1. UKRAINE eHealth Strategy - “Strategic and Architectural Options for Effective Implementation and Integration - Zlatan Šabić Kiev, Ukraine, April, 2016 1

2. Options for… 1. Objectives/Value 2. Architectures  Overall Conceptual Architecture  Functional Architecture  Technical Architecture 3. Implementation  Implementation Strategy  Planning Strategy and Indicators of Progress  Funding  Investment Plan 4. Governance  Leadership and Implementing Structures  Regulations, Standards and Interoperability  Legislation, policy and compliance 2

3. 1. Objectives/Value WHY are we doing this? 3

4. Defining objectives  What is the purpose of eHealth systems to be introduced and how is that related to the overall development objectives?  Considering the overall development objectives and strategies, are there opportunities to use the eHealth as an innovation that can critically influence them?  Define value that eHealth brings, e.g.  Better/new service delivery models  Supported financing models  Improved information for policy/decision making  Administrative efficiency and productivity of the public health system  …  Relationship to other development plans/strategies 4

5. Objectives can come from challenges Typical eHealth Challenges Support clinical and administrative processes to: strengthen primary care to be first point of contact and gatekeeper for patient navigation of delivery system facilitate inter-provider communication (hospital-to-hospital; hospital-to-primary care) to provide technical assistance, supervision and training support doctors’ multi-sited practice and remote medical treatment improve provider-patient relations and benefit people by reducing information asymmetry allow results based payment models, such as paying integrated care networks (e.g., capitation), or paying for a package of services (e.g., bundled payments) … Integrate data flows to support: balanced service delivery model through levels of care effective management of medical alliances or networks horizontal integration of individual preventive and curative care services vertical integration of care expansion of cost effective “intermediate” facilities provide flexible clinical and administrative data analytics to make delivery system accountable for population health provide flexible clinical and administrative data analytics to allow measurement and feedback on outcomes, costs and quality processes to strengthen performance evaluation and assessment and make delivery system accountable for population health access to accurate and timely information to strengthen integrated planning and coordination of medical reform … 5

6. Objectives - other considerations  The IT value does not appear instantly; it grows as the utilization of IT evolves from using the IT as a tool for efficiency improvement to the business integrator and enabler.  IT can be the decisive factor in achieving the reforms’ goals, and considering wider context, it can become the enabler of the reforms in sector’s that would otherwise be limited or even not possible.  Think of priorities and feasibility 6

7. 2. Architectures WHAT needs to be developed 7

8. Architectures – Conceptual Architecture  Agree on Conceptual System Architecture (CSA) before moving to functional requirements, to be able to make decisions on various implementation time-frames, implementation strategies and investments.  The CSA defines functional separation of systems, services and applications to be implemented.  It implicitly defines possible implementation options. 8

9. CSA  Identification of building blocks  No details Health Data Exchange Platform Tools and services for data exchange based on minimal standards. Central Reference Registries MPI health data dictionary providers professionals health services ICD-xx … Shared EHR Common Application Systems Two way referral ePrescription central appointments common payment … … Grassroots/Regional Systems in Health Facilities (EMRs) PHC Hospitals Laboratories Emergency Regional EHR? … Other Systems Public health & Vertical Registries Pharmacies Social protection … Web interface for manual access to central systems Central Systems 9

10. Conceptual Architecture – it can be one scheme, but needs to answer key design questions  The set of potentially large number of options shall be reduced by deciding on key design dilemmas, for example:  Centralized vs. distributed EMR?  Functional separation per level of health care (primary, secondary) and per business functions (outpatient, inpatient, laboratory, radiology, emergency, …)  Do Primary Health Care (PHC) and Specialist/Secondary Health Care (SHC) use separated Electronic Medical Records (EMR)?  How is data exchange provided between systems using a standard messaging?  Are data from EMR’s (PHC and SHC) aggregated into some sort of Central EHR (Central Electronic Patient Registry – CEPR; or Central EHR), providing subset of data for policy making, and also allowing data exchange between PHC and SHC systems?  If there is one, centralized EMR, how are PHC, SHC and CEPR systems are built around it?  … 10

11. Data collection vs. process oriented design D E S I G N Zlatan Šabić, 2012. Top management Middle management Operational management Operational, daily data with high level of details Summary, synthetic data, but with enough details to effectively support tactical managerial control Higly-synthetic data, oriented to future and support to strategic planning Data collection Daily operations, generating data

12. Data collection vs. process oriented design D E S I G N  Data collecting will not be very useful for daily business processes and will never collect accurate data that we can trust. Data produced as a result of “data collection process” are:  not accurate,  not timely reported,  not useful for support of daily business processes, and  generating more workload

13. Data collection vs. process oriented design D E S I G N  The IT system must be implemented into the heart of the health system to directly support its business processes and thus operate on real, operational, transaction data  Collecting and extracting information from these databases is a trivial task then. Generated data are “by-product” of real business processes – they can be trusted as it has been aggregated from operational data generated by real people in real business processes. HEEALTH SYSTEM PHC Hospitals... Business processes -EMR - referrals - provided services … -EMR - referrals - provided services … Databases POLICY MAKING MANAGEMENT DATA EXTRACTION … … Pharmacies … …

14. CSA – example, Kazakhstan 14

15. Functional Architecture  After deciding on CSA, general functional description of key components of CSA shall be described – systems and services.  It is NOT making specifications for procurement, it is defining the conceptual structure to be foundation for functional standards and recommendations for the implementers to follow  The functional descriptions shall not be detailed, but it must be clear what each of components is consisting of. 15

16. Functional Architecture WHAT exactly needs to be implemented  Service Delivery  Primary Health Care ISs  Hospital ISs  Pharmacy ISs  Patient Portal  ePrescription  eReferrals  LIS  RIS  …  Service Delivery  Primary Health Care ISs  Hospital ISs  Pharmacy ISs  Patient Portal  ePrescription  eReferrals  LIS  RIS  … Admitting Billing Medical Records Ward Medicine Operating room Inpatient Pediatric Pharmacy Radiology Emergency Room Laboratory Dietary Ob/Gyne … Admitting Billing Medical Records Ward Medicine Operating room Inpatient Pediatric Pharmacy Radiology Emergency Room Laboratory Dietary Ob/Gyne … 16

17. Functional Architecture WHAT exactly needs to be implemented  Public Health  Public Health Statistics  Epidemiological Surveillance  International Health Surveillance  Quarantine Services Management  Epidemic Containment Monitoring  Health Education  …  Public Health  Public Health Statistics  Epidemiological Surveillance  International Health Surveillance  Quarantine Services Management  Epidemic Containment Monitoring  Health Education  …  Disease Management  Cancer Registry  Diabetes Registry  Hypertension Registry  Coronary Arterial Disease Registry  HIV Registry  …  Disease Management  Cancer Registry  Diabetes Registry  Hypertension Registry  Coronary Arterial Disease Registry  HIV Registry  … 17

18. Functional Architecture WHAT exactly needs to be implemented  Resources and Regulation  Health Facilities & Services Licensing/Accreditation  Health Devices & Technologies Registration  Drugs registration and management  Central Reference Registries  Health Data Dictionary  …  Resources and Regulation  Health Facilities & Services Licensing/Accreditation  Health Devices & Technologies Registration  Drugs registration and management  Central Reference Registries  Health Data Dictionary  …  Payment Systems  Health Insurance Funds ISs  Payment and budgeting mechanisms  …  Administration  Human resources Management  Financial management  Supply Chain management  Fixed Assets Management  Information Assets management  …  Payment Systems  Health Insurance Funds ISs  Payment and budgeting mechanisms  …  Administration  Human resources Management  Financial management  Supply Chain management  Fixed Assets Management  Information Assets management  … 18

19. Functional Architecture WHAT exactly needs to be implemented  Governance and Management  Annual Budgeting & Planning  Budget Utilization Monitoring  Fixed assets Accounting & Control  Procurement Monitoring  Suppliers Performance Monitoring  HHR Deployment Monitoring  Contracts Management  Retail Drug Price Monitoring  Adverse Drug Reaction Monitoring  Licensing & Accreditation Compliance Monitoring  Health laws/standards compliance Monitoring  Health Programs Development  Service Quality and Monitoring  Emergencies Response Monitoring  International Health Cooperation  Governance and Management  Annual Budgeting & Planning  Budget Utilization Monitoring  Fixed assets Accounting & Control  Procurement Monitoring  Suppliers Performance Monitoring  HHR Deployment Monitoring  Contracts Management  Retail Drug Price Monitoring  Adverse Drug Reaction Monitoring  Licensing & Accreditation Compliance Monitoring  Health laws/standards compliance Monitoring  Health Programs Development  Service Quality and Monitoring  Emergencies Response Monitoring  International Health Cooperation 19

20. Functional Description Example: What do you mean by PHC System ?  Support for outpatient business flow (registration, scheduling/appointment, initial consultation, examinations, examination review and additional consultations, treatment session, drug prescription and administration, hospitalization instruction,…)  Access to and update of EMR  Health risk appraisal (integrating data about the patient’s condition obtained from laboratory, radiology/imaging, or other equipment or technology-related tests and/or procedures, capturing and monitoring patient health risk factors, capturing and monitoring vital signs data, such as height, weight, pulse, respiratory rate, blood pressure, … )  Progress notes (performed/planned (Laboratory) procedures, diagnosis, goals (provider’s and patient’s) and follow-up plans, medications prescribed, education materials, consultation/referrals, patient condition or status, …)  Problem list (problem status, problem summary list, monitoring of health risk factors, link problems with orders and results, link problems to clinical practice guidelines, …)  Architecture – centralized vs. regional? 20

21.  Orders  Referrals  ePrescription  Integrated Clinical Practice Guidelines (CPG) - import/create/edit the CPG guidelines, (re)configure business flow according to CPGs, documentation management following CPG, …  Clinical decision support  Multidisciplinary care plans  Prevention  Access to health insurance data  … Functional Description (cont.) Example: What do you mean by PHC System ? 21

22.  Support for inpatient business flow (registration, hospitalization instruction, hospitalization procedure, consultations, examinations, inpatient treatment, nurse assignment, surgery, drug management, …)  Registration and scheduling  Access to and update of EMR  Problem list (problem status, problem summary list, monitoring of health risk factors, link problems with orders and results, link problems to clinical practice guidelines, …)  Laboratory Information System (LIS)  Radiology Information System (RIS)  Referrals  Orders  ePrescription Functional Description Example: What do you mean by Hospital IS ? 22

23.  Disease Management  Integrated Clinical Practice Guidelines (CPG) - import/create/edit the CPG guidelines, (re)configure business flow according to CPGs, documentation management following CPG, …  Care plan  Alerts  Internal pharmacy management  Service/Cost administration (may include DRG)  Quality assurance  Access to health insurance data  … Functional Description (cont.) Example: What do you mean by Hospital IS ? 23

24. No need to define everything… Source: “Overview of IT Adoption Status in Peking University People’s Hospital”, LIU FAN, Assistant President of Peking University People’s Hospital, 2014 24

25. “Analysis-Paralysis” Defining everything?

26. Architectures – Functional Architecture  The point of describing functional architecture is not to design everything to be implemented by the government. The purpose is to define on conceptual level the structure that will allow creation of functional standards and recommendations. 26

27. Architectures – Technical Architecture  Conceptual technical architecture – how are databases and systems hosted, client/server architecture vs. web based SOA, how are systems connected, what are the basic communication protocols, …  End-user computing facilities (computers, printers, scanners, …)  Local area networks in health facilities  Last-mile communication infrastructure (who, how, …)  National (WAN) communication infrastructure  Systems and applications hosting environments – central data center(s) based on cloud computing (who, how, relationship with other national platforms, …)  … 27

28. Technical Architecture - example 28

29. Example: Technical architecture based on national eGov infrastructure (Estonia X-Road) PHARMACIS AND FAMILY DOCTORS 2009 X-Roads, ID-card, State IS Service Register HEALTH CARE BOARD - Health care providers - Health professionals - Dispensing chemists HEALTH CARE BOARD - Health care providers - Health professionals - Dispensing chemists STATE AGENCY OF MEDICINES - Coding Centre - Handlers of medicines STATE AGENCY OF MEDICINES - Coding Centre - Handlers of medicines POPULATION REGISTER PHARMACIS 2010 january PHARMACIS 2010 january BUSINESS REGISTER HOSPITALS 2009 HOSPITALS 2009 FAMILY DOCTORS 2009 FAMILY DOCTORS 2009 SCHOOL NURSES 2010 september SCHOOL NURSES 2010 september EMERGENCY MEDICAL SERVICE 2011 EMERGENCY MEDICAL SERVICE 2011 eHealth Foundation NATIONAL HEALTH INFORMATION SYSTEM 2009 Health Insurance INSURANCE REGISTER CLAIMS & REIMBURSMENT PRESCRIPTION CENTRE 2010 january Health Insurance INSURANCE REGISTER CLAIMS & REIMBURSMENT PRESCRIPTION CENTRE 2010 january PATIENT PORTAL 2009 HCP PORTAL 2011 PATIENT PORTAL 2009 HCP PORTAL 2011 XROADS GATEWAY SERVICE 2009 29

30. Architectures – Technical Architecture  Again, the point of describing technical architecture is not to design everything to be implemented by the government. The purpose is to define on conceptual level the structure that will allow creation of technical standards and recommendations. 30

31. 3. Implementation Nice architecture, but HOW will it be developed? 31

32. Implementation Strategy  For each of identified component:  What is the basic implementation strategy, for example, open market model vs. centralized one solution for all?  How many separated systems will be actually implemented for the component to be implemented?  Who will implement it? Who is responsible for the functioning of it? Who is responsible for the content of databases?  What is the transition strategy ?  What is the plan of gradual introduction of regulations and standards? Who is responsible? How are stakeholders and users involved?  What is the plan for establishing needed structures for governance, their re-structuring, capacity building, establishing of stable funding mechanisms, etc. ?  Change management strategy? 32

33. Basic implementation model Many IT service providers IT governance monopolyliberalized market One IT service provider monopolynot likely to happen One organization implements IT services for the whole sector Many organizations are implementing different systems that cooperate You can have different model for different systems, for example:  PHC, policlinics, municipality hospitals – IT governance monopoly  Regional hospitals – liberalized market You can have different model for different systems, for example:  PHC, policlinics, municipality hospitals – IT governance monopoly  Regional hospitals – liberalized market 33

34. Implementation – critical decision  What will be implemented directly by the government, and what will be implemented locally, by regions and/or facilities?  Possible implementation strategy:  Government will define and enforce the standards and regulations for that implementation.  Government will implement some central functions (which ones?), to ensure implementation of conceptual functional and technical architectures, to ease data exchange, and to stimulate more development on local level.  Most of the implementation will be done by regions and medical facilities. They will purchase solutions available on ICT market, but only those which are certified by the government to be compliant to regulations and standards.  Actually, the government is not physically implementing eHealth (except some central systems), it creates the stimulating and encouraging environment for the organized and regulated eHealth development in Moldova.

35. Implementation Strategy A, example This model might make sense for central electronic health record (CEHR - the subset of electronic medical record used for the purposes of data exchange and statistical/policy reporting) Hospital Information System Emergency Information System GOVERNMENT HEALTH FACILITIES CEHR G A T E W A Y (web based communication services) Primary Health Care Information System eHealth Regulations and Standards enforce the use of service For example, “all implemented PHC systems must have interface to CEHR, using XY standard)” EMR

36. Implementation Strategy B, example Government implements central PHC system. Facilities can use it, or they can chose to use other solutions. If they use it, they use common EMR (that is not the same as CEHR) GOVERNMENT HEALTH FACILITIES CEHR G A T E W A Y (web based communication services) This facility uses centrally developed and hosted Primary Health Care Information System EMR Centrally developed and hosted Primary Health Care Information System This facility uses it’s own Primary Health Care Information System

37. Implementation Strategy, example: How to regulate liberalized market option? eHealth Regulation and Standardization - Components of CSA - Functional requirements -Technical standards - Data exchange standards - Data structures standards -… Certification Procurement and implementation of only certified solutions Monitoring of compliance and conformance Feedback ICT INDUSTRY GOVERNMENT HEALTH FACILITIES 37

38. Improve Enabling Environment Implement Grassroots Systems - Basic PHC EMR systems - Basic hospital EMR systems - Tele-consultations - Clinical decision support systems - Post-treatment e-consultations - Off-line consultations - Post-discharge patient management - … Integrate Data Flows - Central Reference Registries - MPI - Shared EHR - Health Data Exchange Platform - Common Cluster Systems (two-way referrals, ePrescription, central appointment, common payment, …) - … Implementation strategy – balancing systems and integration efforts 38

39. IT Service Delivery Options Delivery StrategyCharacteristicsAdvantagesDisadvantages in-sourcing Internal capacities are used for the design, development, maintenance, execution, and/or offer of support for the service. Direct control Freedom of choice Familiarity with internal procedures Cost and time for delivering services Dependence on internal resources and competencies outsourcing Engaging an external organization for the design, development, maintenance, execution, and/or offering of support of the service. Focus on core competencies Reducing long-term costs Less direct control Unfamiliarity with the skills of supplier co-sourcing A combination of in- and outsourcing in which various outsourcing organizations work cooperatively throughout the lifecycle. Time to deliver services Better control Complexity of projects Intellectual property and copyright protection 39

40. IT Service Delivery Options (cont.) Delivery StrategyCharacteristicsAdvantagesDisadvantages multi-sourcing Multiple organizations make formal agreements with the focus on strategic partnerships (creating new market opportunities). Expanded market opportunities Competitive response opportunities Complexity of projects “Culture clash” business process outsourcing (BPO) An external organization takes over a business process, or part of one, at a cheaper location (for example, call center). One-counter functionality Access to specialized skills Loss of knowledge Loss of relationship with the business application service provision Computer-based services are offered to the customer over a network. Access to complex and expensive solutions Support and upgrades included Access only to facilities, not knowledge “Culture clash” 40

41. Implementation – Planning Strategy  Define planning horizons. Try to be comprehensive in defining architectures and governance, but do not plan everything immediately. Rather, make detailed plans for 3 years period, and more strategic plan for 5-10 years, but with less details, …  Define Progress Indicators  Define planning documents, for example:  “eHealth Strategy” (policy and strategy paper with simplified details on implementation)  “eHealth Implementation Plan/Road Map” with more details on functional architecture, business models, technical architecture, legal and standardization issues, programs/projects to be implemented, budget, timeframe, responsibilities,, etc.  Define re-planning dynamics 41

42. Implementation - Funding  Funding business models that enhance incentives for implementation.  Funding structure that follows the decision making structure (“who gets the money for something, that one is making decision about it, but is also responsible for that”).  For example, is central implementing agency 100% on budget, or it needs to be partially financed by IS users (polyclinics, hospitals)? Also, is everything implemented/financed by that central unit? If not, does it mean polyclinics and hospitals have budget for eHealth? These are all different models of funding that will require some decisions and institutional/legal changes – and that needs to be clearly stated and planned in the Strategy, so the government can approve it.  Who decides on investments?  Funding of national, regional and local level? Substitutes, co- financing, …  … 42

43. Implementation – Investment Plan  It shall not be too detailed, but must cover the implementation of crucial components. It must be clear how will it be implemented, in which timeframe and how will it be financed.  Implementation Matrix (Component, Time-frame, Estimated Investment)  Investment Matrix (Component, Project/Program/Activity, Investment Source) 43

44. Implementation - Funding  Funding business models that enhance incentives for implementation.  Funding structure that follows the decision making structure (“who gets the money for something, that one is making decision about it, but is also responsible for that”).  For example, is central implementing agency 100% on budget, or it needs to be partially financed by IS users (polyclinics, hospitals)? Also, is everything implemented/financed by that central unit? If not, does it mean polyclinics and hospitals have budget for eHealth? These are all different models of funding that will require some decisions and institutional/legal changes – and that needs to be clearly stated and planned in the Strategy, so the government can approve it.  Who decides on investments?  Funding of national, regional and local level  …

45. Stimulation mechanisms 45 Stimulation/ Innovation Fund ($$$) Certification according to functional and technical standards HF1 HF2 HF3 SP1 SP2 SP3 SP1 SP3 Stimulation fund + HF Budget + HF Budget HF contracts SP Tender Ministry of HealthHealth Facilities (HF), or regions? HF2 Source: Ministry of Health of the Republic of Kazakhstan, 2013 Software Solutions Project proposals

46. 4. Governance Nice plan, but WHO will run it? 46

47. Governance – Leadership and Implementing Structures  Who will lead the implementation of the Strategy on 4 levels? Be very clear and specific in defining structures for:  Policy. What is the long term responsibility of the policy level? Who is doing it? What is the revised organizational structure needed, ….  Regulation and standardization. What is the long term responsibility of the regulation and standardization level? Who is doing it? What is the revised organizational structure needed, ….  Implementation Management. What is the long term responsibility of the implementation management level? Who is doing it (some sort of central institution only, or hospitals/PHC, or, groups of hospitals/PHC are also managing the part of it?), what is the revised organizational structure needed, what additional capacity is needed, ….?  Operations. What is the long term responsibility of the operations level? Who is doing it? What additional capacity is needed? How to do it on national, regional and local levels? Who is responsible for operations in health facilities? How are implementation management and operations separated? Data management and data quality assurance issues? 47

48. Separation of governance, implementation and operations is important Governance -Policy -Standards -Regulations Governance & Regulation Information Analytics & Management Implementation Management & Quality Mgmt. Implementation Support Business processes Main implementation body/bodies: - Information Analytics & Mgmt. - Coordination of Implementation - Data Quality Mgmt. - Contracting the implementation - Operations IT Industry – Solutions/Operations HC Facility 48

49. Identify needed Regulations, Standards and Interoperability requirements  Terminology/Health Data Dictionary  Codes and directories  Business Processes/Functional Standards  Basic data semantics/structures standards (e.g. EMR, referrals, prescriptions, orders, imaging).  Identification and authentication services  Messaging standards  Software certification standards (important for all implementation models, but very important in case of open market implementation model)  … 49

50. Identify legislation, policies and compliance requirements  Changes of laws and internal rules/rulebooks needed for the implementation  Privacy policy  Compliance to other privacy policies (national, international)  Access and consent policy  Audit policy  Software certification and licensing policy  … 50

51. Main implementation body/bodies  One or more (eHealth Center? eGov?)  Legal status – controllable, but agile (agency, public enterprise, foundation, …)  Ownership  Business model  Key organizational units/staffing  Responsibilities/Technical processes  Knowledge/capacity needs  … 51

52. Look for examples from other sectors/countries  Estonia e-Health foundation  Founded by 7 main stakeholders (Ministry of Social Affairs of Estonia, North Estonia Medical Centre, Tartu University Hospital Foundation, East Tallinn Central Hospital, Estonian Hospitals Association, The Estonian Society of Family Doctors, Union of Estonian Emergency Medical Services)  Founders are Board members  Ministry has policy unit, participating in e-HF Board  Has basic budget + charges for services + fights for external financing (EU funds, global funds, international projects, consulting, …)  No developers, all project managers  Runs infrastructure Source: http://www.e-tervis.ee/index.php/en/ 52

53. Look for examples from other sectors/countries  Many (blended) options  HIF “runs the show” (Croatia, Slovenia)  Health Information Center as the part of Strategic development Unit of the MoH; no HIF (Kazakhstan)  Public enterprise strongly connected to HIF and Pension Fund; HIF strictly limited to HIF systems (Sarajevo Canton, Bosnia)  Department in MoH+strong HIF (Macedonia)  Very strong directorate in MoH; health insurance not involved (Turkey)  eGovernment Center implementing integrated PHC+SHC solution (Armenia)  Small unit in MoH (Kosovo) 53

54. Critical Questions C A P A C I T Y  Under what conditions the introduced IT systems will be sustainable in long term?  What are the institutional and individual responsibilities for the system development and implementation? What organizational arrangements are needed for the system implementation, maintenance and future improvements (development teams, implementation teams, system support and maintenance units, …)?  What managerial capacities are needed for the management of the process?  What managerial and technical processes need to be established in order to facilitate and control the implementation process?  What body of knowledge is needed for the teams to run the processes well? What knowledge will be needed for system users to use the system on daily basis?

55. Critical Questions (cont.) C A P A C I T Y  What information will be needed for the system implementation? Who will provide that information?  As a result of the system implementation, what software packages will be considered as organizational resource for goods and services delivery, and what packages will be needed as resources for the system development and implementation?  How will the infrastructure for the future system be implemented and maintained? Who will be institutionally responsible for that?  What budget will be needed for the system implementation, maintenance and future improvements? What are rough estimates of investment and recurring costs?

56. Capacity for IT governance grows in time C A P A C I T Y

57. 57

58. UKRAINE eHealth Strategy - “Strategic and Architectural Options for Effective Implementation and Integration - Zlatan Šabić Kiev, Ukraine, April, 2016 58