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Challenges to Pathology Informatics in the Era of the Electronic Medical Record


... such that LISs, RISs, and pharmacy systems replicate only 'top-level' data to EMRs ... Government health insurance plans in Canada & U.K. now ... – PowerPoint PPT presentation

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Title: Challenges to Pathology Informatics in the Era of the Electronic Medical Record

Challenges to Pathology Informatics in the Era of
the Electronic Medical Record
  • Bruce A. Friedman, M.D.
  • Department of Pathology
  • University of Michigan Medical School
  • Ann Arbor, MI
  • (email)
  • (blog)

Organization and Structure of this Presentation
  • Goal today is to map out future of pathology
    informatics in an era when the EMR dominates
    healthcare computing
  • To achieve this goal, will make series of SWAGs,
    first about future of healthcare followed by lab
    medicine pathology
  • Having established this personal context, will
    then proceed to a discussion about the future of
    pathology informatics
  • Basic underlying thread is that lab
    operations/processes will become more
    decentralized, global, and complex
  • No shortage of challenges for pathology
    informatics as a discipline however, nature
    style of approach will change

Ten Predictions About the Future of Healthcare in
Prediction 1 More Specific Earlier Diagnoses
(Lab Tests Imaging)
  • New biomarkers (e.g., cancer, cardiovascular) now
    being developed, tested, adopted at
    unprecedented rate
  • Lab test panels will expand to mega-panels
    (100-200 tests) for diagnosis, monitoring, and
    wellness testing
  • Also, increased used of focused mini-panels of,
    say, 4-10 proteins fingerprints for individual
    tumors diseases
  • Biomarkers enable earlier dx of disease
    challenges to payors/clinicians oriented toward
    overt signs/symptoms
  • Imaging technology improving continuously,
    yielding greater specificity when coupled with
    biomarker panels

Prediction 2 Increased Emphasis on
Personalized/Customized Medicine
  • Personalized medicine will provide ability to
    offer appropriate therapy to the right patient
    when needed
  • Personalized drug cocktails developed only
    through knowledge of signaling of abnormal cells
    how to disrupt
  • Treat a disease with appropriate agents/doses for
    cure avoid harming normal tissues and lengthy
    hospital stays
  • Proteomics will ultimately be more clinically
    important than genomics serum more accessible
    for lab testing
  • Analysis of results of standard mega-panels
    will require sophisticated computer analysis
    professional oversight

Prediction 3 Increased Decentralization of
Healthcare Delivery Away from Hospitals
  • Hospital beds will be reserved for unstable
    medical patients, trauma patients, and research
  • Less severe patients will be seen on outpatient
    basis moderately ill patients sent home with
  • Satellite clinical units more convenient for
    patients will keep them away from drug-resistant
    bugs in hospitals
  • Satellite units more consumer-friendly because
    will need to compete for patients on
    regional/global basis
  • Hospitals satellite facilities linked via IT
    and video will function as cogs in integrated
    virtual enterprise

Prediction 4 Home Care Becomes More
Professional Institutionalized
  • Continuous shift of care to less expensive
    venues ICU gtgeneral care gtoutpatient
    gttechnology-enabled homes
  • As sicker patients migrate to home settings,
    families will need more sophisticated acute
    monitoring services/support
  • Devices for monitoring/interpreting physiologic
    parameters biomarkers from home care will be
    more available/affordable
  • Clinical information will be automatically
    transmitted to clinical analysts in healthcare
    monitoring nodes for a fee
  • Such an arrangement requires large capital
    investment in infrastructure/retraining proof
    of cost-efficiency for payers

Prediction 5 Health System EMRs Perceived as
Dominant Clinical Systems
  • For three decades, ancillary systems (labs,
    rad, pharma) have been the dominant clinical
    systems in hospitals
  • Recent public emphasis on errors in healthcare
    standardization for efficiency placed spotlight
    on EMRs
  • C-level executives historically interested in
    PA/PM systems now favoring EMRs under direct
    control of CIOs
  • Healthcare executives view the ancillaries as
    feeder- systems for EMRs one-stop shopping for
  • Problem is that labs and radiology growing
    increasingly complex cant wedge all relevant
    data into the EMRs

Prediction 6 Healthcare Information Both More
Integrated More Fragmented
  • Momentum behind increasing power/influence of the
    EMRs being installed in major health delivery
  • Increasing interest/funding of RHIOs
    (regionalized health information orgs)
    reincarnation of failed CHINs of past
  • RHIOs will also fail but not until billions of
    dollars wasted health systems have no
    interest/incentives in data-sharing
  • Simultaneous with centralization, LISs becoming
    more fragmented with emergence of V-LISs
    (networked modules)
  • RISs no longer highly integrated with
    reporting/scheduling systems that are separate
    from the PACS imaging systems

Prediction 7 Consumerism Will Alter Basic
Healthcare Delivery Style/Processes
  • The web is educating a generation of
    knowledgeable healthcare consumers no longer
    passive about care
  • Consumers going bare higher co-pays for
    services will cause healthcare consumers to shop
    more by price
  • Some reform of healthcare system beginning at
    bottom with for-profit clinics being developed
    in big-box stores
  • Web will also enable price-comparisons for
    ambulatory care services fee schedules will be
    posted in all facilities
  • Greater expectation from providers that their
    patients will take more responsibility for their
    own health wellness

Prediction 8 Healthcare Goes Global
Competition/Collaboration Across Boundaries
  • Healthcare going global with many countries
    offering discounted procedures orthopedic,
    cosmetic, fertility
  • Medical tourism catering to uninsured/insured
    with high co-pays, pts. wanting to jump queues
    in UK/Canada
  • With quality vetting of offshore sites,
    incentives for governmental health programs to
    offer overseas choices
  • India taking lead and utilizing U.S.-trained
    physicians in modern hospitals, performing
    cutting-edge operations
  • Dubai Healthcare City (DHC) partnering with
    prestigious players example of quality/well
    financed global nodes

Prediction 9 Private Insurance System Will
Persist with Government as Guarantor
  • There are going to be major expenditures as we
    move to new era of personalized medicine with US
    leading the way
  • Nation now spending about 1.65 trillion a year
    on healthcare -- 15 percent of gross domestic
  • Not sure how high percentage can rise, but most
    significant problem now is growing numbers of
  • I dont think nation has an appetite for major
    role of government in managing the healthcare
  • The private insurance system, with all its
    faults, will persist but with federal
    underwriting of care for uninsured

Prediction 10 Clinicians May Co-opt Activities
of Diagnostic Hospital Depts.
  • Because of skill in placing catheters, a portion
    of radiology has morphed from diagnosis to new
    forms of therapy
  • Rivalry between radiologists, cardiologists,
    vascular surgeons competition for cardiac cath
    stent placement business
  • In long run, I believe that patients will
    gravitate to those clinicians who can dx disease
    and treat any complications
  • Lesson relevant for both radiologists/pathologists
    need to come to these specialties with higher
    level of clinical skills
  • Both groups needs to gravitate more toward
    theranostics pathologists may have better shot
    because control of labs

Ten Predictions About Future of Lab Medicine,
Lab Computing, and Pathology
Prediction 1 Lab Testing Will Flourish with
Links to Personalized Medicine
  • Personalized medicine defined as picking the
    right drug for the right patient tight link with
  • Avoids side effects of chemotherapy promises
    more effective rx possibility of reuse of
    abandoned drugs
  • Clinical trials will be refashioned in terms of
    the selection of subjects promise of greatly
    reduced costs
  • Blue ribbon organization, Personalized Medicine
    Coalition, already formed to promote this
  • The clinical labs hopefully will sit at the
    epicenter of this emerging discipline lab
    profiling is a prerequisite

Prediction 2 Simple Test Panels Gradually
Replaced by Mega-Panels
  • Rapid emergence of multiple new biomarkers will
    usher in era of mega-panels (100-200 tests per
    panel) as routine
  • Mega-panels particularly revealing when coupled
    with sophisticated imaging location biomarker
  • Cost of mega-panels not necessarily extravagant
    because of improved multiplexed testing with
    minimal reagent usage
  • Clinicians will need assistance in test result
    interpretation as complexity of lab reports
    increases unique lab opportunity
  • Many of these biomarkers will be patented in some
    way, increasing costs legal review of these
    patents under review

Prediction 3 LISs Will Flourish Hospital EMRs
Cannot Integrate All Complex Lab Data
  • Because of the size and complexity of mopath
    data formatting constraints, EMRs cant
    accession all lab data
  • Irony (and proof of statement) is that even the
    hospital-based LISs wont be able to accommodate
    all lab data
  • Same applies to RISs and PACS control of image
    servers in IDNs nearly always turfed to IT
    personnel in radiology
  • Reminiscent of situation two decades ago when
    hospital execs assumed that HISs would handle all
    clinical activity
  • Accord must be reached such that LISs, RISs, and
    pharmacy systems replicate only top-level data
    to EMRs

Prediction 4 LIS Architecture Will Migrate to
Software-as-a-Service Model
  • This architecture was originally called
    application service provider (ASP) obtained
    modest LIS/LIMS successes
  • ASP service model was merely traditional
    client-server applications with HTML front-end
    added as after-thought
  • New name, Software as a Service (SaaS), now
    gaining traction as a new approach to renting
  • Current net-native SaaS applications offer high
    functionality, high reliability, and relatively
    low cost
  • Will take a few years for SaaS architecture to
    take hold in lab and healthcare PC application
    will take hold quickly

Prediction 5 Smaller Labs Perform Mainly
Routine Testing Outsource Esoteric
  • Because of increasing complexity of molecular dx,
    many smaller labs will need to outsource esoteric
  • Alternative business model evolving whereby labs
    may initially prep samples then hand-off to
    reference labs
  • Test results will become less important than the
    interpretations drawn from the patterns of
  • Many lab professionals operating in hospital labs
    will function primarily as data
  • Some labs professionals will begin to carve out
    careers as consultants to clinicians about
    lab/personalized medicine

Prediction 6 Molecular Diagnostics Outsourced
to Specialized Servers
  • Most hospital-based LISs not capable of managing
    the complex results (and result volume) from
    molecular dx
  • Higher-end labs will maintain specialized
    mopath servers other labs will link to their
    reference lab servers
  • Hospital MDs will order molecular dx tests via
    local LIS view results consultations by
    linking to remote servers
  • We will need new approach to lab computing such
    that LISs can respond to what-if questions
    beyond reporting
  • Challenge of molecular POCT devices will
    clinicians be tempted to manage smaller
    analytical instruments?

Prediction 7 Surgical Pathology Replaced
Gradually by Genomic/Proteomic Analysis
  • Morphologic assessment of tumors other lesions
    will be supplanted by molecular
    analysis/interpretation of tissue
  • HE surgicals, in short term, will be the gold
    standard approach has other advantages (e.g.,
    low cost, rapid TAT)
  • Hematopathology provides ideal model for change
    integrate molecular diagnostics in parallel with
  • First step -- break down barriers between AP and
    CP all neoplastic tissues analyzed
  • Not sure how resident training will be organized
    post merger study of morphologic molecular
    basis of disease

Prediction 8 Clinical Labs Will Embrace Testing
for Complementary Medicine
  • What is now known as complementary medicine
    will be gradually absorbed/integrated into
    mainstream medicine
  • May include dietary supplements, megadose
    vitamins, herbal preparations, acupuncture, and
    massage therapy
  • Mainstream commercial reference lab such as BRLI
    now emphasizing active participation in this
    approach to care
  • Look for hospital-based labs to follow suit what
    would be typical test offerings of a
    complimentary medicine lab?
  • Certain labs will also begin to align with MDs in
    splinter movements like anti-aging provide
    favorite panels

Prediction 9 Race Between Molecular Imaging vs.
Biomarker Profiling of Lesions
  • Siemens purchases CPL and GE Medical purchases
    Biacore integrate knowledge of proteins
  • Goal is to identify both space occupying lesions
    and their molecular basis pace of molecular
    imaging quickening
  • On lab side, biomarker profiling of tumors
    cardiovascular lesions growing more sophisticated
    as new tests discovered
  • These two approaches may be synergistic but
    extremely important for two disciplines to
    collaborate more actively
  • Academic disciplines probably too rigid to break
    down and create unified departments of
    diagnostic medicine

Prediction 10 Direct Access Testing Thrives
Based on Marketing/Branding
  • Direct access testing (DAT) has not flourished
    past five years major player (QuesTest) has also
    exited from market
  • This despite high level of interest by consumers
    in healthcare special interest in lab tests
    test results easy to understand
  • Problem has been that DAT players (web brokers)
    have not been sophisticated enough in
    marketing/branding of lab tests
  • Situation has changed DAT web sites like Direct
    Laboratory Services ( now
    getting message
  • DAT sites also emphasizing test discounting
    important because most DAT payments are currently

Visualizing the New Clinical Labs, LISs, EMRs,
Healthcare Delivery Systems
An Emerging Vision for the Clinical Laboratories
  • Personalized medicine and molecular diagnostics
    will place more sophisticated testing beyond
    reach of many labs
  • Molecular pathology reference labs will
    inter-operate with hospital-based labs to offer
    cutting-edge biomarker panels
  • Central lab personnel will manage increasingly
    provide QC oversight over POCT nodes in satellite
    centers home care
  • Lab professionals will increasingly be called
    upon to provide consultative services help
    determine therapeutic options
  • Labs/hospitals will provide DAT services for
    regional consumers patients will order using
    discretionary accounts

An Emerging Vision for the Laboratory
Information System (LIS)
  • Hospital labs/LISs will serve as
    aggregators/integrators for information steams
    from POCT and multiple reference labs
  • The multifunctional LIS replaced by the virtual
    LIS, an integrated intra-lab network composed of
    various modules
  • These modules (SLAMs supplemental lab
    application modules) selected based on lab
    mission desired functions
  • Virtual LIS will migrate to web with SaaS model
    this will be cheaper backend vendors will
    provide integration of SLAMS
  • Pathology informaticians will pay less attention
    to managing the LIS more to data
    integration/formatting consulting

An Emerging Vision for the Consumers of
Laboratory Services
  • Increasingly knowledgeable consumers will
    exercise increased control over expenditures
    choice of lab tests
  • Consumers may request tests by name from their
    PCPs tests, test panels, and fingerprints will
    become branded
  • Consumers will have special relationship to labs
    lab testing accessible technology to monitor
  • Healthcare and labs will become more
    service-oriented because of competition lessons
    learned from reference labs
  • Home testing kits and DAT options will increase
    dramatically consumers will auto-diagnose
    themselves report for rx

An Emerging Vision for EMR/LIS Interactions
  • History now repeating itself from 1980s idea
    surfacing that EMRs reign supreme and that
    ancillaries only feeder systems
  • C-level healthcare executives favor/fund the EMRs
    because under their control this approach will
    eventually falter
  • EMRs will bog down due to complexity volume of
    data competition for space between transactions
    clinical history
  • For clinical hx, EMRs will ultimately only
    accession top level summary data with pointers
    to detailed lab results images
  • LIS functions gravitate to web services model
    C-level executive exercise less control over lab
    data management

An Emerging Vision for Diagnostics Therapy
  • Theranostics lab testing to dx disease, select
    correct rx regimen, monitor the patients
    response to the therapy
  • Pathologists/lab scientists need to break out of
    pure diagnostics service delivery model therapy
    will be king
  • Ideal time to break out of mold diseased tissues
    will be attacked by designer molecules wherever
    they occur in body
  • Lab professionals will increasingly become the
    gatekeepers for choice of therapy based on
    patients molecular profile
  • Will require entry into pathology by MDs with
    more clinical orientation good model will be
    interventional radiology

An Emerging Vision for Molecular Imaging
Consider Synergies with AP
  • Need to keep a sharp eye on progress in molecular
    imaging GE Healthcare and Siemens also
    purchasing IVD companies
  • Goal with imaging pharmaceuticals is to both
    define the dimensions of a lesion characterize
    its biologic nature
  • Also plans to link imaging pharmaceuticals with
    radio-pharmaceuticals (or other toxic agents) to
    attack lesions
  • GE Healthcare has launched a re-imagining
    campaign to educate healthcare professionals
    about molecular diagnostics
  • Large lab mega-panels plus molecular imaging will
    usher in an era of early diagnosis of
    pre-symptomatic lesions radical shift

An Emerging Vision for Digital Imaging in
  • Digital images will account for an increasing
    share of the digital information that comprises
    the lab digital archives
  • Slow start for digital imaging in pathology lack
    of integration into LISs resistance to
    integration of images into reports
  • Workable business models for telepathology
    evolving sweet spot will be greater efficiency
    within multi-hospital systems
  • Advantage for radiologists has been that new dx
    modalities (CT, PET) have been digital from the
    time of image creation
  • Shaped by their radiology experience, younger
    clinicians will demand access to the key images
    and graphics in CP/AP

An Emerging Vision for the Globalization of
  • Many healthcare services will move off-shore
    price differentials for surgical procedures (and
    ? quality) will make inevitable
  • Non-covered services like cosmetic surgery will
    gain traction initially for less affluent
    consumers who desire them
  • Government health insurance plans in Canada
    U.K. now under pressure to reimburse for
    off-shore health services
  • Medical tourism brokers on the web steer
    patients to off-shore providers for a commission
    introduces bias into process
  • I anticipate for-profit or non-profit
    organizations will evolve to serve as
    accrediting/inspection bodies for offshore

Integrating All of These Predictions into an
Overarching Scenario for Pathology Informatics
Defining the Pathologist Informatician as We
Launch into the 21st Century
  • The number of pure pathologist-informaticians
    will continue to be small they will be located
    in major academic centers
  • Both clinical anatomic pathologists without
    pure informatics focus will spend increasing time
    on IT projects
  • Career ladder for pathology informaticians
    through the health system central IT hierarchy
    will be less attractive in future
  • Look for collaborative efforts between
    ancillaries (e.g. pathology radiology) will
    require each others talents
  • Mainstream pathologists will morph into both
    informatician and theranostic specialist able to
    both diagnose/treat disease

Information Management Will Slowly Achieve Parity
with Information Creation
  • Parity forced on pathology depts. because
    surgical pathology will decline some molecular
    testing will be outsourced
  • Integration of all lab data streams must occur
    within department prerequisite for consulting
  • Also increased need for data-mining tools tools
    to access most recent knowledge about diagnosis
    and treatment
  • Changes will occur against backdrop of increasing
    interest in lab testing in internal medicine
    improved molecular imaging
  • All of these changes will require radical changes
    in pathology residency programs will not take
    place without some conflict

Why Not Strategic Alliance with CIOs Clinicians
Managing Health System EMRs?
  • Typical promotion patterns for older
    informaticians was to accept promotions into
    health system central IT groups
  • Now believe that this is unwise better course of
    action is to look inward enhance internal lab
    computing assets
  • Instincts of central hospital IT groups is
    homogenization, standardization, setting modest
    (i.e., attainable) IT goals
  • These attitudes developed because of need to
    satisfy heterogeneous professional groups
    multiple failures
  • Only at the departmental level (e.g., lab,
    radiology) does the desire remains to exceed
    expectations to innovate

Role of Pathologists in Paradigm Shift to Early
Diagnosis and Treatment
  • With molecular imaging and mega-panels, medicine
    will shift to early diagnosis of pre-symptomatic
    diseases in consumers
  • This shift will affect all aspects of healthcare
    delivery MD training, pharma industry, clinical
    trials, costs, hospital beds
  • Standard drugs (plus new drugs) will need to be
    re-tested for efficacy/safety for rx of
    pre-symptomatic diseases
  • Hypertrophy of wellness model most illnesses
    will be treated in patients during visits with
    no chief complaints
  • Pathologists labs will have keys to kingdom
    in that they will be the gatekeepers for release
    of personalized drugs

Criticality of Higher Level of Training in
Pathology Informatics
  • Pathology informatics has never been introduced
    in meaningful way into pathology residency
  • Related in part to the small cadre of
    informaticians embedded in the various academic
    pathology programs
  • Also confusion and ambiguity about intrinsic role
    of informatics/computers tools vs. academic
  • After 15 years campaigning for change, my new
    chairman elevated clinical/research informatics
    to division level
  • Probably would not have happened without critical
    role that research informatics plays in
    genomics/proteomics research

Take Home Summary Points from Lecture
  • Consensus on part of the majority of pathologists
    that the future of the field lies in molecular
    diagnostics IT
  • Healthcare and lab medicine/pathology now in
    throes of series of wrenching financial,
    technical, scientific change
  • Medical specialty boundaries more porous than in
    past competition among MDs for procedures and
    product lines
  • Pathologists informaticians located in the eye
    of the storm molecular diagnostics IT
  • Key question is whether pathologists are
    inventive and sufficiently entrepreneurial to
    reinvent themselves field