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Mike Leavitt, Secretary of Health and Human Services


Washington, DC


Friday, October 7, 2005

Remarks at the first Meeting of the American Health Information Community

The promise of health information technology (health IT) is known to every person at this table. Each of you, and others observing this meeting today, have given dozens, and some of you hundreds, maybe even some of you thousands, of speeches on the power of health IT to transform health care in this country. For that reason, I will not dwell on potential or promise, just progress.

This group is about progress: serious, measurable, urgent progress toward meeting the President�s goal of electronic health records being available to Americans, and the power of electronic health records to make the health care system patient-centered and safer. It�s about producing higher quality, lower cost health care, with fewer mistakes and less hassle.

Why is this group different than any of the hundreds of others who regularly gather under different banners and acronyms for the same purpose? Spoken bluntly, the answer is market power.

Around this table sits representatives of the federal and state agencies that pay for and regulate a major piece of the $1.7 trillion dollars a year spent on health care in America. For many years, health care providers, payers, patients and governments at all levels have dealt with the dilemma of how a segment of society, as diverse and fragmented as this one, could reach in a free market system the conclusions necessary to accomplish interoperability. My conclusion: the federal government has to lead by using its market power and capacity to convene. We need to lead with our feet.

For that reason it is highly significant that the Departments of Veterans Affairs, Defense, Commerce and Treasury, as well as the Office of Personnel Management, and at HHS, the Centers for Medicare and Medicaid Services and -- essentially -- the United States Public Health Service community are at this table with a shared commitment to unify around breakthroughs that can give us near-term results and an architecture, standards, certification process that can continue giving results far into the future. Collectively we represent more than 40 percent of the market; and when more than 40 percent of a market acts in unison, it moves the market. The question is, will it move in the right way?

Moving in the right way will require the private sector to be involved. Without the advice of private purchasers, payers, providers and patients, it�s likely that government would make mistakes, create unintended consequences and miss innovative opportunities.

This type of collaboration does not take away the hard decisions, but it does improve acceptance of them. And, collaboration doesn�t eliminate the need for regulation, but it does put the power of the market to work to get more done, faster with less disruption of the good aspects of our health care system.

Good collaborations are much more than compromise; they are problem-solving expeditions that create tireless momentum toward a defined end goal. They are messy, difficult and complicated, but in markets this complicated they are also indispensable. And that is what the American Health Information Community is about.

It is important to speak plainly about how the Community�s influence will be exercised. The Community is a Federal Advisory Committee. The charter empowers you to advise the Secretary of Health and Human Services. When the Community has collaboratively reached a conclusion on its advice, I intend to give significant weight to your recommendations. Most importantly, I intend to act, using the rule-making authority provided me under statute, to implement the standards, architectures and certification processes in the programs under my management. Just as importantly, the other federal agencies are here because they intend to do the same. We will identify the means to accomplish the results that the Community seeks, and this will take both federal government as well as private sector action. In some cases, our actions will be referred to National Institute of Standards and Technology, in the Department of Commerce, for government-wide implementation. With appropriate lead times for adjustment, we will work to change the way the health care market operates.

As I mentioned, I would like to draw your attention to our name, the �Community.� Seventeen people sit at this table, but seventeen people do not make up the community. Not even close. There are thousands of people, hundreds of groups, already productively engaged in the development of standards, deployment of technologies and protection of privacy for years. All those efforts need to be part of the Community�s work. The American Health Information Community is the hub of a collaboration of collaborations if you will, or a network of networks. It is a place where advice will be consolidated and recommendations made that allow health IT vendors and purchasers to confidently move forward with certainty and coordination.

We all serve in a representative capacity. It is our obligation to reach out to those who are not at the table and give them a voice -- to listen to them, to learn from them and to represent their views in our deliberations.

We will use the depth, expertise, reach and experience of other people and organizations that are critical to our success. The National Committee on Vital and Health Statistics (NCVHS) has significant expertise and more than fifty years experience as a public advisory body. I�m pleased to say that the NCVHS chair, Dr. Simon Cohn, has expressed to me NCVHS�s support and engagement. We will invite NCVHS to be actively engaged in our work.

Another important federal advisory group is the President�s Information Technology Advisory Committee, or, in the Washington tradition, something we call PITAC. PITAC too can be helpful in supporting our work and we will use them.

We need to engage the broad network of people connected to health IT standards, certification and privacy/security protection. Yesterday, I was pleased to announce that the U.S. Department of Health and Human Services has contracted with three partners to carry out the tasks of standards harmonization, technology certification and security and privacy enhancements. These partners -- the Health Information Technology Standards Panel (HITSP), the Certification Commission for Health Information Technology (CCHIT), and the Health Information Security and Privacy Collaboration (HISPC) -- provide the foundation for our market-driven strategy for advancing interoperability and accelerating adoption. Very soon we will also announce the consortia which will develop prototypes for nationwide health information network architecture.

If you are a Standards Development Organization, I�m talking about you. We want your perspective and are ready to work jointly to make progress. If you care about technology certification, I�m talking about you. We need to be clear about what we want from health information technology, and we can do this in part through certification, and we intend to learn from the thousands of people already involved in these efforts.

If you are concerned about patient privacy and confidentiality, I�m talking about you too. We�ve contracted with a consortium of state leaders to better understand the differences in organization-level implementation of privacy and security rules and in state laws that affect privacy and security practices, so that we can build an interoperable system that respects these differences and advances existing protections of a patient�s confidential medical records.

We will lead a public dialogue that may include public meetings, workshops, forums, symposia, mini-summits, and maybe even major summits. The point is that this Community, by its very nature and intent, is visible and transparent to everyone.

Finally, I will ask members of the Community to chair work groups that will be tasked with very specific assignments. These work groups will include many of the best health information technology minds in our country. They will help us sort through the complexities of health information technology adoption and interoperability.

Now let�s talk about how we operate. The Community's purpose is to advise the Secretary. I would like us to employ a collaborative consensus model to develop this advice. This doesn't mean we will wait for unanimous agreement. We're going to keep moving forward constantly, weighing the component pieces of decisions as to their relative importance in the larger picture.

When we arrive at important milestones along the way, I will validate support with a formal vote. If I have bypassed dissent too many times, and a majority is not achievable on a validation vote, it will be clear that I, as Chair, have miscalculated. If this happens, we will pause and recalibrate our approach.

Let's turn to the subject of our agenda and path forward. First, I should comment on the crosscurrents and competing pressures of adoption and interoperability. Let's be perfectly clear -- we have to do both.

Adoption and interoperability have something in common. Alone they have some worth, but together their value compounds. Our challenge is to find that pathway in which we can move both adoption and interoperability together so that we can tap that value.

Interoperability is hard to achieve and it won't happen quickly. The full vision and definition will change over time and we need to adapt as it does. It is better to take available, imperfect progress/action and then migrate toward the pure vision. Progress will come in phases. Each phase must produce value and prepare for the next.

We took a major step toward adoption and interoperability earlier this week. I signed proposed e-prescribing rules that will provide the most meaningful financial incentive ever for investment in health IT -- stark exceptions paired with anti-kickback safe harbors for e-prescribing and electronic health records technology. The full exception and safe harbor for electronic health records would be linked to product certification which is based on technology standards, security standards and clinical standards.

Earlier I indicated that it was market power that distinguishes the Community's capacity to move things forward from other efforts. The truth of that is overshadowed by another market factor. We have to produce value quickly. The market will jump behind our effort only if we're making progress that is visible and evident. If we are to lead toward a vision of interoperability, we have to make decisions faster than the market does.

I am committed to decisions that give us early and fast progress, but also progress that makes real changes and that lasts. To do this, we need a means for organizing ourselves and structuring our work. When I spoke to each of you on the phone about serving on the Community, I mentioned that we would meet every four to six weeks. This is an aggressive schedule, but one that I feel matches the challenges and opportunities before us.

Our immediate task is to identify specific breakthrough projects -- that is, important use cases that can begin to lay the foundation for adoption and interoperability.

Let me give you a current and inspiring example of a breakthrough project: this one comes from the Gulf Coast. Some estimate that more than half of the medical records in New Orleans were destroyed by the flooding. I've been told that 40 percent of the evacuees were taking prescription medications before the storm hit. People were displaced without their medications and, in many cases, had no better understanding of what they were taking than to describe it as �a little, oval-shaped purple pill.� This is serious. We are talking about people's health.

In just seven days, a public-private partnership, which included the American Medical Association, Gold Standard, the Markle Foundation, RxHub, SureScripts, and the Louisiana and Mississippi Departments of Health, launched a secure, online Web site where authorized health professionals could access the medication and dosage information for evacuees.

A woman with breast cancer was able to resume her treatment regimen. A man who took insulin was able to resume his dosage and avoid a diabetic coma. These are just two of the many stories we have heard about how the collaborative breakthrough saved lives.

The system they developed isn't perfect, but it's a step forward and given time, it will improve. If you can do something like that in seven days, don't tell me it should take years to make progress. Incremental progress trumps perpetually deferred perfection. We need real benefits, for real people, real fast; this needs to be our mantra.

Let's talk about our work plan and agenda. My grandparents used to put puzzles together as a family. They would be spread out on a table in their front room for days at a time. My grandmother was very deliberate in the way she approached a puzzle. She would begin by framing in the picture by working on the border pieces. After all, border pieces had that smooth outside edge making it clear they were part of the frame. She would work from the corners, and then extend to the other edges, then into the center. Each member of the family was then assigned a particular section of the puzzle to work on.

With each piece that was matched, there were fewer to select from, making it easier to accomplish the harder sections that had little or no color variation.

Our job is solving a puzzle. As a starting point, we've identified 14 potential breakthroughs in three general areas: consumer empowerment, health improvement and public health protection. For example, a breakthrough in consumer empowerment could be an online medication list for consumers who want their physicians -- anyplace, in their community or while on vacation -- to know what medications they are taking. This is what the Gulf Coast project did for evacuees, but it can be done fast for a very large group that needs our help. Or, consider a health improvement breakthrough, in which we could develop a childhood immunization registry for parents and pediatricians, so that we don't have to remember our children's vaccinations anymore. And, public health protection breakthroughs like bio-surveillance are of great need, as I will describe shortly.

I propose to handle the potential breakthroughs much like my grandfather approached his puzzles, first getting them all on the table. Then we'll group ideas that we think have potential into categories. After some deliberation, ideas will be assigned to a work group to dive into the details, develop game plans, resolve conflicts, and bring back to the Community options for how to proceed.

The Community sets the vision and defines the where; the work groups gather information and present us with options for the how and the when for us to consider. For example, if a work group determines that there is a standard already, the work group just has to work with our standards harmonization partner to validate it, provide us with the information so that we as a Community can recommend adoption of the standard, and we move on. If there is no standard, the work group has to gather information and work with the standards harmonization partner to understand the options and bring the information back to us. And this is similar for certification, architectures, policies and other enablers of progress.

So today, we need to decide what breakthrough projects we should start with and then quickly determine what can be accomplished and what we have to do to gain results. We can then charge a work group to get this work done and to be accountable for their efforts.

I have a personal breakthrough priority. Tomorrow, I will be traveling to East Asia to the areas most impacted by the avian influenza -- something more commonly referred to as the bird flu, or the H5N1 virus. The virus is spreading rapidly among poultry -- 140 million have already died. To date, more than 115 humans have been infected and half of them have died. We have no pre-existing immunity to this deadly virus. Let me restate that: no pre-existing immunity. NONE.

As Secretary of Health and Human Services I feel an urgent need for improved bio-surveillance in this country to help protect us from both pandemics and bioterrorism. Preparation for these threats must become a national priority.

I am going to be asking state, regional and local health organizations to join together to enhance our preparation. I want a system that will stream emergency room data from local, state and national health authorities multiple times a day. And, I want this operational by the end of 2006. I ask that we convene as key experts on bio-surveillance and public health authorities as a first breakthrough work group.

Last revised: January 27, 2006


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