AMIA’s Doug Fridsma: Time for the Feds to Truly Open Up Patient Records to Fully Interoperable Data Use

Doug Fridsma, M.D., Ph.D., president and CEO of the American Medical Informatics Association (AMIA), continues to be a voice for progress and change in clinical informatics, healthcare IT, and the U.S. healthcare system. Most recently, during comments delivered at the 2016 ONC [Office of the National Coordinator for Health IT] Annual Meeting, Dr. Fridsma called on public and private stakeholders to provide patients with total access to their complete electronic health data. Just prior to his participation at the ONC Annual Meeting on Thursday, June 2, AMIA released the following statement, to be attributed to Fridsma:

“Access to information and the ability to integrate and use information has changed how individuals book travel, find information about prices and products, and compare and review services. Information can empower individuals, but health care has lagged behind other fields. It is unconscionable that in 2016 most patients are unable to obtain their entire medical record unless they print it out. 

While progress has been made in the last several years to support patients’ access to their information through various electronic means, such as Blue Button and patient portals, this is not sufficient to make patients first-order participants in their care, their health and their research efforts. Patients deserve nothing less than total access to their complete electronic health data.

Modifications to HIPAA [the Health Insurance Portability and Accountability Act of 1996] through HITECH [the Health Information Technology for Economic and Clinical Health Act of 2009] set the foundational expectation that patients have a right to an electronic copy of their health information. Guidance from OCR [the Office of Civil Rights] clarifying this right in terms of form, format and manner of access is another important step forward. Yet, the operationalization of these policies has only rendered slivers of information available for patients to use as they see fit. Patients have a right to all of their health information, not just what CMS [the federal Centers for Medicare & Medicaid Services] defines through meaningful use, or what ONC’s certification program deems necessary to meet CMS’s definition.

AMIA believes if the information is stored electronically, patients are entitled to their entire medical record in an electronic format, and not just a summary record or the limited data that a vendor chooses to make available via portal or API. Patients deserve more than PDFs, and the benefits of digitizing healthcare will only be realized when patients – and providers – have fluid, portable data. By developing a functionality as simple as “print all,” we will empower patients to more fully participate in their care by spurring an ecosystem of wellness and mHealth apps; we will improve the quality and frequency of participation in precision medicine, and other kinds of research; and we will foster a data-driven feedback loop between patients and their providers

We commend federal efforts to improve access, such as recent guidance from the HHS Office of Civil Rights, as well as initiatives to educate providers and patients on the rights afforded by HIPAA. But until we develop the electronic equivalent of “print all” for patients, which goes beyond PDFs and summary records, we will continue our struggle to free patient data. APIs may provide improved access over portals, but they carry forward the fundamental paradigm of closed systems with a predetermined notion of which data the patient should access.

Today, we call on the federal government to enable patients to have total control of their complete medical record by removing a prohibition found in certification that restricts the use of unstructured data, and we call on CMS and OCR to use their levers so that such functionality is broadly available to every patient by 2018.

ONC must remove the prohibition on the “unstructured document” document-level template and require certified health IT to enable patients to have a full extract of their health data. The prohibition – originally included to prevent unstructured data overload – has outlived its usefulness. Further, this prohibition has muted conversations on data portability for providers looking to switch EHRs, who currently only have access to summary records of their patients’ data. Removing the prohibition and allowing use of the entire suite of CDA templates is aligned with FHIR-based resources to support multiple modes of exchange.  Convergence is not only possible, it’s likely, given the direction of standards development.

Access to information and the ability to integrate and use information has changed how individuals book travel, find information about prices and products, and compare and review services. Information can empower individuals, but health care has lagged behind other fields. It is unconscionable that in 2016 most patients are unable to obtain their entire medical record unless they print it out.”

Following his participation in the ONC Annual Meeting, Fridsma spoke later last week to HCI Editor-in-Chief Mark Hagland about his and AMIA’s broad policy aims in the current moment in U.S. healthcare. Below are excerpts from that interview.

There are a lot of waves of policy currents washing up against each other these days. How do you see the current policy landscape right now?

We’re seeing a lot of transitions right now. We’re seeing sort of the end of the meaningful use era and the beginning of a new era focused around MIPS and alternative payment models. So you’re seeing a change in levers, in carrots and sticks. And anytime there’s significant change, it’s a time of significant risk, but also significant opportunity. We’ve tried to see this as a time where we can take what we’ve learned from previous conversations and flow it forward, and make some mid-course corrections and fill in some gaps we might have missed earlier.

Doug Fridsma, M.D., Ph.D.

Do you think that federal healthcare officials are listening to industry leaders right now?

That’s a hard question to answer, because in some situations, they may not be listening enough, and in other ways, they might be listening ‘too much’—meaning they may be focused on perspectives or groups that might be influential but don’t represent the broadest interests involved.

We need for federal healthcare authorities to be facilitating transformational change but not in a rigid way, correct?

Yes, that’s right. In our EHR 2020 report [AMIA’s “Report of the AMIA EHR 2020 Task Force on the Status and Future Direction of EHRs”], we said we need to focus legislation and regulation on things that are important. You hear from many different kinds of voices. And if each voice says the federal government has to focus on three things, but the federal government listens to everyone, it can lead to “90” things that they’re pushing. And it can be very challenging to navigate through that space. It’s all becoming very challenging for folks to try to navigate. We’ve always advocated that the regulations should be focused on some of the key priorities you want taken care of; it’s important to pick those priorities that will involve substantive levers, towards the path of least regret.

At AMIA, we’ve been advocating for three major things. One is, we have all this activity focused on MIPS [the Medicare Incentive-based Payment System] and alternative payment models; we’re focused on registries; and interconnecting systems to other systems. But what’s missing is some kind of periodic table for health information. If we had those elemental building blocks in place, then we could mix and match. So for example, if we had standard ways in which we represented prescription information or laboratory information or numerical information versus categorical information; if we had all those fundamental building blocks, we could propose new kinds of information and new kinds of exchange. So one of the promises as well as challenge is this: vital signs and diagnoses and laboratory tests are articulated in different ways. So you have a situation where electronic health records have to represent information in different ways, to calculate all different kinds of results. So a lab test should have a name, a result, a unit of measure, and a reference range., that basically says, the normal reference range is between these two numbers.

So for example, if everybody uses a LOINC code type, and the same name for a test, and the same format for representing measurements, that’s a fundamental starting point. And we don’t always represent those things in the same way. You could have a SNOMED code or LOINC code for blood pressure, but you could represent it as a fraction—120/80, or as a Mercury measure, etc. The challenge is we don’t have agreement yet on some of those fundamental building blocks. But we’re starting to make progress in that direction. And once you’ve got that collection of different elements.

You’re talking about establishing common vocabulary standards, right?

It’s both syntax—the structure of things—as well as common vocabulary standards. So diagnoses should be either all in SNOMED or in ICD-10. Because if half of the quality measures use SNOMED terminology and half use ICD-10, or perhaps one or two other formats, then everyone has to collect the data in several formats. So we’ve got to have some consistency, and some elements, that periodic table, those building Lego blocks, so we can consistently format and define things. And FHIR [the Fast Healthcare Interoperability Resources standard] will be a big advance in that respect. Second, we’ll likely have high degrees of interoperability separated by deserts of very poor interoperability. What I mean is, we’ll have a Cerner ecosystem or an Epic ecosystem or a Meditech ecosystem, and so on. So people within those ecosystems will be able to exchange a great deal of data, but moving in between those ecosystems will be difficult. So when you’re a patient, you can request your patient record. And you may not get every single data point; but you’ll get a set of records that allows you to move your documents from one system to another. And we’ve been advocating that you should be able to have your laboratory tests, pathology reports, everything, stored in a consistent format. If it’s preserved as a consolidated CDA, it should be stored thus. And the two kinds of documents approved under meaningful use were the transitions of care document and the care summary document. But those don’t represent your full medical record. Because you’ll have your lab, pathology, and radiology reports as well. So in addition to structured information, we also need unstructured information.

Meanwhile, organizations are beginning to share structured information, but the value of that structured information has begun to wane, particularly as we allow patients to have their full medical record. We’ve said that patients are really a story or a narrative about how their disease process has affected their life and their family and how it progressed over time. And I think we lose that if we only consider structured information as important to share. I think of structured information as very useful for the delivery of care, around clinical decision support, etc. The AMIA community is very interested in advancing personalized medicine; and applying big-data analytics, particularly to create new associations of information and to find relationships in the narrative, will advance if we can share information from structured data.

And that means giving patients access to their full EHR, in a manipulable format?

Yes, that’s right: to support things like discovery of new knowledge and to support precision medicine activity, we really do need to make sure that patients have access to their full medical record, in a computable format, not just a PDF format. That’s a necessary component. And to go back to this discussion about ecosystems, the way you’ll move through the Cerner and Epic ecosystems, will not be through only through sharing structural elements, but through sharing unstructured elements—that full medical record.

So by analogy, if I look at a document through Google e-mail, I can use e-mail tags and do spreadsheets. But if I want to move something form the Google ecosystem to the Microsoft Office system, there’s a function that allows me to export all of the text, in such a way that I can import it into Microsoft Office. And vice versa. And there’s an analogy to that in healthcare. APIs will help us with exchanges of data. But to support patients, we need that full export or copy of the medical record. Because when you move from your primary care doctor to others outside your network, typically, these are in emergency room or life-threatening situations that require you to see a specialist. And that specialist will need the pathology reports and read the narrative that is the patient story—not just structured elements. So that is tremendously important for us.

Meanwhile, another important element to consider is the ability to both send information and receive the information sent. And right now, in certification, we only test the sending part, not the receiving part. And so as a result, we are challenged sometimes with interoperability, because people can use a variant of a standard. The standards have optional elements. The problem is that when you send, it can be either A or B or C. But if you truly want interoperability, the receiving systems have to receive A AND B AND C. And right now, we don’t test that. And options and complexities have a cost. And right now, those options and complexities have costs that are hidden in the system.

So those are the things we’ve been advocating for. Now, I think that ONC has both an opportunity to do some of this stuff on their own, but also to develop partnerships that would be helpful. For example, a full extract of the medical record—that’s where a full partnership with OCR, would be tremendous. OCR has already said that patients should have access to their medical records at low or no cost. So ONC could remove the certification criterion around structured data, and they could really advocate so allow the patient to be provided with a complete, computable, electronic copy of their electronic medical record. And ONC has within their purview a certification program. So they could test both the sending and receiving aspects of that. So in some cases, a copy of the full medical record in a computable format, that’s where a partnership with COR would be very strong. And the certification element, ONC could do on its own.

And in terms of APIs, one would hope that as the market begins to converge around a particular way to represent API information, that ONC can accelerate that process by really beginning to require certain elements that seem to be pretty stable, and by requiring those elements that could be the beginning of this periodic table of elements of clinical information.

That is a long list of to-do’s. Is there anything else that needs to be done, in your view, in this context?

Yes, in addition to all that, we have to make sure that we look at the whole continuum of work, so that we think about how to integrate consumer devices with EHRs, with interfaces, with all related systems. First, there’s the consumer who might have Fitbit or whatever—that needs to integrate with the 10 to the 3rd… the size of a practice is kind of at that scale. And that data needs to integrate with practice information. But also, as we think about population health, we need to make sure we’re collecting data in ways that allows us to collect billions of data points. So that what we do for research purposes and with precision medicine, we’ve got to make sure that we’ve got the data so that we can answer those discovery questions.

So we need the individual-level data; that full, computable representation of the individual chart, so that we can do discovery of the patient’s narrative and story and move between different ecosystems; and finally, we have to test for interoperability, so that both sides of the send/receive equation are working. Those are very simple things, but they’re very powerful. So those things will be important and represent the next step of that path of least regret. In other words, where this is all headed is that we need to get to that learning health system that we’ve been advocating for, and which we hope will eventually come.