VISITING COMMITTEE ON ADVANCED TECHNOLOGY (VCAT)
MINUTES OF JUNE 9-10, 2009, MEETING
Ehrlich, Gail, VCAT Exec. Dir.
NIST Leadership Board
St. Pierre, Jim
Bloch Consulting Group
Healthcare Information and Management Systems Society (HIMSS)
Federal Technology Watch
Department of Energy and Pacific Northwest National Laboratory
Note: Each of the presentations summarized below are available from the June 2009 meeting agenda on the VCAT website.
Call to Order and VCAT Agenda Review
Dr. James Serum, the VCAT Chair, called the meeting to order at 8:27 a.m. He reviewed the meeting agenda which will focus on NIST’s role in documentary standards, with two case studies in the areas of Smart Grid and Healthcare IT. The Committee will also comment on the correct balance between NIST research in these areas and the support for related standards. The VCAT Vice Chair, Dr. Vinton Cerf, agreed to lead the VCAT feedback session to develop preliminary input for the Committee’s FY 2009 Annual Report.
Dr. Patrick Gallagher, the NIST Deputy Director, introduced the new VCAT member, Dr. Alton (Al) Romig, Jr, Executive Vice President, Deputy Laboratories Director, and Chief Operating Officer, Sandia National Laboratories.
For more details, see the presentation.
Update and Priorities – Dr. Patrick Gallagher, Deputy Director, NIST
Presentation Summary – Dr. Gallagher provided an update on NIST staff awards and recognition, news, management priorities, budget, and planning. Items of note include:
- Gary Locke, who was confirmed as the Secretary of Commerce on March 24, 2009, visited both NIST sites at Gaithersburg, MD, and Boulder, CO. He promotes technology and is a very visible supporter of NIST programs, in particular, Smart Grid activities.
- NIST is continuing its focus to build a world class safety program by integrating safety into its work and within a phased approach. Rich Kayser has assumed the duties of the Special Assistant for Environment, Safety, and Health. Other completed safety actions including those related to the Boulder plutonium spill as well as the development of a NIST Safety Action Plan which is being implemented.
- NIST is recognized in the President’s Science and Innovation Plan as strategically positioned to help the Nation improve its innovation performance and respond effectively and efficiently to national priorities. The President has proposed to double the NIST laboratory and construction budget over a ten-year period and to grow the Hollings Manufacturing Extension Partnership (MEP) and the Technology Innovation Program (TIP).
- As part of the American Recovery and Reinvestment Act (ARRA), NIST received funding totaling $580 million in direct appropriations as well as $10 million from the Department of Energy (DOE) for Smart Grid and $20 million from the Department of Health and Human Services (HHS) for Health IT.
- Dr. Gallagher also highlighted the FY 2010 budget requests that comprised $60.5M of new NIST laboratory-based programmatic initiatives focused on key national priorities in energy, environment, healthcare, cybersecurity, manufacturing, and physical infrastructure; $14.7 million to expand the Hollings MEP; $4.9 million to fund new TIP competition areas; and $48.4 million in additional funding for construction of research facilities.
Dr. Gallagher reviewed the purpose of this VCAT meeting and emphasized the need for the Committee to provide feedback on the interplay between the NIST role in documentary standards and the NIST laboratory programs in the presidential priority areas of Smart Grid and Healthcare IT. Three general questions about NIST’s role in this area were posed to the Committee for their active discussion following the presentations.
For more details, see Dr. Gallagher’s presentation.
- The group discussed how maintenance and operation funding is being addressed as a result of NIST substantial increases to its construction budget. The Committee was also reminded that about half of the ARRA funding for the NIST laboratory account included the cost for equipment.
- Dr. Gallagher assured the Committee that NIST could manage the large increase in the number of people working at NIST under Fellowships covered by ARRA funding. The issue of mortgage management and the downstream pressure for continuing to fund ARRA grants is small for NIST, particularly since the agency has made a large capital investment with these funds.
- The evaluation process for the ARRA competitive research grants will ensure merit-based awards under this program and that no advantage will be given to collaborative work versus external work.
- The renovation plans for the NIST Boulder laboratories was described in more detail. The FY 2009 appropriation also included funding to add new space at JILA in Boulder, which was one of the overcrowded facilities that the Committee visited last October.
- The VCAT Chair commended Dr. Gallagher for his concise articulation of the NIST role and recommended that it be documented. The NIST role tends to be exploiting its technical expertise, putting standards on a sound technical and scientific foundation, and having political neutrality.
- In discussing the value of planning workshops, it was noted that a series of external workshops organized by NIST with participation from some of the VCAT members resulted in one of the best overall roadmaps that addresses the needs of the healthcare and biotechnology industry and maps a role for NIST over the next few years.
Promoting U.S. Innovation and Competitiveness through Documentary Standards - Overview of NIST Role in Documentary Standards – Dr. Belinda Collins, Director, Technology Services, NIST
Presentation Summary – To set the stage for the subsequent presentations, Dr. Collins provided an overview of Documentary Standards, the U.S. Documentary Standards System, and NIST’s role in this area. A documentary standard is a document that defines a product, process, or system. These standards include test methods, interoperability specifications, building and fire codes, and protocols. An important distinction is that a documentary standard is not a measurement artifact, such as a kilogram, or an ethics code, or a regulatory limit. Dr. Collins summarized how documentary standards support technology and innovation as the bridge between research and products as well as how they can become barriers to innovation and trade under certain circumstances. She also addressed the importance of the documentary standard development process with its transparency, rules, due process, appeals process, and multiple players across industry and government. While the American National Standards Institute (ANSI) accredits more than 200 Standards Developing Organizations (SDOs) and represents the United States in ISO/IEC, NIST coordinates the federal use of standards and conformity assessment with the private sector as mandated by the National Technology Transfer and Advancement Act and the Office of Management and Budget (OMB) Circular A119. Dr. Collins also highlighted the roles of the NIST Laboratories, including transferring research results into documentary standards and providing leadership for technical committees and SDOs. This participation enables NIST to move its technical expertise to the standards and policy arena.
Dr. Collins also spoke about the complexity of the U.S. Documentary Standards System and its strengths and weaknesses. For example, the United States has an important bottoms-up system with active industry engagement that leads to voluntary, consensus-based standards developed in an open, transparent, and balanced process. However, there is no central authority unlike in Europe, China, Japan, Canada, and much of Latin America and Africa. Also, in the U.S. system, the government is a participant among the multiple competitive players and not the primary driver. The United States can be disadvantaged by lack of adequate leadership, high costs, and duplicate efforts. There are several challenges for the United States in developing documentary standards, including strong foreign competition, but there is no clear path for working across sectors, technologies, and competing interests. In closing, Dr. Collins identified several opportunities for the United States, such as a stronger central responsibility largely in the coordination arena where Government better defines its requirements and where NIST can leverage its strengths more effectively.
For more details, see Dr. Collins’ presentation.
- NIST develops very few documentary standards. In most cases, the agency provides technical input to consortia on consensus standards, such as those developed by ANSI and American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE). One of NIST’s strong roles is the research it performs prior to being involved in documentary standards committees. According to one member, the value of the NIST laboratories is dependent on translating their research into the standards.
- The members discussed the value of NIST as a neutral third-party government agency in the process. For example, one member noted that based on first-hand experience with standards activities involving several companies, it has been very helpful to have NIST serve the role as a technical arbiter.
- Safeguards against undisclosed intellectual property in the standards process is a concern.
- NIST has a "loose" connection with the International Telecommunication Union, a treaty organization, through individual memberships in this U.S. Department of State-led function. NIST also has a Memorandum of Understanding with ANSI to help the agency in its U.S. coordination role.
- The issue of not providing free on-line standards related to procurement or regulation was raised.
- Concern was expressed over China developing the standards for its U.S. and world-wide exports.
- The group elaborated on different roles for NIST in documentary standards. Dr. Gallagher emphasized that the VCAT should address two issues – what coordination role should NIST play in the federal sector and how does this role drive the activities of the laboratories. The VCAT Chair remarked that the Committee’s advice should first be given in the context of Smart Grid and Healthcare IT, and then generic.
- Metrics for success related to NIST’s coordination role should include a report on how the consensus-based standards are being used. An audit of NIST involvement in standards with the percentages of staff time for both past and future activities could be helpful to measure NIST’s contributions.
NIST Role in the Smart Grid – Dr. George Arnold, National Coordinator for Smart Grid Interoperability, NIST
Presentation Summary – Dr. Arnold’s talk focused on NIST’s role in the coordination of the development of a standards framework for Smart Grid interoperability. NIST’s activities in Smart Grid are being driven by the realization that this is an once-in-a-lifetime opportunity to modernize and transform one of the Nation’s most critical infrastructures. By working in partnership with industry, SDO’s, the private sector, DOE, federal and many state regulatory commissions, NIST is leading and driving the effort to establish the standards foundation that will allow the Smart Grid to work.
Dr. Arnold described the drivers for the Smart Grid which are aimed at achieving changes in the generation of electricity, load, reliability and security, and requirements. For example, the change to renewable sources requires storage and a distribution network representing a significant change in the architecture of the Grid. Interoperability at many levels and standards are absolutely critical to achieve the needed automated management, operation and control of a two-way flow of power and information across the Grid. Dr. Arnold also identified the multitude of key industry players in Smart Grid.
In May 2009, Vice President Bide, Secretary Locke, and Secretary Chu held a meeting of approximately 70 CEOs and senior business leaders to discuss the challenges involved with achieving the Smart Grid and to engage their active support and commitment. The Energy Independence and Security Act (EISA) of 2007 assigned NIST the role, in cooperation with other organizations including DOE and a number of SDOs, to have "primary responsibility to coordinate development of a framework that includes protocols and model standards for information management to achieve interoperability of smart grid devices and systems…" NIST has a specific set of capabilities to respond to this role and, in particular, its expertise in measurement and standards research along with its documentary standards expertise support its strong leadership in coordinating documentary standards coordination.
Dr. Arnold also stressed the urgent need for standards using Smart Meters as an example. He also described the areas where interoperability standards are needed, and showed a diagram of a plug-in hybrid electric vehicle as an example of the complexity involved with coordinating these standards produced by different SDOs. The rest of the presentation covered the need for a Standards Roadmap; a comparison of Smart Grid effort with the Next Generation Telecom Network; NIST’s Three Phase Plan; the initial standards identified for inclusion in NIST Interoperability Framework Release 1.0; and the establishment of a public/private Smart Grid Interoperability Standards Panel by the end of 2009.
For more details, see Dr. Arnold’s presentation.
- Dr. Arnold’s title of National Coordinator for Smart Grid Interoperability reflects the responsibilities assigned to NIST from Congress.
- Unlike the development of the Open Systems Interconnection Model, NIST has a "top-down" role in coordinating Smart Grid standards in terms of bringing the right people together to develop the technical solutions. According to Dr. Arnold, the expertise should come from industry along with NIST’s technical expertise but the NIST role is primarily a coordination facilitation role.
- Standards are also needed for the electrical and physical interconnection of distributed energy resources to inject power into the grid.
- Canada is involved through participation in the National Association of Regulatory Utility Commissioners.
- The Department of Defense (DOD) is involved in the standards dialogue. NIST and DOD are also members of an interagency task group chaired by DOE. A pilot is being proposed in Colorado to link together a number of DOD installations and the Boulder and Fort Collins private sector grids. NIST and DOD are also members of an interagency task group chaired by DOE.
- A set of Principles of Operation for the Smart Grid has been developed by the GridWise Architecture Council as well as those developed at the recent White House meeting on Smart Grid with CEOs.
- The issue of the need for speed versus the need for quality was raised in regard to electric powered vehicles.
- It would be helpful to know the prioritization of the 16 standards identified for the NIST Interoperability Framework Release 1.0 according to their critical need for speed and what roles the NIST labs should play in those areas where speed is most critical.
Smart Grid: Vision, Status, Challenges – Mr. Steve Widergren, Smart Grid Interoperability and Standards Coordinator, DOE (former Administrator for the GridWise Architecture Council (GWAC))
Presentation Summary – Mr. Widergren described the Smart Grid concept, vision, and status, and noted the importance of interoperability to its success. The vision is to bring digital intelligence and real-time communications to transform grid operations. This effort involves numerous operational stakeholders and supporting organizations. Mr. Widergren indicated that participation of the demand side in system operation is a major change to the Grid which will affect the cost of electricity. He shared the results from studies on the value of demand response and key findings from two GridWise Demonstration Projects, emphasizing that a smart grid can deliver and enable carbon savings. The potential impacts of high penetration of plug-in vehicles on the U.S. Power Grid were also highlighted. In regards to metrics, Mr. Widergren summarized DOE’s recent biannual report under review by OMB which provides the status of smart grid deployment utilizing 20 proposed metrics.
Turning to smart grid challenges, Mr. Widergren described those associated with value proposition; the business environment and regulatory landscape; interoperability; and reliability, robustness, and resilience. He stressed that standards are not enough unless the entire stack interoperate. He also characterized the deployment of the smart grid vision as a journey where one size does not fit all.
Mr. Widergren also covered DOE issues related to interoperability and the GWAC. Comprised of 13 respected experts who are volunteers from cross-sector organizations, GWAC seeks to promote and enable interoperability. The Council is very pleased with NIST’s engagement as a partner and its focus on interoperability. Mr. Widergren summarized the expected impacts from interoperable systems which are expected to provide compounded benefits, and provided the context for the framework called for under EISA. GWAC and NIST will hold the third annual Grid-Interop Forum in November 2009 to engage stakeholders in this roadmapping effort. In conclusion, Mr. Widergren summarized GWAC accomplishments, collaborations with NIST, and some of the players involved with the interoperability coordination landscape. GWAC is working very closely to align with NIST and support all of the agency’s efforts under the EISA directive.
For more details, see Mr. Widergren’s presentation.
- The group asked several technical questions about the data from the various studies on demand response, with extended discussions on the cost effectiveness of carbon versus nuclear sources as well as the impact of geography on long-range transmission.
- The topic of coordination activities between North America with Europe or Asia was raised.
Importance of NIST Laboratory Research Programs to Support Smart Grid Standards – Dr. David Wollman, NIST
Presentation Summary – Dr. Wollman focused his presentation on the importance of NIST laboratory research programs to support the development and adoption of Smart Grid standards. He emphasized that interoperability depends on both reliable standards and validated performance which is a clear role for NIST, and that the NIST Smart Grid Research Program can support both the standards as well as the conformity testing. Dr. Wollman described the activities and potential impacts of the NIST smart grid vision which is aimed at accelerating smart grid interoperability standards and building up the smart grid research program. For example, a strong research program will help advance the technology and anticipate needed key measurements.
NIST smart grid research spans many of its laboratories in the areas of electric power metrology and power electronics, building systems, cybersecurity and networking, and industrial control and security. Dr. Wollman presented a diagram of how NIST’s research maps onto smart grid functions which is an output of NIST’s roadmapping efforts. He also provided program details on how NIST research supports smart grid standards through each of the following mechanisms: calibration and testing of smart grid equipment, leadership of standards committees, interagency coordination and roadmapping, information models, specific federal roles and responsibilities, and measurement science and research. In summary, NIST is ramping up its smart grid interoperability standards providing a strong federal coordination role; NIST research supports smart grid standards and testing through different mechanisms; and more closely coupled bidirectional interactions between NIST research programs and standards/testing is possible in the future.
For more details, see Dr. Wollman’s presentation.
- Prior to this presentation, Dr. Arnold was asked if the speed for developing the framework and standards is more dependent on the budget or the people and normal sequence. The speed is dependent on the people and the process, not the budget.
- On the diagram showing how NIST research maps onto smart grid functions, there was concern over the activity labeled, "Secure Communication Interface" and how this will be addressed in the overall architecture and work safely for the public. The group recognized that this is a conceptual model and agreed that the network architecture piece must be designed carefully and correctly and made secure. Mr. Widergren noted that this is a very high-level diagram and there are a series of diagrams that provide the details. Dr. Arnold emphasized that there are no assumptions that any of the communications will use the public internet and that the security of the underlying data networks is a major task area with significant resources supporting this effort. It was suggested that the term "Information Flows" be used instead and fit into the architecture to allow customers to access their information through the public internet.
- The VCAT Chair stated the need to see the prioritization of NIST research that supports the critical points on the roadmap since NIST does not have the capability to perform all of the needed research in support of every measurement on the smart grid.
- The need for hardening standards was raised. This topic was recently discussed by the Smart Grid Task Force and is definitely on the radar as an issue to be addressed. NIST can play a role in both the classified and unclassified areas of the Smart Grid.
Jerry Stenbakken of the Quantum Electrical Metrology Division, Electronics and Electrical Engineering Laboratory, provided a laboratory tour of NIST’s work in Phasor Measurement Units (PMUs). NIST has developed the SynchroMetrology Laboratory to address the need for calibration of electric power instrumentation that links power measurements to Coordinated Universal Time, UTC. NIST currently offers special-test calibration of PMUs. Deployment of these devices provides the greatest improvement in the visibility of the state of the power grid of any measurement devices. With the great interest in expanding the use of PMUs in power grids many new manufacturers are offering PMUs. Although they all claim to meet the IEEE standard performance requirements for these devices, this is not always the case. NIST is the only National Metrology Institute to provide traceability for PMUs and is currently calibrating PMUs for use on the expanding Brazilian power grid. The NIST SynchroMetrology Laboratory has received significant support from DOE over the past two years.
Overview of NIST Role in Healthcare IT – Ms. Cita M. Furlani, Director, Information Technology Laboratory (ITL), NIST
Presentation Summary – Ms. Furlani provided an overview of NIST Role in Healthcare IT, including the need for healthcare IT (health IT) and its impact. The U.S. healthcare industry lacks a comprehensive nationwide information infrastructure. A standards-based, secure, interoperable nationwide healthcare infrastructure is needed, which is of critical importance to individual citizens and our nation. Health IT is a national priority as illustrated by several quotes from the Obama Administration and recent Congressional initiatives.
NIST has been involved with health IT standards for many years. The Advanced Technology Program at NIST, which no longer exists, recognized the need for health IT and provided seed funding in the 1990s for the NIST laboratories to become involved in health IT standards development and related activities. All of the infrastructural and interoperability issues that NIST had been addressing for many years in other domains needed to be applied to the healthcare domain. Over the years, NIST has collaborated with numerous organizations active in the evolving standards and testing landscape, including: standards and certification organizations; key healthcare delivery organizations; industry groups; key industry players; other Federal agencies; and key advisory committees. Ms. Furlani represents NIST on the Health IT Standards Committee, a federal advisory committee. With respect to health IT standards in the federal arena, there are agencies with policy and regulatory roles, such as HHS; agencies with research roles, such as NIST; and agencies that are healthcare providers, such as the Department of Veterans Affairs and DOD. The federal efforts include HHS approval of health IT-specific standards for federal use, the Federal Health Architecture E-Government Line of Business Initiative, and the Nationwide Health Information Network (NHIN). NIST has played an important role in each of these areas.
Ms. Furlani emphasized that NIST has a critical role to play in health IT due to its breadth of knowledge in infrastructure and interoperability, its mission to work with industry, its global reputation in health IT based on its long standing involvement in the standards communities, and its past experience in e-commerce, security, and networking. NIST’s roles are articulated in the Federal Health IT Strategic Plan 2008-2012. Now is the time to build on the momentum of public-private collaborations, as recognized by ARRA which includes several activities for NIST, including $20 million from HHS for NIST to continue its work in advancing healthcare information enterprise integration through activities such as technical standards analysis and establishment of conformance testing infrastructure. Ms. Furlani also described the importance of improving standards through tests and NIST’s critical role and successes in this area, such as the HL7 Clinical Document Architecture. Moving forward, NIST is expanding the health IT infrastructure to other environments such as home healthcare; applying its NIST-wide competencies to address future clinical needs, personalized medicine, and cognitive reasoning; advancing usability and accessibility of health information technologies; and researching the standards and testing needs for evolving technologies.
For more details, see Ms. Furlani’s presentation.
- NIST’s testing activities include participating in a yearly Connectathon in which numerous health IT vendors demonstrate interoperability..
- The legal ramifications of the infrastructure are the purview of the policy committee under ONC; NIST focuses on the technical issues.
- NIST is also collaborating with the National Science Foundation and other federal agencies to implement its directive under ARRA to establish an R&D program for Health Care Information Enterprise Integration Research Centers.
- NIST has a program that is focused on looking at interoperability issues, including those at the front end of the innovation process.
- NIST’s research efforts will initially address Electronic Health Records (EHR) which are mostly textual to reflect Presidential directives and Congress, but also recognizes the need for other data and imaging as well.
- The VCAT Chair stressed the importance for the Committee to understand how NIST prioritizes its projects in both Smart Grid and health IT.
Issues and Challenges Associated with Healthcare IT – Ms. Carla Smith, Executive Vice President, Healthcare Information and Management Systems Society (HIMSS)
Presentation Summary – In her opening remarks, Ms. Smith remarked that HIMSS is a big supporter of NIST and is very appreciative of NIST’s work and its benefits to the healthcare industry. Established in 1961, HIMSS is focused on advancing the best use of information and management systems for the betterment of healthcare and dedicated to leading transformational change through the effective use of health IT. As further background information, Ms. Smith described the organization’s membership of over 23,000 individuals and 350 corporate members; its structure with over 90 committees, task forces, and work groups; and its multiple resources including the Davies Award, analytical capabilities, education, professional development, guides and toolkits, and publications. For example, the research arm of HIMSS has developed the Electronic Medical Records (EMR) Adoption Model reporting on health IT adoption with data collected annually from over 51,000 hospitals on their IT purchases, implementation, and plans. In 2008, most U.S. hospitals were at a moderate level of maturation. Regarding public private partnerships, HIMSS is a supporter of the Healthcare Information Technology Standards Panel (HITSP), a standards harmonization group, which began four years ago in response to a request from the Office of the National Coordinator (ONC). Ms. Smith also described the activities of the Integrating the Healthcare Enterprise (IHE), a nonprofit organization, and the Certification Commission for Health Information Technology (CCHIT), an independent nonprofit organization, which certifies the functionality of EHRs with an open transparent process.
Turning to Health IT issues and challenges in ARRA, Ms. Smith remarked that this Act is an economic stimulus referred to by many as the "foundation for healthcare reform." In regard to healthcare reform issues, she elaborated on an earlier comment about telemedicine and the need to transmit information over geographically diverse locations in the U.S. securely and appropriately and remarked that NIST is at the plate in part to make this type of information transmission a reality available to all Americans. Ms. Smith reviewed the basic requirements of ARRA and discussed the definitions of "meaningful use" and "certified" EHR technology. She stressed that the certification could not be done without harmonized standards and without the test tools and testing methodologies that are available through NIST.
The last part of the presentation focused on some observations from HIMSS. The health IT provisions in ARRA are considered the first step in healthcare reforms. Access to healthcare is an enormous issue and HIMSS believes the goal is to use IT meaningfully for improved quality and cost effectiveness, not simply delivering the technology. The health IT priorities for 2009 are defining meaningful use and a meaningful user; understanding who the certifying body will be, the criteria, and the testing tools; identifying harmonized standards; and achieving a framework for incentive payments. Ms. Smith noted that NIST has a role in how to test for meaningful users and she was pleased to hear that NIST was meeting with the ONC to discuss this topic. While reviewing the list of health IT community priorities for 2010 and beyond, Ms. Smith remarked that HIMSS needs to be working with entities like NIST to make sure that the testing, models, and reference implementations are in place. Lastly, Ms. Smith covered HIMSS recommendations on meaningful use and stressed that HIMSS is interested in harnessing the good work already supported with taxpayer funds, such as the work at NIST, rather than reinventing the wheel.
For more details, see Ms. Smith’s presentation.
- HIMSS has experienced an explosive growth in the past nine months as a result of the increased activities at the federal and state government level which have awakened the health IT world.
- HIMSS relationship with the IHE was expanded upon. HIMSS supports the work within the IHE. The engineers working to solve the problems of interoperability are volunteers from their companies and not employees of HIMSS or the IHE. All of their work is published in the public domain. Ms. Smith emphasized that IHE would not work without NIST.
- NIST collaborates with CCHIT and provides test tools for CCHIT to incorporate in its certification processes. Also, as mandated by the ARRA, NIST is collaborating with the ONC to enable a robust certification process.
- Ms. Smith addressed the question of why incentives are needed for adopting IT tools that improve quality and cost effectiveness. She emphasized that there are early adopters who are trail blazers, moderate adopters who are bit more conservative, and a few percent of very low adopters. Although health care accounts for a significant percentage of our Gross Domestic Product (GDP), it is still a cottage industry. According to Ms. Smith, the vast majority of healthcare in the United States takes place in small physician practices which may not have an IT person. They also face the issues of learning about the vendors, implementation issues, staff training, and changing workflows. Another problem is that the return on investment for IT and healthcare has not been clearly stated. HIMSS believes that there are enough best practices available and enough momentum to help the clinician understand the benefit and be able to start the adoption. One of the key roles given to the ONC under the ARRA is to achieve widespread adoption of EHR, which shows that Congress believes that the appropriate use of IT could be a tool to help the GDP. The ONC wrote a federal IT strategic plan two years ago and has submitted an operational plan to Congress for carrying out their ARRA mandate, which is to be updated every six months.
- The use of a manufacturing extension partnership model to help the small practices was raised. ARRA calls for regional extension centers to be set up by the ONC.
- The group discussed the need for cybersecurity in this area. Ms. Smith remarked that HIMSS is addressing cybersecurity in its references to privacy and security. HIMSS has focused specifically around providing tools to hospitals and physician practices that they can implement to increase the probability of having secure and private health IT.
- The HIMSS Davies Award was built on the Malcolm Baldrige criteria. The purpose of this Award is to disseminate best practices for achieving excellence and actual return on investment while improving the quality of patient care. Information on this award is available in the public domain. HIMSS also engages with the Baldrige award winners in the healthcare category to share their stories and how to make the best use of IT.
Importance of NIST Laboratory Research Programs to Support Healthcare IT Standards – Ms. Lisa Carnahan, Manager, Interoperability Group, ITL, NIST
Presentation Summary – Ms. Carnahan described the importance of NIST laboratory research programs to support health IT standards as they relate to interoperability, security, and emerging technologies. In the area of interoperability, NIST is undertaking a standards testing infrastructure project to carry out its responsibilities under ARRA. Ms. Carnahan noted that this work builds on NIST efforts in this area prior to ARRA. Ms. Carnahan emphasized that NIST is also involved in standards development activities, such as those related to the processing of clinical documents with reusable components. In describing the framework for building test systems, Ms. Carnahan noted that NIST is building an infrastructure that takes advantage of NIST’s collaborations with outside organizations.
Turning to security, NIST provides standards and guidelines that apply to health IT, carries out an Identity Management Program, and performs authentication research. For example, NIST Special Publication (SP) 800-63, "Electronic Authentic Guideline" addresses four levels of assurance related to identity management. This guideline is the basis of trust models for federal agencies and HITSP is considering this guideline for its trust model. Ms. Carnahan remarked that a key issue in healthcare is trusting communities and organizations. The ITL Identity Management Program has been active in biometric standards and explores critical issues as barriers to trust, for example, trusting partner organizations that vouch for the identities of people.
In the emerging technologies area, NIST has a healthy research project in medical device communications with IEEE involvement and a pervasive IT program covering body sensors and implants using radio frequency (RF) signals. An IEEE task group on Body Area Networks requested NIST to look at the signal strength, interference among devices, and the security and reliability of the devices. Ms. Carnahan described the operating scenario and the corresponding channel models related to the signal strength along with an example of an implant in the upper stomach. One of the models was based on NIST’s RF propagation software and visualization expertise to create the 3-dimensional body image. In summary, NIST research efforts contribute to the documentary standards necessary to achieve the healthcare vision in the United States.
For more details, see Ms. Carnahan’s presentation.
- The group discussed the technical problems, issues, and research agenda related to interoperability. The members noted that research areas include heterogeneous databases and structures, bridge software for legacy code, wireless technology and real-time technology, visualization, and privacy issues. This is a huge system architecture problem involving a very large number of parties and different sources and formats of information, including accessing data from various devices. The big problem is how to get this ensemble of information sources into a form where it can be easily exchanged in an understandable and usable form with all the needed privacy protections. According to one of the members, the need for access controls is ephemeral. Economic incentives are needed for people to adopt and use the equipment and practices that will allow the information to be assembled and shared effectively. Although standards testing is needed to verify that the various implementations work, which is an important role for NIST, it does not solve the bigger problem. The members would like to know the scope of NIST work to address the other challenges.
- In regards to channel models and signal propagation, the group discussed the possibility of using Bluetooth technologies. One member suggested that a valuable role for NIST could be to learn how to analyze the propagation of various frequencies in the human body from one place to another.
- The group discussed how other countries are implementing EHR standards. For example, countries with top down decisions may look like they have succeeded in this area but may still have to address the problem of interoperability. NIST should be aware of the problems and contribute where appropriate.
- A VCAT member noted that NIST is not necessarily in a position to develop EHR standards, but rather validate the implementation of the standards. Ms. Carnahan stressed that NIST is actually involved in the standards development process in some areas where the researchers can point out the parts that may be technologically wrong and make corrections. Although NIST is not driving the choice of standards, its testing work and the standards development process go hand in hand.
- A VCAT member raised the issue of sequestered data and its impact toward moving to open access to patient information.
Enabling Clinical Information Sharing: Standards and Testing Demo – Dr. Bill Majurski, Project Lead, Infrastructure Integration Software and Systems Division, ITL, NIST
Presentation Summary – Dr. Majurski provided an overview of the Cross Enterprise Document Sharing (XDS) Standard along with a demonstration of the XDS concept and the NIST XDS test suite, used globally to ensure correct implementation and interoperability of XDS. The diagram of XDS within a community illustrated that every enterprise, such as a hospital or doctor’s office, has a repository, which could feed into a document sharing registry. In response to industry’s needs for the electronic availability of patient information to healthcare providers, NIST has been working on the technical interfaces between the repositories and the registry. The NIST prototype introduced in 2004 was refined in collaboration with other vendors and has now evolved into the reference implementation and test tool for XDS. Dr. Majurski described the IHE profile development approach which includes vendors testing their "profile" implementation on the NIST reference server. NIST co-authored all seven IHE profiles with the goal of operability and develops and maintains reference implementations for five of the profiles. At the present time, XDS has been adopted in the United States by HITSP, CCHIT, and the NHIN, and is part of the national healthcare infrastructure plans in the United States, Canada, France, and several other countries. France, which has a different social system for decision making than the United States, has declared that their national healthcare environment will be managed by XDS. There are also major developments in other countries, including Italy, China, Japan, and Australia. NIST reference implementations and test tools are open source and used globally at test events each year. Between 50 and 60 vendors test XDS worldwide every year and Dr. Majurski helps manage these testing events. With on-going committee work and research on future extensions, NIST continues to serve as a primary architect of new developments.
To demonstrate the NIST registry/repository reference implementation test tool, Dr. Majurski showed test data from IBM with their permission. The NIST server is specifically tooled to detect problems or successes on a specific test to help the vendors test their implementations of the specification. This is the kind of testing that the vendors do before they meet each other in a testing event. As the administrator, only NIST can see all of the test results. Each vendor sees only their own results.
For more details, see Dr. Majurski presentation.
- Dr. Majurski provided examples of XDS-related products, including IBM’s central index registry product. He emphasized that a repository is not a system, but rather the interface to a system. Regarding end devices, Dr. Majurski noted that file format is not predefined for XDS, it can handle any type of file.
- In the discussion on how XDS addresses cybersecurity, Dr. Majurski remarked that access control to health records has the same issues as other IT domains. One of the VCAT members stressed the importance of the XDS format having the capability of validating which parties have access to the information. Ms. Furlani remarked that security issues of authentication, trust, and privacy are integral in all of ITL’s work, and therefore, not explicitly mentioned in Dr. Majurski’s presentation. The VCAT Chair noted that it would be of value to the Committee for NIST to present its work in this area so that the members could identify other areas that need attention. Another member stressed the need for NIST to provide the technical details of its program plans.
Announcements from the VCAT Chair
- The Committee’s 2008 Annual Report was just delivered to Congress and is now public information.
- Nominations for the VCAT Chair and Vice Chair will take place after the October 2009 meeting. The election process will be discussed in more detail at that meeting.
- Dr. Arnold and Ms. Furlani were requested to specifically address the three questions on the agenda for their respective area for discussion at the next day’s meeting.
Roundtable Discussion on Key Questions for the VCAT – Part I: Deputy Director’s Responses
To set the context for the roundtable discussion, Deputy Director Gallagher presented his responses to the following key questions regarding NISTs role in documentary standards:
- What aspects of NIST’s federal coordination role best leverage the technical capabilities of the NIST laboratories?
- How could NIST enhance its support of other Federal agencies in meeting U.S. Government needs for voluntary consensus standards?
- What would be the potential impacts on the NIST laboratory programs of NIST elevating the priority of its standards coordination role?
In addressing the first question, Dr. Gallagher noted that the federal coordination role for NIST as defined in the National Technology Transfer Advancement Act and OMB Circular A119 is to promote the use of consensus-based standards and coordinate uniformity assessment activities. Consensus-based standards will a) eliminate the cost to the Government of developing its own standards and decrease the cost of goods procured and the burden of complying with agency regulation; b) provide incentives and opportunities to establish standards that serve national needs; c) encourage long-term growth for U.S. enterprises and promote efficiency and economic competition through harmonization of standards; and d) further the policy of reliance upon the private sector to supply Government needs for goods and services. He emphasized that many of NIST’s external stakeholders understand the coordination role but do not understand its relationship to the NIST laboratory functions. NIST’s federal coordination role best leverages the technical capability of the NIST laboratories in those areas that a) require expertise in measurement or advances in measurement science; b) leverage the agency’s experience in participating in standards development; and c) leverage the agency’s "neutrality".
In response to the second question, there must be a defined process to "coordinate" federal use of standards. In addition, there needs to be an objective-based strategy to promote standards development or harmonization that is responsive to agency needs, including timeliness, attributes of standards, and areas of standards development.
Dr. Gallagher remarked that the third question was poorly worded. He emphasized that the standards development role is unique for NIST with very large impacts. Positive impacts include more visibility for NIST along with greater relevance and engagement through its coordination function with other organizations. A possible negative impact is that this role could involve such large efforts that NIST would become a job shop and not be able to carry out other functions.
For more details, see Dr. Gallagher’s presentation.
- The group discussed the historical shifts in standards development activities by the private sector and the government. In the early 1900’s, most of the documentary standards development activities arose in the private sector. The government became engaged in standards development for military specifications around World War II. After writing thousands of military specifications, DOD realized that this activity was an inefficient use of their time and the private sector became involved again. The National Bureau of Standards, and now NIST, always retained the physical standards. The government has never set all of the documentary standards in the United States but will promulgate government specific standards when it cannot use private sector standards.
- The group discussed the broad definition of "coordination" and how NIST carries out this role. In some areas, the coordination role has a significant leadership component and in other areas the role may be just convening the group. Dr. Gallagher agrees that the NIST role is defined rather loosely and asks whether there is an opportunity to strengthen the NIST role in practice. The government plays a role with the private sector in stimulating the development of certain standards when there is a critical national need.
- The group raised the issue of NIST’s coordination role in developing a coherent architectural concept for the Smart Grid. Dr. Gallagher noted that NIST was also given a very specific role through EISA to promote the interoperability of the system and agreed that the architecture is an immediate issue. Dr. Arnold confirmed that there is no architecture for the smart grid and that NIST is working with others to provide a reference architecture.
- NIST’s opportunity to work collectively with private industry was discussed. Dr. Gallagher summarized several drivers for the federal government’s involvement in the standards process, including an explicit interest in having an infrastructure in place to promote widespread use of renewable systems. In regards to the process, the NIST coordination role is the mechanism for promoting equity and fairness in the system. NIST has a real opportunity to get involved in the early stages of challenges to help define the process and contribute technical expertise, where appropriate.
- One of the VCAT members suggested that NIST be more explicitly involved with on-going research activities in academia covering smart grid and cybersecurity. As part of their coordinating role, NIST would be providing a tremendous service to the United States by connecting the research activities of the private sector with academia. Dr. Gallagher agreed that being aware of all of the research components is critical to the coordination role.
- The authority for agencies to coordinate with NIST is through OMB. An annual report of standards activities is provided to OMB who could deny the use of particular standards or withhold funding if an agency did not coordinate their activities with NIST. Dr. Gallagher reiterated that NIST’s unique coordination role is poorly defined. He would like to see more activity at the front end in defining how the process will work rather than just tracking issues. Also, NIST programs have the strongest leverage in the measurement aspect to help apply the standard.
- The group discussed NIST’s interactions with state agencies involving the smart grid. NISTs convening efforts have been critical in bringing together organizations that represent the state utility regulators as well as the federal regulators.
- In addition to helping to shape NIST policy, the VCAT has a significant role in informing other parties about the needs of industry and academia and how NIST can respond to these needs.
- Dr. Gallagher and Aneesh Chopra, the new Chief Technology Officer in the White House, have been discussing the spectrum of government tools that can basically promote technology solutions in Presidential priority activities, such as energy and healthcare. This spectrum ranges from research activities to procurement. Chopra does not see clear leadership functions or role assignments within the federal government that address the middle segment that includes direct and applied research standards and demonstrations and he is looking at NIST as this venue.
- The members discussed the need for conceptual papers in each priority area that describe the NIST role. These documents could include the high level steps involved in the creation of a consensus based standard with clear roles assigned to other agencies, private industry, national labs, academia, and others to meet specific outcomes. NIST’s success in coordinating this process would be measured on filling this spectrum. Dr. Gallagher remarked that NIST’s role can be strengthened by making sure that the agency can define the government issues and policy objectives at the beginning of the standards development process.
- The VCAT Chair noted that the smart grid and health IT presentations demonstrated NIST’s understanding of the relationship and use of its laboratory expertise to carry out its standards role. The understanding of the technology relative to the elements of a standard places NIST in a unique role.
- Another VCAT member emphasized that NIST in its coordination role will need a strategic partner with architecture and system analysis capability. Dr. Gallagher responded that NIST is engaging in strategic partnerships in this area rather than directly leveraging the labs.
- Dr. Gallagher noted that NIST’s laboratory programs changes the character of its involvement in the standards process from a more bureaucratic coordination to one of technical input.
- The group discussed the difficulty of providing baseline data on the proportion of NIST programs dedicated to measurement science to enable technology innovation versus support of standards. Dr. Gallagher emphasized that NIST laboratories do not exist to support technical experts in the documentary standards process but will leverage the process as appropriate. NIST has a measurement science role which may be drawn on when certain standards are tied to measurements, for example, in the area of protein measurements.
- A member again raised the need for an architecture for smart grid and health IT standards which identifies the skills and gaps.
- Technology Services provides the staff function for the coordination of documentary standards at the interagency level. However, the coordination role for a particular standards area is basically in the respective laboratory. For example, the staff function for health IT resides in ITL.
Roundtable Discussion on Key Questions for the VCAT – Part II
- As an example of how NIST research supports documentary standards, Ms. Furlani spoke about NIST earlier work in biometrics measurements and the subsequent need for a NIST program in usability to better understand how people interact with biometric systems. Usability is crucial to health IT and will become critical in the smart grid. NIST will continue this very fundamental research program which has applications in many other areas.
- The group discussed the need for an internal process or investment strategy for deciding when to use direct NIST funding versus other agency funding to support standards activities. In most cases, NIST uses their direct funding to support standards development activities, but on occasion, there are urgent national needs where other agencies provide funding to stimulate the related standards activities, such as biometrics. Management is focusing on the standards development issue as a role-based external driver for the agency’s programs. However, management still needs to address whether these are high priority activities and identify the needs. NIST is primarily a research laboratory with most of its funding supporting basic and applied measurement science, and where necessary, inserts its technical expertise in to the documentary standards process. Dr. Gallagher agreed that a planning process is important for addressing the NIST role.
- Ms. Furlani reported that NIST developed a draft guideline for the security architecture of the health IT system and is working on these guidelines for smart grid with the respective individuals.
- According to Ms. Furlani, managers are always making resource choices. For example, it is not worthwhile to send additional staff to standards activities unless there is a technical strength needed in a critical area where NIST can bring its technical expertise and have a leadership role.
- The group discussed the impact on NIST’s resources on developing the framework of a security architecture for health IT and smart grid. This may be a potential conflict in resource requirements and the NIST role. A VCAT member suggested that NIST may want to consider documenting this process so that another organization can test the software and developing a strategy for defending the agency against being consumed inappropriately to carry out verification and testing activities. NIST does have strategies. Ms. Furlani replied that there are many examples where NIST has developed a prototype and turned it over to the Government Services Agency (GSA) or other organizations to do the implementation. In regards to verification and testing, NIST will develop the infrastructure and tools for industry use. Technology Services is consulted regarding the best method for establishing an accreditation program and conformance testing process.
- The group discussed further the implications of both the EISA and the ARRA assigning specific standards development activities to "NIST" not the "NIST laboratories" and the importance of responding to these Congressional mandates. Dr. Gallagher remarked that it is important for NIST to understand the tools and capabilities that the agency needs to carry out its coordination role. Historically, NIST has not been involved in issues, such as smart grid, where the coordination role is a "strong form" that calls for NIST to coordinate the actual harmonization and standards efforts. This role change is driving NIST to change its behavior.
- The VCAT Chair reiterated two points raised earlier: 1) the need for NIST to have a process for determining whether the desired standards activities fall within the priorities of the research laboratories, and if not, how will they be addressed; and 2) the need to structure the administrative efforts of the coordination role outside of the laboratories, including the ability to recruit other research entities to pursue areas where the needed capabilities are beyond the NIST mission. Dr. Arnold noted that most of the ARRA funding provided to NIST for smart gird is in fact being contracted out to partners, such as the Electric Power Research Institute. Although five of the NIST laboratories are providing technical capabilities due to their past involvement in documentary standards related to smart grid, there are significant gaps which will be covered by contracts. In the area of health IT, NIST collaborates with other relevant federal agencies, industry, academia and professional societies. Dr. Gallagher stressed that NIST in its coordination role wants to leverage the entire universe of participants very effectively.
- Another VCAT member noted that NIST has an historic opportunity to embrace its coordination role and consider changing the organization structure to carry out this role. For example, a temporary laboratory could be created which brings together all of the appropriate individuals from the different NIST laboratories to carry out some of the research in a given area, such as smart grid. A strong coordination role includes strong leadership for involving universities, companies, and other organizations.
VCAT Feedback Session – Annual Report Input
The VCAT Vice Chair, Dr. Vinton Cerf, led the feedback session and summarized the member’s ideas for consideration in the Committee’s 2009 Annual Report. Possible topics include NIST conduct of its standards coordination role; NIST standards objectives; architectural frameworks; and additional points such as other agency connections, safety, awareness of outside activities; strategic planning; and understanding system design.
The specific input under each of these topics is available in Dr. Cerf’s summary slides.
- NIST’s "coordination" role should be defined broadly so that the agency is not limited in its ability to carry out this role.
- NIST’s role in preparing the architectural concept for the Smart Grid may be an issue.
- There are historical opportunities and challenges to NIST stemming from health IT and smart grid coordination assignments. For example, this strong coordination role provides NIST an opportunity to assume a leadership role in issues of national importance and leverage the large universe of external participants.
- Functional issues related to NIST coordination role might be addressed in the report.
- Congress may have requested NIST to undertake the coordination efforts in smart grid and health IT standards because these are national scale infrastructure, which is a big challenge.
- One of the VCAT members noted that a matrix showing stakeholders and data needs in health IT resembles an entire computer science curriculum ranging from interoperability to cybersecurity.
- The enforcing authority of NIST in its coordination role is another issue.
- A proposal to set up VCAT subgroups in smart grid and health IT will be discussed between the VCAT Chair, Vice Chair, and NIST Deputy Director.
- The architectural frameworks for Smart Grid and health IT should address cybersecurity as well as physical security.
- In the Smart Grid area, NIST’s interactions have been extraordinarily vigorous and active. For example, Dr. Gallagher and Dr. Arnold have personally briefed Secretary Chu. Also, NIST has been working extremely close with DOE’s Acting Assistant Secretary for Electricity Delivery and Energy Reliability as well as individuals in other parts of the department.
- The report should explicitly define the term, "security" in its various references.
Dr. Serum remarked that the VCAT meetings are now a collaborative effort with NIST and thanked the Committee members and the NIST staff for their great interactions. Dr. Gallagher also expressed his appreciation for the Committee’s input which is critically important to NIST. He also suggested that future meetings could be focused on cybersecurity which would address many of the issues raised during the meeting and on building codes which are another form of documentary standards where NIST plays different roles.
The meeting was adjourned at 11:30 a.m. on June 10, 2009.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
Executive Director, NIST Visiting Committee on Advanced Technology
Dr. James Serum
Chair, NIST Visiting Committee on Advanced Technology