A caution to readers: This post is about methods for certifying Electronic Health Record (EHR) technologies used by physicians, medical practices, and hospitals who hope to qualify for federal incentive payments under the so-called HITECH portion of the American Recovery and Reinvestment Act (ARRA). It may not be as critical as the larger health care reform effort or as entertaining as Sarah Palin, but it WILL matter to hundreds of thousands of physicians, influencing how difficult or easily those in small and medium size practices acquire health IT. And indirectly for the foreseeable future, it could affect millions of American patients, their ability to securely access their medical records, and the safety, quality, and the cost of medical care.
Three weeks ago, on July 14-15, 2009, the ONC's Health IT Policy Committee held hearings in DC to review and consider changes to CCHIT's current certification process. The Policy Committee is one of two panels formed to advise the new National Coordinator for Health IT, David Blumenthal. In a session that was a model of open-mindedness and balance, the Committee heard from all perspectives: vendors, standards organizations, physician groups, and many others.
And then, on July 16, they released their final recommendations on what is now referred to as "HHS Certification." The effects of their recommendations - these are available online and should be read in their entirety to grasp their extent - are potentially monumental, and could very positively change health IT for the foreseeable future.
At the heart of these hearings was the issue of who will define the certification criteria and who will evaluate vendors' products. Among many others, we have voiced concerns that the Certification Commission for Health Information Technology (CCHIT), the body currently contracted by HHS to perform EHR certification, has been partial to traditional health IT vendors in defining the certification criteria, and in the ways certification is carried out, and thereby able to inhibit innovation in this industry sector. Despite its leaders' claims that the certification process has been developed using an open framework, CCHT's obvious ties to the old guard IT vendors have created an overwhelming appearance of conflict of interest. That appearance has not been refuted by CCHIT's resistance to and delays in implementing interoperability standards, or by its focus on features and functions over safety, security, and standards compliance.
In the hearings that led to the recommendations, longtime IT watchers were treated to some extraordinary commentary, much of which dramatically undermined CCHIT's position.
"HHS Certification means that a system is able to achieve government requirements for security, privacy, and interoperability, and that the system would enable the Meaningful Use results that the government expects...HHS Certification is not intended to be viewed as a 'seal of approval' or an indication of the benefits of one system over another."
In other words, as the definition of Meaningful Use is now tied to specific quality and safety improvements and cost savings that result from health IT -- among them e-Prescribing, quality and cost reporting, data exchange for care coordination, and patient access to summary health data -- HHS Certification will closely follow. Rather than pertain to an EHR's long list of features and functions, some of which have nothing to do with Meaningful Use, certification will be focused on each IT system's ability to enable practices and hospitals to collect, store, and exchange health data securely.
Who Determines the Certification Criteria
The Office of the National Coordinator - not CCHIT - would determine certification criteria, which "should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and (b) achieve the Meaningful Use Objectives." As regulator, funder for this project, and a major purchaser of health services, the government, not users or vendors, will now determine HHS' Certification criteria.
A New Emphasis on Interoperability
"Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit." That is, functions/features criteria will be broadly defined, but there will be a greater focus in the future on the specifics associated with bringing about straightforward data exchange.
Multiple Certifying Organizations
ONC would develop an accreditation process and select an organization to accredit certifying organizations, then allow multiple organizations to perform certification testing. In other words, the Committee recommended that CCHIT's monopoly end.
Third Party Validation
The "Validation" process would be redefined to prove that an EHR technology properly implemented and used by physician or hospital can perform the requirements of Meaningful Use. Self-attestation, along with reporting and audits performed by a Third Party, could be used to monitor the validation program.
Broader Interpretation of HHS Certification
HHS Certification would be broadly interpreted to include open source, modular, and non-vendor EHR and PHR technologies and their components.
These bold, forward-thinking proposals from the HIT Policy Committee have not been accepted yet. But in our opinion they should be. These measures would encourage new technologies to enter the market for physician medical practices seeking EHR technology, and wrest control away from the legacy health IT vendors that have maintained barriers and delayed adoption, so you can be sure that the old guard players are doing everything possible to have them rejected.
But these are hugely progressive steps in the right direction, toward allowing HIT to enable improvements in care and cost efficiencies that would be in the best interests of users and the public at large. If implemented, the changes recommended by the HIT Policy Committee would create greater choice, more standardization, lower price, less interruption of the practices -- as well as a check from CMS or Medicaid each year to help smooth the implementation, starting in 2011.
by DAVID KIBBE, BRIAN KLEPPER and JOHN MOORE
Now that the legislative language of the HITECH Act — the $20 billion health IT allocation within the economic stimulus package — has been set, it’s time to identify a National Coordinator (NC) for Health IT who can capably lead that office. As many now realize, the language of the Bill can be ambiguous, requiring wise regulatory interpretation and execution to ensure that the money is spent well and that desired outcomes are achieved. Among other tasks, the NC will influence appointments to the new Health Information Technology (HIT) Policy and Standards Committees, refine the Electronic Health Record (EHR) technology certification process, and oversee how information exchange grants and provider incentive payments will be handled.
Previously we have described our concerns with US health information technology and the policy agenda that has grown up around it. In the case of EHRs specifically, the tools that have been developed to date are often non-ergonomic, excessively costly, non-interoperable, and interruptive of practice work flows. They continue, in many cases, to use client-server rather than Web-based technologies, creating barriers to lower cost and easy data exchange. Most important, these issues are obstacles to the organic, market-driven development of a nationally compatible health IT platform. In large measure, they have resulted from the protectionist influence of powerful health IT firms whose interests would be best served by approaches that build on proprietary and pre-Internet health IT designs rather than upon innovation that would move health care closer to e-health.
We believe the key question for the Office of the National Coordinator (ONC), as the Secretary of HHS’ principal Health IT adviser, is centered on whether and how health policy encourages innovation. Will the NC promote desperately-needed progress in the development, implementation and use of health IT, or constrain it under well-meaning but often over-zealous certification and standard setting? Will we buy innovative tools that let both providers and patients achieve better quality and lower cost, or buy yesterday’s expert systems that resulted in our current problems? Will we facilitate and build on incremental solutions, or continue to delay action through endless expert panels, meetings, and rules-setting exercises?
The aperture of innovation can be opened much wider than it has been. Here are five individuals, each of whom, we believe, as National Coordinator, would encourage innovation and change from the status quo. All of these people have demonstrated a vision of health care connectedness, quality, and efficiency that are in the common, rather than the special, interest, and each has the administrative skills and savvy to bring that vision to fruition.
Farzad Mostashari, MD MPH
Assistant Commissioner
Primary Care Information Project
New York City Department of Health
and Mental Hygiene
Dr. Mostashari chairs the Primary Care Information Taskforce, whose goal is to bring about the adoption of public health-oriented health information technology in underserved communities. He is a primary care physician with the unprecedented experience of having rolled out EHR technology to physicians and medical practices serving over 30 percent of New York City’s Medicaid and underserved population. Among the largest and most successful EHR implementations in the country, this effort has included 1,500 public and private sector medical practices, rather than simply one large enterprise. An epidemiologist, Dr. Mostashari understands data and has the statistical expertise necessary for decision making at the individual, community, and population levels.
Dr. Mostashari has hard-won hands-on experience with implementing EHR technologies in the small and medium-sized medical practices that make up 75 percent of America’s medical community, as well as knowledge that extends to public health and preventive services. He would bring a pragmatic vision of connected health for all Americans.
Carol Diamond, MD, MPH
Managing Director, Health Program
Markle Foundation
Dr. Diamond chairs Markle’s Connecting for Health program, a public-private collaborative working to realize the full potential of information technology in health and health care. Among other significant achievements, she led the multi-year collaborative that produced the Common Framework for Networked Personal Health Information, the widely-endorsed (and current default) set of principles and practices that govern the exchange of personally identified health data among health care institutions, and between health care institutions and lay people. Dr. Diamond works with many private sector groups, government agencies, and health information technology bodies. She played a role with federal agencies and the health IT community in the development of www.KatrinaHealth.org, a secure web site that made prescription medication histories available to doctors and pharmacists caring for evacuees whose medical records were destroyed in the hurricane.
If the new NC must possess particular skills, it will be those of mediator and coalition builder. With a deep understanding of the challenges and opportunities ahead, Dr. Diamond has led national health IT collaboratives that actually produce results people, provider organizations, and health IT companies, can use.
Peter Basch, MD
Medical Director for Clinical Ambulatory Systems
Medstar Health System
Dr. Basch, DC area MedStar Health’s medical director for e-Health, has been a leader in applying IT to the needs of physicians. An early EHR adopter in his own practice at MedStar Health, Dr. Basch now is directing EHR implemention throughout all of MedStar’s ambulatory practices. He is a frequent writer, speaker and expert panelist on EHRs, interconnectivity, health care’s transformation through IT, and the sustainable business case for information management and quality. Dr. Basch served as the chairman of the Maryland Task Force on EHRs that recently issued its final report. He has co-chaired the Physicians’ EHR Coalition, is a board member of the eHealth Initiative, and a member of the American College of Physicians’ Medical Informatics Subcommittee and Medical Services Committee.
With Dr. Basch, we’d get deep technical expertise, direct experience with implementation, credibility among practicing physicians and their membership organizations, an a voice that can represent primary care within large enterprises.
Carolyn M Clancy, MD
Director, Agency for Healthcare Research and Quality
Washington, DC
Prior to Dr. Clancy’s appointment on February 5, 2003, Dr. Clancy was Director of the Agency’s Center for Outcomes and Effectiveness Research (COER), then AHRQ’s Acting Director. A general internist and health services researcher, she was a Henry J. Kaiser Family Foundation Fellow at the University of Pennsylvania. Before joining AHRQ in 1990, she also was an assistant professor in the Department of Internal Medicine at the Medical College of Virginia in Richmond. Dr. Clancy holds an academic appointment at George Washington University School of Medicine (Clinical Associate Professor, Department of Medicine) and serves as Senior Associate Editor, Health Services Research. She has served on multiple editorial boards (currently Annals of Family Medicine, American Journal of Medical Quality, and Medical Care Research and Review). Dr. Clancy has published widely in peer reviewed journals and has edited or contributed to seven books. She is a member of the Institute of Medicine and was elected a Master of the American College of Physicians in 2004. Few people in DC have the credibility and respect that Dr. Clancy deservedly enjoys.
Carolyn Clancy has grace, patience, vision, and deep knowledge of health care processes. She hung on at AHRQ throughout the Bush years, clear demonstration that she understands and can skillfully negotiate DC’s landmines. And perhaps as well as anyone, she understands the opportunities that lie ahead for evidence-based medical care in the United States. That background would allow her to foster effective leadership and innovation throughout health care.
Adam Bosworth
CEO, Keas, Inc.
San Francisco, CA
Mr. Bosworth joined Google in July 2004, having left BEA Systems, and earlier, Microsoft. In early 2006, he gained widespread attention as being “architect, Google Health.” Bosworth is widely recognized as a pioneer and key figure in the evolution of extensible markup language, or XML, the standard upon which e-commerce most depends. Bosworth was a senior manager at Microsoft, where he drove the company’s XML program from 1997 through 1999. He was then named General Manager of Microsoft’s WebData organization, a team focused on refining the company’s long-term XML strategy. While at Microsoft, he was also responsible for designing and delivering the Microsoft Access PC Database product, and he managed the development of the HTML engine used in Internet Explorer 4 and Internet Explorer 5. He is one of the most successful software engineers of the past 25 years, chief product manager for numerous well-known products that have changed our every day world, including Internet Explorer, Microsoft Access, extensible markup language XML, and Google Health’s Personal Health Record.
Over the last couple years, Mr. Bosworth has impressed health care audiences with the scope of his knowledge and vision for how more broadly conceived health IT could positively shape the supply, delivery and financing of health care. An outside-the-box candidate par excellence, he has complete fluency in how software and standards for data exchange work. Although relatively new to the health care sector (compared with our other recommended candidates), Mr. Bosworth’s unparalleled technical expertise, history of consistent innovation, and his fresh approach to health care’s structural problems might be just the infusion the industry needs.
Dr. Kibbe is known as an innovator and independent thought leader in US primary care and consumer health IT. A co-developer of the ASTM Continuity of Care Record standard (CCR) that utilizes XML for computable health information exchange, he is an experienced clinician who practiced medicine in private and academic settings for more than 15 years. Dr. Kibbe has taught informatics at the School of Public Health, University of North Carolina at Chapel Hill, and founded two health care IT companies. From 2002 until 2006, Dr. Kibbe was the founding Director of the Center for Health Information Technology for the American Academy of Family Physicians (AAFP), the membership organization that represents over 95,000 U.S. family doctors. The Center is now the locus of the AAFP’s technical expertise, advocacy, research and member services associated with health IT, and a leading international resource on information and communications technology for physicians in primary care.
