Excerpt from Casino Healthcare by Dan Munro.
Part 3 of 3
In Part 2 of this series we saw how Vehicle Identification Numbers (VINs) were established by the National Highway Transportation and Safety Administration (NHTSA) and how they brought order to the chaos of vehicle tracking on a national scale.
In fact, there’s a much larger list of NHTSA standards beyond just vehicle identification. Under Title 49 of the United States Code, Chapter 301 ‒ Motor Vehicle Safety ‒ the NHTSA has a legislative mandate to issue Federal Motor Vehicle Safety Standards (FMVSS) and Regulations “to which manufacturers of motor vehicle and equipment items must conform and certify compliance.”
With some dating as far back as 1968, Part 571 of FMVSS lists a range of standards around just one safety category called Crash Avoidance. To understand the level of detail, here are the first four standards in that sub-category.
- Standard No. 101 ‒ Controls and Displays
- Standard No. 102 ‒ Transmission Shift Lever Sequence
- Standard No. 103 ‒ Windshield Defrosting and Defogging
- Standard No. 104 ‒ Windshield Wiping and Washing System
What we’ve collectively determined ‒ and need to consider for healthcare ‒ is the enormous safety benefit that national standards bring to a wide range of industries like motor vehicle manufacturing and air transportation. Relative to our health data, national standards can and should be leveraged for patient safety, security and privacy. First for electronic health records, of course, but also for devices, sensors and apps that collect and manage patient data.
Health data that’s interoperable and searchable is also a core requirement to larger objectives around transforming our healthcare system. Strategies like population health, personalized medicine, patient engagement and Accountable Care Organizations are largely dependent on accurate, near real‒time access to health data by everyone across the entire healthcare delivery ecosystem. Absent these basic capabilities, the U.S. is falling behind other countries that are able to forge ahead as true pioneers.
Finland is among the first countries to consolidate EHR data as a way to build a national patient archive. They see true population health as not only a strategic and competitive advantage for the whole country (population of about 5.5 million), but also as way to build patient trust around sensitive health information.
So far, people are really rather happy about these services, not just because the information is available at their fingertips but also because they think it is a good way to guarantee data security. When they check their information, they can also access a log that tells them exactly which organizations have been looking at their data – and this helps build trust in the system. Anne Kallio, Head of Development at the Ministry of Social Affairs and Health in Finland
The American system, on the other hand, has elected to optimize health data for revenue and profits ‒ not safety and quality. In our system, health data is used for billing, of course, but it’s also considered proprietary and siloed as a way to intentionally lock patients into networks of health plans and/or provider networks. Sometimes our health data is de-identified and sold to the highest bidder.
In other cases, providers charge patients a “copy fee” for accessing their own health data. Naturally, the higher the fee, the less likely we are as patients to switch providers. A recent study proves the captive effect of higher costs for patients to access their own health data.
In states that imposed caps on fees for medical records, patients changed their primary doctors 11% more frequently and their specialty doctors 13% more frequently. The Hidden Cost in Changing Doctors [Stanford Graduate School of Business ‒ June, 2015]
Revenue aside, we’ve also created a culture of fear around protecting data that is so irrational that it often trumps clinical safety outright. Paul Levy described a recent example with his article ‒ We’ve Been Swindled.
Upon arrival, he was whisked through the ED and was being prepped for surgery, but the doctors wanted to have a clearer sense of the location of the [kidney] stones. His kidneys were in no condition to have another CT with contrast, and so they wanted to look at the CT scan that had been taken just an hour earlier at the urgent care facility. There was no way to electronically deliver the image to the BWH team.
To solve this basic lack of simple transferability (unrelated to the more complex task of interoperability), the CT scan was burned onto a thumb drive and walked (0.3 miles) for hand delivery. This isn’t just absurd or comical in 2015 ‒ it’s morally repugnant and indefensible. In cases like this (and countless others), technology is an outright impediment to life‒saving clinical care. The charade here is that vendors, payers and providers are uniform in their insistence that this is necessary to “protect our privacy.”
Standards that do allow for communication in healthcare are largely the domain and primary function of several organizations, such as Health Level Seven International (HL7).
Founded in 1987, Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. HL7’s 2,300+ members include approximately 500 corporate members who represent more than 90% of the information systems vendors serving healthcare.
Without going into the history of the standards work HL7 International has done successfully for the last 28 years, there’s an exciting development with a new standard called Fast Health Interoperable Resources or FHIR (pronounced ‘fire’). Adding fuel to the excitement are quotes like this.
FHIR is the “HTML” of healthcare. It’s based on clinical modeling by experts but does not require implementers to understand those details. Historically healthcare standard were easy for designers and hard for implementors. FHIR has focused on ease of implementation. John Halamka ‒ CIO at Harvard and Beth Israel Deaconess Medical Center ‒ Setting Healthcare Interop on Fire ‒ Forbes
Today, FHIR is working its way to becoming an official standard in healthcare. Later this fall, it will move from DSTU1 (Draft Standard for Test Use version 1) to DSTU2 ‒ at which point it will be considered enough of a standard to be openly supported (if not officially endorsed) by the Office of the National Coordinator (ONC). Developers have already started building, testing and deploying actual solutions using its framework.
So is FHIR the long awaited answer for true interop in healthcare?
One of the principal architects and lead developers of FHIR is a software engineer named Grahame Grieve. The development of FHIR represents a significant engineering achievement (spanning years and thousands of hours). As the FHIR project lead, his engineering domain expertise on FHIR is literally second to none.
One of several remaining challenges ‒ unsolved by FHIR ‒ is a key field called Master Patient Index ‒ or MPI. FHIR is a “framework” that can easily support an MPI ‒ but it isn’t an MPI itself. An MPI ‒ any MPI ‒ must be developed outside of FHIR (for use with FHIR). Which begs the question ‒ if FHIR is the emerging standard for interop in healthcare ‒ do we even need an MPI? I posed this question to Grahame. His reply was steeped in the engineering tradition and discipline of efficient coding.
Yup. MPI is unavoidable.
FHIR may well be the HTML of healthcare, but we still need an MPI for any system to determine “who the hell we are.” Anyone can generate an MPI of course and every electronic health record solution includes an MPI, but each one is different. There is no standard (and none pending) for this critical field used throughout the entire healthcare delivery ecosystem.
We could have one ‒ we should have one (in much the same way that we have a VIN for vehicles) ‒ but Congress reversed their original intent for this even though it was baked into the 1996 legislation known as HIPAA (see Who Stole U.S. Healthcare Interop?) .
The original legislation called for the creation of a National Provider Identifier and a National Patient Identifier. The Provider Identifier was implemented, but the Patient Identifier was subsequently “de-funded.” In effect, HHS (and by extension ONC) is legally banned from any work toward a National Patient Identifier ‒ which is equally reprehensible and indefensible. This isn’t the fault of HHS/ONC, of course, but it is absolutely the fault of Congress.
“It’s time that Congress recognize the inability to accurately identify patients is fundamentally a patient safety issue. CHIME Interim Vice President of Public Policy Leslie Krigstein ‒ Patient ID Highlighted as Barrier to Interoperability during Senate HELP Hearing
A false positive match occurs when two truly non-matching records are declared to match, while a false negative match occurs when two truly matching records are declared to be a non-match. While a majority of CIOs believe their false negative and false positive error rates are at or below industry standard, a considerable percentage believe their health records have rates that far exceed 8 percent.
“Of the nearly 65 percent of CIOs reporting use of unique identifiers, over half (58%) are using at least one other strategy – probabilistic, deterministic, biometric, etc. Yet, even with the use of such varied strategies, false negative and false positive error rates are still unacceptably high.” Summary of CHIME Suvery on Patient Data‒Matching ‒ May, 2012
Clearly many of the healthcare industries largest associations also agree with this assessment. I’ll close with this lengthy passage from one such coalition which wrote to Congress in May of 2011. (bold emphasis mine).
“An informed national-level patient identity solution would enhance, not compromise, the privacy and security of patient health information. An informed national-level patient identity solution does not mean a national identity number or card. Technological advances now allow for much more sophisticated solutions including patient onsent, voluntary patient identifiers, metadata identification tagging, controlled segmented access, access credentialing, sophisticated algorithms, and other echnologically advanced solutions.
“In the absence of an informed national-level patient identity solution, the states, health IT Regional Extension Centers (RECs), large health plans, various consortiums, and individual electronic health record vendors have had to develop their own patient identify solutions. As the nation moves forward with greater urgency toward the system-wide adoption of electronic health records, this essential core functionality to ensure the match of a patient with his or her information remains conspicuously absent. The multitude of different solutions and the lack of a national coordinated approach to patient-data matching pose major challenges for our health information infrastructure. Patient safety, privacy, and security depend on getting this core element right and soon.
“An informed identity solution provides unambiguous identification, is cost effective, and is tremendously effective in reducing false negatives in the patient matching process. As a result, an informed patient identity solution is an essential building block to achieving the nationwide exchange of health information, as well as improving patient safety and reducing healthcare costs, fraud, and abuse. As the nation works to achieve the “meaningful use of certified EHR technology” and widespread information exchange, an informed patient identity solution becomes an ever more critical factor for healthcare.”
Letter of Recommendation to Congress by The Coalition for an Informed Patient Identity Integrity Solution ‒ comprised of the American Health Information Management Association (AHIMA); American Medical Informatics Association (AMIA); Association of Medical Directors of Information Systems (AMDIS); College of Health Information Management Executives (CHIME); Healthcare Information and Management Systems Society (HIMSS); HIT Now Coalition; and the National Association of Healthcare Access Management (NAHAM).
We can debate the logic of comparing vehicle identification to patient identification, but that’s really just an academic distraction. It’s patently obvious that people are not cars, but as long as there are enormous commercial interests that intersect with millions of consumers daily ‒ like auto manufacturing or healthcare ‒ it’s the obligation of every government to tilt the market in favor of safety and quality ‒ not revenue and profits.
Nowhere is this more obvious or critical than healthcare. Driving and air travel are largely optional. Arriving on a gurney at an ER is not. Of all the fears that people may have as passengers on that gurney, the ability to share important, life-saving health data at the point of care shouldn’t be one them.
Until we solve the first riddle of who we are to the healthcare system, true data interop will remain the chew toy of competing commercial interests and the Kabuki dance of “information blocking” will continue unabated. Playing on the fears that we’re somehow safer without a national patient identifier is effective marketing, but it’s technically false. We’re actually less safe (and less private) using an antiquated, 9‒digit numbering system developed in the 1930s.
Mandating a unique ‒ and technically superior ‒ patient identifier may not be the biggest problem in healthcare IT, but it is absolutely the first. Absent this critical standard, we will continue to struggle with competing interests, technical workarounds, and hand‒delivered data. Contrary to the headline question for this series, interoperability isn’t a business or technical challenge at all. It’s really a moral one of the highest priority.
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