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

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


1
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
  • bfriedma_at_umich.edu (email)
  • www.labsoftnews.com (blog)

2
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

3
Ten Predictions About the Future of Healthcare in
General
4
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

5
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

6
Prediction 3 Increased Decentralization of
Healthcare Delivery Away from Hospitals
  • Hospital beds will be reserved for unstable
    medical patients, trauma patients, and research
    subjects
  • Less severe patients will be seen on outpatient
    basis moderately ill patients sent home with
    monitoring
  • 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

7
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

8
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
    clinicians
  • Problem is that labs and radiology growing
    increasingly complex cant wedge all relevant
    data into the EMRs

9
Prediction 6 Healthcare Information Both More
Integrated More Fragmented
  • Momentum behind increasing power/influence of the
    EMRs being installed in major health delivery
    networks
  • 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

10
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

11
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

12
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
    product
  • Not sure how high percentage can rise, but most
    significant problem now is growing numbers of
    uninsured
  • I dont think nation has an appetite for major
    role of government in managing the healthcare
    system
  • The private insurance system, with all its
    faults, will persist but with federal
    underwriting of care for uninsured

13
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

14
Ten Predictions About Future of Lab Medicine,
Lab Computing, and Pathology
15
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
    pharmacogenomics
  • 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
    approach
  • The clinical labs hopefully will sit at the
    epicenter of this emerging discipline lab
    profiling is a prerequisite

16
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
    specificity
  • 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

17
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

18
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
    applications
  • 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

19
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
    testing
  • 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
    abnormals
  • Many lab professionals operating in hospital labs
    will function primarily as data
    integrators/consolidators
  • Some labs professionals will begin to carve out
    careers as consultants to clinicians about
    lab/personalized medicine

20
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?

21
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
    morphology
  • First step -- break down barriers between AP and
    CP all neoplastic tissues analyzed
    biochemically/morphologically
  • Not sure how resident training will be organized
    post merger study of morphologic molecular
    basis of disease

22
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

23
Prediction 9 Race Between Molecular Imaging vs.
Biomarker Profiling of Lesions
  • Siemens purchases CPL and GE Medical purchases
    Biacore integrate knowledge of proteins
    immunochemistry
  • 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

24
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 (www.directlabs.com) now
    getting message
  • DAT sites also emphasizing test discounting
    important because most DAT payments are currently
    out-of-pocket

25
Visualizing the New Clinical Labs, LISs, EMRs,
Healthcare Delivery Systems
26
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

27
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

28
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
    health/wellness
  • 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

29
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

30
An Emerging Vision for Diagnostics Therapy
Theranostics
  • 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

31
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

32
An Emerging Vision for Digital Imaging in
Pathology
  • 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

33
An Emerging Vision for the Globalization of
Healthcare
  • 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
    services

34
Integrating All of These Predictions into an
Overarching Scenario for Pathology Informatics
35
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

36
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
    theranostics
  • 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

37
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

38
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

39
Criticality of Higher Level of Training in
Pathology Informatics
  • Pathology informatics has never been introduced
    in meaningful way into pathology residency
    programs
  • 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
    discipline
  • 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

40
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
    knowledge/experience
  • Key question is whether pathologists are
    inventive and sufficiently entrepreneurial to
    reinvent themselves field
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