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

bfriedma@umich.edu (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

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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