Wednesday, April 22, 2009

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.


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.


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.


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.

Saturday, April 18, 2009

An Open Letter to the New National Coordinator for Health IT - Untying HITECH’s Gordian Knot: Part 1

Congratulations to David Blumenthal on being named National Coordinator for Health Information Technology (ONCHIT). Dr. Blumenthal will be the person most responsible for the rules and distribution of the American Recovery and Reinvestment Act’s (ARRA) nearly $20 billion allocation, referred to as HITECH, designated to support physician and hospital adoption of health information technologies that can improve care.

The job is fraught with difficulties, which Dr. Blumenthal has readily acknowledged. His recent New England Journal of Medicine (NEJM) Perspective, “Stimulating the Adoption of Health Information Technology,” is a concise, clear and honest appraisal of two of these challenges, namely how to interpret and act upon the key terms used in the legislation, “meaningful use” and “certified EHR technology.” Dr. Blumenthal gets to the heart of the matter by identifying the tasks on which the National Coordinator’s success will most depend, and which will foster the greatest controversy.

The country needs Dr. Blumenthal to succeed. The issues are complex and, with huge ideological and financial stakes involved, politically charged.

Even so, we believe there are straightforward ways to help physicians and hospitals take advantage of this opportunity to use health IT to improve care. This article is the first of a series in which we’ll try to disentangle the Gordian knot of inter-related issues embedded in HITECH. Below we identify six issues. Then we address the first.

A defining paragraph in Dr. Blumenthal’s NEJM article offers his vision of the problem:

….[M]uch will depend on the federal government’s skill in defining two critical terms: “certified EHR” and “meaningful use.” ONCHIT currently contracts with a private organization, the Certification Commission for Health Information Technology [CCHIT], to certify EHRs as having the basic capabilities the federal government believes they need. But many certified EHRs are neither user-friendly nor designed to meet HITECH’s ambitious goal of improving quality and efficiency in the health care system. Tightening the certification process is a critical early challenge for ONCHIT. Similarly, if EHRs are to catalyze quality improvement and cost control, physicians and hospitals will have to use them effectively. That means taking advantage of embedded clinical decision supports that help physicians take better care of their patients. By tying Medicare and Medicaid financial incentives to “meaningful use,” Congress has given the administration an important tool for motivating providers to take full advantage of EHRs, but if the requirements are set too high, many physicians and hospitals may rebel — petitioning Congress to change the law or just resigning themselves to forgoing incentives and accepting penalties. Finally, realizing the full potential of HIT depends in no small measure on changing the health care system’s overall payment incentives so that providers benefit from improving the quality and efficiency of the services they provide. Only then will they be motivated to take full advantage of the power of EHRs.

Here are issues that, to develop rules that can make the most of emerging Health IT trends, deserve clarification:

  1. The term “electronic health record” (EHR) is unclear and imprecise, especially given the wide-ranging tools that can be used to manage health information in electronic format. Before developing rules that will guide our use of these tools, a clearer definition is essential.
  2. In thinking about health IT, it is useful to separate health data from the applications used to manage health data. Separating them is critical to better understanding the role of standards, certification and the criteria used to validate physicians’ and hospitals’ claims on HITECH’s incentive funds.
  3. In a certification process, the appropriate scope of “basic [EHR] capabilities” should be limited to the critical few. Given constraints on time and resources and the “meaningful uses” that Congress wishes to promote, does it make sense to require a large package of features or a more limited set of basic capabilities?
  4. How should the certification process be structured to ensure fairness, flexibility and openness to innovation? Does the current certification process meet these criteria?
  5. The roles patients and consumers might play in any determination of “meaningful use” are important, but are left on HITECH’s sidelines. How can health IT policy enhance the patient’s health care experience and participation?
  6. Will the incentive payments envisioned by HITECH actually encourage implementation of EHR technologies, and result in improvements in patient care quality? Or are better mechanisms available that can systemically improve care?

1. Definitions

First, let’s admit that there is no precise, universally-accepted meaning for “EHR.”

The term sometimes refers to medical records themselves, digital files containing a person’s health data and information. We believe this is what both Presidents Bush and Obama intended for the meaning when they have stated that all Americans should have their own electronic medical records. Individuals should be able to access their health information in electronic formats (of which there are many), and not just in paper records. Patients with their own EHRs can access them, give viewing permission to others, download them to computers or cell phones, and use software applications to manage and transfer the records in digital formats.

However, EHR may also mean a software application - like Intuit’s Quicken for financial management or Microsoft Office for business productivity - used by doctors, nurses, and staff in a medical practice, hospital or other clinical setting. (EMR, for “electronic medical record,” was an earlier term for this same class of software, now less used.) EHR software is typically utilized for creating, storing and managing a patient’s care-related and billing data. Dr. Blumenthal uses this meaning in the passage above; EHRs are certifiable software programs that have “capabilities.” We might also point out that EHR software for ambulatory care is very different from EHR software used in hospitals.

Unfortunately, many people have come to believe that a specific class of EHR software is required to consume and utilize the EHRs that are digital health records. But this is completely inaccurate. Many types of technologies can be used to manage digital records. If, for example, your electronic health record is a discharge summary written by a physician in Microsoft Word or PDF - two very common digital file format standards for text documents - you could use any number of word processing software programs to view that EHR, including some that are open source and/or free. Google Health, Microsoft HealthVault and WorldDoc store health records electronically for retrieval or updating by patients and the professionals or institutions that care for them. Even data that are digitally formatted in less publicly familiar standards, such as DICOM for radiological images and XML for structured medication or lab data, do not require an EHR application. Many types of software - personal health record applications (PHRs), image viewing programs, e-Prescribing applications, and even web browsers - can be used to create, consume, store, manage, and then transmit these data successfully. Each of these software programs, alone or in combination, deserves to be considered an EHR technology, by virtue of the fact that its main purpose is to handle electronic health records.

Further, the Certification Commission for Health Information Technology (CCHIT), initiated by the Health Information Management Systems Society (HIMSS), later re-organized as a non-profit and contracted by ONC while David Brailer was the the National Coordinator, insists that EHR software products must: a) include hundreds of features and functions, based on a model of such software that many would term “comprehensive,” and; b) be supplied by a single vendor. This EHR definition prohibits CCHIT certification for many simpler, less feature-rich, and less expensive EHR applications. It also prevents end-users from assembling EHR software from components from separate vendors and submitting this for CCHIT certification.

The upshot is that the term “EHR” is no longer very useful. It creates more confusion than it resolves. This is more than a quibble. One can never be certain what EHR refers to: health data in electronic format; a technology that is designed to handle electronic health records in some fashion; an EHR software program that has fewer or different features and functions than those required by CCHIT, or one that has been assembled from compatible modules; or a CCHIT-certified, comprehensive software application from a single vendor whose product has been accepted by CCHIT.

It is not necessary to accept this confusion. Ever-expanding technological options, more than anything else, have made the term EHR obsolete. However, we think clarity is especially important now, as we face the challenge of setting rules to determine who will and will not qualify for ARRA/HITECH funding. If the language we use to define key terms is arbitrary, capricious, biased or simply out-of-date, the guidance we follow will fail to be fair or, more importantly, in our national best interest.

So, in an effort to reach the appropriate level of clarity, we suggest that “EHR technology” replace the terms EMR or EHR in ONCHIT’s lexicon. The term would be defined as:

“An information technology tool, such as a software program or application, that is used to create, consume, manage or transport health data in electronic or digital form.

This definition is very broad, allowing many different kinds of technologies to qualify as meaningfully useful — required by HHS and ONC — and without requiring features and functions that are not useful. For the market to work and to encourage optimal innovation that can benefit all Americans, it is important to allow recognition and certification of single function applications that can mix-and-match with others, as well as more comprehensive packages, according to the needs, the budget, and customers’ capacity to adopt. A first step is to create clarity in the language used to describe these tools.

Friday, April 10, 2009

A Self-Fulfilling Prophecy: The Continuity of Care Record Gains Ground As A Standard

We live in a time of such great progress in so many arenas that, too often and without a second thought, we take significant advances for granted. But, now and then, we should catalog the steps forward, and then look backward to appreciate how these steps were made possible. They sprung from grand conceptions of possibilities and, then, the persistent focused toil that is required to bring ideas to useful fruition.

We could see this in a relatively quiet announcement this week at HIMSS 09. Microsoft unveiled its

Amalga Unified Intelligence System (UIS) 2009, the next generation release of the enterprise data aggregation platform that enables hospitals to unlock patient data stored in a wide range of systems and make it easily accessible to every authorized member of the team inside and beyond the hospital - including the patient - to help them drive real-time improvements in the quality, safety and efficiency of care delivery.”

The announcement was amplified by a New York Times article, earlier this week by Steve Lohr about New York Presbyterian’s collaboration with Microsoft, now beyond the pilot stage, to transfer patient data into consumer-controlled personal health records (PHRs). The article acknowledges that Google, as well as Microsoft, are now actively engaged as well with major health care institutions - Mayo Clinic, Cleveland Clinic, Kaiser Permanente - to automatically move patient data into PHRs.

The facilitating technology in all these efforts is the Continuity of Care Record (CCR) Standard. Here is the Wikipedia entry, cited in the Microsoft announcement, describing the CCR. It is

“a patient health summary standard. It is a way to create flexible documents that contain the most relevant and timely core health information about a patient, and to send these electronically from one care giver to another.

Because it is expressed in the standard data interchange language known as XML, a CCR can potentially be created, read and interpreted by any EHR or EMR software application. A CCR can also be exported in other formats, such as PDF and Office Open XML (Microsoft Word 2007 format).”

The creation of a new industry standard is an immense undertaking of breathtaking audacity, vision, skill and hope. It starts from scratch to craft a highly useful, flexible tool that can be easily adopted by developers, who are focused on wide-ranging aspects of common problems.

The CCR Standard was developed by a collaborative - the Massachusetts Medical Society[1] (MMS), the HIMSS (HIMSS), the American Academy of Family PhysiciansAmerican Academy of Pediatrics (AAP), and other health informatics vendors - under the auspices of ASTM International, a not-for-profit organization that develops standards for many industries, including avionics, petroleum, and air and water quality. David Kibbe MD, my friend, colleague and often co-author on the Health Care Blog, was a co-developer of the CCR, and serves as the 2008-2010 chair of the E31 Technical Committee on Healthcare Informatics, the leadership group within ASTM that works with individuals and organizations on the implementation and use of the CCR standard in the US and abroad, (AAFP), the

The CCR’s increasing adoption by major players is testament to the soundness of its vision and its utility. It’s advance will allow patient health data to be easily transported from one platform to another, intact and with integrity, so that better decisions can positively impact care, health, and the costs of achieving them.

This is something we can all acknowledge and admire, because it fulfills the common mission - better, more affordable care for better health - that brings us together on this site.