Electronic Health Record (EHR) information and news

Physicians and other “Eligible Providers” and hospitals are deep in the first phases of the programs supported by the HITECH legislation. Many who already had robust EHR systems were able to have them upgraded and certified to the ONC criteria, attest to Meaningful Use Stage One, and have received incentive payments from CMS. While there may be a few eligible providers who were still in a paper environment when ONC-ATCB 2011/2012 certified EHRs became available in the fall of 2010 and have since progressed to implementing certified EHR technology and receiving incentive payments, these are few and far between. Planning for, choosing, installing, configuring, and populating a new EHR, and then demonstrating meaningful use, requires both support and time. Many of the clinicians practicing in small independent settings can expect that this will be at least a 12 month process, but more likely one that takes 18 months or longer, even with good Regional Extension Center or vendor support.

While the HIT Policy Committee has recommended delay of the introduction of Meaningful Use Stage Two for a year, it has also recommended a set of Stage Two objectives and measures that are significantly more aggressive than those of Stage One. New standards and certification criteria will, of course, follow as the recommendations make their way through the rule making process. As all this rolls out, it is worth taking a fresh look at currently available EHR products, what certification means for the purchasers of these products, and where the industry may be heading.

As noted in my earlier letters, there are two EHR certification processes available to health IT companies and developers. CCHIT develops one and conducts testing and certification for both. Federal (ONC-ATCB) certification was designed to stimulate innovation by limiting its federally- developed criteria to the minimum necessary to support meaningful use. If the number of ONC-ATCB certified EHRs on the CHPL is a measure of success, this program has certainly been successful; there are over 700 products from which to choose. Every eligible provider wants and expects this floor when purchasing a new system, but many will find that not all of these products support their patient care needs as expected. Further, many of the new developers of these products may not be viable long term. Market innovation is always fraught with risk… some financial, some, particularly in the case of health care, related to safety. When newly purchasing an EHR, ONC ATCB certification is key… but it does not guarantee that all of the functionalities are integrated (e.g., data can be shared between your e-prescribing solution and your quality calculation and reporting engine). It does not certify for back up functions (e.g., risk of loss of critical patient data.) And many of the functions that you may take for granted (e.g., the ability for multiple users in your office to work on a record simultaneously) are not checked. And, of course, it does not consider the needs of specialists.

CCHIT Certified® programs are multi-stakeholder, consensus-based sets of criteria independently designed to focus on protecting the consumer – providers and patients. These programs support innovation by creating a sound and robust foundation of functional criteria which are tested for integration, include state of the art security, and assure that any relevant interoperability standards are incorporated. Specialty certification programs provide assurance to cardiologists, child health providers, dermatologists, behavioral health providers, oncologists, and ambulatory obstetrical clinicians that their specific needs will be met. All CCHIT Certified 2011 products have been verified to be functioning in a stable clinical environment and all Ambulatory EHRs has been rated for basic usability. In addition, the CCHIT programs include criteria designed to test and support clinical workflows, not mandated objectives. CCHIT certification provides assurance that many of the well defined needs of the practicing clinician that are not included in ONC-ATCB certification can be met by the EHR that is also CCHIT Certified.

Having certified almost 800 products over the past several years and having worked with over 300 subject matter experts, we recognize, however, that there are still unmet needs and the EHR environment will be in evolution for many more years. Providers everywhere, both clinicians and institutions, look forward to “plug and play” interchange capabilities similar to applications on an iPhone. There are currently no standards for the type of data portability that is required to transfer a complete patient record with all of its nuances from one EHR to another, a problem, if many of the 700 ONC-ATCB certified products are not viable in the market over the next few years. And the changing environment, as delivery systems integrate and take on the risk of managing populations of patients, will demand more and more of EHR systems. We know that there is need for more emphasis on care coordination, patient safety, usability, and, of course, interoperability.

The challenge of finding and implementing a system that will work well now and in the future for a given ambulatory clinical setting can be daunting, but not impossible. Yes, it should be ONC-ATCB certified in order to be eligible for meaningful use incentives. But this provides limited assurance that the system will perform as needed with respect to patient care. Adding CCHIT certification with or without specialty criteria adds the consumer protection assurance of certification. Most importantly, though, both programs are evolving. Current ONC-ATCB 2011/2012 certification will no longer be active when new criteria associated with Stage Two are published regulation. And CCHIT Certified programs will continue to grow and focus on the demand for systems that are more responsive to clinician and patient needs in this dynamic health care environment.

Karen M. Bell, MD, MMS
Chair, Certification Commission

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

Here’s the final chapter of David Tao’s look back at his experience with certification and CCHIT.

In life in general, and in development of software, standards, and certification criteria, we learn and grow more by trial and error than we do when everything goes smoothly. Frederic Brooks’ classic software engineering book The Mythical Man-Month said “Plan to throw one away; you will anyhow.“ Hence we need prototyping and iterative refinement. The CDA Consolidation Project is fresh on my mind. I voted negative in its HL7 ballot, but that doesn’t mean it won’t succeed, only that it has issues to fix. It would have been a miracle to get that complex task right the first time.

For more, read the entire post.

One of the reasons that “usability” of EHRs has been so elusive is that it has had no clear definition.   We’ve heard that it is a barrier to full EHR adoption, but without a sense of what it is and how it could be measured, it’s difficult to improve.    We have defined its attributes –efficiency, efficacy, and satisfaction as one carries out one’s tasks – and identified some early basic ways to assess usability as it pertains to safety.     But we have yet to come to consensus on how to achieve an environment where focused, organized, comprehensive clinical information is immediately available in the time and format that is needed and how to assure that data can be quickly and easily incorporated into the electronic record of choice.

Discussions are now in progress at both federal and state levels on the topic, and the National Institute of Standards and Technology (NIST) has been working on a Usability Framework that will be shared in early June.   National Coordinator for Health IT, Dr. Farzard Mostashari, has signaled the need to progress in this arena, and to do so with a goal of improvement…not a goal of measurement for certification or other qualifying purposes.   The Certification/Adoption Work Group of the federal Health IT Policy Committee has heard a full day’s worth of testimony on usability in preparation for making recommendations to the full Committee.    As a result of this activity and the work done to date, we now have a foundation on which to build:

1. A usable system has access to comprehensive data and integrates all elements of data input, storage, and use.   This requires interoperability and assurance that all components (or modules) of the system are integrated, as is the case for CCHIT Certified® 2011 products.
2. Usability refers to how an EHR supports clinical workflow — not a unique measure, objective, or criteria.   Including practicing clinicians in the process of determining and assessing usability is therefore critical to its success.
3. Tools will be required that can quickly find and filter accurate data that is specific to the user and presented as information that can be organized to support real time patient care in different settings   –  one size does not fit all situations or exam rooms.
4. Usability testing will change as hardware and operating systems evolve –  what may be applicable in a Windows desk top environment may  not work in an  iPad or other mobile smart device environment.
5. Usability must address the access needs of persons with disabilities.
6. Attention to patient communications (both efferent and afferent) will need to be incorporated into the usability framework.  Use of EHRs affects the patient-clinician interaction.
7. Vendors understand that usability will provide a marketing edge.    Many of the larger more stable vendors have already invested in usability programs in house with clear principles and practices.   These programs are not, however, transparent, and many products are reconfigured to meet customized needs at installation, necessitating assessment in the working environment.
8. User centric design and human factors research are robust scientific fields that can guide the development of usable systems, as well as add to the current measurement base.
9. Usability testing should result in demonstrated improvement in specific outcomes, such as measures of patient safety, provider productivity, and clinician satisfaction with workflows.
10. Usability will likely be improved as we migrate to a “plug and play” EHR environment, where one individual workflow application can be exchanged for another which will integrate with those already in place.

So…what can we expect in the coming months?    Clearly, we will be seeing greater access to interoperable health data as one of the key components of usability.   We can also expect NIST to continue to refine and develop a framework based on human factors research and user centric design that will guide the development of more robust usability testing.    I hope that we will see ONC Certification Criteria move toward integration testing and criteria that are oriented toward clinical workflow.    Ultimately, new applications and approaches will evolve and usability testing will evolve along with them.    In the meantime, CCHIT will continue to conduct basic patient safety focused usability testing that has been validated and demonstrated to have inter-rater reliability on all CCHIT Certified® 2011 ambulatory EHR products.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

David Tao continues sharing his experiences with CCHIT and the certification process. In this edition, he describes four prototypical controversies he faced in content, vocabulary, and transport.

I could go on with more examples. That’s part of the challenge of interoperability work, as evidenced by the fact that ONC and the HIT Standards Committee still have all of the above issues to ponder for Stages 2 and beyond. I should mention that one more big controversy arose in the very first year, when CCHIT was newly formed and struggling to figure out how to set the interoperability bar. Eyes were upon those first members to resolve the CDA vs. CCR debate. Unlike the four issues above, where we took a stand, we weren’t ready to force a decision in 2006, and then HITSP was formed by ONC to deal with such “standards harmonization” issues. So at least our punt had a receiver (and football wasn’t locked out)!

Read the entire post.

More from David Tao on his experiences with CCHIT and the certification process.

One thing I learned is that no group can please all the people all the time. Sometimes, people wondered why we proposed some criteria and not others, or proposed the timeframes that we did. So we tried to explain these “whys” in a white paper Interoperability, Supplying the Building Blocks for a Patient-centered EHR in mid-2009 which still exists on the website of writer John Morrissey. It described the context for what we were doing and the “methodical march” to increasing levels of information interoperability that we proposed. I don’t think this was well understood by the public, who might have thought some of what we did was arbitrary. But here’s what was in our mind (well, I can only speak for myself – mine at least).

Read David’s insights. Or start with Part 1 of this series.

Seasoned CCHIT Work Group member, David Tao will be publishing some of his thoughts and lessons learned about certification.

From the first post in the series.

It’s been a long time since I blogged, even though there have been many HIT topics to blog about, such as Stage 2 meaningful use, the ONC Standards and Interoperability Framework, the ONC Strategic Plan, the NPRM on Medicare Shared Savings (Accountable Care Organizations), and more. I’m getting back on the wagon. One topic I’ve wanted to blog about for a while, even though it’s not a current “hot topic” in the news, is my experience in the Certification Commission for Health Information Technology (CCHIT) prior to the establishment of the ONC certification program. This bubbled to the surface when I read a HISTalk “Time Capsule” posting. So I’ll write another mini-series (probably two or three parts). This first post will simply introduce the “cast of characters” and how they interacted. The next posts will talk about what the Interoperability Workgroup of CCHIT did, and how its work through 2009 related to the ONC-ATCB certification program as we know it today. There are useful lessons learned.

Read the entire post.

Dr. Karen Bell, CCHIT Chair, delivered testimony to the the Certification/Adoption Work Group Health Information Technology Standards Committee on April 21, 2011, regarding usability:

In keeping with CCHIT’s mission, we first undertook the development of usability rating in 2008, launching it with our independently developed, voluntary CCHIT Certified® 2011 Ambulatory EHR program in October 2009. With the release of this first version of usability testing, we recognized that more sophistication would need to be added to the program in the future. Adapting a description developed by the National Institute of Standards & Technology (NIST) in 2007, we defined usability as the effectiveness, efficiency, and satisfaction with which the intended users can achieve their tasks in the intended context of product use. In the development of its “first-step” usability rating instrument, CCHIT endeavored to reflect the perceived usability of an ambulatory EHR application as rated by its content experts (i.e., 3 trained and experienced testing jurors that include at least one practicing physician) during an inspection process that follows a typical clinical workflow.

This focus on inspecting an EHR following a comprehensive clinical workflow differentiates our CCHIT Certified programs from the current ONC-ATCB testing, which does not, since ONC testing is meant to be executed criteria by criteria to allow certification of EHR technology modules for which there is no expected integration testing. We therefore believe that a usability testing process should be based on and limited to an integrated testing approach to certification.

Download the testimony (PDF).

ONC has notified us that they are having problems with EHR technology display functions on their Certified Health IT Product List (CHPL).

We have already notified ONC of issues. Vendors should report any problems—with specific examples—to ONC.certification@hhs.gov with “CHPL” in the subject line.

ONC is working to resolve these issues.

If you practice medicine, you need the latest knowledge, tools and instruments specific to your specialty….and ready access to as much relevant information as possible about each patient. The latter is the driving force behind the current push for you to adopt and use an electronic health record (EHR) as part of your basic set of tools. Like your other major technical investments, your EHR must meet your needs for functionality. It must also possess state of the art security and be “interoperable” to the extent possible. At present, however, true interoperability – the ability to work with and communicate with other sources of information that give you the full picture of your patients’ health and history—remains the holy grail of medical informatics.

Why is interoperability such a challenge? And when can you expect to “plug and play”, meaning easily get information to and from any lab that is convenient for your patient, get a feed from a patient’s Holter monitor while he is wearing it, or see a current problem list to which all of your patient’s doctors have contributed? The challenges to achieving this type of data access are both technical and cultural.

The key to understanding interoperability on the technical side is to understand the various categories of standards necessary for disparate electronic information sources to communicate reliably and usefully – vocabulary or terminology standards, messaging standards, and a standard approach to implementation guidance. Using the transmission of lab orders and results as an example, we need a consistent vocabulary that goes far beyond the name of the test. We need standard terminology for everything related to the patient, for information identifying you as the ordering clinician, for presentation of results, for how the normal ranges are presented, for qualifying information about the test, for example, was the sample hemolyzed), and for qualifying information about the result such as recommendations for a follow up test. At present, we have standard terminologies for many of the actual test names, but little else.

Messaging standards determine how the information or data elements are packaged for secure travel over the internet. The good news is that there are a limited but sufficient number of messaging standards at present and a lot of work has been done to date to select the one that is most appropriate for a given situation. Continuing with our example with respect to lab data, the HIT community has agreed that HL7 (Health Level 7) is the most appropriate approach for messaging laboratory related information.

The most difficult step in the technical process is standards for implementation guidance. Simple translation: when the data are delivered to a disparate EHR system, implementation guides allow the second system to accept and integrate them in a way that makes them as presentable to the clinician as if it were entered locally. Implementation guides are specific for different types of data and need to work for all types of EHRs. While initial work on implementation guides for several types of lab data has commenced, a lot more work is necessary in this area before the industry can achieve true interoperability for lab data and information. Meanwhile, implementation guidance still needs to be written for many other types of data.

One frequently hears the terms “syntactic interoperability” and “semantic interoperability.” The former simply refers to the basic capability to communicate and exchange information and is the first step. Semantic interoperability is the ability to automatically interpret the data in the information exchanged meaningfully and accurately in order to produce useful results as defined by the end users of both systems. Much of the interoperability currently available clinically is in the first category: summary documents can be exchanged, opened, read, and stored. The data elements in these documents, however, may need to be extracted and manually keyed into the new system if they are to be used independent of the initial document.

The cultural challenges to interoperability may be even more daunting than the technical challenges. There needs to be both demand and a business case on the part of participants and the technology vendors to make the necessary investments in interoperability and put it to use. Laboratories with multiple different technological platforms will require a return on investment if they need to replace these platforms in order to be interoperable with EHRS. Providing data from a home based system that monitors anticoagulant effect to a clinician who is responsible for dosing will require that the clinician be compensated in some way for the time and expertise necessary to appropriately monitor the patient virtually. Lastly, and especially relevant to laboratory data, we need to assure that our laws and regulations allow for and support the exchange of electronic data. CLIA, the Clinical Laboratory Information Act, has been a barrier to health information exchange between clinical labs and others who need access to laboratory information. This Federal legislation has been under review for several years with the intent to issue guidance or modify its restrictions so as to allow information to flow where it is needed, not just to the ordering clinician.

Efforts in all these areas have intensified with the passage of ARRA (the American Recovery and Reinvestment Act of 2009). We still, however, have a long way to go to achieve true semantic interoperability in the healthcare industry. This should not stop us, however, from taking advantage of what information can be exchanged now, which includes patient summary data and documents. In order to facilitate this exchange, the Office of the National Coordinator for Health Information Technology (ONC), an agency of HHS, has developed a set of standards, services, and policies which allows participating providers to send but not query, find, and access, patient summary information and documents to known and trusted recipients. Known as the Direct Project, this set can be used by clinicians or institutions, public health departments, and laboratories to “push” information to receiving entities. A number of Health Information Exchange (HIE) organizations at local, regional, and statewide levels are also exchanging summary documents and public health information. Check with your local medical society, Regional Extension Center (REC), or HIE program to learn more about how you may participate in information exchange, using your certified EHR.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.
She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.