Australian Digital Health Agency A Health Interoperability Standards Development, Maintenance and Management Model for Australia Final, Version 1.1, 28 January 2020 Prepared by: Author: Executive Consultant: David Rowlands ADHA Standards Development Model Final, Version 1.1, 28 January 2020 DOCUMENT INFORMATION Document Provenance This document is the final deliverable of a contract, dated 3 January 2019, between the Australian Digital Health Agency and JP Consulting (Aust) Pty Ltd. Document Acceptance A Health Interoperability Standards Development, Maintenance Deliverable Details and Management Model for Australia, Final, Version 1.1, 28 January 2020. Accepted on Behalf of ADHA by: Mr Michael Costello ______ / ______ / ______ Accepted on Behalf of JP Consulting by: Mr Jeff Parker ______ / ______ / ______ Author Contact Details Company JP Consulting (Aust) Pty Ltd. ACN 065 387 573 Postal Address PO Box 512, Albion Qld 4010, Australia Contact Person Jeff Parker, Managing Director. Mobile: +61 411 110299 E-mail address [email protected] Web Address http://www.jpconsulting.com.au Report Author David Rowlands, Executive Consultant Related Documents 1. A Health Interoperability Standards Development, Maintenance and Management Model for Australia, Executive Summary Report, Final, Version 1.0, 30 June 2019. 2. A Health Interoperability Standards Development, Maintenance and Management Model for Australia, Supplement, Final, Version 1.0, 30 June 2019. Document History Version Date Changes Author(s) 1.1 28 January 2020 Updated Final. Included client feedback Jeff Parker 1.0 30 June 2019 Final Version David Rowlands 0.2 30 May 2019 Updated Draft for Review David Rowlands 0.1 14 May 2019 Initial Internal Draft David Rowlands Author: David Rowlands 2 of 154 ADHA Standards Development Model Final, Version 1.1, 28 January 2020 TABLE OF CONTENTS 1 INTRODUCTION ................................................................................................. 9 1.1 Methodology ................................................................................................................. 9 1.2 Definitions ..................................................................................................................... 9 PART A: ANALYSIS OF THE PROBLEM ............................................................... 10 2 THE NEED FOR STANDARDS ........................................................................ 11 2.1 Interoperability is impossible without standards ................................................... 11 2.2 Drilling down .............................................................................................................. 12 2.3 Other benefits of standards ....................................................................................... 15 2.3.1 Safety ....................................................................................................................... 15 2.3.2 Comparability .......................................................................................................... 16 2.3.3 Preventing information blocking ............................................................................. 17 2.3.4 Improving economic productivity............................................................................ 18 2.3.5 Simplifying and accelerating product development ................................................ 18 2.3.6 Improving health literacy ......................................................................................... 18 2.3.7 Facilitating international trade ................................................................................. 19 2.3.8 Standards and innovation ......................................................................................... 20 3 THE NATURE OF STANDARDS AND STANDARDISATION ......................... 21 3.1 What are standards?.................................................................................................. 21 3.2 What are interoperability standards? ...................................................................... 22 3.3 What is standardisation? ........................................................................................... 23 3.4 The nature of standards and standardisation for health sector interoperability 25 3.4.1 Market failures ......................................................................................................... 25 3.4.2 Development timeframes ......................................................................................... 27 3.5 Characteristics of high-quality standards ............................................................... 28 3.6 Requirements for appropriate, effective and efficient standards development ... 30 3.6.1 Principles.................................................................................................................. 31 3.6.2 Roles and functions .................................................................................................. 35 3.6.3 Trends in standards development............................................................................. 38 3.7 A complex adaptive ecosystem .................................................................................. 44 3.7.1 Complex adaptive systems ....................................................................................... 44 3.7.2 The ecosystem .......................................................................................................... 45 4 LESSONS LEARNT ......................................................................................... 48 Author: David Rowlands 3 of 154 ADHA Standards Development Model Final, Version 1.1, 28 January 2020 4.1 Lessons from our past ................................................................................................ 48 4.1.1 2010-11 to 2016 ....................................................................................................... 50 4.1.2 From 2016 – ADHA ................................................................................................ 52 4.1.3 Cultural issues .......................................................................................................... 53 4.2 Lessons from overseas ............................................................................................... 53 4.2.1 The UK, USA and Europe ....................................................................................... 53 4.2.2 WHO fora on Health Data Standardisation and Interoperability ............................. 54 4.2.3 Global Digital Health Partnership ............................................................................ 55 4.2.4 Lessons from eHealth more broadly ........................................................................ 55 4.3 Lessons from other industries ................................................................................... 56 4.4 Lessons from management science ........................................................................... 59 4.5 Summary – Key lessons ............................................................................................. 59 PART B: CURRENT STATE ANALYSIS ................................................................ 61 5 DEMAND FOR INTEROPERABILITY STANDARDS IS INCREASING ........... 62 5.1 Strategic shifts in the health system ......................................................................... 62 5.2 Tactical pressures....................................................................................................... 64 5.3 Strategic shifts in IT................................................................................................... 66 5.4 Tactical shifts in markets .......................................................................................... 69 5.5 Summary – Demand factors ..................................................................................... 70 6 SUPPLY CAPABILITY IS CONSTRAINED ...................................................... 71 6.1 Suppliers ..................................................................................................................... 71 6.1.1 Data content suppliers .............................................................................................. 72 6.1.2 Health Concept representation suppliers ................................................................. 74 6.1.3 Data exchange standard suppliers ............................................................................ 76 6.1.4 Data integrity standard suppliers ............................................................................. 81 6.1.5 Suppliers of complementary services ...................................................................... 82 6.2 Standards development orientation ......................................................................... 85 6.3 Unbalanced investment ............................................................................................. 86 6.4 Political awareness and will ...................................................................................... 87 6.5 Orchestration.............................................................................................................. 88 6.6 Analysis of Australia’s current situation against success factors .......................... 89 6.7 Strengths, weakness, opportunities and threats ...................................................... 91 6.8 Stakeholder analysis .................................................................................................