BREAKING NEWS: At HIMSS18, CMS’s Verma Announces MyHealthEData Initiative, to Give Patients Control of their Data | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

BREAKING NEWS: At HIMSS18, CMS’s Verma Announces MyHealthEData Initiative, to Give Patients Control of their Data

March 6, 2018
by Mark Hagland
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On Tuesday morning at HIMSS18, CMS Administrator Seema Verma announced a broad new initiative to empower patients to control their health data

On Tuesday morning, March 6, at the Sands Convention Center in Las Vegas, on the second full day of the annual HIMSS Conference, Seema Verma, Administrator of the federal Centers for Medicare and Medicaid Services (CMS), announced the launch of a new initiative called “MyHealthEData,” aimed at revolutionizing the relationship of U.S. healthcare consumers to their patient data.

Verma spoke to about 1,000 people at 9 AM Pacific time in Las Vegas at the Sands; at about the same time, CMS’s website carried the announcement, which stated that, “Today, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new Trump Administration initiative – MyHealthEData – to empower patients by giving them control of their healthcare data, and allowing it to follow them through their healthcare journey.”

As the CMS announcement stated, “Last year President Trump issued an Executive Order to Promote Healthcare Choice and Competition Across the United States. In response the Administration is moving towards a system in which patients have control of their data and can take it with them from doctor to doctor, or to their other healthcare providers. The government-wide MyHealthEData initiative is led by the White House Office of American Innovation with participation from the Department of Health and Human Services (HHS) – and its Centers for Medicare & Medicaid Services (CMS), Office of the National Coordinator for Health Information Technology (ONC), and National Institutes of Health (NIH) – as well as the Department of Veterans Affairs (VA). The initiative is designed to empower patients around a common aim - giving every American control of their medical data. MyHealthEData will help to break down the barriers that prevent patients from having electronic access and true control of their own health records from the device or application of their choice. Patients will be able to choose the provider that best meets their needs and then give that provider secure access to their data, leading to greater competition and reducing costs.”


CMS Administrator Seema Verma on Monday morning (credit: Peter
Ashkenaz, Office of the National Coordinator)

Further, the announcement said, “The MyHealthEData initiative will work to make clear that patients deserve to not only electronically receive a copy of their entire health record, but also be able to share their data with whomever they want, making the patient the center of the healthcare system. Patients can use their information to actively seek out providers and services that meet their unique healthcare needs, have a better understanding of their overall health, prevent disease, and make more informed decisions about their care.”

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The announcement added, “Today in an address at the Healthcare Information and Management Systems Society (HIMSS) Annual Conference in Las Vegas, Administrator Verma also announced the launch of Medicare’s Blue Button 2.0 – a new and secure way for Medicare beneficiaries to access and share their personal health data in a universal digital format. This enables patients who participate in the traditional Medicare program to connect their claims data to the secure applications, providers, services, and research programs they trust. For example, Medicare’s Blue Button 2.0 will allow a patient to access and share their healthcare information, previous prescriptions, treatments, and procedures with a new doctor which can lead to less duplication in testing and provide continuity of care. Medicare’s Blue Button 2.0 is expected to foster increased competition among technology innovators to serve Medicare patients and their caregivers, finding better ways to use claims data to serve patients’ health needs.” With regard to the Blue Button program, Verma noted that, while Medicare beneficiaries have for a few years now had access to some of their Medicare claims via Blue Button functionality, that data has been in raw form, without any contexting that could make it truly useful for Medicare patients; and Blue Button 2.0 will facilitate that needed contexting. “Currently,” she said, “we give our beneficiaries this data in Excel or PDF formats, without any help in helping them to understand the context of it. That’s useless if that’s hard to understand.”

Administrator Verma also spoke of the need to move forward to empower patients with their data and information, in remarkably personal terms, recounting an episode in which her husband had collapsed while the two of them were not together, and was rushed to an emergency department, for what turned out to be heart failure. “He spent a week in the hospital,” she recalled. “At the end, we asked for his records at discharge. The doctors looked a little bit uncomfortable. After a little while, they handed me five pages of paper, which was essentially a discharge summary, and a CD-ROM. After the federal government has spent $30 billion in EHRs, providers are producing CD-ROMs???” she exclaimed. “Most computers don’t even take CD-ROMs anymore. And when I finally accessed the information on the CD-ROM, it was missing a lot of clinical information, including recent tests. This isn’t just my experience, it’s happening to patients all over the country. It’s all too common to patients to have to drive to separate locations to access their records. A doctor I spoke with last month had twins, and it took him, a doctor, six months, to access his children’s records.” Such experiences, now in 2018, are totally unacceptable, she made it clear. And she made it clear that she believed that the MyHealthEData initiative could force the entire healthcare industry to reform itself to improve things, from hospitals and physician practices, to health insurers, to EHR vendors.

“The reality,” Verma said, “is that once the information is freely flowing from patient to provider, the advances in coordinated, value-based care, will be greater than anything we could imagine today. Things could have been different for my family if my husband could have authorized me to have his health records on his phone,” she said. “Or if he could have notified me that he was in distress. And better yet, maybe we could have predicted his cardiac arrest days before, if his watch could have tracked his health data, and sending that data to alert his doctor, and possibly prevent what happened. My husband is part of the 1 percent that survives his condition. We shouldn’t have to depend on chance” for that type of outcome, she emphasized.

“Through the MyHealthEData initiative,” Verma continued, “this administration is focused on putting patients first, truly first, by giving them the information they need to truly improve their health. This administration will pull every lever to create a health information ecosystem that tailors the health system” to improve outcomes, she said. “Our administration is completely aligned”—including across the Veterans Administration healthcare system, the Department of Defense, and other healthcare-related federal agencies—"to achieve this goal. And the time is now. Hospitals and doctors” have extensive access to electronic patient records, she noted, “and nearly everyone has access to a smartphone. And smartphones in particular create the portability needed to create mobility… Uniform standards being drafted in the 21st Century Cures Act that will allow for information-sharing. The technology and regulatory requirements are finally coming together,” she emphasized.

In all this, Verma said, “Privacy and security of patient data will be the center of all of our efforts. We must protect the privacy and security of patient data. CMS will be announcing a complete overhaul of the meaningful use program for hospitals and the advancing care information category” under the MIPS (Merit-based Incentive Payment System) program for physicians. “Ensuring the security of healthcare data will be an absolute requirement to avoid negative” payment penalties under MIPS, she said. “We will be laser-focused on increasing interoperability and giving patients access to their data. Last year, CMS finalized requirements around EHR certification. This ensures that patients will be able to share data via APIs”—application programming interfaces.

Meanwhile, she said, “We are also ensuring that hospitals and doctors are not engaged in data-blocking. We will not tolerate this practice anymore. It’s not acceptable to limit patient records or to prevent them from seeing their complete history outside their particular healthcare system. It’s the priority of this administration to make sure that every patient can access” their full patient records.

In addition, Verma announced, “We’re going to overhaul E&M codes”—the requirements under Medicare around documenting evaluation and management codes in the patient record, on the part of physicians—“to make it easier to document. We will be updating and streamlining them, so doctors can spend less time using their EHRs and more time seeing patients.”

Verma called on all stakeholder groups within U.S. healthcare to play their part in these changes, including health insurers. “Today, we are calling on private health plans to join us in sharing their data with patients because enabling patients to control their Medicare data so that they can quickly obtain and share it is critical to creating more patient empowerment,” Verma said in her speech.

Further, the CMS Administrator noted, “In Medicaid, we will be working with states to make sure they can make their claims data available to beneficiaries as well. And now, I call on all insurers to give their patients their claims data electronically. Over the course of the year, we will be examining all the ways we can work with health insurers, to make sure we can make this [happen]. We will also shift our focus to patient access to data. And we will be studying ways to reduce duplicate and unnecessary testing. Work against duplicate tests and unnecessary treatments. For those in the healthcare industry who are already working to make data more secure and available, we give you our full support, and will work with you. However, for those of you who still subscribe to the outdated idea that they can restrict patients’ access to their data, I encourage you in the strongest terms” to rethink those old notions.

“Let’s empower our patients to achieve access to their records whenever and wherever they choose,” Verma said at the conclusion of her speech. “We cannot do this alone, but together,” amazing things are possible. “Ten years from now, I hope we will look back on today as the start of a new era… and let’s make sure that what we’ve announced in Vegas doesn’t stay in Vegas.”

Verma was introduced by Jared Kushner, who in his role as the lead in the Office of American Innovation, Verma recognized as a partner in the federal healthcare agencies’ efforts to move the healthcare industry forward around data and information issues.

 

 


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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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