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Challenges to Pathology Informatics in the Era of the Electronic Medical Record
Bruce A. Friedman, M.D.Department of Pathology
University of Michigan Medical SchoolAnn Arbor, MI
[email protected] (email)www.labsoftnews.com (blog)
Slide 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
Ten
Predictions
About the
Future of
Healthcare in
General
Slide 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
Slide 5
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 #2: Increased Emphasis on Personalized/Customized
Medicine
Slide 6
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
Prediction #3: Increased Decentralization of Healthcare Delivery Away from Hospitals
Slide 7
Continuous shift of care to less expensive venues; ICU =>general care =>outpatient =>technology-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 #4: Home Care Becomes More Professional &
“Institutionalized”
Slide 8
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; can’t wedge all relevant data into the EMRs
Prediction #5: Health System EMRs “Perceived” as Dominant Clinical
Systems
Slide 9
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
Prediction #6: Healthcare Information Both More Integrated &
More Fragmented
Slide 10
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 #7: Consumerism Will Alter Basic Healthcare Delivery
Style/Processes
Slide 11
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 #8: Healthcare Goes Global; Competition/Collaboration Across
Boundaries
Slide 12
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 don’t 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
Prediction #9: Private Insurance System Will Persist with Government
as Guarantor
Slide 13
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
Prediction #10: Clinicians May Co-opt Activities of “Diagnostic” Hospital
Depts.
Ten Predictions
About Future of Lab
Medicine, Lab
Computing, and
Pathology
Slide 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
Slide 16
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
Prediction #2: “Simple” Test Panels Gradually Replaced by Mega-Panels
Slide 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 can’t accession all lab data
Irony (and proof of statement) is that even the hospital-based LISs won’t 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
Slide 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
Slide 19
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
Prediction #5: Smaller Labs Perform Mainly Routine Testing & Outsource
Esoteric
Slide 20
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 #6: Molecular Diagnostics Outsourced to Specialized Servers
Slide 21
Morphologic assessment of tumors & other lesions will be supplanted by “molecular” analysis/interpretation of tissue
H&E 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
Prediction #7: Surgical Pathology Replaced Gradually by
Genomic/Proteomic Analysis
Slide 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
Slide 23
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”
Prediction #9: Race Between Molecular Imaging vs. Biomarker Profiling of
Lesions
Slide 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
Visualizing the New
Clinical Labs, LISs, EMRs, &
Healthcare Delivery Systems
Slide 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
Slide 27
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 Laboratory Information System
(LIS)
Slide 28
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
An Emerging Vision for the Consumers of Laboratory
Services
Slide 29
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 EMR/LIS Interactions
Slide 30
Theranostics = lab testing to dx disease, select correct rx regimen, & monitor the patient’s 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 Diagnostics + Therapy =
Theranostics
Slide 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
Slide 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
Slide 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
Integrating All of These
Predictions into an
Overarching Scenario for Pathology
Informatics
Slide 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 other’s talents
Mainstream pathologists will morph into both informatician and theranostic specialist able to both diagnose/treat disease
Slide 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
Slide 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
Slide 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
Slide 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
Slide 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