Medical Informatics Perspectives on Leveraging the Electronic Medical Record in Pharma

1
Medical Informatics Perspectives on Leveraging
the Electronic Medical Record in Pharma

• November 8, 2006
• Scot M. Silverstein, MD
• Assistant Professor of Healthcare Informatics and
  IT
• Director, Institute for Healthcare Informatics
• Drexel University, College of Information Science
  Technology
• (Former Director of Published Information
  Resources The Merck Index, MRL)

2
Goals

• 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
  needs.
• Raise awareness of difficulties in implementing
  large-scale EMR, and how Medical Informatics
  professionals can help (interestingly, analogous
  sociotechnical issues are found in pharma).

3
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
  Computing
• University of Illinois Urbana-ChampaignThe
  Graduate School of Library and Information
  Science
• Indiana UniversitySchool of Informatics
• Indiana UniversitySchool of Library and
  Information Science
• University of MarylandCollege of Information
  Studies

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
4
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.

5
The challenge

• Deliver effective drug post-marketing
  surveillance in an increasingly aggressive
  marketplace.

6
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//www.gao.gov/new.items/d06402.pdf , p. 5.

7
Gartner Predicts 2006 document Life Science
Manufacturers Adapt to Industry
Transitionshttp//www.gartner.com/DisplayDocumen
t?doc_cd134309

• 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
  risks.
• ... 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.

8
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.

9
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,
  http//fermat.nap.edu/books/0309103045/html/104.ht
  ml

10
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,
  http//fermat.nap.edu/books/0309103045/html/102.ht
  ml

11
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.

12
The Informatics Subspecialties
13
NIH training programs in Medical
Informaticshttp//www.nlm.nih.gov/ep/GrantTrainIn
stitute.html
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).
14
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
  Inquirer
• 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,
  Medzilla.com 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.

15
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

16
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
  issues.
• 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
  http//www.usmedicine.com/article.cfm?articleID9
  32issueID66
• United Kingdom NHS initiative Doctors fear 6bn
  IT project will be a fiasco. The Guardian,
  February 8, 2005. http//society.guardian.co.uk/i
  nternet/story/0,8150,1407903,00.html
• 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.
  http//www.baselinemag.com/article2/0,1397,160858
  2,00.asp

17
Why is Medical Informatics important? (cont.)

• Healthcare IT and its environment are core
  competence
• 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
  systems.
• 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

18
National EMR Initiatives U.S.

• Transforming Health Care The Presidents Health
  Information Technology Plan
• http//www.whitehouse.gov/infocus/technology/econo
  mic_policy200404/chap3.html
• 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
  professionals.
• Office of the National Coordinator for Healthcare
  IT (ONCHIT)- established April 2004
• http//www.hhs.gov/healthit/

19
National EMR Initiatives U.K.

• National Programme for IT in the NHS (described
  as the worlds biggest government IT project)
• http//www.connectingforhealth.nhs.uk/
• 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
  databases
• 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
  information.

20
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//exlpharma.com/events/ev_brochure.php?ev_id
  17
• 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
  Services MERCK CO., INC. HOSPITAL
  PERSPECTIVE The Challenges and Limitation of
  Merging Electronic Health Information Robert N.
  Hotchkiss, MD Director, Clinical Research
  HOSPITAL FOR SPECIAL SURGERY STANDARDIZATION
  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

21
Upcoming DIA-sponsored conference

• The Quest to Enable the Electronic Clinical
  Trial Finding Clarity in a Confusing World
  (Dec. 2006, http//www.diahome.org/product/11116/0
  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

22
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
  3.
• 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

23
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
  2.
• 1 Computational Statistics in the Data
  Sciences, George Mason University,
  http//www.scs.gmu.edu/jgentle/compstat/index.htm
  l
• 2 Application of data mining techniques in
  pharmacovigilance. Wilson AM, Thabane L,
  Holbrook A., Br J Clin Pharmacol. 2004
  Feb57(2)119-20.

24
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//www.ischool.drexel.edu/faculty/
  ssilverstein/medinfo.htm

25
Access Patterns to a Website on Healthcare IT
Failure Scot M. Silverstein MD, Yunan Chen,
Christine Wania College of Information Science
Technology, Drexel University
Background
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
technology.
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
Methods
Conclusion
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
obtained.
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//www.ischool.drexel.edu
/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.
26
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
  information.
• 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.

27
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.
1995756-60
28
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)
29
Observed Drivers Health System Administration
30
Observed Drivers Information Technology (MIS)
31
Observed Drivers Clinicians
32
The undesired dynamics
Administration

• CEO
• COO
• CFO
• Gen Counsel

• CIO
• IT staff
• Consultant

• Clin leaders
• (SVP, COS,
• Dept. Chairs)
• Clinicians
• Service Mgr.

Information Technology
Medicine
33
Medical Informatics as Intermediary
Administration

• CEO
• COO
• CFO
• Gen Counsel

MI

• CIO
• IT staff
• Consultant

• Clin leaders
• (SVP, COS,
• Dept. Chairs)
• Clinicians
• Service Mgr.

Medicine
Information Technology
34
The desirable dynamics
Administration

• CEO
• COO
• CFO
• Gen Counsel

MI

• CIO
• IT staff
• Consultant

• Clin leaders
• (SVP, COS,
• Dept. Chairs)
• Clinicians
• Service Mgr.

Medicine
Information Technology
35
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.

36
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.

37
Additional Reading

• Managing Technological Change Organizational
  Aspects of Health Informatics. Nancy M. Lorenzi,
  Robert T. Riley (Springer-Verlag, 2nd edition,
  2004, http//www.amazon.com/Managing-Technological
  -Change-Organizational-Informatics/dp/0387985484
  ).
• Advance for Health Information Executives
  Medical Informatics, Friend or Foe, R.
  Gianguzzi, May 1, 2002, p. 37-38

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
impossible."
39
Questions?
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