This is a presentation of the draft roadmap for essential standards development: strategic options and policy instruments by Marco Eichelbert

1. The Draft Roadmap for Essential
Standards Development:
Strategic Options and Policy Instruments
Dr. Marco Eichelberg
OFFIS-Institute
for Information Technology

2. Mission Statement
The eStandards Roadmap describes
– actions to be taken jointly by SDOs and Policymakers
that together
– will warrant a more effective development,
deployment and maintenance of essential eHealth
standards, profiles and tools needed
– to enable a safe and cost-effective large-scale
deployment of eHealth solutions in Europe and beyond
– taking into account the needs and perspectives of:
Citizens, Workforce, eHealth Market, and the Health
System
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3. The Roadmapping Process
• The development of a roadmap is always a
consensus process and there are many routes
• This is why we have the conference today
– Your experience and your opinion are important to us
– Tell us what you agree/disagree with
– Tell us what we are missing so far
• The eStandards Roadmap will be published in three
iterations and open for public comment:
– 05/2016: Draft Roadmap
– 12/2016: Final Roadmap
– 04/2017: Endorsed Final Roadmap
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4. High Level Architecture
• What are the topics that need to be covered in
the roadmap for 2017-2020?
– In which fields is eHealth standardization
important?
– What should be the priorities?
• We tried to answer this question based on an
analysis in three dimensions:
– High-level use case
– Scope of deployment
– Layer of interoperability
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5. Putting it all together: the High Level Architecture
• We analyzed the use cases realization scenarios in the
ReEIF:
– Which are the scopes of deployment?
– Which standards/profiles are used?
– Which layer(s) of interoperability are covered?
• We performed a logical grouping of the standards used
within each layer, resulting in 15 “roadmap components”
• For each component,
– user needs, state of the art, gaps and overlaps,
legal/policy/adoption opportunities were analyzed
– recommendations were derived
• Today we can only present the main recommendations,
but there is more!
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6. Roadmap Components
1. Legal, Regulatory and Procurement
2. Health Information Exchange Policy
3. Care Process and Workflow
4. Prescription & Dispensing
5. Patient-generated, Sensor, and Medical Device Data
6. Specialized Reports
7. Patient Summary
8. Clinical Query
9. Document Directed Transmission
10. Document Sharing and Access
11. Terminology and Ontology Content and Services
12. Patient Consent
13. Indexing and Directory Services
14. Security
15. User Authentication
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7. Eleven Draft Recommendations (Part 1: on Standards)
1. Make it easier to refer to specific standards and
specifications in eHealth (public) procurement –
establish a standards sets repository
2. Develop free and open tools-based access to
standards for implementation and deployment
3. Increase the visibility of clinical best practices in
terms of professional guidelines linked to generic
workflows and information sets
4. Detail a clear governance and maintenance process
for each set of standards related to an identified
combination of use cases
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8. Eleven Draft Recommendations (Part 2: on Data)
5. Support the flow of health data between record
systems and (mobile) devices (break down the silos)
6. Make it safe and easy to migrate to the cloud for
health and healthcare data to become interoperable
7. Provide guidance on the interpretation of the medical
device directive in case of personal use of eHealth
and mHealth services (Active Assisted Living)
8. Consider broadening the scope of the European
Health Terminology Services (being developed under
CEF) to include the full range of health data, including
patient generated, sensor and medical device data
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9. Eleven Draft Recommendations (Part 3: on Usage)
9. Clinical model content should be shared
internationally, irrespective of the particular paradigm
used in its creation, and the incorporation of such
content in clinical applications should be encouraged
10. Localisation of standards sets should be supported
and guided to prevent local adaptation of the
underlying standards that “break” cross-border or
cross-realm interoperability
11. Establish an eHealth Standards Observatory, for the
purpose of monitoring
– the use of standards sets related to use cases
– the use of terminologies in data capture and data exchange
– the adoption of cross-border guidelines
(including patient summary)
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10. Strategic Options and Policy Instruments
• The need for standards is well recognized. Standards
and standards sets in health informatics are developed
by SDOs at a global level. SDOs also prepare for
localization to the European/national level
• However there is not enough clarity on the exact
process and level of detail required to actually make
full use of the potential of standards in implementation
(on the basis of a clear realization scenario)
• How do we make the process between relevant SDOs
and policy makers work? Through this collaboration we
aim to invigorate the eHealth Market and trigger the
adoption of eHealth by the Workforce and the Citizens
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11. Strategic Options: Co-existence of standards and SDOs
• Options to address the co-existence of
competing/overlapping standards:
1. Full blown competition between SDOs, leaving it to the
eHealth Market and individual decision makers to choose
the realization scenario that fits best for them
2. Employ the envisioned European SDO Platform to
achieve coopetition among SDOs in creating fit-for-
purpose realization scenarios for Europe
3. Delegation to a European eHealth Competence Centre to
achieve harmonization of standards across Europe
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The new European Directive on Standardization suggests option 2.

12. Strategic Option: Open up the SDO Collaboration
• SDOs are rooted in, depend upon, and service a broad
community of stakeholders that develop and deploy eHealth
solutions and services
• These stakeholders will choose a realization scenario to
actually implement a standards set for real-life deployment
• Realization scenarios need to have a conformance testing and
attestation process connected to it, so that:
– Implementers are brought together and learn from each other;
– Standards developers are confronted with standards use in practice;
– Attestations can be easily referenced in procurement documents;
– The standards development life cycle actually comes alive across SDOs
• SDOs can together be made responsible for monitoring the
development and maturing of the realisation scenarios
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13. Strategic Options: Global to Local SDO Collaboration
• The actual development and maturing of the realization
scenarios needs to be done by engaging the community
• Some of the work needs to span the global to local
continuum, with the ultimate focus being local deployment
• The European SDO Platform can coordinate such activity, but
stakeholders need to invest in global participation in SDO
activities, furthering European interests at a global level
• The European SDO Platform needs national mirror
organizations that will localize the realization scenarios and
make local deployment easy and cost-effective
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14. Strategic Options: Tooling
• In support of the standards development life-cycle,
tools and data need to be shared across SDOs
• When standards sets and tooling provide software
components for interoperability, an open source
licensing model is recommended
• Monitoring of the usage of standards sets in terms
of implementation and adoption can be
incorporated in the tooling
– Monitoring of standards sets is part of the lifecycle and is
needed to insure quality and maturity of the standards.
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15. Conclusion
• The roadmap tries to identify
– Concrete problems related to the 15 fields for eHealth
standardization
– Strategic / policy options for a better collaboration among
SDOs
• The work is not done yet
– Let us know what you think! We would like to hear your
opinion: http://bit.ly/eStandRev
– Please provide feedback on the draft roadmap document
in May
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16. Thank you for
your attention
www.estandards-project.eu
Comments: http://bit.ly/eStandRev
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