[This Transcript is Unedited]
THE NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
Hubert H. Humphrey Building
200 Independence Avenue
Washington, D.C.
MR. COHN: Good morning. I want to call this meeting to order. This is the second day of meetings of the National Committee on Vital and Health Statistics.
The national committee is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy.
I am Simon Cohn. I am associate executive director for health information policy for Kaiser Permanente, and chair of the committee.
I want to welcome committee members, HHS staff, and others here in person, and of course also welcome those listening in on the internet.
I, of course, as usual want to remind all committee members and others to speak carefully, clearly, and into the microphone, so that those listening in on the internet are able to hear us.
With that, let's have introductions around the table and around the room. For those on the national committee, I would ask, if you have any conflicts of interest relating to any of the issues coming before us today, would you please so publicly indicate during your introductions.
MR. HARDING: I am Richard Harding. I am the chairman of neuropsychiatry at the University of South Carolina, a member of the committee, and I have no conflicts regarding these matters.
MR. BLAiR: Jeff Blair, Medical Records Institute. I am a member of the committee, and I am not aware of any conflicts of interest.
MR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the committee.
MR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology to the director of AHRQ, liaison to the full committee.
MR. HUFF: Stan Huff with Intermountain Health Care, and the University of Utah, Salt Lake City, a member of the committee, and no conflicts or potential conflicts that I am aware of today.
MS. CARR: Justine Carr, health care quality, Beth Israel Deaconess Medical Center in Boston, member of the committee, and no conflicts.
MR. WILLIAM SCANLON: Bill Scanlon from Health Policy R&D, member of the committee no conflicts.
MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, no conflicts, member of the committee.
MS. MC CALL: Carol McCall, Humana, member of the committee, no known conflicts.
MR. STEINWACHS: Don Steinwachs, Johns Hopkins Bloomberg School of Public Health, member of the committee, no conflicts.
MR. LOCALIO: Russell Localio, University of Pennsylvania School of Medicine, member of the committee, and I have no conflicts.
MR. VIGILANTE: Kevin Vigilante, Booz-Allen Hamilton, member of the committee, no conflicts.
MR. ROTHSTEIN: Mark Rothstein, University of Louisville School of Medicine, member of the committee, no conflicts.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina, member of the committee and no conflict.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the committee, and no conflicts.
MS. WARREN: Judy Warren, University of Kansas School of Nursing, member of the committee, and no conflicts.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, executive secretary.
MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the committee.
MS. BARTLETT: Virginia Bartlett, IMS Health.
MR. THOMPSON: Jeff Thompson, Wexler and Walker.
MR. MARTIN: Russ Martin, Pfizer.
MS. FRANKLIN: Angela Franklin, Blue Cross Blue Shield.
MR. TURNER: Sam Turner, Faster Cures.
MS. JONES: Catherine Jones, CDC, National Center for Health Statistics, and staff to the executive committee.
MS. SPECTOR: Nancy Spector, American Medical Association.
MS. NARCISSI: Jean Narcissi, American Medical Association.
MS. POKRA: Anna Pokra from AHRQ, staff lead to the quality subcommittee, and staff to NHII.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, committee staff.
MR. HOLLAND: Frank Holland(?), American Dental Association.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee on standards and security.
MS. FLEISCHER: Judy Fleischer, American Optometric Association.
MR. DICKINSON: Gary Dickinson, EHR Standards Consulting.
MS. DICKERSON: Audrey Dickerson, HIMS.
MS. MEEKER: Erica Meeker, HIPAA Compliance Alert.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC, and staff to the NHII work group.
MS. NOLTE: Emily Nolte, National Opinion Research Center.
MS. SIGMAN-NU: Marilyn Sigman-Nu(?), America's Health Insurance Plan.
MR. STEINDEL: Paul Steindel, American Medical Association.
MR. DE CARLO: Mike DeCarlo, Blue Cross Blue Shield Association.
MR. RODEY: Dan Rodey, American Health Information Management Association.
MR. COHN: Thank you all for joining us. I should also -- Paul, would you like to introduce yourself?
MR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee, no conflicts.
MR. COHN: I should publicly disclose, although I don't think this is a conflict, that I was recently appointed an advisory member to the HIMS board. I don't think I have even been seated yet, but I have been notified.
Since Mark is obviously presenting and is part of HIMS, and I think there will be other HIMS presenters, I just want to publicly disclose that.
Now, with that, let's move into the agenda discussion. This morning we begin with an update from the certification commission on health information technology.
I want to welcome Mark Leavitt, who is the chair of the CCHIT, as well as the medical director for HIMS. So, I want to thank you for coming. I know it is a busy time for you, and we really want to thank you for taking time.
Following that, we will have a presentation. The title here is the ANSI health information standards board panel.
It is really, I believe, an update from ANSI HISB, as well as from the ISO TC-251, on what is happening both nationally and internationally. At least, that is my understanding.
Following that, we have a presentation from Dan Friedman, who is actually a former member of the NCVHS, on health statistics and health information infrastructures in other countries, and he has been doing work for NCHS, sort of looking at some of that. I think it should be a very interesting presentation.
Beyond that, we will be having reports and discussions relating to work plans and sort of updates from the subcommittees and work groups.
I think, as you will all remember, we have disposed of all action items yesterday during our discussions, so there are actually no action items.
Now, as mentioned yesterday, we are actually not taking a lunch break, and instead we will be taking two 10 to 15-minute breaks through the morning basically going through, with the idea that we will be adjourning probably around 1:15, is the expected completion time here. So, that is just to remind everybody, as well as inform those who are on the internet. With that, I want to once again welcome Mark. Thank you for coming, and I will turn the floor over to you.
MR. LEAVITT: Thank you very much, Doctor Chairman. It is really my pleasure to be here, and give you a chance to hear about the certification commission for HIT.
As you said, it is a busy time for us. We are responding to an RFP right now with a 30-day window. So, it has been kind of 24/7 for the last few weeks. So, if I look a little bit bleary eyed, that is the reason.
I also look forward to answering your questions, because we really want to satisfy the entire industry and community that what we are doing is in the best interests of everyone.
I do appreciate the opportunity and let's go ahead and move forward. What I would like to cover today is a little bit about how we came to be, the origin of CCHIT and our mission, talk about how we are organized, to satisfy that mission, and then talk about what it is that we are doing, our scope, our deliverables and our time line.
Then I want to talk about how we do that, our process for development of certification criteria and test processes.
Then I will show you, not in detail because there isn't really time, but the concept of our work products that we circulate for public comment.
We will talk about the phase I work products, which came out about two months, and I will give you a little preview of the phase II work products, which are not ready, but at least give you a preview.
Then I will briefly talk about the future of CCHIT. We are at an inflexion point in our existence. The organization is really only nine months old, but we are at an inflexion point in responding to this federal request for proposal, and I will talk a little bit about how we would change and what would happen if we win the proposal and, of course, that is an if.
It is a competitive proposal situation and we don't know the outcome, but we will tell you what we would do, what our plans would be.
Before I start, I should ask if any committee members have any other topics you would like me to add to the agenda, or otherwise we will take the questions at the end.
Okay, let's talk about how we came to be. In July of 2004, you are all aware of the framework for strategic action that was published by the Health and Human Services Department.
A lot of the creation of this was Dr. David Brailer, the national coordinator, less than 90 days after he was appointed, as you well know. That was more than the 24/7 experience. That was probably a 36/7 framework.
That framework contained four goals. It had 12 strategies to meet those goals, and it had eight key actions.
One of the specific key actions listed in the framework was a private sector certification process for health IT products.
It was supporting several of the strategies, although if you look at strategy number two, reducing the risk of EHR investment, that was probably the one that it primarily targeted.
It also would support the development of health information networks, would support incentivizing EHR adoption.
So, CCHIT was formed concurrent with the release of the strategic framework. An important point to make is that it is a voluntary private sector response to a call for action.
It was not formed at the direction or mandate of the government, there was no government funding, no statutory origins to CCHIT. It is a voluntary private sector response to a call for action.
It was founded by three non-profit health IT associations. I work for one of those, the Health Care Information and Management Systems Society, HIMS.
The second was the AHIMA, the American Health Information Management Association. The third was the National Alliance for Health Information Technology, the Alliance.
They formed a panel to nominate the first panel of commissioners, and my selection as chairman was part of that process.
They provided the seed funding -- you could call it start up funding -- and resources for the commission, and we held our first official meeting in September 2004.
We don't have an exact calculation, but the cash seed funding was about $150,000 in expenditures. We are talking about meeting rooms and teleconference circuits and that, and probably $250,000 in staff resources.
They basically detailed staff members pro bono to the commission, and I spent about half time for six months, and I have been pretty much spending 75 to 80 percent of my time on the commission for the past few months.
In June of this year, about 30 days ago, CCHIT received broadened funding support, and we announced this on, I believe, June 6.
We received unrestricted grants totalling $110,000 from the seven organizations you see here: The American Academy of Family Physicians, the American College of Physicians, Hospital Corporation of America, McKesson Corporation, Sutter Health, United Health Foundation, and Wellpoint Health Networks.
In addition, we received $215,000 in grants to support the development of our test processes from the California Health Care Foundation.
I think that the bottom line here is that this shows the breadth of support which CCHIT has endeavored to develop and is developing among the various stakeholders.
Let's talk about the mission. The mission statement is to accelerate the adoption of robust interoperable HIT throughout the U.S. health care system, by creating an efficient, credible, sustainable mechanism for the certification of HIT products.
What do we mean by robust? We mean that IT, when implemented in the real world by hospitals and physicians and nurses, delivers the expected benefits, improvements in quality and safety and efficiency.
We also mean it delivers the expected protection of patient information, protecting their privacy.
Interoperable, that has been defined, actually, for us now, and you know that means the useful and efficient exchange of information between systems.
So, our goal is to accelerate the adoption of what I just said, robust interoperable HIT, and to do that by creating a mechanism to certify these products.
Now, we have some guiding principles for success, and these are three. First is timeliness. We felt that decisive action by the private sector was needed right now.
Health care IT adoption has followed an interesting curve. It has not taken off the way most technologies, as they diffuse into the marketplace, there is an early adoption part, and then they take off into the mainstream, and then they saturate.
Everyone now has a PC. That is getting into that saturated part. Health care IT adoption has remained in the left part of that curve so long that it has created a situation where something is going to happen.
There was concern that, for example, there could be legislation that would mandate HIT, and most people in the private sector, and maybe many in government, felt that wouldn't be the most efficient way to accomplish that.
So, we wanted to take action now. The second principle is value. We knew that we needed to deliver value for all the key stakeholders.
Again, because this is voluntary and not mandatory, we need to satisfy all the stakeholders and the larger health care community. Eventually, obviously, the patient or health care consumer has to see value from this.
Finally, integrity. Potentially certification can steer and direct market places and can impact on the success of vendors.
So, we have to operate in a very credible, objective and transparent manner, just as the national committee here operates.
The certification itself, we felt, needed to be objective and, to the greatest extent practical, laboratory verified.
That word laboratory has been the subject of a lot of discussion. It might not strictly mean we take the product and we put it in a sealed room.
It simply means that you have an objective process which is not subject to bias, and I can talk more about that later, if you like.
A few more points to clarify. Product certification is different from organizational accreditation. There are organizations doing an excellent job of accreditation of providers, of physicians. We are not trying to do that.
We are certifying products before they are bought. The main value comes before the product is purchased, so that we can help influence the purchase of products that deliver what is needed. It has nothing to do with professional certification of individuals.
The second point is that, at this point, we feel certification is a binary decision, a pass fail decision, not a subjective comparative rating system.
While the industry might like to have a comparative point system, and that may be very complementary to what we do, these are basic standards that we feel all the products need to meet.
We wanted to leave room above the line of certification for the kind of competition and innovation that will be needed, because we are still at the early stages of development of these products.
Finally, a voluntary process, not a government mandate. That means that the initial certification requirements must be based in the realities of the market.
If we want to influence the market place, we have to move them there through a road map that shows the future direction of certification, and the future requirements, giving the market time to respond, and develop the products to meet those requirements.
If we were to put out an initial certification requirement that almost no product could meet, we would not be meeting our mission of accelerating the adoption of IT. We would be slowing it down.
Just to use an analogy -- and those of you who know me know that I like analogies, I often use them to the point of fault -- but if you look at the adoption of personal computers and computing technology, the inflexion point in the curve for personal computer was when the IBM PC emerged.
It created a virtual standard that everyone knew would be there. The next tipping point was ethernet networking and finally, as you are enjoying today, wireless networking.
If you buy a laptop, you are pretty assured that, if you take it to a coffee shop, the wireless access point in the coffee shop, and the wireless card in your laptop will talk, and you will not have to hire a consultant, and it will not cost $10,000 or $50,000 to make them work, as it does for a physician office to try to make their system talk to a laboratory or some other entity that they need information from. So, we are trying to create that similar effect of a tipping point in the adoption of technology.
The way certification accelerates adoption is by increasing the confidence of the providers to investment in and adopt the HIT, by ensuring that, as these products are adopted, they will be interoperable within the emerging national health information network.
Third, we feel we can enhance the availability of HIT adoption incentives that are now becoming available from private purchasers and, in fact, public purchasers and payers for health care. I show that in the diagram.
The block for providers right now is their hesitancy to implement and purchase IT until the costs and the risks are lower or the incentives are higher.
The problem that vendors of HIT face in lowering the cost of their products is literally the hesitancy of the providers.
The sales cycles are very long and the sales costs are high. I was a vendor for 15 years. The cost of selling the EHR is half the cost the doctor pays to buy it. That doesn't improve the product, it doesn't help implement it. It is just the selling cost.
It may be subsidizing our airline industry somewhat, but we probably shouldn't be doing that. So, if providers understand what they need and are more confident and focus on the things they need to do to differentiate products, I imagine that the cost and time of sales goes down. Then the money can go into lowering the cost of the product, or developing a better product. Either way, the industry wins.
Finally, the payers and purchasers who are now just stepping up to the line to offer incentives -- and there are some notable programs, and I will mention bridges to excellence, but I know there are others that are providing incentives.
If an office adopts information technology, they would be faced with a very difficult task if they had to sort through the 200 different products on the market and figure out which ones could provide the quality improvements and the safety improvements and the cost effectiveness improvements that they want.
So, we can help simplify that process for them and prevent that from being an overhead item that adds cost. So, this diagram you are seeing here just shows it is a positive cycle that builds on itself.
There is less risk for providers, they buy more and cost less to sell to them. That attracts investment to the HIT market, lowers the cost of HIT, and the payers and purchasers are now able to offer those incentives with more confidence. Those incentives help the providers buy, and you get a cycle that builds on itself.
In doing this, again, because it is voluntary, we need to deliver value to each of the stakeholders. We have identified three key stakeholders. We have many stakeholders, but three that there is actually a balance between.
The first is obviously the end users, the HIT end users, the providers, the organizations that buy these systems. Second is the vendors. Third is the payers and purchasers who are prepared to offer these incentives. We need to deliver value for each.
The end user needs to know that if they paid attention and buy the certified product, they are much more likely to get a product that they can succeed with.
The vendors have to feel and recognize that, because of certification, even if it costs them something to submit their product, they will get a more than 100 percent return, basically, either in revenues or ease of sales or more understanding on the part of the buyers, so that they can focus more on improving the products and less on convincing people that it is safe and it is not going to go away.
For the payers, we owe them the assurance that these products will deliver the benefits they want. Of course, standards organizations are very important to us.
Standards are the substrate on which we build certification. We don't develop our own standards. We take the standards and determine how to certify against them.
Other stakeholders that are very important are the consumer, clearly, public health, which is an important customer for the data, if I can use the term customer. I should say recipient of data, to meet their needs. As well, clinical research and quality organizations. We consider them all important.
Let's talk about how we are organized to meet the needs of those stakeholders. We have a commission. Currently we have 13 commissioners. I am the 14th and I don't vote.
We have formed four work groups made up of subject matter experts who serve voluntarily. In fact, we don't even cover their travel at this stage in our development. They volunteer their time and their travel costs. They are drawn throughout the industry.
The four work groups are focusing on functionality of EHRs, interoperability of EHRs, security including privacy, and reliability of EHRs. The fourth is a little different. It works on the actual process of certifying.
We have formed a new work group which is just a recombination of the existing members who are now focusing on the very real practical aspect of, let's get these use cases written and write our test plans.
To interact with the industry, we look to organizations. Sometimes they exist. If we want to interact with physicians, we can go to physician associations.
If we want to interact with vendors, they actually formed an association in response to this called the EHR Vendor Association. Payer and purchaser associations, interdevelopment organizations, and so on.
We will outreach to individuals as well as to organizations, and when we look at the public comment results, you will see some information about that.
It is very important, as we do this, to maintain balance and diversity on the commission and the work groups. We pay a lot of attention to this.
The commission has a formal structure. We have to have two to four members from each of the three key stakeholder groups, two to four representing providers or physicians, or provider organizations, two to four from the vendor community, two to four from the purchaser or payer or purchaser coalition community, and then two to four can be drawn at large from other stakeholders.
We actually had some government members ex officio, although they have not been attending since there was word that there would be an RFP. They have not attended at all, to keep complete isolation there. Standards development organizations and others.
Then the work groups, which are formed at the direction of the commission, we formed these through an open call for participation.
The three founding organizations help us communicate. They have very powerful communication vehicles out for the industry. It would have cost a lot of money to try to get the word out otherwise.
So, we used them to get the word out and the press, and we received 275 applications to that open call for participation.
We went through a process of ranking them b qualifications and adjusted for stakeholder balance. Each work group has two co-chairs. The two co-chairs must represent two different stakeholders.
Each work group has an additional eight to 10 members, qualified experts from a diversity of backgrounds. In fact, sitting in here, one of the staff members here is on our functionality work groups, Steve Steindel.
Let's talk about what it is we promised to do. First of all, we set our initial scope as certifying electronic health record products for the ambulatory care setting.
The reason we chose that is, everyone felt that is where we had the most benefit to deliver, the biggest adoption gap, the most lag.
You know, the adoption percentage is about 15 percent overall, more in large physician clinics, lower in solo practices.
A couple of statistics, in case some of you aren't familiar with them, half of all United States physicians -- and there are about 700,000 physicians, and 500,000 who see patients in offices -- half of those practice in a group of four or less. Three fourths practice in a group of nine or fewer.
So, the adoption in the smaller offices, it may well be under 10 percent, and certainly the adoption of EHRs that have safety features and clinical decision support is well under that figure.
That is where the benefit was to be gained. The deliverables we committed to were to deliver a pilot process first, in September of this year, and to follow up with operational capability for certification, and a road map showing future certification plans one to two years in the future.
The road map looks something like this. You list the requirements for certification this year and you show the forecast requirements for the next year and one more year beyond.
Of course, those forecasts are not perfect or precise, but it gives the industry general direction, because the product cycles are six months to 12 months and 18 months, and they need that time to respond.
This is our current time line and this is now subject to adjustment because of what has been happening with the federal government and the HHS strategy.
We hit our target so far. As I said, we formed the group in September, formed the work groups in November. On April 18, we had our first phase I interim work products available for comment.
We published them on our web site, got the word out through the associations and the press, allowed a 30-day period for public comment and also did open calls -- we called them town calls -- for a week.
We did four open ones plus approximately three more that were specific outreach to groups that we felt weren't getting the message, just because they weren't in the industry circles that we had good communication with.
We are now just getting ready to publish the phase II work products for another 30-day period, and I will talk a little bit about those.
We will be having town calls. I will be using my voice a lot from the week of July 11-25, just back to back one-hour town calls.
We planned to publish our pilot test requirements and start that pilot test at the end of September. That is going to need to change, because we are responding to this request for proposal, and it puts the pilot test date in December, if the contracts are awarded at the end of September.
So, we will probably slide that back and spend those two months gearing ourselves up into this new role, if we win the RFP.
So, I have talked about the phases, and I probably don't need to go into them more. I will point out that phase I was data gathering, go out and get the evidence, find out what are the needs, what are the available standards, what are the priorities among the various stakeholders for these different functionalities, and let's put that out there and see if the public feels we got the evidence right.
Then, looking at the evidence, make some recommendations about certification requirements, and that is phase II and we will be publishing that.
I would like to just briefly explain the process the work groups go through to do that. They start with an available standards framework. In the case of functionality, they were the beneficiaries of a lot of hard work for a couple of years from HL7, developing the draft standard for trial use of an electronic health record, functionality standards.
They started with that as a framework, added the evidence of what are the priorities from the various stakeholders, what is the availability in the market place, what is the practicality of certification.
You know, that is considered as well. There may be a functionality that is important, but it is just extremely difficult to test and certify reliably, and you might not be able to.
Then they went through a decision process, and either said, we are going to require this year, we think it is going to be required next year or two years hence, putting it on the road map, or it is not something we need to certify. That doesn't mean people won't have this feature. It just means it is not something that we need to test.
As they look at each element, they consider the priority and the availability as two axes in the matrix. If it is of high priority, it is essential, and it is available, and you probably need to certify that, if it is testable.
If it is essential, but not quite yet, or if it is not available yet, then you could consider it for the road map, that it would appear on the requirements in one or two years.
If it is an optional feature, not necessary, or it is unclear whether it could be delivered and developed, then you don't certify it.
I will show you the documents, and you won't be able to read any details. I just want you to understand the general structure. You know about spread sheets on power point slides.
Anyhow, they are still up there on the internet as the phase I work products, but the public comment period is closed. Everything is at www.cchit.org.
This is the functionality work group spread sheet, and it is too wide to fit on the screen. This is the left part. So, you will see that they drew the functions from the HL7 EHR draft standard for trial use, the ambulatory subset.
They had started to develop the evidence on priorities from among the various stakeholders. They developed evidence of availability. That is the column in 2005 availability.
They then got into the detailed criteria and, of course, didn't yet fill in the phase II part, do we certify it in 2005, 2006, 2007. So, that is being done now, and that will come out in phase II.
The interoperability work group, they had quite a difficult challenge. They didn't have a single standards framework to build on. They couldn't even get their spread sheet to look like the other spread sheet, but they did a great job.
They isolated the interoperability challenges into use cases, particular components of the use cases. For example, laboratory and imaging is a use case. A component might be receiving lab results.
Since we basically don't have any standards based interoperability now, in the form that we want to get, they listed, what are the barriers we need to overcome, what standards are available, what vocabularies are available, what is missing.
That became their work product. Again, they couldn't make recommendations, and that will be part of phase II.
The security and reliability group also had a framework called the common criteria, which is used for the security of products, although it may be more complex than is appropriate for at least this year's work on ambulatory care products.
They were able to develop those, look at the priorities among doctors, payers, vendors, patients, and they actually made some preliminary recommendations.
Those were subject to change. They just thought, let's get them out there and see what people think about them.
The certification process group was not the developer of a spread sheet. They had to tell us how they were thinking of certifying. So, there is a document on there.
They developed a concept of a spectrum of test methods. On the far left of that is something called self attestation.
Basically, the producer of the product says, I have read the requirements, I meet them, and they sign. On the far right of that is, laboratory testing, give us the product, go away, we will lock it in a room, we are going to test it.
In between is something that you would call -- they call it in vivo testing or field testing. For example, you might ask the developer of the product to put it through its paces while you are dialed in over the internet watching, and you have a jury, for example, watching on the screen and you say, show us that it does this.
So, they simply considered all of those as tools in an armamentarium, and looked at the different things we were trying to certify, and which tool was most appropriate.
Now, some of our stakeholders push us far to the right and say, put it in the lab and beef that thing up. Some of our stakeholders say, that is going to cost millions of dollars, you are going to make it impossible. How about just letting us sign. The vendors, of course, would prefer that.
There is precedent. Medical devices, a lot of it is vendors self certify the devices as meeting the requirements.
So, we are still in the process of sorting this out, but we think it is actually going to be a mix. We think there are elements that could be self attested, some elements that really do need to be tested in a lab, some that are best tested in the field with a small panel of experts.
We want to keep objectivity, but we also have to be efficient and practical. I would like to just talk about the results of the comment period in a general way, which we found interesting.
First of all, it was a 30-day period. Many people said, 30 days is too short, but we were working to a schedule.
So, I have developed this graph, and this shows when the comments came in. It was all done on line and, as you can see, there is a bit of waiting toward the end of the period.
Now, my theory is, if we gave them 45 or 90 days, would the curve look any different? Thank you. So, we are probably going to stick with that 30 days as the turn around time.
We were pleased to see about two thirds of the responses were from organizations, and they had to actually check a box saying, this was approved by my organization, not just I belong to an organization and I am responding.
The third were individuals. We like that, too, because we don't want individuals to feel cut off from this process.
Then, what type of source it was. About 10 percent were physician associations and another seven percent were individual physicians.
In terms of provider organizations, about 10 percent were health systems, and about four percent were academic medical centers. If you add that together, you get about 31 percent or about a third of our responses were from providers.
The vendors represented 29 percent, about a third. The rest was kind of a mix. We had other associations, we had four percent from government, one percent from consumers -- a number we want to increase -- about 12 percent from consulting organizations.
In general, we thought we were getting out there and had a good spread. Then the other interesting fact is, we did a study on were they positive or negative, what were the kind of comments.
This was only for comments directed to the commission. The ones directed to the work groups were very specific, this line item needs to be changed, you have forgotten this.
We haven't done this kind of analysis on those. The work groups are going through every single comment. The commission went through the comments that were directed to us.
In general, you have about 18 percent that were supportive, about 28 percent, the largest number, constructive suggestions.
About 18 percent were requests to be included, a stakeholder that said, I didn't know about this, why didn't you tell me sooner, please include us.
About 18 percent were concerns, broad or specific, but generally broad. About 18 percent were format issues. Another principle that I see here is, there is not universal format for publishing work products.
We offer them in PDF which the government uses as kind of a safe way to publish things, and we used PDF when people wanted spread sheets.
We also published in a format that was easily printable, and then you had to zoom in to view it on the screen, and we got comments saying, I can't see it.
So, we are probably going to publish two forms, one that says, best for viewing, one that says best for printing.
We are trying to be very customer focused and friendly here, because we really only exist on the good will of all these stakeholders. So, we are going to do even better.
We also got a lot of nice positive comments about the depth of the work and, really, we really appreciate the work of these volunteers. The commissioners and work group members have put in phenomenal amounts of time.
The work groups have been meeting weekly to twice a week for often 90 minutes to two hours, and a lot of them are being assigned homework in between meetings. So, it has been a tremendous effort.
What is coming in phase II? The first thing is, there is a saying, you have to eat your own dog food. We are going to harmonize our own formats between the different work groups.
We got some comments saying, they don't seem to tie together as much as they should, un-interoperable. So, we have to do that.
So, we have agreed on a common format for the work products, where we will categorize the criteria and show the source and references, show the priorities, availability, and the recommendations, and any lengthy discussions go into foot notes. So, I probably don't need to go through these. These are just cross walks that show how we move there.
The other thing we are working on -- and it is not completely clear whether we will have these ready by July 11 for this public comment cycle, is a first draft of use cases.
The first issue is, no one has clearly defined exactly what that means in this new world, but we consider them to be realistic patient care scenarios that you use for test purposes, and they would let you demonstrate that the product fulfills the functionality, interoperability and security criteria.
We also know that we are going to need to collaborate and develop common use cases with a number of other organizations in the new HHS health IT strategy. So, any that we develop would not yet be subject to that harmonization of use cases.
MR. COHN: Mark, can I hold you for just a second, because you are doing great. I do, I think, need to not so much remind you, but maybe remind the whole committee, as you know, we are in the middle of an RFP process, and this is a federal advisory committee.
I just want to make sure that everybody realizes that we need to ask you to be very circumspect in any discussions related to the RFP.
I don't see anything going on in the overheads that is a problem, but I of course have no idea what you may say about them.
MR. LEAVITT: I will stick to the overheads.
MR. COHN: I do need to sort of inform the committee members that, even though the thing that you may most want to ask has to do with the RFP process or whatever, you really are precluded from asking about it. I just wanted to warn you, this is also a conversation that we need to warn the next panel about also.
Do not feel in any way singled out on this one, but obviously it just is the awkwardness of the various federal processes.
MS. GREENBERG: In a way it just shows how prescient we are as a committee, since we invited all of you before we knew that there was going to be this process.
MR. COHN: The information is very valuable, and please go ahead. I just thought I should warn everybody about that.
MR. LEAVITT: That is good, and you are right, we have to be careful. I will restate, I think the fact that we are responding is public information. There is a list of the respondents.
The details of the response are not public yet, so we won't really talk about that, although it may be that at some time it does become public. I don't really know. So, you may get to see it in that manner.
It is very public what Secretary Leavitt has announced, and I am just going to show a picture that talks about that.
I think you are all aware he has announced this American health information community. You are all aware of the RFPs. That is public information. They were released June 7.
The first is a standards harmonization process. The second is a compliance certification and inspection process. We are responding to that.
The third is to be awarded to six contractors to develop prototypes for a national health information network.
The fourth is to develop privacy and security solutions for interoperable health information exchange, a contractor that will look at differences between state policies and provider organization policies, and try to sort out that very confusing situation.
If you drew a picture of what they are talking about, you read his announcements, and you see these four contractors working in parallel, and you see the American health information community and the national coordinator working together to synchronize what is happening, and also NIST collaborating. This is mentioned also, and having to satisfy multiple public and private sector stakeholders.
So, in terms of the view of the future, that is all I can show you, is that picture, and then I think I would like to stop and thank you once more for inviting me and ask if you have any questions I can answer.
MR. COHN: Mark, thank you. I do apologize to the committee for taking all the fun out of the questions, but I think the background and obviously the work, I think, is very exciting. Let's start with questions.
MR. HOUSTON: Nice job, really exciting stuff. Your pass fail certification, is that then updated yearly, or is it -- as you take different views, vendors may stay current, may not stay current. So, is that updated continually, and is that available on a web site as to whether somebody has pass failed?
MR. LEAVITT: Good question. Here is the structure. There will be criteria each year. So, we expect to update the criteria.
If you think of the 2005 federal gas mileage standards and the 2006 federal gas mileage standards, it is a similar model.
So, there will be the 2006 criteria and the 2007 criteria, and when a vendor applies and is certified against that, that is published on the web site, this product meets the 2006 criteria.
Now, that is permanent for that product and that version. So, they don't have to come back next year and retest against those six.
If they want to test that product or a newer one against the 2007 criteria, that is fine, or that same product against the newer criteria, but it doesn't invalidate the fact that they met that. It doesn't expire. We don't need to recheck the product.
MR. REYNOLDS: And you will include in each of your years if new standards come out or any of those other things?
MR. LEAVITT: That is the reason to have these criteria coming out every year, is the new standards. We couldn't possibly certify much in the way of interoperability in 2005 or 2006. So, we see that really coming on in 2007 and 2008.
MR. REYNOLDS: If this is available out there, one of the things we run into a lot is that the small physician offices really don't know the next thing that is going to happen or really don't know if this is going to be okay.
MR. LEAVITT: We hope this will help them.
MS. MC CALL: You actually touched on it in your response, but it has to do with certification for interoperability.
Given the systems that you have seen, do you see a big shift that is going to have to take place in existing vendors and systems, once interoperability comes on line?
MR. LEAVITT: That is another good questions. I think that the newest product developers have seen this coming.
So, I think the industry is going to be able to respond to this. The products that have been out there the longest will have the biggest challenge, because of the issue of all of the users that have to learn to do things a little differently when it is interoperable.
That is the reason to have this forward looking road map. One of the challenges we will have is, how do you deliver exciting new benefits quickly, in a way that doesn't disadvantage a substantial part of both the vendors and the end user market place.
MS. MC CALL: The 15 percent base, if they are all larger practices, are probably sitting on top of architecture that may not support over.
MR. LEAVITT: You raise an important point in terms of the timeliness. We need to take advantage of the fact that there is only 15 percent adoption, and that is why we are running so fast. This window will close. They will all become permanent systems and we won't have interoperability. That is why we are trying to make this happen so quickly.
MR. REYNOLDS: Another quick one. Do you see this structure fitting other things other than EHR?
MR. LEAVITT: This isn't a topic we have discussed. At the moment, we would like to certify a comprehensive electronic health record product.
Of course, the RFP, which is public information, asks the certification vendor to certify inpatient electronic health records in the second year of the contract, and the networks through which they interoperate, or the network components, in the third year of the contract, public information from the RFP.
We discussed certifying modules, the electronic prescribing module, the laboratory result module. Then you have to certify interoperability between the modules, so you can buy your lego blocks and they can snap together.
We decided it was probably too big and too difficult a task. So, we are not going to be offering certification for a subsystem that only performs part of the task. That is our current plan.
If we win the RFP and get into inpatient EHRs, that is absolutely subject to reconsideration, but right now, for ambulatory care, it is a small enough solution and generally a small enough set of functions that we are going to focus on the complete electronic health record.
MR. COHN: I am always wondering whether Harry was referring specifically to EHR systems, or whether this might be more generally applicable.
MR. REYNOLDS: That is exactly what I mean.
MR. COHN: I actually mean more like things like some of the HIPAA issues.
MR. REYNOLDS: That is where I was going.
MR. LEAVITT: We have no plans to do that in terms of the scope of our work. There is also evidence that electronic health records could benefit from this process, whereas the problems of the financial systems and the HIPAA issues in the financial systems are being already approached. There are approaches and solutions, and we decided that that probably is not within our scope.
MR. FITZMAURICE: I have a question that deals with coordination and collaboration. HL7 has an electronic health record technical committee with an interoperability subcommittee.
CCHIT has a work group on interoperability. It seems to me that they both will probably develop use cases for the electronic health record that both define definitions -- that have their own definitions of interoperability, but CCHIT will develop a certification criteria, the HL7 functional performance criteria will be developed by the HL7 committee.
A lot of this was started when the government financed or supported the development of EHR functionality that led to the draft standard for trial use of the electronic record.
So, I have a question. It is moving toward a finally balloted standard with conformance criteria for meeting that standard.
In your opinion, would it be useful to have the work of HL7 accelerated toward a final standard with coordination among HL7, CCHIT and AHIC for the government, or is it not needed because CCHIT is already moving forward and moving ahead.
MR. LEAVITT: Thank you, Mike. The certification body will not be developing standards. Although it doesn't really replace the work, it is actually dependent on the work of the standards body and, therefore, anything that helps the standards body arrive at its decisions sooner and more completely is good for us.
We actually see it as kind of a waterfall model. The standards body develops the standard. We figure out how to test against it efficiently.
However, since it is often the first time a standard is tested, we will have feedback. You know some of the elements of the standard are hard to test, or nothing does that, are you sure.
So, we will have some feedback for refining the standard. So, I guess, to the extent the standards are in the draft stage, we would like to work with them as early as they are available.
We are doing our prototype, we feed back information, then you have your final standard, and your final certification probably happens a year or two after that.
So, we see that as being a way we can work together, but we never want to be in a position of trying to originate standards within CCHIT. We just figure out how to test to them.
MR. VIGILANTE: Thanks, great presentation. A couple of questions. One, among the major vendors who have most market share, the five or six big vendors in the space, are they pretty much all represented in your interoperability work group and, if they are, what is the -- how do they play together?
That may be kind of hard to answer, but is it -- do you get a sense of commitment among them, that this is something that we really need to do, or this is we have to kind of show up and pretend to do something. That is part one.
Part two is, with regard to Mike's question and your response to it about wanting standards early and then testing against them, to what extent are the CHI standards relevant to that, and are you looking at them and potentially testing against them as well.
MR. LEAVITT: Good, thank you. On the first part of the question, how do you deal with the fact that the competitiveness of vendors, or the fact that there is some number of large ones, first, we can't possibly have every vendor represented. It is not congress. It is not an elected panel with one from every single panel.
In fact, we try to create a culture that says, when you come in the door or dial up the phone for your work group meeting, you need to leave your interests -- you bring your knowledge and leave your agenda behind.
Now, it is always imperfect, but that is the culture that we are trying to create, and so, they are there as industry experts, not as advocating for a particular vendor, because we don't have enough people to do that.
Steve Steindel is here. He is actually on one of the work groups, the functionality work group. Maybe I could ask you to share your comment, because you have been there in those meetings, about that topic.
MR. STEINDEL: I serve on the functionality work group, but I think I will address also some comments on the interoperability work group as well.
The functionality work group, we went through a kind of assimilation process within the group and the group process.
In the very first meetings, there was definitely the vendors' stake. People were saying, I have to represent my position. The providers were saying, I have to represent my position, et cetera.
By the time the third or fourth meeting went around, when the people were realizing they were working toward a synergistic solution, it started to get much more cooperative, and people left their particular company hats aside, and started to talk about this as a group process, where the vendors would input information not about their product, but about the products in general, and how the functionality we were talking about could be expressed in total.
It turned out to be very synergistic, very learning, when the providers would ask for something and the initial vendor feedback was, wait a minute, that is impossible, there would be a lot of further discussion and modification from both points of view, and creating a very, very good, what I thought became a stronger and stronger set of testing criteria, and also with respect to the road map.
Mark didn't stress it, but the road map actually is down at the certification criteria level. So, we could have a function that we want expressed now, that is not expressible, but we want it expressed at a very, very high level today from a certification criteria point of view, and drill down.
This gets to the question with regard to CHI, et cetera. Alicia Bradford, who is part of the CHI process, is the other federal person sitting on one of the certification commissions, and she is sitting on interoperability. The CHI is being brought up there consistently.
From the functionality point of view, as we heard, we are not ready to do that today but you will see, from the certification criteria, we start asking for standards introduction a couple of years down the line.
Those are referring to not specifically the CHI standards, but the actual like Snomed and HL7 and LOINC, that we would be using. So, it is feeding into the process.
From the interoperability point of view, I think to a large extent the same type of thing has happened, that they started off with individual biases and then developed into the use case process, and decided which use cases can be expressed over time, and how to introduce them.
MR. COHN: We have Paul and then Carol, and then we will wrap up the session. Before Paul starts, I just want to take a moment to acknowledge him.
Obviously, Paul is a member of the committee, but I do want to reflect back, that actually a lot of this started in terms of functionality with an IOM activity related to patient safety which Paul chaired.
I can still remember a weekend probably a year or two ago now where we actually all sat down and began to draft out the initial piece on functional standards and what sort of functionality was required, that subsequently became the work that subsequently was fed into HL7. So, Paul, I just wanted to reflect on that as well as acknowledge you for a second, before whatever question you ask.
MR. TANG: I think you will relate to this, because you are an electrical engineer as well, but in my remote past I did a little bit of design work for IBM.
In their integrated circuit test, your design had to be 99 percent testable using the external pins. I reflect on that because you talk about how some of this stuff you can't test, or you find it difficult to test.
Then this question that Mike raised about the separation between the standards development organization and the certification when, in actuality, if we separated the people who design circuits from the people who have to go out and test it, it may not match.
One thought is, don't you need to incorporate the testability criteria in your design process. So, in some sense, a criteria for setting standards really should be the testability.
So, instead of having a sequence of steps, get the requirements, go put some standards around it, and then figure out how to determine conformance. It should probably be mixed, because that is the lesson learned from the early circuit designers, because they had to have that kind of reliability.
In a sense, your process is talking about getting that reliability in this market. I should have preceded this, but I think your presentation was very clear about a very clear need, and addressing it in a very clear way, and I really appreciate that.
The second part, then, check me if I stray in terms of the RFP process, but you started out, of course, because there was a need there, and you created this organization that addresses that need very squarely.
Now we have this new RFP, and does the kind of persistence of the organization depend on this in any way? I don't know how to quite ask it.
MR.COHN: I don't think you can, Paul. I would judge that you are straying off into the RFP conversation. Is there another way you want to ask that?
MR. TANG: Let me try it. I am not trying to add to the RFP process. I am trying to say, do we only need one of these around? Is that part of the way of having this stuff coordinated, along the lines that Mike asked?
MR. LEAVITT: We believe you only should have one of these.
MR. COHN: Paul, thank you for rephrasing that. Carol?
MS. MC CALL: This is more of a food for thought question, and it is not just to you, Mark. It is actually to everybody.
How extensible is the model into different domains? In particular -- and I keep thinking back to what we are doing in the quality work group -- how extensible is it to the development of metrics and definitions and standards and, therefore, their certification in some way, perhaps according to a different -- obviously -- definition, and then ultimately their incorporation.
So, it is food for thought, but it is a delightful presentation today. It seems like an elegant and robust model, and I would just be curious as to your thoughts as to how portable the mechanisms may be, in your opinion.
MR. LEAVITT: Thank you. Again, I appreciate the support that you voice. This is going to be very interesting as we try to extend it -- again, the public and the RFP, that you are going to try to extend it to the inpatient world and eventually to the networks.
I believe extending it to the inpatient world is just a matter of more complexity but not fundamentally different.
Certifying the networks is fundamentally different and, in fact, the analogy, again, to use a simple one -- well, let's just use computers. We are certifying the plug. When we are certifying an EHR, we are certifying the computer and the plug on the computer, but the network that you plug into, that is the other side.
That is a different thing, and I think it will be much more heavily -- it is very technical. It is really a technical job.
When you talk about functionality of EHRs, you really get into everything, philosophy and values. The networks really should be a black box, when you put stuff in it comes out the same and no one could possibly crack into it and get information.
Then you turn it over to the engineers to make sure that it does that. So, I think it will be much less controversial and far more technical, and then we will just have to cross that bridge when we come to it.
MR. COHN: We are finishing off right now, I am sorry. We need to finish off. I would, however, sort of comment that actually this whole standards criteria, certification, really does apply to everything. I mean, it is really one of the values of the committee, where you have the high level view and then the question is, how do you really implement it. So, I think it really does fall in.
Mark, I want to thank you for a wonderful presentation, and I think it has been illuminating. I am sure the quality work group may want to, at some point, have you come, or one of your staff to sort of further discuss with them.
What I am going to recommend is that, given we are putting some breaks in here, let's take a 10-minute break to allow for the next group to come on, but once again, thank you very much for making time.
[Brief recess.]
MR. COHN: I want to once again welcome the panel. It is listed here as the ANSI health informatics standards board panel, but it is really, I think, also talking about the ISO TC, and sort of international efforts. So, we are obviously delighted to have you here today.
My understanding is that Audrey Dickerson will be starting, followed by Gary Dickinson, followed by Robert Owens, Bob Owens. I obviously want to thank you.
I do want to, once again, I think you heard at the last session, obviously given that we are in the middle of an RFP period -- and I think we have talked about this privately also -- but obviously we, as a committee, need to stay away from discussions of things related to RFPs, and you will see me moving in quickly if the conversation strays into that, if questions go into that.
In some ways, it is the most fun thing to talk about, but given that we are in an open period, we obviously have to follow federal rules. So, with that, Audrey, why don't we let you start, and thank you all for being here.
Agenda Item: ANSI-HISB Panel. Audrey Dickerson.
MS. DICKERSON: Thank you. Greetings. Today I am reporting about the status of international standards in the United States.
The importance of consensus standards was highlighted in Secretary Leavitt's talk on June 6 at the HIMS summer summit in New York City.
Using the examples of a clock and the historic march of the railroad across the continental United States, the importance os standards was outlined.
Standards are frequently written into laws and policies, such as appliance energy standards in laws in Arizona and New Jersey, IT security standards into policies in Georgia.
Globally, consensus standards are in wide use. In Japan, they comply with all international standards and in Germany, where the government standards building is 10 stories tall, a block long and a block wide, the German standards minister says that Germany complies with 85 percent of all international standards. The European Union writes SIN and ISO standards into laws and policies within each country.
In the United States, work with consensus standards groups is considered voluntary, and paid through an interested industry member, or out of pocket by the standards volunteer.
Standards are part of our lives every day. The reason we can use an electric plug for any appliance or a piece of equipment is that the plug prongs and outlets are standardized to specific sizes.
In banking, we are able to use a synchronous transfer mode on line, participate in commerce, and order airline tickets.
Without consensus standards, these would not be interoperable. Imagine a city or even a town where the stop signs were different colors and the road lines were red and green.
Long ago, in the field of music, someone decided that one nomenclature could be used for all types. Today, with many genres of music, they all use the same notes, lines, base and treble clef.
These are some of the roles for HIT standards. Currently, for most of the U.S. health care system, this level of interoperability has not been achieved.
HIMS gives the Davies award for EHR implementation to hospitals, ambulatory care, and public health. These are some of the notes after EHR implementation has occurred: access to specialists improved by 80 percent within two years, while unnecessary tests were prevented, less costly options for care were identified, and number of visits were decreased annually by patient, due to timely identification and resolution of health issues.
Medication turn around time from order initiation to delivery to patient decreased to .53 hours. Adverse drug reactions were reduced, as pharmacist time was redirected to working with physicians.
There was noted improvement in patient safety with compliance to ambulatory EHR problem lists that went up to 97 percent. Allergy documentation went to 100 percent, and pain assessment to 95 percent.
There was completed encounter documentation that, on the average, decreased from 5.2 days with paper to 1.3 days with an EHR.
Using standards, Dicom has revolutionized the radiology with filmless departments, and internet sharing of radiology pictures to a standard from ISO TC 215, called web access to Dicom persistent object.
Access to complete, consistent data for building best practices, research and public health surveillance is a future goal.
Consensus standards reduced technical barriers to trade, by providing a balance of interest between providers, end users, vendors and payers, with due process, using a method that addresses all comments, and a draft document and appeals process.
The cost of goods may be reduced, as standards can be used to settle disputes using a business plan. Sharing information provides involvement of affected stakeholders, and encourages economic research.
Demand has increased as consensus standards are implemented, tested and certified. The re-authorized technology transfer act, public law 104-114, national technology transfer and advancement act of 1995, provides a mechanism for cooperative research.
As part of the consensus process, ISO TC 215 was organized in 1998. The scope developed then is still relevant.
Standardization for health information technology to achieve compatibility and interoperability between independent systems, reducing duplication of effort and redundancies.
In the beginning, the technical committee for health informatics had six work groups and two liaisons. Today, we have eight work groups and over 100 draft standards in the consensus process, including our first clinical research document currently being balloted now in clinical genomics.
Some of the most important liaisons are listed here: The International Electronic Electrical Engineers, Health Level 7, Digital Imaging and Communications in Medicine, the International Council of Nurses, International Medical Informatics Association, International Electrical Technical Commission, Integrating the Health Care Enterprise, and Clinical Laboratory Standards Institute.
This September, in Japan, HIMS and ISO TC 215 are hosting a global summit. This summit will listen to HIT world leaders describe and discuss what standards are needed for global EHR interoperability, and how global standards developers can meet this need.
Our motto is, global standards used locally worldwide and, if you are not using standards, your competitor is.
Consensus standards are a recognized, credible, organized business method for achievement. All good ideas at not inside the United States.
Products for export that have one set of standards are cheaper to produce. Import products can be compatible with our needs, can reduce duplication and increase harmonization, can reduce errors, and increase patient safety, and we can have global interoperability. IT plays a key role in supporting the optimization of HIT consensus standards.
Currently, the United States enjoys approximately 60 percent of the market share of goods. However, a new country, China, has entered the world market place, including the market in health information technology.
Using and working in international consensus standards is necessary for the United States to become a full partner in global health information technology.
Health and Human Services, as a department member, would be leveling the playing field for all U.S. participants in consensus standards to the same as global counterparts.
As recommended subject matters experts join the U.S. delegation, the U.S. perspective becomes a part of each new standard published. The cost of goods decreases as genres develop, not new nomenclatures.
MR. COHN: Audrey, thank you very much. Obviously, we will have conversation and questions before all the presenters to. Gary, I think you are on next.
MR. DICKINSON: Good morning. My name is Gary Dickinson. I am an independent consultant. I am also chair of the U.S. technical advisory group to ISO TC 215, and I will be following up with further information from Audrey's presentation.
There is a handout of my slides, which includes the TC 215 work program, which you may have some interest in, identifying the seven working groups within the technical committee and the various work items that they are currently addressing.
The other thing I wanted to note is that, in the handout of presenters, you will see references to ASTM. Those are not current references. ASTM was the original secretariat of the ISO 215 and that was taken over by HIMS here two years ago. So, the references to ASTM are obsolete.
I wanted to identify that the United States is in a very strong leadership position within ISO 215. Obviously, the United States holds the secretariat to the committee in the form of Audrey Dickerson, who is the secretariat, and the HIMS organization that supports us in a secretariat role.
We have three conveners of the eight working groups. The United States has three conveners for three of those working groups, Michael Glickman, working group two on data interchange, Dr. Christopher Schute, working group three on semantic content, and Mr. Todd Cooper, working group seven, medical devices.
Also, we have a vice convener of working group four, who is Laurie Forquet. Working group four focuses on security.
We also have several other representatives in key positions within ISO TC 215. Dr. Ed Hammond has recently been appointed as the ambassador to developing countries, to try to draw in developing countries, those with emerging interest and efforts in EHR and also health information technology.
Solomon Apavu(?) actually leads two different groups within ISO TC 215, the consumer policy committee, as well as the e health task force.
We also, as a result of our secretariat, the fact that the United States is the secretariat of ISO TC 215, we nominated the current chair of ISO TC 215, who is Dr. Denel Sae Qwak(?) of Korea.
It is of interest to note that a number of U.S. ANSI accredited standards have been promoted to ISO. These are a few of them: the ASTM laboratory analyzer interface standard, the HL7 version three reference information model has currently been approved and is ready for publication.
The HL7 version 2.5 messaging specification has not been promoted to an ISO standard and is going through the process.
A series -- I don't know how many there are off the top of my head, something in the range of 15 different IEEE MIB medical device standards have now been promoted, or are in the process of being promoted through the ISO TC 215 process.
It is also of interest to note that the Dicom version 3.0, diagnostic imaging standard, is being promoted through the ISO process, and that will be a standard that will emerge by reference. Essentially, the ISO standard will simply be a cover pointing to the Dicom version 3.0 imaging standard, not a separate incarnation of that standard.
The U.S. Tag has currently 51 members, which includes a broad range of interests across the industry. Certainly providers, standards developers, professional and trade associations, some of whom you see here -- I don't know if this is an absolutely complete list, but I tried to grab as many as I could find. There are multiple members from some of these organizations. So, you won't see 51 total identified here.
Moving on, then, there are government agencies involved, vendors, academics who are also providers, and various consultants are also on the U.S. technical advisory group to ISO TC 215.
We have a good balance of stakeholders as you see, and a good depth of technical expertise in many topic areas. We do need to fill important gaps.
That is what this slide goes to, basically. You will notice that we have had good participation and influence in some of the working groups, particularly working group two on data interchange, working group three on semantic content, working group four on security, working group seven on medical devices.
We have what i would consider to be -- this is my assessment of our participation and influence -- moderate influence in working group one on data structure, but we have had minimal influence on two of the working groups, simply because we don't have the experts in our groups to apply to those particular areas. This includes working group five on health cards, and working group six on pharmacy and medication requirements.
The working group eight is newly formed, and hopefully we will have good representation, we expect to have good representation, in that space.
A key objective that has come out of a reorganization process within ISO TC 215 over the last year and a half or so is basically that ISO will not necessarily produce standards in the sense of writing them from scratch.
ISO TC 215 will, wherever practical, seek to meet the need for international standards by first adopting documents or standards produced by others, with only those amendments which are necessary.
Second, by encouraging other suitable bodies to develop standards to fulfill ISO TC 215 objectives, and third, by developing its own standards only where neither of the above is achievable.
The precedents for doing this, of course, is that we start with requirements, and I think this is something that is very interesting.
If you notice the work group structure within ISO TC 215, you notice there are two requirements work groups working group six on pharmacy and medications, and working group eight on EHRs.
It is a little strange to note that requirements seem to have been an afterthought of this process, and hopefully they are now emerging as something that is going to be important as a precedent to our specifications.
Ultimately, what we are looking at from the standpoint of requirements, of course, is the what and the why, what is the requirement, the why being the rationale for that requirement, but not necessarily the how, being the implementation details of the actual specifications for implementation.
This also sets the bench mark for achievement within the standards development process, allowing us, then, to g back and test the standards that are produced against the requirements that we sought to achieve in the first place.
Of course, that allows us to establish a road map for the future. So, none of the things we talked about in terms of fulfilling these development objectives can be achieved unless we know what the requirements are, and have a requirements based road map, where we can begin to fill that in.
The concern, of course, is that if we develop a road map simply by saying, well, we have this simple set of standards universally around the world, let's figure out where they belong, that really isn't a road map. That is simply a compilation of our historical vestiges. It does not give us necessarily a path forward in terms of a road map for future use.
The key issues for the TC as well as the U.S. Tag obviously are to gain participation of key stakeholders to promote, in particular, the user perspectives and objectives, including consumers, providers and health plans, who tend to be underrepresented, at least consistently underrepresented in many of our standards development activities. That doesn't mean they don't show up, it just means that they may not show up more than once.
Then, of course, to focus on the clinical care-wise focus, as well as the technical HIT-wise focus of our efforts. To ensure balance of producers and users, consumers of standards.
Continuing on with our key issues, we want to ensure global relevance across the bastions of EHR and HIT, which of course tend to be the more developed countries, to include, of course, the emerging markets in developing countries, as well as the various ways that medicine is practiced around the world in what I have characterized here as easter, western and alternative medicine, although I am sure that there are many others that could be added.
The other thing, of course, is to ensure the validation of standards. We have many, many standards that have been developed over many years that conveniently become shelfware, because they simply haven't passed muster of validation in real world implementations.
One of the key issues, of course, that came out of the previous presentation is to ensure that our standards have testable performance criteria, not just that we wrote a neat specification, but we actually have a way to test performance against that, from that standpoint.
So, what can government do? Obviously, the key question for this committee, hopefully, is to insist -- I am fairly dogmatic about this so that I can get to the core of it -- to insist on requirements first, to make sure that we know what problem we are trying to solve before we go off and try to write a specification to do something.
Insist that standards be developed as components of a strategic road map, looking forward, again, to requirement space.
Insist on credible broad-scale validation of our published standards, not just that we have got something neat, now we have published it, and it will become a missive to the world, but yet does not have appropriate validation to ensure its viability in the long term.
Again, the same thing I said before, insist on standards with testable performance criteria, and to ensure, obviously, the competent performance measurement process, which is what we just talked about with Mark Leavitt's presentation.
One of the things we found, when we did the HL7 EHR TC work on the EHR system functional model, was that it was very helpful to have expertise, to be able to draw in expertise that would not otherwise participate in the process.
One of the ways to do that was to facilitate their participation, to help them with travel, meeting fees nd those kinds of things, not necessarily paying them, although a small stipend would be useful as well, but basically to identify experts.
That would certainly help our process, that would not otherwise be involved, by giving them some modest inducement to participate. So, that would be my other final recommendation for the government. Thank you.
MR. COHN: Gary, thank you very much. Bob Owens?
MR. OWENS: Good morning. I am the chairman of the informatics standards board. I was really struggling as to what to present today in terms of an update, given the events of the last 30 days.
We just had our standards meeting last week, where we took some key votes in looking at what we can do to facilitate coordination across the industry and moving forward.
In fact, if you notice, I came in a little late. I was still on a conference call this morning, continuing to work on documents to that effect.
What I thought I would do is, it seems that health care continues to try to carve itself as a unique sector of the United States and it relates to standards, and it is really not.
I think it is important that at least this committee understands some of the basics as to how ANSI came into being and what the standards board participation has been to date, and its commitment moving forward, or ANSI's commitment moving forward.
In a voluntary standards system, this is kind of the overview of what I thought we would go through today. How did the standards system evolve, what has been ANSI's role, what are the legislation and regulations that govern the use of standards by government agencies, who is using them, and then some brief information on the health care informatics standards board's accomplishments to date, realizing that there are several, again, key things that we have done, and mindful of the RP discussion that we need to just, I guess, speak in generalities at the moment.
The U.S. standards system is a bottom up dispersed system. What that means, it is kind of from the grass roots SDO level, and from those that are involved, similar to the American Revolution of fierce independence, that you duke it out down below, and then what rises is the cream to the top, and at that point in time you start to forge the steel and eventually have a solid product.
If you look in the European countries, the governments are, in fact, very much a part of their standards development efforts, and where they pay for the development of the standards, and pretty much dictate, from the top down, exactly what standards are developed, how they are developed, and how they are implemented.
That is why you see, in the European community, a lot more standards adoptions, because it is a top down system.
In the United States, especially since 1995, you have seen an increase in the use of standards by the government agencies for both procurement and regulatory purposes.
ANSI itself is dated back to the late 1800s, early 1900s, when you had all these different IEEE, the National Fire Protection Association, American Society of Testing and Materials, and so on and so forth, that came to be.
Basically, after World War I, in 1918, the Department of Commerce, in working with ASTM, IEEE, decided to form this new thing called ANSI, and then worked basically through NIST as a member of ANSI in the Department of Commerce, working together to form this private and public partnership to basically manage the standards administration for the United States.
What that means is also that all standards kinds of activities are, in fact, managed in that joint partnership.
In 1947, as a result of World War II, basically it was the air lift, that we were moving supplies over to Europe, and we needed a way to basically ensure that the information that we were talking about in the depots, both here and in the United States, and some of our allies over in the European area, we were talking apples and apples, again getting to some discussion of interoperability. So, ISO was created.
ANSI is one of the founding members of ISO and is, in fact, the only pathway from the United States to the International Standards Organization community.
Specifically, how does that tie with what Audrey and Gary are doing? Basically, ANSI has delegated its responsibility for secretariat to him but, in fact, continues oversight and review of the ISO TC 215.
ANSI's board, the health informatics standards board, is one of the key issues. Actually, it was around the table there where we actually said we needed to take our standards in the United States to the international community and really promote interoperability.
It was really out of that health care informatics standards board that ISO TC 215 was birthed. We went and initially had 11 countries sign up for a meeting in London, and eventually it became the committee that it is today.
Throughout the 1970s and 1980s, there were different attempts by the federal government to look at how do we get better control of the standards and develop a strong affirmation of the private sector leadership.
In the 1990s, it basically started with the different legislation and regulation that was coming out, the National Transportation Act that was mentioned earlier, 104-113 and OMB 80-119.
The basic principles of the U.S. system basically come down to these five things: openness, that anyone that wants to participate or has a dog in the fight, as it were, has the ability to be there -- balance, that you don't have any of the room loaded by any one area, transparency, due process and consensus,
Sometimes we tend to joke, but sometimes it really is reality. Consensus could be a level of disagreement that everyone enjoys.
The structure of the U.S. standardization system, ANSI is the coordinating body for the private sector to accredit its SDOs.
It looks to support itself through membership fees and sales of publications, so that it is self sustaining, and it looks at getting entities that are appropriate to coordinate the standards throughout.
NIST obviously is coordinating the government part of that, and looking at the lab accreditation research specialized area.
The standard developing organization is really where all the work happens, and they can be made up of independent professional organizations, trade, and exclusively standards groups, basically those that are only in the business of creating a standard.
There are a lot of SDOs out there. Not all of them are accredited by ANSI, but a lot of them are. To get accredited by ANSI, again, you are assuming that that basically is giving it the assumption, and we audit the fact that they adhere to those five principles that I showed you earlier.
In the law, the National Technology Transfer and Advancement Act in 1955, HIPAA, which you are all familiar with, the Telecommunications Act of 1995, Consumer Product Safety Act.
In public policy, it is OMB circular, the Presidential Order, basically directing all federal agencies to use standards related activities and guidelines.
The Department of Defense is using the standards. Here are different agencies that, in fact, have either adopted or, in some fashion, implemented the voluntary consensus standards. As you can see, it goes way past the health care sector.
Again, rather than just bore you with all the details of operating policies and procedures, I would encourage you to go out there, read the procedures for accreditation, at least at a high level, so you get a familiarity of what ANSI is really about, versus it is not this big, bad brother in the sky, it is about ensuring due process and ensuring that the U.S. standards system is the best that it can be.
The other thing that you will see out there is links to three organizations that are basically key within ANSI right now.
The HSSP is the Homeland Security Standards Panel. The NSP is the nanotechnology panel, and then ANSI HISB is the Health Care Informatics Standards Board, which is ANSI's only board, and responsible currently for informatics within the health care sector.
This, again, just goes through some of the specifics relative to either congressional action, or Presidential orders and the like, as to what specifics are out there quoted in terms of standards being used.
The key thing here is -- this is -- you look at, in 2003, a direct response to the congressional GAO report. The homeland security panel was established to basically coordinate standards across the entire United States as it relates to homeland security, and I should add that it is not just the United States.
Part of homeland security involves international coordination, especially when you get into the intelligence and other activities necessary to really affect U.S. security. This panel is responsible as it relates to those standards activities.
Then the White House Office of Science and Technology Policy called upon ANSI in 2004, basically to come together and create nanotechnology standards, so that there could be, in fact, terminology, nomenclature, and coordination of the various standards toward a fast track implementation of nanotechnology.
Both of these organizations are broad based, inclusive, and I should add the difference between a panel and a board, within ANSI's eyes, a board is made up of ANSI members, a panel is made up of both ANSI members and non-members. So, that is really the distinction that you should look at, as we look at the three different areas.
In terms of the health care informatics standards board, we actually evolved from a panel structure many years ago.
It was looked at, that basically the panel was going beyond perhaps its scope as a panel, in coordination, and getting more into the development, which made it more into a need for a governance board. So, it was transitioned into the board.
I believe it is between 10 -- we are trying to look at history -- between 10 and 15 years ago. The mission of the Health Care Informatics Standards Board is to provide an environment that facilitates, coordinates, harmonizes and promotes the use of national and international health care informatics standards.
The purpose is to be the coordinating body for the development efforts in health care informatics standards in the United States, and represent the interest of standard development organizations, as well as the interests of the users, consumers, hardware and software developers, suppliers, and the rest of the stakeholders, again, looking at trying to ensure that a balanced representation is there.
We monitor and publicize and facilitate the development of common conventions for data structure, basically looking at different activities and what we can do to harmonize the U.S. Tag.
We coordinate with them, obviously, to ensure that what goes to the international community is consistent with what we are doing in the United States and vice versa.
The guiding principles that we have basically developed in the Health Care Informatics Standards Board -- and Simon, I guess you were actually one of the co-authors with Chris Schute, on a common reference model for health care information way back when. That is an approved ANSI guiding principle as it relates to vocabulary. So, thank you for that effort.
In terms of the terminology model, common models for implementation of health care information exchange, and a common trust framework for privacy and security.
In the last few years, we got the SDOs to basically agree on an approach for coordination and conflict resolution, in essence, how do we deal when you have more than one standard for a particular space, and how do you do your thick gap analysis and the like.
That is done. In fact, because the SDOs have signed up to be governed by that protocol, it has the teeth now to be able to help manage through that process.
A strategy to address health care informatics requiring harmonization and interoperability, and the U.S. knowledge base, those three, standard road map, basically NIST is working with the Health Care Informatics Standards Board on a road map project, that will create the landscape for all health care informatics standards, if you will, what goes where. We will look to the SDOs and other interested parties to bring that in, and we will have that road map.
You also have a U.S. health information knowledge base, which is basically a semantic data base that is developed based on an ISO standard.
We started off with the HIPAA standards, but we will look to continue to expand that in both of these tools, to give the SDOs a place to put their work efforts, so that it has a common presentation and a common cross reference, and a common use tool across the industry.
In summary, ANSI obviously has a proven track record, we believe, for standards coordination, not just within the health care sector, but within the entire United States and globally, for that matter, as it relates to the ISO, and being a founding member of such.
It is working, ANSI is working, with its current health care informatics standards board to raise the collaboration coordination to a new level. I am going to stop there, at the moment.
ANSI is the pathway that all United States based standards organizations need to go through to participate in the international standards community, ISO.
As steward of the U.S. standards strategy, ANSI will continue to respond to both public and private sector standards coordination needs as they arise.
We have kind of -- just one note on the RFP. ANSI has kind of taken the approach that, regardless of who wins any of the RFPs, at the end of the day, ANSI is still the body responsible for coordination of standards within the United States. So, as such, it will have to be able to work with whoever wins.
MR. COHN: Thank you all very much. I think it was a very interesting set of presentations.
Agenda Item: Questions and Discussion.
MR. COHN: Obviously, it is time for questions and discussions. I guess I wanted just to ask, just to start off, and this is probably more of a request for something coming back to us as a document.
I think Audrey is probably the one to ask on this one, but I noticed Gary sort of gave us a list of U.S. standards that had become ISO standards. I am not sure if that was a complete list or just some examples.
I think it would be useful for us to receive something where we could actually see U.S. standards that had been approved, as well as other standards that were not U.S. standards that had been approved, this sort of issue in the pipeline, so that we could sort of review that. If that is something you could provide us, it would be very useful.
MS. DICKERSON: Yes, I can provide that.
MR. COHN: I don't mean the 100-page version. I was thinking of a page or two letter to sort of help us with that. Thank you.
MS. DICKERSON: There are quite some interesting standards that are making their way through now. One, of course, is the European EHR document. That is being balloted for the second time.
There are two draft documents now on the table for identification. Then there are, of course, all the messaging standards, the clinical genomics one that I mentioned, that we are looking for a U.S. expert for.
There are no standards currently in the clinical genomics area, and this, of course, would be for hypertext mark up language.
Then, of course, there are all the security documents, PKI and a group of them. So, there are a lot of things going through the international area.
MR. COHN: If you would reflect in the note about things that are sort of in process, that would also be useful.
MR. STEINDEL: this isn't a question, Simon, This is just a comment on the very nice presentations, and timely.
I got the sense there was a specific recommendation and a general recommendation. The first was an HHS representative to ANSI.
Right now, HHS functions through an FDA representative to ANSI, and it would be very nice if that was formalized at the department level. That is just a comment on that recommendation that was made.
Second, there was an undercurrent -- I don't think it was a specific statement, but very clear that there was a feeling that the federal agencies should be more involved with the international standards setting process.
I will say, from my point of view at CDC, I have difficulty getting the agency involved with international standards setting, unless there is a clear statement from the department that we be involved.
So, it would be useful if the committee felt we should go in that direction, for a recommendation to go forward. So, I thank you for both of those.
MR. COHN: Michael, is this on this issue, or a different issue?
MR. FITZMAURICE: It is on the testimony.
MR. COHN: What I was just going to say that that issue, I would actually look to our standards and security subcommittee to come back with some thoughts on that, and that may be a subject for a letter or whatever. I am just kind of looking to our co-chairs here, to refer that as an agenda item for them to consider.
MR. FITZMAURICE: I have a short question for each of you. For Gary, I am not sure that you mentioned -- maybe you did and it just slipped me by -- that unlike the United States have laws that they must follow ISO standards. Could you name a couple of those countries? I don't mean this to be a test or anything.
MR. DICKINSON: I am not sure. Audrey referred to Germany.
MR. FITZMAURICE: I think one of them is Japan, and I think the European countries have to follow things that have been ratified by SIN and SIN and ISO have virtually the same standards.
MS. DICKERSON: There is the agreement. It took me a while, when they say the VA agreement, I automatically think Veterans Administration, but in ISO language, the VA agreement is the Vienna Agreement that says all European standards and ISO standards that are developed in the same space are just balloted once.
Then they are written, not because ISO says they have to be, but because each of the countries takes the standards and then writes them into laws.
MR. FITZMAURICE: So, international standards certainly are important for them, and probably becoming more important for us as they get more and more into the health domain.
Audrey, you mentioned that China was a growing country, and that that is one of the reasons why the United States should be involved in the ISO standards, among many other reasons.
Has China expressed interest in, or does China currently participate in, any of the ISO technical committees, and have they expressed any interest in the health technical committee?
MS. DICKERSON: China is currently a member of ISO TC 215. We have two levels of membership. We have the participating level, of which there are 24 countries, and we have the observing members, which are 16.
In order to change from observer to participator, all they have to do is send a letter. China is currently an observer, and they are considering becoming a participating member.
They have recently opened their own China informatics institute for standards, and part of that is their health standards. So, they are really moving far.
In addition to that, ISO is part of a group called MOUMG, which is the memorandum of understanding management group.
ISO is a part of that, along with the International Technical Union, IEC, and the UNECE, which is the commission for Europe.
The four of them together form a group for business process and health. TC 215 has a seat at that table. The next meeting is in Bejing.
MR. FITZMAURICE: Point well taken. A question for you, Bob. It was an outstanding primer that you gave. You gave a history of standards that I didn't know about, and I have been involved in them for quite a while.
From all of you, I have learned a lot of things that I didn't know before. Maybe I should have, but I just didn't.
You mentioned, in talking about one of your slides on HISB accomplishments on the common approach to coordination and conflict resolution, you mentioned something about a new protocol, I think.
I am not sure if you mentioned the word teeth or not, and then later on, when you were talking about a summary you sid there are some discussions with ANSI.
I am not sure if you said you couldn't talk about them, or they hadn't been resolved. Is there something changing in the methods by which the Health Informatics Standards Board coordinates across the standards bodies?
MR. OWENS: I think you are asking two questions. On the first question, the protocol, yes, there is a protocol.
What we did, we basically worked with the SDOs and, in fact, we created a work group of the SDOs and other interested parties to develop their criteria under which they would like to be, I guess, governed, managed, relative to standards conflict issues, including the appeals process and all of that.
Until, frankly, the RFP let, we had the protocol. All the SDOs agreed to be governed by it and, in fact, we actually used that protocol for three instances within health care, and actually ANSI adopted that same protocol to deal with the telecommunications issue in another instance.
So, it is tried by fire that it works. Recently, ANSI said, well, since the SDOs had all signed up on it at once, or under that protocol, that we could, in fact, give it teeth and actually look to the board to be the arbitrator, if you will, in using that protocol toward a decision, if necessary.
Again, today, the three or four issues that have been brought up within the health care informatics standards board have been resolved in using that protocol, but obviously there is still duplication in the industry. So, a lot more of that type of thing needs to occur.
In terms of the second question, where do we go from here, obviously the RFP is a statement that more than ANSi members need to be at the table, and moving the health care industry forward.
This is where I look at it as basically everyone, for whatever reason in the health care community, has seen the need to create their own sand boxes.
I think the RFP process, and what Dr. Brailer's office is, in fact, challenging us all to do, is to rethink the notion of, we all need our own sandbox, and create one big one in which we all can work.
ANSI is basically the coordinating entity for all other sectors of the United States for that very purpose. So, it would only stand to reason that they would look at what they need to do to make that happen.
As I said earlier, the difference between a B and a P is that boards typically require ANSI membership under the ANSI charter, and panel members do not.
So, we are looking at what kind of an organizational structure would be necessary in the health care space to, in fact, make coordination happen, regardless of who wins the RFP.
MR. COHN: Thank you very much. Paul, I think we will have a final question and then we will wrap up after this.
I am just reminded that, obviously, as part of the charge and charter of the NCVHS, the international standards and international issues do fall into all of this. So, I would remind subcommittees that this really is an area that we are concerned, and want to make sure is successful. Paul, last question and then we will wrap up.
MR. TANG: Thanks for your presentation. It was very clear and helpful, and it is very clear from the whole community now that the need for standards is there, and what SDOs and the accrediting bodies and organizing bodies contribute to that.
Drawing an analogy, let's say, as people need YFI standards, or other standards about plug and play, it is really vendors getting together to make that happen so that it is transparent to the consumer.
In some sense, that is sort of the way it has been for health care with the messaging standards, because it really doesn't matter to the doctor or the nurse or whoever is using the system, how the information gets from one place to another.
As you move to the realm of functionality, in particular in the clinical space, it seems like you really need clinicians participating in a real way. I think that is part of what Gary is saying in terms of the requirements and specifications.
How do we get from the people involved in these standards development processes intimately. You observed that there is enough end user, clinician, participation in the process.
One limitation, of course, is the travel money, but the other is they are just involved in their practice. What other ideas do you have for pulling in these folks to get really vetted both the functional requirements as well as the work flow, which is so critical to making it accepted?
MR. OWENS: To my last statement, I think that is really what we are looking at. There are associations -- the American Medical Association, American Dental Association, American Association of Cardiology -- all of these folks represent a constituency.
So, that is expertise that you want at the table. Not all of them are perhaps ANSI members or care to be ANSI members.
So, in order to get the input, we need to look at -- or ANSI is, in fact, looking at -- what opportunities do we have to change, or what is it that we have to change in perhaps an organizational governance structure to allow those to come to the table.
The other side of that is, not only do you want to make sure that it is truly provider driven. You want to make sure it is consensus provider driven, because you don't want any one provider coming in to the table representing how they do it in their particular practice or institution, and have that become the way for the entire United States.
So, I think it is about balance. I think it is about looking at morphing an organization within health care that, again, gets rid of the multiple sand boxes, and forces all the constituencies to work together in a single sand box, toward a common solution that works for all.
MR. TANG: Can I follow up a little bit?
MR. COHN: Briefly.
MR. TANG: The challenge is, we have heard about the need for global standards. You can't get the provider -- I am not sure association representatives necessarily will infuse the information -- I know you agree with that.
How do we take the process to them? One of the ways that we used for the HL7 draft standard approach was to actually do the regional bus trip, to try to get more information from the field.
Maybe there is -- maybe the question is, are you thinking about ways of getting to them, rather than actually holding it in international places, which makes it completely inaccessible.
MR. OWENS: I think what we are looking at, if you look at what the industry is basically asking or being required to respond to, is come up with an approach that determines your requirements, that determines specific use cases, that determines specific standards gaps and analyses that are tested and vetted amongst a great constituency.
You look at the culmination of all of that effort toward an outcome that vendors can take and implement. At the end of the day, a particular provider will probably rely heavily on their particular information system vendor to give them what they need to do what it is they need to do to practice.
I think working collectively in that broader scope of activity, which really does go beyond true traditional standards development into a whole use case, and into a whole testing and methodology, that that whole group of stuff, if you will, culminates into an information system that, through tried and true efforts, the grass roots practitioner can provide their input like they would in any other type of a user group, through a system vendor, and hopefully that information would continue to bubble up through the system.
MR. COHN: Thank you all. I think we need to wrap up at this point, and I want to thank you all for some very interesting presentations.
As I said, I don't feel this is the end of the conversation, but really the beginning of it. Audrey, I will look forward to getting a document from you which I can share with the rest of the committee.
Obviously, a piece of this is clearly an item for the standards and security subcommittee, to come back with some thinking to the full committee, but I do want to thank the three of you for some really very interesting discussions.
Now, what we are going to do is transition to I think our final presenter of the day. Dan Friedman, I have seen you sitting over there. Is your stuff on the computer, do you need to load it on, or do you have anything?
Anyway, we are very pleased to have Dan Friedman come and join us. What I am going to suggest is that we have this presentation and then we will take another 10 minute break and then we will go into our last session, once again, finishing at 1:15.
Dan, obviously, I want to thank you for coming and joining us. You can tell that I am incredulous that you don't have power point. I have become so dependent on them, that it is hard to imagine giving a presentation with them.
We want to thank you for joining us. As everyone knows, Dan is a former member of the NCVHS and actually was the lead on the 21st Century vision of statistics.
I think we also commented -- and Marjorie, yesterday, actually wore an outfit that went with the cover of the new book that you have, I think, been editor of. So, once again, I want to congratulate you on that.
Obviously, when I talked to Dan a while ago, I had heard he was doing some work for NCHS looking at health information infrastructures in other countries, and that there may be some learnings for us around all of that.
I don't think this is the end of the conversation on this particular topic, but I wanted him to come today to at least introduce the topic and get us thinking about it. So, Dan, thank you for coming.
Agenda Item: Health Statistics and National Health Information Infrastructure.
MR. FRIEDMAN: Thank you, Simon. Before I get started, what time do you want me to end, or what time do you want the discussion to end, Simon?
MR. COHN: I would think 12:10?
MR. FRIEDMAN: Okay, good. What I am going to be doing is providing you with a status report on a project that is currently in process on the relationship of health statistics to national health information infrastructures.
I am using the phrase national health information infrastructures advisedly, and I am using it as Dr. Brailer has suggested, with a small n, small h, and two small is.
I am going to start by making a few preliminary remarks, then talk about the purpose of the project, a few words on background and methods, and outline of the final report, and then provide you with a little bit of current status information in terms of nation snapshots on the relationships between health statistics and national health information infrastructures, and then some discussion of some very basic analytic issues.
What I am going to try to do, Simon, is talk for probably around half an hour, or until either you raise your hand and say this is excruciatingly boring, or until I lose my voice.
Preliminary thought, first of all, thanks for the invitation to come today. The work that I am going to be presenting, as I will make clear in a couple of minutes, is very much an outgrowth of work that was conducted here at the committee, both an outgrowth of the work that was conducted by the NHII work group, as well as the joint NCVHS NCHS HHS data council work group, dear departed work group, on developing a health statistics vision for the 21st Century.
When I was a member of the committee, I was really privileged to work with Simon and Jeff and Don Detmer, John Lumpkin, Barbara, Paul Newacheck, as well as certainly Debbie Jackson and Marjorie.
I really appreciated the opportunity to be on the committee and, as I said, I appreciate the opportunity to be here today.
I also should mention that Ed Sondik came to the committee, I think it was in 1997 or 1998, with the idea and the request that ultimately became the project for developing a vision for health statistics for the 21st Century, and Ed also is essentially the sponsor of this current project.
Then, in addition, my final thanks go to my friend, Steve Steindel, as well as Dave Ross, of the Public Health Informatics Institute, both of whom have been extremely generous with their time, their insights, and their support as I have tried to wend my way through this somewhat overwhelming project, as, indeed, has my friend and constant collaborator, Ed Hunter.
As I said, this is a work in process and I am here today seeking your reactions, comments and suggestions. I am especially interested in some discussion of terminological and conceptual issues that I am going to be pinpointing.
I should also indicate, for most of you who don't know me, that I am not an informatician. I am not a medical informatician, I am not a public health informatician. I am a public health information content guy, with all of the advantages and disadvantages of that.
In conducting this project, at times, I have often felt a little bit like a stranger in a strange land, and partially, as a result, in writing the final report, which I am doing now, I have been doing what I think of as defensive research and defensive writing, which means that the report is about half done and it already has over 100 pages of text, 30 pages of references, 15 pages of tables and figures, et cetera, et cetera, which is what one does when one is really unsure of whether or not you know enough.
The overall purpose of the project is to develop a more specific assessment of the potential contribution of NHIIs, and especially sharable and shared electronic health records to health statistics.
The specific purposes include describing the current status of national strategies for shared EHRS in Australia, Canada, England and New Zealand, especially as they relate to health statistics.
Second, to summarize key themes relating to the potential of shared electronic health records for health statistics and barriers to achieving that potential that emerged during interviews with key informants in those four countries.
Third, to summarize key themes emerging from key informant interviews in the United States. Fourth, delineate major analytic issues and the relationship between shared EHRs and health statistics. The fifth, to propose a brief set of next steps for the United States.
Background, as I said, this project is a direct outgrowth of two previous NCVHS activities, the work group on national health information infrastructure that, in November 2001, issued its report on information for health, which I am now holding up. It is an attractive light blue color.
In that, and on the cover, there was this basic graphic. In any case, on the cover is a graphic of three intersecting circles. One of those circles is the health care provider dimension, another the personal health dimension, and the third, the population health dimension.
In the report, we described that graphic as a means for conceptualizing the capture, storage, communication, processing and presentation of information. In other words, data sources, data collection, data streams, data analysis and data dissemination.
In the report of the next year, on shaping a health statistics vision for the 21st Century, we tried to build on the NHII final report.
In that report, in the health statistics vision report, we stressed the themes of, collect data once, use it many times, re-purposing data, and consolidating data streams, and those themes were also expanded upon in the book that I understand Ed Sondik and Marjorie were hawking yesterday.
The project can also be seen in the context of the July 2004 framework for strategic action both for improving population health strategy to streamlining quality and health status monitoring, as well as Dr. Brailer's January 2005 letter to the committee.
Underlying the project purposes is really the question of whether the basic vision of collect once, use many times, and re-purposing of data is possible and, if it is possible, is it feasible.
Can, in fact, we consolidate data streams within public health? Can we consolidate data streams for clinical care, population health and personal health.
Is it possible? Is it feasible? Is it a process of endless striving for an unattainable goal, or is it a reasonable expectation for a reasonable and achievable product.
As Dave Garretts of Healthlink has indicated, we need to focus on both the completeness of the vision as well as our ability to execute the vision.
Some of you may have heard this story, and I apologize. My mother was a public health pediatrician, who was in her early 90s when I was on the committee and working on the health statistics vision process.
She never worked for CDC, but she was always a big booster of CDC. I used to talk to her about the work, and I explained that I was going to CDC to do a presentation. Ed Sondik and I were going to do a presentation on the health statistics vision process.
Her parting words to me at the time were something to the effect of, well, dear, I hope that Dr. Copeland enjoys your hallucinations.
That really was at the nut of it, and is at the nut of it. In Australia, the key informants that I talked to described the notion of collect once, use many times, re-purposing, replacement of population health data streams with data from a shared EHR as nirvana, and that was not said in a complimentary way. It was said with the connotation of an unattainable idea.
In New Zealand, it was described by some of the people I spoke with -- only some -- as the holy grail, again, as an unattainable ideal.
In the United States some of the people -- certainly not all that I spoke to -- described it as science fiction.
Terminological issues. As I said, Dr. Brailer has termed NHII a term of art and, as I have gotten more and more into this project, I have grown sympathetic to that characterization.
What I am really focusing on is national strategies for shared and shareable electronic health records, and elements that support them, with EHRs defined here as longitudinal, hopefully cradle to grave, collection of patient-centric identifiable data that are cross provider and cross sector within health care, not necessarily the desk top record, and not necessarily a single record kept in a single location.
This really draws upon the National Health Service definition way back in 1998 of electronic health record, where they distinguish between the electronic patient record and the electronic health record.
It also draws upon the ISO TC 215 drafts of definition, scope and context of an integrated care EHR, where they really try to separate the notion of the EHR as a repository from the notion of the EHR as a system.
Health statistics we defined as numerical data that characterized the health of the population and the influences that affect its health.
Methods, as I said, there are four countries plus the United States, where I have been doing my research. All of the research, I should add, has been done over the phone and in the comfort of my home basement office. So, this has not been in any way a junket.
The research has been of two different types of work. One is materials review, where I have reviewed just pounds and pounds of government and other reports, web sites, presentations, and articles in peer reviewed and trade journals.
At last count -- and I am not trying to do a complete census. There are probably at least 30 internet based journals that have sprung up since 2000, many of which are country specific, that deal with e health and related issues. It is quite remarkable and quite overwhelming.
Then, the second, in addition to materials review, has been a series of key informant interviews. These were initially funded only for the United States, but I rapidly learned that it is absolutely essential to talk to people in order to be able to separate out the brochure-ware aspect of government reports from, in fact, what is going on.
As one person I spoke to in England said, the NHS reports, he described as being useful for pushing the agenda and the time frame, rather than as actual documentation of expectations of achievement, or actual documentation of actual achievement.
This was really brought home to me when I spoke with one person in Australia, who was a national level population health information content guy, very knowledgeable about what was going on in the United States and other countries.
He was talking to me in a very complimentary way about what was going on here in the United States. I mean, he was just glowing in his praise.
He said something to the effect of, you really have it knocked in the United States. You have got the vision and you are implementing the vision.
I said something like, could you expand on that. He said, sure. There is this report, and it shows this diagram of three intersecting circles, and it shows that population health data and clinical data and personal health data are all one and the same, and that is what you are doing there, and I wish we could do it in Australia.
That really brought home to me how little one can tell in terms of what is actually going on from reading government reports.
I have interviewed around 100 people, including 16 in Australia, 18 in Canada, 20 in England, about a dozen in New Zealand, and about 30 in the United States.
These have all been informational interviews. They are unstructured and largely informal. They have been tailored to each respondent.
If I were starting all over again, I would do it a little bit differently. I did have some basic issues that I tried to cover with everybody.
The types of respondents included people at the national level with responsibilities for population health monitoring and research/health statistics, as well as people at the national level for the development of shared EHR agendas, and people at the sub-national level with similar responsibilities, as well as people with clinical and particularly clinical informatics responsibilities.
The final report is in process, as I mentioned, and in it I am going to try to very briefly put the development of national health information infrastructures into a health system context, because that is something that we typically ignore or just sort of assume, but I think is very important. It is not going to be a full discussion.
Then I will be providing the nation specific snapshots and, since the nation specific snapshot chapter is already 60 to 70 pages, I need to think of another word to substitute for snapshot.
In there, I am going to be describing the locus of national responsibilities for shared EHRs, current status and plans, EHR definition, country specific, NHII elements related to shared EHRs, EHR storage, patient and provider participation, patient identification, and uses for population health monitoring and research.
Then there will be a chapter on key themes from the four country interviews, key themes from the United States, and analytic issues.
What I am going to try to do is spend five minutes, maybe 10 minutes, and see how far I can get with some information about my assessment of what is going on in the four countries, and then I am going to wrap up with a quick discussion of some analytic issues.
Why don't I -- Simon, you are the chair. Australia, Canada, New Zealand and England. I definitely want to spend a few minutes on England. Why don't you choose another country.
MR. JAMES SCANLON: Why don't we start with England, actually. Everyone thinks they are the furthest ahead.
MR. FRIEDMAN: All right, so I am going to start with England, and then I am going to circle back around and I can come back to Canada.
MR. COHN: That sounds fine, and then I do want to, at the end -- I am sort of getting from your presentation that you are obviously in the midst of writing this also.
So, I do want to also offer up the option -- I think what you are saying is fascinating, even if you aren't using power points, and we may very well want to have you come back for sort of an update in September or November. So, you don't have to feel that you have to cover the whole world.
MR. FRIEDMAN: I would be glad to come back and, frankly, one of the reasons -- and I perseverated over this with Marjorie and Debbie and Hunter -- one of the reasons I decided not to use power point is that I really didn't want to have these comments memorialized on the internet.
Th