1. Introduction to Health Record Banks William A. Yasnoff, MD, PhD, FACMIHarvard University. Cambridge, MA. October 15, 2012

2. 2 2 Where are Patient Records? n Medical Knowledge Explosion n Provider Response: Specialization & Sub- specialization n Result: Patient Records Scattered l No one has access to comprehensive longitudinal patient records l Records are on paper so can’t be processed, organized, accessed easily n Public health reporting incomplete, delayed

3. 3 3 Health Information Infrastructure n Goal: “Comprehensive Electronic Patient Information When and Where Needed” n Components l EHRs – all information electronic l Health Information Exchange (HIE) – mechanism for finding, aggregating, and delivering comprehensive records for each person

4. 4 4 Completeness of Information

5. 5 5 “Fetch and Show” HIE Approach n Improve cooperation by allowing stakeholders to retain data n Eliminate trust problems of central repository n Use Internet to exchange data rapidly & inexpensively (need standards for interoperability) n Development encouraged with very modest funding from 2004-8 n $564 million to states in 2009 (HITECH)

6. 6 6 Analysis of Scattered Model n Relates directly to existing process for obtaining “outside” records at office visits l Contact “outside” provider l Ask for records (typically sent by fax) n Addresses “if only this could be automated” wish of providers n Does not scale n Does not allow searching n Example of automating “how we do it now” vs. using IT to solve the underlying problem

7. 7 7 What is a Health Record Bank? http://www.healthbanking.org/video1.html

8. 8 8 Analysis of Health Record Banks n Advantages l Patient consent – Forces stakeholder cooperation – Ensures privacy (each patient sets own privacy policy) l Central repository – Searching  value-added services n Challenges l Disruptive l Minimal funding (so far)

9. 9 9 Potential Issues 1. Obtaining the Patient Records11. Historical & Paper Records 2. Ensuring Comprehensive Records12. Security of Repository 3. Ensuring Patient Participation 13. Need for Standards 4. Implementation Strategy & Cost14. Operational Efficiency 5. Financial Sustainability15. Handling Images 6. Patients Withholding Records16. Handling Mental Health Records 7. Assuring Patient Privacy17. Master Patient Index for Deposits 8. Why Hasn’t This Been Done?18. “Out of Town” Patient Visits 9. Has Already Failed (e.g. Google)19. Use of Data for Research & Policy 10. Public Health Reporting20. Existing Efforts Are Solving This …

10. 10 HII Business Model Problem n How Can HII be Sustained? l Why build if it cannot be sustained? l Critical early question for any IT system n Persistent Unsolved Problem l Involves both cost and value n Three Business Model Categories (not mutually exclusive) l Taxation l Leverage Health Care Savings l Leverage New Value Created

11. 11 HII Business Model: Option 1 - Taxation n Rationale: HII is public good, all should pay n Possible mechanisms l Excise tax on health insurance claims (VT) l Excise tax on hospital charges (MD) n Essentially “universalizes” HII component of healthcare n Politically unpopular & difficult l Especially when amount is non-trivial l Early $50B/yr estimated cost  $166/person/year [$55/mo for family of 4]

12. 12 HII Business Model: Option 2 – Leverage Savings n HII expected to reduce health care costs by 3-13% [8% is a good working estimate] l 8% x $2.6T = $208 billion/year n Problems l Savings not proven l Allocation and timing of savings? l “Savings” = “Lost Revenue” n Has consistently failed in communities l No responsible CFO will pay now for unproven future savings

13. 13 HII Business Model: Option 3 – Leverage New Value n Rationale: Stakeholders should be willing to pay for new value created by HII n Examples of new value l Replace paper delivery of lab results (75¢) with electronic delivery [Indianapolis] l Reminders and alerts – “Peace of Mind” – ER notification – Prevention Advisor – Medication refill reminders l Research queries (require searching) l Advertising (to consumers)

14. 14 Questions? William A. Yasnoff, MD, PhD william.yasnoff@nhiiadvisors.com 703/527-5678 BACKUP SLIDES

15. 15 ISSUES

16. 16 1. Obtaining the Patient Records n Need providers to transmit records on request l Request from “RHIO” or “HIE” may or may not be honored l Request from patient MUST be honored under HIPAA – If patient requests electronic records (e.g. via health record bank), they must be provided in electronic form n MU Stage 2 “view, download, and transmit” reinforces patient access to records ISSUES

17. 17 2. Assuring Comprehensive Records n All records must be electronic l Need >85% physician adoption n Free EHRs for physicians paid by health record bank l Cost is $10/person/year – 600K physicians needing EHR – 300 million population – 500 people/physician needing EHR – Internet-accessible EHR ≤ $5,000/year  $10/person/year n Also incentivizes patient signup

18. 18 Completeness of Information ISSUES

19. 19 3. Ensuring Patient Participation n No upfront or ongoing required costs l Optional services for a fee OK n Recommendation from trusted source: physicians n Minimal signup effort l Waiting room of physician office n With physician recommendation, 90%+ patient compliance anticipated n Need to incentivize physicians to sign up patients (e.g. with free EHR) ISSUES

20. 20 4.HRB Implementation Strategy PATIENT CONTROL CENTRAL REPOSITORY Stakeholder Cooperation ensures Electronic Patient Data provides Benefits 1. Clinical:  Quality,  Costs 2. Reminders/Alerts 3. Research Benefits 1. Clinical:  Quality,  Costs 2. Reminders/Alerts 3. Research produces pay for enables Low Costs results in Privacy protects reinforce Financial Incentives Financial Incentives allow ensure Key Design Decisions Estimated Startup Costs: $5-8 million

21. 21 Health Record Bank Organization Customer Support Marketing Operations HRB Operator Board of Directors Management HRB Corp. (for-profit) regulate via contract % of profit RESPONSIBLE FOR: Policy Governance Oversight RESPONSIBLE FOR: Obtaining Capital Operating HRB Executive Director Other Staff(Optional) Community Non-profit Community Board of Directors Other communities use same HRB ISSUES

22. 22 5. Financial Sustainability n Costs (with 1,000,000 subscribers) l Operations: $6/person/year l EHR incentives: $10/person/year n Revenue l Advertising: $5/person/year (option to opt out for small fee) l Optional Reminders & Alerts: >= $18/person/year – “Peace of mind” alerts – Preventive care reminders – Medication reminders l Queries: ? n No need to assume/capture any health care cost savings (!!) ISSUES

23. 23 6. Patients Withholding Records n Patients already withhold records l 13-17% in surveys l Without control, these patients will opt out n If patients don’t control records, who is trusted enough to do it on their behalf? n In HRB, patients will be warned when they choose to suppress information n Physicians are not liable for consequences of withheld information l Fully documented in HRB n Potential exceptions to patient control to prevent fraud (e.g., controlled substances) ISSUES

24. 24 7. Assuring Patient Privacy n Health record banks NOT covered by HIPAA l But HIPAA allows information release without consent for treatment, payment, operations n Health records banks ARE covered by l ECPA – Electronic Communications Privacy Act (1986) – Consent of subscriber required for any access by private party l Federal Trade Commission enforcement of online privacy policies – Can shut down sites in violation ISSUES

25. 25 8. Why Hasn’t This Been Done? n Technology l Tools now allow rapid deployment n Difficult for Existing Stakeholders l Existing healthcare stakeholders are competitors l Will be wary of another stakeholder’s health record bank n Desire to use information for competitive advantage l Many healthcare stakeholders do not want to share information n No obvious source of startup funds ISSUES

26. 26 9. Has Already Failed (e.g. Google) n Google Health Failure l National focus – Didn’t achieve sufficiently comprehensive information to generate value for any specific consumers l Trust – Privacy policy did not fully protect users – Inherent distrust l Business model – Based on “search” – Not an effective health record bank model

27. 27 HRB Examples n Washington State Pilots (4) l Inadequate funding  insufficient marketing l Very small communities  cannot achieve sustainability n Harvard U’s MyDataCan (just started) l Trusted by consumers (double encryption) l Obtain comprehensive records l “App Store” business model l Includes personal data beyond health ISSUES

28. 28 10. Public Health Reporting n Health Record Banks can provide public health reporting l Immunizations l Surveillance – Lab tests – Diseases – Syndromes n More timely reporting n More complete reporting n Reporting done “on behalf of” providers l Consent not required (by law) ISSUES

29. 29 11. Historical & Paper Records n Not normally collected by Health Record Bank n Optional scanning services can be used – pdf files (“images”) of paper records – ? OCR processing so content available – Cost is a challenge n Over time, most historical records become less important l Issue of historical and paper records is a temporary issue (in general) l But there are exceptions, e.g., old EKG ISSUES

30. 30 12. Security of Repository n Central repository prerequisite for security l Network security is unsolved problem l Need information in one place to assure protection n Less information “exposure” in central repository l Transmitted only once for each use (vs. twice in distributed model) n Massive breach risk independent of storage l Mechanism for retrieval either way l Encryption of data at rest reduces risk ISSUES

31. 31 13. Need for Standards n All health information infrastructure requires standards l Regardless of architecture n ONC/CMS activities are successfully leading to widespread use of standards n Health Record Banks eliminate an entire class of interoperability l With HRBs, only interoperability is between HRB and provider l Otherwise, all systems must be interoperable with all others (challenging!) ISSUES

32. 32 14. Operational Efficiency Source: Lapsia et al, Int J Med Informatics (in press)

33. 33 Operational Efficiency (cont.) Source: Lapsia et al, Int J Med Informatics (in press) ISSUES

34. 34 15. Handling Images n Not likely to be stored in Health Record Bank (at least at first) l Very large storage requirements l Available from other sources l “Pointers” to images are sufficient n Will store imaging reports n HRBs may store “small” images l e.g., EKGs ISSUES

35. 35 16. Handling Mental Health Records n Probably better to avoid mental health records at first l Very sensitive l Public policy issue l Leave decision about deposit to patients n Patients can decide what information is available, so can suppress mental health records if they wish n Mental health medications would likely be included ISSUES

36. 36 17. Master Patient Index for Deposits n Deposits with ambiguous identification can be held by health record banks l Investigate manually to determine correct patient l Correspondence between provider identifier and HRB account can then be established n Over time, accurate mapping from provider identifiers to HRB accounts  effective MPI n Patient access to records is another opportunity to find and correct errors ISSUES

37. 37 18. “Out of Town” Patient Visits n Each patient’s data available in one place l Accessible anywhere via Internet n Route new information to existing record l Direct deposit to remote health record bank (via MU Stage 2 “transmit”) l System of forwarding “foreign” deposits among health record banks (later) l Information deposited by patient ISSUES

38. 38 19. Use of Data for Research & Policy n Clinical Trial Subjects l Ask HRB subscribers if they want to be notified if they qualify for clinical trials l Researchers will pay fees to send messages to potential subjects n Reports from data for research & policy l Ask HRB subscribers if their data can be aggregated into reports for research & policy (with anonymity protected) l Share revenue from fees with users as incentive (“interest bearing” HRB accounts) ISSUES

39. 39 20. Existing Efforts are Solving This (10 slides)

40. 40 Health Information Infrastructure n Goal: “Comprehensive Electronic Patient Information When and Where Needed” n Components l Electronic Health Records (EHRs) – all information electronic l Health Information Exchange (HIE) – mechanism for finding, aggregating, and delivering comprehensive records for each person

41. 41 EHR Adoption n CMS incentive program is very helpful n Adoption increasing rapidly n But … expected best outcome is 50% adoption by physicians in 2015 n How can adoption by vast majority of physicians be assured?

42. 42 Health Information Exchange(HIE) n Mechanism for finding, aggregating, and delivering comprehensive records for each person n Distributed /Scattered /“Fetch and Show” Model l Allow stakeholders to retain data l Use Internet to exchange data rapidly & inexpensively (need standards for interoperability) l Maintain index of record locations in each community l Aggregate each patient’s records when needed

43. 43 Clinical Encounter Index of where patients have records Temporary Aggregate Patient History Patient Authorized Inquiry Hospital Record Laboratory Results Specialist Record Patient data delivered to Physician LHII Records Returned Requests for Records Scattered Model Clinician EHR System Encounter Data Stored in EHR Pointer to Encounter Data Added to Index

44. 44 Index of where patients have records Temporary Aggregate Patient History Authorized Inquiry from LHII Hospital Record Laboratory Results Specialist Record Patient data delivered to other LHII LHII Records Returned Requests for Records U.S. another LHII

45. 45 Analysis of Distributed Model n Relates directly to existing process for obtaining “outside” records at office visits l Contact “outside” provider l Ask for records (typically sent by fax) n Addresses “if only this could be automated” wish of providers n Does not scale n Does not allow searching n Example of automating “how we do it now” vs. using IT to solve the underlying problem

46. 46 PCAST Report (12/2010) n “HIEs have drawbacks that make them ill- suited as the basis for a national health information architecture.” l Significant administrative burdens l Lack of financial sustainability l Lack of interoperability l Architecture does not allow effective scaling

47. 47 HIE Survey (Ann Int Med 154,10:666-71, 2011) n 179 HIEs Surveyed n Only 13 met Meaningful Use Stage 1 l Covering 3% of hospitals, 0.9% of docs l Just 6 of these 13 financially sustainable n None of the 179 HIEs met criteria for “comprehensive system” n “These findings call into question whether RHIOs in their current form can be self- sustaining and effective in helping U.S. physicians and hospitals engage in robust HIE to improve the quality and efficiency of care.” [abstract]

48. 48 Consumer-Mediated HIE: Health Record Bank (HRB) n Secure community-based repository of complete health records n Access to records completely controlled by patients (or designee) n “Electronic safe deposit boxes” n Information about care deposited once when created l Required by HIPAA n Allows EHR incentives to physicians to make outpatient records electronic n Operation simple and inexpensive

49. 49 HRB Solves HII Problems n Privacy l Patient control each person sets their own privacy policy n Stakeholder Cooperation l Patients request data all stakeholders must provide it (by law) l HRB profit allocations to data partners n Making Information Electronic l Business model provides free EHRs for physicians n Financial Sustainability l New compelling value for patients ~$23+/person/year recurring revenue ISSUES

50. 50 BACKUP SLIDES Health Record Bank Operation Health Record Bank Rationale Where are Patient Records? PCAST Report Recommendations Questions? ISSUES

51. 51 Clinical Encounter Health Record Bank Clinician EHR System Encounter Data Entered in EHR Encounter Data sent to Health Record Bank Patient Permission? NO DATA NOT SENT Clinician Inquiry Patient data delivered to Clinician YES optional payment Clinician’s Bank Secure patient health data files Health Record Bank Operation BACKUP SLIDES

52. 52 HRB Rationale n Operationally simple l Records immediately available l Deposit new records when created l Enables value-added services l Enables research queries n Patient control l Trust & privacy l Stakeholder cooperation (HIPAA) n Low cost facilitates business model n Can create EHR incentive options l Pay for deposits l Provide Internet-accessible EHRs BACKUP SLIDES

53. 53 Where are Patient Records? n Medical Knowledge Explosion n Provider Response: Specialization & Sub- specialization n Result: Patient Records Scattered l No one has access to comprehensive longitudinal patient records l Records are on paper so can’t be processed, organized, accessed easily n Clinical and policy decisions based on incomplete data BACKUP SLIDES

54. 54 PCAST Recommendations (12/10) n Recommendation 1: Distributed System of Record Elements Tagged with XML Metadata l Protected by “digital rights management” l Held in multiple repositories l BUT … DRM failed for music & movies (with only one data type and one access option) n Recommendation 2: Create “Universal Exchange Language” for Interoperability l $20-40 million over a few months l BUT … Problem has been unsolved for decades BACKUP SLIDES