Trillium Bridge Bridging Patient Summaries across the Atlantic
WP 5 – Policy Convergence Draft strategy briefs
Version: 1.0
Date of Issue: September 1, 2015
FP7-610756 Trillium Bridge Draft Strategy Briefs
2 Document Information
Deliverable name (dc:title): Draft strategy briefs Deliverable No. (dc:identifier) 5.1, Final Work Package WP5: Policy Convergence Date of Issue (dc:date.issued): September 1, 2015 Status Proposed final draft for consortium review Version (dc:relation.hasVersion) 3 Replace (dc:relation.replaces): n/a File Name FP7-SA610756-Trillium_Draft_Strategy_Briefs.docx Nature1 (dc:type) R Disseminiation Level2 PU (dc:accessRights)
Name Organisation Responsibile (dc:publisher): Dipak Kalra EuroRec Responsibile (dc:publisher): Author (dc:contributor.creator): Autore (dc: contributor.creator): Contributor (dc:contributor): Contributor (dc:contributor):
Contributor (dc:contributor):
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Contributor (dc:contributor): Contributor (dc:contributor):
Contributor (dc:contributor): 4
1 Please indicate the nature of the deliverable using one of the following codes:R = Report, P = Prototype, D = Demonstrator, O = Other 2 Please indicate the dissemination level using one of the following codes: PU = Public PP = Restricted to other programme participants (including the Commission Services). RE = Restricted to a group specified by the consortium (including the Commission Services). CO = Confidential, only for members of the consortium (including the Commission Services).
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6 Document History
Date Vers. Editor Change Status
28/02/2015 0.1 Dipak Kalra Initialization Draft
30/3/2015 0.2 Dipak Kalra Updated to summarise the workshop, Draft update some templates and to add an annex with the workshop agenda
30/3/2015 0.2 Dipak Kalra Additional annex reformatting the Draft plus material out of templates
31/3/2015 0.3 Dipak Kalra and Catherine Updating further templates following the Final draft Chronaki workshop, updated Approach section
1/9/2015 1.0 Dipak Karla Update of the Executive Summary Final
8 Please note that the template contents and many discussion contributions were produced by many of the consortium members on both sides of the Atlantic.
10
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12 Table of Contents
1 EXECUTIVE SUMMARY ...... 5 14 2 BACKGROUND ...... 6 3 APPROACH ...... 7 16 4 STRUCTURE OF THE TEMPLATE FOR CAPTURING DETAILS OF EACH POLICY AREA ...... 9 5 TOPIC AREA TEMPLATES: EDUCATION...... 11 18 6 TOPIC AREA TEMPLATE: INCENTIVES ...... 16 7 TOPIC AREA TEMPLATE: INNOVATION ...... 20 20 8 TOPIC AREA TEMPLATES: FUTURE STANDARDISATION ...... 24 9 TOPIC AREA TEMPLATE: CROSS-VENDOR INTEGRATION ...... 30 22 10 TOPIC AREA TEMPLATE: PRIVACY AND SECURITY ...... 35 11 TOPIC AREA TEMPLATE: RESEARCH ...... 40 24 12 ANNEX 1: DETAILED NOTES OF THE E-CONSULTATION WITH EXPERTS ...... 44 13 ANNEX 2: AGENDA AND PARTICPANT LIST FOR THE MARCH BRUSSELS WORKSHOP ...... 58 26
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28 1 Executive Summary
30 This report is the second release version of the first deliverable from work package 5 of the Trillium Bridge project: D5.1. This work package considers the areas of strategic change and collaboration 32 will be needed to catalyse the wide-scale adoption and use of shared health summaries to support unscheduled (including emergency) patient care on both sides of the Atlantic. 34 The work package is targeting the development of adoption strategies, and to propose 36 recommendations for policy convergence between the US and the EU to facilitate these adoption strategies. Seven key topics are identified as being the most important areas in which adoption 38 strategies may be needed:
40 Education Innovation 42 Incentives Future standardisation 44 Cross vendor integration Privacy and security 46 Research
48 This deliverable reports the investigations into the principal challenges that may need to be 50 addressed for such scaling up, under these seven topic areas, and some candidate approaches are proposed. These are presented as a series of templates, at present each having some 52 incomplete sections that will be populated in the coming weeks.
54 This release version reflects the main conclusions to date of initial project meetings and lessons learned so far during Trillium Bridge, specific e-consultations with transatlantic experts on these 56 seven topic areas, and the outcomes of a transatlantic workshop held on 23rd and 24th March, in Brussels. The outcomes from that workshop are still being consolidated, so this deliverable 58 represents a work in progress on that content, which will be revised and republished in Deliverable 5.2. 60 The work in this deliverable will be updated during April and May 2015 through further online 62 consultation with relevant domain experts. Through this consultation process a set of recommended adoption strategies and areas for policy convergence will be proposed. They will be 64 presented and discussed during the eHealth week conference in May 2015, in Riga. The final consensus agreement on these adoption strategies and recommendations will be published as the 66 second and final work package 5 deliverable: D5.2.
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68 2 Background
70 It is recognised that it is challenging to deliver safe and effective care to patients presenting to a general practitioner or emergency department in a context where there is no background health 72 information on the patient. Medical summaries, sometimes given to patients to carry on paper when they travel, and at other times sent urgently by fax, have long been used as a method of 74 quickly informing an emergency care provider of the salient facts to enable them to make safe and optimal decisions. On the other hand, many unscheduled care encounters are handled in the 76 absence of any such summary information, and many healthcare providers are used to dealing with clinical situations where they have to infer all that they need to know, including scenarios in 78 which a patient is unconscious or unable to give a clear account, and where there be no relative or other carer to provide this information. 80 Clinically led developments of standardised medical summary specifications have been published 82 over many years, in different countries and by different specialties, the most widely known being the ASTM Continuity of Care Record (CCR). The CCR is a generic medical summary intended to 84 convey salient information when handing over the care of a patient from one organisation to another, such as when a patient is discharged from hospital. Standards bodies such as HL7 have 86 developed technical representations of this summary that can be exchanged as electronic messages. There have been subsequent but divergent activities in the US and the EU to formalise 88 the representation of an emergency care summary that can be used to inform an unscheduled clinical encounter. Recognising that there is value in transatlantic collaboration to support 90 emergency care scenarios when European patients travel to the US and vice versa, the Trillium Bridge project has brought together informatics experts and representatives from key standards 92 bodies to create a bridging translation between these summary specifications. That work has been reported in project deliverables from the packages 2, 3 and 4. 94 Work package 5 takes as its starting hypothesis that this bridging has been successfully specified 96 and is ready to be implemented by the vendors of EHR systems and other eHealth infrastructure components and services. It basically ask the question "What else is needed in order for this 98 bridging specification to be widely adopted and incorporated into products, deployed across Europe and the US, successfully used by healthcare organisations to generate meaningful 100 summaries, for receiving healthcare providers to trust and make good use of that summary information, and for all stakeholders to be comfortable with the protections in place over these 102 information flows." looking to the future, this work package also asks "What are the implications of the learning from this project and the experience of developing standards for health summaries, for 104 the future of health informatics standardisation, and what are the future areas of research that still need to be explored." 106 These are challenging questions, and in order to remain focused on the needs of this project, the 108 adoption strategies in the seven topic areas primarily focus on the success of transatlantic shared health summaries. Inevitably, though, some of the challenges and therefore some of the strategies, 110 apply more generally to the sharing of health information between care provider organisations and between countries. 112
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FP7-610756 Trillium Bridge Draft Strategy Briefs 3 Approach 116 The seven topic areas were initially developed during the drafting of the Trillium Bridge proposal, 118 and ratified during the negotiation phase. In the early months of the project members of this work package participated in the other more technical work packages, in order to help identify early on 120 any issues and challenges that could have adoption strategy and policy implications as well as lessons learned. A cross-fertilisation of ideas also occurred between members of this project and 122 members of SemanticHealthNet, which has work packages relating to the scaling up and sustainability of semantic interoperability, which is clearly also part of the challenge space of the 124 Trillium Bridge project.
126 A set of challenges under each of the seven topics was drafted during the first year of the project starting with the collection of patient stories. It was originally hoped to hold an initial transatlantic 128 focus group meeting In May 2014. For various strategic reasons relating to the overall status of the transatlantic cooperation it was considered better advised to postpone this first policy workshop 130 from month 11 as originally planned to month 21 in the extended 24 month work plan. The overall approach in preparing this deliverable as well as forthcoming work to produce 132 deliverable D5.2 (Feasibility study of transatlantic exchange of EHRs) appears in Figure 1.
Survey Monkey st Questionnaire & 1 Challenges in the 7 Recommended Initial templates Consultation topics experts (Nov 2014–Dec 2014)
SHN Industry Forum Interoperable large-scale clinical healthcare payers, for semantic Standards nd research, business ministries and interoperability, 2 Development and intelligence and insurer policies for consultation Profiling learning healthcare interoperability January 28, 2015 Organisations
Trillium Bridge Initial rd Consultation with Workshop, 3 Deliverable 5.1 Recommendations Trillium Bridge Consultation short, medium, long Policy Briefs community March 23-24, 2015 term
EU/US Stakeholder Deliverable 5.2r1 Specific Measurable, Revision of EU/US Workshop May 10 with input from Actionable Realistic roadmap; Alignment 2015, eHealth Week, demonstrations and Timed (SMART) with PHC-34 and the Riga potential users recommendations eHealth JA
134 Figure 1: Approach in the preparation of D5.1 and (prospectively) D5.2
136 Through an online consultation process led by the project coordinator a matrix of experts mapped to the seven topic areas was constructed, and used for initial waves of e-consultation to brainstorm 138 the most important challenge areas and potential success strategies for each topic. A questionnaire was set up in Survey Monkey in November 2014 and communicated to the 64+ 140 experts that comprise the wider transatlantic community in Trillium Bridge. These are people initially invited as experts, as well as individuals or organizations that have provided a subsequent 142 expression of interest in the project. Among the questions asked were recommendations for additional people that should be approached in the Trillium Bridge efforts to further unpack and 144 prioritize the issues.
146 Following the initial consultation phase that lasted until Christmas 2014, important reflections were received which can be consulted in Annex 1.
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148 This input, along with rich interaction in the SemanticHealthNet Industry Forum at the end of 150 January 2015, were then used to populate a preliminary version of the template presented in the next section and to launch a second consultation process in preparation for the March 23-24 152 workshop.
154 The next stage of preparation for the March 23-24 Workshop has been to gather descriptions of existing resources and initiatives, on both sides of the Atlantic that contribute to the draft strategic 156 approaches. When coupled with experience gained through the Trillium Bridge project itself, this is helping to identify the remaining gaps and the potential for transatlantic convergence on closing 158 those, including specific concrete recommendations for the EU-US co-operation roadmap.
160 A template for capturing the complete description of each topic area has been developed, and these initial e-consultation inputs populated the first parts of these templates, which were 162 presented as release 1 of this deliverable (D5.1). A second round of consultation along with research on possible parallel initiatives and discussions with the European Commission led to 164 several revisions and refinements to the original template.
166 All along, the purpose of this template structure has been to help organise and capture the opinions and discussions of the contributing expert stakeholders. Each template therefore reflects 168 a heterogeneity of views, formats and levels of detail, and still has some incomplete fields. Annex 1 provides the more detailed written inputs that were used to generate the initial template content. 170 The initial templates were used to guide the intensive discussions during the transatlantic workshop held on 23rd and 24th March, in Brussels. 28 experts (including EC Officials) participated 172 in a mixture of plenary and breakout group sessions. The workshop agenda and participant list is included in Annex 2 of this report. 174 From these inputs, a set of recommendations for short and medium and long-term actions is now 176 being constructed, including recommended actions for the EU-US cooperation roadmap. These recommended actions will be presented and discussed at a final project workshop to be held 178 during eHealth week in Riga, in May 2015. The consensus outcome of that workshop will be reported as deliverable 5.2. 180
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FP7-610756 Trillium Bridge Draft Strategy Briefs 4 Structure of the template for capturing details of each policy area 184
Topic area Principal goal(s) from the perspective of this topic, to contribute to the successful scaling up of the transatlantic sharing of patient summaries
Issues to be A paragraph summarising the challenges with achieving that goal – why is this addressed difficult and probably requiring strong actions by various stakeholders?
Specific outcomes What eventually needs to be achieved in order to reach the goal stated above?
Strategic What are the concrete actions and activities that we recommend be undertaken to approaches achieve the above outcomes. These can be ingredients (sub-components) or stepping stones (a kind of roadmap).
Stakeholders 1. Numbered list stakeholders who need to be most 1. Role played by that involved strongly engaged in delivering these strategic numbered stakeholder: approaches decision maker, 2. …. funder, effector, or 3. ….. user of the solution 2. …. 3. ….
Relevant resources Simple (bullet like) list of existing policies, published resources (such as guidelines and initiatives in and educational materials, standards, tools, communities) or projects that can Europe already be used to help achieve these strategic approaches, or will make it easier – in Europe
(The name, a sentence summarising its contribution, and a reference/link)
Relevant resources Simple (bullet like) list of existing policies, published resources (such as guidelines and initiatives in the and educational materials, standards, tools, communities) or projects that can US already be used to help achieve these strategic approaches, or will make it easier – in the US
The name, a sentence summarising its contribution, and a reference/link)
Experience gained What have we learned in this project that is also a resource to help deliver these through Trillium strategic approaches: it could be insights, or know-how or particular specifications Bridge
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Inter-dependencies Are there any strategic approaches identified by the other topic areas that, if with any of the other delivered, will help achieve these approaches, or are any absolutely critical topic areas dependencies on success in the other topics?
Prioritised What are the main initiatives that could now be undertaken jointly by the EU and opportunities for the US, or undertaken on each side separately but synergistically (i.e. aligned)? transatlantic convergence
Barriers needing to What barriers that need to be overcome can also benefit from aligned initiatives? be overcome to achieve those opportunities
Recommended Stakeholder (referring to numbers used earlier) Timeline: short, medium and • Short term… • n - n months long term actions • Medium term…. • n –n months • •
Proposed concrete Are there any specific action points that should be introduced into the next iteration actions for the of the EU-US co-operation roadmap (i.e. which might need to be backed at EU/US co-operation political level, on both sides of the Atlantic)? roadmap
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188 5 Topic area templates: Education
190 Innovations such as the transatlantic patient summary must be backed up by adequate investments in workforce education. This topic area considers how to foster the development of 192 training for all health professional disciplines and specialties who will create or use data items that are contributing to the summary, so that they use terms and information structures consistently and 194 will make best use of summary data coming from other provider systems. This includes promoting the development of guidance and training for all health professional disciplines and specialties, and 196 patients, about the creation, maintenance and use of good quality health summaries, and helping clinicians to understand the extent of reliance they should place on health information received 198 through a transatlantic summary from another country.
200 Education Objectives: 1. Promote the development of guidance and training for all health professional disciplines and specialties, and patients, about the creation, maintenance and use of good quality health summaries
2. Help clinicians to understand the extent of reliance and trust they should place on health information received through a transatlantic summary from another country
Issues to be 1. The target group for education and training intervention is the end addressed user of the patient summary, as opposed to the technical developer. 2. Elaboration of an education strategy to facilitate the extensive use of patient summaries presupposes that the summary specifications, usage contexts and maintenance guidelines are finalised and agreed. 3. Full-scale interoperability of patient summaries, and universal confidence in their integrity and value will take some time to establish, but in the short-term advances can be made nationally before full international/trans-Atlantic implementation take place. 4. The scope of the patient summary education brief is to ensure that end-users, both professionals and patients, are convinced of their value and that professionals know how to create, use and maintain them. 5. Clear objective and learning outcomes need to be specified, taking account of three high level targets: a. Under-graduate healthcare professionals b. Continuous professional development (CPD/CME) for existing employees c. Patients (citizens?) 6. Education programmes must be aligned to two main content areas: a. Awareness and appreciation of the benefits of summaries, i.e. the value proposition b. Best practice is creating, using and maintaining summaries 7. Education programme content should take account of a. The variable practice in creating, and especially in maintaining, health summaries, partly because of differing perceptions of how valuable such summaries are to colleagues, and partly because of institutional culture in how patient summaries are created and maintained.
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b. The limited consensus on what levels of problem severity and detail should be included, which acute or short term events to include, if non-medical health factors belong in summaries. c. The poor guidance or consensus on when items should be removed from a summary or declared inactive, and summaries therefore tend to accumulate content rather than being carefully curated. d. The fact that different specialities have different concerns, and therefore value different kinds of content in a summary - and are not always good at considering future users from other professions and care settings. Few professionals have experience of sharing summaries with patients, and vice versa.
8. Lack of trust by clinicians in information “not collected here”, and they re-take histories, duplicate tests etc. 9. The need for clinicians to be able to determine the provenance of received information 10. The purpose of the patient summary must be known, and it made clear that the summary does not supercede the clinicians judgement or care 11. Clarity must be established around liability, which is considered outside the scope of this topic.
Specific outcomes
Strategic 1. Determine objectives and learning outcomes for professionals in the approaches two content areas outlined above a. Awareness and value proposition (to understand the extent of trust and reliance professionals can/should place on a patient summary received from elsewhere, and the reliance to place on content that has been mapped from other terminology systems or translated between languages).
b. Creation, use and maintenance (the role and ideal content of patient/condition summaries, how and how often these should be updated, how to best use them to facilitate well- integrated person centred care and how to share their maintenance and use with patients).
2. Determine objectives and learning outcomes for patients (to learn how to maintain their health and healthcare summary, and/or to collaborate with health professionals on a shared summary, and how to use this, potentially along with more detailed health information, to become more active in their own health and wellness strategy, healthcare decision-making and empowerment. (Education of patients may be as simple initially as providing them with a cover page “How to read and interpret your patient summary”, similar to what financial institutions provide their client when they receive a financial summary. It could also encourage patients to interact with their providers to correct, or add information to their summaries where necessary.)
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3. To use health summaries as a tool to improve health literacy across the populations. 4. For healthcare professionals to understand some of the key principles of health informatics and interoperability, in particular about the use of clinical terminologies and clinical models to construct and populate patient summaries, and about the value and limitations of mappings to broker across heterogeneous terminologies and languages. 5. For healthcare professionals and patients to understand about the role of information security to protect privacy when summaries are shared, the limitations of what can be achieved through security measures, and the roles that they can play in ensuring that good information governance practice is followed.
Stakeholders 1. Healthcare professionals 1. user involved 2. Patient associations 2. user 3. Healthcare professional associations 3. effector 4. Education providers 4. effector 5. Health apps developers 5. effector 6. Public health agencies 6. sponsor 7. EHR system vendors 7. effector 8. Ministries of Health, health insurers 8. decision-maker 9. Medical defence associations 9. decision-maker Relevant Resources and initiatives do not necessarily have to be specific to patient resources and summaries, especially in the early stages of education, when use and initiatives in acceptance are being promoted nationally on both sides of the Atlantic. Europe General undergraduate/pre-service and post-graduate/in-service/CPD programmes in EHR, EPR, health informatics, health information management and health ICT in universities, as starting point.
Across Europe and the US there is a range of resources available already, and actively being edited, curated, expanded etc, to form a matrix of healthcare roles, competences and curriculum guidelines. Cf the work of the EU-US MoU established Working Group on Healthcare Workforce development. While much of this material is important in the broader context of health informatics, it can be searched for content relevant to patient summaries.
http://wiki.siframework.org/Workforce+Development+Work+Group http://hitcomp.siframework.org/
Relevant resources and See above. initiatives in the Also work done by AHIMA and its GHWC (Global Health Workforce US Council)
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Experience gained Importance of vendors and professional associations through Trillium Stable standards required Bridge
Inter- Innovation dependencies with Incentives any of the other Privacy and Security topic areas Prioritised Promotion at medical congresses (informal Way – advocacy, newsletters opportunities for etc) transatlantic US associations tend to have both Informatics and education sections and convergence could prescribe learning goals and paths. Harmonised summary for clinicians needed Harmonised specifications needed for vendors MUIII - opp for new resources Cooperation among associations – AMIA, EFMI, AHIMA
Barriers needing It is essential that any education measures identified are integrated into the to be overcome to undergraduate training of doctors, nurses and all healthcare professionals, achieve those as well as being available (mandated?) for practicing professionals. opportunities The critical point is that personnel who create/contribute to patient summaries according to agreed standards should be persuaded that the standards are enforced and be able to trust the information contained in the summaries.
Recommended 1. Identify champions (with authority), eg 3 months short, medium and CMO’s long term actions 2. Ensure buy-in by decision makers 3-6months 1. Elaborate benefits of patient (any or all of these summaries could be Roadmap 2. Communicate need for education for actions) stakeholders to ensure widespread adoption 3. Clarify definition of the international patient ? summary, emphasising that it is standards based 4. Define the selling points and value ? proposition 5. Finalise technical specification for ? summaries 6. Define learning outcome for different target (timelines groups dependent on items 7. Develop curriculum guidelines 3,4 and 5 which are 8. Source/create content outside the scope of 9. Identify venues for education services the education topic) 10. Identify delivery media/modes
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Proposed actions Prescribe/mandate professional development of relevant healthcare for the EU/US co- professionals in this critical information sharing of patient summaries. CPD operation should be recorded, certified and perhaps contribute to the registration of roadmap personnel. Overlap emerging between the workstreams of interoperability and workforce development and this should be reflected in the
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FP7-610756 Trillium Bridge Draft Strategy Briefs 6 Topic area template: Incentives 208 This topic area explores the possible financial and non-financial incentives that may encourage 210 high levels of completeness of summaries, and for the implementation and deployment of EHR systems and other eHealth infrastructure products and services that conform to Trillium Bridge 212 specifications. This is important since safe clinical decision making on the basis of a communicated patient summary relies upon its accuracy and completeness (e.g. allergy list, 214 medications), whereas clinicians are not currently very motivated to maintain summary data within their own systems (they often know their own patients well). 216
Incentives A currency for patient summaries: determine the financial and non- financial incentives needed to encourage high levels of adoption of high quality patient summaries, and for the deployment of conforming EHR systems Issues to be The ready availability of useful patient summaries to support safe and addressed effective care to unfamiliar patients will require health professionals to invest time in maintaining good quality summaries on all of their patients, and for the wide scale deployment of EHR systems that support the transatlantic exchange of patient summaries possibly based on Trillium Bridge interoperability specifications. Incentives may be required for different stakeholder groups to achieve this.
Specific objectives
• Turn demonstrations into specifications • Incentivize the pre-requisites to exchange of summary records, e.g., NCP, privacy policy, identifier, certification of health care providers • Achieve motivation for exchange of the patient summary • Ability to produce patient summaries that are of sufficient quality and conform to specification • Focus on what is meaningful to the consumer of the patient summary • Address clinical requirements
Strategic 1. Healthcare professionals will feel incentivized to configure and maintain approaches patient summaries if their design is professionally led, reflects the information that they believe most relevant to their specialty perspective on the patient, and not through automated summary generation that results in overcrowded extracts of the less relevant information. The incentive will be greater if we can reach consensus across specialties on a single summary (or summary profiles for specialties or diseases) that can genuinely allow interdisciplinary collaboration. May want to start with the unplanned care use case before addressing continuing and specialty care 2. Health care providers should be reimbursed or given other incentive payments for maintaining complete and up-to-date summaries on their patient populations. 3. It should be a required component of healthcare professional accreditation and staff appraisals that they can demonstrate competence and commitment to creating and updating healthcare summaries on their patients.
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4. Patients should be given incentives through their health insurer, such as discounted premiums, if they maintain an up-to-date health and wellness summary, or demonstrate that they contribute to a summary maintained by their local health care provider. Patients should be incentivized to receive training and become accredited “ePatients”. 5. An important incentive will exist when it is possible to demonstrate how good quality shared summaries make continuity of care safer, more efficient and cost effective. Metrics are needed on how to assess the quality of a patient summary, and on how to demonstrate the value of sharing good-quality summaries. 6. In determining high quality summaries, we should distinguish between provider to provider patient summary; and EHR to EHR transfer of structured or semi-structured data or automatic synthesis of a patient summary particularly in relation to problems and medications. In redesigning processes attention should be paid to workload and workflow. 7. Patient’s ability to audit provides an incentive to the patient. This creates a downstream incentive to the health care provider to provide the tools to allow patient access to their summaries. 8. Cultural change of General Practice as a result of the increase in women GPs who prefer to work in groups.
Note: Local incentives can produce local results that enable cross-border exchange of patient summaries
Recommendation: Review the successful demonstration of exchange of patient summaries and the incentives that worked in these programs.
Stakeholders 1. The Citizen 1. effector involved 2. Patients Associations 2. effector 3. The Health Professional 3. sponsor 4. Healthcare professional associations 4. evidence producer 5. Education providers 6. Healthcare funders and insurers 7. Healthcare Institutions Types of Incentives: 8. Research organisations 1. Legal 9. Advocacy groups 2. Clinical 10. Other stakeholders in the cross-border service 3. Economical value chain 4. Social Relevant resources and initiatives in Europe
Relevant CMS Incentive program… resources and initiatives in the US
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Experience gained through Trillium Bridge
Inter- • The business model must provide incentives for implementation dependencies with • Informatics education for clinicians any of the other topic areas
Prioritised opportunities for transatlantic convergence
Barriers needing to be overcome to achieve those opportunities
Recommended Stakeholder Action Timeframe short, medium and long term actions Provider Review the successful 6 months demonstration of exchange of patient summaries and the incentives that worked in these programs. Include local incentives that are in place.
Provider Provide CME/CPDs for education 2 years after on maintaining patient systems and summaries and the creation and training policy maintenance of the underlying and tools are in patient data. place
Provider Financial incentives to providers for the creation and sharing of patient summaries
Provider Measure and reward the maintenance of high quality data in EHRs
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Patient Travel insurance companies require patient summaries
Proposed actions for the EU/US co- operation roadmap
Other Thoughts • Health Care Professionals or Healthcare Provider should define the PS structure and contents • Perception of reputation is an incentive relevant in healthcare
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FP7-610756 Trillium Bridge Draft Strategy Briefs 7 Topic area template: Innovation 220 This topic area considers how best to stimulate a vibrant market in applications that capture and 222 deliver patient summaries that are meaningful and useful to care providers and meaningful and useful to patients e.g. mobile device apps. There are presently some perverse incentives, and 224 disincentives, to establishing business models for scaling up the exchange of summaries. Hosting the infrastructure to communicate patient summaries across borders is expensive to establish and 226 maintain, including the various governance and translation services. The summary sender is not responsible for the care required urgently elsewhere, or its costs. The receiver will get paid for 228 delivering care, and might actually be paid more for performing tests that duplicate recently performed tests. Cross border services are presently most used by business travellers and 230 holidaymakers, not the most ill or elderly.
232 Innovation Stimulation of a market supporting the patient summary in applications that capture and deliver patient summaries, evolving novel products, software as service packages and novel business models and opening up new markets and customers for differently thinking entrepreneurs. Issues to be Vendors need to perceive a market that justifies their investments in addressed implementing the Trillium Bridge interface, and applications for clinicians and for patients that enable the easy curation of patient summaries, and support views of communicated summaries that aid safe and effective decision making. This market will be driven by procurements within the health sector and by consumer purchases. This in turn need to be stimulated by value demonstration from early adopters. It will need to be a global market, underpinned by global standards, and motivated by a hunger for comprehensive, ready-to-use,.patient-specific information and patient-relevant knowledge.
Strategic 1. Demonstrate the success and value of sharing patient summaries, approaches internationally, potentially using showcase events such as the world Olympics. 2. Efforts and strategies towards a clinically consistent and technically standardised summary must be global, using and contributing to international standards, to avoid fragmentation within the marketplace of implementations. This should be complemented by promoting a culture of using standards rather than inventing local solutions, while at the same time encouraging invention of new systems and methods of bridging gaps when current standards are inadequate and of seamless transition between old and new standards. 3. Establish an independent, international, non-governmental entity. This entity's purpose is to certify and promote small businesses that function as trusted third parties (TTPs). While the TTP certifying entity may be initiated with government grants, revenues from business incubation and differentiation, business owner-investor meetups, certification, marketing, and education will drive the entity's long-term sustainability and profitability. The entity will certify TTPs which, through software, web, and customer-support services, curate and aggregate computable patient summaries, enable patients to find and successfully report inaccuracies in summaries, permit exclusively patient-authorised access to health summaries, and link summaries to patient-specific information derived from multiple sources including EHRs and to patient-relevant knowledge and decision supports. As a minimum,
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TTPs must repeatedly demonstrate that its management of clinical summaries conforms to international standards, functioning as the most reliable single point of information available about each patient's health history and health status. 4. The TTP Certifying Entity will partner with insurance payers, foundations focused on global health, and other motivated research funders to determine which constellations of patient summary characteristics best predict high-value processes (usability, utility, comprehension, repeated use) and outcomes (user actions that can be definitively linked to subsequent improvements in objectively measured health indicators) for the full range of demographic subgroups. The Entity will encourage investigators to look beyond the demographic predictors of patient or provider disinterest in clinical summaries (e.g., patient education, provider age) and to explore the clinical summary characteristics (e.g., user interface design) that overcome the reluctance of disinterest-prone subgroups 5. Patients must be supported to be well prepared, and motivated, to engage in self-management and the management of their health information, recognising that the patient perspective (and therefore their health information) will reflect not only the science of their conditions but the impact their health status has on their lives. This may lead to patients becoming accredited in self-management skills through eHealth tools (“ePatients”). 6. Develop incentives for current stakeholders to invest in standards compliance.
Stakeholders 1. Healthcare professional associations 1. effector involved 2. Education providers 2. effector 3. Healthcare funders and insurers 3. sponsor 4. Research organisations 4. evidence 5. Healthcare consumers (i.e., patients, informal caregivers). I submit that consumers should be prioritzed first on this list. Relevant resources and initiatives in Europe Relevant Disease Advocacy Groups (e.g., cancer, MS, diabetes) resources and National Institues of Health (e.g., NCI, NHLBI) initiatives in the Note that standardized inclusion of a family genomic history category in the US clinical summary would elevate discourse about the clinical summary, enabling it to be considered a clinically relevant tool for personalized medicine. Using the C-CDA as an example, the encounter note and plan of care sections offer the most current and significant information for patient follow- up and for future provider briefing. The experience with encounter notes in the European eHealth effort should be examined. US attempts to standardize and corporatize free-text encounter notes and care plans, which should probably be left alone as the most accessible and real portion of the clinical summary, have been (in the writer's opinion) wasteful of limited resources.
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Experience gained We learned that interoperability standards are necessary but not sufficient through Trillium to make clinical summaries so indispensable to end users that they simply Bridge can't do without them. Patients and providers perceive little value in standardized EMRs (as Robert Wachter explains in his March 21, 2015 New York Times op-ed "Why Health Care Tech Is Still So Bad). To deliver exceptional marginal value, clinical summaries must be more than just standardized extracts from EMRs. They must, in fact, respond to the end user needs expressed in high-priority user stories representing disruptive business cases for new entrants to the HIT marketplace. A standardized international clinical summary must be tuned, first and foremost, to a primal user story (such as the terrors of unplanned care in an unfamiliar place) that resonates with consumers and providers of diverse demographics in various EU countries and US states. We also learned that methods and systems of interoperability developed with government funding and incorporating rapidly and unpredictably changing government mandates, may be too costly or impractical for small startups to successfully integrate into new products that will charm end users. This lesson implies that a potential TTP Certifying Entity should point inventors and entrepreneurs toward the end zone without dictating how to get there. Interdependencies As noted above, the topic of Innovation is interdependent with other topic with any of the areas including: research, education, standards, security and privacy other topic areas
Prioritised Given the widespread concerns among all healthcare consumers about opportunities for medical mistakes and breaches of sensitive personal information and the transatlantic pushback among healthcare providers against billing-focused EMRs, the convergence business opportunity exists for suppliers of a "just-enough standardized" international clinical summary that addresses end user pain points in the context of the unplanned care use case. Barriers needing Government offers barriers by requiring and then changing standards, to be overcome to offering incentives and penalties for standards compliance but not achieve those enforcing compliance, financing a standards development industry that opportunities profitably engages in endless standards development, never sufficiently funding independent R&D on the actual impact of standards on healthcare outcomes for diverse demographic and clinical patient subgroups, and catering to healthcare providers with scant concern about patients. HIT is not an end, in and of itself, and there is no evidence to date that HIT is a medium that will transform healthcare delivery, make it more cost-effective for funders, or improve the quality of life for patients. A mindset among policy makers that ignores this conundrum is, arguably, the greatest barrier of all.
Proposed actions See the "Strategic Actions" section above. Also: (1) Encourage for the EU/US co- government and policy makers to introduce mature standards and commit operation to stability of these standards, giving HIT businesses a necessarily roadmap predictable infrastructure. (2..) Build an investment bridge (in addition to policy, care delivery, and standards bridges) enlisting the asssistance of corporate grantmakers whose global employees would benefit from international clinical summaries such as Gates Foundation.
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Recommended Stakeholder Timeline: short, medium and • action… • long term actions • … • Stakeholder Timeline • action… • • … •
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236 8 Topic area templates: Future Standardisation
238 The Trillium Bridge summary will need to interface with many other health informatics specifications and standards, and it will therefore be vital to engage standards development 240 communities (e.g. through the JIC) in adopting the summary as a standard and interfacing it with other relevant standards. One of the key problems is that standards have traditionally been 242 developed in silos, within individual SDOs, whereas patient summary communication, and other similar flows needed in the future, use multiple standards together. The Joint Initiative Council of 244 ISO TC 215 has enabled some degree of mutual awareness of forthcoming standards across SDOs, and cross-balloting of them if relevant, and work is in progress to allow standards from 246 other SDOs to be incorporated by ISO by reference. However, the SDOs need to better enable the easy and reliable bundling of multiple SDO standards that do need to be used together to deliver 248 specific interoperability solutions. This topic considers how to engage SDOs in adopting the patient summary as a global standard and interfacing it with other relevant standards supported by 250 interoperability assets. It will also consider how standards could be better promoted by health ICT policy makers and decision makers and the industry. 252
Future Engage SDOs in adopting the patient summary as a global standard standardisation and interfacing it with other relevant standards supported by interoperability assets Standards must target clearly defined purposes and interoperability use cases, and meet clearly specified user requirements Standards need to be actively promoted by health ICT policy makers and decision makers and the industry Issues to be A transatlantic, and ultimately global, market in interoperable services for addressed handling and communicating health summaries will require many (technical, semantic and security) standards. Despite being developed and published by different SDOs, the portfolio of standards needed to deliver a wide-scale and acceptable solution must be capable of being implemented together by different vendors in reliable and consistent ways. Industry (and downstream end users) must be able to judge and trust that these standards have been developed to a high quality. SDOs will therefore need to collaborate to deliver “joined up” standards that are of high quality and are maintained in synchrony. The development of standards is not always a clear response to well documented requirements, and targeted to enable a particular and well delineated functional (interoperable) capability. Scope creep often occurs, sometimes resulting in standards that might meet multiple use cases but are too complex for any one of them, and/or which overlap in scope with other standards. This can easily result in vendor confusion about when to use each standard, variability in how complex standards are implemented, and is an inhibitory factor to the overall uptake of standards by the health ICT sector. The adoption of standards can be more expensive than in house proprietary approaches to implementing the same function, especially if conformance testing is part of that adoption process. Conformance to standards needs to be included within procurement specifications, and standards need to be used within nationally or regionally procured platforms and services.
Specific outcomes
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Strategic 1. Priorities for standards development need to include: approaches • relevant terminology reference sets and value lists bound to information structures for each of the categories of information to be included in summary, along with a methodology for maintaining these; • clinical models and templates to formalised the data structures for each of the main headings of information to be included in summary, that are internationally agreed and interface cleanly with terminology value lists; • internationally standardized access policy frameworks to enable global conformance to any access rules specified by the patient or their healthcare professionals; • identity management including eID, recognised across Europe and related to a standardised representation of user authorisations. 2. Standards that support the interoperability of health information must address the clinical requirements for the inclusion of provenance data, and for ensuring appropriate access controls for the communicated information. 3. SDOs and other producers of terminology systems need to make available reliable and quality assured translations of their terminologies across European languages and cross mappings to other relevant terminologies. These syntax and terminology mappings should be targeted at helping to avoid the risk of erroneous duplication of information when summary data are integrated from multiple source systems that have used different terminology systems. 4. The process for developing healthcare semantic standards needs to consider compositional language approaches and not only specialising and constraining information models. 5. Formalised collaborations between SDOs must result in well aligned, harmonised standards that can be used seamlessly together to deliver relevant interoperability functionality. These collaboration agreements should lead to a singular portfolio of standards per high level function that are supported by all SDOs as a collective solution to interoperability. 6. Profiles of a standard developed separately need to be regularly consolidated for consistency and ease of use. 7. Clinician and patient interoperability requirements for specific shared care scenarios must be understood before the scope and detail of standards to deliver that interoperability are specified. 8. The development of the standards need to better align the purposes of direct care with clinical research, public health and other aggregated (“secondary use”) data uses. 9. Individual standards need to have a well described scope and intended exploitation purpose before they are developed. There needs to be a published method of validating that the resulting standard does fulfil its
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intended scope, and if there are any important limitations or issues relating to its adoption for that scope. 10. Interoperability assets need to be promoted internationally, and openly accessible in a range of relevant computable formats (including for example semantic web formats), to encourage their adoption. 11. Governance and authorisation agreements, between countries, is needed to endorse the adoption of international standards for patient summaries rather than using local or national ad hoc standards. 12. We need to rethink standards development, deployment and maintenance, with most standards being published electronically, in computable formats for ready incorporation into tools and products.
Stakeholders 1. SDOs 1. Effector involved 2. Regional and national governments 2. Requirements holder 3. Trans-national agencies / policy-maker 4. Healthcare professionals 3. Requirements holder 5. Patient associations / policy-maker 6. Healthcare managers 4. requirements holder 5. requirements holder 6. requirements holder Relevant Several national projects related to the usage of the Patient Summary are resources and or are going to be implemented across Europe, among them for example: initiatives in The Netherlands is working on “generic data for patient transfer”, Europe an implementation of CCR/CCD, with more explicit specification of terminology, focusing on SNOMED CT. This is run by the joint Dutch UMCs in conjunction with the health IT institute (and SNOMED NRC) Nictiz. See (in Dutch…) http://www.nictiz.nl/page/Expertise/Specialistische-zorg/Generieke- overdrachtsgegevens/Klinische-bouwstenen
Italy has defined the Patient Summary (called Profilo Sanitario Sintetico) as one of the core documents foreseen by the National EHR-S (Fascicolo Sanitario Elettronico). It is a clinical document authored by the GP conceived for supporting unscheduled events (e.g. emergency). Currently there are Several different PS “flavors” defined by each region (all of them based on the HL7 CDA R2) (some of them are specialization of the PS template defined by HL7 Italy). An harmonization project has been right now started in HL7 Italy with the support of most of the regions for aligning the template with the latest national requirements.
At the European level the most important current initiatives related to the Patient Summary are : Joint Action work on implementation of guidelines The EXPAND and the Trillium Bridge projects H2020 : PHC-34 challenges
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Relevant resources and ONC Interoperability Roadmap and other inputs provided by Alex Lippitt to initiatives in the be copied in US
Experience gained through Trillium Need on focusing on few, common and relevant sections (problems, Bridge allergies, medications).
Any transformation applied to the exchanged document implies costs and information losses, any long term sustainable solution should tend to reducing the transformation / transcoding required through an harmonization activities.
For supporting the transitional phase the availability of consolidated (official) maps is critical.
Inter- Prerequisites for this action are: dependencies with any of the other topic areas • The availability of well defined use cases, user stories and scope for the exchanged data
– For achieving this both SDOs and clinicians need to be involved for securing the process.
• Achieve an agreement at the policy level, define a governance for those services
key points / lessons learned where pointed out
Authorities should not act as they were “standardization bodies”(standards should follow a consensus based process)
o The role of authorities in the standard development, endorsement and promotion is however recognized.
• Having a narrow scoped use case may help us to demonstrate it successfully this provides momentum for future expansions
– Narrow scope doesn’t imply a narrow vision, the solution should consider potential future perspectives
• A shared harmonized standard may act as an enabler factor even if we can have different levels of maturity of the interested implementers (countries)
• It has been identified as a key point the role of the Value Set Authority as operated in US
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Prioritised opportunities for transatlantic convergence Barriers needing to be overcome to achieve those opportunities
Recommended R1: Include in eHealth Network Agenda for May Timeline: short, medium and the presentation of evidence from Trillium Bridge • R1 : short term long term actions with proposed further action. • R2 : short term R2: Define clearly what are the patient stories that the International Patient Summary can fulfil and • R3 : medium term socialize it among stakeholders
R3: Clinicians, Patients, and Standards • R4: short term Developing Organization members in EU and US should be actively engaged in an incremental • R5 medium term standard development, refinement, and validation process leading to an international patient summary standard.
R4 : A political process should be initiated for establishing a Value Set Authority (VSA) at European Level building on lessons from the NLM VSA.
Note to be further analysed if this potential EU authority should cover one or both roles:
Content steward (organizations defining and maintain value sets is separate from VSA)
Service provider organization for assuring the governance, the quality assurance and the value set distribution
R5: Establish as part of the standards definition and validation process, conformity testing for adoption by users and vendors (after the initial specifications have been consolidated)
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Proposed • Support an iterative adoption-driven process leading to an International concrete actions Patient Summary standard. This should be an incremental process for the EU/US co- driven by milestones towards a pragmatic international patient operation summary that can be implemented by vendors roadmap • In order to be able to do it, Europe needs a process for forming an authority to contribute to this IPS specification: The SDO coordination platform initiative under the Joint Action might be that authority
• We need to obtain a Bilateral commitment for piloting the IPS, as demonstration of the standard that are promoted and selected by ONC, EU commission and the eHealth Network.
• EU and US should make concrete steps towards establishing a international patient summary specification starting from the baseline of Problems, Medication, Allergies established by Trillium Bridge.
• The SDO platform established by the eHealth Joint action working closely with the eStandards consortium will monitor the effort on the International Patient Summary to inform/update future versions of the EU/US roadmap
• Engage EU and US experts including the US National Library of Medicine and leading US providers, within the EU ASSESS-CT project to evaluate the core problem value set (disorder subset) of SNOMED- CT for expressing problems.
• Engage EU and US experts including for the US National Library of Medicine within the EU OpenMedicine project to identify and evaluate value set (s) appropriate for product identification in the context of the international patient summary.
• Evolve the epSOS/Trillium Bridge section on allergies with structure and value set that can be easily implemented based on the information already identified by vendors/providers.
• Value Health explores business models building on the International Patient Summaries.
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FP7-610756 Trillium Bridge Draft Strategy Briefs 9 Topic area template: Cross-Vendor Integration 258 This topic explores the cross-vendor alignment of terminologies and data structures, initially 260 through mappings, that enable each vendor to generate and export a valid summary, to import and combine summary data coming from other systems. This includes the role of conformity 262 assessment.
Cross vendor Enable every EHR system vendor to generate and export a valid integration summary, and appropriately combine summaries with other data
Issues to be Health summaries are represented differently in different EHR systems, addressed and offer users different capabilities for creating and using summary information, including linking this to other parts of a patient’s EHR. Vendors will need to be able to import and export summary data according to the Trillium Bridge summary specification, and develop methods of allowing clinicians to see imported data alongside locally held data (for example, an integrated medication record) whilst differentiating the imported data for medico-legal purposes. Given the wide deployment of legacy systems, conformance to the Trillium Bridge specification needs to have been validated using realistic legacy data. This may include mapping locally coded data (or even uncoded data) to the terms used within the interoperable summary. Vendors will need to consider, and probably to collaborate with other app developers, to enable patient access to health summary information.
Specific objectives Incentive for Vendors: vendors consider first their national or regional market and need to be encouraged for developing solutions that are able to answer the needs of the diverse users that have local needs related to their care process in their organisation of countries Access, display and store data shall be allowed by patient and national regulation Readable and understandable by the end-user (Patient and Professionals)
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Strategic 1. Conformance assessment needs to go beyond simulation through approaches reference implementations and test data, and be closer to real world validation with a realistic set of user organisations and local system configurations, including some typical legacy environments with a more basic infrastructure and with realistic existing systems and data, considering a. Two scenarios: HCP mediated and Patient Mediated b. Visualise Patient Summary or Encounter Summary c. Integrate information in systems d. Report back Patient Summary info (HCER) 1. There needs to be a better fit between the expressions used by clinicians in different care settings, and by patients, and the representations supported by standards: structures, vocabularies - especially in safety critical areas such as allergies and adverse drug reactions. The representation support should be consistent with the existing data within the systems used by the end-users 2. Care plans need to be genuinely team based, and incorporate inputs from patients as well as clinicians. 3. The provenance of health information, including its currency, must be represented and included consistently within the shared information. 4. Requirements for interoperability need to be enforced. Investment and cross-vendor collaboration is needed to lobby for regulations in support of transatlantic health information exchange that will bring patient benefit. 5. Interoperability Conformance Assessment Testing is also required in order to enforce the common framework. Developing common test tools will enhance solutions with less effort.
INCENTIVES The objective is to increase choices and drive adoption of the profiles and standards Several tools can be used: PCP (Pre Commercial Procurement) and PPI (Public Procurement of Innovative solutions), tools from the EU Commission. See Frquently Asked questions (http://ec.europa.eu/information_society/newsroom/cf/dae/document.cfm? doc_id=5207 ) Provide toolikit fro the procurers (i.e. Antilope project) Promote Project/Vendors’ best practices Existence of IoP framework and specific payment reforms that need information exchange (US) Participation to IHE Connectathons
Stakeholders 1. EHR system vendors 5. user involved 2. SDOs and standards profiling agencies 6. effector 3. Healthcare funders and insurers 7. sponsor 1. Healthcare Providers and Procurers 2. Health ministries 8. user 1. Patient (Patient Mediated Scenario) 9. policy-maker 10. user
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Relevant resources and 4. epSOS (www.epsos.eu) and Trillium Bridge initiatives in (http://www.trilliumbridge.eu ) Europe 5. EU PCP and PPI initiatives (see EU Commission website: http://ec.europa.eu/digital-agenda/en/search/site/PPI) 6. ICT Vouchers for training and conformance via structured funds 7. UK integration toolkit
Relevant See annex resources and In synthesis: initiatives in the • ONC – interoperability roadmap and Health IT certification Program US • SI framework EU/US cooperation • HSPC (HC services platform consortia) Public-Private Organisation to create an open standardised API • Meaningful Use (MU) requirement on creating a PS document within 24hrs • eHealth Initiative • HealthyWay • HL7 Structured Documents Workgroup Project (Intl) and FHIR (Intl) • Health Story Project • IHE profiles (Intl) – PCC profiles
Experience gained The two main the lessons learnt is that the success of such project is not through Trillium only related to the mapping technical even if it is still a challenge and the Bridge patient mediated scenario seems more close to adoption Preconditions are needed: National/regional infrastructure: patient and HCP identification, HCP qualification, patient consent,… Security and safety Consensus to be established: Semantic transformation and master value catalogues: o How to find terminologies and guidelines on how to use them o Maintenance issues Patient identification issues taken into account the identification process for existing identifiers
Inter- • Security and privacy dependencies with • Education any of the other • Incentives topic areas • Use cases and user stories need to be analysed thoroughly based on existing needs
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Prioritised • For cross Infrastructure: opportunities for transatlantic transactions shall be generic (see IHE profiles) convergence Common set of templates Coding system: limit the mapping
Translation
Common or mapped cross community metadata • For vendor systems:
Implementation of standards
Incentives: clear requirements, for development and implementation
Testing and conformity assessment program (common testing tools)
Sharing innovation • Prioritise use case for implementation, testing and conformance
Barriers needing Several barriers were identified from vendors side as well as user side: to be overcome to Eu and US markets are not at the same maturity with not the same achieve those objective opportunities The necessity to show the interest to share medical documents at short and medium terms for vendors and authorities (with national//regional other priorities) National Infrastructure and market need to be in place as pre conditions. End-users usability and system availibilities: some conditions should be in place (regulation, standard and profiles, terminology,… Find a roadmap to start Recommended short, medium and • Short term long term actions PCP initiative for interoperability in Europe Explore opportunities for joint strategies for testing tools Conformity assessment testing Assess payment reforms as a driver for new services – business cases Guidelines for procurers and for vendors on implementation Engaging with US Data provenance (S&I framework) • Medium term EU Actions on creating an EU Marketplace Harmonisation of specific values set based on use cases (allergies, etc) Harmonisation for transport, security and content standards based on UC and other
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Proposed actions • R1 Promote Incentives for vendors on both sides of the for the EU/US co- atlantic operation • R2 common conformity assessment scheme and roadmap mutualisation of testing tools across the atlantic
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FP7-610756 Trillium Bridge Draft Strategy Briefs 10 Topic area template: Privacy and Security 268 This topic considers adoption strategies for addressing legal issues, eIdentification, security and 270 privacy protection and the establishment of a transatlantic trust framework. A consent and a trust model are needed to ensure information transfers are lawful and meet concerns at each level 272 down to individual healthcare sites. For example, information sharing agreements may be needed, access policies either need to accompany each summary, or be agreed in advance, including 274 about the onward propagation of a received summary. Interoperability of authorisations and purposes of use need to be mapped, and identities and roles of staff at each site need to be cross 276 verified.
Privacy and Legislation as an enabler of transatlantic business use cases security involving sharing of health data
Issues to be The cross-border sharing of personally identifiable patient data between addressed and within EU countries and US states, whether for direct patient care or other purposes, must be demonstrably undertaken in a convenient, trustworthy and reliable way. The same is true for cross-border sharing of supposedly anonymized patient data, which ingenious hackers are able to re-identify based on clusters of constituent data elements (e.g., the combination of US zip code, age, gender, and disease). Current practice on both sides of the Atlantic rarely satisfies the goals of trustworthiness and reliability, as health data is often exchanged provider- provider and patient-provider through non-secure means such as email and fax for reasons including ignorance, unavailability of a more secure equally convenient option, and preference for fungible communication methods that seemingly minimize provider liability for errors and omissions during rapid communication about and with sick patients. Hence clarity in the application of data protection legislation to the health sector, suitability of legislation for the clinical workflow of providers and the personal workflow of patients, and implementation of convenient and affordable organizational and security measures (safeguards) at the providers’ organizations are required before healthcare providers will trust governmental regulations enough to comply with them instead of relying on workarounds such as email and fax. Agreement is needed regarding legitimate approaches for sharing data for health purposes across the Atlantic and necessary safeguards. Such safeguards may also become part of design requirements (privacy by design) of systems facilitating exchange. Examples of such safeguards are measures taken to ensure that
It is possible to verify that a patient summary is only sent to a recognised healthcare provider who is in charge of that patient at that time. the sender is a trusted information source, as well as that the receiver is. the identity of the patient is verified, which is especially important if the patient is authorising the communication. the patient has a priori authorized emergency overrides and is subsequently informed of such access to health data
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no sharing of identifiable patient records is possible without patient knowledge, whether this occurs for direct patient care, for reimbursements or for other purposes.
Use case specific safeguards will be also needed. For example, in some cases patients may themselves act as the authoriser of an individual healthcare professional to access their remote health summary. In other situations, such as in shared care, the authorisation policies and authorisations of individuals need to have been predetermined and be recognised in all participating countries (to enable real-time and appropriate disclosures) while mechanisms are also needed to enable the shared health data to become part of locally held health records.
Beyond sharing data for care purposes, health data should be re-usable for research and quality management purposes, either with consent or acceptably de-identified. (We are aware that no method exists of "acceptable de-identification" that does not allow a clever hacker to re- identify the data. Therefore, government investments in research that makes re-identification so difficult as to be unfeasible is needed. Moreover, the "big data" enthusiasm in health IT reflects a vigorous trade in reselling of de-identified data, which is rapidly re-identified and resold again for marketing and other less savory purposes, such as finding high-risk employees and loan applicants.) There needs to be an agreed and consistent transatlantic approach to what secondary uses of data as for example with what extent of de-identification, such use is permitted without consent, and the nature and terms of consent needed for identifiable data uses for research. Concepts associated to ownership of health data vs rights to access the data need to be also clarified in order to remove barriers related to ownership issues.
Strategic Action may be pursued at three levels approaches (i) Legislation: Health Data exchange must have a clear legal basis. There is general legislature regulating the free flow of data within EU, within the USA and across EU and USA, namely the Safe Harbour framework. epSOS has addressed the implications of the Data Protection Directive for sharing health data across borders in the EU. It is necessary to extend the epSOS analysis to transatlantic exchanges, taking into account the cultural and organizational diversities, as well as the evolving legislation on both sides of the Atlantic. (ii) Agreements: Although the common EU data protection framework and its transatlantic alignment through the Safe Harbour Agreements provide the general legal framework, there will need to be an agreement on specific organizational and security safeguards. The epSOS FWA is an example of such agreement between several MS to run a cross border pilot; the need of similar agreements establishing the circle of trust is anticipated also for any transatlantic pilot services. Legal means to secure the sustainability of these agreements beyond the lifetime of pilots, will need to be explored early on.
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(iii) Codes of practice: agreed and enforceable codes of practice on privacy and data protection support the implementation of the agreements and improve auditability for proactive monitoring and periodic audits undertaken by nominated credible Authorities or Entities on both sides of the Atlantic. (iv) Encouragement of business innovation. Government can point to the requirements for cross-border health information exchange, but only business innovators can devise and implement solutions that entice providers and patients because they are so much more convenient and have far fewer immediate and long-term adverse consequences than fax, email, phone calls, texts and other status quo methods.
Stakeholders 4. Primarily the patients and health 4. user involved professionals 5. effector 5. Privacy protection agencies and health 6. decision and policy- authorities maker 6. Health ministries and professional regulatory bodies
Relevant eHN policies resources and National Data Protection Legislation initiatives in epSOS policies, recommendations and FWA Europe WP29 document on epSOS Implementation of Privacy by Design/Default initiative Risk Impact assessment on data sharing with appropriate risk response plans in place Article 29 Woking Party document on E-Health Data Article 29 Working party document on Consent Article 29 Working party document on Fair Processing EU Model Contracts in case of third countries
Relevant resources and The Small Business Innovative Research (SBIR) grant program of the initiatives in the National Institutes of Health, particularly the National Cancer Institute (NCI) US and other disease- and genomic- or personalized-medicine focused institutes.
Experience gained It was not a primary objective of Trillium bridge to provide solution to legal through Trillium interoperability across the Atlantic; however the use cases analysed Bridge provided an excellent basis for this type of work to be carried out for the purposes of piloting and eventually deployment of such services. Inter- Standardization (privacy by design) and capturing of requirements into dependencies with interoperability specifications any of the other topic areas Education especially in relation to implementing codes of practice
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Prioritised Analysis of data protection practices in eHealth in both sides of the opportunities for Atlantic and implications of Safe Harbour Agreements in the context transatlantic of eHealth convergence Definition of mutually agreed general and use case specific policies, safeguards and measures to protect sensitive patient data including but not limited to access control levels, collection and retaining of audit trail data. Consider an effective process to identify and effectively manage data breaches with particular emphasis on cross border data sharing and arbitration mechanisms. Implementation support including through education and awareness campaigns on privacy and protection of personal data for all entities involved.
Barriers needing to be overcome to While the MoU includes provisions for piloting, there is no specified achieve those transatlantic pilot that would provide the basis for the needed legal analysis opportunities and formulation of policies concerning the exchange of health data.
Barriers to be addressed by the pilot would include - lack of specificity of the Safe Harbour Agreements to the specific requirements of health data - lack of common principles, policies and agreed privacy measures - lack of a governance process for verification of implementation, follow up and maintenance of these agreements
Recommended Stakeholder 1,2, 3 Timeline: short, medium and long term actions - Assess the application of the safe Harbour 6-18 months (6 Framework in the health domain months for procurement and 12 - Identify areas and means of convergence months for carrying in privacy and data protection policies and out a study) systems of implementation of such policies
12-24 months - Draw a list of commonly accepted (specify potentially measures and safeguards and the means within the first stage of supporting and monitoring of their of a pilot) implementation
Proposed Launch a feasibility study focusing on legal and organizational issues concrete actions involved in the use cases addressed by Trillium Bridge in order to assess for the EU/US co- the potential of implementation of business use case. operation roadmap Supplement with a real life pilot to address feasibility in practice through addressing all 4 levels of interoperability and would result in recommendations on a “ transatlantic legal-organizational roadmap” .
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280 11 Topic area template: Research
282 The summary developed through this project will need, in time, to be complemented by other summaries for specific disease or care scenarios. It will therefore be important to engage the 284 health informatics and clinical research communities in developing threads of research that will take this field forwards. Research is needed on the quality of summaries generated at scale, on the 286 relevance of the included data items and any essential gaps, and on the safety and effectiveness of clinical decisions made using the summary. Research will also be needed to collate evidence of 288 value in the shared health summary, to inform the development of other kinds of health summary and to empower patients as users of their health summary. 290
Research Research to collate evidence of value in the shared health summary, to inform the development of other kinds of health summary and to empower patients as users of their health summary
What research and supporting steps would make Trillium Bridge more valuable? Issues to be The success of sharing patient summaries will require many areas of addressed further research. The current summary specification needs evaluation, especially benefits realisation and success strategies for scaling up adoption. Future health summaries may need to be developed with enriched content for specific diseases, and to cater for planned care scenarios. In parallel, research is needed on how patients may best use their own access to the summary as a tool for empowerment and the co- production of health.
Making core concepts consistent and computable:
• Demographics • Meds • Labs • Diagnostics & procedures lists • Allergies • ADT, ...
Proving the value of the Patient Summary
• e.g., with Comparative Effectiveness (CER) • much research has been done but needs to be understood by other communities • more dissemination, review & education needed
Specific outcomes
Strategic Proposed areas needing funded research: approaches 1. Interdisciplinary, shared representations of patient summary information, of care provided and treatment recommendations, to support continuity of care and patient safety 2. The most effective ways to represent the context and situatedness of clinical judgements, and to account for clinical uncertainty 3. Ways to reduce the effort of defining and representing health information
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4. Efficient ways to making core concepts consistent and computable 5. Research into ways of identifying high-risk individuals from their EHR data (e.g. frailty) 6. Care pathways and decision support rules that cater better for multi- morbidity 7. Best practices for putting patients more strongly in control of healthcare decisions and health information flows regarding their data 8. Best practices in motivating and educating patients to curate the information needed for their own health summary, including different modalities of content and different channels such as social media 9. Best practice in educating patients to better communicate their health situations to health care providers, for example the use of patient stories depicting different health, emotional and stress scenarios, and educating patients in how to pose the right questions to their health care providers about treatment options including their costs 10. Identifying patients subgroups for whom the curation of their own health information and communication with healthcare professionals is difficult, which could be for health status, socio-economic, age income, literacy, or cultural reasons, and better equipping them to advocate for their health needs. 11. Metrics on how to assess the quality of a patient summary, and on how to demonstrate the value of sharing good-quality summaries 12. More evaluations into why so many large-scale health ICT implementations fail to deliver the expected benefits 13. More dissemination of evidence, review and education to help understand research outcomes
Stakeholders 1. Research organisations 11. evidence producer involved 2. Health ministries 12. sponsor, decision 3. Research grant funders maker 13. sponsor
Relevant SemanticHealthNet: Semantic Interoperability for Health Network, a resources and Network of Excellence (NoE) funded by the European Union FP7 initiatives in Research Programme, http://www.semantichealthnet.eu Europe EXPAND & SemanticHealthNet Interoperability Asset Register (under development)
Relevant NLM Value Set Authority Center, https://vsac.nlm.nih.gov/ resources and initiatives in the The Value Set Authority Center (VSAC) is provided by the National Library US of Medicine (NLM), in collaboration with the Office of the National Coordinator for Health Information Technology and the Centers for Medicare & Medicaid Services.
The VSAC provides downloadable access to all official versions of vocabulary value sets contained in the 2014 Clinical Quality Measures
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(CQMs). Each value set consists of the numerical values (codes) and human-readable names (terms), drawn from standard vocabularies such as SNOMED CT® , RxNorm, LOINC and ICD-10-CM, which are used to define clinical concepts used in clinical quality measures (e.g., patients with diabetes, clinical visit).
The content of the VSAC will gradually expand to incorporate value sets for other use cases, as well as for new measures and updates to existing measures.
Experience gained through Trillium Bridge
Inter- Incentives dependencies with Education any of the other Future standardisation topic areas Prioritised Consistent terminology binding to consistent record structures opportunities for transatlantic • Research should focus on areas where semantics are the same in convergence original record systems’ representation in the Patient Summary • Value sets should be aligned Research into expansion of value sets (and their value?)
• Agree on the need for global VSAC coordination • Demonstrate and educate policy makers that semantic interoperability is the right approach and requires VSAC • Gain agreement on VSAC governance, concept of operations, functionality Cooperation on QA criteria
• Definition & metrics of quality, what elements of quality are important in assessing the data in the PS Barriers needing to be overcome to achieve those opportunities Recommended Establish EU VSAC or global VSAC plan Timeline: short, medium and • 6 months long term actions • Within 6 months, EC should establish a consultation with nations on VSAC • 12-18 months • Within 12-18 months, establish a program to develop VSAC • 6-12 months • Evaluate willingness to participate in global VSAC coordination • Demonstrate and educate policy makers that semantic interoperability (with Trillium as an
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example) is the right approach and requires VSAC • Gain agreement on VSAC governance, concept of operations, functionality
Stakeholder: • Policy makers • Research organizations • SDOs • … Cooperation on QA criteria
• Definition & metrics of quality, what elements of quality are important in assessing the data in the PS • Ensure clear global consensus Proposed concrete actions for the EU/US co- operation roadmap
292
294
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FP7-610756 Trillium Bridge Draft Strategy Briefs 12 Annex 1: Detailed notes of the e-consultation with experts 296 Education: expert comments 298 Anne Moen, President EFMI; Professor, University of Oslo 300 Health informatics Literacy and cross-disciplinary appreciation for staff, beyond the enthusiasts and 302 champions Education and in-service training to establish mutual understanding across domains of medicine/health and 304 engineering - a MOOC ? Patient education 3.0 - to empower individuals and their families, to assume real accountability about their 306 personal health management, beyond access to own information, beyond passive monitoring and beyond shared decision making 308
310 Mircea Focsa, Associate Professor at University of Medicine and Pharmacy of Timisoara
312 Both the patient and the healthcare provider should understand and be properly trained about the security mechanisms behind the summary information. 314 The sharing procedures should be transparent and easy to implement from the patient perspective. The healthcare provider’s ability to select and maintain the relevant set of clinical data to be part of the 316 summary information. This involves the capability of rating health data based on its usefulness outside its usual healthcare environment. 318
320 Alex Lippitt, HIMSS
322 Incorporating training in good patient summaries (what, when, how, why) as part of the normal course of a young person’s education (with remedial education for the rest of us); requiring that young people 324 demonstrate proficiency in reviewing and updating their patient summaries, as well as proof that updating their patient summaries has become a habit 326 Incorporating training for all clinical personnel on evaluating, building and maintaining good patient summaries including triggering events that would require update 328 Implementing incentives / disincentives for patients to review and update their individual summaries Implementing incentives / disincentives for clinical staff to review and update patient summaries 330 Finding a way to measure outcomes, some sort of validator software that would measure the completeness and conformity of the patient summary 332 Instantiating co-responsibility to patients and their care teams for keeping patient summaries up to date, including proactive outreach from the care team to the patient when time has passed since their last entry 334
336 Lacri Stoicu-Tivadar, Vice-President EFMI, Professor Universitatea „Politehnica” din Timișoara
338 Educating together in common programs medical and technical staff – to raise awareness and create a common language/vocabulary 340 Identifying a strong motivation Learning how to create correct and realistic business plans 342 Solving and explaining privacy and security issues
344
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346 Incentives: expert comments
348 Marcello Melgara, LiSPA, Trillium Bridge WP2 leader (Comparing Patient Summaries) 350 Seamless Interoperability: 352 Interoperability of Minds: train physicians to understand the meaning of the document generated by other physicians from other Countries 354 SDO's empowerment: SDO's should make available liable translations of their Code Systems in (possibly) all EU Languages (this will de facto cover EU and 356 America and (possibly) liable mapping with other relevant Code Systems (this is redundant if 1. and 2.1 are provided) 358 Easy coding: make physicians' life easy, helping coding information Non-conflicting interoperability standards: to allow easy bidirectional mapping 360
362 Christian Lovis, Professor Health Informatics, University Hospitals of Geneva
364 1. It is possible to have a patient summary from a care provider point of view One of the major challenge I see in my past experience in working patient summaries, in our teaching 366 hospitals consortium (HUG), for the shared patient record in Canton of Geneva and in Switzerland, is to convince care providers and their extreme heterogeneous needs and requirements that this is possible. In 368 most cases, I was facing the needs to have a specific summary for each medical specialty, for each type of “transfer” (such as in hospitals, between in and out-patient, …), for each “world” of care (acute, rehab, 370 nursing care, etc), between each type of care providers. So, I think that we have first to build something, including summary itself, but also explanations, dissemination, reports, testimony, etc… that it makes sense 372 and it is possible. 2. It is possible to make it using standards 374 Another point is that most stakeholders consider that it is really hard to make it with standards, that free text is needed, etc. I think that it is possible to do it with standards, but there must be a strong argumentation 376 3. It will improve care safety, care efficiency and cost-effectiveness It is not so evident that this will improve care safety, and efficiency of care providers building it, sharing it, using it. An important point is to 378 collate proofs that this is the case. 4. Moving to a regulatory framework that makes it mandatory In several countries, will be the case with 380 a new federal law in Switzerland, care re-imbursement will require the providers to provide a “e-health- suisse” compliant documentation. This should become a major goal in all countries in order to insure that 382 these documents are available and updated
384 Alex Lippitt, HIMSS
386 Tying provider organization payment to completeness and currency of patient summaries Requiring EHR and PHR systems as part of their certification (conformity assessment) to incorporate 388 workflow and controls that prompt the users to update and review patient summaries based on specific events or the passage of time without update 390 Incorporating the completeness and currency of patient summaries into the assessment of clinical employee performance 392 Providing monetary incentives/disincentives for patients in their insurance premiums and fees for service based on the completeness and currency of their patient summaries 394 Providing a usable set of metrics, aps, and data capture and analysis mechanisms to evaluate, store and accumulate patient and clinician performance by person and organizational units being measured 396
398 Wes Rishel, retired VP of Gartner
400 Summary A great deal of demotivation arises from attempts to have EHRs synthesize patient summaries based on 402 their databases. Furthermore, seemingly minor flaws in the maintenance of ontologies for structured data leads to workflow burdens where a physician must assist in de-duplicating data and deciding which is 404 relevant and whether it is trusted.
406 Challenges will include minimizing the impact of these flaws in interoperability on the day-to-day workflow of
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clinicians. 408 Background 410 Our experience in the US shows that there are two different views of the patient summary. Our attempts to meet both through regulations has resulted in neither being done well. The two requirements are a concise 412 provider-to-provider summary of a patient or of the patient information in the context of a specific visit. The second is an EHR to EHR transfer of structured or semi-structured data about the patient to support EHR 414 functions that provide cognitive support to clinicians.
416 Physicians are trained to dictate patient summaries that are concise, so as not to overburden the reader with irrelevant information. Doing this well is a point of professional pride and receiving poorly organized 418 summaries that contain a mess of irrelevant data is an aggravation. The concern on receipt arises from the time burden reading it and the risk to patient safety that might arise from overlooking an important point. 420 Being concise often involves selecting what information to include. A summary from an orthopedic consultation will seldom involve a summary of the patients blood sugar tests and diabetes medications 422 unless hyperglycemia is relevant to the consultation.
424 When EHRs synthesize patient summaries from their databases, the resulting reports are seen by physicians as both hopelessly overpopulated with information and still insufficient to describe complex 426 patients.
428 US regulations focus on structured data transfer of the "meaningful use common data set", which is listed below. Simply transferring this data from one EHR to another represents some challenges. The standard 430 ontology for smoking status differs in a few respects from ontologies in common use in EHR client organizations. This necessitates a change in data collection with the attendant retraining of clinicians. It has 432 been difficult to establish an ontology of orderable tests and map those to the order sets in use in EHR client organizations. Lab result ID standards are very specific, often exceeding the precision in use in clinical labs. 434 The biggest issues, however, relates to problems and medications. The ontology of medications changes 436 rapidly, there are multiple paths by which changes are proliferated to EHR client, and updates are asynchronous. Furthermore when interoperability happens the structured data that arrives at an EHR may 438 have passed through several other EHRs each of which mapped the ontologies slightly differently. The process of deduplicating incoming information is confounded by the possibility that the same medication may 440 have reached the EHR through multiple paths, and occasionally the coding will have changed. A well- documented early study of cross-vendor EHR exchange of structured data showed that 98 percent of all 442 medications were de-dupable. The other two percent, however, were not necessarily uncommon medications. Metformin, a very common diabetes med, created difficulties because of rapidly proliferating 444 forms for extended release dosage.
446 As a result the workflow for receiving a structured patient summary involves a clinician (usually a doctor) reviewing the incoming data against known data for the patient and deciding which to include and, if there 448 are conflicts, which to believe.
450 Top Challenges Don't commingle clinician-to-clinician summaries with EHR-to-EHR "dumps" of structured data. 452 Avoid the temptation to have EHRs synthetically generate clinician-to-clinician summaries thereby "checking 454 a box" to meet regulatory requirements. If individual EHR developers find way to do that well, great. But making it a requirement that can be met with a droll implementation ultimately demotivates the users. 456 Account for the workload implementations associated with receiving patient summaries. 458
460
462 Meaningful Use Common Data Set (1) Patient name. 464 (2) Sex. (3) Date of birth. 466 (4) Race (5) Ethnicity 468 (6) Preferred language
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(7) Smoking status 470 (8) Problems (9) Medications 472 (10) Medication allergies (11) Laboratory test(s) 474 (12) Laboratory value(s)/result(s). (13) Vital signs – height, weight, blood pressure, BMI. 476 (14) Care plan field(s), including goals and instructions. (15) Procedures 478 (16) Care team members
480
482
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FP7-610756 Trillium Bridge Draft Strategy Briefs Innovation: expert comments 484 Mike Nusbaum, Member JIC, IHE 486 While Trillium Bridge is a trans-Atlantic initiative, one must recognize that adoption of this work cannot be 488 limited only to the EU and the US. This work must be positioned as an “international” effort, and recognized as such, otherwise it will merely propagate the problems we have now (eg. somebody 490 implements a “good idea”, then others are faced with the challenge of implementing that idea or developing their own idea), leading to a fractured world-wide system. 492 Now that a specification has been developed, how can its value be demonstrated? Finding innovative ways to demonstrate, in a very public way, the value of an internationally-developed means to exchange 494 patient information across international boundaries… this is in my view challenge #1. May I suggest that initiatives such as the Olympic Games demonstration project may be a way to meet this particular 496 challenge. If interested, further information on this can be obtained by contacting me directly. I truly believe that we need to develop (globally) a culture of adopting an international standard over 498 development of a grow-your-own solution. The work of Trillium Bridge should be implemented by all vendors globally, and adopted as part of all health infostructures world-wide. A similar business model was needed 500 to connect the world’s telephone systems, banking systems, etc. Note that this will be possible only when clear value can be demonstrated (see points above). This is a cultural challenge that will require our industry 502 to rally around.
504 Amnon Shabo, University of Haifa 506 I wholeheartedly agree with Mike on the need for an international standard. Nevertheless, I'd like to argue 508 that even if, for example, EHR 13606 would have become the agreed-upon standard and adopted worldwide, yet, we wouldn't see effective interoperability and consequently we wouldn't see truly 510 comprehensive, coherent & longitudinal individual's health record, and that's because the individual health data landscape would remain highly fragmented and the source data would remain highly diversified from 512 the generic standard, which presumably all comply to.
514 A recent NYT article described the lack of interoperability even within the same organization or IDN, and I responded to it in a blog post titled "Interoperability and the Messiah", namely, we could continue strive to 516 interoperability but it's similar to religious people waiting for the Messiah... (http://independenthealthrecordbanks.blogspot.nl/2014/10/interoperability-and-messiah.html ) 518 We should certainly continue to develop standards and interoperability mechanisms, but in parallel, we have 520 to promote a change in health record keeping legislation so that we move from a paradigm where each record is kept where it was created to a paradigm where each record is sent to the individual's lifetime EHR, 522 sustained by new organizations whose sole responsibility is to do just that - sustain citizens' health records. These independent health record organizations will then be the major catalyst to finally have more robust 524 standards that all comply to, simply because providers will be required to send the full-blown data to those organizations and the latter will be required to harmonize it and make it useful for the next user. 526 Today, there are no real incentives for current stakeholders to invest in standards compliance, especially as 528 health data types constantly diversify and get more complex, and consequently standards remain a moving target. Summaries are extremely useful but are just the tip of the iceberg. If a recipient of a medical summary 530 wants to dive into the raw data (based on which a summary has been created), it would be very difficult if not impossible to provide such access. But the main issue is more profound - to create a good summary of the 532 individual's health history in the first place, you need all the data available on that individual, and that is what we really miss today - that's the catch we live in... 534 Finally, the standards we develop are generic by nature. We then offer tools to constrain them to specific 536 domains. However, the more constrained a spec is, it is also less expressive and that's where the standard fails - it hits its limits due to the rapidly diversifying data and growing complexity. Therefore, we need to 538 seriously rethink the whole standards development process and perhaps get away from domain-specif standards and move more towards a generic compositional language that is expressive enough to represent 540 the variety of health phenomena.
542 Elaine Blechman, Prosocial, Trillium Bridge Consortium Partner
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544 Innovation: "Innovative business models that will be needed to stimulate a market in EHR systems and 546 applications that capture and deliver patient summaries.”
548 The most innovative business models will focus on delivering technology that motivates and prepares patients to engage in self-management of health information and healthcare, despite challenges that include: 550 stressful circumstances, emotional distress, providers lacking in empathy, and membership in difficult to engage patient subgroups. 552
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554 Future standardization: expert comments
556 Jeremy Thorp, Health and Social Care Information Centre The topics you have identified are all important and relevant and will be useful to progress. There is one 558 angle I’m missing, however, which is where we listen - to clinicians and to patients to understand their requirements. A couple of examples: 560 If I use the European Patient Summary Guidelines as an example, we focussed these on unscheduled care situations. As part of Joint Action proposals currently being drafted with the Commission, we are considering 562 how to extend to other scenarios and how to include patient access, but to do this we need to understand what is needed (some of the points in the section on incentives are relevant here). 564 Inviting the CPME (the Europe-wide medical body) to talk at the upcoming Expand workshop, they have asked to talk about their eID policy, which is obviously topical for them 566 Similarly talking to clinicians using the Summary Care Record in England they have a number of issues which they would like to see addressed, including barriers to access, provenance of data, etc. – all issues 568 which would need to be addressed for widespread acceptability.
570
572 Stefan Sabutsch, ELGA
574 Terminologies for diagnoses, medication (product names and active ingredients), procedures, allergies – at least we need common reference terminologies with clear mappings to local terminologies 576 Identified templates / archetypes for a common understanding of the clinical content and its meaning Harmonised security policies and access rules 578
580 Andrej Orel, Marand
582 Information security. It’s often neglected! I’d like to work in this field! Patient’s safety! In relation to information security. Patients’ safety is correlated to many different aspects, 584 but the correlation to information security is a very interesting subject. Interoperability! Again correlated to information safety. The idea of the “Internet of things” provides us with lot 586 of interesting subjects. The last but not least! Information privilege especially regarding the person (i.e patient’s) rights to privacy. 588 This is a very interesting issue in regarding the Trillium Bridge idea, as the legal issues of the EU vs. USA are more than different. 590
592 Chris Chute, John Hopkins University
594 Standards regulation and requirements by governments remain a “local” problem, there is no global authority. As such, there is little coordination. 596 In the face on #1, many jurisdictions are modestly far down the road, with entrenched legacy decisions that are now difficult to change. 598 Cross SDO collaboration appears to be sought by all, though its effectiveness is uneven and poorly monitored. 600
602 Mike Nusbaum, JIC, IHE
604 Strengthening the global infrastructure to support cross-SDO collaboration. Currently we have many bilateral MOU’s between SDO’s to facilitate collaborative work, and we have a Joint Initiative Council that 606 provides a forum for cross-SDO “information exchange”. In addition, some countries (like Canada, with their Standards Collaborative) have domestic cross-SDO structures that establish domestic standards 608 development and adoption… but only locally. None of these initiatives fully address the need to establish an ecosystem of collaboration that results in the development and adoption of single, global standards. 610 The value of adoption of a truly international standard for the exchange of patient summary information must be articulated, demonstrated, and reinforced by all of us. This goes beyond the EU- 612 US agreement. If we agree on a standard for international exchange of health information, then all vendors should implement it, and all jurisdictions should require it. This is a cultural challenge that will require our 614 industry to rally in a consistent way.
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We need to find better ways to share Trillium’s work internationally, through some kind of global knowledge 616 management infrastructure. Patient summary content, for example, should be registered as an international template in an international template registry, available to all vendors and jurisdictions around 618 the world in an easily consumed format.
620 Ronald Cornet, University of Amsterdam 622 Challenges with today’s standards development and adoption landscape that need to be questioned and 624 maybe changed to meet the needs for cross-SDO collaboration and multi-standards alignment: Implementability of each individual standard. This includes explanatory material, demonstrator applications, 626 and sharing of best practices. Mutual harmonization & (proven) consistency of/between standards. Implementing 1 standard may be hard, 628 implanting n standards is more than n times harder. This complexity needs to be reduced. Proof of compliance. Implementing a standard is hard, assessing that/whether it is done correctly is still hard. 630 Testing mechanisms are needed. Availability of standards. Appreciating the costs for developing and maintaining standards, the (albeit 632 relatively low) costs for using standards is too often a show-stopper. In some cases one doesn’t even know what a standard is about until it is acquired. An open-for-exploration/consideration/research policy would be 634 useful.
636 Alex Lippitt, HIMSS 638 Agreement on a set of use cases and incorporated workflows and transactions that provide a comprehensive 640 set of clinical and patient self-care experience based on a 80/20 rule International alignment on who will be responsible for developing which standards for the various standards 642 components such as content, security and privacy, integration profiles, vocabularies, and so on Elimination of payment for specific vocabularies, nomenclatures, and other in intellectual property, relying 644 instead on fees for the whole complex of standards assessed to individual countries based on some fair allocation 646 Standards based on the level of affordable technology available; conformance assessment would be based on these tiers 648 Required conformance assessment and appropriate seals for those who demonstrate conformance for vendors, infrastructure providers and care provider organizations alike, with reasonable periodic renewal 650 required. Conformance is based on realistic use cases.
652 Becky Kush, CDISC 654 Standards development targeted for healthcare should give a higher priority to the synergies and 656 harmonization efforts with standards for research, public health, outcomes and other such ‘secondary uses’. (Another one-off standard for healthcare, without supporting these learning areas is not what is 658 needed….these worlds should be coming together through standards.) Explore the use of metadata repositories in a federated way, including SHARE and SALUS. 660 Identify how RDF/semantic web technology can best be leveraged. Develop means to communicate the value of standards in areas such as personal health information, 662 personal mobile devices and big data.
664
666 Giorgio Cangioli, HL7 Foundation
668 I think that different SDOs may contribute on those topics acting at different levels
670 Is the (clinical) scope for which information are exchanged cross countries correctly identified and agreed ? (before working on what needs to be harmonized (cross-country and cross-standard) it should be clear why 672 this is needed, and this should be correctly formalized) Only if the scope is clear I can address correctly all the choices about type, granularity of information and 674 required expressiveness.
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How to assure that information exchanged fulfill the clinical scope ? 676 (I know that this statement covers a lot of different aspects, but at minimum assure that there is a common understanding about the content that needs to be exchanged) 678 How to select and use terminologies in a cross-country environment considering the several different related aspects: clinical scope, license issue, mapping with local codes, supporting services 680 How to prepare the ground for assuring that the contents agreed can be correctly used and understood by users (physicians, patients,….) and correctly captured by the existing EHR systems ? 682 (this in order to avoid that agreed implementable exchange standards could be only partially used in a meaningful way [e.g. why not a functional Profile for the Patient Summary]) 684 Considering only 5 items let me consider as final bullet point this that I think is the most difficult to be 686 achieved (since the evaluation on where this “optimal balance” is can vary consistently) Optimal Balance between the “quality” and the “concreteness“ (or if you want the “time to market” of the 688 solution) (I had in my life very different experiences with projects with a strong focus on quality, but without any usable 690 result in real-life, and others too much focused on implementation aspects.) (as we know “time” and “quality” are competing dimensions in the project management pyramid, but both 692 critical in our domain)
694
696
698
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Steve Kay (in response to an early draft of the template), CEN TC251
700 1. Standards must target.... requirements.
As you know, I often state that standards and research are complementary but not interchangeable... in the 702 main, the ideal is to standardise an existing implementation, which has the benefit of standardising something that is both stable (not research) and required (given someone has made the effort to implement 704 it)... it assures a relatively fast passage through the systems by eliminating 'change' and 'surprise'. Stating this also removes some of the concerns raised/ charges levelled at standardisation, varying from being 706 'overly academic' to 'not delivering timely, user-required products. So what I am about to say seems to be in direct contradiction....
708 This preferred 'stability model' is seriously compromised by stakeholder (mainly clinician) understanding of what is required and the still-evolving knowledge of our field presenting an eco-system of interconnected, 710 fluctuating demand/supply... The model then has to be more agile, more negotiation and fluid that involves participants so that the outcome is more often TS rather than IS, and a product that can be trialled before 712 agreement is reached... this is a little like a DSTU, but more inclusive... a soft systems approach if you like, looking at conceptual models and providing a basis on which to build. The process might be accelerated by 714 using a light touch...
Unsurprisingly, I would reference the Concurrent Use work in CEN and the use of ContSys, reference 716 archetypes as one way of taking this agenda forward. (Not the only one!) But I also think that 'education' becomes a strategic response too. I fear that the current wording in the template on strategic approaches 718 will lead to an impossible waiting game, that assumes that some stable model can be reached before attempting any form of standardisation (which is key and necessary for improvement)... I like the ideas of 720 guide-lines being tried/used providing feedback before solidifying 'agreements'.
2. Standards need to be actively...industry
722 Yes! But I think there needs to be value propositions and more attention paid to evaluation/evidence... I tend to think that standards in IT are the closest we come to 'evidence based HI' if only because a working 724 consensus model suggests a common agreement/basis... GBS thoughts on democracy, i.e. 'right of the ignorant to govern badly' comes to mind.. we need to raise the evidence base to inform the would be 726 supporters... conformance must be there, must be testable etc. I also think we need to consider the more formal approaches to animate specs, and this too will change the processes and methods of development, 728 reliability and proof, and the involved developers.
The voluntary contribution I think is becoming increasingly difficult to support, and resources are key for 730 continuity and quality.
3. Engage SDOs in adopting...
732 I'm not sure it is the SDOs who 'adopt' the patient summary.... I do think there is a need to pool resources, consider sustainability questions such as migration/legacy, and synchronise efforts in the 'summary' space... 734 NHS England is already claiming 51.9 million 'summary records', so what does this mean for our International (inc. CEN) community... Do Clinicians accept it? What did the PRSB work vis a vis epSOS and 736 'headings' mean for such initiatives?
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738 Cross-Vendor Integration: expert comments
740 Alex Lippitt, HIMSS
742 Lack of “real-world” conformance assessment, at least in the US, requiring demonstration of conformance by testing with x numbers of peers of different types representing the variety of key trading partners, both in 744 terms of vendors and care delivery institutions. Simulator and reference implementation testing only goes so far. 746 Lack of required testing between partners at different levels of technology to demonstrate that the partner with lower levels of technology can provide what they can and for the higher level of technology to 748 demonstrate its ability to consume what the lower level technology provides, indicating the provenance of the data it has and what is missing 750 Lack of focus on required narrative that provides a universal syntax and language for clinicians, specialists, ancillary providers and patients alike including some structuring of the narrative to demonstrate the thought 752 process for the SOAP Assessment and Plan Lack of compatibility in vocabularies and nomenclatures, especially in difficult but required areas such as 754 allergies and reactions Lack of required provenance documenting the sources and timeliness of information 756 Lack of genuine team based care plans, at least in the US, that incorporate and respond to inputs from clinical staff and the patient alike 758
760 Elaine Blechman, Prosocial, Trillium Bridge Consortium Member
762 Cross-Vendor Integration: "Challenges with today's health ICT systems (EHR systems, apps, etc.) that may need investment and cross-vendor collaboration, in order to enable the creation and exchange of good 764 quality (trustworthy) patient summaries." The greatest challenge to the creation and exchange of good quality (trustworthy) patient summaries in the 766 U.S. (and in EU countries influenced by U.S. policy) is the dilution of meaningful use requirements for sharing patient health information and documents with patients and the lack of enforcement of meaningful 768 use requirements for interoperability. Investment and cross-vendor collaboration is needed to lobby for regulations beneficial to cross-Atlantic patient- and provider mediated health information exchange. 770
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772 Privacy and security: expert comments
774 Georges De Moor, Professor of Health Informatics and Medical Statistics, University of Gent 776 There are different contexts for sharing patient summaries: 778 Shared patient summaries in the context of patient care Shared patient summaries in the context of re-use (e.g. research) 780 Main obstacle in relation with (1) is the guarantee that the receiver is both a recognised care provider and in 782 charge of the patient. Sender, receiver and patient authentication is needed as well as proving the link between the patient and the 784 care provider. The most direct way to guarantee this, is the patient consent (but not always possible).
786 In relation with (2): there is need of a uniform approach and guidelines across the Atlantic for reusing data for other purposes than care a.o. under controlled circumstances via TTPs. 788 Criteria in use for the quality labelling of TTPs and for the choice and use of Privacy Protection Techniques should be uniform. 790 In the case the data need to be identifiable for e.g. research purposes, informed patient consent is again needed. 792
794 Elaine Blechman, Prosocial, Trillium Bridge Consortium Member
796 Privacy & Security: "Barriers to establishing a trusted and accepted governance and security framework for sharing patient summaries between EU and US, and within the EU." 798 The fundamental barrier to trust by patients (who are often reluctant to report sensitive information that enters patient summaries) is a framework (such as HIPAA) that allows breaches of patient records, without 800 patient knowledge, for diverse purposes including national security, healthcare delivery, and relationships with business associates. 802
804
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808 Simon de Lusignan, Professor of Primary Care and Clinical Informatics, University of Surrey
810 The gap between methods in Informatics and why still so many implementations fail No consistent flags for high risk groups in EPR systems. Eg Frail elderly 812 We remain with single condition CDSS while real people have multi morbidity Neither they nor their carers can cope with the cognitive load 814
816 Ronald Cornet, University of Amsterdam
818 Research on Ways to reduce the effort of defining and representing required information, as this is, like knowledge, 820 fractal. Methods to protect privacy, but at the same time share information where possible, and inform patients 822 when relevant. Possibilities and constraints for putting the patient in the driver’s seat. 824
826 Anne Moen, President EFMI, Professor University of Oslo
828 Interdisciplinary, shared representations, toward the goal of a summary of the provided care and treatment and recommendations for future care and patient safety 830 Importance to account for uncertainty, context and the situatedness of clinical judgment in the shared patient summaries 832 Importance of legislation, ethical consideration and professional accountability, relative to practice setting and as minimum, consolidated Trans Atlantic applicability 834
836 Elaine Blechman, Prosocial, University of Colorado, Trillium Bridge Consortium Partner
838 Research: "Research needed beyond Trillium Bridge and its contemporary ECT projects, to enable the sharing of summary information to result in safer and better quality patient care when consulting a new 840 provider. This may include extending the existing summary specifications to support planned care, long term care, as well as growing the evidence of improved outcomes from using shared patient summaries." 842 Research aimed at finding the most effective, vendor-neutral, methods of motivating and preparing patients to curate the information included in a standard patient summary (e.g., meds list) and the unique documents 844 and images generated during healthcare delivery (e.g., MRI images). For example, compare the impact of face to face and social media methods alone and together on patient or family caregiver behavior as 846 measured by behavior products (e.g., number of data elements and artifacts that patients collect and store) as well as by self report (e.g., description of related behavior in last month). 848 Research aimed at finding the most effective, vendor-neutral, methods of motivating and preparing patients to collect information included in a standard patient summary (e.g., meds list) and unique documents and 850 images generated during healthcare delivery (e.g., MRI images) from healthcare enterprises. Preparation might include learning to question healthcare providers about the nature, availability, meaning, and accuracy 852 of standardized and unique data and documents and about their rights to obtain their health information at low or no cost. 854 Research aimed at finding the most effective, vendor-neutral, methods of motivating and preparing patients to communicate with new providers about their health information archives. Communication methods might 856 be explored for user stories involving highly stressful circumstances, emotionally distressed patients, and healthcare providers lacking in communication skills and empathy. 858 Research aimed at finding the most effective, vendor-neutral, methods of motivating and preparing patient subgroups for the curation, collection, and communication tasks described above. Patient subgroups might 860 be distinguished by one or more of these characteristics: health status, socioeconomic status, age, income, literacy. 862 Research aimed at identifying the patient subgroups most difficult to engage in the curation, collection, and communication tasks described above and at determining mutable barriers to subgroup engagement. The 864 focus in this research is on barriers rooted in personal belief systems, subcultural practices, and societal policies that can be changed, and, if changed, would result in more engagement of patients in self-
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866 management of health information and, thereby, of healthcare.
868 Elaine Blechman (in response to an early draft of the template) 870 In response to your request for information about resources or initiatives related to various Trillium policy and 872 strategy templates, I focused on the research template and searched for recent peer-reviewed publications (since 2014) related to the topic of the shared health summary. The seven relevant publications I found, 874 listed below, offered insights into the "patient subgroup" strategic approach:
"9. Identifying patients subgroups for whom the curation of their own health information and communication 876 with healthcare professionals is difficult, which could be for health status, socio-economic, age income, literacy, or cultural reasons, and better equipping them to advocate for their health 878 needs."
Subgroups. Significant patient predictors of ease in curating their own health information and 880 communicating with healthcare professionals were found, in the sample of publications cited below, to include higher levels of education and female gender but not race/ethnicity (Kontos), greater chronic disease 882 burden but not physician facilitation of shared decision making (Peek), self-rated computer ability (Turvey) but not health literacy (Pavlik). In short, educated, computer literate, chronically ill females are the most 884 motivated users of healthcare services and technology, including shared health summaries and records.
Self-Advocacy. There is an evident gap in existing knowledge about how technology can engage 886 unmotivated individuals in self-management of their health. Implications from the sample of publications cited below suggest improvements in the usability, utility and convenience of personal health records (Fuji) and 888 integration of patient-facing technology with the healthcare delivery system (Pearce; Hawley).
Recommendation. Pursue funding for cross-national, research on technology-specific predictors of ease in 890 curating their own health information and communicating with healthcare professionals across all patient gender, education, and health status subgroups.
892 References 1. Fuji, et al. Personal health record design: Qualitative exploration of issues inhibiting optimal use. 894 Diabetes Care 2014:37:e13-314. 2. Hawley, et al. In a maternity shared-care environment, what do we know about the paper hand-held and 896 electronic health record: a systematic literature review. BMC Pregnancy & Childbirth 2014 14:52. 3. Kontos, et al. Predictors of eHealth usage: Insights on the digital divide from the health information 898 national trends survey 2012. J Med Internet Res 2014 Jul; 16(7):e172. 4. Pavlik, et al. Association of patient recall, satisfaction, and adherence to content of an electronic health 900 record (EHR)--Generated after visit summary: A randomized clinical trial. J Am Board Fam Med 2014; 27:209-218. 902 5. Pearce & Bainbridge. A personally controlled electronic health record for Australia. J Am Med Inform Assoc, 2014;0:1-7. 904 6. Peek, et al. The association of patient chronic disease burden and self-management requirements with shared decision making in primary care visits. Health Services Research and Managerial 906 Epidemiology, 2014;1-8. 7. Turvey et al. Blue Button use by patients to access and share health record information using the 908 Department of Veterans Affairs' online patient portal. J Am Med Inform Assoc 2014; 21:657-663.
910
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912 13 Annex 2: Agenda and particpant list for the March Brussels workshop
914 Trillium Bridge Policy Workshop Convergence, Future Standardization, and
916 Sustainability Monday March 23 – Tuesday March 24, 2015
918 The European Commission
920 Avenue de Beaulieu 33 Auderghem, Brussels, Belgium
922
924
926 Monday 23 March, 2015: Research, Innovation, and Standards
928 12:00 – 12:30 Welcome Lunch
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12:30 – 12:45 Welcome by the European Commission and Update on the Transatlantic co- 930 operation, Gerald Cultot
12:45 – 14:00 Introduction and Objectives
932 Where we are: Trillium Bridge update, Catherine Chronaki (15 min)
Where we are going: objectives, your role in the day ahead (Dipak Kalra, 10 934 min)
Policy and strategy convergence topics 936 (2 minute intro per topic, led by Dipak)
o Cross-Vendor Integration 938 o Education o Security and Privacy 940 o Future Standardization o Innovative Business Models plus 5 minutes brainstorming 942 o Research plus 5 minutes brainstorming o Incentives plus 5 minutes brainstorming 944 14:00 – 14:15 Coffee Break
946 14:15 – 15:00 Break-out Sessions o Innovative Business Models (led by Elaine Blechman, Henrique Martins, 948 Alex Berler) o Incentives (led by Virginia Riehl, Marcello Melgara) 950 o Research (led by Jaime Ferguson, Veli Stroetmann)
952 15:00 – 16:00 Report from the break-out groups, plenary responses
16:00 – 17:30 Future Standardization: challenges and opportunities in the context of the 954 work of the EU US roadmap (in plenary)
17:30 – 18:00 Walk to the Restaurant for the Working Dinner (see last page for address and map)
956 18:00 – 18:30 Refreshments (on the first floor terrace)
18:30 – 21:30 Working Dinner: Future Standardization: making an international Patient 958 Summary Standard happen (small group discussions)
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960 Tuesday 25 March , 2015: Education, Incentives, Security and Privacy
962 9.00 – 10.30 Review of Day 1: Dipak Kalra/ Catherine Chronaki
Future Standardization, Giorgio Cangioli (10 min) 964 Innovative Business Models, Elaine Blechman, Henrique Martins, Alex Berler (10 min) 966 Incentives, Virginia Riehl, Marcello Melgara (10 min) Research, Jaime Ferguson, Veli Stroetmann (10 min) 968
Preview of Day 2 970 (2 minute intro plus 5 minutes brainstorming per topic, led by Dipak)
. Cross-Vendor Integration 972 . Education . Security and Privacy 974 10:30 – 10:45 Coffee Break 976 10:45 – 12:00 Break-out sessions 978 . Cross-Vendor Integration (led by Karima Bouquard, Alex Berler TBC) . Education (led by Mary Cleary, Jim Case) 980 . Security and Privacy (led by Michèle Thonnet, Zoi Kolitsi TBC)
982 12:00 – 13:00 Report from breakout groups, plenary responses
984 13:00 -13:30 Working lunch: Putting it all together – and the next steps
986
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988 Workshop participants
Dipak Kalra Mary Cleary [email protected] [email protected] Catherine Chronaki Zoi Kolitsi [email protected] [email protected] Lacri Stoicu-Tivadar Michèle Thonnet [email protected] [email protected] Marcello Melgara Jim Case [email protected] [email protected] Elaine Blechman Giorgio Cangioli [email protected] [email protected] Chris Chute Alex Berler [email protected] [email protected] Jamie Ferguson Gerald Cultot [email protected] [email protected] Veli Stroetmann Peteris Zilgalvis [email protected] [email protected] Hernique Martins Gisele Roesems Kerremans [email protected] [email protected] Iciar Abad Giovanni Patella [email protected] [email protected] Luc Nicolas Roger Lim [email protected] Frank Cunningham Karima Bouquard [email protected] [email protected] Benoît Abeloos Robert Stegwee [email protected] [email protected] Paul Timmers Virginia Riehl [email protected] [email protected] 990
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