Medical Informatics Perspectives
on Electronic Medical Records
Scot M. Silverstein, MD
Assistant Professor of Healthcare Informatics and IT
Director, Institute for Healthcare Informatics
Drexel University, College of Information Science & Technology
April 20, 2006
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 electronic medical records
(EMR) initiatives on the provider side, and how these are
important to healthcare providers as well as other sectors
(e.g., pharma).
• Provide insights into how Medical Informatics experience
in solving provider sector EMR issues is valuable towards
parallel issues in pharma and other R&D 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
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
•
Drexel University
College of Information Science and Technology
•
Florida State University
College of Information
•
Georgia Institute of Technology
College of Computing
Rutgers, the State University of New Jersey
School of Communication, Information, and Library Studies
•
University of Illinois Urbana-Champaign
The Graduate School of Library and Information Science
Syracuse University
School of Information Studies
•
Indiana University
School of Informatics
University of Texas, Austin
School of Information
•
Indiana University
School of Library and Information Science
•
University of Maryland
College of Information Studies
University of Pittsburgh
School of Information Sciences
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 pharmaceuticals.
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://www.philly.com/mld/philly/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 results.
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, healthcare 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 practices.
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 issues.
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UC Davis: clinical IT project is two years behind schedule, over budget, and a fifth of the budget went to an outside consulting
firm [ http://sacramento.bizjournals.com/sacramento/stories/2006/03/06/story3.html?page=1 ]
Department of Defense EMR. Medical records system assailed [http://www.heraldnet.com/stories/06/04/08/100bus_philpott001.cfm ].
DOD’s 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 2005;293(10):1197-203 [ http://jama.ama-assn.org/cgi/content/abstract/293/10/1197 ]
Children's Hospital of Pittsburgh, Department of Critical Care Medicine: Unexpected Increased Mortality After
Implementation of a Commercially Sold Computerized Physician Order Entry System
[http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506 ]
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Bay Pines, Florida VA hospital CoreFLS failure - $472 million [http://www.usmedicine.com/article.cfm?articleID=932&issueID=66]
United Kingdom NHS initiative [Doctors fear £6bn IT project will be a fiasco. The Guardian, February 8, 2005.
[http://society.guardian.co.uk/internet/story/0,8150,1407903,00.html]
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. [http://www.baselinemag.com/article2/0,1397,1608582,00.asp]
Electronic Medical Records
An electronic medical record (EMR) is a computer-based patient medical record. An EMR facilitates

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 interactions

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 referrals.
• 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 President’s Health Information
Technology Plan
–
http://www.whitehouse.gov/infocus/technology/economic_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/
National EMR Initiatives: U.K.
• National Programme for IT in the NHS
– 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 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 world’s biggest government IT project”
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://www.nlm.nih.gov/ep/GrantTrainInstitute.html
1-Harvard-MIT Division of Health Sciences & Technology, 2-Yale University, 3-Columbia University, 4-University of Pittsburgh, 5Johns 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 1969;57:18-21
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•
Nemeth & Cook: “Hiding in Plain Sight”, Journal of Biomedical Informatics 38 [2005], 262–263
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•
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 problems…in 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.
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 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 crossdisciplinary 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 & Physicians
http://exlpharma.com/events/ev_brochure.php?ev_id=17
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, HOSPITAL FOR SPECIAL SURGERY
Charles Jaffe, MD, Vice President, Life Sciences, SAIC
Bill Johnson, President, WILLIAM S. JOHNSON CONSULTING
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, Pharma R&D IM, JOHNSON & JOHNSON PRD
Jerry 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, ELI LILLY AND COMPANY
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 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
Gartner Predicts 2006:
Life Science Manufacturers Adapt to Industry Transitions
http://www.gartner.com/DisplayDocument?doc_cd=134309
•
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.
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 didn’t 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. 1995;:756-60
The Three Stakeholder Groups in More Detail
Administration (purchasers)
• CEO
• COO
• CFO
• Gen Counsel
• CIO
• IT staff
• Consultant
Information Technology (implementers)
• Clin leaders
(SVP, COS,
Dept. Chairs)
• Clinicians
• Service Mgr.
Medicine (users)
The undesired dynamics
Administration
• CEO
• COO
• CFO
• Gen Counsel
• CIO
• IT staff
• Consultant
Information Technology
• Clin leaders
(SVP, COS,
Dept. Chairs)
• Clinicians
• Service Mgr.
Medicine
Medical Informatics as Intermediary
Administration
• CEO
• COO
• CFO
• Gen Counsel
MI
• CIO
• IT staff
• Consultant
Information Technology
• Clin leaders
(SVP, COS,
Dept. Chairs)
• Clinicians
• Service Mgr.
Medicine
The desirable dynamics
Administration
• CEO
• COO
• CFO
• Gen Counsel
MI
• CIO
• IT staff
• Consultant
Information Technology
• Clin leaders
(SVP, COS,
Dept. Chairs)
• Clinicians
• Service Mgr.
Medicine
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
Chief Executive Officer (CEO)
Chief Financial Officer (CFO)
Chief Operating Officer (COO)
General Counsel
Institutional reputation
Board issues
Internal relationships
Financial issues
Up-front costs (capital & expense)
Secondary dollars (longer-term clinical
revenue/technologic expense)
“Return on investment”
Skepticism
Operational changes (in processes)
Managerial control
Staffing
Costs
Liability / litigation on:
Clinical issues
Information security
Observed Drivers: Information Technology (MIS)
Chief Information Officer (CIO)
IT Staff
Consultants
Budget - effects on other projects,
especially MIS (management information
systems)
“Plug and Play” - ease of implementation,
human resource s
IT control - territoriality
IT reputation - insecurity in new clinical
domain
Fear - clinical environments are alien to MIS
Hands-on technology issue s
Job stability
Revenue
Client satisfaction
Future engagements
Observed Drivers: Clinicians
Clinical Leadership (Chief of Staff, VP for
Medical Affairs, Department Chairs, Nursing
VP)
Clinicians (primary users)
Service Line Administrator
Change to clinician workflow
Complaints
Care issue s
Usefulne ss of system (dataset issue s,
adaptability - opposite of plug and play)
Work changes / time issue s
Effects on care quality
Liability
“Grading” & physician practice reporting
Income
Effects on busine ss development
Institutional reputation
Clinician relations
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 judgment.
• 2 year analysis, market investigation, K-T,
business process as for accounting system.
Skepticism/fear/delay
• 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 lab!"
• Loud complaints to Chairs, Sr. VP Med Affairs, CEO
• 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. 1998;2:177-183).
• New IT “can-do’s” 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
advantageous
• System in use within 6 months by 75% of staff, enthusiastic committee
meetings
Success
• System allowed improved scheduling, lab operations and staffing
planning, outcomes assessment, participation in national initiativesAmerican 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.
Conclusions
• 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 doctors.
• 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 impossible."