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Industry Groups Urge ONC to Reorient Goals of EHR Reporting Program, Focus on Health IT Safety, Security

October 18, 2018
by Heather Landi, Associate Editor
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Many healthcare industry groups would like to see the Electronic Health Record (EHR) Reporting Program for health IT developers include a strong focus on patient safety-related usability, EHR training, transparency on EHR vendors’ cybersecurity practices as well as cost transparency.

This feedback came in response to a request for information (RFI) issued by the Office of the National Coordinator for Health IT (ONC) in late August seeking public input on reporting criteria under the EHR Reporting Program for health IT developers, as required by the 21st Century Cures Act. The public comment period ended Oct. 17.

ONC issued the RFI on criteria to measure the performance of certified electronic health record technology (CEHRT). The Cures Act requires that health IT developers report information on certified health IT as a condition of certification and maintenance of certification under the ONC Health IT Certification Program.

According to the Cures Act, the EHR Reporting Program should examine several different functions of EHRs and reporting criteria should address the following five categories: security; interoperability; usability and user-centered design; conformance to certification testing; and other categories, as appropriate to measure the performance of certified EHR technology.

In its comments to ONC, the Bethesda, Md.-based American Medical Informatics Association (AMIA) questioned what it views as the “constrained scope” of the EHR Reporting Program to “provide publicly available, comparative information on certified health IT,” to “inform acquisition upgrade, and customization decisions that best support end users’ needs.”

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Rather, AMIA urged ONC to develop the EHR Reporting Program to measure performance to improve CEHRT security, interoperability, and usability, and not be used simply to provide data for “acquisition decision makers.”

“Especially when viewed alongside the additional provisions in newly developed CEHRT Conditions of Certification, the EHR Reporting Program should be leveraged to bring transparency to how CEHRT performs in production environments with live patient data,” AMIA stated.

“ONC should develop an EHR Reporting Program that more closely approximates a post-implementation surveillance ecosystem, not a government-sponsored ‘consumer reports’,” AMIA wrote in its comments.

Such an ecosystem, AMIA stated, would “illuminate CEHRT performance used in production and would generate product performance data automatically, without users having to submit reporting criteria.”

As proof of concept, AMIA pointed to ONC’s existing nascent surveillance and oversight program for CEHRT that could be leveraged for the EHR Reporting Program. The group also referenced the Food and Drug Administration’s (FDA) Digital Health Software Precertification Program as another example of a federal program that looks to utilize real-world production data.

In addition, AMIA recommends ONC develop interoperability reporting criteria for the EHR Reporting Program by building on previous RFIs meant to “measure interoperability,” including the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and ONC’s “Proposed Interoperability Standards Measurement Framework.”

And, the industry group also urged ONC to prioritize an additional measure that demonstrates a capability to provide patients with “a complete copy of their health information from an electronic record in a computable form.” “This focus would align with top-level HHS priorities to improve patient access to their data,” AMIA noted.

AMIA also recommends alignment between the EHR Reporting Program and other aspects of the Cures-mandated Conditions of Certification.

“The EHR Reporting Program is one more vital piece in improving both EHR performance and care quality,” AMIA president and CEO Douglas B. Fridsma, M.D., Ph.D., said in a statement. “We have a tremendous opportunity to leverage Cures provisions if we hone our focus on EHR performance in the real world.”

In its comments, the College of Healthcare Information Management Executives (CHIME) advises ONC against establishing any complex rating methodologies for scoring vendors. ONC should also consider establishing benchmarks by which to monitor interoperability progress among vendors, CHIME wrote. The organization noted that patients need better education on the risks of using application programming interfaces (APIs), and ONC should partner with their federal partners and stakeholders on this issue, CHIME said.

Many organizations, including CHIME, would like more information about vendors' ongoing support practices, such as the estimated costs of maintenance and software. The Medical Group Management Association (MGMA) recommended making software pricing structures for upfront and ongoing software, training and maintenance costs part of the Reporting Program, as well as all interoperability “connection” fees. MGMA also urged ONC to consider incorporating into the Reporting Program testing criteria that focused on the effectiveness of the EHR’s integration with practice management system software, and costs associated with it.

The American Health Information Management Association (AHIMA) recommended that comparative information made publicly available under the EHR Reporting Program should also contain reporting criteria that reflects the entire lifecycle of the certified health IT product, including acquisition, implementation, ongoing maintenance, upgrades, additional product and/or application integration, and replacement.

Focus on Patient Safety-Related Usability and EHR Training

In its comments, AMIA also urged ONC to view health IT safety as a measurable byproduct of usable CEHRT deployed in live environments. “To understand CEHRT usability performance in situ, ONC should supplement user-reported measures with measure concepts that reflect the safety of health IT,” AMIA wrote.

MGMA recommended that the Reporting Program report on the ability of the software to identify and address patient safety issues. “Poor usability and inefficient clinician workflow can not only fail to prevent adverse events but can actually contribute to them,” the organization wrote.

In comments it submitted to ONC, Pew Charitable Trusts noted that the establishment of the EHR Reporting Program “has the potential to give health care providers, EHR developers, and other organizations better data to address barriers in the effective, efficient, and safe use of health information technology, and improve systems accordingly.”

“In particular, this program could unearth key details on how clinicians utilize EHRs to meet ONC’s goal of reducing clinician burden while improving patient safety. ONC should ensure that the reporting criteria focused on usability—which refers to the design of systems and how they are used by clinicians—also incorporate safety-related provisions,” Pew wrote in its letter.

Pew recommended reporting criteria focus primarily on testing EHR usability to promote patient safety. To this end, Pew identified four principles to guide usability-related reporting criteria—the adoption of a life-cycle approach to developing usability-related criteria; incorporating quantitative, measurable data; limiting burden on end-users; and ensuring transparent methods that prevent gamesmanship.

Pew also provided ideas for existing sources of information that could be adapted into or utilized as safety-related usability reporting criteria, such as the Leapfrog CPOE tool, safety surveillance data from ONC, the ONC SAFER Guides or a 2016 health IT safety measure report from NQF.

“As ONC implements this program, the agency should ensure that the usability aspects of the program focus on the facets of EHR usability that can contribute to unintended patient harm. To achieve that goal, ONC should consider the aforementioned principles in identifying reporting criteria, and data sources that could become part of the program,” Pew wrote in its comments.

Orem, Utah-based KLAS Research and the Arch Collaborative recommended the EHR Reporting Program include criteria focused on EHR training, as better clinician training is critical to EHR usability and clinician satisfaction, the two groups said. The Arch Collaborative is a KLAS-affiliated initiative with more than 130 provider members.

The KLAS-Arch comment cited research findings based on responses by more than 50,000 physicians from more than 100 provider organizations around the globe that suggests EHR satisfaction and usability are directly related to the extent and quality of training users have received. The research indicates that organizations that focus on training to support clinician workflows have higher EHR satisfaction than those that don’t. What’s more, the higher the levels of personalization tool use by the clinicians, the higher the EHR satisfaction score, according to KLAS.

“EHRs are not simple enough to be operated efficiently without ample instruction. It is essential that new providers spend enough time learning how to use the EHR, and it is requisite that providers have the option to participate in ongoing training each year,” Taylor Davis, vice president of innovation at KLAS Research, wrote in the letter. “When an EHR training program is well designed, there will be a demand to attend. A trend that has been noted is that success begets success; when providers share how EHR training has improved their efficiency, their peers become more likely to participate. The key is that the providers must have the option to choose what works for them.”

Need for Greater Focus on Security Posture

The Healthcare and Public Health Sector Coordinating Council's cybersecurity working group highlighted, in its comments on the RFI, the need for more transparency on EHR vendors' cybersecurity posture as part of the criteria of the EHR Reporting Program.

“The challenges to our sector are abundant and we believe these attacks pose direct threats to patient safety,” the group wrote in its comments. The group urged ONC to factor into the EHR Reporting Program the growing incidences of cybersecurity attacks on the sector and the need to work collaboratively to address the threats.

The group outlined a number of items that would better inform providers of a vendors’ security practices, such as access to an auditor’s statement regarding the security posture of the vendor and its products, upon provider request, as well as a software security analysis, whether two-factor authentication is in use, information on role-based access controls and how roles are configured, and, with each release and update, the number of patches provided to address security-related issues.

The group also recommended ONC consider developing a more standard way for vendors to report vulnerabilities with health IT upgrades and releases.

 


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VA, Cerner Leaders Detail Progress on EHR Implementation, Interoperability Efforts

November 14, 2018
by Heather Landi, Associate Editor
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The U.S. Department of Veterans Affairs (VA)’s new $16-billion-dollar Cerner electronic health record (EHR) system will use open application programming interface (APIs) and Fast Healthcare Interoperability Resources (FHIR) standards to enable interoperability with the private sector, according to a Cerner executive, which potentially positions the VA as a leading force to drive interoperability forward in the healthcare industry.

The ability of the VA’s healthcare system to seamlessly share patient data with the U.S. Department of Defense (DoD) as well as health systems and physicians in the private sector continues to be a top concern among Congressional leaders as the VA is now six months in to its implementation of a new Cerner EHR, and the topic dominated a House oversight subcommittee hearing on Wednesday.

Congressional leaders pointed out that interoperability between VA and DoD and between VA and community providers would be key to the success of the VA electronic health record (EHR) modernization effort. “If you can’t make that step work, then this won’t work,” Rep. Phil Roe, M.D., (R-Tenn.) chairman of the House Veterans Affairs committee, said.

During the hearing, members of the House Veterans Affairs' technology modernization subcommittee reviewed the electronic health record modernization (EHRM) program’s accomplishments, to date, and questioned VA and Cerner leaders about implementation planning, strategic alignment with the DoD’s MHS Genesis project, as DoD also is rolling out a new Cerner EHR, as well as interoperability efforts.  

The VA signed its $10 billion contract with Cerner in May 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. The VA project will begin with a set of test sites in the Pacific Northwest in March 2020.

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In October, the U.S. Secretaries of the VA and DoD signaled their commitment to achieving interoperability between the two agencies by implementing a single, seamlessly integrated EHR, according to a joint statement both agencies issued. 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."

However, subcommittee chairman Jim Banks (R-Ind.) noted during the hearing, “Community provider interoperability has always been the elephant in the room. VA-DoD interoperability is very important, but VA is further behind in exchanging records with its community partners. There are helpful tools, such as health information exchanges (HIEs), but no out-of-the-box EHR system completely solves this problem.” Banks added, “Community interoperability is a very real problem, and for $16 billion, VA had better solve it.”

It is estimated that up to a third of VA patients receive care in the private sector.

"I’m not ready to sound the alarm, but I’ve heard very little on the subject [interoperability with DoD and community providers],” Banks said, noting that a review by industry experts indicated that VA and DoD need to be on the same instance of the Cerner EHR in order to achieve seamless interoperability. “That means both departments have to pull patient data from the same database. The two implementations have to be joined at the hip. It raises the stakes. It’s important to put this reality out in the open, and early.”

During her testimony, Laura Kroupa, M.D., acting chief medical officer with the VA’s Office of Electronic Health Record Modernization (OEHRM), noted that interoperability with community healthcare providers was a challenge that VA and Cerner leaders were working together to address.  “Going on the Cerner platform will allow us to utilize national systems in place for interoperability. Our community care councils also look at all the different workflows for how patients get referred into and out of the VA to make sure that information is exchanged and put into the system, not just as a piece of paper or image, but actually the data itself,” she said. Kroupa said project leaders are working to utilize interoperability mechanisms that Cerner currently has as well as HIE initiatives already in place, such as Carequality and CommonWell, to ensure interoperability between VA and the private sector.

John Windom, who leads the VA’s EHR modernization project as the executive director of VA’s OEHRM program, said, “There are two issues—one is technology-based which is solved, the HIEs, CommonWell, Carequality, allow seamless exchange of information. But, there is also another piece, the information has to be put in, and so that information has to be made accessible by the people on those networks; we’ve got the technology piece solved.”

Travis Dalton, president of government services at Cerner, testified that Cerner would use open APIs and FHIR-based integration to enable interoperability between VA and healthcare providers in the private sector.

“We’ve committed to that contractually. It’s going to happen, it’s technically possible and feasible,” Dalton said, adding, “What will be powerful to the industry and commercial partners is if VA and DoD choose a common standard. That will move the industry forward because this isn’t always a technical issue, it’s a standard-based issue. The power of the DoD and VA to make that choice to move it forward will influence the commercial marketplaces. The tools exist, through HIE and Direct exchange; it’s a standards issue.”

Congress created the technology modernization comittee to provide more rigorous oversight of the project amid concerns about the project’s cost and alignment with the defense department’s electronic health record roll-out.

There have been ongoing questions about VA leadership, specifically with regard to the EHR modernization project, beginning with the ouster of the previous VA Secretary, David Shulkin, M.D., earlier this year, as well as other shake-ups, including the resignation of Genevieve Morris only two months after she was tapped to lead the VA’s EHR project.

An investigation by ProPublica, detailed in a report published Nov. 1, asserts that VA’s EHR contract with Cerner has been plagued by multiple roadblocks during the past year, including personnel issues and changing expectations. According to that report, Cerner rated its EHR project with the VA at alert level "yellow trending towards red.” To investigate the underlying factors that have contributed to the EHR project's problems, the publication reviewed internal documents and conducted interviews with current and former VA officials, congressional staff and outside experts.

In parallel, Rep. Banks has expressed concerns with the VA’s “apparent loss of focus” on innovation, specifically as it relates to open APIs. In a letter to acting VA Deputy Secretary James Byrne dated Oct. 10, Banks noted that two years ago the VA initiated an open-API gateway interoperability platform concept, called Lighthouse. Back in March, during the HIMSS Conference, the VA also announced an open API pledge, with the launch of a “beta” version of its Lighthouse Lab, which offers software developers access to tools for creating mobile and web applications to help veterans better manage their care, services and benefits. Banks wrote that these efforts seem to have “lost momentum.”

In the letter, Banks noted that the VA needs a flexible platform to translate data coming in from multiple EHRs and on which to build, and so its private sector partners can build, interfaces to and from medical practice billing systems, insurance companies, external applications, veterans’ devices and one day Medicare and Tricare’s systems. “The need to ‘future-proof’ the technology that VA is acquiring is very real. Moving forward with the open-API gateway and sustaining the open API pledge are important steps to do that,” Banks wrote.

Progress Made in the First 180 Days

During the hearing, Windom outlined the EHRM program’s accomplishments, to date, including the establishment of 18 workflow councils and current state assessments of the initial implementation sites. VA and Cerner project leaders also completed an analysis report to assess the DoD’s MHS Genesis system as EHRM’s baseline. The workflow councils are mostly comprised of clinicians in the field who provide input to enable configuration of national standardized clinical and operational workflows for the VA's Cerner EHR system, Windom said.

Dalton said the site visits of the initial implementation sites provided important insights into VA’s IT needs. “VA has a unique patient population, you’ve got an older, sicker population, with unique needs, such as behavioral health. Some areas that we uncovered that we need to focus on now include telehealth, behavioral health and reporting. These are big content areas,” he said, adding, “I expect the work that we do will help to lead us into the future in that area. We expect that as we work closely together to meet the needs of the agency that will help to makes us better commercially.”

Dalton said the VA Cerner are committed to applying commercial best practices, as well as any lessons learned from our DoD experience, to the VA’s EHRM program.

“We learned some hard lessons with the DoD experience,” he said. “Transformation is always difficult. We’re doing things a lot differently—we’re engaging with sites early and often. We’re also doing more workshops up front, so it’s more of an iterative process.” And, he added, “This is a provider-led process. We have the 18 councils that are assisting us with validation of the workflow.”

 


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EHR Usability Issues Impact Pediatric Patient Safety, Research Finds

November 13, 2018
by Rajiv Leventhal, Managing Editor
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In an analysis of 9,000 pediatric patient safety reports from three healthcare organizations, researchers found that 36 percent of the reports were related to EHR (electronic health record) usability issues.

The research, published in the November issue of Health Affairs, and led by Raj Ratwani, Ph.D., director of the National Center for Human Factors in Healthcare, Washington, D.C.-based MedStar Health, and others, aimed to further understand the specific issues around why pediatric populations are uniquely vulnerable to the usability and safety challenges of EHRs particularly those related to medication.

To understand specific usability issues and medication errors in the care of children, the researchers analyzed 9,000 patient safety reports, over a five-year span, from three different healthcare institutions—two stand-alone pediatric institutions and one adult and pediatric institution that used Epic and Cerner EHRs (two institutions used Epic, and one used Cerner)—that were likely related to EHR use.

Of the 9,000 reports, 3,243 (36 percent) had a usability issue that contributed to the medication event, and 609 (18.8 percent) of the 3,243 might have resulted in patient harm, the researchers found.

“The general pattern of usability challenges and medication errors were the same across the three sites. The most common usability challenges were associated with system feedback and the visual display. The most common medication error was improper dosing,” the research revealed.

The researchers noted in the study that pediatric patients are uniquely vulnerable to EHR usability and safety challenges because of different physical characteristics, developmental issues, and dependence on parents and other care providers to prevent medical errors. For example, they offered, lower body weight and less developed immune systems make pediatric patients less able to tolerate even small errors in medication dosing or delays in care that could be a result of EHR usability and safety issues.

Although the Office of the National Coordinator for Health Information Technology (ONC) has policies to promote usability—such as requiring system developers to incorporate feedback from clinicians into software design and development and mandating the testing of twelve high-risk EHR functions that are primarily related to medication—the researchers noted that these policies have not made a distinction between adult and pediatric populations. However, the 21st Century Cures Act of 2016 requires ONC to establish new voluntary criteria unique to EHRs used in the care of children.

For this research, the 9,000 reports—3,000 from each site—were reviewed to verify whether the events were related to the EHR and medication; determine whether EHR usability contributed to the event and, if it did, identify what the specific usability challenge was; identify the type of medication error; and identify whether the event reached the patient.

Of the 9,000 patient safety event reports that were collected, 56 percent were confirmed as being related to both the EHR and medication. Of these 64 percent had a usability issue as a contributing factor to the safety event, which amounts to 36 percent of the total 9,000 reports analyzed.

Of the 3,243 reports (36 percent) that had usability as a contributing factor, 19 percent reached the patient. Of these, 33 percent did not cause harm and did not require monitoring, 18 percent required monitoring or an intervention to prevent harm, 3 percent resulted in temporary harm, and the consequence was unknown for 46 percent, the researchers revealed.

One example of a usability issue that caused some harm was when a when a physician ordered five times the recommended dose of a medication without receiving an alert from the EHR, although the prescribed dose was outside the recommended range. Both vendor design and development, as well as implementation and customization, may be contributing to the challenges associated with system feedback, the researchers stated.

“To address this systemic problem, vendors and providers should consider developing more comprehensive design guidelines and use generalizable tools to assess usability and safety. The Leapfrog [computerized provider order entry simulation] tool, which assesses clinical decision support functionality, is one example of the types of tools that could improve the safety of implemented EHR products,” they said.

The researchers concluded, “To better prevent usability-related medical errors, the ONC could include safety as part of the voluntary certification criteria of EHRs for use with children and implement usability-related measures to assess EHR performance. Vendors and providers should use rigorous test-case scenarios based on realistic clinician tasks. Finally, the Joint Commission should assess EHR safety as part of its hospital accreditation program. The implementation of approaches such as these is needed to reduce patient harm related to EHR use.”

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