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Medical Informatics Perspectives on Leveraging the Electronic Medical Record in Pharma


(Former Director of Published Information Resources & The Merck Index, MRL) Goals Promote better understanding of Medical Informatics as a formal, ... – PowerPoint PPT presentation

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Title: Medical Informatics Perspectives on Leveraging the Electronic Medical Record in Pharma

Medical Informatics Perspectives on Leveraging
the Electronic Medical Record in Pharma
  • November 8, 2006
  • Scot M. Silverstein, MD
  • Assistant Professor of Healthcare Informatics and
  • Director, Institute for Healthcare Informatics
  • Drexel University, College of Information Science
  • (Former Director of Published Information
    Resources The Merck Index, MRL)

  • 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 EMR initiatives on
    the provider side, and how these may be
    increasingly important to pharma in eClinical
    trials, post-marketing surveillance and other
  • Raise awareness of difficulties in implementing
    large-scale EMR, and how Medical Informatics
    professionals can help (interestingly, analogous
    sociotechnical issues are found in pharma).

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, BerkeleySchool of
    Information Management and Systems
  • University of California, IrvineThe Don Bren
    School of Information and Computer Sciences
  • University of California, Los AngelesGraduate
    School of Education and Information Studies
  • Drexel UniversityCollege of Information Science
    and Technology
  • Florida State UniversityCollege of Information
  • Georgia Institute of TechnologyCollege of
  • University of Illinois Urbana-ChampaignThe
    Graduate School of Library and Information
  • Indiana UniversitySchool of Informatics
  • Indiana UniversitySchool of Library and
    Information Science
  • University of MarylandCollege of Information

University of MichiganThe School of
Information University of North CarolinaSchool
of Information and Library Science The
Pennsylvania State UniversitySchool of
Information Sciences and Technology University
of PittsburghSchool of Information
Sciences Rutgers, the State University of New
JerseySchool of Communication, Information, and
Library Studies Syracuse UniversitySchool of
Information Studies University of Texas,
AustinSchool of Information University of
TorontoFaculty of Information Studies University
of WashingtonInformation School
Guiding Principles of Medical Informatics
  • Clinical IT will significantly benefit healthcare
    quality, efficiency and costs only if done well.
  • People issues are as critical towards success of
    clinical IT initiatives in the provider sector as
    well as in pharma.

The challenge
  • Deliver effective drug post-marketing
    surveillance in an increasingly aggressive

U.S. Government Accountability Office (GAO)
  • In a 2006 U.S. Government Accountability Office
    (GAO) report to Congress on drug safety requested
    after congressional hearings, a GAO investigation
    found that
  • FDA lacks clear and effective processes for
    making decisions about, and providing management
    oversight of, postmarket safety issues. The
    process has been limited by a lack of clarity
    about how decisions are made and about
    organizational roles, insufficient oversight by
    management, and data constraints There are
    weaknesses in the different types of data
    available to FDA, and FDA lacks authority to
    require certain studies and has resource
    limitations for obtaining data. Some of FDA's
    initiatives, such as the establishment of a Drug
    Safety Oversight Board, a draft policy on major
    postmarket decision making, and the
    identification of new data sources, may improve
    the postmarket safety decision-making process,
    but will not address all gaps FDA is taking
    steps to identify additional data sources, but
    data constraints remain 1.
  • 1 Drug Safety Improvement Needed in FDAs
    Postmarket Decision-making and Oversight
    Process, United States Government Accountability
    Office, Washington, D.C., March 2006,
    http// , p. 5.

Gartner Predicts 2006 document Life Science
Manufacturers Adapt to Industry
  • 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.

Institute of Medicine weighs in
  • The Committee on the Assessment of the US Drug
    Safety System of the Institute of Medicine has
    written that
  • the committee believes there is an abundance of
    extraordinary research opportunities that could
    substantially enhance the FDAs regulatory
    processes with respect to both the efficacy and
    safety of new therapeutics. Many of the
    opportunities involve the creation of new
    algorithms and methods to improve the processes
    of preclinical and clinical drug development and
    new processes to enable effective safety and
    efficacy monitoring and evaluation over the
    entire lifecycle of a therapeutic 1.
  • 1 The Future of Drug Safety Promoting and
    Protecting the Health of the Public, Committee
    on the Assessment of the US Drug Safety System,
    Alina Baciu, Kathleen Stratton, Sheila P. Burke,
    Editors, Board on Population Health and Public
    Health Practice (BPH), Institute of Medicine
    (IOM), 2006, Recommendation 4.6, p. 104-105,

Institute of Medicine weighs in (cont.)
  • In its new 2007 report Preventing Medication
    Errors Quality Chasm Series, the Committee on
    Identifying and Preventing Medication Errors of
    the Institute of Medicine has written that
  • Informatics experts should track progress on the
    national health-information infrastructure, look
    for opportunities to gather information about
    drug safety and efficacy after approval,
    coordinate partnerships with external groups to
    study the use of electronic health records for
    drug adverse event surveillance, participate in
    FDAs already strong role in setting national
    standards and track the development of tools for
    data analysis in industry and academe, and
    encourage the incorporation of the tools into FDA
    practice where appropriate 1.
  • 1 The Future of Drug Safety Promoting and
    Protecting the Health of the Public, Committee
    on the Assessment of the US Drug Safety System,
    Alina Baciu, Kathleen Stratton, Sheila P. Burke,
    Editors, Board on Population Health and Public
    Health Practice (BPH), Institute of Medicine
    (IOM), 2006, Recommendation 4.6, p. 102,

What is Medical Informatics?
  • Medical Informatics studies the organization of
    medical information from fine-grained levels
    (e.g., biomedical data modeling) to macro levels
    (e.g., MedDRA, UMLS), the effective use,
    management and dissemination of information using
    computer technology (e.g., EMR, CDSS, CPOE), 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.
  • Has been nearly invisible to pharma for numerous
    reasons, largely due to misunderstanding of the
    field. Unfortunate.
  • e.g., My analysis in PIR ca. 2000 identified
    significant cheminformatics and biomedical
    informatics gaps, and through innovative use of
    technology and compelling arguments we increased
    funding and availability of targeted scientific
    information to MRL RD at least tenfold by late
    2003 over averages kept since 1989. eJournals
    /Alertlink/ SciFinder / CrossFire etc.

The Informatics Subspecialties
NIH training programs in Medical
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).
Medical Informatics What it is not
  • The increasingly common use of awkward
    expressions like "informatics technology" to
    refer to clinical information systems is an
    example of semantic blur. Medical informatics is
    a formal field of study and a scientific
    discipline. Computers in medicine is not the
    equivalent of medical informatics.
  • Yet, position descriptions such as in these
    employments ads, with requirements for neither
    clinical nor medical informatics training or
    experience, are often seen. From the Philadelphia
  • Medical informatics analyst. Company name seeks
    a Medical Informatics Analyst to support resource
    management and medical affairs in their data
    analysis needs. Through downloading of MCS
    database, PC-based analysis of clinical and
    clinically-relevant financial data will be
    performed. Qualifications BA/BS in computer
    science or related discipline, 3-5 years
    experience in PC-based data analysis of health
    care information, knowledge of SAS or similar
    analysis software, knowledge of mainframe DB2
    database architectures, working knowledge of
    CPT-4 and ICD-9-CM coding."
  • From an Internet biomedical employment service, Company name seeks a Director of
    Clinical Informatics. Overall coordination of
    design specifications, implementation and support
    for all internet/browser based systems. Assurance
    of continued, reliable and consistent resources
    and applications to all corporate personnel and
    external users who may rely upon these systems.
    Documentation and control of said software
    systems including package systems and license
    control if necessary. Provide ongoing maintenance
    oversight and management support for said
    systems. Organize and train personnel, both
    internal and external, who will be using said
    products. Client contact and development and
    assist Sales and Marketing as necessary in client
    presentations. Minimum of a BA. MBA preferred.

Medical Informatics what it is not
  • Blur in usage of the term "medical informatics"
    is highly ironic. One major area of study in
    medical informatics research is language (e.g.,
    controlled terminologies, computation
    linguistics) and data modeling.
  • In applied efforts in that area, exhaustive
    attention to lexical and semantic issues and
    intense thinking about precision and imprecision
    in language have led to excellent tools such as
    the National Library of Medicine's Unified
    Medical Language System. Now, it seems the
    medical informatics field is often finding its
    own name used in an imprecise way.
  • Imagine impact of similar difficulty with, say,
    Medicinal Chemistry

Why is Medical Informatics Important to EMR and
other healthcare IT initiatives?
  • 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
  • Cedars-Sinai Hospital in Los Angeles Doctors
    pull plug on paperless system. American Medical
    News, Feb. 17, 2003
  • 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
  • VA hospital CoreFLS failure - 472 million
  • United Kingdom NHS initiative Doctors fear 6bn
    IT project will be a fiasco. The Guardian,
    February 8, 2005. http//
  • 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
    loss. "This project ran into a lot of problems,"
    says one former manager who was involved near the
    beginning of the CRISP project.

Why is Medical Informatics important? (cont.)
  • Healthcare 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 scienceMedical language
    and terminology systemsModeling of medical
    observations and dataMedical coding
    systemsMedical knowledge structuresInformation
    organization and flows in medical
    practiceQuantitative models for medical decision
    makingClinical decision supportMedical image
    processingUser interfaces and ergonomics in
    healthcareHealth information systems
    architectureSecurity and confidentialityEthical
    and legal issues in electronic medical
    recordsOrganizational and sociological issues in
    clinical IT projectsMetrics and methods for
    evaluating healthcare information systemsCost
    and investment issues in healthcare IT

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 (described
    as the worlds biggest government IT project)
  • 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
    the U.K. to almost 300 hospitals and give
    patients access to their personal health and care
    information, transforming the way the NHS works.
  • The infrastructure will include new components
    integrated into existing national reporting
  • A centralized national database, called the NHS
    Care Record, to include all patient electronic
    health records. This data will likely be useful
    for epidemiological studies and drug surveillance
    on a national scale (!)
  • A Patient Demographics Services operation that
    will act as an enterprise master patient index
    (EMPI) for the entire country, based on the
    patient's NHS number, a national patient
    identifier, and demographic and patient encounter

Pharma takes notice Integrating Patient
Information with Drug Development
  • Nov. 2005 Merging Electronic Health Records
    Electronic Data Capture Integrating Patient
    Information with Drug Development
  • http//
  • Exploring the Opportunity for Collaboration with
    Drug Device Firms in Accelerating IT Adoption
    by Hospitals Physicians The governments
    10-year plan to automate healthcare information
    exchange by creating the National Healthcare
    Information Network presents an undeniable
    opportunity to synchronize patient information
    with drug development and increase the overall
    quality of patient care.
  • Drug device companies have been struggling for
    years to successfully and efficiently move away
    from paper data collection towards electronic
    data capture and automated trials. Without a
    unifying body behind this push, data standards,
    interoperability and infrastructure compatibility
    have not been achieved. By piggy-backing on this
    government-lead initiative to automate
    healthcare, drug and device firms can reap the
    benefits of the increased efficiency IT adoption
    at the hospital and physician level will offer
    and utilize this data for more streamlined drug
    development and other uses ed.
  • ExL Pharmas Merging EHR EDC Conference is the
    first opportunity for drug device firms to
    gather with hospitals, physicians and vendors to
    discuss strategies for accelerating IT adoption
    and achieving cross-functional data
    interoperability to streamline processes, improve
    communication and maximize patient care.
  • KEYNOTE PRESENTATION Improving Patient Care
    while Optimizing Efficiency Outlining the
    Potential Benefits from Merging Patient Care and
    Drug Development EffortsBarbara 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

Upcoming DIA-sponsored conference
  • The Quest to Enable the Electronic Clinical
    Trial Finding Clarity in a Confusing World
    (Dec. 2006, http//
    6029.pdf )
  • Learning objectives
  • Discuss medical informatics opportunities to
    improve the benefit-risk assessment of drugs
  • Explain standard controlled terminology and its
    current and future use
  • Summarize how changes in the drug development
    industry impact people and processes
  • Discuss how clinical research can help drive the
    adoption of healthcare IT standards
  • Describe how increasing data transparency can
    benefit the public interest

EMR for post-market surveillance possible?
  • Use of EMR for drug surveillance has begun to be
    studied. There have been exploratory studies on
    this topic and related areas
  • Murff et. al. reviewed current methodologies for
    detection of clinical adverse events including
    electronic methods that can detect events using
    coded data, free-text clinical narratives, or a
    combination of techniques 1
  • Gandhi et. al conducted a similar review
    specifically aligned to drug safety issues and
    believe computerized monitoring for adverse drug
    events using rules or triggers is a high yield
    and relatively inexpensive strategy that should
    be adopted by healthcare organizations 2.
  • Nebeker et. al. described prospective daily
    reviews of EMR data performed by pharmacists as
    an effective way to detect adverse drug events
  • Honigman et. al. reported on an automated,
    computer-based retrospective analysis for adverse
    drug events of one year of data from an EMR,
    including records on over 23,000 patients. The
    conclusion was that computerized search programs
    can detect adverse drug events in such data and
    that such detefction programs demonstrate value
    added for the EMR 4.
  • Efforts in using EMRs for drug post-marketing
    surveillance can also serve as a test bed for
    identifying and resolving issues in broader uses
    of national EMR of even greater significance,
    such as syndromic surveillance for early epidemic
    detection or detection of chemical terrorism or
    bioterrorism. Syndromic surveillance refers to
    using health-related data that precede diagnosis
    and signal a sufficient probability of a case or
    an outbreak to warrant further public health
    response. Hegmann et. al. described a system to
    detect possible bioterrorist attacks during the
    2002 Olympic Games using an EMR-based
    bioterrorism surveillance system. The system
    implemented 50 different analyses that examine a
    range of symptoms to detect and track infectious
    diseases 5.
  • 1 Detecting adverse events for patient safety
    research a review of current methodologies,
    Murff HJ, Patel VL, Hripcsak G, Bates DW, Journal
    of Biomedical Informatics, 36(1-2)131-143,
    Feb-Apr 2003.
  • 2 Identifying drug safety issues from
    research to practice, Gandhi TK, Seger DL, Bates
    DW, International Journal for Quality in Health
    Care, 12(1)69-76, Feb. 2000.
  • 3 High rates of adverse drug events in a
    highly computerized hospital, Nebeker JR,
    Hoffman JM, Weir CR, Bennett CL, Hurdle JF,
    Archives of Internal Medicine 165 (10)
    1111-1116, May 23 2005.
  • 4 Using computerized data to identify adverse
    drug events in outpatients. J Am Med Inform
    Assoc. 2001 May-Jun8(3)254-66.
  • 5 Computer model developed at U. Utah monitors
    bioterrorism, Daily Utah Chronicle (U. Utah),
    Feb. 4, 2002

EMR for postmarket surveillance (cont.)
  • Utilizing large quantities of EMR data,
    innovative statistical models and methods for
    analysis of extremely large datasets (large
    number of observations or large number of
    dimensions), an active area of research, will be
    necessary to supplement and replace more
    simplistic methodologies (e.g., adverse event
    frequency comparisons) for leveraging EMR data.
    Research in computational statistics, for
    example, involves the development of
    visualization and computationally intensive
    methods for mining large, non-homogeneous,
    multi-dimensional datasets so as to discover
    knowledge in the data 1.
  • Research has been done specifically in the
    application of data mining techniques in drug
    surveillance. The authors of one study describe
    knowledge discovery in databases (KDD), a
    technique to detect potential adverse drug events
    involving the selection of data variables and
    databases, data preprocessing, data mining and
    data interpretation and utilization. They
    describe data mining as encompassing a number of
    statistical techniques including cluster
    analysis, link analysis, deviation detection and
    disproportionality assessment which can be
    utilized to determine the presence of and to
    assess the strength of adverse drug event
    signals. The authors concluded that in view of
    the importance of adverse drug events and the
    development of massive data storage systems and
    powerful computer systems, the use of data mining
    techniques in knowledge discovery in medical
    databases is likely to be of increasing
    importance in the process of drug surveillance as
    they are likely to be able to detect signals
    earlier than more common methods currently in use
  • 1 Computational Statistics in the Data
    Sciences, George Mason University,
  • 2 Application of data mining techniques in
    pharmacovigilance. Wilson AM, Thabane L,
    Holbrook A., Br J Clin Pharmacol. 2004

False assumption and underestimations
implementing EMR not as easy as it seems
  • Medical informaticists study the issues that
    impede EMR adoption in clinical settings.
  • What you didnt want to know about clinical
    information technology in large medical centers
    (compare issues to your own project difficulties
    in pharma or CRO settings)
  • See Sociotechnologic issues in clinical
    computing Common examples of healthcare IT
    failure at http//

Access Patterns to a Website on Healthcare IT
Failure Scot M. Silverstein MD, Yunan Chen,
Christine Wania College of Information Science
Technology, Drexel University
Visitor types
Organizational and human factors (sociotechnical)
issues associated with healthcare IT have led to
project difficulties and failures. Detailed case
accounts might improve knowledge sharing between
healthcare organizations on lessons learned and
best implementation practices. Based on an
online search for web-based resources, there
appears to be few relevant sites containing
either high-level or case-level information
regarding healthcare IT difficulty and failure.
Case-level accounts describing issues at a fine
level of granularity, such as detailed accounts
of interactions among clinicians, IT personnel
and healthcare executives, are potentially useful
learning resources. Knowledge sharing via the
Web on best practices for management of
sociotechnical impediments to healthcare IT is
thus suboptimal.
Note The terms in this diagram represent our
categorization of the concepts used by Web
searchers to find our website. For example
healthcare IT might have been expressed as
medical computing or clinical information
Visitor Countries distribution
Case Study Results
Research Questions
We studied access patterns to our website on
healthcare IT difficulties. The distribution of
countries, website visitor types and query types
are shown in the following charts
  • To illustrate the level of interest and knowledge
    sharing about Healthcare IT difficulties, we
    explored two research questions
  • What case-level information about healthcare IT
    project difficulty and failure is available via
    the Web?
  • Who is seeking this information?

Visitor Input Types
We used our website, entitled Sociotechnologic
Issues in Clinical Computing Common Examples of
Healthcare IT Failure, online since 1999, as a
representative information resource. We first
conducted a detailed Web search on various search
phrases representing the concept healthcare IT
failure using three major search engines
(Google, Yahoo, and MSN). The results showed
that our website was nearly unique. We then
tracked views of our website from Sep 27th, 2005
to June 30th, 2006 with a free public tracking
service, eXTReMe Tracking (http//extremetracking.
com). We examined the access logs to determine
viewer IP and referrer (primarily search engine
query, or link from another site) to identify
viewer demographics including country and
organization type, where available. No
personally-identifiable information was sought or
It appears there is an ongoing interest in
information about healthcare IT difficulty among
searchers of varied demographics, as evidenced by
searches on these issues and resultant hits on
our website, one of the few websites that
specifically addresses these issues. At present
such material is uncommon. We believe Medical
Informatics specialists can contribute
significantly to filling this information gap,
and that doing so would be very helpful to the
healthcare IT community.
Visitor Search Engine Referrer Input
Our website Sociotechnologic Issues in Clinical
Computing Common Examples of Healthcare IT
Failure is at URL http//
/faculty/ssilverstein/medinfo.htm It was created
by our first author via an informal collaboration
of AMIA clinical information systems working
group members (CIS-WG) during 1998-2001.
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.

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)
Observed Drivers Health System Administration
Observed Drivers Information Technology (MIS)
Observed Drivers Clinicians
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.

Take-away points
  • The emerging national EMRs will provide a useful
    resource for postmarketing drug surveillance
    activities and research.
  • Clinical IT projects are complex social endeavors
    that happen to involve computers, as opposed to
    information technology projects that happen to
    involve doctors.
  • An understanding of the internal dynamics by the
    medical informaticist is an important asset
    towards facilitating success of EMR initiatives
    and optimal leveraging of its capabilities for
    healthcare providers and for pharma.
  • This understanding and experience relative to
    clinical IT is portable to pharma and can be of
    great value in other eClinical initiatives and in
    collaborations with the provider side.

Additional Reading
  • Managing Technological Change Organizational
    Aspects of Health Informatics. Nancy M. Lorenzi,
    Robert T. Riley (Springer-Verlag, 2nd edition,
    2004, http//
  • Advance for Health Information Executives
    Medical Informatics, Friend or Foe, R.
    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
SAYGR Registry Yale-Saudi Arabia Collaboration in
Clinical Genetics Birth Defects Dec. 1995
Informatics can take us to esoteric places Red
Sand Dunes area, 50 km w. of Riyadh