[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
                        STANDARDS FOR HEALTH IT:
                       MEANINGFUL USE AND BEYOND

=======================================================================

                                HEARING

                               BEFORE THE

               SUBCOMMITTEE ON TECHNOLOGY AND INNOVATION

                  COMMITTEE ON SCIENCE AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 30, 2010

                               __________

                           Serial No. 111-112

                               __________

     Printed for the use of the Committee on Science and Technology


     Available via the World Wide Web: http://www.science.house.gov

                                 ______


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                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                   HON. BART GORDON, Tennessee, Chair
JERRY F. COSTELLO, Illinois          RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas         F. JAMES SENSENBRENNER JR., 
LYNN C. WOOLSEY, California              Wisconsin
DAVID WU, Oregon                     LAMAR S. SMITH, Texas
BRIAN BAIRD, Washington              DANA ROHRABACHER, California
BRAD MILLER, North Carolina          ROSCOE G. BARTLETT, Maryland
DANIEL LIPINSKI, Illinois            VERNON J. EHLERS, Michigan
GABRIELLE GIFFORDS, Arizona          FRANK D. LUCAS, Oklahoma
DONNA F. EDWARDS, Maryland           JUDY BIGGERT, Illinois
MARCIA L. FUDGE, Ohio                W. TODD AKIN, Missouri
BEN R. LUJAN, New Mexico             RANDY NEUGEBAUER, Texas
PAUL D. TONKO, New York              BOB INGLIS, South Carolina
STEVEN R. ROTHMAN, New Jersey        MICHAEL T. McCAUL, Texas
JIM MATHESON, Utah                   MARIO DIAZ-BALART, Florida
LINCOLN DAVIS, Tennessee             BRIAN P. BILBRAY, California
BEN CHANDLER, Kentucky               ADRIAN SMITH, Nebraska
RUSS CARNAHAN, Missouri              PAUL C. BROUN, Georgia
BARON P. HILL, Indiana               PETE OLSON, Texas
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
KATHLEEN DAHLKEMPER, Pennsylvania
ALAN GRAYSON, Florida
SUZANNE M. KOSMAS, Florida
GARY C. PETERS, Michigan
JOHN GARAMENDI, California
VACANCY
                                 ------                                

               Subcommittee on Technology and Innovation

                      HON. DAVID WU, Oregon, Chair
DONNA F. EDWARDS, Maryland           ADRIAN SMITH, Nebraska
BEN R. LUJAN, New Mexico             JUDY BIGGERT, Illinois
PAUL D. TONKO, New York              W. TODD AKIN, Missouri
HARRY E. MITCHELL, Arizona           PAUL C. BROUN, Georgia
GARY C. PETERS, Michigan                 
JOHN GARAMENDI, California               
BART GORDON, Tennessee               RALPH M. HALL, Texas
                HILARY CAIN Subcommittee Staff Director
        MEGHAN HOUSEWRIGHT Democratic Professional Staff Member
            TRAVIS HITE Democratic Professional Staff Member
           MATT McMAHON Democratic Professional Staff Member
           JULIA JESTER Republican Professional Staff Member
                  VICTORIA JOHNSTON Research Assistant


                            C O N T E N T S

                           September 30, 2010

                                                                   Page
Witness List.....................................................     2

Hearing Charter..................................................     3

                           Opening Statements

Statement by Representative David Wu, Chairman, Subcommittee on 
  Technology and Innovation, Committee on Science and Technology, 
  U.S. House of Representatives..................................     8
    Written Statement............................................     9

Statement by Representative Adrian Smith, Ranking Minority 
  Member, Subcommittee on Technology and Innovation, Committee on 
  Science and Technology, U.S. House of Representatives..........    10
    Written Statement............................................    10

                               Witnesses:

Dr. David Blumenthal, National Coordinator for Health Information 
  Technology, Office of the National Coordinator, U.S. Department 
  of Health and Human Services
    Oral Statement...............................................    11
    Written Statement............................................    13
    Biography....................................................    17

Ms. Kamie Roberts, Associate Director for Federal and Industrial 
  Relations, Information Technology Laboratory, National 
  Institute of Standards and Technology
    Oral Statement...............................................    17
    Written Statement............................................    19
    Biography....................................................    22

Ms. Joyce Sensmeier, Vice President, Informatics, Healthcare 
  Information and Management Systems Society
    Oral Statement...............................................    23
    Written Statement............................................    25
    Biography....................................................    31

Dr. Richard Gibson, President, Oregon Health Network
    Oral Statement...............................................    31
    Written Statement............................................    33
    Biography....................................................    38

Ms. Deven McGraw, Director of the Health Privacy Project, Center 
  for Democracy and Technology
    Oral Statement...............................................    39
    Written Statement............................................    41
    Biography....................................................    47

Ms. Deb Bass, President and CEO, Bass & Associates Inc.
    Oral Statement...............................................    48
    Written Statement............................................    50
    Biography....................................................    51

             Appendix 1: Answers to Post-Hearing Questions

Dr. David Blumenthal, National Coordinator for Health Information 
  Technology, Office of the National Coordinator, U.S. Department 
  of Health and Human Services...................................    64

Ms. Kamie Roberts, Associate Director for Federal and Industrial 
  Relations, Information Technology Laboratory, National 
  Institute of Standards and Technology..........................    69

Ms. Joyce Sensmeier, Vice President, Informatics, Healthcare 
  Information and Management Systems Society.....................    70

Dr. Richard Gibson, President, Oregon Health Network.............    71

Ms. Deven McGraw, Director of the Health Privacy Project, Center 
  for Democracy and Technology...................................    72

             Appendix 2: Additional Material for the Record

Letter to Charlene M. Frizzera, Acting Administrator, Centers for 
  Medicare and Medicaid Services, Department of Health and Human 
  Services, from Susan M. Walthall, Acting Chief Counsel 
  Advocacy, and Linwood L. Rayford III, Assistant Chief Counsel 
  for Food, Drug, and Health Affairs, Small Business 
  Administration, dated March 15, 2010, Submitted by 
  Representative Paul C. Broun...................................    74


           STANDARDS FOR HEALTH IT: MEANINGFUL USE AND BEYOND

                              ----------                              


                      THURSDAY, SEPTEMBER 30, 2010

                  House of Representatives,
         Subcommittee on Technology and Innovation,
                       Committee on Science and Technology,
                                                    Washington, DC.

    The Subcommittee met, pursuant to call, at 10:18 a.m., in 
Room 2318 of the Rayburn House Office Building, Hon. David Wu 
[Chairman of the Subcommittee] presiding.


                            hearing charter

                  COMMITTEE ON SCIENCE AND TECHNOLOGY

               SUBCOMMITTEE ON TECHNOLOGY AND INNOVATION

                     U.S. HOUSE OF REPRESENTATIVES

                        Standards for Health IT:

                       Meaningful Use and Beyond

                      thursday, september 30, 2010
                         10:00 a.m.-12:00 p.m.
                   2318 rayburn house office building

I. PURPOSE

    The integration of information technology (IT) with health care has 
the potential to improve patient care and lower escalating health care 
costs. Standards that enable interoperability among products developed 
by different vendors, as well as standards to ensure the privacy and 
security of electronic health care information, are central to 
realizing the benefits of health IT. In 2009, with the passage of the 
American Recovery and Reinvestment Act, Congress created programs and 
incentives to help speed the adoption of health IT, including measures 
to ensure the establishment of technical standards.
    The purpose of this hearing is to examine the progress by the 
Department of Health and Human Services, the National Institute of 
Standards and Technology, and non-governmental health IT stakeholders 
in establishing standards for health IT, providing guidance for their 
implementation, and creating a mechanism to certify that health IT 
products comply with the established standards. Witnesses will also 
discuss future priorities for ensuring the interoperability of health 
IT systems, and the privacy and security of electronic health 
information.

II. WITNESSES

          Dr. David Blumenthal, National Coordinator for Health 
        Information Technology, Office of the National Coordinator, 
        U.S. Department of Health and Human Services

          Ms. Kathleen M. Roberts, Associate Director for 
        Federal and Industrial Relations, Information Technology 
        Laboratory, National Institute of Standards and Technology

          Ms. Joyce Sensmeier, Vice President, Informatics, 
        Healthcare Information and Management Systems Society

          Dr. Dick Gibson, President, Oregon Health Network

          Ms. Deven McGraw, Director of the Health Privacy 
        Project, Center for Democracy and Technology

          Ms. Deb Bass, President and CEO, Bass & Associates, 
        Inc.

III. BRIEF OVERVIEW

    Despite the potential benefits of health IT and electronic health 
records (EHRs) in lowering health care costs and improving patient 
care, the health care industry has been relatively slow to incorporate 
information technology into the delivery of medical services. The lack 
of established standards for health IT has been a key challenge 
hindering wider adoption of this technology. Standards ensure that 
information can be exchanged seamlessly between software and hardware 
devices developed by different vendors or put on the market at 
different times.
    Through the HITECH Act [Title XIII of the American Recovery and 
Reinvestment Act (ARRA), P.L. 111-5], Congress created programs and 
incentives to encourage health IT adoption. In addition, the Act 
provided a mechanism to establish technical standards, and further 
provided that any health IT products purchased with ARRA funds must 
comply with standards established by the Department of Health and Human 
Services (HHS). With guidance from several advisory committees, HHS 
issued a final rule in July of this year identifying the standards that 
would support the first stage of Medicare incentive payments for health 
IT products (termed ``meaningful use'' requirements).
    The initial standards established by HHS provide an important 
baseline of functionality for health IT products. However, many 
standards-related issues have not yet been fully addressed. To ensure 
the seamless exchange of health information among authorized entities 
and realize the full benefit of health IT, the health care community 
will need robust standards and related products for interoperability. 
In addition, the standards process will require coordination to ensure 
that standards developers are able to support the needs of the health 
care community as health IT technology evolves. Finally, baseline 
national privacy and security policies could help health IT developers 
and users alike maximize the benefits of the technology.

IV. BACKGROUND

The Role of IT in Health Care
    Studies and statistics show that a lack of ease in information 
exchange and communication contributes to medical errors and 
duplicative tests, and other wasteful practices. For instance, one 
study found that nearly one out of every five doses of medication given 
in typical hospitals or skilled nursing facilities was somehow in 
error. Most often, the medication was delivered at the wrong time, but 
other times the dosage was wrong or the incorrect medication was 
administered altogether. The study, in the Archives of Internal 
Medicine, further explained that these errors were harmful to the 
patient in 7 percent of cases (40 per day in a 300 patient facility) 
\1\. Other studies have found that miscommunication between doctors, 
patients, and others involved in patient care was a major factor in 80 
percent of medical errors.\2\ Health IT could help medical 
professionals, and their patients, manage complex or chronic 
conditions, identify harmful drug interactions or possible allergies, 
and provide other care support tools.
---------------------------------------------------------------------------
    \1\ Barker, et al. 2002 Medication Errors Observed in 36 Health 
Care Facilities, Archives of Internal Medicine.
    \2\ Woolf, et al. 2004 A String of Mistakes: The Importance of 
Cascade Analysis in Describing, Counting, and Preventing Medical 
Errors, Annals of Family Medicine.
---------------------------------------------------------------------------
    Adoption of health care IT is also widely seen as a way to stem the 
rising costs of health care. According to a report issued by the 
National Academies, an estimated half-trillion dollars per year is 
associated with ``overuse, underuse, misuse, duplication, system 
failures, unnecessary repetition, poor communication, and 
inefficiency.'' \3\ Although estimates vary on the actual savings that 
could be expected from health IT, a study published in Health Affairs 
estimated that a fully interoperable, national health IT network could 
save $77.8 billion a year, equal to 5 percent of annual U.S. health 
care spending.\4\ In addition to reducing costs associated with medical 
errors, health IT could enable other cost-saving measures such as 
prompting physicians to prescribe generic drugs or making tests results 
more readily available, thus avoiding duplicative tests.
---------------------------------------------------------------------------
    \3\ Report by the National Academies, 2005 Building a Better 
Delivery System: A New Engineering/Health Care Partnership
    \4\ Walker, et al. 2005 The Value of Health Care Information 
Exchange and Interoperability, Health Affairs.

Adoption of IT by the Health Care Industry and Technical Standards
    The health care industry has been slow to adopt health IT, despite 
its potential impact. A study published in June of 2008 found that only 
4 percent of U.S. physicians had a fully functional electronic health 
records (EHRs) system, which the authors defined as an EHR system with 
broad range of capabilities including clinical order entry and clinical 
decision support. Thirteen percent of those surveyed in the study used 
a basic EHR, which the study described as one with a minimum set of 
functionalities, such as recoding laboratory data and clinical notes 
and electronic prescribing.\5\
---------------------------------------------------------------------------
    \5\ DesRoches, et al. 2008 Electronic Health Records in Ambulatory 
Care--A National Survey of Physicians, The New England Journal of 
Medicine
---------------------------------------------------------------------------
    One of the key barriers to wider adoption of health IT has been the 
lack of robust, widely-accepted technical standards. To realize the 
benefits of health IT, systems must be interoperable, allowing data 
systems, medical devices, and software from different vendors to share 
EHRs, as well as electronic physician orders for lab tests and drug 
prescriptions, electronic referrals to specialists, electronic access 
to information about current treatment recommendations and research 
finding, and other capabilities. In addition to the need for standards 
to ensure that disparate systems are interoperable, standards are 
needed to meet data security and privacy requirements to enable 
compliance with federal and state patient privacy laws.
    The Science and Technology Committee held hearings on health IT in 
the 109th and 110th Congresses. During those hearings, witnesses 
identified the lack of common standards as one of the challenges facing 
greater health IT adoption. Witnesses claimed that, without these 
standards, health care providers would not have a reasonable guarantee 
that the systems they purchase will be able to exchange information 
with systems that are currently in use, or that may be installed in the 
future. At the hearing held in September of 2007, witnesses agreed that 
NIST should assist HHS in efforts to establish standards for health IT. 
NIST is the Federal Government's lead agency for supporting the 
development of technical standards and conformance testing, and has a 
long history of working with the private-sector, federal agencies, and 
other stakeholders to develop consensus-based standards in fields such 
as electronic commerce, manufacturing, and information security.

HITECH Act

    Congress passed the HITECH Act as part of the American Recovery and 
Reinvestment Act (ARRA) in 2009. The HITECH Act established programs 
and incentives to boost the rate of adoption of health IT systems. It 
also codified the Office of the National Coordinator for Health 
Information Technology (ONCHIT) \6\ and strengthened provisions 
pertaining to privacy and security of electronically stored and 
exchanged health information in federal law. The HITECH Act gave ONCHIT 
the role of overseeing the establishment of standards and a 
certification process for health IT technology, guided by 
recommendations from two Federal Advisory Committees--the Health IT 
Policy Committee and the Health IT Standards Committee--on the 
``implementation of a nationwide health IT infrastructure.''
---------------------------------------------------------------------------
    \6\ Federal efforts to encourage widespread health IT adoption 
began in 2004 when President Bush signed an executive order creating 
the Office of the National Coordinator for Health IT (ONCHIT) within 
HHS, and stated the goal of widespread EHR adoption within 10 years. 
ONCHIT initiated a number of activities, including work on standards 
and certification.
---------------------------------------------------------------------------
    The HITECH Act charged the HIT Policy Committee with providing 
recommendations on areas in need of standards, implementation 
specifications, and certification criteria. The Act further charged the 
Health IT Standards Committee with ``develop[ing], harmoni[zing], and 
recogni[zing]'' standards and related material, and providing 
recommendations on these for consideration by ONCHIT and HHS. The 
HITECH Act directs the ONCHIT to ensure that federal funds expended 
toward health IT technology go toward certified EHR technology that 
incorporates the standards and capabilities developed by the Policy and 
Standards Committees, and promulgated by HHS.
    The HITECH Act also directs NIST to test the standards, 
implementation specifications, and certification criteria that emerge 
from the ONCHIT standards process. Additionally, the HITECH Act charges 
NIST with developing a conformance testing infrastructure, including 
creating technical test beds, and provided NIST with $20 million to 
develop this infrastructure. Conformance testing is necessary to ensure 
that the health IT products meet all of the requirements of the 
standards and that the standards are correctly implemented. To date, 
HHS has approved three testing and certification bodies and product 
certification is expected to begin shortly. In addition to supporting 
HHS with health IT testing and certification, NIST has assisted HHS 
with establishing security standards and guidance for health IT 
products.
    Since the passage of the HITECH Act, much of the work of the two 
advisory committees has focused on providing recommendations to the 
ONCHIT regarding ``meaningful use.'' Under the HITECH Act, medical 
providers are entitled to apply for Medicare incentive payments 
beginning in 2011 if they adopt EHRs for their patients and meet 
certain requirements. Finalized in July of this year, these include 15 
``core set'' requirements and 10 ``menu set'' options. Meaningful users 
must meet the 15 core requirements and at least 5 of the menu set 
options. Core set requirements include using an EHR to record smoking 
status for 50 percent of patients 13 years of age or older and to 
maintain an active medication list for 80 percent of patients. The core 
set includes only one requirement related to data exchange--users must 
perform at least one test of an EHR's capacity to electronically 
exchange information. The menu set options include using health IT 
systems to generate a listing of patients with a specific condition or 
to perform at least one test data submission of immunization data to 
immunization registries. As specified in the HITECH Act, requirements 
will be added for future stages of meaningful use.\7\
---------------------------------------------------------------------------
    \7\ Providers who become meaningful users of EHRs beginning in 2011 
are entitled to Medicare incentive payments. For providers adopting 
EHRs in 2014, no incentive payments will be provided. By 2015, 
providers not using EHRs will be penalized through reductions on 
Medicare payments. Additional requirements will be added in later 
stages of meaningful use. Note, there is a corresponding timeline for 
providers who become meaningful users under the Medicaid incentive 
program.
---------------------------------------------------------------------------
    In addition to specifying the basic functionality for certified 
EHRs, the final rule also included the standards, implementation 
specifications, and certification criteria required to be met by all 
certified EHRs.

National Health Information Network
    In 2005, HHS began developing a National Health Information Network 
(NHIN). It was conceived of as a ``network of networks'' that would 
allow for the secure exchange of health information among health care 
providers. In 2007, HHS awarded contracts totaling $22.5 million to 
nine health information exchanges (HIEs) to begin trial implementation 
of the NHIN.
    ONCHIT has continued work on developing standards and policies for 
a national health information exchange, whose core capabilities include 
the ability to look up, retrieve, and securely exchange health 
information; the ability to apply consumer preferences for sharing 
information; and the ability to apply and use the NHIN for other 
business capabilities as authorized by the health care consumer. ONCHIT 
has continued work on the NHIN, and is now also working on the NHIN 
Direct project, which will include standards, policies, and services to 
enable the transport of medical records between authorized providers.

Privacy and Security
    A number of state and federal laws and regulations cover the 
confidentiality of personal health information. On the federal level, 
the privacy and security of medical information is protected by the 
Health Information Portability and Accountability Act (HIPPA). The 
HITECH Act expanded upon the HIPAA requirements with stricter 
enforcement mechanisms, requirements for breach notification, and the 
expansion of the privacy and security regulations to cover business 
associates of the health care provider.\8\ The HITECH Act also required 
HHS to issues guidance on ``technologies and methodologies that render 
protected health information unusable, unreadable, or indecipherable to 
unauthorized individuals.'' Covered entities that follow the guidance 
issued by HHS but still suffer a security breach are not subject to the 
breach notification requirements or the stricter penalties enacted in 
the HITECH Act.
---------------------------------------------------------------------------
    \8\ Relevant business associates include business partners of the 
provider that may provide various services, such as accounting or 
management, wherein individually identifiable health information is 
disclosed.
---------------------------------------------------------------------------
    The meaningful use requirements give guidance on technologies and 
methodologies (such as encryption) to protect data. They also require 
users of health IT systems to perform a risk analysis to determine the 
nature and likelihood of threats, and to base their security measures 
on this analysis while considering the cost and complexity of needed 
security infrastructure.

V. ISSUES & CONCERNS

    The standards adopted by HHS for meaningful use are an important 
step in establishing recognized standards for health IT systems and 
EHRs. However, while the standards provide a layer of commonality among 
health IT products, the final rule included only minimal provisions 
concerning interoperability.
    At the same time, throughout the country, medical providers and 
states are developing electronic health information exchange networks, 
as well as pursuing other health IT projects. The Federal Government is 
also pursuing the NHIN and NHIN Direct projects. It is unclear whether, 
and to what extent, the standards-related components of these efforts 
are being coordinated to ensure interoperability in the future.
    HHS has recently released an initial standards and interoperability 
framework. This framework will presumably guide the coordination of 
future standards activities, including harmonization, development, 
testing, and priority setting. However, HHS has not yet clearly 
described how it will maintain the transparency and stakeholder input 
that is an important component of the standards setting and development 
process. In addition, the framework does not specify how HHS will 
continue to work with NIST on health IT standards.
    The HITECH Act strengthened privacy and security protections for 
patient information by requiring breach notification of readable data 
and implementing stricter penalties for the disclosure of personal 
health information. However, there is little federal guidance beyond 
HIPAA for implementing these stricter privacy and security measures. 
For example, no guidance exists on the federal level on whether 
individuals must opt-in to or opt-out of an electronic health exchange, 
or on the granularity, or degree, of patient consent needed to disclose 
certain types of health information. These are policy questions, often 
subject to individual state rules, but they impact the technology 
solutions that will be needed by health care providers. In addition, 
while the security measures adopted for EHRs allow for flexible 
implementation, they may prove challenging to implement, particularly 
among small practices.
    Chairman Wu. The hearing will now come to order. Thank you 
all very much for being here today.
    I would like to recognize that there is a group of high 
school students from Beijing, China, with us today. Thank you 
very much for being here, and I hope that you find this 
experience edifying for your future studies.
    And I thank the witnesses for being here and for traveling, 
in some instances, long distances.
    In the Internet age, most of us take for granted being able 
to rapidly and seamlessly share information with someone across 
town, in another state or on the other side of the world. We 
also take for granted the ubiquitous integration of information 
technology in our workplace and in many other aspects of our 
lives.
    In contrast, the health care industry is still surprisingly 
paper-based and is largely unaided by information technology. 
Medical treatment in this country often involves state-of-the-
art technology. However, physicians and other health care 
providers have been slow to adopt health IT systems and 
electronic health records--or EHRs--and are still keeping track 
of our medical information the same way it has been kept 
historically.
    The use of information technology has real-world 
implications for the cost and quality of health care. 
Currently, providers may order a duplicative test because 
previous test results from another provider are not readily at 
hand, or they may miss a harmful drug interaction because a 
patient's full prescription drug record is not available. 
According to most estimates, a fully interoperable health IT 
system could save us billions of dollars in health care costs 
each year. In addition, greater use of information technology 
could prevent some of the medical errors that, as reported by 
the National Academies, are responsible for the deaths of 
approximately 98,000 people each year.
    A key barrier to broader integration of health IT systems 
has been the lack of technical standards to support 
interoperability and protect data and privacy. Many physicians, 
particularly those in small practices where most Americans get 
their health care, are hesitant to take on the considerable 
expense of a health IT system that without common standards may 
not work with the systems of a neighboring health care provider 
or may become prematurely obsolete.
    This is the third hearing the Science and Technology 
Committee will have held on health IT standards since the 109th 
Congress. I am very eager to hear about the progress we have 
made on standards, especially since the implementation of the 
HITECH Act. In that Act, Congress included a directive to the 
federal agencies before us today to establish health IT 
standards and develop related measures to enable different 
manufacturers and vendors to produce software and other devices 
that will work with other products on the market today, as well 
as tomorrow.
    Given the complexity of our healthcare system, with its 
myriad of players and large number of state and federal laws 
governing personal medical information, the HITECH Act charged 
the Office of the National Coordinator with a very difficult 
task. From all reports, the National Coordinator has done an 
admirable job meeting tight deadlines and navigating the needs 
of many stakeholders. NIST has also played an important role, 
lending to HHS its extensive expertise in standards, testing, 
and certification.
    However, as I am sure we will discuss today, we still have 
a long way to go in promoting interoperability, coordinating 
the many health IT projects underway, governing the standards 
development process and providing direction on privacy and 
security. Modernizing our health care system with information 
technology is imperative for lowering health care costs and 
improving patient care, and I look forward to hearing the 
thoughts and recommendations of the witnesses today on how we 
will successfully meet these challenges.
    Chairman Wu. Now I would like to recognize the Ranking 
Member, Mr. Smith, for his opening statement.
    [The prepared statement of Chairman Wu follows:]

                Prepared Statement of Chairman David Wu

    Good morning. I would like to welcome everybody to today's hearing 
on healthcare information technology.
    In the Internet age, most of us take for granted being able to 
rapidly and seamlessly share information with someone across town, in 
another state, or on the other side of the world. We also take for 
granted the ubiquitous integration of information technology in our 
workplace and in many other aspects of our daily lives.
    In contrast, the health care industry is still surprisingly paper-
based and largely unaided by information technology. Medical treatment 
in this country often involves state-of-the-art technology. However, 
physicians and other health care providers have been slow to adopt 
health IT systems and electronic health records--or EHRs--and are still 
keeping track of our medical information the same way they were 50 
years ago.
    The use of information technology has real-world implications for 
the cost and quality of health care. Currently, providers may order a 
duplicative test because previous test results from another provider 
are not readily at hand, or they may miss a harmful drug interaction 
because a patient's full prescription drug record is not available. 
According to most estimates, a fully interoperable health IT system 
could save us billions of dollars in health care costs each year. In 
addition, greater use of information technology could prevent some of 
the medical errors that, as reported by the National Academies, are 
responsible for the deaths of approximately 98,000 people each year.
    A key barrier to broader integration of health IT systems has been 
the lack of technical standards to support interoperability and protect 
data and privacy. Many physicians, particularly those in small 
practices where most Americans get their health care, are hesitant to 
take on the considerable expense of a health IT system that, without 
common standards, may not work with the systems of a neighboring health 
care provider or may become prematurely obsolete.
    This is the third hearing the Science and Technology Committee will 
have held on health IT standards since the 109th Congress. I am very 
eager to hear about the progress we have made on standards, especially 
since the implementation of the HITECH Act. In that act, Congress 
included a directive to the federal agencies before us today to 
establish health IT standards and develop related measures to enable 
different manufacturers and vendors to produce software and other 
devices that will work with other products on the market today, as well 
as tomorrow.
    Given the complexity of our healthcare system, with its myriad of 
players and large number of state and federal laws governing personal 
medical information, the HITECH Act charged the Office of the National 
Coordinator with a very difficult task. From all reports, though, the 
National Coordinator has done an admirable job meeting tight deadlines 
and navigating the needs of many stakeholders. NIST has also played an 
important role, lending to HHS its extensive expertise in standards, 
testing, and certification.
    However, as I am sure we will discuss today, we still have a ways 
to go in promoting interoperability, coordinating the many health IT 
projects underway, governing the standards development process, and 
providing direction on privacy and security. Modernizing our health 
care system with information technology is imperative for lowering 
health care costs and improving patient care, and I look forward to 
hearing the thoughts and recommendations of the witnesses today on how 
we will successfully meet these challenges.

    Mr. Smith. Thank you, Mr. Chairman, for calling today's 
hearing on development and implementation of standards and 
testing for interoperability of health information technology. 
With the enactment of the HITECH Act and other measures since 
our last full Committee hearing on this issue in September 
2007, a follow-up hearing on this topic is certainly 
appropriate and appreciated.
    Interoperability of health IT is vital to ensuring one of 
the greatest benefits of electronic medical records: the 
ability of multiple practitioners in different locations to 
access a patient's medical records. This access helps avoid 
adverse interactions, duplicative testing and other medical 
errors while improving coordination of care.
    To maximize the potential of health IT, it is vital these 
benefits be available not just in a metropolitan area or a 
single state but across state lines. For example, in my own 
Congressional district, it is not uncommon for those in need of 
higher-level health care to seek it in Colorado, South Dakota, 
Kansas or Wyoming rather than from another in-state location 
such as the larger cities of Lincoln and Omaha. It is vital 
that electronic medical records be available both close to home 
and out of state.
    For this reason, and among others, it is appropriate that 
NIST and other federal agencies play a role in developing 
interoperability standards and testing for such technologies. 
NIST in particular is a trusted arbiter of standards 
development and testing and has the proven expertise to assist 
the Department of Health and Human Services in developing 
testing methods to ensure technology is interoperable as 
promised.
    Additionally, we must ensure interoperability standards 
protect private and taxpayer dollars from being wasted on 
technologies which are not proven to be interoperable--not as a 
barrier to future innovations, which could further improve the 
quality and coordination of patient care.
    Thank you again, Mr. Chairman and witnesses. In particular, 
I would like to welcome our witness Deb Bass, who is Executive 
Director of the Nebraska Health Information Initiative based in 
Omaha. I look forward to a constructive session. Thank you.
    [The prepared statement of Mr. Smith follows:]

           Prepared Statement of Representative Adrian Smith

    Thank you, Chairman Wu, for calling today's hearing on the 
development and implementation of standards and testing for 
interoperability of health information technology. With the enactment 
of the HITECH Act and other measures since our last full committee 
hearing on this issue in September 2007, a follow-up hearing on this 
topic is indeed appropriate and appreciated.
    Interoperability of health IT is vital to ensuring one of the 
greatest benefits of electronic medical records--the ability of 
multiple practitioners in different locations to access a patient's 
medical records. This access helps avoid adverse interactions, 
duplicative testing, and other medical errors while improving 
coordination of care.
    To maximize the potential of health IT, it is vital these benefits 
be available not just in a metropolitan area or a single state, but 
across state lines. For example, in my own congressional district it is 
not uncommon for those in need of higher level care to seek it in 
Colorado, South Dakota, Kansas, or Wyoming, rather than from another 
in-state location such as Lincoln or Omaha. It is vital electronic 
medical records be available both close to home and out of state.
    For this reason, among others, it is appropriate NIST and other 
federal agencies play a role in developing interoperability standards 
and testing for such technologies. NIST, in particular, is a trusted 
arbiter of standards development and testing, and has the proven 
expertise to assist the Department of Health and Human Services in 
developing testing methods to ensure technology is interoperable as 
promised.
    However, we must ensure interoperability standards protect private 
and taxpayer dollars from being wasted on technologies which are not 
proven to be interoperable--not as a barrier to future innovations 
which could further improve the quality and coordination of patient 
care.
    Thank you again, Mr. Chairman and witnesses. In particular I'd like 
to welcome one of our witnesses, Deb Bass, who is Executive Director of 
the Nebraska Health Information Initiative, based in Omaha. I look 
forward to a constructive session.

    Chairman Wu. Thank you very much, Mr. Smith.
    If there are Members who wish to submit additional opening 
statements, your statements will be added to the record at this 
point.
    And now it is my pleasure to introduce our witnesses. Dr. 
David Blumenthal is the National Coordinator for Health 
Information Technology at the Office of the National 
Coordinator for the United States Department of Health and 
Human Services. Ms. Kathleen M. Roberts is the Associate 
Director for Federal and Industrial Relations at the 
Information Technology Laboratory for the National Institutes 
of Standards and Technology. Ms. Joyce Sensmeier is the vice 
President of Informatics for the Healthcare Information and 
Management Systems Society. Dr. Dick Gibson is the President of 
the Oregon Health Network. Ms. Deven McGraw is the Director of 
the Health Privacy Project for the Center for Democracy and 
Technology. Ms. Deb Bass is the President and CEO of Bass and 
Associates.
    You will each have five minutes for your spoken testimony. 
Your written testimony will be included in the record for the 
hearing. And when you all complete your testimony, we will 
begin with questions and each Member will have five minutes to 
question the panel. Dr. Blumenthal, please begin.

STATEMENT OF DAVID BLUMENTHAL, NATIONAL COORDINATOR FOR HEALTH 
  INFORMATION TECHNOLOGY, OFFICE OF THE NATIONAL COORDINATOR, 
          U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Blumenthal. Mr. Chairman, Ranking Member Smith, 
distinguished Subcommittee Members, thank you for the 
opportunity to testify today on behalf of the Department of 
Health and Human Services.
    The HITECH Act represents an historic and unparalleled 
investment in health information technology. It lays the 
groundwork necessary to pursue the President's goals related to 
improved health care quality and efficiency and will help 
transform the way health care is both practiced and delivered.
    We have made considerable progress in the relatively short 
time since the HITECH Act's passage. Our recent accomplishments 
include the establishment of two new federal advisory 
committees, the completion of three rulemakings together with 
the Centers for Medicare and Medicaid Services necessary to 
establish Meaningful Use, Stage 1, strengthening coordination 
throughout the Executive Branch on health information 
technology, and the responsible obligation of nearly all of the 
$2 billion that we were authorized to spend under the American 
Recovery and Reinvestment Act.
    My remarks today will highlight progress that ONC has made 
thus far related to interoperability, privacy and security as 
well as our standards and priorities for future stages of 
Meaningful Use. Interoperability and privacy and security are 
themes that are present throughout the HITECH Act. Thus, many 
of our policy and programmatic efforts focus on those themes.
    Established by the HITECH Act, the HIT Policy and Standards 
Committees both regularly issue recommendations on how best to 
fulfill our statutory responsibilities. Both committees include 
a diverse membership with representatives of various 
perspectives from both the public and private sectors. The 
Policy Committee's work on privacy and security exemplifies its 
major contribution, and I want to note that Ms. McGraw has been 
a major contributor through the Policy Committee to that work.
    The privacy and security of electronic health information 
form the bedrock necessary to build trust. To ensure that we 
have timely privacy and security recommendations related to our 
HITECH programs, the HIT Policy Committee formed an 
interdisciplinary privacy and security Tiger Team of experts 
comprised of members from the HIT Policy and Standards 
Committees as well as from the National Committee on Vital and 
Health Statistics. The Tiger Team has already provided valuable 
guidance to ONC and HHS.
    Like its sister committee, the HIT Standards Committee 
plays a critical role in guiding ONC. Since its inception, the 
HIT Standards Committee has issued recommendations to ONC on 
the standards and implementation specifications that should be 
considered to support Meaningful Use Stage 1 and the 
development and maintenance of specific vocabularies to improve 
interoperability.
    With the advice of these committees and extensive external 
consultation, we completed last July three independent 
rulemakings that were necessary to implement Meaningful Use 
Stage 1. These rules cumulatively reflect over 2,000 public 
comments from stakeholders across the health care system.
    The first rule was the EHR incentive program and defined 
Meaningful Use Stage 1. ONC and the Centers for Medicare and 
Medicaid Services worked collaboratively to strike a balance 
that reflected both the urgency of adopting EHR technology and 
the challenges that adoption will pose to health care 
providers. Our approach attempts to move the health system 
upward toward improved quality and effectiveness but at a speed 
that reflects both the capacities of providers who face 
multiple real-world challenges and the maturity of the 
technology itself.
    The second rule defined EHR standards, implementation 
specifications, and certification criteria adopted by the 
Secretary to support Meaningful Use. The initial standard set 
several specific interoperability and security capabilities 
that certified EHR technology must incorporate including e-
prescribing according to specific standards, exchanging 
standardized patient summary records, authenticating users, 
generating audit logs and encrypting health information 
according to standards specified by NIST.
    In the third rule, ONC established a temporary 
certification process. We have now authorized three 
certification bodies. In developing our certification programs, 
we consulted extensively with our colleagues at NIST, which has 
been an invaluable partner in all our efforts to implement the 
HITECH Act.
    We anticipate that future stages of Meaningful Use will 
build on the foundation we have now established and will 
require progressively more rigorous electronic health 
information exchange requirements. In order to develop those 
requirements, we have again asked the HIT Policy Committee to 
make recommendations on what Meaningful Use stages 2 and 3 
should encompass.
    We anticipate that the Standards Committee will then begin 
to focus on the standards implementation specifications and 
certification criteria that will be necessary for future stages 
of Meaningful Use. We also expect the Standards Committee to 
issue recommendations that focus on strengthening security 
capabilities of EHR technologies and on standards for 
electronic health information exchange in support of meaningful 
use. Interoperability will be critical to our success in stages 
2 and 3. We recognize that greater specificity with respect to 
standards is necessary to reach our goals and we will be 
working on adopting additional implementation specifications, 
achieving agreement on vocabulary and code sets for particular 
exchange purposes and comprehensive privacy and security 
capabilities for EHR technology.
    ONC and CMS have accomplished a great deal up to now but 
much remains to be done. We look forward to working with the 
House and Science and Technology Committee on this important 
endeavor, and it has been my privilege to testify before you 
today and I look forward to answering any questions you may 
have.
    [The prepared statement of Dr. Blumenthal follows:]

                 Prepared Statement of David Blumenthal

    Chairman Wu, Ranking Member Smith, distinguished Subcommittee 
members, thank you for the opportunity to submit testimony on behalf of 
the Department of Health and Human Services (HHS) on our progress and 
priorities related to interoperability and the security of electronic 
health records and health information technology (HIT) systems since 
the passage of the Health Information Technology for Economic and 
Clinical Health Act (HITECH Act).
    The HITECH Act represents an historic and unparalleled investment 
in HIT, lays the groundwork necessary to pursue the President's goals 
related to improved health care quality and efficiency, and will help 
transform the way health care is both practiced and delivered. The 
provisions of the HITECH Act are best understood not as investments in 
technology per se, but as efforts to improve the health of Americans 
and the performance of their health care system.
    Interoperability and privacy and security are themes that are 
present throughout the HITECH Act. Consequently, many of our policy and 
programmatic efforts also focus on those themes. We have made 
remarkable progress in the relatively short time since the HITECH Act's 
passage. Our recent accomplishments include: the establishment of two 
new federal advisory committees, the HIT Policy Committee and HIT 
Standards Committee; the completion of the three rulemakings necessary 
to establish meaningful use Stage 1 for the Medicare and Medicaid 
Electronic Health Record (EHR) Incentive Programs; strengthened 
coordination throughout the Executive Branch on HIT; and the 
responsible obligation of nearly all of the $2 billion we were 
authorized under the American Recovery and Reinvestment Act of 2009 
through the creation of several programs that will have a lasting 
impact on the HIT landscape. As we take stock of our successes and 
complete the challenges in front of us, we recognize that much work 
still remains in order to reach our goals for the future.
    The first half of my testimony focuses on the progress that the 
Office of the National Coordinator for Health Information Technology 
(ONC) has made thus far related to interoperability and privacy and 
security, generally, while the second half discusses the work we are 
currently pursuing with respect to standards in order to support the 
latter stages of meaningful use.

Building on HITECH

The HIT Policy and Standards Committees
    Established by the HITECH Act, the HIT Policy and HIT Standards 
Committees both contribute a great deal to our activities and regularly 
issue recommendations on how to best fulfill our responsibilities and 
implement the ambitious agenda set forth by the HITECH Act. Both 
Committees include a diverse membership, with representatives of 
various perspectives from both the public and private sectors. The HIT 
Standards Committee, for example, combines standards experts from the 
private sector with Federal government leaders from OSTP, NIST, DoD, 
VA, and CMS.\1\
---------------------------------------------------------------------------
    \1\ OSTP: Office of Science and Technology Policy; NIST: National 
Institute of Standards and Technology; DoD: Department of Defense; VA: 
Department of Veterans Affairs; CMS: Centers for Medicare & Medicaid 
Services
---------------------------------------------------------------------------
    As we continue to implement the HITECH Act, we are acutely aware 
that it is paramount to implement appropriate policies to keep 
electronic health information private and secure. Privacy and security 
form the bedrock necessary to build trust. Patients and providers must 
feel confident in the processes, policies, and standards in place 
related to HIT and the electronic exchange of health information. Thus, 
to ensure that we have timely privacy and security recommendations 
related to the HITECH programs for which we are responsible, the HIT 
Policy Committee formed an interdisciplinary ``Privacy and Security 
Tiger Team'' of experts comprised of members from both the HIT Policy 
and Standards Committees. Members from the National Committee on Vital 
and Health Statistics (NCVHS) also serve on the Tiger Team to ensure 
the efforts of these committees are coordinated.
    Building on the work of the Tiger Team, the HIT Policy Committee 
has, in accordance with its mandate in the HITECH Act, recently 
submitted recommendations regarding data segmentation technologies to 
ONC, as well as recommendations on obtaining patient consent in various 
contexts. In upcoming months, the Tiger Team in coordination with the 
HIT Policy Committee will continue to prioritize and address additional 
privacy and security issues including: the privacy and security 
requirements for participants in health information exchange activities 
who are not subject to the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) Privacy and Security Rules; 
credentialing assurance levels; individual access; transparency; 
security safeguards; and de-identified data.
    Like its sister committee, the HIT Standards Committee plays a 
critical role in guiding ONC. In August 2009, and again in March 2010, 
it issued recommendations to ONC on the standards and implementation 
specifications that should be considered to support meaningful use 
Stage 1. It has also formed workgroups which focus on clinical 
operations, clinical quality, and implementation. Most recently, the 
HIT Standards Committee established a vocabulary task force under the 
clinical operations workgroup to address vocabulary subsets and value 
sets as facilitators and enablers of meaningful use. In April, 2010, 
the HIT Standards Committee made recommendations to ONC based on the 
work of the clinical operations workgroup and taskforce. These 
recommendations broadly addressed several areas related to the 
identification, development, review, testing, and maintenance of 
vocabularies, value sets, and code sets, as well as the establishment 
of an authoritative vocabulary infrastructure.
    Finally, in response to their charge under Section 1561 of the 
Patient Protection and Affordable Care Act, the HIT Policy and 
Standards Committees recently made recommendations to ONC for the 
Secretary's consideration regarding interoperable and secure standards 
and protocols that facilitate enrollment of individuals in Federal and 
State health and human services programs. On September 17, the 
Secretary adopted this first set of recommendations and they were 
published on ONC's website.\2\
---------------------------------------------------------------------------
    \2\ http://healthit.hhs.gov/portal/
server.pt?open=512&mode=2&objID=3161

Meaningful Use Stage 1
    This past July marked the completion of the three interdependent 
rulemakings that were necessary to implement ``Meaningful Use Stage 
1,'' the first stage of the Medicare and Medicaid EHR Incentive 
Programs. The first rulemaking establishes the requirements that 
eligible health care providers \3\ will need to satisfy in order to 
qualify for incentive payments. The second specifies the technical 
capabilities and standards that certified EHR technology will need to 
include to support these health care providers. And the third creates 
the processes for EHR technology to be tested and certified, thus 
providing confidence and assurance to eligible health care providers 
that the certified EHR technology they adopt will perform as expected. 
These rules, cumulatively, reflect over 2,000 public comments from 
stakeholders across the health care system, and illuminate the initial 
pathway to achieving an integrated and electronically connected health 
care system.
---------------------------------------------------------------------------
    \3\ ``Eligible health care providers'' is used to mean: ``eligible 
professionals, eligible hospitals, and critical access hospitals''
---------------------------------------------------------------------------
    In developing the policies for meaningful use Stage 1, the ONC and 
CMS worked collaboratively to strike a balance that reflected both the 
urgency of adopting EHR technology to improve our health care system 
and the challenges that adoption will pose to health care providers. 
Our approach attempts to move the health system upward toward improved 
quality and effectiveness in health care, but at a speed that reflects 
both the capacities of providers who face a multitude of real-world 
challenges and the maturity of the technology itself.
    In order to ensure that eligible health care providers can obtain 
EHR technology capable of assisting their achievement of meaningful use 
Stage 1, the Secretary adopted an initial set of standards, 
implementation specifications, and certification criteria for EHR 
technology (the Initial Set). Much like meaningful use Stage 1, the 
Initial Set creates a foundation from which we expect to continue to 
build in order to enhance the interoperability and security of EHR 
technology. The Initial Set specifies several interoperability and 
security capabilities that certified EHR technology must include in 
order to support meaningful use Stage 1. With respect to 
interoperability, it specifies that certified EHR technology must be 
capable of submitting information to public health agencies in standard 
formats, that specific standards must be used for electronic 
prescribing, and it specifies certain standards (content exchange and 
vocabulary) that must be used when patient summary records are 
exchanged and when patients are provided electronic copies of their 
health information. With respect to privacy and security, the Initial 
Set requires that certified EHR technology must be capable of 
automatically logging-off a user, access control, authentication, 
generating audit logs, checking the integrity of information that is 
electronically exchanged, and encrypting health information (according 
to standards specified by NIST).
    To ensure proper incorporation and use of the adopted standards and 
implementation specifications EHR technology must be tested and 
certified according to the certification criteria adopted by the 
Secretary. In that regard, we issued, at the end of June, a final rule 
establishing the temporary certification program for health information 
technology that outlines how organizations can become ONC-Authorized 
Testing and Certification Bodies (ONC-ATCBs). Once authorized by the 
National Coordinator, the ONC-ATCBs will test and certify that EHR 
technology is compliant with the standards, implementation 
specifications, and certification criteria adopted by the Secretary. To 
date, three organizations have now been granted ONC-ATCB status by the 
National Coordinator. We are also working on a final rule for a 
permanent certification program that we expect to publish later this 
year and that will be fully operational in early 2012. We expect that 
this program will be more rigorous than the temporary certification 
program and will achieve greater incorporation of international 
standards and best practices through requirements such as accreditation 
and surveillance. In developing our proposals for both the temporary 
and permanent certification programs and, in accordance with the HITECH 
Act, we consulted extensively with our colleagues from NIST. During 
this time, we established an even closer working relationship with the 
experts at NIST and we anticipate continuing to work with them, as the 
certification programs mature. NIST has been an invaluable partner in 
all our efforts to implement the HITECH Act.

Strengthened Coordination
    On a number of fronts, we have actively sought to strengthen 
coordination within the Executive branch on complementary activities 
where the use of adopted standards and implementation specifications 
may be appropriate. In this regard, the Federal HIT Task Force was 
created to facilitate implementation of the President's HIT agenda 
through better coordination among Federal agencies. As noted, under the 
aegis of this HIT Task Force, we are working with the President's 
Cybersecurity Coordinator, Mr. Howard Schmidt, to take full advantage 
of security lessons learned from other Federal programs. We are also 
supporting our colleagues at the Department of Defense and the 
Department of Veterans Affairs on their implementation of the Virtual 
Lifetime Electronic Record (VLER) project, and continuing our work with 
the Federal Health Architecture (FHA).
    Additionally, ONC has maintained a close working relationship with 
HHS' Office for Civil Rights (OCR) and consulted with OCR as it 
developed the proposed modifications to the HIPAA Privacy, Security, 
and Enforcement Rules required by the HITECH Act to strengthen the 
privacy and security protections for health information and to improve 
the workability and effectiveness of the HIPAA Rules. The proposed 
regulatory provisions would, among other things, expand individuals' 
rights to access their information and restrict certain disclosures of 
protected health information to health plans; extend the applicability 
of certain Privacy and Security Rules' requirements to the business 
associates of covered entities; establish new limitations on the use 
and disclosure of protected health information for marketing and 
fundraising purposes; and prohibit the sale of protected health 
information without patient authorization. This proposed rulemaking 
will strengthen the privacy and security of health information, and is 
an integral piece of the Administration's efforts to broaden the use of 
HIT in health care today.

HITECH Programs
    Through implementing the new authorities provided by the HITECH 
Act, we have committed to fostering the support, collaboration, and 
ongoing learning that will mark our progress toward electronically 
connected, information-driven medical care. Several new programs will 
contribute to this progress, including:

          The State Health Information Exchange Cooperative 
        Agreement Program--A grant program to support States or State 
        Designated Entities in rapidly building capacity for exchanging 
        health information across the health care system both within 
        and across states.

          The Beacon Community Program--A grant program for 
        communities to build and strengthen their HIT infrastructure 
        and exchange capabilities. These communities will demonstrate 
        the vision of a future where hospitals, clinicians, and 
        patients are meaningful users of health IT, and together the 
        community achieves measurable improvements in health care 
        quality, safety, efficiency, and population health.

          The Health IT Workforce Program--A multi-pronged 
        approach designed to support the education of HIT 
        professionals, including new and expanded training programs, 
        curriculum development, and competency testing.

          The Strategic Health IT Advanced Research Projects 
        (SHARP) Program--A grant program to fund research focused on 
        achieving breakthrough advances to address well-documented 
        problems that have impeded adoption: 1) Security of Health 
        Information Technology; 2) Patient-Centered Cognitive Support; 
        3) Healthcare Application and Network Platform Architectures; 
        and, 4) Secondary Use of EHR Data.

          The Health Information Technology Extension Program--
        A grant program to establish Health Information Technology 
        Regional Extension Centers to offer technical assistance, 
        guidance, and information on best practices to support and 
        accelerate health care providers' efforts to become meaningful 
        users of EHRs.

Supporting Standards Needs beyond Meaningful Use Stage 1

    We anticipate that future stages of meaningful use will build on 
the foundation we have now established and will require progressively 
more rigorous electronic health information exchange requirements. In 
order to develop those requirements, we have again asked the HIT Policy 
Committee to make recommendations on what meaningful use Stages 2 and 3 
should encompass. The HIT Policy Committee and its Meaningful Use 
workgroup have received testimony and held numerous hearings on topics 
such as care coordination, patient/family engagement, and eliminating 
disparities in health care. This fall the Meaningful Use workgroup will 
be holding additional public meetings, and will be closely monitoring 
implementation of meaningful use Stage 1 to inform its recommendations 
to the HIT Policy Committee. As before, and in response to the 
meaningful use policy priorities identified by the HIT Policy 
Committee, we anticipate that the HIT Standards Committee will also 
begin to focus on the standards, implementation specifications, and 
certification criteria that will be necessary for future stages of 
meaningful use. We also expect the HIT Standards Committee to issue 
recommendations that focus on strengthening the security capabilities 
of EHR technology and on standards for electronic health information 
exchange in support of meaningful use.
    In order to support future stages of meaningful use as well as our 
other initiatives, we determined that a comprehensive standards and 
interoperability framework was needed, and we are currently in the 
process of establishing that framework. The ``Standards and 
Interoperability Framework'' is intended to help us coordinate our 
standards development efforts, and to facilitate the development, 
adoption, and use of high-quality standards and implementation 
specifications. We believe by using the Standards and Interoperability 
Framework, we can develop and maintain a well organized set of 
standards that can be reused across different use cases, and allow for 
greater coordination among public and industry stakeholders.
    Interoperability will be critical to our success in Stages 2 and 3 
of meaningful use. In the Initial Set, we adopted several standards for 
the electronic exchange of health information, but we recognize that 
greater specificity is necessary to reach our goals. In that respect we 
will be working on adopting additional implementation specifications; 
achieving agreement on vocabularies and code sets for particular 
exchange purposes; and comprehensive privacy and security capabilities 
for EHR technology.

Conclusion

    The HITECH Act provides for an unprecedented amount of funding to 
improve the quality and efficiency of health care through HIT, and its 
historic investment will undoubtedly help transition our current 
antiquated, paper-dominated health care system into a high-performing 
21st century health care system. With a nationwide infrastructure of 
HIT in place, that provides the capability of secure interoperable 
health information exchange through consensus built standards, 
patients, providers, and the public will experience the true value 
added for improving health care delivery. It is my privilege to testify 
before you today and I look forward to answering any questions you 
might have.

                     Biography for David Blumenthal

    David Blumenthal, MD, MPP serves as the National Coordinator for 
Health Information Technology under President Barack Obama. In this 
role he is charged with building an interoperable, private and secure 
nationwide health information system and supporting the widespread, 
meaningful use of health IT.
    Dr. Blumenthal received his undergraduate, medical, and public 
policy degrees from Harvard University and completed his residency in 
internal medicine at Massachusetts General Hospital. Prior to his 
appointment to the administration, Dr. Blumenthal was a practicing 
primary care physician; director, Institute for Health Policy; and the 
Samuel O. Thier Professor of Medicine and Professor of Health Policy at 
the Massachusetts General Hospital/Partners HealthCare System and 
Harvard Medical School.
    Dr. Blumenthal is a renowned health services researcher and 
national authority on health IT adoption. With his colleagues from 
Harvard Medical School, he authored the seminal studies on the adoption 
and use of health information technology in the United States. He is 
the author of over 200 scholarly publications, including most recently, 
``Heart of Power: Health and Politics in the Oval Office,'' which tells 
the history of U.S. Presidents' involvement in health reform, from FDR 
through George W. Bush.
    A member of the Institute of Medicine and a former board member and 
national correspondent for the New England Journal of Medicine, Dr. 
Blumenthal has held several leadership positions in medicine, 
government, and academia including Senior Vice President at Boston's 
Brigham and Women's Hospital; Executive Director of the Center for 
Health Policy and Management and Lecturer on Public Policy at the 
Kennedy School of Government; and as a professional staff member on 
Senator Edward Kennedy's Senate Subcommittee on Health and Scientific 
Research.
    He was the founding chairman of AcademyHealth and served previously 
on the boards of the University of Chicago Health System and of the 
University of Pennsylvania Health System. He is recipient of the 
Distinguished Investigator Award from AcademyHealth, and a Doctor of 
Humane Letters from Rush University.

    Chairman Wu. Thank you very much, Dr. Blumenthal.
    Ms. Roberts, please proceed.

STATEMENT OF KAMIE ROBERTS, ASSOCIATE DIRECTOR FOR FEDERAL AND 
   INDUSTRIAL RELATIONS, INFORMATION TECHNOLOGY LABORATORY, 
         NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

    Ms. Roberts. Chairman Wu, Ranking Member Smith and Members 
of the Subcommittee, I am Kamie Roberts, Associate Director of 
the Information Technology Laboratory at the Department of 
Commerce's National Institute of Standards and Technology. 
Thank for the opportunity to appear before you today to discuss 
our role in standards for health information technology.
    Both the President and Congress have recognized that health 
IT is a national priority, and NIST expertise on standards and 
interoperability is key to the fulfillment of the goals of 
health IT, such as higher quality and more efficient care, 
seamless, secure and private movement of data between health 
care providers without compromise or loss of information, and 
fewer errors and redundant tests, to name a few.
    Over its history, NIST has been successful in applying 
emerging IT standards in many national priority domains and 
leveraging collaborations with industry and other federal 
efforts. Health IT is no exception. NIST has been collaborating 
with industry and others to improve the health care information 
infrastructure since the 1990s.
    I would like to quickly note that as with any standards 
effort in the United States, there are strengths and challenges 
in health IT standards activities. The health IT standards 
development effort in the United States is strengthened by the 
robust, open process in which public and private sector 
collaborations are addressing the end goal of interoperable 
EHRs and health IT systems. The many varied partners bring 
their own strengths to the deliberations. At the same time, 
with health IT as a national priority, many standards 
development organizations are working to provide the standards-
based solutions needed, which can sometimes lead to 
conflicting, overlapping or redundant standards.
    A further challenge is the need to accelerate standards to 
keep up with the fast pace of technology advances.
    NIST plays a critical role by providing technical expertise 
early and throughout the standards development process by 
leveraging industry-led, consensus-based standards development 
and harmonization efforts. NIST is helping ensure that the 
requisite infrastructural standards, such as clinical 
information exchange and security are complete and unambiguous.
    NIST testing activities, including developing test tools 
and associated testing infrastructure, reduce the cost to help 
develop IT systems, first, through the early use of testing, 
which can accelerate standards development efforts, and second, 
as vendors implement systems, test tools provided by NIST help 
ensure that standards are implemented correctly.
    Under the temporary health IT certification program, 
testing organizations authorized by the Office of the National 
Coordinator will use the NIST tests to evaluate EHR software 
and systems so doctors' offices, hospitals and other health 
care providers have confidence in the systems that they 
purchase. In addition, NIST is advising ONC on the process by 
which testing organizations will be authorized to test and 
certify the EHR systems.
    There is much to be done in the realm of health IT 
standards, so we have to set priorities. Current priority areas 
include security standards, usability standards, and medical 
device interoperability standards. NIST also advances other 
high-priority health IT standards as needed.
    NIST is actively engaged with private industry, academia, 
and other federal agencies including our colleagues in the 
Networking and Information Technology Research and Development 
Committee in coordination of longer-term health IT standards 
activities to ensure that future technologies can be integrated 
into the nationwide health care infrastructure.
    NIST has a diverse portfolio of activities supporting our 
Nation's health IT effort. With NIST's extensive experience and 
broad array of expertise, both in its laboratories and in 
successful collaborations with the private sector and other 
government agencies, NIST is actively pursuing the standards 
and measurement research necessary to achieve the goal of 
improving health care delivery through information technology.
    Thank you for the opportunity to testify today on NIST's 
activities in health IT standards. I would be happy to answer 
any questions you may have.
    [The prepared statement of Ms. Roberts follows:]

                  Prepared Statement of Kamie Roberts

    Chairman Wu, Ranking Member Smith, and Members of the Subcommittee, 
I am Kamie Roberts, Associate Director of the Information Technology 
Laboratory at the Department of Commerce's National Institute of 
Standards and Technology (NIST). Thank you for the opportunity to 
appear before you today to discuss our role in standards for health 
information technology (IT).
    NIST's mission is to promote U.S. innovation and industrial 
competitiveness by advancing measurement science, standards, and 
technology in ways that enhance economic security and improve our 
quality of life.
    NIST accelerates the development and deployment of information and 
communication systems that are reliable, usable, interoperable, and 
secure; advances measurement science through innovations in 
mathematics, statistics, and computer science; and conducts research to 
develop the measurements and standards infrastructure for emerging 
information technologies and applications.
    As health IT has become a top priority around the nation, it is 
clear that standards and interoperability are key to the fulfillment of 
the goals of health IT:

          higher quality and more efficient care;

          seamless, secure, and private movement of data 
        between healthcare providers without compromise or loss of 
        information;

          access to medical histories (including diagnoses, 
        diagnostic tests, laboratory tests, and medication lists) at 
        the point of care and in emergency settings;

          fewer errors and redundant tests;

          more efficient and effective reporting, including 
        surveillance and quality monitoring; and

          quick detection of adverse drug reactions and 
        epidemics.

    NIST has been successful in applying emerging IT standards in many 
national priority domains and leveraging collaborations with industry 
and other federal efforts; health IT is no exception. NIST has been 
collaborating with industry and others to improve the healthcare 
information infrastructure since the 1990s. Our IT researchers have an 
internationally respected reputation for their knowledge, experience, 
and leadership. As in all NIST endeavors, we are highly recognized and 
respected for our neutrality. Since 2005, NIST has worked closely with 
the Department of Health and Human Services' Office of the National 
Coordinator for Health IT (HHS/ONC). The role of NIST was further 
articulated in the 2008-2012 Federal Health IT strategic plan and the 
American Recovery and Reinvestment Act (ARRA) to:

          Advance healthcare information enterprise integration 
        through standards and testing

          Consult on updating the Federal Health IT Strategic 
        Plan

          Consult on voluntary certification programs

          Consult on health IT implementation

          Provide pilot testing of standards and implementation 
        specifications, as requested.

    The health IT standards development effort is strengthened by the 
robust, open process in which private-public sector collaborations are 
addressing the end goal of interoperable electronic health records and 
health IT systems, where the various partners participate according to 
their strengths. At the same time, with health IT as a national 
priority, many standards development organizations are working to 
provide the standards-based solutions needed, which can sometimes lead 
to overlapping or redundant standards. A further challenge is the need 
to accelerate standards to track the fast pace of technology advances. 
NIST recognizes this need and through close collaborations with the 
health IT community, priority areas are being identified and early use 
of testing is helping to accelerate the development of complete, 
unambiguous standards.

NIST Role in Health IT Standards

    To accelerate health IT standards, NIST is providing technical 
expertise and leveraging industry-led, consensus-based standards 
development and harmonization efforts. NIST plays a critical role by 
participating early in the development process and by helping ensure 
that the requisite infrastructural standards (such as clinical 
information exchange, security, and usability) are complete and 
unambiguous. For example, NIST is collaborating with organizations 
including, Health Level Seven (HL7), IEEE, International Organization 
for Standardization (ISO), and Integrating the Healthcare Enterprise, 
to refine current standards and develop standards that are needed in 
the future, such as standards for the next stages of meaningful use 
criteria (in 2013 and 2015). NIST is also engaged with other Federal 
agencies that have responsibility for health IT standards.
    NIST testing activities, including developing test tools and 
associated testing infrastructure, reduce the cost to develop health IT 
systems by providing developers with an innovative, flexible and 
virtual testbed to confirm that their systems can exchange clinical 
information with other systems. In addition, it is important that 
vendors test their implementation of standards-based health systems; 
without testing it is impossible to know if a standard is implemented 
correctly.
    As a further extension of the NIST testing activities, NIST, in 
collaboration with HHS/ONC, is helping develop a program for the 
voluntary certification of health IT systems as being in compliance 
with applicable certification criteria to meet meaningful use, that is, 
performing specifically defined functions. This effort is two pronged: 
(1) develop the test procedures necessary to certify the systems, and 
(2) define the process by which testing organizations will be 
authorized to test and certify the Electronic Health Record (EHR) 
systems. To address the first prong, NIST published, in August 2010, a 
set of HHS/ONC-approved procedures for testing EHR systems. During the 
development of these test procedures, NIST collaborated with HHS/ONC to 
ensure that the relevant standards and certification criteria were 
consistent and effectively represented within the test procedures. The 
approved NIST-developed test procedures evaluate components of EHR 
systems such as their encryption, how they plot and display growth 
charts, and how they control access so that only authorized users can 
retrieve information.
    Under the voluntary health IT certification program, testing 
organizations authorized by HHS/ONC will use the NIST test procedures 
to evaluate EHR software and systems so doctor's offices, hospitals and 
other healthcare providers have confidence in the systems they 
purchase. As defined in ARRA, the Federal government will provide 
Medicare and Medicaid incentive payments to healthcare providers who 
meaningfully use EHR systems which meet HHS/ONC certification standards 
and criteria.
    In addition, NIST is advising HHS/ONC on the process by which 
testing organizations will be authorized to test and certify the EHR 
systems. This includes advising on all aspects of developing the 
temporary and permanent certification programs and collaborating with 
HHS/ONC during the implementation and operational phases of the 
certification programs. In addition, HHS/ONC has stated its intention 
to use NIST's National Voluntary Laboratory Accreditation Program 
(NVLAP) to perform the accreditation of testing laboratories under the 
permanent certification program.

Standards Priorities

    Working in collaboration with relevant standards development 
organizations, Federal agencies, professional societies, and industry, 
NIST provides technical expertise to enable the acceleration of 
industry-led, consensus-based standards development and harmonization 
to help ensure a complete, unambiguous set of health IT standards for 
clinical information exchange functions such as finding patients, 
discovering patient information, retrieving patient information, 
sending patient information, and allowing information to be sent, such 
as lab test results. Current priority areas include security standards, 
usability standards, and medical device and terminology standards. NIST 
also advances other high priority health IT standards as appropriate.

Security
    To help safeguard health information, NIST is developing a 
harmonized set of security principles and guidelines for use in 
emerging secure health information exchanges. NIST developed a 
systematic approach that organizations can use to design the technical 
security architecture necessary for the secure exchange of health 
information. This approach applies common government and commercial 
practices to the health information exchange domain. Utilizing this 
approach will assist organizations in ensuring protection of health 
data is addressed throughout the system development life cycle, and 
that organizations apply these protection mechanisms in technologies to 
enable the exchange of health information. Other key activities in 
health IT security include:

          Using security automation specifications, NIST is 
        working with HHS's Office of Civil Rights to develop baseline 
        security configuration checklists and toolkits that will help 
        implement and assess the effectiveness of technical and non-
        technical safeguards in the Health Insurance Portability and 
        Accountability Act (HIPAA) Security Rule.

          Conducting outreach and awareness on security 
        challenges, threats, and safeguards including presentations at 
        industry conferences, workshops, Federal Advisory Committee 
        meetings, and other Federal agencies on the application of 
        security standards and guidelines to support health IT 
        implementations.

Usability
    Usability is a critical factor in health IT systems and must be 
considered in future meaningful use criteria. Usability enables health 
IT systems that are safe, effective, and efficient. Building upon our 
foundational work in usability, NIST is performing cutting-edge 
research for usability standards within the healthcare domain. NIST is 
collaborating closely with industry, academia, and other government 
agencies, including HHS/ONC, , the Agency for Healthcare Research and 
Quality (AHRQ), the Food and Drug Administration (FDA), and the 
National Institutes of Health (NIH) to provide guidance in the 
development of health IT usability standards and measurements. To 
pursue these goals, in November 2009, NIST released a usability 
roadmap, designed to deliver specific, objective health IT usability 
standards and define rigorous testing methods to assess compliance. 
This summer, to further refine the roadmap, NIST co-sponsored a health 
IT usability workshop with HHS/ONC and AHRQ to prioritize, align, and 
coordinate short, medium, and long-term strategies to improve usability 
of EHR systems. To help carry out the work defined in the roadmap, a 
public-private multi-year program of research will develop a principled 
framework for measuring the usability of health IT systems, resulting 
in established usability and accessibility standards for systems to 
prevent critical errors and promote effective and efficient use by all 
end users (doctors, nurses, administrators, patients, and others). 
Closely related to usability, accessibility, if implemented in a well-
defined way, has the potential to remove the barriers to using health 
IT systems for the 20% of our population who experience some form of 
disability. Promoting the use of accessibility standards on a voluntary 
basis will achieve a nationwide impact that is truly ``welcoming'' to 
all people.

Medical Device Interoperability Standards
    Medical devices have the ability to communicate with many other 
devices of various makes, models, and modalities. Acute point-of-care 
settings, such as a patient's bedside, require each class of medical 
device to use the same terminology to seamlessly and reliably 
communicate physiological data. As EHR systems are adopted, it is 
important that data from medical devices be easily and fully integrated 
into a patient's EHR. NIST researchers are collaborating with medical 
device and EHR experts to develop point of care medical device and EHR 
standards that meet this need.
    In addition, terminology standards are an important area of focus 
needed to facilitate device interoperability. Terminology standards 
provide the necessary means to enable interoperability of data. For 
example, different device manufacturers sometimes utilize different 
terminology within their devices. Based on this, interoperability 
between these devices or between a device and an EHR is impossible. 
NIST, in collaboration with ISO and IEEE, developed a system to enhance 
medical device interoperability through standard terminology mapping; 
this system is being used across the health IT enterprise.

Beyond Meaningful Use

    NIST is actively engaged with private industry, academia, and other 
Federal agencies, including those in the Networking and Information 
Technology Research and Development (NITRD) community, in coordination 
of longer-term health IT standards development, research, and outreach 
activities. For example:

          There is an ever-growing need to provide remote and 
        home healthcare for aging, underserved (e.g., rural), and 
        chronically ill populations, which can be facilitated by 
        leveraging existing and emerging health IT standards and 
        testing. Telemedicine includes capabilities where wellness 
        checkups and monitoring, diagnoses, and treatment can occur any 
        place and any time.

          Pervasive healthcare explores the use of emerging 
        technologies such as body sensors, implants, and medical 
        equipment for routine monitoring of chronic conditions. Current 
        research includes analyzing the impact of interference from 
        such devices and exploring the potential of applying energy 
        from human movement to power the devices.

          Standards and guidelines are required so that medical 
        records can be retrieved regardless of the format and medium in 
        which they were first created or stored. This preservation will 
        allow doctors to create the medical records of children today, 
        and enable access to those same medical records when those 
        children are adults.

          Standards and terminologies need to be extended to 
        accommodate changing technologies and advances in biomedical 
        knowledge.

          Information needs to be retrieved from notes in EHRs 
        where data is not formatted or structured. EHR systems contain 
        a wealth of information in the notes on a patient's history, 
        symptoms, reactions, etc. Research into the retrieval and 
        analysis of this textual information based on specific search 
        criteria will enable use of key data by the practitioner.

          Advances are needed in image quality for healthcare 
        applications to help ensure, for example, that the colors 
        viewed on a digital image by a medical practitioner are 
        representative of the actual colors when viewed in person.

    NIST activities and collaboration in areas such as these will 
ensure that future technologies can be integrated into the nationwide 
healthcare infrastructure. NIST's pilot projects and/or programs doing 
basic research in these emerging technologies have potential for 
immediate and big impact applications in healthcare. Using NIST core 
competencies to expand research in these areas is in direct support of 
the goals of health IT.
    NIST has a diverse portfolio of activities supporting our nation's 
health IT effort. With NIST's extensive experience and broad array of 
expertise both in its laboratories and in successful collaborations 
with the private sector and other government agencies, NIST is actively 
pursuing the standards and measurement research necessary to achieving 
the goal of improving healthcare delivery through information 
technology.
    Thank you for the opportunity to testify today on NIST's activities 
in health IT. I would be happy to answer any questions that you may 
have.

                      Biography for Kamie Roberts

    Kamie Roberts is the Associate Director for Federal and Industrial 
Relations of the Information Technology Laboratory (ITL) at the 
National Institute of Standards and Technology (NIST). As Associate 
Director, Roberts provides a focal point for interactions with 
industry, government and international communities in key ITL program 
areas. She is responsible for the management of technical and 
administrative staff serving the needs of the ITL and NIST management, 
including but not limited to coordination of NIST Health Information 
Technology strategy and telemedicine research activities, ITL strategic 
planning, and IT standards liaison.
    During 2009, Roberts served as the Acting Division Chief of the 
Software and Systems Division in ITL. The division develops software 
testing tools and methods that improve quality, conformance to 
standards and correctness. The division also participates with industry 
in the development of forward-looking standards. Key focus areas 
include health information technology, software quality, computer 
forensics, voting systems and test method research.
    From October 1996 to June 1998 and again from April 2002 to June 
2006, Roberts served as the Acting Deputy Director of the Information 
Technology Laboratory. She was responsible for the day-to-day 
administration, financial, and personnel management of the laboratory 
and assisted in the direction of the scientific and technical 
activities of the Laboratory divisions.
    Roberts served in the Office of Enterprise Integration, ITL, NIST, 
coordinating Department of Commerce activities in the area of 
enterprise integration. Roberts also served as special assistant to the 
NIST Director in the Director's role as Chair of the Committee on 
Applications and Technology of the Administration's Information 
Infrastructure Task Force. Previously, Roberts was on detail as 
technical staff to the Director of NIST in the position of Program 
Analyst. Prior to December 1994, Roberts performed research in the 
areas of distributed systems, transaction processing, X.25 networking 
standards and integrated services digital network standards.
    Roberts received a B.S. degree in Mathematics with a minor in 
Computer Science from Clarion University of Pennsylvania in 1986 and 
received a Masters Degree in Computer Science at George Washington 
University in 1998. Since 1986, she has been a Computer Scientist at 
the National Institute of Standards and Technology (NIST).
    Last updated: 11/17/2010

    Chairman Wu. Thank you, Ms. Roberts.
    Ms. Sensmeier, please proceed.

  STATEMENT OF JOYCE SENSMEIER, VICE PRESIDENT, INFORMATICS, 
     HEALTHCARE INFORMATION AND MANAGEMENT SYSTEMS SOCIETY

    Ms. Sensmeier. Thank you, Chairman Wu, Ranking Member Smith 
and Subcommittee Members. My name is Joyce Sensmeier and I 
serve as Vice President of Informatics at HIMSS, where I 
oversee the clinical informatics, standards, interoperability, 
privacy and security initiatives for the Society. It is a 
pleasure to be with you today before the Subcommittee and 
alongside these distinguished panelists.
    I present these comments on behalf of HIMSS, a cause-based, 
not-for-profit organization exclusively focused on providing 
global leadership for the optimal use of information technology 
and management systems for the betterment of health care. HIMSS 
represents more than 30,000 individual members of which two-
thirds work in health care provider, governmental, and not-for-
profit organizations. HIMSS also includes over 470 corporate 
members and more than 85 not-for-profit and provider 
organizations that share our mission. Supporting the adoption 
and meaningful use of health IT is a key focus for HIMSS 
membership, and as a nurse and a clinician with several decades 
of experience, I am deeply committed to improving patient 
safety and outcomes. It is in that vein that we have addressed 
the two questions posed by the Subcommittee.
    The first question is related to the progress ONC has made 
since passage of the HITECH Act. Prior to passage of HITECH, 
and for many decades, standards development organizations used 
open, consensus-based, volunteer-driven processes working in 
silos developing health IT standards. With the passage of the 
HITECH Act, a new process for oversight of health IT standards 
has been implemented. While forward progress is being made, we 
would like to identify three specific areas of concern.
    First, data transport and basic security are focus areas 
where selected standards are missing yet necessary for 
achieving interoperability. For example, until the recommended 
transport standards are identified, EHR vendors will be forced 
to support all available transport methods or risk developing 
software that may not meet future interoperability needs. This 
lack of guidance in the first stage of Meaningful Use and the 
standards criteria creates marketplace confusion and wastes 
existing resources, ultimately delaying progress.
    Second, we would like to express concern regarding the 
selection of multiple standards for the same criterion such as 
the selection of two clinical summary standards, CCR 
[Continuity of Care Record] and CCD [Continuity of Care 
Document]. When two standards are selected, vendors and 
providers must choose to either support one or instead support 
both, which is costly, resource-intensive and minimizes health 
information exchange across organizations. It is our 
recommendation that only one standard be selected for each 
criterion in futures Stages of Meaningful Use.
    Our third area of concern is the timing of identifying and 
selecting the standards in subsequent rules. Timing is critical 
to ensure the industry can appropriately incorporate these 
standards into the product development and implementation 
cycle. Thousands of EHR systems are currently being developed 
and upgraded by vendors and implemented by health care 
providers. To ensure optimal software development and testing 
and safe implementation, the final rules for Meaningful Use and 
standards should be available 18 months before the next stage.
    The second question relates to the strengths and weaknesses 
of the current health IT standards identification and 
development process. HIMSS was pleased that the final rule 
established standards criteria for supporting stage 1 of 
Meaningful Use and specifically that structured lab test 
results and appropriate implementation guidance were added. 
HIMSS urges CMS, ONC and NIST to ensure that all contractual 
engagements in the standards harmonization are coordinated and 
leverage the public domain work products of standards 
harmonization bodies such as HITSP [HIT Standards Panel] and 
Integrating the Healthcare Enterprise, IHE. We also request 
that they complement rather than duplicate each agency's 
efforts when creating testing procedures, tools, services and 
reference implementations and that they embrace a transparent 
and open consensus process with the private sector.
    We also recommend that HHS publish implementation guidance 
for all selected standards, publish standards for data 
transport, financial transactions, security and health 
information exchange as soon as possible, publish the process 
and schedule for harmonizing standards, and set up one 
repository such as the National Library of Medicine for 
licensure and access to all standards and implementation 
guides. HIMSS is pleased to see these final rules being 
implemented in order to put into action the legislative and 
Executive Branch intent to transform health care using IT.
    I thank you for this opportunity, and I would be happy to 
answer questions, and we look forward to providing our members' 
expertise to help transform health care in the United States.
    [The prepared statement of Ms. Sensmeier follows:]

                 Prepared Statement of Joyce Sensmeier

    Good morning. My name is Joyce Sensmeier and I serve as Vice 
President of Informatics for HIMSS, where I oversee the clinical 
informatics, standards, interoperability, privacy and security 
initiatives for the Society. It is a pleasure to be with you today 
before this Subcommittee and alongside these distinguished panelists.

Background

    I present these comments today on behalf of HIMSS, a cause-based, 
not-for-profit organization exclusively focused on providing global 
leadership for the optimal use of information technology (IT) and 
management systems for the betterment of healthcare. Founded 50 years 
ago, HIMSS and its related organizations have offices in Chicago, 
Washington, DC, Brussels, Singapore, Leipzig, and other locations 
across the U.S. HIMSS represents more than 30,000 individual members, 
of which two-thirds work in healthcare provider, governmental and not-
for-profit organizations. HIMSS also includes over 470 corporate 
members and more than 85 not-for-profit organizations that share our 
mission of transforming healthcare through the effective use of IT and 
management systems. HIMSS frames and leads healthcare practices and 
public policy through its content expertise, professional development, 
and research initiatives designed to promote information and management 
systems' contributions to improving the quality, safety, access, and 
cost-effectiveness of patient care.
    I have been deeply involved in the harmonization and adoption of 
health IT standards during my decade at HIMSS. With co-sponsor, the 
Radiological Society of North America, I led HIMSS' effort to develop 
and manage Integrating the Healthcare Enterprise (IHE), a global 
initiative that drives the adoption of health IT standards for clinical 
needs. I also led HIMSS' involvement with the Healthcare Information 
Technology Standards Panel, or HITSP, a federal standards harmonization 
initiative, while also collaborating with another organization to form 
the Alliance for Nursing Informatics, a collaboration of 27 distinct 
nursing informatics organizations that I co-chair.
    I became Board Certified in Nursing Informatics in 1996, and am an 
adjunct faculty member at Johns Hopkins University in Baltimore. This 
year, I am honored to be recognized as a Fellow of the American Academy 
of Nursing, a credential held by more than 1,600 nursing leaders 
throughout the world.
    On behalf of HIMSS members, we commend Congress and President 
Barack Obama for their vision and commitment to transform our national 
healthcare delivery system through the use of IT.

HIMSS and HITECH

    I was asked to come before the Subcommittee today to share HIMSS 
perspective on the progress of federal efforts in the standards arena 
to support the first stage of Meaningful Use. in this testimony, we 
will aim to address the specific questions posed by the Subcommittee.
    The American Recovery and Reinvestment Act of 2009 (ARRA) includes 
billions of dollars in Medicare and Medicaid incentive payments to 
providers and hospitals for the ``Meaningful Use'' of certified health 
IT products, which are addressed in the Health Information Technology 
for Economic and Clinical Health (HITECH) Act portion of the statute. 
The HITECH Act requires the Department of Health and Human Services 
(HHS) to take regulatory action in several areas, including electronic 
health record (EHR) incentives for eligible professionals and hospitals 
(Meaningful Use), standards and certification criteria, a Certification 
Program, and privacy and security.
    The HITECH Act also requires the Secretary of HHS to establish 
certification criteria and standards for achieving Meaningful Use. HHS 
and the Office of the National Coordinator for Health Information 
Technology (ONC) established a Final Rule on the Standards, 
Implementation Specifications, and Certification Criteria that are 
being used to support Meaningful Use for the start of the incentive 
payment programs in 2011.
    The HHS/ONC Initial Set of Standards, Implementation 
Specifications, and Certification Criteria for Electronic Health Record 
Technology Interim Final Rule were published in the Federal Register in 
January 2010. After receiving more than 400 responses from HIMSS and 
other organizations, ONC released its Final Rule on July 28, which 
included the resolution of technical challenges related to some of the 
standards and implementation specifications. The Final Rule went into 
effect on August 27, 2010.

Response to Subcommittee Questions

    Supporting the adoption and Meaningful Use of health IT is a key 
focus for the HIMSS membership. It is in that vein that we have 
addressed the questions posed by the Subcommittee. We were asked by 
this Subcommittee to particularly address two issues, the first of 
which is:

         ``What progress has ONC made since the passage of the HITECH 
        Act in meeting the need for interoperability and information 
        security standards for electronic health records and health IT 
        systems?''

    Prior to the passage of the HITECH Act, and for many decades, 
standards development organizations (SDOs) used an open, consensus-
based, volunteer-driven process, working in silos to develop health IT 
standards. While this is important work that is being leveraged by 
healthcare entities today, each SDO has its own priorities, goals and 
objectives. As a result, while many standards are available, there are 
multiple gaps, redundant efforts, and limited adoption in live health 
IT systems.
    Also, standards are often not implemented consistently enough 
across individual organizations or products to enable interoperability. 
By necessity, hospitals and clinical practices invent one-off 
integration ``solutions'' when implementing IT products, which is a 
major impediment to interoperability. Implementation guides or 
specifications are also necessary to ensure that standards are 
implemented in the same manner to allow multiple systems to share data. 
These implementation specifications are typically developed by SDOs, 
such as Health Level 7 (HL7) or SNOMED, and standards-profiling 
organizations, such as IHE.
    Prior to enactment of the HITECH Act, U.S. health information 
exchange priorities were set by the American Health Information 
Community (AHIC), the Federal Advisory Committee established by HHS. 
These priority use cases were given to HITSP through a $22-million, 
five-year contract awarded to the American National Standards Institute 
(ANSI), which was funded by HHS and managed by ONC. In an open, 
consensus-based process involving 966 member organizations and more 
than 900 volunteer stakeholders, HITSP technical committees selected 
and harmonized standards to address the interoperability of the use 
cases. This stakeholder engagement was widespread across both federal 
and private sectors, and a number of the HITSP specifications, which 
are available in the public domain, are in the process of being tested 
and implemented. During its tenure, HITSP developed over 130 
interoperability specifications that were subsequently accepted, 
recognized, and/or adopted by HHS.
    With the passage of the HITECH Act, a new process for oversight of 
the health IT standards process has been implemented. During this 
transition period, a degree of momentum in the advancement, 
harmonization and implementation of health IT standards has been lost. 
The healthcare community was previously aligning with the HITSP 
process, and vendors and health information exchanges were adopting its 
recommended standards and specifications. Today, the HIT Standards 
Committee determines priorities and recommends standards to support the 
Meaningful Use criteria. While the Committee's efforts are not overtly 
based on an open, consensus-based process, it has designated task 
forces and work groups to execute specific tasks, and these groups 
invite testimony to incorporate feedback from the healthcare community. 
The regulatory process stemming from the HITECH Act includes designated 
comment periods to accommodate public feedback, which allows ``real 
world'' experience and subject matter expertise to inform the final 
regulations. Compliance with the standards identified in the Standards 
and Meaningful Use final rules will be verified by the National 
Institute of Standards and Technology (NIST) testing procedures and the 
EHR certification process.
    These inputs have informed the Standards, Implementation 
Specifications and Certification Criteria, as well as the Stage 1 
Meaningful Use final rules, which incorporate a beginning set of 
standards and several implementation guides to enable interoperability. 
Leveraging the open, consensus-based work products of HITSP and using 
implementation guides from standards profilers such as IHE is essential 
for quickly, efficiently and cost effectively advancing health IT 
efforts to allow providers to realize the incentives. This type of 
reuse was accomplished with selection of HITSP/C32 as the 
implementation specification for the Continuity of Care Document (CCD) 
and the Continuity of Care Record (CCR) clinical summary content 
standards for Stage 1 Meaningful Use, and thus, is a positive example 
of leveraging previous work and ensuring the interoperability of those 
standards when implemented. However, there are significant gaps in 
standards for interoperability in Stage 1 Meaningful Use.
    We would like to identify three specific areas of concern regarding 
standards selection for Stage 1 Meaningful Use. First, data transport 
and basic security are focus areas where selected standards are 
missing, yet necessary for achieving interoperability. We understand 
that Stage 1 is not intended to force interoperability on a healthcare 
community that is not technically ready to meet the requirement. 
However, identifying the accepted transportation method will have a 
dramatic impact on preparedness for Stage 2. For example, it is 
important to designate standards for documenting the content of 
clinical summaries, but if we don't know how to transmit these 
summaries or acknowledge their receipt, we will have limited 
interoperability. Until the recommended transport standards are 
identified, EHR vendors will be forced to support all available 
transport methods or risk developing software that may not meet future 
interoperability needs. This lack of guidance creates marketplace 
confusion and wastes existing resources, ultimately delaying progress.
    Second, we would like to express concern regarding the selection of 
multiple standards for the same criterion, such as selection of two 
clinical summary content standards--CCR and CCD. When two standards are 
selected, vendors and providers have to choose to support one standard, 
or instead, support both, which is very costly, resource intensive, and 
minimizes interoperability capabilities across organizations. It is our 
recommendation that only one standard is selected for each criterion in 
future stages of Meaningful Use.
    Our third area of concern is the timing of identifying and 
publishing the selected standards in subsequent rules, which is 
critical to ensure that the industry can appropriately incorporate the 
standards into the product development and implementation cycle. 
Thousands of EHR systems are currently being developed and upgraded by 
vendors and implemented by healthcare providers. Recent statistics show 
that sales of hospital EHR systems nearly doubled from 2008 to 
2009.i To ensure optimal software development, testing, and 
safe implementation by providers, the final rules for Meaningful Use 
and certification criteria should be available 18 months before the 
next stage of Meaningful Use commences.
    ONC has published a Standards and Interoperability Framework and 
has recently completed the long-awaited contracting process for 
promoting interoperability and Meaningful Use. The goal of this 
framework is to create a collaborative, coordinated, incremental 
standards process that is led by the industry in solving real-world 
problems. The selected contractors will each be working to complete 
specific components of the framework, including use case development, 
standards harmonization, implementation specifications, tools and 
services. It is ONC's stated intent to leverage the health IT 
community, professional organizations, government agencies and 
standards organizations to ensure that all of their work comes down to 
a harmonized set of standards and implementation specifications. It is 
essential that ONC and its contractors deliver on this promise, and use 
an open, transparent, coordinated process to engage the community and 
leverage their collective efforts in order to maximize industry 
involvement and ``buy in'' to the effort.
    Going forward, a centralized and coordinated process is needed for 
engaging SDOs and harmonization organizations, such as IHE, in meeting 
the needs for interoperability and information security standards for 
EHRs. While government can be an enabler for this standards 
coordination process, a neutral and uniform approach is necessary to 
ensure that the principles of transparency, openness, stakeholder 
representation, healthcare leadership, industry engagement, 
impartiality and balance, due process, consensus, relevance, and 
effectiveness are maintained. A timely evaluation of the optimal 
process for standards coordination is needed to address this urgent and 
important need.
    In this testimony, we have previously suggested that the open, 
consensus-based and public domain work products of HITSP and IHE should 
be leveraged to quickly, efficiently and cost effectively advance 
standards for health IT. To this end, IHE is a global non-profit entity 
that has, over the past decade, developed a framework for standards-
based interoperability of health IT systems that is being adopted and 
implemented worldwide. Each IHE integration ``profile'' describes a 
clinical requirement for systems integration and outlines a standards-
based solution to address it. IHE profiles address critical 
interoperability issues related to information access for care 
providers and patients, clinical workflow, security, administration, 
transport and information infrastructure. IHE profile development 
includes multiple opportunities for public comment review and feedback. 
Vendors that implement IHE specifications participate in annual testing 
events hosted in a structured and supervised environment, to ensure 
compliance, and publish integration statements for their IHE-compliant 
products prior to real-world implementation.
    A number of THE transport profiles, such as Cross Community Access 
(XCA), support the exchange of health information and documents across 
communities and are being implemented in the Nationwide Health 
Information Network and various regional health information exchanges 
in the U.S. and worldwide. Reuse of these profiles in the U.S. 
standards identification and development process will build on a 
foundation of proven implementation guides that will accelerate 
standards adoption and save valuable time and resources.
    The second issue that we were asked to address is:

         ``What are the strengths and weaknesses of the current health 
        IT standards identification and development process, and what 
        should the top standards-related priorities be for future 
        health IT activities?''

    HIMSS was pleased that the Final Rule established standards 
criteria for supporting Stage 1 of Meaningful Use including:

          Removal of All or Nothing

          General relaxation of the requirements, specifically, 
        implementation of drug-drug and drug-allergy interaction checks

          Maintenance of an active medication list

          Addition of structured lab test results

          Removal of LOINC code requirement

          Removal of requirement to submit electronically in 
        Stage 1

          Change to a core and menu objectives approach

          Addition of a requirement to generate patient lists 
        by specific conditions

          Expanded clinical quality reporting measures

          Moved requirements to check insurance eligibility and 
        submit claims to Stage 2

          Added guidance to expand capability to submit 
        electronic syndromic surveillance data to public health 
        agencies

          Clarified numerous privacy and security criteria

          Moved more aggressive requirements to Stage 2

          Added appropriate implementation guidance

    As discussed previously, we were disappointed that HHS did not 
further leverage HITSP and other harmonization work, such as IHE. 
Millions in federal taxpayer dollars and thousands of volunteer hours 
by committed subject matter experts were expended on harmonization 
efforts. Recognizing this work would have accelerated Meaningful Use 
adoption. HIMSS urges the Centers for Medicare and Medicaid Services 
(CMS), ONC and NIST to ensure that all contractual engagements for 
standards harmonization and coordination efforts:

          Incorporate HITSP and IHE work products and test 
        tools

          Complement (versus duplicate) each agency's efforts 
        when creating testing procedures, testing tools & services, and 
        reference implementations

          Embrace transparent and open consensus processes with 
        the private sector

    The HITECH Act set the vision for transforming the healthcare 
setting and these final rules are key components in implementing that 
vision. To achieve HITECH's vision, we recommend that HHS address the 
following:

          Publish implementation guidance (such as IHE and 
        HITSP interoperability specifications) for all selected 
        standards

          Publish data transport, financial transactions, 
        security and health information exchange standards as soon as 
        possible

          Publish the process and schedule for harmonizing 
        standards and developing implementation specifications

          Set up one repository (such as the National Library 
        of Medicine) for licensure and access to all standards and 
        implementation guides

          Publish, as soon as possible, federal health IT best 
        practices guidelines

    Finally, HIMSS urges HHS to publish criteria pertaining to Stage 2 
Meaningful Use at least 18 months before the beginning of Stage 2. This 
will enable sufficient time to develop, test, and deploy software 
conforming to these standards and implementation guides so that all 
eligible users can become meaningful users. Beyond the specific 
concerns associated with the Standards, Implementation Specifications, 
and Certification Criteria for Meaningful Use Stage 1, HIMSS is 
concerned that Meaningful Use and interoperability will be hindered 
without addressing two key areas, a patient identity solution and 
security of personal health information.
    In response to this question, I would also like to highlight an 
important work product of one of HIMSS' many multi-stakeholder member 
workgroups--the Patient Identity Integrity Workgroup. Last year, this 
workgroup published a landmark white paper describing the challenges 
and costly efforts healthcare organizations face every day in their 
efforts to ensure the integrity (accuracy and completeness) of data 
attached to or associated with an individual patient, including the 
correct pairing or linking of all existing records for that individual 
within and across information systems.
    Obviously, patient identity integrity is of central importance to 
achieving quality of care, patient safety, and cost control. In 
addition, the primary goal for nationwide health information exchange 
is to allow authorized users to quickly and accurately exchange health 
information in an effort to enhance patient safety and improve 
efficiency. Achieving this goal is dependent on the ability to link or 
match multiple, disparate records relating to a single individual.
    This white paper describes nine key influencers for improving data 
integrity in this area. One key influencer listed is the need for 
standards for patient identification data and format, and another has 
to do with the need for a study of the current technical solutions 
available to uniquely identify a patient. Using the results from the 
study, we can anticipate the exponential exacerbation of problems and 
errors with patient data matching in the health information exchange 
environment and evaluate potential solutions. We can do this by having 
current data on available technical capabilities as we formulate an 
``informed patient identity solution,'' a position discussed in the 
white paper and endorsed by the HIMSS Board of Directors.
    Finally, I would like to highlight an annual HIMSS Security Survey 
that examines in-depth information from healthcare organizations 
regarding security implementation practices and technology uses. The 
HIMSS Security Survey, now in its third year, analyzes the responses of 
IT and security professionals from healthcare provider organizations 
across the U.S. regarding the policies, processes and tools in place at 
healthcare organizations to secure electronic patient data. The study 
covers a multitude of topics regarding organizations' general security 
environment, including access to patient data, access tracking, and 
audit logs, use of security in a networked environment and medical 
identity theft.
    Last year, we probed our respondents with regard to their 
preparedness and approach for meeting new privacy and security 
requirements contained in ARRA, and we were privileged to provide 
testimony to the HIT Standards Committee as to the results and trends 
uncovered in this study.ii This year, we have partnered with 
the Medical Group Management Association (MGMA) to include an even 
larger population of ambulatory and medical group practices. The 
results of this year's study will be available in early November, and 
we would be happy to provide those results to the Subcommittee.

Closing

    HIMSS is pleased to see these final federal rules and the ONC 
Standards and Interoperability Framework and related contracts being 
implemented in order to put into action legislative and executive 
branch intent to transform healthcare using IT. Through our robust 
member structure, we will continue to evolve our positions to reflect 
the current needs of health IT professionals to improve healthcare 
quality, safety, efficiency, and access for all. HIMSS believes that by 
linking credible health IT principles emanating from our members' needs 
and experiences, we will help our nation successfully transform 
healthcare using effective IT.
    Celebrating our 50-year history of serving the healthcare 
community, HIMSS remains deeply committed to working with federal and 
state leaders in a bipartisan manner to improve the quality, safety, 
and efficiency of healthcare for all through the appropriate use of IT 
and management systems. HIMSS members appreciate and understand the 
cultural and technical challenges that healthcare providers face in 
meeting the requirements for Meaningful Use.
    In closing, I'd like to highlight a few health IT initiatives 
within HIMSS that aim to recognize best practices in the use of health 
IT and measure the level of EHR adoption throughout the U.S. These 
initiatives will be critical reference points in evaluating the success 
of the HITECH Act in transforming the way we do healthcare. To 
recognize healthcare's excellence in using IT to improve access, 
safety, quality and efficiency, the HIMSS Nicholas E. Davies Awards of 
Excellence iii recognizes management, functionality, 
technology and value--the pillars of health IT success. Objectives of 
the Davies program include promoting the vision of EHR systems through 
concrete examples; understanding and sharing documented value of EHR 
systems; providing visibility and recognition for high-impact EHR 
systems; and sharing successful EHR implementation strategies.
    The awards focus on four healthcare settings: organizations, 
ambulatory sites, public health, and community health organizations. 
Since 1994, the Davies program has honored 71 healthcare organizations, 
private practices, public health systems, and community health 
organizations that have implemented health IT, specifically EHRs, in 
their respective locations. I invite members of the Subcommittee to 
visit HIMSS' State HIT Dashboard iv to locate Davies winners 
in or near your Districts. Mr. Chairman, I'm pleased to report that 
there are two Davies winners in your home state of Oregon: Kaiser 
Permanente Northwest in Portland,v and the Indian Health 
Service in Warm Springs.vi
    Next, I would like to highlight the HIMSS Analytics' EMR 
Adoption ModelSM (EMRAM).vii Knowing the baseline 
of current adoption of health IT is critical to understanding the 
realities at U.S. hospitals and the federal government's EHR adoption 
goals. According to quarterly health IT implementation census data from 
HIMSS Analytics, the use of health IT among healthcare providers has 
steadily increased over the past four years.
    Using a census survey, HIMSS Analytics' EMRAM tracks adoption of 
EMR applications within all 5,217 U.S. civilian hospitals and health 
systems and scores hospitals based on their progress towards meeting 
the criteria for various stages within the Model. There are eight 
stages for hospitals, ranging from 0 to 7, as they move to a completely 
electronic environment (Stage 7); at the pinnacle of the model, paper 
charts are no longer used in the delivery of patient care.
    As of June 2010 viii:

          16.3 percent of U.S. hospitals (850 of 5,217) have 
        achieved ``Stage 4'' or higher of the Adoption Model. This is 
        up from 3.7 percent in December 2006.

          Another 50.2 percent of U.S. hospitals (2,621 of 
        5,217) have achieved ``Stage 3.''

    As it has for the past six years, HIMSS Analytics will continue to 
gather data and release quarterly updates of its census-based survey, 
shedding light on EHR adoption levels.
    Driving the appropriate use of health IT will improve patient 
safety and the quality, accessibility, and cost-effectiveness of 
healthcare. Thanks to our informed and committed member volunteers, 
HIMSS will be a leader in the transformation. HIMSS looks forward to 
working with the legislative and executive branches in helping to 
ensure that the components of the HITECH Act are appropriately 
implemented. HIMSS actively equips its members with the knowledge and 
tools they need to successfully navigate these regulations, including 
FAQs, white papers, and educational webinars.ix
    Again, it was a pleasure to be with you today before this 
Subcommittee and alongside these distinguished panelists. I would be 
happy to answer questions that members of the Subcommittee may have and 
look forward to providing our members' expertise to help you transform 
healthcare in the U.S. Thank you for this opportunity.

    i CIS Purchase Decisions: Riding the ARRA Wave. Klas. 
August 2010. Available at: http://www.klasresearch.com/Store/
ReportDetail.aspx?ProductID=589
    ii http://www.himss.org/content/files/
HIMSS2009SecuritySurveyReport.pdf
    iii http://www.himss.org/davies
    iv http://www.himss.org/statedashboard
    v http://www.himss.org/davies/pastRecipients--org.asp
    vi http://www.himss.org/davies/pastRecipients--ph.asp
    vii http://www.himssanalytics.org/hc--providers/emr--
adoption.asp
    viii http://www.himssanalytics.org/stagesGraph.html
    ix http://www.himss.org/economicstimulus
                     Biography for Joyce Sensmeier




    Joyce Sensmeier is Vice President of Informatics for HIMSS, the 
largest U.S. not-for-profit healthcare association focused on providing 
global leadership for the optimal use of information technology. HIMSS 
represents more than 31,000 individual members, 470 corporate members 
and 30 not-for-profit organizations that share its cause-based mission.
    Sensmeier joined HIMSS as the Director of Professional Services in 
2000. In her current role she is responsible for the areas of clinical 
informatics, standards, interoperability, privacy and security. 
Sensmeier became Board Certified in Nursing Informatics in 1996, earned 
the Certified Professional in Healthcare Information and Management 
Systems in 2002, and achieved HIMSS fellowship status in 2005. She is 
an adjunct faculty member in the School of Nursing at Johns Hopkins 
University in Baltimore. She previously served at Palos Community 
Hospital in Palos Heights, Illinois as a nursing coordinator leading 
clinical information system implementations.
    Sensmeier has made contributions to enabling health information 
exchange through standards profiling and harmonization initiatives. She 
led advancement of Integrating the Healthcare Enterprise (IHE), an 
international standards profiling organization which, over the past 
decade, has achieved both regional and international adoption of its 
public domain technical framework. She is President of IHE USA, and 
previously served as the Standards Implementation Technical Manager for 
the Healthcare Information Technology Standards Panel (HITSP).
    An internationally recognized speaker and author of multiple book 
chapters, articles and white papers, Sensmeier was recognized in 2010 
as a fellow with the American Academy of Nursing, a credential held by 
1,600 nursing leaders throughout the world. She is co-founder and co-
chair of the Alliance for Nursing Informatics, a collaboration of 27 
distinct nursing informatics organizations that represents a unified 
voice for nursing informatics professionals.
    Sensmeier received a BSN from Elmhurst College and a Masters degree 
in Nursing Administration from St. Xavier University, both in Illinois.

    Chairman Wu. Thank you.
    Dr. Gibson, please proceed.

 STATEMENT OF RICHARD GIBSON, PRESIDENT, OREGON HEALTH NETWORK

    Dr. Gibson. Chairman Wu, Ranking Member Smith, good morning 
and thank you for the opportunity to discuss health information 
technology standards. My name is Richard Gibson. I am a 
practicing family physician and former emergency physician and 
have nearly 20 years of experience in health information 
technology.
    On the status of current standards, the Meaningful Use 
final rule has been well received by providers. We applaud the 
Office of the National Coordinator and the Centers for Medicare 
and Medicaid Services for seriously considering the many 
comments received over the past nine months. They have been 
extraordinarily responsive in making rules as straightforward 
and as pragmatic as possible while still moving the country 
forward to electronic health records that promise to improve 
the quality and consistency of health care.
    Concerning the standards-related priorities for the future, 
my comments will go to the area of helping small practices in 
the short term to connect to each other directly while we await 
the more complete and widespread health information exchange.
    We need a standard for transmitting provider text notes. 
Providers expect to be able to review the text reports produced 
by other providers. Historically, these text reports have been 
produced by transcribing notes that physicians dictated, say, 
for an office visit, a consultation note, a surgical procedure 
and the like. We need a specific continuity-of-care document or 
continuity-of-care record for these text documents to be most 
useful for patient care.
    We need a standard for exporting and importing patient 
information directly between EHRs and directly provider to 
provider. Meaningful Use stage 1 does not require EHRs to have 
the ability to export and import patient information directly 
to and from other EHRs. As clinicians move to electronic health 
records, we need to enable our EHRs to transfer patient 
information as easily as fax machines accomplish that transfer 
now. The office staff needs to be able to press a button to 
send information to the next physician. This concept and the 
next two have been promulgated by Wes Rishel at Gartner and 
have led to the NHIN [Nationwide Health Information Network] 
Direct Project.
    We need a standard directory for health Internet addresses. 
After a provider decides to refer the patient to another 
physician, the provider or her staff member could go onto the 
Internet and search for the provider's authenticated health 
Internet address. This could be entered into the sending 
physician's electronic health record, which would send an 
encrypted packet of information directly to the receiving 
physician's electronic health record. Later, states will need a 
record locator service so that emergency departments can pull 
data from the patient's previous providers.
    We need a standard for document transfer that can 
accommodate providers still on paper records. It will be years 
before all providers have electronic health records. We need a 
standard that sends patient information like an e-mail 
attachment so that providers on paper records can still print 
the information. Once they do get an EHR, the same attachment 
could be imported into that EHR.
    We need an EHR functionality requirement for quality 
measure reporting. Smaller practices under the current rules 
would likely need to seek the help of consultants to produce an 
acceptable quality measures report. This reporting needs to be 
a core EHR function specified by a consistent nationwide 
requirement so that providers in any practice can again press a 
button to produce submission-ready reports on a chosen measure.
    We need a national model for privacy and patient consent. 
In Portland, we often see patients from southwest Washington. 
Having significantly different privacy laws between Washington 
and Oregon would lead to uncertainty, missed information and 
the unnecessary duplication of diagnostic testing. We need a 
federal effort to convene, sponsor, and mandate development of 
model rules and laws that each state could take through its own 
legislative process. We need to set appropriate expectations on 
provider access controls to patient information. In our largely 
fee-for-service health care system, one cannot exactly predict 
which doctor or nurse may take care of them on any given 
occasion. Our model needs to set the expectation in the 
patient's mind that it is not possible to predict precisely who 
will need access to their record in the course of their care.
    Finally, we need a model for the complete health record 
being available to the provider. Although the provider can 
infer some of the patient's diagnoses from a medication list 
and allergy list alone, it is crucial that providers see all 
the medications and allergies when they prescribe. Without this 
guarantee, patients could be hurt. Similarly, providers need 
access to the full laboratory and imaging reports when they are 
trying to make a diagnosis. Redacting these data because they 
imply a certain restricted diagnosis is unsafe and could 
ultimately result in physical harm to the patient.
    Chairman Wu and Ranking Member Smith, thank you for the 
opportunity to testify on these important issues. I would be 
happy to answer any questions you may have.
    [The prepared statement of Dr. Gibson follows:]

                  Prepared Statement of Richard Gibson

    Chairman Wu and Members of the Subcommittee, good morning and thank 
you for the opportunity to discuss health information technology 
standards, current status and future needs. My name is Richard Gibson. 
I am President of Oregon Health Network. I am a practicing, board-
certified family physician, and a former board-certified emergency 
physician. I have nearly 20 years' experience in health information 
technology, including working with several major hospital systems and 
Oregon health information exchange planning efforts.

SUMMARY OF RECOMMENDATIONS

    During my testimony I will offer my opinion on the current status 
of recent standards, discuss challenges to EHR adoption, and make the 
case for the following new national standards:

          A standard for transmitting provider text notes.

          A standard for exporting and importing patient 
        information directly between EHRs and directly provider-to-
        provider.

          A standard directory for Health Internet Addresses.

          A standard for document transfer that can accommodate 
        providers on paper records.

          A standard EHR functionality requirement for quality 
        measure reporting.

          A national model for privacy and patient consent, 
        access control, and availability of the entire health record.


STATUS OF CURRENT STANDARDS

Meaningful Use Final Rules Are Well Received
    The delivery of the Final Rule on the CMS EHR incentive program has 
been well received by the provider community. As far as Stage l of the 
Meaningful Use objectives and measures, the uncertainty is now over. 
This is been enormously helpful to providers. We applaud the 
consideration that the Office of the National Coordinator and CMS have 
shown to the many comments received over the past six months. This 
office has been extraordinarily responsive in making rules as 
straightforward and pragmatic as possible while still moving the 
country forward to electronic health records that actually improve the 
quality and consistency of healthcare. We very much appreciate the 
obvious collaboration between the Office of the National Coordinator 
and the Centers for Medicare and Medicaid Services and would encourage 
continued coordination among all federal agencies working in health 
information technology to achieve the needed improvement goals in 
public health, mental health, and long term care through health 
information exchange.
    In particular, the use of Core Requirements and Menu Set 
Requirements for Meaningful Use, in place of the ``all or nothing'' 
approach was very helpful in giving providers and EHR vendors some 
flexibility in meeting Stage 1 Meaningful Use criteria. It is also very 
helpful to providers and vendors to set the expectation that Stage 1 
Menu Set Requirements will become Core Requirements in Stage 2. Vendors 
and providers now know what to plan for over the next several years. 
The Meaningful Use Final Rules have provided structure and organization 
in electronic health records, previously characterized by a 
disorganized marketplace where individual products could not 
communicate effectively with each other.

The HITECH Act Has Ushered Great Progress
    EHR vendors now have a clear roadmap for the next two years of what 
will be required of their software as a minimum for clinician adoption. 
They know what workflows need to addressed by the EHR. The vendors know 
the capabilities required of their EHR software in order for it to be 
certified. Some current EHR products may not be able to achieve 
certification. Clinicians now know that financial support is available 
if they use certified EHRs and demonstrate their meaningful use. 
Clinicians understand how their use of EHR will be measured. The HITECH 
Act has done as much as it can to remove uncertainty in clinicians' 
minds about whether or not to pursue an EHR. Enough of the EHR 
incentive variables are now known for providers, hospitals, and health 
systems to make reasoned choices about when and how they will acquire 
an EHR. The HITECH Act has brought focus and consistency to EHR 
adoption. It is now clear what needs to be done, even if it is not 
quite as clear how long it will take.

CONCERNS ABOUT ADOPTION OF ELECTRONIC HEALTH RECORDS

Adoption of EHRs is a Prerequisite for Interoperability
    We have an enormous effort still ahead of us. Before going on to 
the specific standards that are the topic of today's hearing, we need 
to acknowledge that the standards have relatively little application 
unless individual healthcare providers have electronic health records 
in the first place. Most of the more than 400,000 Eligible 
Professionals still need to acquire an electronic health record, and 
most of that effort will be in small physician offices. CMS has 
estimated the five-year cost of acquiring an electronic health record 
for an eligible professional to be $94,000. EHR incentive plans through 
Medicare and Medicaid will cover 47 to 67% of that estimated cost. As a 
general rule, EHRs still do not allow providers to see more patients in 
a day, spend more quality time with their patients, or guarantee better 
or more consistent health outcomes for their patients. In short, even 
with the generous EHR incentive program, there still may not be a 
sufficient financial rationale for individual providers or small 
practices to invest in electronic health records.

Implementing an EHR is Stressful for the Provider
    Implementing electronic health records in small physician offices 
is not like purchasing a copy machine or a fax machine. In addition to 
the great capital expense, the EHR is markedly disruptive to both the 
clinical and administrative functions of the office. Every provider, 
medical assistant, receptionist, and billing staff member needs to 
change the way they do their work. Even with excellent training, it 
usually takes 2-12 months before providers are fully comfortable on 
their new tools. On a new EHR, each office visit takes longer--this 
means increased waiting times for patients or a fewer number of 
patients per day for the provider. It is not uncommon for providers on 
a new EHR, after a full 8-10 hour day of seeing patients, to finish 
their charts on the computer at home for three or four hours in the 
evening. Even those providers who believe in the patient care benefits 
of an EHR are exhausted by the process in the first year.

EHRs Viewed Unfavorably by Many Providers Because of Administrative 
        Documentation
    Many providers who do not yet have EHRs in their office have 
commented to me how much they dislike the output received from many 
other physician office EHRs or from hospital EHRs. They specifically 
complain about how many pages these EHR reports require and how 
difficult it is to find the small bit of useful clinical information 
within. Upon investigation, most of this low-value verbosity comes from 
physicians documenting specific history and physical exam findings 
required to support their billing. Also, as medicolegal requirements 
ratchet up, clinicians feel a need to document with a date-time stamp 
every single finding and every single item of data that they have 
reviewed. The existing cumbersome EHR reports impair the clinical 
process and can put the patient at risk by making important information 
obscure. Clinicians criticize the EHR for this clumsy reading even 
though the cause lies with our current payment and administrative 
systems, and not the EHR itself, which is otherwise widely agreed to be 
highly legible. Most clinicians would prefer to go back to simpler 
charting that more closely reflects their thought process. These EHR 
changes will need to await payment reform.

IT Professionals with Multiple Skills Needed for EHR Implementation
    Another challenge in implementing electronic health records in 
small provider offices is the lack of technical expertise and support 
for the office. The providers are busy with a full schedule seeing 
patients. Medical assistants are putting patients in rooms or they are 
continuously on the phone with patients. Front office staff members are 
trying to make appointments and handle incoming calls. The billing 
staff is overwhelmed with insurance paperwork. Most providers and 
staff, especially those in small practices, don't have time to become 
fluent in the use of the new system, much less become expert in 
training others to use the system. Typical small physician 
implementations start two to three months before the expected launch 
date of the software. All current paper-based workflows need to be 
examined and re-designed for the new software. This requires analysts 
who are not only familiar with software but familiar with the 
healthcare office process. Bringing the majority of the 400,000 
Eligible Professionals up to speed on an EHR in the next several years 
will be challenged by a lack of IT implementation professionals.

EHR Technical Requirements Can Be Challenging for Smaller Practices
    Small physician practices are already spending 40-60% of their net 
revenue on overhead. Space in small physician offices is at a premium 
and providing a physically locked computer space within the physician 
office is difficult. Physician offices do not typically have the 
technical expertise to manage the computers in the clinical areas as 
well as the office computer network and the larger computers that act 
as servers and tape backup for the EHR software. Hosting provider EHRs 
on centralized servers supporting multiple practices may address this 
concern, but many of the currently used office EHRs are not yet ready 
for this step-up in technology. Many small towns do not have local 
computer hardware professionals to support physician offices. The 
Regional Extension Centers (RECs) exist to assist physicians in this 
context but even with generous funding, the RECs will be challenged to 
meet the enormous demand in the next several years.

STANDARDS-RELATED PRIORITIES FOR THE FUTURE

A Standard for Transmitting Provider Text Notes
    When providers care for patients as a team, they expect to be able 
to review the patient's relevant laboratory results, diagnostic imaging 
reports, diagnostic images, and text reports that have been produced by 
other providers. Historically these text reports were produced by 
transcribing notes that physicians dictated for an office visit, a 
consultation note, a surgical procedure, and the like. These text 
reports are crucial for the coordination and transfer of care among 
providers. One of the Meaningful Use Core Requirements for Eligible 
Professionals calls for the capability to exchange ``Key Clinical 
Information'' among providers and gives examples of such data. The 
Requirement leaves the interpretation of ``key clinical information'' 
up to the provider. The HITECH Act specifies that the content standard 
for a patient summary will be the Continuity of Care Document (CCD) or 
Continuity of Care Record (CCR). These two documents have 17 sections 
containing mostly lists but there is no standard CCD or CCR for the 
specific text documents most useful for patient care. Physician office 
EHRs and hospital EHRs need to be able to export and import CCDs or 
CCRs specifically created for these crucial physician-authored reports.

A Standard for Exporting and Importing of Patient Information Directly 
        Between EHRs and Directly Provider-to-Provider
    As noted above, health information exchange is predicated upon 
providers having electronic health records. Oregon is currently 
developing a statewide plan for the operation of local, regional, or 
statewide health information exchanges. There is discussion as to what 
health information should be exchanged and how that exchange should be 
managed, for example, directly from provider to provider or from 
provider to central information exchange to another provider. There are 
pros and cons of these two ends of the spectrum. Three points need to 
be made here. First, even if one has a centralized health information 
exchange (HIE) the EHR still needs to export and import the common 
patient information such as laboratory reports, diagnostic imaging 
reports, diagnostic images, and provider text reports from the HIE. The 
HITECH Act already specifies the content standard for most of these 
data types but Meaningful Use Stage 1 does not require EHRs to use this 
function. Second, HIEs are not yet well established. Complex 
centralized patient data repositories serving as HIEs are likely to be 
expensive to build and maintain and it may take a number of years 
before most providers have access to an affordable HIE of this nature. 
Third, central clinical data repositories may not be as trusted by 
patients as direct exchange of information from one provider known by 
the patient to another provider known by the patient. EHRs that can 
directly export and import data are required even if HIEs are present, 
and such EHRs have the added benefit that they can be used among 
providers when an HIE is not available. The next round of regulations 
needs to require that EHRs can export and import these data types 
directly to and from other EHRs without requiring a central health 
information exchange.
    It should be noted that importing clinical data from an outside EHR 
into one's own EHR will be very challenging technically and culturally. 
Typical use of a CCD or CCR has them displaying the outside information 
in the equivalent of a ``Correspondence'' section of the electronic 
record. This is certainly better than having no information at all, but 
if we wish physicians to order less duplicate testing, we will need to 
devise technical standards where the results of an outside diagnostic 
test appear in the EHR results table very close to the internally-
obtained test results.
    Most ambulatory care in this country is delivered by providers in 
the patient's local area. Providers in each specialty are likely to 
know their colleagues in the other specialties from whom they receive 
and to whom they send consultation requests. Much of the time these 
consultation requests are arranged by the provider or by one of his/her 
staff members. In a paper world this is conveniently handled by a phone 
call and/or faxing of the clinical documents. The Receiving Physician 
is very appreciative of having organized patient information from the 
Sending Physician ahead of the patient arriving in the Receiving 
Physician's office. As clinicians move to electronic health records, we 
need to enable our EHRs with the ability to transfer patient 
information as easily as fax machines accomplish that transfer now. The 
Sending Physician knows what data need to go ahead of the patient. All 
EHR vendors need to provide this export/import function at the point of 
care for use by office staff This concept and the next two have been 
promulgated by Wes Rishel at Gartner and have led to the NHIN Direct 
Project.

A Standard Directory for Health Internet Addresses
    If providers are going to electronically export patient information 
for immediate use by another provider, they will need to have a system 
of Health Internet Addresses and provider directories. A Certificate 
Authority will need to be established that can guarantee the 
authenticity of a provider's Health Internet Address. After a provider 
decides to refer the patient to another physician, whether next-door or 
in another state, the provider or his/her staff member could go onto 
the Internet and search for the provider's authenticated Health 
Internet Address. This could be entered into the provider's EHR, which 
would send an encrypted packet of provider text reports (for example, 
Office Visit Notes), recent laboratory results, diagnostic imaging 
reports, and diagnostic images to the Receiving Physician's EHR, which 
would similarly import the patient information. Both provider offices 
would be assured of immediate transmittal and receipt and the 
authenticity of the providers' identities. A state, regional, or 
national body could provide a similar function by building a Master 
Provider Index. For the basic function of a provider pushing patient 
information to another provider, there is not a need for a centralized 
clinical data repository. In the longer run, we need a method where an 
emergency department, for example, could pull patient data from other 
providers and hospitals when the patient or family member is unable to 
say where he or she has been cared for previously. This would require 
the more complex function of a Record Locator Service, which would keep 
track of the disparate electronic sources of a patient's clinical data. 
A state or regional organization could furnish a Record Locator 
Service.

A Standard for Document Transfer That Can Accommodate Providers on 
        Paper Records
    It will be years before all providers have electronic health 
records. For the next few years, providers will need to be confident 
that they can manage patient information to support patient care 
whether the Sending Physician or the Receiving Physician, or both, or 
neither, is on an EHR. Imagine the Sending Physician has an EHR that 
produces a concise, thorough patient information document. The Sending 
Physician looks up the Receiving Physician's Health Internet Address 
and sends the document directly from her EHR like an attachment to an 
e-mail. The Receiving Physician, unbeknownst to the Sending Physician, 
does not have an EHR. No problem--he receives the document as an 
attachment to a secure e-mail, prints it out, reviews it, and includes 
it in his paper charts. Once he acquires a certified EHR, he will be 
able to import the document easily without resorting to printing. We 
need a transfer standard that is human readable and that is flexible in 
terms of the technology required on the receiving end.

A Standard EHR Functionality Requirement for Quality Measure Reporting
    The Standards and Certification Criteria Final Rule is clear about 
what quality measures Eligible Professionals will submit as part of the 
Core Requirements. I appreciate the ONC making these measures 
consistent with the Physician Quality Reporting Initiative. Although 
the data elements for figuring the numerators, denominators, and 
exclusions of each measure are clear, many EHRs will have difficulty in 
getting their EHR software to produce these numbers automatically. 
Business intelligence tools built into most EHRs are currently 
immature. Smaller practices would likely need to seek the help of 
consultants in order to produce an acceptable report from their EHR. 
The necessary clinical data should be present in a certified EHR but 
smaller EHR vendors will be challenged to include adequately 
sophisticated report writing tools in their products that can be used 
directly by clinicians. Quality measure reporting needs to be a core 
EHR function specified by a consistent nationwide requirement, so that 
providers in any practice can press a button to produce submission-
ready reports on a given measure.

A National Model for Privacy and Patient Consent
    Currently Oregon is trying to establish health information exchange 
privacy and patient consent standards for use within the state. I 
applaud these efforts but think that EHR adoption would be much 
enhanced by having consistency in privacy and patient consent across 
all 50 states. In Portland we often see patients from Southwest 
Washington. In the course of a busy office day, clinicians need access 
to previous records. Having significantly different privacy laws in 
Washington versus Oregon would lead to uncertainty, missed information, 
and unnecessary duplication of diagnostic testing. Currently, providers 
may exchange health records for purposes of payment, treatment, and 
operations without explicit patient consent. If it is decided that a 
patient needs to specifically consent to have their provider send or 
retrieve their health information, then we need a standard so that any 
vendor's EHR can effectively communicate the obtained patient consent 
with any other vendor's EHR in any other state. We need a federal 
effort to convene, sponsor, and mandate development of model rules and 
laws that each state could take through its own legislative process. A 
``Uniform Privacy Code,'' as it were, like the Uniform Building Code, 
would provide interstate consistency and give EHR vendors confidence 
that their software would perform consistently wherever it is used.

Setting Appropriate Expectations on Provider Access Control to Patient 
        Information
    About six years ago at Providence Health and Services in Oregon, we 
looked at the access to the electronic chart for a typical four-day 
hospital stay. More than 65 different people had appropriate access to 
the patient's chart during and after their hospital stay. Depending on 
their role, some staff members had access to only a part of the 
patient's information. It is unpredictable which provider will need 
immediate access to a patient's chart at any given time. On a hospital 
floor, a physician might ask a colleague to take a look at her patient. 
The Receiving Physician walks right over to the computer and begins to 
examine the patient's information. Nurses frequently are called from 
one unit to another according to the ebb and flow of patient census and 
they need immediate access to the records of that unit's patients. The 
nature of fee-for-service healthcare makes it difficult to predict who 
will be taking care of the patient next. As an emergency physician, I 
would see people on Saturday night and refer them to the orthopedist to 
be seen first thing Monday morning. When they show up at the 
orthopedist's office, that doctor or her partner needs immediate access 
to the full electronic health record even though they have never seen 
the patient before. Our model needs to set the expectation in the 
patient's mind that it is not possible to predict exactly who will need 
access to their record in the course of their care. To balance these 
relatively open provider access controls, I do believe we have an 
opportunity to involve the patient in reviewing the log of who looked 
at their records. Most confidentiality breaches in electronic health 
records are associated with people who have approved access to a given 
electronic health record system but use their access inappropriately in 
looking up information of a friend or colleague for whom they are not 
caring.

A Model for the Complete Health Record Being Available to the Provider
    Access to the entire health record is important for providers 
taking care of patients. It is crucial that providers see the entire 
medication list, the entire allergy list, the entire problem list, 
pertinent laboratory results, and diagnostic imaging studies. Although 
the provider can infer some of the patient's diagnoses from the 
medication and allergy lists, it is crucial that providers see all the 
medications and allergies when they prescribe. Without this guarantee, 
the patient could be hurt when a physician prescribes a medication that 
interacts with one that they are already taking or to which they have 
developed an allergy in the past. Most physicians would be very 
uncomfortable practicing in an environment where some information about 
the patient in front of them may have been redacted. Similarly, 
providers need access to the complete laboratory reports and diagnostic 
imaging results when they're trying to make a diagnosis. Hiding these 
data because they imply a certain ``restricted'' diagnosis is unsafe 
and could ultimately result in physical harm to the patient. I 
acknowledge that most providers do not need to see the office visit 
notes from sensitive psychotherapy sessions and these parts of the 
records should be restricted to the mental health therapists only. 
Everyone else needs to see the full health record.

CONCLUSION

    In summary, The HITECH Act and the Meaningful Use regulations have 
dramatically accelerated interest in electronic health records. The 
proposed standards have assured clinicians and EHR vendors of a level 
playing field where EHRs will ultimately be able to communicate with 
each other. The regulations appropriately require evidence not just of 
EHR implementation, but of improved intermediate healthcare outcomes. I 
respectfully request that the next round of standards builds on the 
progress of the current standards. Let national standards enable our 
small physician offices to communicate directly with each other using 
tools that can be mastered by the provider or office staff. We need a 
specific transfer standard for the most crucial provider-authored text 
notes. National regulations must require that EHRs can directly send 
and receive patient information initiated by the office staff at the 
point of care using the equivalent of e-mail attachments and Health 
Internet Addresses while we wait for more complex exchange methods to 
be developed. These tools can be used by physician offices still on 
paper records as they prepare to move to an EHR. Finally, we need a 
national privacy and patient consent model for states to use creating 
their own legislation so that patients and providers can be confident 
that clinicians always have all the information in front of them that 
they need to provide consistently superior care.
    Chairman Wu and Members of the Subcommittee, thank you for the 
opportunity to testify on these important issues. I would be happy to 
answer any questions you may have.

                      Biography for Richard Gibson

    Richard Gibson is President of Oregon Health Network, a nonprofit 
using Federal Communications Commission funds to extend a medical-
grade, high-bandwidth network to all Oregon hospitals, community 
colleges, and clinics for the underserved. He is a practicing family 
physician and former board-certified emergency physician. Previously he 
was Senior Vice President and Chief Information Officer for Legacy 
Health, an integrated delivery network in Portland, Oregon. Before that 
he was Chief Medical information Officer for Providence Health and 
Services, Oregon Region, also an integrated delivery network in 
Portland, Oregon.
    Dr. Gibson practiced family medicine in Forks, Washington, a 
logging town of 3,000, four hours west of Seattle. He was an emergency 
physician in Port Angeles, Washington, a community of 20,000 three 
hours west of Seattle. He received a BS in Biology from Stanford 
University and an MD from Case Western Reserve University in Cleveland. 
He holds a PhD in Medical Informatics from the University of Utah and 
an MBA from The Wharton School.
    Outside of practicing medicine, Dr. Gibson has spent his 
information technology career helping physicians, health systems, and 
independent software vendors acquire, develop, and implement electronic 
health records for use in physician office and hospital settings. He 
has advised the State of Oregon in electronic health records, health 
record privacy and security, health information exchange, and 
telemedicine.

    Chairman Wu. Thank you very much.
    Ms. McGraw, please proceed.

   STATEMENT OF DEVEN MCGRAW, DIRECTOR OF THE HEALTH PRIVACY 
          PROJECT, CENTER FOR DEMOCRACY AND TECHNOLOGY

    Ms. McGraw. Okay. Thank you. Chairman Wu, Ranking Member 
Smith and the staff. I really, very much appreciate the 
invitation to testify before you on the privacy and security 
challenges raised by widespread adoption of health IT.
    What we do at CDT is develop and promote pragmatic privacy 
and security policy and technology solutions for a health 
system that we really hope will be increasingly characterized 
by electronic health information exchange to improve individual 
as well as population health, and I also chair the Health IT 
Policy Committee's privacy and security team that Dr. 
Blumenthal mentioned, and I appreciate the thanks. We are in a 
very good place, I think, for making some progress on these 
issues.
    We know from survey data that the public is actually quite 
enthusiastic about what we are doing with health IT but they 
also express, in equal numbers, concern about privacy. You 
can't have one without the other. Essentially, privacy is not 
the obstacle to doing all this and getting it done; it is the 
enabler, and we need to consider it that way and pay it serious 
attention, and clearly this Subcommittee agrees or you wouldn't 
have asked me here today in a hearing that is largely about 
standards. And we will talk about security standards because 
that is where standards really come into focus, probably less 
so on the privacy side.
    We do have the privacy and security regulations of HIPAA, 
and of course states have laws as well, and those are the 
baseline, but we are really changing the way we are going to be 
moving health information and setting up new infrastructures 
and so we have to consider what we need to layer on top of what 
we already have, and in addition, we are talking about health 
information technology, not just protecting health information, 
and so we need to think about the strong role that technology 
can actually play in helping us to accomplish a comprehensive 
and flexible framework of privacy and security protections that 
will build that trust layer that will enable us to go forward.
    As I mentioned before, we are in a much better place than 
we were a few years ago when we were arguing about privacy. We 
are still arguing about it but we actually, the work that 
Congress did in the HITECH legislation has pushed us 
tremendously forward, and in addition, the financial incentives 
that are part of the HITECH incentive program give us 
additional policy levers to really push us into a better place 
with respect to privacy and security.
    We still do have gaps to address, of course. You know, this 
is not something that is never done. We need to be continuously 
paying attention to this, and so I am going to talk a little 
bit about security and I am going to give some credit to one of 
my panelists from HIMSS. They did a survey fairly recently of 
large health care organizations that indicated that security is 
far less of a priority than we would hope. Just to lay out some 
examples, fewer than half conduct the annual risk assessment 
that the HIPAA security rule requires. Fifty-eight percent of 
these organizations say they actually don't have security 
personnel, and 50 percent reported spending three percent or 
less of their resources on security. And again, this is a 
survey of large organizations and not small practices, although 
as you will see in HIMSS' written testimony, they are doing 
this survey next, I think. Those will probably be some very 
sobering numbers but they are a lesson for us. We really need 
to be quite serious about this. When you think about what the 
root is of the public's concern, a lot of it is about 
inappropriate access to records, for which security is a 
primary gatekeeper.
    Now, we know that with respect to what an electronic health 
record has to have in order to be certified, there are 
functionalities that have to be present, and Dr. Blumenthal 
mentioned some of these--the ability to encrypt data, the 
ability to generate an audit trail, but there is actually no 
clear requirement to use the functionalities. The HIPAA 
security rule is very flexible. It says that some of them are 
addressable. Similarly, in Meaningful Use, you have to conduct 
a risk assessment and address any deficiencies, but here you 
have the functionalities in the record and we are not are being 
terribly clear with providers about using them. I think that is 
a major deficiency. We need to raise our expectations certainly 
with respect to small providers. You know, a piece of health 
data is sensitive no matter who is holding it, whether it is a 
large institution or a single physician practice. But in terms 
of the level of resources that the smaller physician practices 
can put into this, clearly we need something that is scalable 
and something that works for them now with a glide path to 
greater expectations down the road.
    So I am reaching the end of my time. My written testimony 
has a number of other gaps that I have discussed there, 
including the HIPAA deidentification standard. We are seeing an 
increasing emphasis on access to and use of deidentified data 
for a range of purposes. Certainly when data is deidentified, 
stripped of identifiers, it is much more privacy protective, 
but we actually don't have a legal prohibition against 
reidentification that we can enforce, and that is something 
that Congress could actually do to really help secure trust. 
Again, the deidentified data issue is a big one. HHS is doing a 
study. I think after that comes out, we ought to talk seriously 
about what the right next steps are.
    So I am going to close. I had a real ambitious oral 
statement here for five minutes. As I noted before, assuring 
privacy and security to the level where we have the trust of 
the general public in what we are trying to build here really 
is an ongoing commitment and the fact that you have put privacy 
and security on this agenda, even two years after HITECH when a 
lot of people are saying, ``didn't we do this already?'' shows 
that you agree, which is terrific.
    So thank you again for the opportunity and I am happy to 
answer any questions that you might have.
    [The prepared statement of Ms. McGraw follows:]

                   Prepared Statement of Deven McGraw

    Chairman Wu and Members of the Subcommittee:
    On behalf of the Center for Democracy & Technology (CDT), I thank 
you for the opportunity to testify today.
    The Center for Democracy and Technology (``CDT'') is a non-profit 
Internet and technology advocacy organization that promotes public 
policies that preserve privacy and enhance civil liberties in the 
digital age. As information technology is increasingly used to support 
the exchange of medical records and other health information, CDT, 
through its Health Privacy Project, champions comprehensive privacy and 
security policies to protect health data. CDT promotes its positions 
through public policy advocacy, public education, and litigation, as 
well as through the development of industry best practices and 
technology standards. Recognizing that a networked health care system 
can lead to improved health care quality, reduced costs, and empowered 
consumers, CDT is using its experience to shape workable privacy 
solutions for a health care system characterized by electronic health 
information exchange.
    You have asked me to address, in particular, the main challenges 
for personal privacy and information security presented by health 
information technology (health IT), as well as the privacy and security 
gaps and priorities that remain to be addressed for future health IT 
activities. Not surprisingly, the main privacy and security challenges 
in health IT result from gaps in current law and a lax approach to 
enforcement, accountability and oversight. My testimony below focuses 
on those gaps. However, since the broad topic of the hearing deals with 
health IT ``standards,'' I have referenced some comments endorsed by 
CDT urging a measured role for government in setting and enforcing 
standards for health IT.

Introduction

    Survey data consistently show the public supports health IT but is 
very concerned about the risks health IT poses to individual 
privacy.\1\ Contrary to the views expressed by some, privacy is not the 
obstacle to health IT. In fact, appropriately addressing privacy and 
security is key to realizing the technology's potential benefits. 
Simply stated, the effort to promote widespread adoption and use of 
health IT to improve individual and population health will fail if the 
public does not trust it.
---------------------------------------------------------------------------
    \1\ National Consumer Health Privacy Survey 2005, California 
HealthCare Foundation (November 2005); study by Lake Research Partners 
and American Viewpoint, conducted by the Markle Foundation (November 
2006); Consumer Engagement in Developing Electronic Health Information 
Systems, AHRQ Publication No. 09-0081EF (July 2009).
---------------------------------------------------------------------------
    To build and maintain this trust, we need the ``second generation'' 
of health privacy--specifically, a comprehensive, flexible privacy and 
security framework that sets clear parameters for access, use and 
disclosure of personal health information for all entities engaged in 
e-health. Such a framework should be based on three pillars:

          Implementation of core privacy principles, or fair 
        information practices; \2\
---------------------------------------------------------------------------
    \2\ Although there is no single formulation of the fair information 
practices or FIPs, CDT has urged policymakers to look to the Markle 
Foundation's Common Framework, which was developed and endorsed by the 
multi-stakeholder Connecting for Health Initiative. See http://
www.connectingforhealth.org/commonframework/index.html.

          Adoption of trusted network design characteristics; 
---------------------------------------------------------------------------
        and

          Strong oversight and accountability mechanisms.\3\
---------------------------------------------------------------------------
    \3\ See ``Policy Framework for Protecting the Privacy and Security 
of Health Information,'' http://www.cdt.org/paper/policy-framework-
protecting-privacy-and-security-electronic-health-information (May 
2008); ``Beyond Consumer Consent: Why We Need a Comprehensive Approach 
to Privacy in a Networked World,'' http://www.connectingforhealth.org/
resources/20080221-consent-brief.pdf (February 
2008).

    This requires building on--and in some cases modifying--the privacy 
and security regulations under the Health Insurance Portability and 
Accountability Act (HIPAA) so that they address the challenges posed by 
the new e-health environment. It also requires enacting new rules to 
cover access, use and disclosure of health data by entities outside of 
the traditional health care system and stimulating and rewarding 
industry implementation of best practices in privacy and security.
    In a digital environment, robust privacy and security policies 
should be bolstered by innovative technological solutions that can 
enhance our ability to protect data. This includes requiring that 
electronic record systems adopt adequate security protections (like 
encryption; audit trails; access controls); but it also extends to 
decisions about infrastructure and how health information exchange will 
occur. For example, when health information exchange is decentralized 
(or ``federated''), data remains at the source (where there is a 
trusted relationship with a provider) and then shared with others for 
appropriate purposes. These distributed models show promise not just 
for exchange of information to support direct patient care but also for 
discovering what works at a population level to support health 
improvement. We will achieve our goals much more effectively and with 
the trust of the public if we invest in models that build on the 
systems we have in place today without the need to create new large 
centralized databases that expose data to greater risk of misuse or 
inappropriate access.
    We are in a much better place today in building that critical 
foundation of trust than we were two years ago. The privacy provisions 
enacted in the stimulus legislation--commonly referred to as HITECH or 
ARRA--are an important first step to addressing the gaps in privacy 
protection. However, more work is needed to assure effective 
implementation and address issues not covered by (or inadequately 
covered by) the changes in ARRA.
    In my testimony below, I call for:

          Establishing baseline privacy and security legal 
        protections for personal health records (PHRs);

          Ensuring appropriate limits on downstream uses of 
        health information;

          Strengthening protections against re-identification 
        of HIPAA de-identified data;

          Encouraging the use of less identifiable data through 
        the HIPAA minimum necessary standard;

          Tightening restrictions on use of personal health 
        information for marketing purposes;

          Strengthening accountability for implementing privacy 
        and security protections; and

          Strengthening accountability for implementing strong 
        security safeguards.

Health IT: Key Privacy and Security Concerns

Establish Baseline Protections for PHRs
    To keep pace with changes in technology and business models, 
additional legal protections are needed to reach new actors in the e-
health environment and address the increased migration of personal 
health information out of the traditional medical system. Personal 
health records (PHRs) and other similar consumer access services and 
tools now being created by Internet companies such as Google and 
Microsoft, as well as by employers, are not covered by the HIPAA 
regulations unless they are being offered to consumers by covered 
entities.\4\ In the absence of regulation, consumer privacy is 
protected only by the PHR offeror's privacy and security policies (and 
potentially under certain state laws that apply to uses and disclosures 
of certain types of health information). If these policies are 
violated, the FTC may bring an action against a company for failure to 
abide by its privacy policies. The policies of PHR vendors range from 
very good to seriously deficient.\5\
---------------------------------------------------------------------------
    \4\ HIPAA applies only to covered entities--providers, health 
plans, and health care clearinghouses. Section 1172 of the Social 
Security Act; 45 CFR 164.104. As explained in more detail below, ARRA 
extended the reach of some of HIPAA's regulations to business 
associates, which receive health information from covered entities in 
order to perform functions or services on their behalf.
    \5\ The HHS Office of the National Coordinator commissioned a study 
in early 2007 of the policies of over 30 PHR vendors and found that 
none covered all of the typical criteria found in privacy policy. For 
example, only two policies described what would happen to the data if 
the vendor were sold or went out of business, and only one had a policy 
with respect to accounts closed down by the consumer.
---------------------------------------------------------------------------
    The absence of any clear limits on how these entities can access, 
use and disclose information is alarming--and has motivated some to 
suggest extending HIPAA to cover PHRs. However, CDT cautions against 
applying a one-size-fits-all approach. The HIPAA regulations set the 
parameters for use of information by traditional health care entities 
and therefore permit access to and disclosure of personal health 
information without patient consent in a wide range of circumstances. 
As a result, it would not provide adequate protection for PHRs, where 
consumers should be in more control of their records, and may do more 
harm than good. Further, it may not be appropriate for the Department 
of Health and Human Services (HHS), which has no experience regulating 
entities outside of the health care arena, to take the lead in 
enforcing consumer rights and protections with respect to PHRs.
    CDT applauds Congress for not extending HIPAA to cover all PHRs.\6\ 
Instead, Congress directed HHS to work with the Federal Trade 
Commission (FTC) to come up with recommendations for privacy and 
security protections for PHRs. This PHR ``study'' was due February 2010 
but has not yet been released.
---------------------------------------------------------------------------
    \6\ Under ARRA, PHRs that are offered to the public on behalf of 
covered entities like health plans or hospitals would be covered as 
business associates. Section 13408.
---------------------------------------------------------------------------
    The agencies need not start from scratch in developing their 
recommendations. In June 2008, the Markle Foundation released the 
Common Framework for Networked Personal Health Information outlining a 
uniform and comprehensive set of meaningful privacy and security 
policies for PHRs. This framework was developed and supported by a 
diverse and broad group of more than 55 organizations, including 
technology companies, consumer organizations (including CDT) and 
entities covered by HIPAA.\7\ In addition, CDT in 2010 issued a report 
with further guidance to regulators on how the provisions of the Markle 
Common Framework could be implemented in law.\8\ Establishing these 
protections will likely require Congress to extend additional authority 
to HHS and/or the FTC.
---------------------------------------------------------------------------
    \7\ See http://connectingforhealth.org/phti/#guide. A list of 
endorsers can be found at http://www.connectingforhealth.org/resources/
CCEndorser.pdf.
    \8\ ``Building a Strong Privacy and Security Framework for PHRs,'' 
http://www.cdt.org/paper/building-strong-privacy-and-security-policy-
framework-personal-health-records (July 2010).

Ensure Appropriate Limits on Downstream Uses of Data
    As noted above, HIPAA applies only to ``covered entities.'' 
However, under the HIPAA Privacy Rule, entities that contract with 
HIPAA covered entities to perform particular services or functions on 
their behalf using protected, identifiable health information (or PHI) 
are required to enter into ``business associate'' agreements.\9\ Such 
agreements may not authorize the business associate to access, use or 
disclose information for activities that the covered entity itself 
could not do under HIPAA.\10\ The agreements also are required to 
establish both the permitted and required uses and disclosures of 
health information by the business associate \11\ and specify that the 
business associate ``will not use or further disclose the information 
other than as permitted or required by the contract or as required by 
law.'' \12\
---------------------------------------------------------------------------
    \9\ 45 CFR 164.502(e)(1) & (2).
    \10\ 45 CFR 164.504(e)(2)(i).
    \11\ Id.
    \12\ 45 CFR 164.504(e)(2)(ii)(A)
---------------------------------------------------------------------------
    This combination of provisions demonstrates that HHS intended to 
place limits on what a business associate can do with health 
information received from a covered entity. However, one large national 
business associate has been accused of using data they receive from 
covered entities to support other business objectives,\13\ and some 
privacy advocates have long suspected that such practices are more 
widespread.
---------------------------------------------------------------------------
    \13\ See http://www.alarmedaboutcvscaremark.org/fileadmin/files/
pdf/an-alarming-merger.
pdf, pages 14-16.
---------------------------------------------------------------------------
    In ARRA Congress took a significant step toward strengthening 
accountability for business associates by making them directly 
accountable to federal and state regulators for failure to comply with 
HIPAA or the provisions of their business associate agreements.\14\ HHS 
recently issued a proposed rule making it clear that accountability 
also extends to subcontractors of business associates, taking positive 
steps toward maintaining a consistent level of accountability for 
privacy and security protections as personal health data moves 
downstream.\15\ CDT strongly applauds these actions.
---------------------------------------------------------------------------
    \14\ ARRA, section 13404.
    \15\ 75 Fed. Reg. 40867-40924, at 40885 (July 14, 2010).
---------------------------------------------------------------------------
    However, CDT remains concerned that the HIPAA Privacy Rule is not 
sufficiently clear with respect to the important role of business 
associate agreements in placing clear limits on how business associates 
and their subcontractors can use and disclose patient data received 
from covered entities. The reports of business associates using health 
information to develop additional lines of business not directly 
related to the services they have been asked to perform by their 
covered entity business partners are either: (1) an indication that 
HIPAA is not being adequately enforced or (2) evidence that some 
business associate agreements are too permissive with respect to 
additional uses of information. In this testimony below CDT calls for 
stronger enforcement of HIPAA. Further, in comments to HHS CDT has 
urged revising the Privacy Rule to require business associate 
agreements to expressly limit the business associate's access, use and 
disclosure of data to only what is reasonably necessary to perform the 
contracted services.\16\ Failure to appropriately account for and 
control downstream uses of data will jeopardize building trust in 
health IT.
---------------------------------------------------------------------------
    \16\ http://www.cdt.org/comments/cdt-comments-hhs-proposed-rule 
(hereinafter, CDT Comments).

Strengthen Protections Against Re-identification of HIPAA De-Identified 
        Data
    HIPAA's protections do not extend to health information that 
qualifies as ``de-identified'' under the Privacy Rule. As a result, 
covered entities may provide de-identified data to third parties for 
uses such as research and business intelligence without regard to HIPAA 
requirements regarding access, use and disclosure. In turn, these 
entities may use this data as they wish, subject only to the terms of 
any applicable contractual provisions (or state laws that might apply). 
If a third party then re-identifies this data--for example, by using 
information in its possession or available in a public database--the 
re-identified personal health information would not be subject to 
HIPAA.\17\ It could be used for any purpose unless the entity holding 
the re-identified data was a covered entity (or had voluntarily 
committed to restrictions on use of the data).
---------------------------------------------------------------------------
    \17\ If a covered entity has a reasonable basis for knowing that 
the recipient of ``de-identified'' data will be able to re-identify it, 
the data does not qualify as de-identified. See 45 C.F.R. 
164.514(b)(2)(ii).
---------------------------------------------------------------------------
    There is value to making data that has a very low risk of re-
identification available for a broad range of purposes, as long as the 
standards for de-identification are rigorous, and there are sufficient 
prohibitions against re-identification. Neither condition is present 
today. A number of researchers have documented how easy it is to re-
identify some data that qualifies as de-identified under HIPAA.\18\
---------------------------------------------------------------------------
    \18\ See, for example, Salvador Ocha, Jamie Rasmussen, Christine 
Robson, and Michael Salib, Re-identification of Individuals in 
Chicago's Homicide Database, A Technical and Legal Study (November 
2008), http://web.mit.edu/sem083/www/assignments/reidentification.html 
(accessed November 20, 2008).
---------------------------------------------------------------------------
    Congress recognized this, and ARRA requires HHS to do a study of 
the HIPAA de-identification standard; that study, due in February 2010, 
is delayed. CDT has urged HHS to revisit the current de-identification 
standard in the Privacy Rule (in particular, the so-called ``safe 
harbor'' that deems data to be de-identified if it is stripped of 
particular data points) to ensure that it continues to present de 
minimis risk of re-identification.\19\ However, Congress need not wait 
for the issuance of the study. To ensure consumers are protected, 
Congress should enact provisions to ensure data recipients can be held 
accountable for re-identifying data.
---------------------------------------------------------------------------
    \19\ See http://www.cdt.org/healthprivacy/
20090625-deidentify.pdf for a more comprehensive discussion 
of CDT's views on the HIPAA de-identification standard.

Encourage Use of Less Identifiable Data
    Although the HIPAA provisions for de-identifying data need to be 
revisited and strengthened, CDT also believes that privacy risks are 
lessened when data has been anonymized to the greatest extent possible. 
In particular, many non-treatment uses of health data--including 
quality, research and public health--can be effectively done with data 
where sufficient patient identifiers have been removed to make it 
anonymous to the recipient. Unfortunately, federal and state privacy 
laws do not sufficiently promote the use of less identifiable data. 
Instead, they permit (in the case of HIPAA) or require (in the case of 
many state reporting laws) the use of fully identifiable data 
(including patient names, addresses, phone numbers, etc.), providing 
little incentive to remove identifiers from data before its use.
    Under the collection and use limitations of fair information 
practices, data holders and recipients must collect, use and disclose 
only the minimum amount of information necessary to fulfill the 
intended purpose of obtaining or disclosing the data. The HIPAA Privacy 
Rule incorporates these principles in the ``minimum necessary'' 
standard, which requires covered entities to use only the minimum 
necessary amount of data for most uses and disclosures other than 
treatment. This standard is intended to be flexible, but HHS has not 
issued any meaningful guidance on this standard. As a result, covered 
entities and their business associates frequently express concerns 
about how to implement it, and CDT suspects that few covered entities 
or business associates take affirmative steps to minimize the 
identifiability of data.
    The Privacy Rule does provide for two anonymized data options--de-
identification (as discussed above) and the limited data set, which can 
be used for research, public health and health care operations). These 
data sets provide greater privacy protection for individuals, but are 
not useful for all purposes due to the number of identifiers that must 
be removed before the data can qualify for either option.
    ARRA attempts to strengthen the Privacy Rule's collection and use 
limitations by strongly encouraging covered entities to use a limited 
data set to comply with the minimum necessary standard, as long as 
limited data is sufficient to serve the purposes for the data access or 
disclosure.\20\ This section of ARRA also requires the HHS Secretary to 
issue guidance on how to comply with the minimum necessary standard. In 
comments to HHS, CDT has asked HHS to be clear in its guidance that 
covered entities must address the identifiability of data in order to 
be in compliance with the minimum necessary standard.\21\
---------------------------------------------------------------------------
    \20\ ARRA, Section 13405.
    \21\ See CDT Comments, supra note 16.

Tighten Rules Regarding Use of Patient Data for Marketing
    The use of sensitive medical information for marketing purposes is 
one of the most controversial practices affecting health privacy. In 
health privacy surveys, use of data for marketing ranks as a top 
concern among respondents.\22\ Consequently, protections against the 
unauthorized use of personal health information for marketing purposes 
are critical to building trust in new e-health systems.
---------------------------------------------------------------------------
    \22\ In the 2006 Markle Foundation survey referenced in footnote 1, 
89% of respondents said they were concerned about marketing firms 
getting access to their personal health information online, and 77% 
described themselves as ``very concerned.'' http://www.markle.org/
downloadable-assets/
research-doc-120706.pdf.
---------------------------------------------------------------------------
    The HIPAA Privacy Rule has provisions intended to limit the use of 
health data in marketing, but it historically was subject to a number 
of exceptions. There also has been little regulatory or legislative 
investigation of health marketing practices.
    In ARRA, Congress took some steps to tighten the definition of 
``marketing'' in the Privacy Rule. Under the new provisions, 
communications that are paid for or ``subsidized'' by third parties are 
marketing, and therefore require prior patient authorization--even if 
those communications would otherwise not be construed as marketing 
because they qualify for one of the existing exceptions. But even this 
new provision includes exceptions that could swallow the rule. For 
example, HHS has initially interpreted subsidized treatment 
communications to be outside the new ARRA rules requiring prior patient 
authorization. As a result, a covered entity can use a patient's data 
without consent to send her a letter urging her to switch to a 
different brand medication, even if that communication was paid for by 
the manufacturer of the medication.\23\ Patients will experience these 
communications as marketing and mistrust any system that allowed this 
to happen without their authorization.
---------------------------------------------------------------------------
    \23\ HHS did give patients the right to opt-out of receiving 
subsidized treatment communications, but an opt-out is not as 
protective of patient privacy as requiring prior consent.

Strengthen Accountability/Enforcement

    When Congress enacted HIPAA in 1996, it included civil and criminal 
penalties for noncompliance, but those rules have never been adequately 
enforced.\24\ The Office for Civil Rights (OCR) within HHS, charged 
with enforcing the HIPAA privacy regulations, had not levied a single 
penalty against a HIPAA-covered entity in the nearly five years since 
the rules were implemented, even though that office found numerous 
violations of the rules.\25\ The Justice Department had levied some 
penalties under the criminal provisions of the statute, but a 2005 
opinion from DOJ's Office of Legal Counsel (OLC) expressly limited the 
application of the criminal provisions to covered entities, forcing 
prosecutors to turn to other laws in order to criminally prosecute 
certain employees of covered entities who have criminally accessed, 
used or disclosed a patient's protected health information.\26\
---------------------------------------------------------------------------
    \24\ ``Effectiveness of medical privacy law is questioned,'' 
Richard Alonso-Zaldivar, Los Angeles Times (April 9, 2008), http://
www.latimes.com/business/la-na-privacy9aor09.0.5722394.story.
    \25\ Id. Although this story is two years old, to the best of our 
knowledge no civil monetary penalties have been assessed since that 
time. Over the last couple of years HHS has extracted monetary 
settlements (most recently from large chain pharmacies) for what were 
largely violations of the HIPAA Security Rule. In materials connected 
with these settlements, HHS made it clear that the amounts being paid 
in settlement of the alleged violations were not civil monetary 
penalties.
    \26\ See http://www.americanprogress.org/issues/2005/06/
b743281.html for more information on the OLC memo and the consequences.
---------------------------------------------------------------------------
    A lax enforcement environment sends a message to entities that 
access, use and disclose protected health information that they need 
not devote significant resources to compliance with the rules. Without 
strong enforcement, even the strongest privacy and security protections 
are but an empty promise for consumers. Further, HIPAA has never 
included a private right of action, leaving individuals dependent on 
government authorities to vindicate their rights.
    In ARRA, Congress took a number of important steps to strengthen 
HIPAA enforcement: \27\
---------------------------------------------------------------------------
    \27\ See Sections 13409-13411 of ARRA.

          State attorneys general are now expressly authorized 
        to bring civil enforcement actions under HIPAA, which puts more 
---------------------------------------------------------------------------
        hands on the enforcement deck.

          As mentioned above, business associates are now 
        directly responsible for complying with key HIPAA privacy and 
        security provisions and can be held directly accountable for 
        any failure to comply.

          Civil penalties for HIPAA violations have been 
        significantly increased. Under ARRA, fines of up to $50,000 per 
        violation (with a maximum of $1.5 million annually for repeated 
        violations of the same requirement) can now be imposed.\28\
---------------------------------------------------------------------------
    \28\ Of note, the increased penalties went into effect on the day 
of enactment--February 17, 2009. State Attorneys General are Limited to 
the previous statutory limits--$100 per violation, with a $25,000 
annual maximum for repeat violations.

          HHS is required to impose civil monetary penalties in 
        circumstances where the HIPAA violation constitutes willful 
---------------------------------------------------------------------------
        neglect of the law.

          The U.S. Department of Justice can now prosecute 
        individuals for violations of HIPAA's criminal provisions.

          The HHS Secretary is required to conduct periodic 
        audits for compliance with the HIPAA Privacy and Security 
        Rules. (The HIPAA regulations provide the Secretary with audit 
        authority, but this authority has rarely if ever been used.)

    The ARRA provisions are a major advancement in enforcement of 
federal health privacy laws, but enforcement is still lax. To 
strengthen accountability and further build public trust in health IT, 
CDT has two recommendations: (1) deem providers who are found to be in 
significant violation (either criminally responsible or found to be in 
willful neglect of the law) ineligible to receive subsidies under the 
federal health IT incentive program, and (2) provide individuals with a 
limited private right of action to enforce their HIPAA privacy rights.
    With respect to the former (declaring a significant HIPAA violation 
to be a disqualification for health IT subsidies), it is hard to 
justify providing tax dollars as a reward for meaningful use of health 
IT to an entity in significant violation of our nation's privacy laws.
    With respect to a private right of action for privacy and security 
violations, CDT recognizes that providing such a right for every HIPAA 
complaint--no matter how trivial--would be inappropriate and 
disruptive. However, Congress should give consumers some right to 
privately pursue recourse in specific circumstances. For example, 
policymakers could create compliance safe harbors that would relieve 
covered entities and their business associates of liability for 
violations if they meet the privacy and security standards but would 
allow individuals to sue if they could prove the standards had not been 
met. Another suggestion is to limit the private right of action to only 
the most egregious HIPAA offenses, such as those involving intentional 
violations or willful neglect.

Strengthen Accountability for Strong Security Safeguards
    According to a recent survey of large health care organizations 
conducted by the Health Information Management Systems Society (HIMSS):

          Fewer than half (47%) conduct annual risk assessments 
        (which are required under the HIPAA Security Rule),

          58% have no security personnel, and

          50% reported spending 3% or less of organizational 
        resources on security.\29\
---------------------------------------------------------------------------
    \29\ See testimony of Lisa Gallagher, Senior Director of Privacy & 
Security, HIMSS, http://healthit.hhs.gov/portal/
server.pt?open=512&objID=1817&parentname=CommunityPage 
&parentid=28&mode=2∈-hi-userid=11673&cached=true
 (November 19, 2009).

    The prospect of storing and moving personal health data 
electronically in an environment where security is a low institutional 
priority should give us all pause. We need--through certified 
electronic health record requirements and enhancements to the HIPAA 
Security Rule--stronger requirements with respect to data security, as 
well as more proactive education and guidance from regulators. Under 
the meaningful use incentive program, the certification requirements 
include a number of important security functionalities, including the 
ability to encrypt data in motion and at rest, the ability to generate 
an audit trail, and authentication and access controls.\30\ However, 
there is no clear requirement, either in the meaningful use criteria or 
in the HIPAA Security Rule, to actually implement and routinely use 
these functionalities. Providers are required under meaningful use to 
perform a security risk assessment and respond to any deficiencies 
discovered, but this falls short of a clear requirement to implement or 
have a plan for implementing the functionalities required for EHR 
certification. CDT is continuing to advocate with regulators for 
strengthened security requirements. Providers with fewer resources 
(such as small physician practices) may need to have security 
requirements scaled up over time; policymakers should, however, 
consider imposing greater obligations on the connecting infrastructure 
to better address gaps or potential weak links as these systems 
develop.
---------------------------------------------------------------------------
    \30\ http://edocket.access.gpo.gov/2010/pdf/2010-17210.pdf.

Promote a Measured Role for Government in Health IT Standards

    Although most of this testimony concerns health IT privacy and 
security, CDT would like to take this opportunity to reference a set of 
collaborative comments drafted by the Markle Foundation and endorsed by 
a broad range of stakeholders, including CDT. The comments concern the 
role of standards in health IT and urge a limited role for government 
in certifying health IT.\31\ CDT asks that these comments also be 
included in the Subcommittee hearing record.
---------------------------------------------------------------------------
    \31\ http://www.markle.org/downloadable-assets/
20090430-meaningful-use.pdf (see in particular, 
section 4) and http://www.markle.org/downloadable-assets/
20100510-collabcmts.pdf.

Conclusion

    To establish greater public trust in HIT and health information 
exchange systems, and thereby facilitate adoption of these new 
technologies, a comprehensive privacy and security framework must be in 
place. From traditional health entities to new developers of consumer-
oriented health IT products to policymakers, all have an important role 
to play in ensuring a comprehensive privacy and security framework for 
the e-health environment. Thank you for the opportunity to present this 
testimony, and I would be pleased to answer any questions you may have.

                       Biography for Deven McGraw

    Deven McGraw is the Director of the Health Privacy Project at CDT. 
The Project is focused on developing and promoting workable privacy and 
security protections for electronic personal health information.
    Ms. McGraw is active in efforts to advance the adoption and 
implementation of health information technology and electronic health 
information exchange to improve health care. She was one of three 
persons appointed by Kathleen Sebelius, the Secretary of the U.S. 
Department of Health & Human Services (HHS), to serve on the Health 
Information Technology (HIT) Policy Committee, a federal advisory 
committee established in the American Recovery and Reinvestment Act of 
2009. She co-chairs the Committee's Privacy and Security ``Tiger Team'' 
and serves as a member of its Meaningful Use, Information Exchange, and 
Strategic Plan Workgroups. She also served on two key workgroups of the 
American Health Information Community (AHIC), the federal advisory body 
established by HHS in the Bush Administration to develop 
recommendations on how to facilitate use of health information 
technology to improve health. Specifically, she co-chaired the 
Confidentiality, Privacy and Security Workgroup and was a member of the 
Personalized Health Care Workgroup. She also served on the Policy 
Steering Committee of the eHealth Initiative and now serves on its 
Leadership Council. She is also on the Steering Group of the Markle 
Foundation's Connecting for Health multi-stakeholder initiative.
    Ms. McGraw has a strong background in health care policy. Prior to 
joining CDT, Ms. McGraw was the Chief Operating Officer of the National 
Partnership for Women & Families, providing strategic direction and 
oversight for all of the organization's core program areas, including 
the promotion of initiatives to improve health care quality. Ms. McGraw 
also was an associate in the public policy group at Patton Boggs, LLP 
and in the health care group at Ropes & Gray. She also served as Deputy 
Legal Counsel to the Governor of Massachusetts and taught in the 
Federal Legislation Clinic at the Georgetown University Law Center.
    Ms. McGraw graduated magna cum laude from the University of 
Maryland. She earned her J.D., magna cum laude, and her L.L.M. from 
Georgetown University Law Center and was Executive Editor of the 
Georgetown Law Journal. She also has a Master of Public Health from 
Johns Hopkins School of Hygiene and Public Health.

    Chairman Wu. Thank you very much, Ms. McGraw.
    Ms. Bass, please proceed.

  STATEMENT OF DEB BASS, PRESIDENT AND CEO, BASS & ASSOCIATES 
                              INC.

    Ms. Bass. Thank you. Chairman Wu, Ranking Member Smith, 
Committee Members, staff and guests, thank you for the 
opportunity to present on this very important topic. I am 
honored to be amongst such esteemed members of the health care 
community, my fellow testifiers, all who are contributing so 
much to the advancement of health care reform.
    In preparing for this testimony, I spent considerable time 
reflecting on our experiences in Nebraska. There is a great 
deal of expert dialog on the topic. Certainly, hearings like 
this provide additional subject matter expertise that will 
surely benefit the ongoing development of standards for 
interoperability and information security and health care 
reform in general. It is clear that this Committee has 
significant data and information at its disposal to continue 
its pursuit to develop solid and workable standards.
    I would like to focus my testimony on principles Nebraska 
has implemented in this arena and respectfully share with you 
the lessons that we have learned as we directly apply the 
success of those efforts for those at the Office of the 
National Coordinator who are developing these critical 
standards.
    There are three areas that have contributed tremendously to 
Nebraska's success in implementing the federal health care 
initiatives of achieving Meaningful Use: One, extensive and 
persistent stakeholder engagement; two, physician engagement; 
three, sharing the knowledge among the States.
    As President and CEO of Bass and Associates and Executive 
Director of NeHII, the Nebraska Health Information Initiative, 
I have worked closely with the NeHII team and project members 
to ensure we engaged key stakeholders across our state. We 
knocked on doors, developed educational materials, and launched 
community-based consumer education campaigns. We spoke in 
cities and across rural Nebraska--rotary clubs, state 
associations and chamber of commerce meetings. In short, no 
stone was left unturned in our efforts to engage citizens 
across the state. The Office of the National Coordinator has 
done an excellent job of reaching out to the stakeholders 
including our own opportunity to host Dr. Blumenthal on his 
recent visit to Nebraska. Dr. Blumenthal took time from his 
busy schedule to tour the NeHII-enabled facilities and witness 
the successful health information exchange up close. I am 
certain his travels are extensive and require a great deal of 
effort but the benefits of these stakeholder visits across the 
country are immeasurable.
    As the ONC develops its next set of standards, I strongly 
urge them to continue to avail themselves of stakeholder 
conferences, meetings and other opportunities to demonstrate 
their continued support of these standards, and I express 
appreciation for the efforts states make to understand, 
implement and adhere to these guidelines. The stakeholder 
engagement is especially important as standards are being 
examined and released, and particularly those supporting the 
ONC's efforts to develop technical standards to address 
interoperability demands. At its March 24, 2010, HIT Standards 
Committee hearing, ONC identified the need to support a broader 
set of stakeholders and providers in information exchange. This 
I believe was another critical step in the right direction to 
encourage stakeholders. We have included our circle for 
pharmacists, dentists, chiropractors and school nurses.
    NeHII was implemented using the most current available 
standards and we remain committed to conforming to standards as 
they are developed. We will make every effort to pursue the 
conversations and affirmations from NeHII participants in 
setting those standards to guarantee the ability of HIEs to 
operate with the least amount of impact to daily operations.
    Recently, I met with a state that, while it possessed all 
the components to successfully build an HIE, is struggling with 
the critical issue of physician adoption of their HIE. Our 
conversations around solutions to reverse this trend revealed 
how difficult it is to move forward on interoperability of 
electronic records without fully engaged physicians. At NeHII, 
we are fortunate to have Dr. Harris Frankel, a respected Omaha 
practicing board-certified physician, who serves as the NeHII 
visionary. In this capacity, he is able to reach deep within 
the physician community as a respected leader and as one of 
their own. I cannot tell you the number of times Dr. Frankel's 
reach within the physician community allowed us access to 
respected physicians who became champions of NeHII and 
therefore supported interoperability across the health care 
spectrum. Dr. Blumenthal is a practicing physician and enjoys 
this esteem as well. His continued contact with the physician 
community toward adhering to standards and interoperability of 
electronic records will be the cornerstone to engaging this 
critical constituency and ultimately one of the key success 
factors of health care reform.
    Finally, I believe the Office of the National Coordinator 
should continue to be a dedicated resource for current 
information in offering a collection of lessons learned and 
best practices for states to rely upon. A national repository 
of best practices from all states would be a helpful guide in 
that direction. We at NeHII have offered, and to date 16 states 
have accepted, our privacy and security policies for states to 
utilize and as an example for drafting their own policies. 
Sharing this information has engendered goodwill, trust, and a 
shared commitment. I urge the ONC to facilitate the sharing of 
knowledge among states throughout the reform effort. The ONC's 
Support Grant Opportunity administered through RTI [Research 
Triangle Institute] is an excellent example of encouraging 
states to cooperatively identify barriers and share knowledge 
in overcoming them.
    Chairman Wu, Ranking Member Smith, and Members of the 
Committee, thank you for the opportunity to testify today. Your 
commitment to reach out to those who shoulder the largest part 
of health care reform effort is much appreciated and will go a 
long ways toward its continued success. I look forward to 
answering your questions. Thank you.
    [The prepared statement of Ms. Bass follows:]

                   Prepared Statement of Deborah Bass

    Chairman Wu, Ranking Member Smith, Committee Members, Staff and 
Guests:
    Thank you for the opportunity to present on this important topic. I 
am honored to be among such esteemed members of the health care 
community, my fellow testifiers, all who are contributing so much to 
the advancement of health care reform.
    In preparing for this testimony, I spent considerable time 
reflecting on our experiences in Nebraska. There is a great deal of 
expert dialogue on this topic in the industry. Certainly, hearings like 
this provide additional subject matter expertise that will surely 
benefit the ongoing development of standards for interoperability and 
Information security, and health care reform in general. It is clear 
this committee has significant data and information at its disposal to 
continue its pursuit to develop solid and workable standards.
    I would like to focus my testimony on principles Nebraska has 
implemented in this arena and respectfully share with you lessons 
learned I believe directly apply to the success of the efforts for 
those at the Office of the National Coordinator who are developing 
these critical standards.
    There are three areas that have contributed tremendously to 
Nebraska's success in implementing the federal health care initiatives 
of achieving meaningful use:

          Extensive and persistent stakeholder engagement

          Physician Engagement and,

          Sharing knowledge among States

    As President and CEO of Bass & Associates, and Executive Director 
of NeHII, the Nebraska Health Information Initiative, I worked closely 
with our NeHII team and project members to ensure we engaged key 
stakeholders across the State. We knocked on doors, developed 
educational materials and launched community-based consumer education 
campaigns. We spoke in the cities and across rural Nebraska at Rotary 
Clubs, State Associations and Chamber of Commerce meetings. In short, 
no stone was left unturned in our efforts to engage citizens across our 
State. The Office of the National Coordinator has done an excellent job 
of reaching out to stakeholders, including our own opportunity to host 
Dr. Blumenthal on his recent visit to Nebraska. Dr. Blumenthal took 
time out of his busy schedule to tour NeHII-enabled facilities and 
witness our successful health information exchange up close. I am 
certain his travels are extensive and require a great deal of effort, 
but the benefits of these stakeholder visits across the country are 
immeasurable.
    As the ONC develops its next set of standards, I strongly urge them 
to continue to avail themselves of stakeholder conferences, meetings, 
and other opportunities to demonstrate their continued support of these 
standards, and express appreciation for the effort States make to 
understand, implement and adhere to their guidelines across the 
country. This stakeholder engagement is especially important as 
standards are being examined and released, in particular those 
supporting the ONC's efforts to develop technical standards to address 
interoperability demands. At its March 24, 2010 HIT Standards Committee 
hearing, ONC identified the need to support a broader set of 
stakeholders and providers in information exchange. This, I believe, 
was another critical step in the right direction to encourage 
stakeholders to embrace the new standards.
    NeHII was implemented using the most current available standards, 
and we remain committed to conforming to new standards as they are 
developed. We will make every effort to pursue the conversations and 
affirmations from NeHII participants in setting those standards to 
guarantee the ability of HIEs to operate with the least amount of 
impact to daily operations.
    Recently, I met with a State that, while it possessed all of the 
components to successfully build an HIE, is struggling with the 
critical issue of physician adoption of that same HIE. Our 
conversations around solutions to reverse this trend revealed how 
difficult it is to move forward on interoperability of electronic 
records without fully engaged physicians. At NeHII, we are fortunate to 
have Dr. Harris Frankel, a respected Omaha practicing, board-certified 
physician, who serves as the NeHII visionary. In this capacity, he is 
able to reach deep within the physician community as a respected leader 
and as one of their own. I cannot tell you the number of times Dr. 
Frankel's reach within the physician community, and not a little of his 
Midwestern charm, allowed us access to respected physicians who became 
champions of NeHII and therefore supported interoperability across the 
healthcare spectrum. Dr. Blumenthal, as a practicing physician, enjoys 
this esteem as well. His continued contact with the physician community 
toward adhering to standards in interoperability of electronic records 
will be the cornerstone to engaging this critical constituency and, 
ultimately, one of the key success factors of health care reform.
    Finally, I believe the Office of the National Coordinator should 
continue to be a dedicated resource for current information in offering 
a collection of lessons learned and best practices for States to rely 
upon. A national repository of best practices from all States would be 
a helpful guide in that direction. We at NeHII have offered, and to 
date 16 States have accepted, our Privacy and Security policies for 
States to utilize as an example for drafting their own policies. 
Sharing this information has engendered good will, trust and a shared 
commitment. I urge the ONC to facilitate the sharing of knowledge among 
States throughout the reform effort. The ONC's Support Grant 
Opportunity, administered through RTI, is an excellent example of 
encouraging States to cooperatively identify barriers and share 
knowledge in overcoming them.
    Chairman Wu, Ranking Member Smith and members of the Committee, 
thank you for the opportunity to testify today. Your commitment to 
reach out to those who shoulder the largest part of the health care 
reform effort is much appreciated and will go a long way toward its 
continued success. Thank you.

                       Biography for Deborah Bass




    Ms. Deborah Bass is the Executive Director and active board member 
for the Nebraska Health Information Initiative (NeHII). NeHII is the 
statewide health information exchange in the State of Nebraska. Ms. 
Bass directed the creation of this 501 (c) (3) non-profit corporation 
and currently oversees and manages the continued efforts in the 
development of Nebraska's statewide Health Information Exchange (HIE). 
Her duties have included creating and developing stakeholder 
relationships, building consensus and support for the organization, 
communications and implementing Board of Directors recommendations, 
managing vendor relationships, recruiting and building the management 
team, developing and implementing the consumer educational campaigns, 
leading the committee effort to develop the privacy, security and 
operational policies, writing the business plan, planning and leading 
the organization's public events and a multitude of other activities 
associated with implementing HIE. She is a regular public speaker for 
national conferences on a number of topics surrounding the development 
and future of HIE.

    Chairman Wu. Thank you, Ms. Bass.
    And now it is in order for questions, and the Chair 
recognizes himself for five minutes.
    Dr. Blumenthal, in Dr. Gibson's testimony, he notes that 
there aren't enough IT implementation professionals to help 
with the implementation of health IT systems. Can you tell us 
what the Office of the National Coordinator has done to provide 
assistance to educational institutions to expand the health IT 
workforce? And Dr. Gibson, can you tell us what other 
assistance may be helpful to educational institutions to help 
with workforce needs. Dr. Blumenthal?
    Dr. Blumenthal. Thank you, Mr. Chair. We agree with Dr. 
Gibson, and in fact, the HITECH legislation very wisely 
encouraged us to support the training of health IT 
professionals. We have provided funding to 84 community 
colleges around the country to train a group of IT 
professionals who will be certified as competent to assist with 
the installation and maintenance of information technology but 
also to help professionals and hospitals with redesigning their 
work flow to take advantage of those new technologies.
    We also have a series of curriculum development grants, one 
of which has gone to the Oregon Health Science University, to 
develop the curricula for these community college programs and 
we have developed a certification exam through a contract, a 
grant, actually, with another university to be able to certify 
these professionals. We expect to train in excess of 40,000 new 
health information technology professionals. The first class 
has enrolled in community colleges as of this fall so they will 
be graduating in the winter and in the spring of this year. So 
that will be in time for Meaningful Use Stage 1. It would be 
nice if they had been trained before the HITECH Act was passed 
but we are trying to live within the realities that we face.
    Chairman Wu. Thank you very much.
    Dr. Gibson.
    Dr. Gibson. I think that the training that has been 
prescribed is excellent and I think it will help a great deal 
and I believe in that. Oregon is a proud leader in training 
many of those people at the community college level. I think 
practices will find it helpful, and it should address some of 
the need. I am concerned just with the many hundreds of 
thousands of eligible providers that the timeline might be a 
bit longer than we expect but I think we are all going in the 
right direction right now on that.
    Chairman Wu. Terrific. Thank you very much.
    Last week the Office of the National Coordinator released a 
framework that will coordinate future work on interoperability 
and standards. How will the framework identify priorities and 
allow for stakeholder input and interface with the Health IT 
Standards Committee?
    Dr. Blumenthal. The framework is a means to an end, Mr. 
Chairman. Actually our priorities for developing standards are 
identified by the Meaningful Use framework, by the requirements 
for Meaningful Use that health professionals and providers 
across the country have to meet. We go backward, we work 
backward from the Meaningful Use requirements to identifying 
the standards, the capabilities that electronic health systems 
have to have, and that actually gives us guidance which the 
Health IT Standards Committee then works on to recommend 
standards. So it is really an ends-driven process. We focus on 
outcomes, the health of patients and what the record has to do 
in order to improve the health of patients, and that gives us 
guidance as to standards.
    The framework that you referred to is a method of producing 
those standards, so once we know which standards we need, we 
then go to the framework and say what is the process for 
standards development. That process needs to be inclusive. It 
needs to be inclusive of other federal agencies like NIST. It 
needs to be inclusive of stakeholders. It needs to be inclusive 
of standards development organizations, the profession and all 
the many voices that are interested in our standards work. But 
ultimately it is not a standards-driven process, it is a health 
care-driven process, and we are trying to put in place the 
requirements for records to make them tools to improve the 
health and safety of the population.
    Chairman Wu. Thank you.
    And Ms. Roberts, you mention in your testimony that NIST is 
working with Health and Human Services' Office of Civil Rights 
to develop baseline security configuration checklists as well 
as conducting outreach and awareness about security challenges 
for health IT. Can you focus down on the specific challenges 
for smaller practices in implementing these security 
regulations?
    Ms. Roberts. Yes. One of the things, the very first thing 
that a small practice needs to do is a risk assessment to 
determine what the risk is in the environment that they are in 
and then based on their risk assessment they can choose which 
security controls they would need to put in place in order to 
meet the security requirements spelled out in the security 
rule. So it is sort of graduated. If the risk is fairly low, 
then they don't have as many controls they need to put in place 
but larger practices have more risk and they will have to put 
more in place.
    Chairman Wu. Thank you very much.
    Mr. Smith, five minutes.
    Mr. Smith. Thank you, Mr. Chairman.
    I am wondering if any of our witnesses could comment on how 
perhaps consumers could be empowered through health IT. And I 
understand we want to maintain privacy but I think that 
consumers, if they become patients, would be empowered and I 
think more effective in managing their own health care, perhaps 
assuming better health habits and so forth through health IT, 
and if anyone would wish to talk about that.
    Dr. Gibson. Yes, I would like to address that. I think that 
electronic health records really will allow patients to be much 
more involved in their health care than they are now because I 
believe ultimately they will have access to the full 
professional record, not a diminished record that has only part 
of it. Ultimately they will have access to all their laboratory 
results, diagnostic imaging reports, problem lists, medication 
lists, allergy lists. They will be looking at the same data 
that their providers look at, and with the use of the Internet 
so that they can bone up on what the professional diagnoses 
are, I think they will come to the table saying, you know, I 
have read about this, I have concerns about how this treatment 
might affect my lifestyle and that sort of thing. So we are 
quite looking forward to having patients more on an equal 
footing with their providers because of the spreading of 
electronic data into the home.
    Ms. McGraw. The law has always required providers to 
provide patients with a copy of their health information if 
they ask for it but Congress took some significant steps 
forward in that regard to make sure that happens by being very 
clear when a provider has an electronic health record, that 
copy has to be electronic, and then with respect to the 
Meaningful Use criteria, there are a number of provisions that 
are required for Meaningful Use that involve sharing data with 
patients, and not just when they ask, but giving them a 
discharge summary, for example, and instructions and a summary 
of their care, and I suspect that in stage 2 this will be 
enhanced even more. And the other thing that Congress did was 
to say not only can you get your electronic copy of your 
record, but if you want your provider to send it to your 
personal health record if you have opened up one of those 
either because the provider gave it to you or your health plan 
sponsors one or you signed up for one from an Internet company 
like Microsoft or Google. So I completely agree with you and it 
is absolutely privacy enhancing to give people copies of their 
data. It helps to reduce errors because patients catch them.
    Ms. Bass. I would like to comment on real-life examples 
that we have seen in Omaha. We have had an operational HIE now 
for over 18 months and throughout the State of Nebraska, not 
just Omaha. Our opt-out rate--we are an opt-out platform. The 
opt-out rate has been anywhere between one and a little over 
three percent of the general population. I think Nebraska has 
been viewed as somewhat of a conservative state, so I think 
that speaks well to how well the consumer is anxious to have 
this opportunity. Many times when we educate them about their 
decision that they make at this point, at the point of care, 
their comment is, so if I sign up for this, I am not going to 
be handed the pencil and clipboard every time I see my 
physician. I can say it is interesting how many times that 
comment is made.
    I also have had situations, and I think sometimes we think 
it is a generational thing that the older generations are more 
concerned versus the younger generation are very interested in 
having this information. I have had elderly individuals that 
come to the office, and my receptionist will call me and she 
will say there is one of those individuals out there. They had 
opted out of the system and then they educated themselves and 
they were adamant to be back into the system and they asked me 
how long will this take for you to do the processing, and we 
have made it difficult. Once they have opted out, we make it 
difficult for them to get back in. But they want to know how 
long is it going to take for me to get back into the system now 
that I understand what this is all about.
    Mr. Smith. Okay. What about then connecting the care and 
consumer, their own detection of perhaps what might be 
necessary or even with the advice of their provider tying that 
to the financing? I think that there is not--anecdotally, I 
think that there is not enough access to the dollars associated 
with the care over the phone. I mean, when you have providers 
say well, we don't provide that over the phone. Is there any 
way we can tie that in? I mean, I would think there would be 
less concern about--but still we need to be sensitive to the 
privacy issues but to involve consumers more in the financing 
of their care, whether it is third-party payer or not.
    Ms. Bass. I can go on to comment about some of these real-
life examples. One of the individuals that came to the office 
that insisted to be opted back in as soon as possible had just 
had to experience a second round of testing because he left one 
health system and went to another health system, and he 
received a bill for that, and he said so I understand if I sign 
up for this, this is not going to happen any longer, and we 
said yes. He got it. And I think there are many out there that 
as we are having to pay for more and more of our health care 
costs are becoming much more aware of what it costs and 
duplicative tests and how to avoid them.
    Mr. Smith. Okay.
    Ms. Sensmeier. I would just like to speak to the standards 
aspect of that. There are standards available from the HITSP 
work products for consumer empowerment which would enable their 
personal health record data to be exchanged with the electronic 
health record, so work is there to support your concerns.
    Mr. Smith. Okay. Thank you.
    Chairman Wu. Thank you very much, Mr. Smith.
    Dr. Gibson, you noted in your testimony that implementing 
EHRs is somewhat stressful for physicians, particularly in 
small practices, and that further, it is essential that we are 
able to transfer patient information as easily as fax machines 
accomplish that transfer today. What are the biggest challenges 
in making this data transfer that easy for physicians, 
particularly in small practices?
    Dr. Gibson. The technology needs to be such that the 
provider himself or herself or their staff can do it directly, 
that they can do it without perhaps having a health information 
exchange in their local or regional area, and that is the key 
point. If an electronic health record for a small practice is 
going to exchange with a health information exchange, that 
electronic health record will still need to export those data, 
and the point of my testimony is just let us make a requirement 
that electronic health records can export and import those data 
directly because most care occurs among providers who are known 
to each other so if you are in John Day, Oregon, your family 
doctor and perhaps a surgeon are likely to be in the same town. 
They are going to be known to each other and to the patient and 
so the need is for the office of the family doctor to be able 
to send the records to the surgeon without requiring that the 
State of Oregon provide a health information exchange. We will, 
ultimately. So my comments address the shorter-term need of 
saying let us require in the next round of standards that the 
EHRs have to do it so you just put in the address of the 
receiving provider and then it is done without requiring a 
third party to intervene.
    Chairman Wu. Thank you very much.
    Ms. McGraw, there is a lot of personal data openly 
available today and we deidentify some of that data. You 
addressed the reidentification phenomenon and potentially the 
need to impose some sanctions for reidentification. Can you 
unpack that set of ideas a little bit for us? This is a hot 
issue for us.
    Ms. McGraw. Yeah. I rushed through it a bit. So we have a 
standard in the HIPAA privacy rule for data deidentification 
and there are two prongs to it. One is what is called a safe 
harbor because it is fairly easy for people to implement. There 
are 19 different common identifiers that you must strip out of 
the data in order for it to qualify as deidentified, and it 
doesn't mean that it goes down to zero risk of reidentification 
but the risk is supposed to be very small. And then the other 
mechanism, if you want to be able to leave some identifiers in 
like dates of service, for example, which are often needed in 
research but other identifiers are not. So you can use a 
statistician and they can do their math magic to make it so 
that it meets the same standard of having a very low risk of 
reidentification. So that is already in the law.
    The problem I think is, number one, the safe harbor was 
created more than five years ago and now, as you mentioned, 
Chairman Wu, there is a lot of other personal information 
widely available on the Internet and with respect to 
reidentification, the risks are about what the recipient might 
have access to in order to connect the dots and put that data 
set together in a way that makes it possible to reidentify 
individuals. And so we tend in the law to treat deidentified 
data as though it has reached some sort of holy grail moment of 
posing no risk at all regardless of who gets it or what data 
they have access to. So we need to rethink the standard. I 
think that is what HHS is focusing on now at the direction of 
Congress. But even if we tighten the standard as much as we 
possibly could, to still make that data more widely available 
as it has lots of important purposes both in health care as 
well as in business analytics. If in fact that data goes to an 
entity who then reidentifies it, puts two and two together, we 
don't right now have a mechanism in the law to reach them to 
say you weren't supposed to do this. Right now, you would hope 
that entities when they release the data actually contractually 
require the entities not to reidentify it, but even that if it 
happens, because it is not required to happen, that is the 
extent of accountability is only through that contract and 
usually only the contracting parties, not law enforcement or 
governmental authorities or even an individual under a private 
right of action.
    Chairman Wu. Does anyone else want to comment on this 
reidentification problem?
    Dr. Blumenthal. Mr. Chairman, it is very much on our minds 
as we go forward at the Office of National Coordinator. We do 
have a study that is ongoing. I think we are going to have to 
look at the science of deidentification and identification, if 
you will, and come to a consensus on what level of risk we can 
tolerate for reidentification and then what level of removal, 
what kinds of removals of information are required to get to 
that level of risk, and that is going to require that we 
continually look at the Internet and the information that is 
available, and it is not going to be a one-time judgment. It is 
a judgment that we are going to have to continue to make based 
on how the technology advances. But it is something that we 
recognize is critical to assuring public trust and enabling 
some of the most valuable uses of information to go forward.
    Chairman Wu. Thank you. Earlier we had a sidebar discussion 
about proper compensation for Meaningful Use. There will be 
compensation for Meaningful Use from Medicare and Medicaid. To 
what extent would compensation from private insurers be helpful 
in the uptake of health care information technology?
    Dr. Blumenthal. We think, at the Office of National 
Coordinator, it would be extremely valuable. The Federal 
Government does pay for probably 40 percent, roughly, of the 
health care bill but there is another 60 percent that benefits 
from the availability of health information technology. In 
August we actually worked with some of the major insurance 
companies to help to get them to agree to begin to incorporate 
meaningful use in their pay-for-performance programs. So United 
Health Care, Aetna, and Wellpoint all agreed that they would 
start to look for Meaningful Use as an indicator of either high 
performance or quality improvement and United Health Group said 
that they were going to launch a pilot project to make loan 
funds available in two states for physicians who want to adopt 
electronic health records.
    Chairman Wu. And how much of a bump are the private 
insurers considering for Meaningful Use?
    Dr. Blumenthal. You mean how much are they willing to put 
on the table? I think that remains to be seen. We are going to 
keep working with them. We are actually going out to meet with 
the Blue Cross Association in a month or so to talk about the 
same issue. What I can assure you is that we will continue to 
work with them to try to make sure or try to assure that their 
contribution is a meaningful contribution.
    Chairman Wu. Ms. Bass.
    Ms. Bass. Thank you, Chairman Wu. I would like to comment 
on this as well. Blue Cross Blue Shield of Nebraska has been a 
significant player in the implementation of HIE and they 
currently pay a license fee of $25,000 a year plus a dollar per 
member per year and we are talking about increasing that levy 
to $1.50. So they have been an active participant but I will 
tell you that we have also met with the other providers or the 
other payers in the State of Nebraska and they are somewhat 
hesitant to play a role in this, and their answer, 
understandably so, is that we deliver health insurance on a 
national perspective so we are looking for a national strategy 
versus having to accommodate state by state. So again, to be 
able to help us find a way around that obstacle, it is critical 
that we have them participate.
    And then to go back to your previous point about the 
deidentified/reidentified data, that was a huge issue for us as 
we developed our privacy and security policies, and hence--we 
were talking about this prior to the HITECH Act. So originally 
we were designed for treatment and payment purposes only, but 
even to this point in time we only provide eligibility 
verification for Blue Cross Blue Shield and it is because of 
this fear of reidentification, and we have excluded all 
research for that fear.
    Chairman Wu. Thank you.
    Dr. Gibson, my understanding is that there is a private 
insurer in Portland, Oregon, which provides some compensation 
for use of health information technology to private providers. 
Can you tell us something about that?
    Dr. Gibson. I am sorry. I am unaware of that. I am sorry I 
am not able to contribute. Can you give more----
    Chairman Wu. I think it is the Providence Group. I am not 
completely confident of that.
    Dr. Gibson. Okay. That they would provide funding for 
sharing of health information? Yes.
    Chairman Wu. That is, if the record--if reimbursement is 
submitted to Providence, that Providence would provide a small 
bump in the reimbursed amount.
    Dr. Gibson. Oh, the Providence health plan does provide--I 
apologize, Chairman Wu. You are absolutely right. Providence 
health plan does provide--give extra one percent payment to 
physicians if they have an electronic health record. 
Absolutely. Thank you for reminding me.
    Chairman Wu. It is one percent?
    Dr. Gibson. One percent.
    Chairman Wu. Thank you very much, Dr. Gibson.
    Dr. Gibson. Thank you.
    Chairman Wu. Mr. Smith, do you have any further questions?
    Mr. Smith. Just one briefly.
    Dr. Blumenthal, it is my understanding that some large 
organizations, health care organizations, kind of are early 
adopters and they have been innovative. How do we dovetail what 
they have already done and how do we take that into account, 
you know, without rendering the progress that they have made 
useless or certainly the expenditures that they made 
worthwhile?
    Dr. Blumenthal. Well, fortunately, though the United States 
lags behind most of the western world in its adoption and use 
of information technology in health care, there are some large 
organizations that are leaders in the United States and I think 
are as far along or further along than any place else in the 
world, and these are organizations whose names we would all 
recognize, places like the Mayo Clinic and the Cleveland Clinic 
and Intermountain Health Care in Salt Lake City, and so that is 
good news. They will, because of their farsighted investments, 
be eligible for Meaningful Use compensation just as any other 
organization would be. We are trying to take advantage of the 
lessons they have to learn--they have to teach, and we 
certainly engage them. We engage them in our Policy Committee. 
We have representatives from Intermountain on our Policy 
Committee, for example, as well as from the Rankin Street--on 
the Standards Committee, someone from the Rankin Street program 
which is in Indianapolis, which is another leader in health IT. 
So we take advantage of their input on an almost daily basis in 
terms of our policy development.
    Our learning--our effort to enhance the adoption of health 
information technology works to a large degree through a 
program called the Regional Extension Center Program. This is a 
program that is actually modeled on the USDA Agriculture 
Extension Program, and its goal, if I can sort of over-
generalize and over-simplify, is to bring the latest 
information technology of the family doctor the way the U.S. 
Agriculture Extension Service brings technology to the family 
farm. That group, that program is oriented towards small 
practices and underserved areas including rural areas and to 
critical access hospitals. Now, they will be trying to channel 
the lessons that have been learned elsewhere in our health 
system to make them available to the least well-resourced, 
least IT-sophisticated members of the health care community, 
and that is why we have focused them on small primary care 
practices in underserved areas and critical access hospitals, 
but they will create learning communities that we hope will 
take advantage of the latest progress that has been made.
    Mr. Smith. And then very briefly, we have heard a little 
bit about the ARRA funds, they are going to go away, and Dr. 
Blumenthal, can you speak to how that might be addressed long 
term? I mean, can we achieve a lot with a one-time expenditure 
as opposed to maintaining the need for a budget line item in 
perpetuity?
    Dr. Blumenthal. Well, one way to think about the ARRA 
funding is as a pump primer, so ultimately the use of health 
information technology in my view is a part of the business of 
health care and it should be a private sector responsibility. I 
think the investment that the Congress and the Administration 
have made was meant to correct a market failure which stemmed 
from the fact that we don't sufficiently reward providers for 
care for high performance, lower cost, higher quality. We pay 
them by piecework whether it is a high-quality or high-cost 
product or a low-quality product. So there wasn't an incentive 
to pay the money that is required in order to get health 
information technology so I think we needed to prime the pump.
    We will very soon, I think, see that it becomes an 
essential part of providing care to the American people, one 
that physicians, nurses, health care institutions don't feel 
they can afford not to have, and at that point I think the 
Federal Government and my office can pass the baton to the 
professional community, to the hospitals, the nurses of the 
country, and the market will take off and do its own work for 
the American people.
    Mr. Smith. Okay.
    Dr. Gibson. I thoroughly agree with Dr. Blumenthal. If you 
survey providers a year after they have gone on an EHR, 90 
percent of them say they would never go back to paper, so they 
realize the benefits. It is that intervening year that I think 
that the priming of the pump that Dr. Blumenthal's office and 
CMS have provided for is adequate to the degree that it will 
stimulate doctors to switch over. Once they get over, there 
will be a network effect. They won't be able to communicate as 
easily with their colleagues without an electronic health 
record. I think that consumer pressure will be such that, 
``gee, doctor, don't I have access to your records; if not, why 
not?'' So I believe that that will take over and I don't see a 
longstanding line item in the budget for this.
    Mr. Smith. Ms. Sensmeier?
    Ms. Sensmeier. Yes. Another thing to note is, since 1994 
HIMSS has sponsored the Davies Award, which awards 
organizations and public health systems, community health 
organizations and private practices for implementing electronic 
health records, and it is notable that they all identify the 
return on investment for them. I mean, it is certainly a huge 
investment up front but at the end they have improved their 
processes and really all of them have achieved cost savings, so 
that is noteworthy as well. And two of them are from the State 
of Oregon, two of the winners, Chairman Wu.
    Mr. Smith. Ms. Bass.
    Ms. Bass. Thank you. We take that call from the ONC to be 
sustainable within four years very seriously, and we are 
already beginning to see some of the opportunities just as the 
web services came from the World Wide Web, we are beginning to 
see HIE services, and I visited with a group this morning about 
some of the things that we are doing to be able to generate 
revenue, and I can go into detail on some of those but we are 
very confident that we will be seeing many opportunities to 
create revenue through the health information exchange.
    Mr. Smith. Okay. Thank you, Mr. Chairman.
    Chairman Wu. Thank you.
    Many of you traveled long distances and also spent a lot of 
time and energy preparing your testimony, and I want to give 
you all an opportunity to add anything to your testimony that 
we have not asked about today.
    Dr. Blumenthal. I just want to express my gratitude to the 
Congress for putting in place the HITECH Act. I think it is a 
superb piece of legislation that as I have gotten to know it 
and trying to implement it, I have been impressed at how it 
addresses almost all the major issues that we need to address 
with respect to the implementation of an electronic health 
system in the United States. That is not to say it is going to 
be easy but I think you have given us a great start. So my 
appreciation to you and your colleagues.
    Chairman Wu. Thank you, Dr. Blumenthal.
    Anyone else?
    Ms. Roberts. I would like to echo his comments as well as 
to thank the Committee for recognizing NIST's role in health IT 
and ensuring that we are involved as a partner with ONC in 
making this go forward. Thank you.
    Chairman Wu. We appreciate NIST's work.
    Ms. Sensmeier.
    Ms. Sensmeier. Thank you, Chairman Wu. I just would like to 
briefly go back to your comments on the workforce and I want to 
emphasize how important that is, and also recognize the role of 
nurses in this process. It is often a silent voice, and there 
are 3.1 million of us out there and there are approximately 
9,000 informatics nurses working in the United States helping 
to implement and lead these projects. So it is critical work 
and I appreciate the support that you have put to the workforce 
efforts in making sure we all have the competencies for 
informatics we need to do this work.
    Chairman Wu. Thank you very much.
    Dr. Gibson. I also would like to commend Congress for the 
HITECH Act, the Meaningful Use final rule, and the remarkable 
cooperation between the Office of the National Coordinator and 
the Centers for Medicare and Medicaid Services who have brought 
order out of chaos within electronic health records. We now see 
where we need to go. I think it will be very challenging to get 
there. I also want to state that I believe that this 
information technology is crucial in terms of bringing down 
health care costs in the long run. We are not the answer. We 
are an enabling technology that ultimately will allow all the 
care to be subject to review and comparison to national 
scientific standards, and I think it will be a useful 
technology in the long run as we work on the challenging 
problem of health care and health care cost and quality. Thank 
you for allowing me to testify.
    Chairman Wu. Thank you very much.
    Ms. McGraw.
    Ms. McGraw. I feel like I got some good opportunities to 
speak so I don't have anything to add but I am happy to follow 
up with additional information such as ideas about the 
deidentification/reidentification issue, the security issues I 
raised and anything else in my testimony.
    Chairman Wu. Thank you.
    Ms. Bass.
    Ms. Bass. I too would like to echo, thank you for the work 
that you have done. It has been outstanding.
    One point I do want to make when we are talking about 
enabling EHR to talk to other EHRs to be aware of the interface 
fees that can be obstacles, and I just wanted you to be aware 
of that piece of information. Also, I would like to close with 
the fact that I too was a registered nurse for 20 years before 
I went into technology, and I am very thankful that because of 
the work you are doing, people are no longer asking me what 
technology has to do with nursing. Thank you.
    Chairman Wu. Thank you very much, and thank you all for 
appearing before the Subcommittee this afternoon. The record 
will remain open for two weeks for additional statements from 
Members and for questions to any follow-up questions the 
Committee may ask of the witnesses. The witnesses are excused 
and the hearing is adjourned. Thank all very, very much.
    [Whereupon, at 11:31 a.m., the Subcommittee was adjourned.]

                              Appendix 1:

                              ----------                              


                   Answers to Post-Hearing Questions
Responses by Dr. David Blumenthal, National Coordinator for Health 
        Information Technology, Office of the National Coordinator, 
        U.S. Department of Health and Human Services

Questions submitted by Chairman David Wu

Q1.  As your testimony describes, there are many health IT 
implementation activities currently occuring around the country. Could 
you please describe how the standards needed for all of these 
initiatives, such as state and national health information exchanges 
and meaningful use, are being coordinated by the Office of the National 
Coordinator?

A1. The Health Information Technology for Economic and Clinical Health 
(HITECH) Act includes several sections that authorize the Office of the 
National Coordinator for Health Information Technology (ONC) to 
coordinate standards activities and, in so doing, assure that 
meaningful public input is obtained.
    The HITECH Act established two Federal Advisory Committees (the HIT 
Policy Committee and HIT Standards Committee) from which we regularly 
seek recommendations. Each committee plays a specific role with respect 
to standards coordination. The HIT Policy Committee is charged with 
recommending the areas in which standards, implementation 
specifications, and certification criteria are needed for the 
electronic exchange and use of health information as well as a priority 
order for the development, harmonization, and recognition of standards, 
implementation specifications and certification criteria. The HIT 
Standards Committee is charged with recommending to the National 
Coordinator the standards implementation specifications, and 
certification criteria developed for the electronic exchange and use of 
health information. It is also responsible for recognizing harmonized 
or updated standards from an entity or entities for the purpose of 
facilitating the achievement of uniform and consistent implementation 
of such standards and implementation specifications. Finally, once HIT 
Standards Committee recommendations are issued to the National 
Coordinator, the HITECH Act requires that the National Coordinator must 
determine whether to endorse each standard, implementation 
specification, and certification criterion recommended for the purposes 
of adoption by the Secretary under section 3004 of the Public Health 
Service Act.
    Among these activities and within this statutory context, ONC has 
also recently developed and established the Standards and 
Interoperability Framework (the Framework) to proactively identify 
areas requiring standards harmonization, development, and coordination 
across the many activities in which we are engaged.
    The Framework seeks to implement a coordinating process that is 
inclusive of SDOs, the provider community, and the public with the 
purpose of developing and harmonizing standards and specifications. The 
Framework supports the coordination of standards from the 
identification of a particular challenge requiring new or harmonized 
standards, to the testing and certification criteria that are necessary 
to ensure compliance with those standards.
    Each step in the Framework is meant to engage affected and relevant 
stakeholders to assure full participation and involvement from 
qualified, knowledgeable resources. This is especially important in 
working with healthcare standards, which in most cases have been 
developed by collaborative processes external to the Framework and 
which have a cumulative body of knowledge to draw from.

Q2.  What efforts is the Federal Government involved in to help 
coordinate and align U.S. health IT standards with those used 
internationally?

A2. ONC has been regularly involved in international health IT 
standards coordination meetings with leadership from a number of 
countries including Canada, the UK, and Australia. Earlier this month, 
ONC staff participated in a meeting convened in Cambridge, MA by Health 
Level 7 International (HL7) to discuss standards development and 
coordination.
    Across our international partners, there is an interest in finding 
commonality in health IT standards, and significant progress has been 
made, including the widespread adoption of international standards such 
as the Systematized Nomenclature of Medicine - Clinical Terms (SNOMED). 
SNOMED originated as a U.S.-England collaboration, but is now 
maintained by The International Health Terminology Standards 
Development Organisation (IHTSDO). This summer, the IHTSDO announced an 
agreement with the multi-lateral World Health Organization (WHO) to 
integrate SNOMED into the WHO's international classification of disease 
(ICD) terminology.
    Additionally, ONC is supporting, along with the Healthcare 
Information and Management Systems Society (HIMSS) and the American 
Health Information Management Association (AHIMA), a US-led Secretariat 
to the technical advisory group (TAG) for ISO TC 215, the international 
standards organization for health care standards.

Q3.  You mentioned that ONCHIT is working on a study regarding the de-
identification of private data. When will this study be published?

A3. The draft report associated with the study was recently submitted 
and is currently under review by ONC and the HHS Office for Civil 
Rights, because of its relevance to the HIPAA Privacy Rule. Given that 
the report may require further revisions in response to questions and 
comments from our respective offices, we cannot, at the present time, 
predict a specific publication date for the report. We do, however, 
intend to make it publicly available as soon as possible. We would be 
happy to furnish your staff and the committee staff with a copy of the 
final version of the report as soon as one becomes available.

Questions submitted by Representative Paul D. Tonko

Q1.  CMS has announced that it will promulgate regulations for the 
HITECH Act in three stages. Stage 1 measures focus on capturing and 
sharing data. Stage 2 will target advanced care processes with clinical 
decisions support services. Stage 3 will concentrate on improving 
health care outcomes. It appears that results from Stage 1 will heavily 
influence the regulatory process in later stages.

A1. CMS received numerous comments from providers, advocates, and 
Congress on the proposed rule for the Medicare and Medicaid EHR 
Incentive programs which included Stage 1 of meaningful use. We 
carefully evaluated these comments and tried to accommodate concerns in 
a way that provides flexibility for providers while moving forward on 
the adoption and meaningful use of certified EHR technology. During 
future rulemaking for the other Stages, we plan to take a similar 
approach to engage stakeholder input as well as take into account our 
experience and results from Stage 1.
    For Stage 1 measures, we worked to meet the statutory objectives of 
improving the quality of health care, reducing medical errors, reducing 
health disparities, increasing prevention, and improving the continuity 
of care among health care settings. Further, we identified core 
objectives that are both patient-centered and crucial to laying the 
foundation for obtaining value from meaningful use. For example, 
providing electronic copies of health information to patients will not 
be useful if the copies do not contain basic information such as a 
problem list, medication list, or allergy list.
    We provided some possible specificity about Stage 2, but will not 
finalize details about other stages until later rulemaking. There are 
two reasons for this.

        1.  We want to get results from Stage 1 to help us determine if 
        the requirements that we have set are appropriate.

        2.  Many of the requirements for later stages will be dependent 
        on infrastructure improvements that are anticipated over the 
        next several years due to HITECH funding.

Q2.  How does CMS/HHS plan to measure physician progress and challenges 
associated with implementing Stage 1 before moving to alter stages? 
Will CMS/HHS gather data from a range of physician stakeholders before 
implementing later stages?

A2. ONC is taking a number of actions to gather input from physician 
stakeholders. First, ONC's Office of Provider Adoption Support--in 
collaboration with the ONC funded Regional Extension Centers--has 
launched the Meaningful Use Vanguard (MUV) program, identifying 
providers who are committed to leading the way in meaningful use of 
certified EHR technology. The program is designed to support feedback 
mechanisms for Stage 1 implementation, future stages, and monitoring 
the general progress and barriers of the program. ONC will provide 
quantitative and qualitative data collected from MUV to the HIT Policy 
Committee, as that federal advisory committee deliberates and makes 
recommendations to the National Coordinator for Stages 2 and 3. Second, 
ONC is undertaking a new survey effort in cooperation with the National 
Center for Health Statistics to obtain information from a nationally 
representative set of physicians at various stages of EHR adoption 
about the barriers to and benefits of achieving the Stage 1 meaningful 
use criteria. Finally, Dr. Blumenthal has personally undertaken a set 
of outreach efforts, meeting with professional groups across the 
country to hear about their progress and challenges.
    CMS is working to educate providers about the EHR incentive program 
and meaningful use, and tailoring outreach efforts based on the 
questions received from stakeholders. CMS has posted over 100 
frequently asked questions and answers on its website, and will soon be 
posting meaningful use specifications for each meaningful use measure 
to further educate providers on all of the objectives. CMS will also be 
monitoring the participation in the Medicare and Medicaid EHR Incentive 
Programs, to determine if particular segments of the provider community 
such as certain physician specialties or geographic locations are 
having more difficulty registering or successfully demonstrating 
meaningful use. This data will enable CMS to target its outreach 
efforts strategically. Through the attestation data that CMS will begin 
collecting in April 2011, they will be able analyze if some of the 
measures are more challenging to achieve than others. Both CMS and ONC 
intend to fully leverage all available data collected as well as 
program experiences with implementing stage 1 for purposes of informing 
later stages of meaningful use criteria.

Questions submitted by Representative W. Todd Akin

Q1.  A number of traditionally hospital-based physicians are eligible 
for incentives under the HITECH Act program. Some of these physicians 
are concerned that the rules and the ``meaningful use'' requirements 
released to date don't necessarily apply to the way they actually 
practice or use electronic health records. What are the plans to ensure 
that hospital-based physicians, such as anesthesiologists, pathologists 
and radiologists, who are deemed eligible for the incentives, are able 
to successfully participate in the program?

A1. The Medicare and Medicaid meaningful use incentive programs final 
rule conforms to the Continuing Extension Act of 2010 which addresses 
provider concerns about hospital-based providers in ambulatory settings 
being unable to qualify for incentive payments by defining a hospital-
based eligible professional (EP) as performing substantially all of his 
or her services in an inpatient hospital setting or emergency room 
only. Hospital-based EPs are those who furnish 90 percent or more of 
their covered professional services in a hospital inpatient setting, or 
hospital emergency department and thus are not eligible for incentive 
payments.
    CMS understands the scope of the Medicare and Medicaid EHR 
incentive programs is vast and that doctors and hospitals across the 
country have varying degrees of awareness of EHRs and of the program. 
As a result, CMS is conducting wide-scale outreach to educate those 
eligible for the program--hospitals and eligible professionals, as well 
as States, and provider stakeholders. Outreach has already started and 
will continue for the coming months and years to prepare and encourage 
participation by all who are eligible. Some accomplishments and plans 
to date include:

          CMS conducted awareness tracking among potential 
        participants to gauge levels of knowledge and inform outreach 
        efforts. This tracking will continue as the program launches.

          CMS established a specific website for the program on 
        cms.gov and are actively promoting it through all related 
        communications channels reaching these audiences. This website 
        provides detailed information about eligibility, requirements, 
        how to participate, and more in digestible portions to assist 
        providers with learning and understanding the information. This 
        website will continue to grow with content and tools for 
        providers to learn about the program.

          CMS facilitated, in conjunction with ONC, a bi-weekly 
        hospital and provider stakeholder call to share information and 
        receive feedback from the field. The stakeholders are committed 
        to helping in the educational effort of their constituents.

          CMS continues to conduct training for multiple 
        audiences, including rural providers, through open door forums, 
        CMS-hosted trainings, presentations at key conferences and 
        webinars, partnering with ONC both at the national and local 
        levels.

          HHS is actively engaging its 10 Regional Offices to 
        promote and educate on the program through local activities and 
        collaboration with the States and ONC Regional Extension 
        Centers.

    In the coming months surrounding the launch of the programs, we 
will be promoting the program through both traditional and non-
traditional media as well as introducing an Incentive Program 
Information Center to assist those participating in the program and to 
answer their questions.

Questions submitted by Representative Paul C. Broun

Q1.  As a primary care physician with over three and a half decades of 
clinical experience, I understand the importance a patient's laboratory 
data has towards a proper patient diagnosis. This laboratory data is 
essential to many of the quality measures in the Final Meaningful Use 
rule (rule). How have you addressed the funding challenges between the 
necessary interfaces of laboratory information systems, where 
pathologists house patient laboratory data, and Electronic Health 
Records (EHR)? In particular, smaller laboratories need financial 
assistance in acquiring these interfaces, which at this time, only 
large national laboratories can afford.\1\
---------------------------------------------------------------------------
    \1\ See page 4, bullet point 6 in the attached March 15, 2010 Small 
Business Administration, Office of Advocacy letter to Charlene M. 
Frizzera, Acting Administrator of the Centers for Medicare and Medicaid 
Services.

A1. The ability to electronically receive laboratory test results is an 
important tool for improving patient care and we recognize that certain 
financial and technical challenges need to be overcome to realize all 
of the benefits that this HIT can provide. We are engaged in several 
efforts that we hope will help tip the scales and lower the costs and 
barriers to obtaining and implementing laboratory interfaces. Our 
Regional Extension Centers are working with health care providers to 
help them become meaningful users and in doing so are providing 
training and support services related to EHR adoption; offering 
information and guidance to help with EHR implementation; and giving 
technical assistance as needed. A primary focus of this activity is 
working with providers and EHR vendors on implementing interfaces, with 
an immediate priority on lab interfaces. The state health information 
exchange grantees are working and partnering with both national and 
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smaller independent labs on several fronts:

          Gaining participation of clinical laboratories in 
        health information exchange networks so that providers can 
        receive lab results from several labs with a single interface.

          Providing financial and technical support to 
        independent and hospital labs to defray the costs of 
        establishing laboratory information system interfaces.

          Advancing adoption of LOINC standards through 
        translation and validation services and value sets, to make it 
        easier for providers to incorporate and use labs results in 
        EHRs.

    Finally, the Nationwide Health Information Network Direct project 
we are leading is developing technical specifications and reference 
implementations that we also anticipate will lower the cost of 
establishing interfaces.

Q2.  Given the rule's numerous measures that eligible health care 
providers must meet to receive EHR incentive funding and prevent 
financial penalties after 2015, how will you deal with eligible health 
care providers who regrettably fail to meet the rule's numerous 
required measures? For example, some pathologists who practice outside 
of a hospital may be eligible for funding, but they do not evaluate 
some of the measures included in the final rule due to not having 
direct patient contact that most of the rule's measures envision.

A2. In accordance with the statute, eligible health care providers must 
be able to demonstrate meaningful use of certified electronic health 
record (EHR) technology by 2015 in order to avoid negative Medicare 
payment adjustments in future years. While the Medicare and Medicaid 
EHR Incentive Programs have similar reporting requirements, the 
Medicaid Incentive Program does not include payment adjustments for 
eligible professionals and hospitals who are unable to successfully 
demonstrate meaningful use.
    The use of EHRs among eligible health care providers varies greatly 
by specialty, and CMS understands that not all measures will apply to 
all providers. The requirements of meaningful use for Stage 1 have been 
adjusted to be more flexible based upon comments received during the 
rulemaking process. The measures have been divided into a core set and 
a menu set. Where it may be impossible for an eligible professional 
(EP) or eligible hospital to meet a specific measure, an exclusion is 
defined in the final rule. If an exclusion applies to an EP or eligible 
hospital, then such an EP or eligible hospital does not have to meet 
that measure in order to be determined a meaningful EHR user. For 
instance, if an EP such as a pathologist writes fewer than one hundred 
prescriptions during the EHR reporting period, then the EP would be 
excluded from meeting the measure associated with electronically 
prescribing medication. Added flexibility also allows eligible 
providers to defer reporting on up to five menu set measures.
    The requirements for meaningful use for Stage 2 and 3 of this 
program will be set through open and transparent rulemaking. 
Consideration will be given to public comment from stakeholders during 
future rulemaking. HHS anticipates the need to make changes into 
account to the overall HIT infrastructure and lessons learned from 
Stage 1 implementation for implementing future stages of the program.
                   Answers to Post-Hearing Questions
Responses by Ms. Kamie Roberts, Associate Director for Federal and 
        Industrial Relations, Information Technology Laboratory, 
        National Institute of Standards and Technology

Questions submitted by Chairman David Wu

Q1.  You testify that NIST is heavily engaged in usability research. 
What are some of the challenges currently associated with usability? 
How does NIST establish the priorities for this research? How does NIST 
ensure that the research is utilized?

A1. Usability is fundamental to the adoption of health IT. It enables 
users--in the case of healthcare clinicians and consumers alike--to use 
products quickly and easily to accomplish their goals. Usability of 
health IT systems can offer efficiencies of scale in improving 
healthcare and reducing disparities, and enable more effective use of 
information technology to improve health and maintain wellness.
    Challenges in achieving usability in health IT systems include: 
designing systems to support tasks, not complicate them, so that 
clinicians can focus on their patients; designing effective user 
interfaces that reduce complexity of operations and training time; 
establishing consensus based usability standards with quantifiable test 
methods to assess compliance with the standards; and, determining 
specific objective pass/fail criteria for usability certification.
    NIST sets priorities for this research by collaborating with and 
receiving input from many individual stakeholders in the public and 
private sectors, including Federal agencies, standards development 
organizations, professional societies and non-profit organizations, 
academia, healthcare delivery organizations, industry, and consumers. 
Extensive input from these parties was critical to the NIST-led 
development of a usability road map focusing on R&D priorities. 
Recently, NIST, the Department of Health and Human Services' Office of 
the National Coordinator for Health Information Technology (ONC) and 
the Agency for Healthcare Research and Quality (AHRQ) held a workshop 
to further refine the road map by determining a prioritized list of 
short, medium, and long-term strategies to improve usability of 
electronic health record (EHR) systems.
    To help ensure that the usability research is utilized, NIST is 
providing stakeholders with focused guidance on usability and 
accessibility, such as methods for building usability into product 
design and development from the beginning. NIST is also disseminating 
the research outcomes broadly to the stakeholder community through 
workshops, publications and presentations at key health IT meetings and 
conferences. In addition, NIST's collaborations with the ONC will 
enhance development of data on usability in the event that 
certification criteria in this area are considered in the future.

Questions submitted by Representative W. Todd Akin

Q1.  A number of traditionally hospital-based physicians are eligible 
for incentives under the HITECH Act program. Some of these physicians 
are concerned that the rules and the ``meaningful use'' requirements 
released to date don't necessarily apply to the way they actually 
practice or use electronic health records. What are the plans to ensure 
that hospital-based physicians, such as anesthesiologists, pathologists 
and radiologists, who are deemed eligible for the incentives, are able 
to successfully participate in the program?

A1. NIST's efforts focus on enabling adoption of health IT by 
accelerating standards development and testing efforts within the 
health IT domain. Questions related to the meaningful use criteria and 
physician incentives are under the purview of the Department of Health 
and Human Services.
                   Answers to Post-Hearing Questions
Responses by Ms. Joyce Sensmeier, Vice President, Informatics, 
        Healthcare Information and Management Systems Society

Questions submitted by Chairman David Wu

Q1.  In your testimony, you note that ``data transport and basic 
security are focus areas where selected standards [for meaningful use] 
are missing,'' and that having these standards available would make it 
much easier for vendors to prepare for phase two of meaningful use.

     Has the Office of the National Coordinator, or any other body, 
developed a standards roadmap, that would help software developers and 
device makers build products that meet future requirements? Would such 
a roadmap or guide be beneficial?

A1. We are not aware of a publicly available national standards roadmap 
or guide. We do agree that such a roadmap would help software 
developers and device makers build products that meet future 
requirements. A standards roadmap would also allow the industry to work 
in a coordinated effort to plan future software development cycles and 
implement standards in a manner that builds on a consistent foundation 
to more advanced capabilities.
    However, we would like to clarify that when we stated ``data 
transport and basic security are focus areas where selected standards 
[for meaningful use] are missing,'' we were not saying that there are 
standards gaps, or that additional standards need to be developed for 
these focus areas. Many data transport and basic security standards are 
already published and available; they simply need to be selected by CMS 
and ONC for future stages of meaningful use and certification criteria.

Q2.  Included in the NIST FY2011 budget request is a $10 million 
initiative for Standards and Conformity Assessment for Interoperability 
in Emerging Technology. What level of funding do you believe is 
necessary to support NIST's health IT activities? If more funding were 
available, what priorities would you recommend to support standards for 
interoperability and related measures?

A2. Without knowing what requirements are included in the NIST FY2011 
budget request, it is difficult to suggest a necessary level of 
funding. However, priorities for this funding should address the need 
for a broad and extensible test infrastructure which is critical to 
ensure standards-based interoperability between health IT applications. 
This infrastructure should include a modular, web-based testing 
environment that provides a variety of conformance and interoperability 
testing services to support instance validation testing, isolated 
system testing, and peer to peer system testing.
                   Answers to Post-Hearing Questions
Responses by Dr. Richard Gibson, President, Oregon Health Network

Questions submitted by Chairman David Wu

Q1.  The meaningful use criteria require that providers do a risk 
assessment to gauge the appropriate level of security they will need 
for their health IT systems. What type of experience do physicians have 
in performing security risk assessments? What resources exist to help 
them?

A1. Most small physician practices have no experience in performing 
security risk assessments. Larger physician offices could possibly 
already have someone on their staff familiar with IT security risk 
assessments especially if they are currently supporting their own in-
house electronic health record. Even in the larger physician offices, 
they are likely to be rusty on risk assessment skills. With a checklist 
provided by a Regional Extension Center or by their specialty society, 
an experienced staff member might be able to carry out their own 
security risk assessment for that larger physician office. Smaller 
physician offices are unlikely to be able to perform this assessment 
without significant help. Perhaps a small physician office could 
perform their own security risk assessment if they were provided a 
plainly written, nontechnical, detailed checklist with full 
explanations of each risk topic. The staff member or physician could 
read the explanation of each question and be guided through how to 
indicate their level of risk on each topic. Generally, I am not aware 
that there are many resources currently available to help physicians 
with IT security risk assessments. It is certainly not a routinely 
advertised or discussed service among physicians. There is an 
opportunity for private firms to compete in offering a fixed price IT 
security risk assessment based on the size of the physician practice. I 
can envision many smaller and some larger practices taking advantage of 
this route as they might be uncomfortable making their own risk 
assessment.
                   Answers to Post-Hearing Questions
Responses by Ms. Deven McGraw, Director of the Health Privacy Project, 
        Center for Democracy and Technology

Questions submitted by Chairman David Wu

Q1.  The meaningful use criteria require that providers do a risk 
assessment to gauge the appropriate level of security they will need 
for their health IT systems. What type of experience do physicians have 
in performing security risk assessments? What resources exist to help 
them?

A1. The security risk assessment required by the meaningful use 
criteria is essentially the same risk assessment required by the 
security regulations under the Health Information Portability and 
Accountability Act of 1996 (HIPAA). However, the Security Rule applies 
only to electronic protected health information. Consequently, 
providers who are adopting electronic health records for the first time 
have no experience in conducting these risk assessments. Further, 
providers who are upgrading existing systems may have little-to-no 
familiarity with the new, more advanced security features and functions 
present in certified EHR technology. Providers in small practices may 
not have the resources to hire in-house IT security professionals.
    For these risk assessments to be effective, it is essential that 
providers perform them effectively. To help providers comply with the 
HIPAA security rule, there are written materials on the websites of 
both the Centers for Medicare and Medicaid Services (CMS) (which, until 
recently, enforced the HIPAA security rule) and the HHS Office of Civil 
Rights. These resources are a good start, but they are not sufficient 
to ensure that providers participating in the meaningful use program 
are actively implementing adequate security. Vendors of certified EHR 
technology should educate their provider customers on how to deploy the 
EHR security functionalities--but vendors are not a good, consistent 
source of support on how to comply with security laws, or to implement 
good security practices.
    CDT has recommended that the Regional Extension Centers (RECs) 
established in the HITECH legislation provide hands-on assistance to 
providers to implement the security risk assessment. However, it is not 
clear that the Regional Extension Centers have the expertise to 
adequately take on this role. Also, given that providers need only 
attest that they have performed a security risk assessment, is unclear 
that the security meaningful use provisions will be much of a priority 
for the RECs. It will be important to monitor compliance with the 
security meaningful use provisions during Stage 1 of the program to 
ensure that consistent implementation of good security practices is a 
top priority.

                              Appendix 2:

                              ----------                              


                   Additional Material for the Record


   Letter to Charlene M. Frizzera, Acting Administrator, Centers for 
    Medicare and Medicaid Services, Department of Health and Human 
 Services, from Susan M. Walthall, Acting Chief Counsel Advocacy, and 
  Linwood L. Rayford III, Assistant Chief Counsel for Food, Drug, and 
 Health Affairs, Small Business Administration, dated March 15, 2010, 
               Submitted by Representative Paul C. Broun














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