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@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 =>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

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; can’t 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 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

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 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

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 • 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

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 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

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 other’s 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