An Open Letter to the New National Coordinator for Health IT: Part 2 - Opening the Aperture of Innovation

One of the important decisions before Dr. Blumenthal and his colleagues at ONC and HHS is whether the national health information network will be one of closed appliances that bundle together proprietary hardware, software, and networking technology, or one of open data exchange and management platforms in which the component parts required to do medical computing can be assembled from different sources. If the former direction is chosen, power and control will be concentrated in the hands of a very few companies. If the latter, we could see an unprecedented burst of disruptive innovation as new products and services are developed to create the next generation of e-health services in this country.

Separating the data from the devices and applications, and maintaining a certain degree of independence of both from the networks used for transmission, is far more than a technical quibble. It can determine the economics of technology in stunning ways.

A familiar example may help here. On April 10, 2009, BusinessWeek reported that Apple was approaching a milestone: one billion iPhone Apps downloaded. This is an amazing number in that it occurred in less than a year, but even more surprising because it might never have happened at all. Prior to July, 2008, the Apple iPhone was a closed appliance that could only offer up applications developed for the iPhone by Apple; for example, the iPhone offers a calendar and contact management app, but these are Apple products. Third-party developers and programmers had no way to make their apps run on the iPhone, and Apple might have kept it this way.

Then, in the summer of 2008, Apple released an upgrade of the software that runs the iPhone and iTouch which included an SDK (software development kit ) that allows third-party developers to create software that can be downloaded and run on the iPhone and iTouch; some of these apps are free and others cost up to a few dollars. Whamo! Suddenly the iPhone became the hottest development platform on the planet. As the New York Times technology blog observed, "Fizzy pints of virtual beer, lightsaber simulators and ancient flutelike instruments [and several health and medically related applications] all have one thing in common: they’re flying off the digital shelves of Apple’s App Store for the iPhone and iPod Touch." Apple has created a website with a counter showing the actual numbers of apps as they download, and a list of the top 20 most popular apps at the iTunes store. No one knows for sure what has been the size of the economic stimulation that resulted from opening up Apple's iPhone platform to third-party development, but it must be many hundreds of millions of dollars and perhaps even billions, and certainly thousands of jobs have been created.

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It is not coincidental that the Internet itself was made possible by several legal cases that lost AT&T its monopoly position mandating the use of a specific device - an AT&T telephone - to handle voice data, on AT&T's private network. As Jonathan L. Zittrain writes in his remarkable book "The Future of the Internet and How to Stop It" --

These [legal] decisions [against AT&T] paved the way for advances invented and distributed by third parties, advances that were the exceptions to the comparative innovation desert of the telephone system. Outsiders introduced devices such as the answering machine, the fax machine, and the cordless phone that were rapidly adopted. The most important advance, however, was the dial-up modem, a crucial piece of hardware bridging consumer information processors and the world of computer networks, whether proprietary or the Internet.

With the advent of the modem, people could acquire plain terminals or PCs and connect them to central servers over a telephone line. Users could dial up whichever service they wanted: a call to the bank’s network for banking, followed by a call to a more generic “information service” for interactive weather and news.

The separation of devices that might utilize data, from the data itself, eventually made it possible for millions of computers of all kinds, makes and configurations to connect with one another over the Internet. Today, audio data in many different formats travel freely over the Internet, and these are consumed, interpreted and put to use by many thousands of devices and the applications running on those devices. If we send you an MP3 file of a song or a conference recording, we don't need to specify the device or application you will use to decode and "play" that file. If we call you on the phone today, you might answer on a cellular phone, a land line-connected phone, or a computer running Skype. Each of these needs to "understand" the data in great detail: no one dictates which device the consumer has to use.

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What do these examples have to do with health IT and HITECH? Just about everything. They illustrate the layers of standards that operate on a digital network: physical wires/cables (or wireless) components of the network; devices connected to the network; applications running on the devices; data of various kinds created and used by the applicaitons; and finally and most importantly, the social interaction based upon the content - that is, the purpose and meaning - of the whole by users.

The future of today's health care IT systems seems to be converging on a handful of enterprise-run networks that do not interconnect, and a dozen or so health IT applications from companies that have the power to decide who can connect, what tasks they can accomplish, under what terms, and at what cost. The irony here is that while Microsoft and Google appear eminently capable of finding ways to exchange health data securely over the Internet in partnerships with New York Presbyterian Hospital and CVS Pharmacy, among others (see "Patient Records Inch Into 21st Century," New York Times, April 5, 2009 , and "CVS joins Google Health Rx network: millions can access medication records online," April 6, 2009), the traditional health IT industry seems to be declaring itself unable to free the data from its proprietary applications and devices quite so easily. Instead, they want a certification process to attach to the software applications from a select group of vendors BEFORE we get interoperability, based on the products' features and functions, only one of which is the ability to handle the data layer. In the process, we believe they are acting more like the old AT&T than the new Apple iPhone.

Congress in its wisdom attached incentive payments to the social interaction layer of the network: "meaningful uses" are by definition the outcomes of the deployment of networked technologies and data exchanges, not necessarily referable to specific applications and devices themselves. This is real progress. Having done that, the next layer down, the data layer, is where attention ought to be paid in order for successful and widespread meaningful uses to proceed and economic stimulus to be unleashed in the health IT economy.

The government can and should facilitate the private sector's arrival at agreement about the content of clinical data that it wants to become accessible to providers and patients over the network; it can also decide in what structures those data elements are formatted or packaged; and it can certainly set expectations and specifications for the protection of privacy of the packages and their contents, whether coded data, text, images, audio, or video. With a limited set of available and well tested standards, this could be done quickly and easily, and would immediately be seen as advancing implementation of the "meaningful uses" that Congress and HSS wish to see.

Here is where the Gordian knot of HITECH needs to be untied. There is no need for ONC to regulate the next layers, the applications, device layers or networks, or to link its specifications for the data to specifications for those products and services that will use the data. They need to know when to stop tying the knot, in other words.

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Here's the risk: limiting the kinds of devices and software applications that can handle standardized health care data to a few government (or government agent)-certified products would dramatically stifle innovation and utility while raising (or at least maintaining) costs. Imagine if the government told consumers they had to buy a Dell computer to connect to the Internet, or an iPod to listen to digital music recordings, or computers running Microsoft Vista to use email. Worse still, imagine we all had to use a modern-day version of the private network Prodigy in order to exchange health data of any kind. By locking in the use of data to a specific product/device/application or even a specific class of products/devices/applications, consumers suffer by not having the choice that an open market permits. Nor do they benefit from innovation and competition that arise from comparisons of service, features, usability, and price. And society doesn't get the economic stimulus, or, rather, it goes to a few large corporations only.

Physicians are, generally speaking, fearful that they will see their EHR choices limited to the expensive and difficult-to-implement products that CCHIT now certifies. David Blumenthal is quite right to worry that doctors will "rebel" if given only the choice of a small number of products that are notoriously not "user-friendly" and not designed to meet the goals of "meaningful use" set by Congress.

But we don't believe that the deeper problem is CCHIT or the dubious politics of hiring a vendor-run organization to certify the vendors' products. That real or apparent conflict of interest is an issue, but it's not the major one. Rather, it is the potential linkage of incentive payments to a certification process that would require specific applications to manage health data. That is the root of the the dilemma that Dr. Blumenthal et al. now face; this is the Gordian knot that needs to be undone.

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on healthcare professional and consumer technologies. Brian Klepper PhD is a health care market analyst and a Founding Principal of Health 2.0 Advisors, Inc.

Click here to read Part 1 of the Kibbe & Klepper series: An Open Letter to the New National Coordinator for Health IT - Untying HITECH's Gordian Knot.

Five Recommendations for an ONC Head Who Understands Health IT Innovation

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.