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HIT Advisory Committee Advances Recommendations on Core Data for Interoperability

April 19, 2018
by Heather Landi
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The Health Information Technology Advisory Committee, a federal advisory committee to the Office of the National Coordinator for Health IT (ONC), voted Wednesday to approve nine recommendations to update the list of data elements that vendors must exchange to be considered interoperable.

The 21st Century Cures Act established the HIT Advisory Committee, which replaces two separate health IT policy committees that were previously overseen by ONC—the Health IT Policy and Standards Committees. Its role will be to provide guidance on policies, standards, implementation specifications, and certification criteria relating to the implementation of a health information technology infrastructure that advances the electronic access, exchange, and use of health information.

The nine draft recommendations were developed by the U.S. Core Data for Interoperability Task Force, a specialized task force within the 30-member HITAC. The U.S. Core Data for Interoperability (USCDI) standards, and the process for updating core data sets, will eventually funnel into the Trusted Exchange Framework and Common Agreement (TEFCA) draft, an outline of minimum standards that health information networks must meet to be able to exchange patient health data. The approved HITAC recommendations will go to ONC in a letter that its staff will consider while crafting TEFCA.

One key recommendation centers around establishing a six-stage maturation process through which data classes would be promoted, starting with when a new data element is proposed through its inclusion as a new USCDI data class and then to widespread adoption.

The goal of the data class maturation process is to identify data classes with broad applicability to advance interoperability. In stage 5, for instance, policy levers will be used to promote widespread adoption of the USCDI data class, and qualified health information networks (QHINs) and their participants are required to update their technology to support the new USCDI data class. TEFCA establishes QHINs as a vehicle to help facilitate a standardized methodology for HIE inter-connectivity, along with a new administrative organization, the Recognized Coordinating Entity (RCE).

The co-chairs of the USCDI task force, Christina Caraballo and Terry O’Malley, M.D., pointed out that in stage 1, any stakeholder can propose data objects and use cases in a shared public resource. “The purpose is to widely seek out nominations for data of value,” O’Malley, who is a geriatrician at Massachusetts General Hospital, said.

HITAC also approved the recommendation to publish the USCDI annually as a reference edition, with quarterly bulletins as data elements progress from one stage to the next.

The other recommendations approved were:

  • Expand the USCDI as each data class completes Stages 1-4 without a predetermined timeline
  • Incorporate public feedback in each stage
  • Test USCDI Process by Addressing Critical Trusted Exchange Framework Requirements
  • Ensure the Voice of the Patient is Represented and Heard
  • Support the Process of Data Item Harmonization as a Condition for Data Class Advancement
  • Establishing a data management process to modify established USCDI data classes
  • Establishing a data governance structure for USCDI


HITAC committee members discussed many of the challenges facing the group as it works on the structure and process for updating USCDI standards. The committee members noted the need for a Data Class Work Group as a group of stakeholders with the responsibility to define the data class, apply applicable semantic standards, harmonize data elements and produce a data class sufficiently specified to be tested. The DCWG will be steward of the data class through cycles of testing and revision.

One challenge will be the cost and resources to stand-up a public resource for data elements to be proposed and the work required for pilot testing, as well as the time and resources required to stand up a data class work group and the impact to ONC.

“The data class has to have a steward, an interested party, who wants to see it through. It’s going to take effort and structure to get that done,” O’Malley said.

Another committee member noted that the process of harmonization is critical and will be very difficult. “It will take time and effort to do this well. That’s going to be one of the challenges for this group. The point of this stage (stage 2) is to get something that can be tested. Some data elements have no problem getting through stages 1 and 2 and there are some that need work, particularly the attachments of standards to them,” the committee member said.

Another committee member voiced concerns about the timeline to deliver updated USCDI data elements to the marketplace and the need to keep patients at the center of interoperability efforts. “You should consider making it a condition of payment, so no one gets paid for medical services unless there is a digital record provided to the patient. You should look at the approach of delivering stage 1 in a human readable form that could be shared with patients as soon as it is digitally available. Make it a condition of payment; HHS [the U.S. Department of Health and Human Services] and CMS [the Centers for Medicare and Medicaid Services] have that leverage to make that domino fall into place.”

USCDI task force members also emphasized the importance of ensuring the voice of the patient is represented and noted the challenge of how to engage patients and consumers in the process. To this end, the task force recommended establishing a process that engages patient representatives in data class creation, and noted that specifically designated representatives may be required for the DCWGs. In its presentation, the USCDI task force noted that “This is no longer a ‘nice to have’ but rather a ‘must have’ as we shift into patient-centric, value-based healthcare delivery.”



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Epic Plans Meeting for Non-Epic Users on Data Sharing Capabilities

August 16, 2018
by Heather Landi
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Verona, Wis.-based Epic is inviting healthcare provider organizations that don’t use Epic’s electronic health record (EHR) to its “un-Users Group Meeting” at its Verona headquarters to learn how to exchange data with Epic.

The event, planned for September 26, will provide information to healthcare provider organizations about how to exchange charts with providers in their community who use Epic, even if providers use a different EHR— or no EHR at all.

According to Epic’s unUGM website, the event is for “executives and strategic leaders of provider organizations who want to learn and discuss how to exchange with providers in their community who use Epic.”

“Access to a patient’s information, regardless of where he or she has been seen, helps providers deliver the best patient care. The first Un-Users Group Meeting (unUGM) is another way we’re reaching out to the leaders of health systems using other EHRs—or even no EHRs—to help them get connected to the Epic users in their communities,” Dave Fuhrmann, Epic’s vice president of interoperability, said in a prepared statement.

According to the event agenda, topics of discussion include options for exchanging patient data with providers through Carequality, Care Everywhere, health information exchange (HIE) and Direct messaging, as well as patient-directed options, including MyChart, Share Everywhere, Lucy, and Blue Button.

There will also be discussion about interoperability success stories, using both non-Epic and Epic EHRs, and the current state of coordinated care in the U.S. and the use of existing tools to close care gaps, improve communication, and reduce costs.

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Amazon, Google, IBM and Other Tech Giants Pledge to Remove Barriers to Interoperability

August 14, 2018
by Heather Landi
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Six of the world's biggest technology companies, including Microsoft, Google, IBM and Amazon, made a joint pledge at the White House Monday to remove interoperability barriers and to make progress on adoption of health data standards.

The announced came during the Blue Button 2.0 Developer Conference in Washington, D.C. where Microsoft joined with Amazon, Google, IBM, Salesforce and Oracle to jointly commit to support healthcare interoperability by advancing healthcare standards such as HL7 (Health Level Seven International), FHIR (Fast Healthcare Interoperability Resources), and the Argonaut Project. They also pledged to remove interoperability barriers, particularly as it relates to the adoption of technologies enabled through the cloud and artificial intelligence (AI).

Dean Garfield, president and CEO of the Information Technology Industry Council, said in a statement, “Today’s announcement will be a catalyst to creating better health outcomes for patients at a lower cost. As transformative technologies like cloud computing and artificial intelligence continue to advance, it is important that we work towards creating partnerships that embrace open standards and interoperability.

“We commend the White House Office of American Innovation for their leadership in being a catalyst for moving health care beyond siloed systems and varied data standards. As well, we celebrate Amazon, Google, IBM, Microsoft, Oracle, and Salesforce for their commitment to helping to advance open healthcare standard. The opportunity to unleash greater innovation in health care is here and working together we can seize it,” Garfield said.

In a joint statement, the technology companies made a commitment to remove barriers to “frictionless data exchange,” noting that they share “the common quest to unlock the potential in healthcare data, to deliver better outcomes at lower costs.”

The commitment specifically states:

“In engaging in this dialogue, we start from these foundational assumptions: The frictionless exchange of healthcare data, with appropriate permissions and controls, will lead to better patient care, higher user satisfaction, and lower costs across the entire health ecosystem.

Healthcare data interoperability, to be successful, must account for the needs of all global stakeholders, empowering patients, healthcare providers, payers, app developers, device and pharmaceuticals manufacturers, employers, researchers, citizen scientists, and many others who will develop, test, refine, and scale the deployment of new tools and services.

Open standards, open specifications, and open source tools are essential to facilitate frictionless data exchange. This requires a variety of technical strategies and ongoing collaboration for the industry to converge and embrace emerging standards for healthcare data interoperability, such as HL7 FHIR and the Argonaut Project.

We understand that achieving frictionless health data exchange is an ongoing process, and we commit to actively engaging among open source and open standards communities for the development of healthcare standards, and conformity assessment to foster agility to account for the accelerated pace of innovation.”

Gregory J. Moore M.D., Ph.D., vice president of healthcare, Google Cloud, said in a statement, “We are pleased to join others in the technology and healthcare ecosystem in this joint commitment to remove barriers and create solutions for the adoption of technologies for healthcare data interoperability. This will enable the delivery of high quality patient care, higher user satisfaction, and lower costs across the entire healthcare ecosystem.”

Patients should have access to their data, said Mark Dudman, head of global product and AI development, IBM Watson Health, in a statement following the announced commitment. Patients also should have the flexibility to use products and services across different healthcare systems, with confidence that they all are working seamlessly for their care, he said. “We are proud to participate in this pledge and look forward to working with industry and the developer community to ensure appropriate access to data and the use of that data to support vibrant communities and solve health challenges for people everywhere.”

In a blog post, Josh Mandel, chief architect, Microsoft Healthcare, notes that interoperability is an overlapping set of technical and policy challenges, from data access to common data models to information exchange to workflow integration – and these challenges often pose a barrier to healthcare innovation.

Mandel, who previously worked at Google Life Sciences and on the research faculty at Boston Children’s Hospital where he worked on the SMART Health IT Platform, notes that support for the Meaningful Use Common Clinical Data Set grows and it is becoming easier to plug new tools into clinical workflows, analyze clinical histories, collect new data, and coordinate care.” Many of these technical capabilities have been available within small, tight-knit health systems for a long time – but developing these capabilities has required complex, custom engineering and ongoing maintenance and support. Driving toward open architecture makes adoption faster, easier and cheaper,” he wrote.

True interoperability in healthcare requires end-to end solutions, rather than independent pieces, which may not work together, Mandel wrote. “Transforming healthcare means working together with organizations across the ecosystem. Today’s joint interoperability statement reflects the feedback from our healthcare customers and partners, and together we will lay a technical foundation to support value-based care.”


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Industry Stakeholders Urge ONC to Move Forward on Information Blocking Rules

August 8, 2018
by Heather Landi
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In a strongly worded letter to National Coordinator Donald Rucker, M.D., several healthcare and health IT industry groups expressed frustration with the Office of the National Coordinator for Health IT’s lack of progress in publishing information blocking regulations, as required in the 21st Century Cures Act.

“It has been 601 days since the 21st Century Cures Act was signed into law. Every day that the administration delays implementation of these critical provisions places patients at risk of harm,” the letter states. Stakeholders including Health IT Now, Research!America, Oracle, the American Medical Informatics Association (AMIA), the American Academy of Family Physicians, Cambia Health Solutions and Claim Your Health Data Coalition signed the letter dated August 6.

In the letter, addressed to both Dr. Rucker and Daniel Levinson, inspector general of the Department of Health and Human Services (HHS), the stakeholder groups note that the 21st Century Cures Act, which was enacted in December 2016, requires the HHS Secretary to “issue regulations to prevent information blocking and to also identify reasonable and necessary activities that do not constitute information blocking.” Further, the law requires ONC to implement a standardized process for the public to submit reports on claims of health information technology products or developers of such products not being interoperable or resulting in information blocking and actions that result in information blocking. “The Office of the Inspector General (OIG) has enforcement authority over vendors and providers who are found to engage in information blocking,” the letter states.

The stakeholder groups also contend that “information blocking poses a significant risk to patient safety and greatly contributes to increased costs and waste in the health care system.”

According to reporting from Politico, during ONC’s 2nd Interoperability Forum this week in Washington, D.C., Rucker told the form audience that ONC is still working on the rule. The rule’s release has been delayed several times and is not expected to be released in September.

“Rucker emphasized Monday that his goal is to make protocols and standards that would let large amounts of health data flow easily between health providers, not just individual patient charts. He and other officials emphasized that ONC’s work is all being done within the confines of HIPAA,” the Politico article stated. Rucker also noted that properly defining which behaviors do and don’t constitute information blocking is “hard to sort out,” and the rule is a “work in progress,” Politico reported.

In a separate statement regarding ONC's delay in issuing an information blocking proposed rule, Douglas Fridsma, M.D., Ph.D., AMIA president and CEO, said, "Information blocking is the absence of interoperability, and there are numerous reasons why information may not flow as intended. Some of these reasons are technical, others for business or policy reasons. The socio-technical interoperability stack is complex and so too is the task of identifying which among its layers is responsible for information blocking. This rule must be critically calibrated to account for these layers, and it must be part of a larger conversation about how we will address other aspects of the socio-technical interpretability stack. Now is the time to initiate this broad conversation through release of the proposed information blocking rule."

In the letter, the industry groups also cautioned that “information blocking impedes provider access to the most current, accurate or complete information on their patients. As the administration proposes and implements new rules related to open APIs and interoperability in Medicare’s payment rules for hospitals and doctors, the lack of clear rules of the road needlessly creates uncertainty for vendors and providers alike.”

“We understand the nuance required but feel that it is past time for a proposal to be made,” the stakeholder groups wrote in the letter.

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