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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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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Unified EHR Interoperability Standards Advised

Unified EHR Interoperability Standards Advised | EHR and Health IT Consulting |

The Office of the National Coordinator for Health IT (ONC) released the 2015 Interoperability Standards Advisory earlier this year and opened up the public comment period until Friday, May 1, 2015 at 5:00 pm ET. This advisory focused on determining the best EHR interoperability standards and implementation specifications for the healthcare industry throughout the nation.

ONC hopes to develop a single public list of standards that can reach clinical interoperability of medical information. On May 1, the Healthcare Information and Management Systems Society (HIMSS) announced that the organization sent a letter to Karen DeSalvo, MD, MPH, MSc, National Coordinator for Health Information Technology at the Office of the National Coordinator (ONC), with comments on the 2015 Interoperability Standards Advisory.ONC

HIMSS hopes to work with ONC to further identify and develop effective EHR interoperability standards and implementation specifications. Currently, HIMSS commented in the letter its support for a variety of the standards that would push forward health IT interoperability on a nationwide scale. The organization also supports ONC’s outline in the Interoperability Roadmap of publishing updated EHR interoperability standards on a yearly basis.

HIMSS also commented on the importance of developing a united set of best available EHR interoperability standards that would bring about data aggregation and best practices. This set of standards would lead to improved quality of care and patient health outcomes, HIMSS representatives stated in the letter.

“Through the use of EHRs, clinical documentation not only serves to record individual patient experiences but, if the data are collected and reported in a standardized fashion, they can also be aggregated to discern best practices in clinical care which will ultimately lead to improved care and outcomes,” the HIMSS letter states. “The ONC 2015 Interoperability Standards Advisory should represent a cohesive set of standards and terminologies that, when used together, will enable the ability to share and compare quality data.”

Some vital areas that would benefit from better analysis of this data are clinical research, quality audits, and clinical care. HIMSS also asks ONC to include a column for emerging standards to act as supplement to the already existing EHR interoperability standards as well as a column for value sets.

HIMSS recommended some key features that should be incorporated in the EHR interoperability standards and implementation specifications. Additionally, ONC’s 2015 Interoperability Standards Advisory lacked privacy and security guidelines needed for effective healthcare data exchange that protects patient information. HIMSS offered a series of privacy and security standards that ONC can include in its final advisory. These include audit log, authentication, and risk assessment among others. HIMSS worked with other stakeholders to develop these security standards and hopes ONC will include the information once it releases the finalized document.

In general, HIMSS and ONC are dedicated to expanding health information exchange across the country in order to ensure better quality of care and reduced healthcare costs.

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Is EHR Interoperability Being Blocked by Health Systems?

Is EHR Interoperability Being Blocked by Health Systems? | EHR and Health IT Consulting |

EHR interoperability has been the topic of discussion among many healthcare stakeholders in recent months. On a national level, federal agencies like the Office of the National Coordinator for Health IT (ONC) are gearing toward advancing secure and effective healthcare data exchange.

While EHR interoperability is a major goal among top stakeholders, there are alleged healthcare providers and health IT designers that may be participating in a practice called “information blocking.” On April 10, ONC released a Report to Congress on Health Information Blocking to address these concerns.

Health information blocking essentially takes place when individuals or organizations knowingly impede the sharing of electronic medical data. The report specifically states steps that the federal government can take to deter this practice and move toward nationwide data exchange.

This blockage of EHR interoperability goes against the ultimate goals of the EHR Incentive Programs. The amount of time and funds the federal government invested in the implementation of EHR systems and health IT tools may be in vain if health information blocking spreads across the country.

At this moment in time, it is difficult to pinpoint how much health information blocking is impeding healthcare data exchange among medical care entities. It is also a complex term to define, as some aspects of preventing the exchange of information could be related to ensuring patient privacy and data security.

Earlier this year, ONC released the Shared Nationwide Interoperability Roadmap to further advance the connection of EHRs and health IT systems in an attempt to share healthcare data across state borders. While the roadmap discussed the challenges associated with EHR interoperability, it set out specific steps developers and providers can take to meet this overarching goal and ultimately improve patient care.

ONC explains that there are certain individuals within the health IT industry that are incentivized toward managing health information in ways that interfere with its effective exchange across the medical sector. In order to overcome some of the issues around information blocking, ONC offers several suggestions.

First, it is beneficial to have greater transparency in the development processes of certified health IT products or services. ONC also recommends Congress to establish rulings that deter information blocking in the healthcare industry. When illegal business practices are uncovered, these individuals should also be immediately referred to appropriate law enforcement agencies.

ONC also encourages the federal government to continue collaborating with the public and private sectors in establishing new technologies that aim to improve interoperability of healthcare data across the country. The report also states that Congress could stimulate EHR interoperability by working with the Centers for Medicare & Medicaid Services (CMS) to discourage information blocking and reward medical organizations through payment incentives for successful EHR data exchange.

ONC believes that it is vital to overcome the issues surrounding information blocking in order to ultimately meet the major goals behind healthcare IT implementation and provider access of patient data. The federal government will need to address these problems in the coming years as the healthcare industry poises to expand health data exchange around the country.

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Value-based Interoperability: Less is more

Value-based Interoperability: Less is more | EHR and Health IT Consulting |

Interoperability in health care is all the rage now. After publishing a ten year interoperability plan, which according to the Federal Trade Commission (FTC) is well positioned to protect us from wanton market competition and heretic innovations, the Office of the National Coordinator for Health Information Technology (ONC) published the obligatory J’accuse report on information blocking, chockfull of vague anecdotal innuendos and not much else. Nowadays, every health care conversation with every expert, every representative, every lobbyist and every stakeholder, is bound to turn to the lamentable lack of interoperability, which is single handedly responsible for killing people, escalating costs of care, physician burnout, poverty, inequality, disparities, and whatever else seems inadequate in our Babylonian health care system.

When you ask the people genuinely upset at this utter lack of interoperability, what exactly they feel is lacking, the answer is invariably that EHRs should be able to talk to each other, and there is no excuse in this 21st iCentury for such massive failure in communications. The whole thing needs to be rebooted, it seems. After pouring tens of billions of dollars into building the infrastructure for interoperability, we are discovering to our dismay that those pesky EHRs are basically antisocial and are totally incapable or unwilling to engage in interoperability. The suggested solutions range from beating the EHRs into submission to just throwing the whole lackluster lot out and starting fresh to the tune of hundreds of billions of dollars more. When it comes to sacred interoperability, money is not an object. It’s about saving lives.

Every EHR vendor flush with cash from the Meaningful Use bonanza is preparing to take its unusable product to the next level, machine interoperability is shaping up to be the belle of the ball. A simple minded person may be tempted to wonder why people who, for decades, manufactured and sold EHRs that don’t talk to each other, are all of a sudden possessed by interoperability fever. The answer is deceptively simple. After exhausting the artificially created market for EHRs, these powerful captains of industry figured out that extracting rents for machine interoperability is the next big thing.

The initial pocket change comes from selling machine interoperability to their current bewildered (or stupefied) clients, and to less fortunate EHR vendors. But the eventual windfall will not come from the health care delivery system or the hapless patients caught in its web. How much do you think access to a national and hopefully global network of just-in-time medical and personal data is worth to, say, a pharmaceutical company giant? How about life insurance, auto insurance, mortgage, agribusiness, cosmetics, homeland security, retail, transportation? Google built an empire by piecing together disjointed bits of personal data flowing through its electronic spider webs. What do you think can be built by combining everything Google knows with everything your doctor knows and everything you know about yourself?

Machine interoperability is not about patient care in the here and now. Interoperability is not about ensuring that all clinicians have the information they need to treat their patients, or that patients have all the information they need to properly care for themselves. Interoperability is about enriching a set of interoperability infrastructure and service providers and about electronic surveillance of both doctors and their patients. Machine interoperability is about control, power and boatloads of hard cash.

For example, if you are hospitalized, it makes sense that your primary care doctor should know that you are (not in the past tense), and when you are discharged, he or she should be appraised of what transpired during your hospital stay. In the old days, before the advent of hospitalists, this could be assumed. Today, thanks to more efficient division of labor, not so much. If the government was genuinely concerned about smooth transitions of care, it would mandate that upon discharge, hospitals must provide all pertinent information to the primary care doctor, and the patient, by any means necessary. If this meant that a piece of paper is stapled to the patient’s robe, and that the hospital employs an army of delivery drones for the purpose, so be it. Eventually, hospitals, which are big businesses, would come up with the most cost effective and efficient way to be compliant with the law.

That’s not how things currently work or how they are envisioned to work. Discharge summaries have a mandated format of structured data elements, complete with metadata, based on government approved standards that change with frightening regularity. Furthermore, to satisfy regulations, the summaries must be generated and transmitted electronically from one “certified” EHR to another, allowing for a host of intermediaries to access and collect said data or at the very least its metadata. Consulting with the PCP by phone for an hour doesn’t count. Sending the information from a non-certified software package doesn’t count. Printing and sending over information by special courier doesn’t even begin to count. Attempting to build a device that streams the information as it happens directly into the PCP medical record will get you excommunicated or burned at the stake.

If you refer a patient to cardiology service, and in a misguided senior moment decide to pick up the phone and talk to the cardiologist at length about this patient, it doesn’t count. If the cardiologist pens a concise and beautiful letter to you after she sees your patient, thanking you for the referral and summarizing her impressions and plan of care in proper English, it doesn’t count. The only thing that counts is a lengthy clinical summary containing all the sanctioned data elements sent from you to the cardiologist, copied in its entirety and returned from the cardiologist to you, hopefully with some indication about what happened during the consult. Having your EHRs talk to each other this way is considered interoperability. Whether you actually read the interoperated information is irrelevant. As long as the contents are captured by the network for other uses, it’s all good.

But wait, there is more. If you practice, say, in St. Louis, Missouri and work for a huge health system or somehow managed to string together a machine interoperable network with the twenty or so specialists you use on a regular basis and the four hospitals where you have admitting privileges, that’s not good enough. Nothing is good enough unless any research lab in Hopewell, New Jersey or Bangalore, India can discover you on the (inter)national interoperability network and request data about a patient you may have treated five years ago, and nothing will be good enough unless any app store developer in Cupertino, California can discover your patient and subsequently obtain her medical data once she downloads a free diet app from iTunes.

Are you “just” a patient eager to be “engaged” in your own care? Picking a doctor who will spend two hours with you listening carefully and explaining things you don’t understand, and who will give you his cellphone number in case you have more questions, doesn’t count. Getting a team of physicians together on a conference call to brainstorm about your mom’s options, doesn’t count. Building a long term relationship with your pediatrician and having her come see your sick kid at home because your car is in the shop and your toddler can’t keep any food down, and now the baby won’t stop crying, doesn’t even register on the interoperability radar. Nothing counts unless you log into a website or an app, accept the cookies, the tracking beacons, the small print, and then click on some buttons to verify that you are a “Never smoker”, or to peruse machine generated visit notes that even your doctors don’t read anymore.

Perhaps machine interoperability on a national scale is a wonderful thing, but so is having arugula in every fridge. There is absolutely no evidence that either one will improve health and/or reduce the price of care. Every dollar spent on national machine interoperability is a dollar that was previously used, or could be used, to provide medical care. Where did we find the moral fortitude to demand that people experience adverse outcomes at least three times before letting them have a slightly more expensive pill, while spending billions of dollars to incentivize the purchase of unproven and often failing technologies? If we are supposed to be parsimonious in our use of health care resources, if we are supposed to choose wisely in all other areas, where is the comparative effectiveness research showing that expensive machine interoperability on a grandiose global scale provides more value than cheaper and simpler localized or human mediated communications?

  • Add one doctor visit for every Medicare beneficiary for the next 8 years
  • Give primary care a 20% raise for the next 4 years
  • Double the number of residencies for the next 3 years
  • Educate 60,000 new primary care doctors from scratch
  • Buy an iPhone glucose monitor for every diabetic patient and an iPhone BP monitor for every hypertensive patient (no, I’m not a “technophobe”)
  • Put a brand new playground, a gym teacher and a home economics teacher in every elementary school in the U.S.
  • End homelessness in America

These are some of the things we could do with the billions of dollars spent on machine interoperability. Which has more value for our collective health? How did health care become a fully owned subsidiary of the computer industry? Who authorized this unholy acquisition and how much were those brokers paid? Have we forfeited our right to choose, or even know, how endless fortunes are steadily interoperating out of our treasury and into the hands of global technology firms? Publishing fuzzy ten year plans on obscure websites, so the Technorati can tweak them, doesn’t count. Publishing thousands of pages of regulations in the federal register, so interest groups can preview the fruits of their labor, doesn’t count either. Raiding public coffers to please friends and family and to curry political favors is hardly a disruptive innovation, so let’s just call it what it is.

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Innovative Health IT Products Sought Through ONC Challenge

Innovative Health IT Products Sought Through ONC Challenge | EHR and Health IT Consulting |

Ever since the Medicare and Medicaid EHR Incentive Programs have been established, the adoption and implementation of EHR systems and other health IT products has been tremendous. The health IT sector in general has been expanding greatly over the last several years.

The Office of the National Coordinator for Health IT (ONC) reports that almost $700 million was invested in medical technologies during the first quarter of 2014, which shows an 87 percent growth when compared to the first quarter of 2013. Health IT products and mobile health applications are all leading the way in changing the way doctors and consumers interact across the healthcare continuum.Health IT Products

Nonetheless, ONC explains that even with the evident growth in the health IT sector, many startups are still challenged in acquiring pilot partners that will help develop their health IT systems and show that their product is effective for the industry. These pilot partners are necessary for acquiring the data needed to establish a health IT product as successful among potential investors and customers including healthcare systems, payers, and the patient community.

As such, ONC is looking to create stronger relationships to help innovators bring new health IT products to the market. ONC has announced a new challenge program: the Market Research and Development Pilot Challenge.

To participate in the challenge, health IT developers will need to work with host sites like hospitals, clinics, pharmacies, or laboratories to create pilot proposals. ONC will be offering $300,000 through a year-long commitment to truly develop new and revolutionary health IT products for the medical sector.

The funding will be distributed among six teams who will then initiate the pilot, collect a variety of data, evaluate the product, and distribute the results with ONC’s assistance. After six months, the teams will be expected to return an evaluation report about their findings. The very first steps to take, however, is to select the right team, create an overall plan, and prepare the pilot proposal.

For each team, ONC will first award $25,000 when the pilot teams are selected and then another $25,000 after the pilot development and evaluation period is completed. In addition to this challenge, ONC will also be initiating sessions around the nation to train the health IT startup community on federal regulations, privacy and security standards, payment reforms, and funding opportunities that will affect the outcome of their services or health IT products.

The forward push for increasing the number of health IT solutions among providers and medical systems leads a pathway toward sharing patient data quickly and efficiently across the healthcare continuum. The National Coordinator for Health IT Karen B. DeSalvo has spoken about the need for EHR interoperability and helped develop the ONC roadmap to reach this goal.

“We heard loudly and clearly that it was time to focus on interoperability as a priority and we articulated why the time is now to achieve the vision.  First, as a nation, we have made significant progress in digitizing the care experience such that there is now data to be shared.  Second, consumers increasingly expect and demand real-time access to their electronic health information,” DeSalvo stated. “Informed by your input and feedback we acted on this opportunity.”

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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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