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Title: Medical%20Informatics%20Perspectives%20on%20Electronic%20Medical%20Records

Medical Informatics Perspectives on Electronic
Medical Records
  • Scot M. Silverstein, MD
  • Assistant Professor of Healthcare Informatics and
  • Director, Institute for Healthcare Informatics
  • Drexel University, College of Information Science
  • April 20, 2006

  • Promote better understanding of Medical
    Informatics as a formal, cross-disciplinary
    clinical/IT specialty, lift veil of mystery that
    leads to misuse of term.
  • Raise awareness of national electronic medical
    records (EMR) initiatives on the provider side,
    and how these are important to healthcare
    providers as well as other sectors (e.g.,
  • Provide insights into how Medical Informatics
    experience in solving provider sector EMR issues
    is valuable towards parallel issues in pharma and
    other RD IT initiatives.

The iSchools
Focus is on how people seek, use or interact with
information using technology, not simply on
technologic devices and computer programs.
  • University of California, Berkeley School of
    Information Management and Systems
  • University of California, Irvine The Don Bren
    School of Information and Computer Sciences
  • University of California, Los Angeles Graduate
    School of Education and Information Studies
  • Drexel University College of Information Science
    and Technology
  • Florida State University College of Information
  • Georgia Institute of Technology College of
  • University of Illinois Urbana-Champaign The
    Graduate School of Library and Information
  • Indiana University School of Informatics
  • Indiana University School of Library and
    Information Science
  • University of Maryland College of Information

University of Michigan The School of
Information University of North Carolina School
of Information and Library Science The
Pennsylvania State University School of
Information Sciences and Technology University
of Pittsburgh School of Information
Sciences Rutgers, the State University of New
Jersey School of Communication, Information, and
Library Studies Syracuse University School of
Information Studies University of Texas,
Austin School of Information University of
Toronto Faculty of Information Studies University
of Washington Information School
Guiding Principles
  • Clinical IT will significantly benefit healthcare
    quality, efficiency and costs only if done well.
  • Clinical computing and business computing
    (management information systems) are different
    subspecialties of computing.
  • People issues are as critical towards success of
    clinical IT initiatives in the provider sector as
    well as in other healthcare sectors such as

Health-care sector must focus on switch to
electronic records
  • Dr. Glenn Steele Jr., president and CEO of
    Geisinger Health System, Philadelphia Inquirer,
    April 20, 2006 ( http//
    14382256.htm )
  • An anxious son in New Jersey logs on to the
    Internet and stays up-to-date on his elderly
    parents' medical care in Pennsylvania. Doctors
    at a small community hospital perform a heart
    test on a newborn, and pediatric cardiologists at
    a children's hospital 60 miles away monitor the
    test via advanced video-feed capability. Doctors
    click on a computer screen and have immediate
    access to a patient's medical history and test
  • Such are the advantages of information technology
    systems. They make test results available much
    faster, enable caregivers to provide
    computer-generated prescriptions and other
    patient orders, and even remind caregivers to
    check for certain conditions or schedule tests.
    Electronic health records make sense, but fully
    implementing them is a gigantic and formidable
    challenge that requires patience and a
    willingness to do things differently. And we have
    barely begun, though the push for greater use of
    IT is coming to the health-care industry with the
    force of a freight train.
  • Like so many other reforms, IT promises to lower
    costs, increase quality, and transform our bulky
    system into a more efficient, user-friendly
    machine Successfully implementing an electronic
    health record requires substantial resources for
    workflow analysis, software, testing, and
    training - both before and after implementation.
    To capture any cost and time efficiencies,
    health-care organizations must redesign and
    automate complex work processes.
  • Organizations will also need to find, attract,
    train, and retain an IT team with the necessary
    technical and clinical skills. Estimates are that
    it will take an additional four years to train
    10,000 such workers - that's only two per U.S.
    hospital, with none left over for physician

Problems with healthcare IT
  • A number of very expensive healthcare IT project
    difficulties and failures have appeared in the
    literature in recent years in large part due to
    organizational change resistance, internal
    political struggles, lack of expertise in IT
    implementation processes most suitable for
    clinical environments, and other sociotechnical
  • UC Davis clinical IT project is two years behind
    schedule, over budget, and a fifth of the budget
    went to an outside consulting firm
  • Department of Defense EMR. Medical records
    system assailed http//
    06/04/08/100bus_philpott001.cfm . DODs new
    state of the art medical record-keeping system
    has reduced patient access to many military
    outpatient clinics and has lengthened workdays
    for many doctors.
  • Hospital of the University of Pennsylvania. Role
    of computerized physician order entry systems in
    facilitating medication errors. Koppel et al.,
    JAMA 2005293(10)1197-203 http//jama.ama-assn.
  • Children's Hospital of Pittsburgh, Department of
    Critical Care Medicine Unexpected Increased
    Mortality After Implementation of a Commercially
    Sold Computerized Physician Order Entry System
  • Bay Pines, Florida VA hospital CoreFLS failure -
    472 million http//
  • United Kingdom NHS initiative Doctors fear 6bn
    IT project will be a fiasco. The Guardian,
    February 8, 2005. http//
  • Cedars-Sinai Hospital, Los Angeles Doctors pull
    plug on paperless system. American Medical News,
    Feb. 17, 2003
  • Others website Sociotechnical Issues in Health
    IT Common Examples of Health IT Failure
  • Pharma examples CRISP project - In the 1990s,
    pharma struggled to erect a modernized clinical
    data system known as CRISP (Clinical and
    Regulatory Information Strategic Program), a
    project that current and former information
    systems workers came to regard as a 100 million
    fiasco. "This project ran into a lot of
    problems," says one former manager who was
    involved near the beginning of the CRISP project.

Electronic Medical Records
  • An electronic medical record (EMR) is a
    computer-based patient medical record. An EMR
  • access of patient data by clinical staff at any
    given location
  • accurate and complete claims processing by
    insurance companies
  • building automated checks for drug and allergy
  • clinical notes
  • prescriptions
  • scheduling
  • sending to and viewing by labs
  • The term has become expanded to include systems
    which keep track of other relevant medical
    information. The practice management system is
    the medical office functions which support and
    surround the electronic medical record.
  • According to the Medical Records Institute, five
    levels of an Electronic HealthCare Record (EHCR)
    can be distinguished
  • The Automated Medical Record is a paper-based
    record with some computer-generated documents.
  • The Computerized Medical Record (CMR) makes the
    documents of level 1 electronically available.
  • The Electronic Medical Record (EMR) restructures
    and optimizes the documents of the previous
    levels ensuring inter-operability of all
    documentation systems.
  • The Electronic Patient Record (EPR) is a
    patient-centered record with information from
    multiple institutions.
  • The Electronic Health Record (EHR) adds general
    health-related information to the EPR that is not
    necessarily related to a disease.

Clinical decision support systems
  • Four key functions (Perreault Metzger, 1999)
  • Administrative Supporting clinical coding and
    documentation, authorization of procedures, and
  • Managing clinical complexity and details Keeping
    patients on research and chemotherapy protocols
    tracking orders, referrals follow-up, and
    preventive care.
  • Cost control Monitoring medication orders
    avoiding duplicate or unnecessary tests.
  • Decision support Supporting clinical diagnosis
    and treatment plan processes and promoting use
    of best practices, condition-specific guidelines,
    and population-based management.

National EMR Initiatives U.S.
  • Transforming Health Care The Presidents Health
    Information Technology Plan
  • http//
  • President Bush has outlined a plan to ensure that
    most Americans have electronic health records
    within the next 10 years. The President believes
    that better health information technology is
    essential to his vision of a health care system
    that puts the needs and the values of the patient
    first and gives patients information they need to
    make clinical and economic decisions in
    consultation with dedicated health care
  • Office of the National Coordinator for Healthcare
    IT (ONCHIT)- established April 2004
  • http//

National EMR Initiatives U.K.
  • National Programme for IT in the NHS
  • http//
  • The National Programme for IT, delivered by the
    new Department of Health agency NHS Connecting
    for Health, is bringing modern computer systems
    into the NHS to improve patient care and
    services. Over the next ten years, the National
    Programme for IT will connect over 30,000 GPs in
    England to almost 300 hospitals and give patients
    access to their personal health and care
    information, transforming the way the NHS works.
  • Described as the worlds biggest government IT

What is Medical Informatics?
  • Medical Informatics studies the organization of
    medical information, the effective management of
    information using computer technology, and the
    impact of such technology on medical research,
    education, and patient care.
  • Formal, NIH-sponsored field on which NIH has
    provided many millions of dollars in training
    grants for the last two decades.
  • Not as visible as should be to healthcare.
    Nearly invisible to pharma. Why?

NIH training programs in Medical
Informatics http//
1-Harvard-MIT Division of Health Sciences
Technology, 2-Yale University, 3-Columbia
University, 4-University of Pittsburgh, 5-Johns
Hopkins University, 6-Medical University of South
Carolina, 7-Vanderbilt University, 8-Indiana
University - Purdue University at Indianapolis,
9-University of Wisconsin Madison,10-University
of Minnesota Twin Cities, 11-University of
Missouri Columbia, 12-Rice University,
13-University of Utah, 14-University of
California Irvine, 15-University of California
Los Angeles, 16-Stanford University, 17-Oregon
Health Science University,18-University of
Washington (training is provided by other
universities via internal funds as well).
The Informatics Subspecialties
Why is good clinical IT difficult?
  • Lindberg Computer Failures and Successes,
    Southern Medical Bulletin 19695718-21
  • Computer experts per se have virtually no idea of
    the real problems of medical or even hospital
    practice, and furthermore have consistently
    underestimated the complexity of the problemsin
    no cases can building appropriate clinical
    information systems be done, simply because they
    have not been defined with the physician as the
    continuing major contributor and user of the
  • Nemeth Cook Hiding in Plain Sight, Journal
    of Biomedical Informatics 38 2005, 262263
  • Just beneath the apparently smooth-running
    operations of healthcare is a complex, poorly
    bounded, conflicted, highly variable, uncertain,
    and high-tempo work domain. The technical work
    that clinicians perform resolves these complex
    and conflicting elements into a productive work
    domain. Occasional visitors to this setting see
    the smooth surface that clinicians have created
    and remain unaware of the conflicts that lie
    beneath it. The technical work that clinicians
    perform is hiding in plain sight. Those who know
    how to do research in this domain can see through
    the smooth surface and understand its complex and
    challenging reality. Occasional visitors cannot
    fathom this demanding work, much less create IT
    systems to support it.
  • Wears Berg Still Waiting for Godot, JAMA
    Vol. 294 No. 2, July 13, 2005
  • Throwing IT at a health care system to remedy
    high medication error rates will not be effective
    unless the organizational reasons for those
    failures also are addressed. These reasons are
    hidden in the "messy details" of clinical work
    complexity uncertainty conflicting goals gaps
    in supplies, procedures, and coordination
    brittleness of tools and organizational routines.

Why is Medical Informatics important?
  • Clinical IT and its environment are core
  • Recognition that organizations are simultaneously
    social (people, values, norms, cultures) and
    technical (tools, equipment, technology). These
    elements are deeply interdependent and
    interrelated. Good design and implementation is
    not just a technology issue but also one of
    jointly optimizing the combined sociotechnical
  • Medical Informatics training recognizes these
    issues and trains cross-disciplinary specialists
    accordingly. Curriculum example
  • Fundamental of computer science Medical language
    and terminology systems Modeling of medical
    observations and data Medical coding
    systems Medical knowledge structures Information
    organization and flows in medical
    practice Quantitative models for medical decision
    making Clinical decision support Medical image
    processing User interfaces and ergonomics in
    healthcare Health information systems
    architecture Security and confidentiality Ethical
    and legal issues in electronic medical
    records Organizational and sociological issues in
    clinical IT projects Metrics and methods for
    evaluating healthcare information systems Cost
    and investment issues in healthcare IT

Pharma takes note of provider side EMR efforts
  • Nov. 2005 Exploring the Opportunity for
    Collaboration with Drug Device Firms in
    Accelerating IT Adoption by Hospitals
  • http//
  • Speaking Faculty Landen Bain,
    Healthcare Liaison, CDISC Michael Barrett,
    Managing Partner, CRITICAL MASS CONSULTING Brian
    Chadwick, Partner, LOOKLEFTGROUP Sue Dubman,
    Director of Applications for the Center of
    Bioinformatics, NATIONAL CANCER INSTISTUTE Robert
    N. Hotchkiss , MD , Director, Clinical Research,
    Vice President, Life Sciences, SAIC Bill
    Les Jordan, Life Sciences Industry Technology
    Strategist, MICROSOFT Stan Kachnowski, PhD,
    Professor, Health Information Public Policy,
    COLUMBIA UNIVERSITY Becky Kush, PhD, President,
    CDISC Jim Langford, President, DATALABS Gary
    Lubin, Co-Founder, MERCK CAPITAL VENTURES Somesh
    Nigam , PhD, Information Management Director,
    Schindler, DrPH, President, CYTEL RESEARCH Steve
    Schwartz, Senior Vice President, Business
    Development, ALLSCRIPTS Martin Streeter,
    Partner, LOOKLEFTGROUP Barbara Tardiff, MD, MBA,
    Executive Director, Research Information
    Services, Clinical Regulatory Information
    Services, MERCK CO., INC. Cara Willoughby,
    Consultant, Scientific Communications/Regulatory,
  • KEYNOTE PRESENTATION Improving Patient Care
    while Optimizing Efficiency Outlining the
    Potential Benefits from Merging Patient Care and
    Drug Development Efforts Barbara Tardiff, MD, MBA
    Executive Director, Research Information
    Services, Clinical Regulatory Information
    PERSPECTIVE The Challenges and Limitation of
    Merging Electronic Health Information Robert N.
    Hotchkiss, MD Director, Clinical Research
    EFFORTS Interchange Standards The Key to
    Linking Healthcare and Clinical Research
    Information Rebecca Kush, PhD, President, CDISC
    Landen Bain, Healthcare Liaison, CDISC Sue
    Dubman, Director of Applications for the Center
    of Bioinformatics, NCI

Gartner Predicts 2006 Life Science
Manufacturers Adapt to Industry
Transitions http//
  • The swift and severe judgment in favor of the
    plaintiff in the first Merck Vioxx trial sent a
    shock wave through the biopharma industry.  It
    shows that biopharma manufacturers must do more
    to ensure that healthcare providers and the
    public have an accurate, ongoing assessment of
    medication risks.  Biopharmas must also ensure
    that information on these risks is communicated
    promptly in an open, understandable manner. 
    Posting clinical trial information on a web site
    is one step towards greater transparency, but
    does not provide information in a way that
    easily enables ... comparisons of benefits and
  • ... It is still well recognized that all the
    possible side effects of a medication cannot be
    uncovered using only a randomized sample of
    study subjects.  The true test of long-term
    safety and efficacy can only be determined when
    trial data is combined with other sources of
    information such as clinical encounters, adverse
    events (MedWatch) or observational studies
    (National Registry of Myocardial Infarction).
  • In the future, it is hoped that the EMR system
    will capture point-of-care information in a
    standardized format that can be used for drug
    surveillance.  Today, biopharmas must be content
    with these other available, if imperfect,
    information stores.

Gartner Predicts 2006 (cont.)
  • Biopharmas ... should look at risk from multiple
    perspectives ... they must also get actively
    involved in defining the electronic health and
    medical record so that it will contain the type
    of information required to make better safety
    assessments in the future.
  • Biopharmas that ignore the opportunity to use
    analytical tools to proactively review
    contradictory sources of study information (for
    example, pre- and post-approval clinical data
    sets, as well as registries) will miss essential
    signals regarding product safety. Yet today, only
    a small percentage of biopharmas routinely
    utilize personnel with medical informatics
    backgrounds to search for adverse events in
    approved drugs.

Case Study
  • What you didnt want to know about clinical
    information technology in large medical centers
  • Compare issues to your own project difficulties

The often divergent goals of three main groups
within a medical center
From Sittig DF, Sengupta S, al-Daig H, Payne TH,
Pincetl P. The role of the information architect
at King Faisal Specialist Hospital and Research
Centre. Proc Annu Symp Comput Appl Med Care.
The Three Stakeholder Groups in More Detail
Administration (purchasers)
  • CEO
  • COO
  • CFO
  • Gen Counsel
  • CIO
  • IT staff
  • Consultant
  • Clin leaders
  • (SVP, COS,
  • Dept. Chairs)
  • Clinicians
  • Service Mgr.

Information Technology (implementers)
Medicine (users)
The undesired dynamics
  • CEO
  • COO
  • CFO
  • Gen Counsel
  • CIO
  • IT staff
  • Consultant
  • Clin leaders
  • (SVP, COS,
  • Dept. Chairs)
  • Clinicians
  • Service Mgr.

Information Technology
Medical Informatics as Intermediary
  • CEO
  • COO
  • CFO
  • Gen Counsel

  • CIO
  • IT staff
  • Consultant
  • Clin leaders
  • (SVP, COS,
  • Dept. Chairs)
  • Clinicians
  • Service Mgr.

Information Technology
The desirable dynamics
  • CEO
  • COO
  • CFO
  • Gen Counsel

  • CIO
  • IT staff
  • Consultant
  • Clin leaders
  • (SVP, COS,
  • Dept. Chairs)
  • Clinicians
  • Service Mgr.

Information Technology
Medical Informatics role
  • Responsible for helping these three groups
    understand they are all working toward the same
    goal, and ensuring medical center personnel
    collaborate efficiently and productively.
  • Understanding and work with the stakeholder
    drivers (motivators) and dynamics (interactions)
    in detail will help the MI proactively intervene
    and avoid retrospective correction after problems
    have arisen.

Observed Drivers Health System Administration
Observed Drivers Information Technology (MIS)
Observed Drivers Clinicians
Case highlights - Invasive Cardiology
  • 6,000 procedures/year. EDC system sought for new
    device and modality trials and evaluation, PI,
    benchmarking, operations reporting, inventory.
  • In house development/customization ruled out by
    CIO - turnkey policy - despite clinician
  • 2 year analysis, market investigation, K-T,
    business process as for accounting system.

  • Vendor product acquired but sat unused for almost
    a year before operationalization was considered -
    skepticism by CIO, COO, clinicians
  • Only .75 FTE's assigned. MIS person chosen had no
    experience working in tough, high-volume,
    critical care areas. Scared.

Beginnings of conflict
  • A Steering Committee was initiated, led by
    cardiac services executive relatively unfamiliar
    with IT
  • CIO, IT staff adamant that vendor product should
    not be modified even though clinicians wanted the
    data and workflow components of the package to be
    adjusted to their busy clinical environment and
    customs (rather than the other way around).
  • MIS department began to blame the physicians for
    being "non-cooperative" with them, stubborn,
    unable to finalize decisions about the package,
    and responsible for lack of project progress.

Conflicts increase
  • Cardiac services administrator blamed for "not
    controlling the doctors. Pushed for install.
  • Unstable platform, kept crashing, losing data.
  • Attempted install in the cath lab went so poorly,
    and was so misaligned with needs, expectations,
    work flow, and the tremendous patient
    responsibilities, that the demoralized and
    frustrated cath lab staff demanded in a hostile
    tone that the MIS people "get out of our cath
  • Loud complaints to Chairs, Sr. VP Med Affairs,
  • Large political battle in high revenue area (25)

Medical Informatics as intermediary
  • Consultant called in unable to resolve problems
    (fear of being tough).
  • COO / CFO skeptical of benefits of project
    altogether, wanted to kill project, 500K already
    spent, relations disrupted
  • Medical Informaticist hired by CEO/Sr. VP to
    mediate / resolve issues
  • MI investigates finds many changes needed,
    creates 10-point plan and phased timeline
    oriented to clinical realities

Remediation begins
  • Move to stable platform suitable for cath lab
    environment resisted by CIO IT staff due to
    resources involved, but pushed through by
    informaticist through persuasion of key
    stakeholders, especially CEO, COO, Sr. VP
  • Informaticist created collaborative and
    participatory work team environment, a
    non-traditional methodology in MIS but crucial
    for clinical computing settings (Participatory
    Design of Information Systems in Healthcare,
    Sjoberg C, Timpka T Journal of the Amer. Medical
    Informatics Assoc. 19982177-183).
  • New IT can-dos hired, increased independence
    from central IT control, again through persuasion

Remediation continues
  • Cardiologists given major input to steering
    committee and workgroups and report development
  • MI identified criticality of data remodeling for
    the cardiologist's needs - and led the effort (IT
    personnel or clinicians alone could not do)
    core competency of MI.
  • New data model crafted collaboratively,
    consistent w/lab practices and national standards
    but far surpassing the latter to meet day-to-day
    needs. ACC dataset problems identified.
  • Dictation allowed to supplement case report
    generation so clinicians not boxed-in

Rapid improvement
  • Clinicians, service administrator, COO
    representative allowed to define statistical
    reports and definitions/terminology.
  • Meet desire for research data, performance
    improvement, operations improvement while
    allaying fears of inaccurate report cards.
  • Agile methodologies (e.g., iterative and
    incremental development) approach was SOP. Not
    as possible in pharma due to validation and other
    regulatory requirements, but some degree of
    avoidance of process zealotry and
    methodological fanaticism possible and
  • System in use within 6 months by 75 of staff,
    enthusiastic committee meetings

  • System allowed improved scheduling, lab
    operations and staffing planning, outcomes
    assessment, participation in national
    initiatives- American College of Cardiology
    (ACC), Society for Thoracic Surgery (STS), and
    Genentech National Registry of Myocardial
    Infarction (NRMI).
  • Received recognition for excellence by national
    cardiology figures, and JCAHO. Source of
    conflict became source of pride.
  • Trust built with clinicians allowed inventory
    module to be rapidly implemented (months)
  • 1 million savings realized the following year.

  • Clinical IT projects are complex social endeavors
    in unforgiving clinical settings that happen to
    involve computers, as opposed to information
    technology projects that happen to involve
  • An understanding of the internal personnel
    dynamics by the medical informaticist is an
    important asset towards facilitating success.
  • This understanding and experience should be is
    portable to pharma and can be of great value in
    eClinical initiatives and in collaborations with
    the provider side.

Additional Reading
  • Organizational Aspects of Health Informatics
    Managing Technological Change. Nancy M. Lorenzi,
    Robert T. Riley (Springer-Verlag, 1995).
  • Advance for Health Information Executives
    Medical Informatics, Friend or Foe, Robert
    Gianguzzi, May 1, 2002, p. 37-38

Dean Sittig, Director of the national Clinical
Informatics Research Network (CIRN) for Kaiser
Permanente "There are many different
constituencies, and hence views, which must be
considered when attempting to develop an
integrated clinical information management system
in any large medical center ... we believe that
without a full-time, on-site medical
informaticist, the difficulty of the task
increases to the point of becoming nearly