Industry Stakeholders Urge ONC to Move Forward on Information Blocking Rules | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

Industry Stakeholders Urge ONC to Move Forward on Information Blocking Rules

August 8, 2018
by Heather Landi
| Reprints

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.

The Health IT Summits gather 250+ healthcare leaders in cities across the U.S. to present important new insights, collaborate on ideas, and to have a little fun - Find a Summit Near You!


/news-item/interoperability/industry-stakeholders-urge-onc-move-forward-information-blocking-rules
/article/interoperability/new-directtrust-ceo-sees-potential-applying-its-trust-framework-other

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

October 15, 2018
by David Raths, Contributing Editor
| Reprints
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.”

Webinar

Safety & Unintended Consequences of Interoperability: Establishing High Reliability Principles & Techniques

Interoperability may seem like just a technology challenge, but in actuality it is a people, process, and technology challenge. Healthcare systems increasingly look to create high-reliability...

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.”

 


More From Healthcare Informatics

/article/interoperability/va-dod-leaders-signal-commitment-achieving-interoperability-what-uphill

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

October 15, 2018
by Heather Landi, Associate Editor
| Reprints
"There is no precedent for this level of interoperability in healthcare,” says one industry thought leader
Click To View Gallery

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.

Webinar

Safety & Unintended Consequences of Interoperability: Establishing High Reliability Principles & Techniques

Interoperability may seem like just a technology challenge, but in actuality it is a people, process, and technology challenge. Healthcare systems increasingly look to create high-reliability...

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.”


Related Insights For: Interoperability

/news-item/interoperability/carequality-seeks-input-fhir-based-exchange

Carequality Seeks Input on FHIR-Based Exchange

October 12, 2018
by Rajiv Leventhal, Managing Editor
| Reprints

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.

See more on Interoperability

betebettipobetngsbahis