinical advisor for interoperability at Cambridge, Mass.-based InterSystems, And, adoption of the FHIR standard will help bring healthcare forward, essentially catching up healthcare IT to the technology and domains used by Facebook, Google and Amazon.

However, Leftwich, who is an HL7 International board member, also says that for the foreseeable future, healthcare providers will need to translate between different standards—HL7 v2, HL7 v3 and Consolidated-Clinical Document Architecture (C-CDA) and FHIR—as there will be a need to transform back to earlier standards so that legacy systems can consume data.

Leftwich chairs the HIMSS Office of the National Coordinator for Health IT (ONC) Interoperability Standards Advisory Task Force and has previously served on the HIMSS Interoperability and Standards Committee. In addition, he is co-chair of the IHE USA Implementation Committee. He recently founded and is co-chair of the HL7 Learning Health Systems Workgroup and a past co-chair of the HL7 Patient Care Workgroup. Most recently he served as chief medical informatics officer for the State of Tennessee Office of eHealth Initiatives. Leftwich recently spoke with Healthcare Informatics Assistant Editor Heather Landi about the promise of FHIR in healthcare and the near-term “hybrid” environment that healthcare organizations will be operating in as the FHIR standard continues to be built out.

There is a lot of discussion about the promise of the FHIR standard to transform healthcare organizations. What role do you see FHIR playing in healthcare IT?

There’s no doubt, it will transform organizations. It allows the same type of information exchange that we’re used to in other domains and accessing information on multiple different servers, and that might be information for a particular individual that exists in different electronic health records (EHRs). FHIR will make it much easier to access all that information. However, the other reality is that, for the foreseeable future, we will live in a hybrid world of standards. There’s the existing standards, HL7 v2 and C-CDA, and they are not going away, not in the next 10 or 20 years. They will still be in use, and the HL7 version 2 standard is the most widely used standard, and it’s being used in countless systems out there and people aren’t going to simply replace those systems. They are going to continue to use those systems because that standard does what it does very well, as far as exchanging lab orders and lab results, between the EHR and the lab system. FHIR, as it’s built out over the next two or three years, will be a standard that can be used to translate between standards and allow those systems that are legacy systems using an older standard to still exchange information within the ecosystem of health information data. But there will still be a huge portion of the information ecosystem that use older standards, so having FHIR as one means of translating between different standards will be the reality of the future.

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Russell Leftwich, M.D.

InterSystem has created a health information exchange (HIE) platform that’s enabled it to translate between HL7 v2 and C-CDA documents and FHIR, in both directions, so that people can use that as way of aggregating data about an individual and as a patient. If they turn that data into FHIR-based data, then it’s much easier to search and manipulate the data. I think that is one way FHIR will transform things at the point of care because once that data is in FHIR format, people will then use mobile devices to access that data, for things like decision support. FHIR is very adaptable to mobile devices such as smartphones and tablets, but also to mobile devices that are monitoring as well as medical devices, and the Internet of Things will be enabled by FHIR being the mechanism of interoperability. I think it will all feed into this hybrid ecosystem of different standards co-existing and FHIR will be the glue that ties all that together.

What is the latest progress on the FHIR standard?

We’re already starting to see FHIR-based apps and FHIR development going on. There was a panel at a meeting that I attended yesterday where people from four different organizations talked about how they are using FHIR in their organizations. In July, HL7 will have a two day event where different individuals and organizations will demonstrate what they’ve already done with FHIR within their organization. Right now, people have these apps that are enabled to use FHIR to access the data in that organization’s EHRs system but because these apps have been developed with earlier versions of FHIR, they won’t be easily carried across different organizations. Over the next year or two, as FHIR becomes stable enough and more developed, then apps will be developed. Organizations will have an app that you can get from an FHIR app store and actually be able to use that wherever your organization is.

Where does FHIR go from here?

That’s the future that’s coming very soon, the apps that people are using now are more proof of concept within the organizations. They’re using the apps and they are tremendously useful because they allow practitioners to do things and access the data in a way they couldn’t previously. And there’s work to be done with FHIR, as different parts of FHIR are not yet built out, particularly those parts that deal with very complex clinical data elements. The part of FHIR that deals with the more basic things like what’s the information around a patient or information around a particular condition, the way we specify a condition or a lab test, those things are fairly far along in FHIR. But more complicated concepts that relate to specialties and genetics and things like that are yet to be fully built out in FHIR. What needs to happen is that the entire FHIR community and the clinicians in particular need to get together, one data element at a time, and agree on a model, or how to represent that piece of data. You have to have that to really have interoperability across organizations. You have to agree that this is how we’re going to define this particular clinical data element or a particular diagnosis, but it’s not as complicated as some of these more sophisticated data elements.

So, FHIR will not eliminate the HL7 version 2 standard for now. What should health IT leaders be doing to ensure their information systems are prepared for this hybrid ecosystem of different standards?

Organizations certainly need to be planning their information architecture, if you will, for that future, which is probably not that far off, perhaps the next two to three years. I think they need to be strategic about the architecture they build out and the capabilities that are in the information architecture to adopt new standards like FHIR, but also to allow access to data that exists in these legacy systems that use older standards. And that’s because organizations can’t just go out and replace all these systems that are in use now. The average hospital in the US has something approaching 100 different IT systems within their hospital, and many of those systems are legacy systems that use older standards. But those standards work very well for what they are doing. They need to enable to make the best use of that data from these legacy systems in the future, so organizations need to have a strategy to bring these different types of data together.

One of the advantages of FHIR is that, in the past, to create an interface between two of those legacy systems using the existing standards like HL7 v2 and HL7 c-CDA, it took weeks to develop those interfaces. Those same interfaces leveraging FHIR can be developed in a matter of days, sometimes even hours, and having a strategy to adopt FHIR in a way that makes that data aggregation between old systems and new systems is going to be very important to organizations.

So it will be important for healthcare providers to be able to translate between these different standards to be successful, leveraging interoperability to achieve care coordination and value-based care, is that right?

Absolutely, with care coordination being the idea of having a virtual team that’s defined around an individual patient, and of those individuals some will be professionals and some family and community members. And that’s difficult to do right now because there’s no way to put data where it can be accessed by all of that virtual team. But with the FHIR standard, because of its adaptability with mobile devices and because all of the data could be put in a FHIR format, that will enable everybody on the virtual team to then access the data for that patient using a mobile device and using FHIR. And that’s the kind of thing that is already starting to happen within organizations. I would foresee in the next couple of years where it’ll start to happen more and more across organizations where there’s an HIE where they can access data with mobile devices and FHIR. And another angle to this that I think is very exciting is that each member of the virtual team will be able to have their own app, because app development with FHIR is relatively simple. And, in that sort of information ecosystem of the future, an app that’s developed for one place should be usable across the world.

So that’s a big part of the promise of FHIR, to create the universal platform that we have with Android and iOS in order to get an app from an app store that anybody can use on their device, anywhere, so that really is the promise of FHIR. And the idea that different individuals can have an app that suits their purposes instead of having to have a constant interface developed for a single EHR, which is prodigiously expensive. As an alternative, they can have an app that they got relatively inexpensively from an app store that will work wherever they are. I think a lot of people don’t understand that what’s been done with FHIR to this point is more proof of concept than it is proven out. What we’ll see in the next year or two with FHIR will be the realization of that promise of FHIR being a standard that can tie things together and give us access to all of the data about individuals as opposed to the data that’s in a single system.

 


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New DirectTrust CEO Sees Potential for Applying its Trust Framework in Other Healthcare Contexts

October 15, 2018
by David Raths, Contributing Editor
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Former Cerner exec Scott Stuewe seeks closer relationship with EHR vendors
DirectTrust CEO Scott Stuewe

In July the nonprofit DirectTrust named former Cerner executive Scott Stuewe its new CEO to replace founding CEO Dr. David Kibbe. In a recent interview with Healthcare Informatics, Stuewe spoke about working more closely with EHR vendors and expanded opportunities for his organization’s trust framework.

Stuewe spent 24 years at Cerner, including working on interfacing and systems integration. His last three years there were spent focused on the Commonwell Health Alliance and trying to convince Cerner clients to get more involved, so working on interoperability issues is not new to him.

In fact, the role at DirectTrust seems like a logical next step in his career. “I spent some of the most exciting years of my life working on systems integration efforts,” he said. The Commonwell effort gave him an opportunity to get to know key players in the interoperability space. He also participated in Carequality advisory group, where he got to know people at Epic and other places that had not been active in Commonwell.

I asked Stuewe what he had discovered about the strengths of DirectTrust in his first few months.

“I think what was new to me was the strength of the trust framework as a technical trust framework,” he said. Other interoperability groups have trust frameworks that are legal and policy documents. “Those documents are the bread and butter of what those organizations are about. DirectTrust has this technical trust framework. which is about stretching the highest security mechanism across identity-proofed endpoints, and that is kind of a unique model. That is the advantage of the trust framework that DirectTrust represents – that identity proofing process and technologies associated with it are hardened at a level that really nothing else at its scale can really point to.”

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When I interviewed Dr. Kibbe in June, he spoke about how DirectTrust was working with the Office of the National Coordinator on an extension of its trust framework to FHIR. I asked Stuewe if he saw that as an area with potential.

He replied that it is a huge opportunity for DirectTrust. He said something like SMART on FHIR uses the same technologies that are in use in Facebook and other social media platforms. But higher levels of trust need to be established in healthcare than has been used in social media, where there have been some very large-scale data breaches. “The way the FHIR community has so far imagined that connections will be made is that the end points, that is, the provider organizations, take the responsibility to ensure that the people who are able to get to their data are who they say they are and are appropriate,” Stuewe said. People do all sorts of secure transactions over the internet, but they do so using a public key infrastructure (PKI) of the sort that DirectTrust represents, he added. “I think there is great potential there. We have demonstrated it is doable, but it does require both the caller and receiver to make relatively small accommodations for the certificates that will enable that exchange. That is not the way FHIR has been rolled out so far.”

What are some other areas where DirectTrust needs to make progress?

Stuewe says the organization could make more headway by engaging with the EHR vendors who so far have not been very engaged with DirectTrust. “There are some gaps in features among the EHRs that frankly are the same gaps we saw in query-based exchange in Commonwell. There are usability problems; the way a given feature surfaces in one EHR is so different than another that you can’t even do the same work flow across the two systems.”

He noted the same was true in query-based exchange and it took three years of meetings with the EHR vendors showing each other their user interfaces to make progress. “That is what I believe we can get done in DirectTrust,” he said. “Our clinician work group issued a consensus statement on the features/functions required for Direct to be fully adopted by the clinical community. The problem is we don’t have enough of the EHR players as participating members to really stimulate that conversation. I am eager to reach out and point this out because we are actually not that far from being able to make tremendous headway. In fact, there are a ton of things we can do right now. We are already at 1.7 million addresses and 50 million transactions per quarter. It is really happening. But there are a whole lot of things DirectTrust could do that it can’t right now given the differences in the way the EHRs work.”

Stuewe said that by far the biggest opportunity for DirectTrust is to apply its trust framework in other contexts. “FHIR is one of them, but we look at some other healthcare communication vectors, and believe healthcare communication can be secured by our PKI regardless of what standards or technologies are used for those.”

He added that it would be important to identity-proof the consumer at scale to enable more comfort from provider organizations around the connections people are going to want to make to them. “We believe that has a huge value and I think given the entry of the large consumer-based organizations into the world of healthcare, that is the opportunity we have,” Stuewe explained. “If you combine FHIR, a trust framework and a major consumer player, then that is when you can make a lot of this stuff actually work. I am excited about it.”

 


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VA-DoD Leaders Signal Commitment to Achieving Interoperability, but What Uphill Challenges Will They Face?

October 15, 2018
by Heather Landi, Associate Editor
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"There is no precedent for this level of interoperability in healthcare,” says one industry thought leader
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The U.S. Secretaries of Veterans Affairs (VA) and Defense (DOD) have signaled their commitment to achieving interoperability between the two agencies by implementing a single, seamlessly integrated electronic health record (EHR), according to a joint statement published last week.

VA Secretary Robert Wilkie and Defense Secretary James N. Mattis signed a joint statement Sept. 26 pledging that their two departments will “align their plans, strategies and structures as they roll out a EHR system that will allow VA and DoD to share patient data seamlessly,” according to a press release about the joint statement.

“The Department of Defense and Department of Veterans Affairs are jointly committed to implementing a single, seamlessly integrated electronic health record (EHR) that will accurately and efficiently share health data between our two agencies and ensure health record interoperability with our networks of supporting community healthcare providers,” the joint statement from Wilkie and Mattis states. “It remains a shared vision and mission to provide users with the best possible patient-centered EHR solution and related platforms in support of the lifetime care of our Service members, Veterans, and their families.”

The VA and the DoD are both undertaking massive projects to modernize their EHR systems and both departments plan to standardize on Cerner’s EHR. The hope is that this will provide a more complete longitudinal health record and make the transition from DoD to VA more seamless for active duty, retired personnel and their dependents. Once completed, the project would cover about 18 million people in both the DoD and VA systems.

The VA signed its $10 billion contract with Cerner May 17 to replace VA’s 40-year-old legacy health information system—the Veterans Health Information Systems and Technology Architecture (VistA)—over the next 10 years with the new Cerner system, which is in the pilot phase at DoD.

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DoD began rolling out its EHR modernization project, called Military Health System (MHS) Genesis, in January 2017 at Fairchild Air Force Base and three other pilot sites in Washington State. The DoD EHR overhaul contract, which was awarded in 2015 to Cerner, Leidos and others, is currently valued at $4.3 billion. The new EHR system is expected to be deployed at every military medical facility in phases over the next five years.

“There is no precedent for this level of interoperability in healthcare, but one can hope the DoD-VA effort will drive the evolution of meaningful interoperability forward and benefit everyone,” says Dave Levin, M.D., chief medical officer at Sansoro Health and former chief medical information officer (CMIO) for Cleveland Clinic. Levin has been observing the VA-DoD interoperability efforts and has written several blogs pointing out the critical challenges facing the two agencies in these efforts.

“There is a long-standing need for the VA and the DoD to be on the same information database for service members and veterans. Cerner is a good product. I am hopeful that Cerner’s commitment to the FHIR (Fast Healthcare Interoperability Resources) standard and to process interoperability standards will be revealed to the general community and implemented wholeheartedly, because at the end of the day, it’s not what’s best for VA and DoD, it’s what’s best for veterans and service members as they consume care along their own personal pathways,” says Shane McNamee, M.D., who previously served as the clinical lead for the VA’s Enterprise Health Management Platform (eHMP) effort and also the VHA business lead for the development and deployment of the VA’s Joint Legacy Viewer. He is now the chief medical officer of Cleveland-based software company mdlogix.

In the press release, Wilkie said the joint statement represents “tangible evidence” of VA and DoD’s commitment. “The new EHR system will be interoperable with DoD, while also improving VA’s ability to collaborate and share information with community care providers. This will ease the burden on service members as they transition from military careers and will be supported by multiple medical providers throughout their lives.”

Wilkie also said the new EHR system will give health care providers a full picture of patient medical history and will help to identify Veterans proactively who are at higher risk for issues, such as opioid addiction and suicide, so health care providers can intervene earlier and save lives.

Specifically, the joint statement pledges that VA and DoD will develop an accountability mechanism to coordinate decision-making and oversight. “The importance, magnitude, and overall financial investment of our EHR modernization efforts demand alignment of plans, strategies and structure across the two departments,” the two agency leaders stated in the joint statement. “To this end, DoD and VA will institute an optimal organizational design that prioritizes accountability and effectiveness, while continuing to advance unity, synergy and efficiencies between our two departments.”

VA and DoD will construct a plan of execution that includes a new organizational structure that optimally coordinates clinical and business workflows, operations, data management and technology solutions and a more detailed implementation timeline.

"We are committed to partnering with the VA to support the lifetime care of our service members, Veterans and their families," Mattis said in the press release. "This modern electronic health record will ensure those who serve our nation have quality health care as they transition from service member to Veteran."

An Uphill Battle for Interoperability

Interoperability between the VA and DoD has been a long-standing goal for both agencies, and the past two decades has seen the agencies making strides to achieve interoperability between two separate health IT systems. However, progress on this front has been slowed by both operational and technical challenges.

Back in April 2016, the DoD and VA signed off on achieving one level of interoperability, after the VA implemented its Joint Legacy Viewer (JLV) the previous fall. The JLV is a web-based integrated system that combines electronic health records from both the DoD and the VA, which enables clinicians from both agencies to access health records.

However, as reported by Healthcare Informatics, during a congressional hearing in July 2016, a Government Accountability Office (GAO) official testified that in 2011, DoD and VA announced they would develop one integrated system to replace separate systems, and sidestep many of their previous challenges to achieving interoperability. “However, after two years and at a cost of $560 million, the departments abandoned that plan, saying a separate system with interoperability between them could be achieved faster and at less overall cost,” Valerie Melvin, director of information management and technology resources issues at the GAO, testified at the time.

Melvin said that the VA has been working with the DoD for the past two decades to advance EHR interoperability between the two systems, however, “while the department has made progress, significant IT challenges contributed” to the GAO designating VA as “high risk.”

And, Melvin summarized the GAO’s concerns about the VA’s ongoing modernization efforts. “With regard to EHR interoperability, we have consistently pointed to the troubled path toward achieving this capability. Since 1998, VA has undertaken a patchwork of initiatives with DoD. These efforts have yielded increasing amounts of standardized health data and made an integrated view of data available to clinicians. Nevertheless, a modernized VA EHR that is fully interoperable with DoD system is still years away,” Melvin said during that hearing two years ago.

Fast forward to June 2017 when then-VA Secretary David Shulkin announced that the department plans to replace VistA by adopting the same EHR platform as DoD. Six months later, Shulkin then said that the contracting process was halted due to concerns about interoperability. According to reports, VA leaders’ concerns centered on whether the Cerner EHR would be fully interoperable with private-sector providers who play a key role in the military health system. VA leaders finally signed the Cerner contract this past May.

The Pentagon also has hit some road bumps with its EHR rollout. In January 2018, DoD announced the project would be suspended for eight weeks with the goal to assess the “successes and failures” of the sites where the rollouts had already been deployed. This spring, a Politico report detailed that the first stage of implementations “has been riddled with problems so severe they could have led to patient deaths.” Indeed, some clinicians at one of four pilot centers, Naval Station Bremerton, quit because they were terrified they might hurt patients, or even kill them, the report attested.

Media reports this past summer indicated that the Cerner platform was up and running at all four initial DoD pilot sites, with federal officials saying the agency is still troubleshooting the platform at the initial facilities, but the overall adoption’s shown “measurable success.” This month, media reports indicated that DoD is moving onto a second set of site locations for its Cerner EHR rollouts, with three bases in California and one in Idaho.

According to the VA press release issued last week, collaborating with DoD will ensure that VA “understands the challenges encountered as DoD deploys its EHR system called MHS GENESIS; adapts an approach by applying lessons learned to anticipate and mitigate known issues; assesses prospective efficiencies to help deploy faster; and delivers an EHR that is fully interoperable.”

While both Levin and McNamee praise the VA-DoD interoperability efforts, they note the substantial challenges the effort faces. In a January blog post, Levin wrote at the heart of this VA-DoD interoperability challenge are two fundamental issues: “an anemic definition of interoperability and the inevitable short comings of a ‘one platform’ strategy.”

In response to the joint statement issued last week, Levin provided his observations via email: “DoD and VA will have separate instances of the Cerner EMR. They will not be on the same EMR with a single, shared record but rather on distinct and separate implementations of the same brand of EMR. The choice of language in the announcement is interesting: they are saying they will create a single EHR [author’s emphasis] through interoperability between these separate EMRs and with the EMRs in the civilian health system, which is essential since a lot care for active duty, Veterans, and dependents is rendered outside the military system. This will depend greatly on the extent and depth of interoperability between the different EMRs.”

Levin continued, “My second observation relates to interoperability between the EMRs, or EHR system, and the many other apps and data services within military health IT. For example, there is an emerging class of apps sometimes referred to as ‘wounded warrior’ apps. These are specially designed for this population. They will need to be effectively integrated into this new IT ecosystem or their value will be greatly diminished, if not lost.”

McNamee points out there are different layers of interoperability—data interoperability, or ensuring data flows back and forth (the Joint Legacy Viewer achieved this level of interoperability, he says), semantic interoperability, in which meaningful information is associated with the data, and then standards-based process interoperability.

The lack of standards-based process interoperability continues to be a roadblock for all healthcare providers, and this issue has yet to be solved by any one specific EHR vendor, many industry thought leaders note.

“The challenges that VA and DoD face are similar to what the rest of healthcare faces in this country,” McNamee says. “There’s more than 10 million patients between these two organizations, meditated across thousands of different sites and the inability to transfer information and process for the VA and the DoD is similar as the rest of the country.”

He continues, “If you talk to any informatics or health IT professional about the most challenging thing that they’ve ever had to do in their career it’s to install an EHR into their hospital; it’s incredibly disruptive and, if not done well, it can negatively impact patient care, reimbursement and morale. VA and DoD are attempting to do this across thousands of healthcare sites, with millions of patients, and hundreds of thousands of healthcare providers, in one project, that’s a daunting task, to do that well and do that seamlessly.”


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Carequality Seeks Input on FHIR-Based Exchange

October 12, 2018
by Rajiv Leventhal, Managing Editor
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Carequality is seeking input from the healthcare community as it looks to add support for FHIR (Fast Healthcare Interoperability Resource)-based exchange.

According to an announcement from Carequality—national-level, consensus-built, common interoperability framework to enable exchange between and among health data sharing networks—member and non-member stakeholders from across the healthcare continuum are encouraged to participate in the new FHIR Implementation Guide technical and/or policy workgroups. The former will concentrate more on specifications and security, while the latter will focus on the “rules of the road,” officials said.

With much of the healthcare industry either starting to implement FHIR at some level, or planning to do so, the Carequality community is thinking ahead to the type of broad, nationwide deployments that Carequality governance can enable, officials noted.

The new policy and technical workgroups are expected to work in concert with many other organizations contributing to the maturity and development of FHIR, and officials attest that the workgroups will not duplicate the work that is underway on multiple fronts, including defining FHIR resource specs and associated use case workflows. Instead, the workgroups will focus on the operational and policy elements needed to support the use of these resources across an organized ecosystem. 

“Carequality has demonstrated the power of a nationwide governance framework in connecting health IT networks and services for clinical document exchange,” said Dave Cassel, executive director of Carequality.  “We believe that the FHIR exchange community will ultimately encounter some similar challenges to those that Carequality has helped to address with document exchange, and likely some new ones as well.  We’re eager to engage with stakeholders to map out the details of FHIR-based exchange under Carequality’s governance model.”

Cassel added, “We believe that adoption of FHIR in the Carequality Interoperability Framework can advance all of these goals by improving the availability of useable clinical information, expanding the scope of exchange, and significantly lowering the costs of participating in interoperable exchange.”

In August, Carequality and CommonWell, an association providing a vendor-neutral platform and interoperability services for its members, announced they had started a limited roll-out of live bidirectional data sharing with an initial set of CommonWell members and providers and other Carequality Interoperability Framework adopters.

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