EHR and Health IT Consulting
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EHR and Health IT Consulting
Technical Doctor's insights and information collated from various sources on EHR selection, EHR implementation, EMR relevance for providers and decision makers
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ONC Embraces Industry-led Testing of Health IT Tools

ONC Embraces Industry-led Testing of Health IT Tools | EHR and Health IT Consulting |

The testing and certification of health IT tools is an important part of the adoption of EHR technology across the healthcare industry. The Office of the National Coordinator for Health IT (ONC) has held the chief responsibility for the certification of EHR systems and health IT tools.

ONC reports that one of its goals is to improve the testing and certifying of health IT tools and published a Federal Register notice on June 9. This notice allows for the National Coordinator to offer more flexibility in accepting test procedures, test capabilities, and data “developed by any person or entity for approved use.”

The reasoning behind the publication of the notice was due to feedback from healthcare industry stakeholders. The feedback involved improving testing efficiency by allowing the inclusion of industry-led testing and certification within the ONC Certification Program.

This news will allow for health IT vendors, developers, and other entities to submit data, test procedures, and test tools to be considered for inclusion within the Health IT Certification Program.

“We are excited about the potential of leveraging community supplied tools because there is no limit to the number that can be submitted and we believe that having more testing flexibility will help the program maximize the efficiencies already created and operational-proven by health IT developers,” ONC reported.

This will create more flexibility and opportunity for those looking for alternative testing resources when it comes to the certification of their health IT tools. Those interested in submitting test tools, test procedures, or test data to be addressed by ONC representatives can do so via the

“The National Coordinator is open to approving test procedures, test tools, and test data that meet the outlined approval requirements above for an applicable adopted certification criterion or criteria,” theDepartment of Health and Human Services (HHS) stated in a document. “By way of this document, we strongly encourage persons or entities to submit such test procedures, test tools, and test data to ONC if they believe such procedures, tools, and data could be used to meet ONC’s certification criteria and testing approval requirements. We also note that there is no programmatic prohibition on the approval of multiple test procedures, test tools, and test data for a certification criterion or criteria.”

Other changes that have been included among federal agencies regarding the adoption of health IT tools include the modification to Stage 2 Meaningful Use requirements. The modifications proposed by the Centers for Medicare & Medicaid Services (CMS) will last between the years 2015 to 2017.

Providers should pay attention to all changes with meaningful use requirements as well as alterations with certification of health IT tools in order to receive financial incentives under the EHR Incentive Programs established by CMS.

All of these changes are reforming the healthcare industry as a whole and providers should expect ongoing policy revisions across the nation in efforts to improve the quality of healthcare services, better population health outcomes, and lower rising costs.

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Beacon Partners’ Bruce Eckert on the Proposed Stage 3 Rule for Meaningful Use—and Beyond

Beacon Partners’ Bruce Eckert on the Proposed Stage 3 Rule for Meaningful Use—and Beyond | EHR and Health IT Consulting |

Bruce Eckert, the national practice director at Beacon Partners Healthcare Management Consultants, leads the strategy, business intelligence, and meaningful use teams at the Weymouth, Mass.-based consulting firm, which recently merged with the New York-based KPMG.

In a meeting at the McCormick Place Convention Center in Chicago with HCI Editor-in-Chief Mark Hagland on Monday, April 13 during the HIMSS Conference, Eckert responded to Hagland’s questions about meaningful use and other issues facing the industry.

Asked about the proposed change to Stage 2 meaningful use requirements that would change the previous requirement that eligible providers get 5 percent of their patients to view, download, and transmit their health information to requiring that only one patient do so—with the anticipation that 25 percent of patients must then view, download and transmit under Stage 3, he admitted that he was as puzzled as everyone else seemed to be, and expressed the hope that federal officials at the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) would clarify that point soon.

Below are additional excerpts from their Monday interview.

What do you think of the Stage 3 proposed rule overall?

I like the structure, in that they're very compressed things down to 8 measures, and the menu sets are embedded in the measures. And they're collecting higher level data than before. So it's a nice framework. And we just did a HIMSS focus group around patient engagement. We had 12 people. Not universally but many are having challenges getting patients to use portals. Not so many problems with secure messaging, because the patients find value in it. So what the patients find value in, works well.

One of the challenges, it seems, continues to be timelines. Your thoughts?

Clearly in my mind, CMS is still trying to recover from the 2014 vendor certification debacle, with a lack of time to catch up. And they're setting up possibly the same timeline compression on the vendor side again coming into Stage 3. But I do think we've learned something from the 2014 CEHRT debacle. And perhaps this flexibility will help, because it might provide some breathing room for organizations.

You’ve just finished moderating a focus group with a diverse group of healthcare IT leaders. What kinds of concerns did they talk about?

They talked about things like appointment reminders, and push messaging for diagnostic results. And they didn't seem to think the patient education element in meaningful use would be difficult.

Overall, how did they perceive the challenges of Stage 3?

Most said it would be challenging, but doable, as long as they get the 2015 CEHRT in, in time. There's nothing really revolutionary in Stage 3, to be honest. And though it's not specifically on there, I think we'll see widespread adoption of PHRs, because a lot of the requirements wrap around that.

Who will manage the personal health record has long been a practical issue in the industry. Has that question been resolved?

Not entirely, but there will be third parties. And if you look at how HealthKit and HealthVault are architected, they really do give the patient the power. So I really do see third party vendors doing this. The issue would be whether they would be considered business associates under HIPAA. But if they add data in, the providers, then they would be covered. But I’ll predict that PHRs will be widely adopted under Stage 3. And I think we're approaching the end of the HIE [health information exchange] era. I attended the ONC's annual meeting in February. And they had a panel with all the former national coordinators together. And one of them said, the honest truth we have to face is that there's no business model for HIEs. That's evidence number one And look at the way meaningful is going. CMS is effectively supporting DIRECT protocols. I can see that whole infrastructure development—from regional HIEs to state HIEs to some anticipated nationwide infrastructure, simply not coming to fruition in the end. I think we're going to see the end of HIEs.

What should our audience be thinking about in the next few years?

Having more data, better data, and the ability to analyze data, will be key. Those organizations that manage and analyze data better will succeed, those that don't, won't. And we really moving in the direction of intensive data consumption, analytics, and management going forward, partly because of the impact of meaningful use.

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Cerner, Epic Participate in CMS Designated Test EHR Program

Cerner, Epic Participate in CMS Designated Test EHR Program | EHR and Health IT Consulting |

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) launched the Designated Test EHR Program more than one year ago, which has essentially been part of the Stage 2 Meaningful Use transition of care objective. This measure requires eligible hospitals, eligible professionals, and critical access hospitals to electronically exchange a summary of care document with a recipient who has differently designed EHR technology developed by another vendor, according to the Office of the National Coordinator for Health IT (ONC).

A second option for eligible hospitals and professionals is to take part in successful testing through the CMS Designated Test EHR Program during the EHR reporting period. ONC recently announced that Epic Systems and Cerner Corporation have decided to participate in the CMS Designated Test EHR Program along with iPatientCare.

During a prior year, Meditech and McKesson also participated in the program. While Epic Systems and Cerner Corporation have joined, a number of vendors dropped out including Athena Health, Meditech, and McKesson. Previously, Athena Health had participated in the pilot before the finalized program launch and was not a CMS Designated Test EHR vendor during the launch.

Currently, more than 5,000 healthcare providers have successfully attested to the transition of care meaningful use objective after conducting the relevant tests. The majority of providers, however, prefer the first option for meeting this particular meaningful use objective – exchanging summary of care information with a provider who has an EHR from a different technology developer.

Essentially, the second option is considered a “last resort” for providers who cannot meet this measure using the first option. Providers should be aware that this transition of care objective can be met at any point during the reporting year and not necessarily during the reporting period.

In order to assist eligible professionals and hospitals struggling to meet this objective, CMS released a FAQ sheet that outlines a solution. If providers are unable to participate in either option of this objective, they will need to provide documentation on their hardship and attest “yes” to meeting the measure as long as they are utilizing a certified EHR system capable of sending summary of care data and attaining the required standards.

“Designated Test EHRs will be registered on a software system, ‘EHR Randomizer’, hosted by the National Institute of Standards and Technology (NIST). The NIST-hosted software system will randomly match an EP, eligible hospital, or CAH with a designated test EHR that is designed by a different EHR technology developer than theirs,” ONC stated on its website.

Healthcare professionals who need to meet the transition of care objective under the Stage 2 Meaningful Use requirements now have the opportunity to test their summary of care exchange through Cerner and Epic technologies.

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EHR Systems Lack Adequate Lab Data Graphing Functions

EHR Systems Lack Adequate Lab Data Graphing Functions | EHR and Health IT Consulting |

Current electronic health record systems lack adequate laboratory data graphing capabilities, according to a study published in the Journal of the American Medical Informatics Association, Modern Healthcare reports.

Study Details

For the study -- which sought to determine the abilities of various EHR systems to display test results -- researchers analyzed eight EHR systems based on 11 criteria.

Of the eight EHR systems included in the study, six had been certified by the Office of the National Coordinator for Health IT, including those from:

  • Allscripts;
  • Cerner;
  • eClinicalWorks;
  • Epic;
  • Meditech; and
  • Partners Longitudinal Medical Record.

The other systems were the Department of Veterans Affairs' Computerized Patient Record System and Glassomics, an EHR prototype designed to work with Google Glass.

The study did not rate the EHR systems by name.


Overall, the researchers found none of the systems met all 11 criteria.

According to the study, the highest-rated system achieved 10 of 11 criteria, while the lowest-rated system achieved five.

The most common problem among EHR systems was the failure to label the vertical, or Y-axis.

Other flaws included:

  • An EHR system that labeled data in reverse order with the most recent data on left instead of the right;
  • An EHR system that did not equally space out data points on graphs, which could result in an erroneous slope when measuring rates; and
  • Three systems that did not include patient identification directly on the graphs.

According to EHR Intelligence, the results showed a lack of standardized workflows among EHR systems, which could lead to an increase in medical errors and a decline in patient safety.

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While EHR Interoperability Remains Vital, Security Fears Abound

While EHR Interoperability Remains Vital, Security Fears Abound | EHR and Health IT Consulting |

The movement toward EHR interoperability is sought by the federal government and certain patient advocacy groups that believe it will lead to improved quality of healthcare, better outcomes, and lower costs. With the Office of the National Coordinator (ONC) releasing an Interoperability Roadmap and issuing a report to Congress addressing the problems of information blocking, it is clear that the healthcare sector will be moving toward greater EHR interoperability and less restrictive health data exchange systems.

After ONC issued its report on information blocking in which EHR vendors were accused of charging additional fees for healthcare providers looking to access patient medical data outside of their facility, Epic Systems was one vendor that decided to drop its fees for exchanging patient data with non-Epic EHR system users. The Milwaukee Business Journal reported Epic System’s fees will be excluded until 2020.

Previously, Epic Systems charged $2.35 for every patient record accessed that wasn’t part of its EHR system. Removing these charges will be a big boost to EHR interoperability. Epic will also be taking part in the Carequality project, which is meant to develop effective health data exchange networks that assist in the sharing of medical information throughout the country.

While EHR interoperability is the name of the game for ONC, other federal agencies, and many healthcare providers, there are certain entities and individuals that do not support the seamless sharing of data. This was clearly seen in the public comments provided to ONC after the release of the Interoperability Roadmap.

“I have many issues with EHRs and interoperability – privacy is one of them. Privacy is a person’s right and this seems to be taken away with EHR interoperability,” wrote one stakeholder. “It allows nationwide access by innumerable people, which is unacceptable.”

Wayne Johnson, a retired Senior Project Manager, wrote to ONC: “I strongly urge you to vote against the proposed implementation of a National Medical Records System, an intrusive, non-secure storage and retrieval system designed to store and track the private medical data of US citizens, citizens who rightfully expect their personal information and effects to be secure from government inspection. I hold a Master’s of Science in software engineering, and I guarantee that the database system you intend to build, regardless of your intentions for security, will be compromised. Unlawful access to the private medical information stored in the system will be achieved. There is no such thing as an absolutely secure networked system.”

Clearly, privacy and security remains a top concern among citizens when it comes to improving EHR interoperability. As such, ONC issued an updated version of its Guide to Privacy and Security of Electronic Health Information in early May.

The guide has been updated to become more user-friendly and geared toward smaller medical practices and healthcare organizations that are addressing privacy and security measures across their facility, according to The National Law Review. While targeting small providers, the guide is also applicable to organizations of all sizes.

Some of the areas ONC focuses on includes identifying when patient authorizations are needed to disclose protected health data, the key questions providers need to ask their EHR vendors about security, and how to develop a security management program that will cover the privacy and security requirements under the Medicare and Medicaid EHR Incentive Programs.

While EHR interoperability remains vital for strengthening the healthcare industry as a whole, providers will need to focus on privacy and security measures to allay the fears of their patients.

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The Blocking of Health Information Undermines Interoperability and Delivery Reform

The Blocking of Health Information Undermines Interoperability and Delivery Reform | EHR and Health IT Consulting |

The secure, appropriate, and efficient sharing of electronic health information is the foundation of an interoperable learning health system—one that uses information and technology to deliver better care, spend health dollars more wisely, and advance the health of everyone.

Today we delivered a new Report to Congress on Health Information Blocking that examines allegations that some health care providers and health IT developers are engaging in “information blocking”—a practice that frustrates this national information sharing goal.

Health information blocking occurs when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information. Our report examines the known extent of information blocking, provides criteria for identifying and distinguishing it from other barriers to interoperability, and describes steps the federal government and the private sector can take to deter this conduct.

This report is important and comes at a crucial time in the evolution of our nation’s health IT infrastructure. We recently released the Federal Health IT Strategic Plan 2015 – 2020 and the Draft Shared Nationwide Interoperability Roadmap. These documents describe challenges to achieving an interoperable learning health system and chart a course towards unlocking electronic health information so that it flows where and when it matters most for individual consumers, health care providers, and the public health community.

While most people support these goals, some individual participants in the health care and health IT industries have strong incentives to exercise control over electronic health information in ways that unreasonably interfere with its exchange and use, including for patient care.

Over the last year, ONC has received many complaints of information blocking. We are becoming increasingly concerned about these practices, which devalue taxpayer investments in health IT and are fundamentally incompatible with efforts to transform the nation’s health system.

The full extent of the information blocking problem is difficult to assess, primarily because health IT developers impose contractual restrictions that prohibit customers from reporting or even discussing costs, restrictions, and other relevant details. Still, from the evidence available, it is readily apparent that some providers and developers are engaging in information blocking. And for reasons discussed in our report, this behavior may become more prevalent as technology and the need to exchange electronic health information continue to evolve and mature.

There are several actions ONC and other federal agencies can take to address certain aspects of the information blocking problem. These actions are outlined in our report and include:

  • Proposing new certification requirements that strengthen surveillance of certified health IT capabilities “in the field.”
  • Proposing new transparency obligations for certified health IT developers that require disclosure of restrictions, limitations, and additional types of costs associated with certified health IT capabilities.
  • Specifying a nationwide governance framework for health information exchange that establishes clear principles about business, technical, and organizational practices related to interoperability and information sharing.
  • Working with the Centers for Medicare & Medicaid Services to coordinate health care payment incentives and leverage other market drivers to reward interoperability and exchange and discourage information blocking.
  • Helping federal and state law enforcement agencies identify and effectively investigate information blocking in cases where such conduct may violate existing federal or state laws.
  • Working in concert with the HHS Office for Civil Rights to improve stakeholder understanding of the HIPAA Privacy and Security standards related to information sharing.

While these actions are important, they do not provide a comprehensive solution to the information blocking problem. Indeed, the most definitive finding of our report is that most information blocking is beyond the current reach of ONC or any other federal agency to effectively detect, investigate, and address. Moreover, the ability of innovators and the private sector to overcome this problem is limited by a lack of transparency and other distortions in current health IT markets.

For these and other reasons discussed in our report, addressing information blocking in a comprehensive manner will require overcoming significant gaps in current knowledge, programs, and authorities. We believe that in addition to the actions above, there are several avenues open to Congress to address information blocking and ensure continued progress towards the nation’s health IT and health care goals.

Information blocking is certainly not the only impediment to an interoperable learning health system. But based on the findings in our report, it is a serious problem—and one that is not being effectively addressed. ONC looks forward to working with Congress, industry, and the health IT community to properly address this problem and ensure continued progress towards achieving the goals of an interoperable learning health system.

ProModel Analytics Solutions's curator insight, April 17, 2015 11:37 AM

Karen DeSalvo-Leads the Office of the National Coordinator for HIT!

Learning From Our Interoperability Failures

Learning From Our Interoperability Failures | EHR and Health IT Consulting |

Currently, when healthcare data moves in this country it does it using fax machines and patient sneaker-nets. Automated digital interoperability is still in its earliest stages, mostly it has a history of being actively resisted by both the EHR vendors and large healthcare providers. We, as an industry, should be doing better, and our failure to do so is felt everyday by patients across the country.

The ONC-defined difference between EHRs and EMRs is that EHRs are interoperable. Yet, as I have said before, we have spent almost a billions of dollars and generally gotten EMRs instead of EHRs.

Comments were due Apr 3 for the ONC Interoperability Roadmap for 2015-2020. This was specifically separated out from the overall ONC Health IT Strategic Plan for which comments have closed.

Both of these plans ignore the lessons in execution from the previous strategic plan for health IT from ONC. The current Interoperability Roadmap mentions the “NwHIN” (Nationwide Health Information Network) for instance, and only covers what it accomplished, which are mostly policy successes like the DURSA (Data Use and Reciprocal Support Agreement). NwHIN was supposed to be a network of networks that connected every provider in the country… why hasn’t that happened?

ONC has forgotten what the actual ambition was in 2010. It was not to create cool policy documents. The plan 5 years ago was to have the “interoperability problem” solved in 5 years. The plan 5 years before that was probably to solve the problem in 5 years. Apparently, our policy makers look at interoperability and say “wow this is a big problem, we need at least 5 years to solve it”. Without any sense of ironic awareness that this is what they have been saying for decades, even before Kolodner was the ONC.

The silliness of this is that we need further planning on this at all. We don’t need a plan for interoperability, we need interoperability. We could just republish the old plan and it would work just as well if ONC executes and just as poorly if ONC does not execute. At what point do we start looking carefully at what has happened before and start saying “Why is this process not working better?” and “What can we do truly differently?”

The alternative to this deep and uncomfortable introspection is self delusion. Our industry has a very bad habit of rebranding rather than rethinking interoperability. Remember Community Health Information Networks (CHINs)? Those were “not sustainable”. So rather than find something that was “sustainable” we rebranded the same basic concepts as Regional Health Information Networks. But they typically failed too. Now the correct term for an unsustainable local exchange networks is a Health Information Exchange. See the problem here? No significant change in thinking or approach, just a rebranding, and the ushering in of a new generation of technology vendors. Swap out the old “bad” technology and protocols, and bring in the new. IHE is bad, we need SOAP. SOAP is bad, we need REST. The Direct Project is bad, we need Argonaut. CCR is bad we need CDA. CDA is bad we need FHIR. See the pattern here? We need to completely step back and ask uncomfortable questions about our overall approach to interoperability.

Patients, nurses and doctors in this country need more than a cursory examination of the issues behind health information exchange. We need to carefully compare and contrast what was said then, and what is being said now. We need to understand why this part of the system continues to fail.

Lets take a brief look at the “in summary our approach is” from the previous plan:

The Nationwide Health Information Network has already demonstrated sharing of patient-health information between the VA, DoD, SSA, and many private sector partners. Extending the Nationwide Health Information Network specifications with additional building blocks such as the Direct specifications will include protocols for provider patient secure messaging, which is a major step towards patient-centered care.

At the time, ONC was backing two protocols, the Direct Project and IHE (as implemented by CONNECT). Here you can see a video of the two protocols being promoted at the 2010 OSCON conference by the two project leaders at the time. Here I am doing essentially the same thing the next year, in 2011. I completely bought into that strategic plan.

Why didn’t those two projects solve the problems over the course of the next 5 years?

From the old strategic document again:

Nationally, the government is developing a standards and interoperability framework (S&I framework) to harmonize existing standards and improve sharing of standards across different organizations and federal agencies, making it easier to broaden interoperability through shared standards for data and services.

The S&I framework, and later Meaningful Use, would deeply endorse the CDA standard as a “harmonized” approach. Now the current roadmap has this to say about CDA:

Though much of the industry has implemented C-CDA as it is required in 2014 CEHRT and subsequently Meaningful Use stage 2, there is significant variability in the implementation of the standard.

Seeing the pattern again? CDA was supposed to be the harmonized standard, and now the industry needs a harmonized standard. This occurs in the “Moving Forward and Critical Actions” section immediately after a discussion of how the industry borked CDA:

HL7’s Fast Healthcare Interoperability Resources (FHIR) effort is one effort that is emerging and exploring ways to accommodate new methods of exchanging information.

During the Health IT ONC annual meeting (Feb 2015), the current ONC specifically held out hope that the Argonaut program was going to really address interoperability issues. (For those that do not know, Argonaut is a project to implement OAuth for a REST API based on SMART that delivers healthcare data using the FHIR standard).

So everybody now loves REST and FHIR.

And they are not wrong, FHIR embraces JSON rather than just XML and REST/OAuth has proven itself as the best way to do moder API implementations.

But FHIR and REST will not solve the problem of interoperability. They are just todays shiny toys that will end up having exactly the same problems that Direct and IHE currently face. The hard parts of interoperability have never been about technology, it has always been about forcing and industry that has substantial disincentives to do interoperability to do it anyway.

The problem is this: The Meaningful Use (MU) incentives have no realistic protocols in place for EHR vendors and EHR users to prove that they are generating compliant versions of the current standards. There are no real meaty required tests for compliance to existing standards. There are no meaty requirements to actually exchange data.

You need to maintain a three pronged approach to interoperability testing in order to ensure that interoperability is going to work.

  1. Require extensive pass-fail interoperability testing for MU3 EHR certification, using simulated exchange scenarios. Ensure that those tests still work in the wild during attestation.

  2. Require that MU attestation force end users of EHR systems to detail who they exchange data with and how, allow them to subjectively rate their EHR vendors support of their interoperability efforts during attestation.

  3. Develop a “tattle tell” interoperability endpoint that can accept and automatically de-identify forwarded CDA/FHIR/whatever files that are the result of real health information exchange, so that “standards bad actors” can be detected in the wild.

Here are the steps required to do extensive pass-fail interoperability testing for MU3 EHR certification, using simulated exchange scenarios.:

  1. Create 1000 different correctly formed CDA and FHIR files.

  2. Design 100 different “treatments” that can be broadly applied to all 1000 profiles. (i.e. “add content showing the patient just had a new HIV test come back positive”, or “add content showing the patient has a new blood pressure reading of whatever/whatever”

  3. Create 100,000 “end states” that represent how the 1000 start states should be transformed by the 100 “treatments”.

  4. In order to achieve MU3 certification, an EHR vendor must demonstrate the ingestion of all 1000 start states encoded in CDA, and properly model all 100 “treatments” on each profile, generating 100,000 different end states, which are then exported to CDA and run through a testing engine that accepts one and only one CCA configuration per test.

  5. During attestation, EHR users will have to inject 6 simulated patient records, and perform 6 “treatments” properly and then send those 6 to the MU testing portal. Those simulated patients should both delivered and retrieved under all approved HIE transfer protocols, including Direct, IHE and Argonaut.

Then, during attestation, the MU portal should leverage the latest version of the DocGraph referral dataset to determine which 10 NPIs the submitting provider has the most shared patients with, who also have MU certified EHRs. Then simply ask who among those 10 providers they are exchanging data with, and how.

Attestors should also be asked to rate their vendors support of their interoperability efforts (from 1-6…provide no option for “neutral”, cause we all know that is a cop-out and if it is available every attestor will choose it).

If attestors are not communicating with the providers they share patients with, then they should not be given Meaningful Use dollars.

If vendors are constantly resisting their customers efforts to exchange data their certifications should be revoked.

You cannot police whether interoperability is functioning without measuring it in the real world, and attestation is your primary tool for measuring what is happening in the market.

This proposal will be unpopular with providers, who will lament that their MU dollars are now dependent on the willingness of others to exchange data with them. But if HHS wants to ensure that its billions of dollars in EHR investment are resulting in Health Information Exchange, it needs to ensure that the exchange is actually working.

It is critical that neither vendors nor users be in a position to “either/or” their way out of real interoperability. Providers choose not to allow patients to communicate with them using Direct, because they could “either/or” give them access to patient data using a portal. All of the HL7 standards have more ‘ors’ than a viking warship.

But “options” is only part of the problem. Even when options have been narrowed and standards are explicit, “in the wild” variation is still common and problematic. As a result, the third component of a “real” interoperability system is a “tattle tell system”. ONC should create a mechanism for providers to upload actual CDA/FHIR/Whatever files that they have gotten from their partners. They should be able to tag those files as being sent from specific EHR systems and version numbers, as well as tagging them with which healthcare providers sent them.

The tattle tale system should immediately de-identify the relevant files, and then pass them through the standards compliance guantlet. ONC has already invested in solid technology to test compliance, and these should be leveraged here. You should publish report cards showing standards compliance by both provider and EHR vendor basis. There should be a “self-testing mode” that is not publicly reported that will allow EHR vendors and providers to test their own file generation process, without fear of repercussion. Vendors and providers should be able to rely on the deidentification logic of this testing service to ensure that they are able to test accurately without sharing PHI unnecessarily.

Part of me feels silly spelling out the details of how these systems should work at this level of detail. Indeed, my specific technical recommendations might need to be tweaked in order to work. But I am providing the detail to illustrate that what I am suggesting is technically possible. But technically possible and bureaucratically viable are two different things.

If ONC wants to support six transport protocols and five data standards, then ALL of those need to supported by ALL end users of EHR systems. If that seems unrealistic (hint.. it is unrealistic) then ONC needs to make tough decisions regarding supported protocols. Because of the walled garden problem (which I have commented on before and will again), Argonaut cannot be a lone transport protocol. You need to support both freedom to move data at patient preference (Direct) and support ease of development against EHRs as a platform (Argonaut). I see no reason why ONC needs to support more than two interoperability standards.

Make no mistake, ONC can either be popular or it can solve the interoperability problem. If you want to be popular, continue to use the word “or” a lot. There are “ors” all over the current implementation standards. In fact, I would like to give the award for “Captain Understatement” to whoever wrote the phrase there is significant variability in the implementation of the standard. That is some priceless phrasing…

Yet within the document, I take most issue with this paragraph:

In some cases the implementation guides provide sufficient clarity, specific implementation instructions and reduce the potential for implementation variability to a minimum. In other cases, further work is necessary among SDOs [Standards Development Organizations] to further refine implementation guidance as well as to develop best practices to improve implementation consistency among health IT developers.

It is clear that no amount of implementation guides are going to get this problem solved. Our industry ignores good implementation guides right along with bad implementation guides. As long as the EHR industry has the opportunity to flub interoperability, it will. EHR vendors and healthcare providers both have a huge motivation to not have interoperability work; as interoperability makes them both vendors and providers fireable. Patients who can move healthcare records around can switch doctors. Doctors who can move healthcare records around can switch EHR vendors. The Health IT industry needs to have comprehensive pass/fail testing that both the EHR vendors and their users have to conform to. ONC needs an ACID test for every interoperability standard it promotes. Then it needs to find a way to inject that ACID test into the real world as much as possible


We do not need more standards or better standards. We need ONC to arbitrarily enforce one single interpretation of the current standards. If ONC wants to change standards, go crazy with that, but in the end we need one single interpretation of those new standards.


If you want to make something change in the real world, it must be measured in the real world. The EPA spends lots of energy getting water samples in the real world. ONC needs to find ways to do the same thing. If the EPA changes its standards for what water quality should be in lakes and rivers, it then enforces those standards by measuring in the wild to ensure that they are properly enforced. The previous philosophy of the ONC has been so hands-off regarding testing that it would be equivalent to the EPA saying “we are going to totally change the standards for water quality in the United States, but we are going to halt our measuring program”. Obviously that would not work, and that is precisely why previous standards have not worked.


Some people feel that ONC does not have a congressional mandate to do the kind of  interoperability testing that I am suggesting. But it does. ONC has a congressional mandate to get interoperability to work, and the only way to get interoperability to work is to do extensive, real-world testing. That is the only reasonable interpretation of this mandate.

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