Health Informatics Standards
Future Directions
Richard Dixon Hughes
BSc, BE(Hons), MEngSc, DipLaw, MLegS(Hons), HonFIEAust, CPEng, FAICD
Deputy Chair, Standards Australia, IT-014 Health Informatics
Chair, Joint Initiative Council for Global Health Informatics Standardization
Member, Advisory Council to Board of Directors of HL7 International
Former Member & Deputy Chair, Board of Directors, Standards Australia
Former Chairman, HL7 Australia 2011-13
Managing Director, DH4 Pty Ltd
1
Outline
• Engineers Australia perspective
• Health Informatics (HI) Standards
– global perspectives
– issues and challenges facing the
global HI community
• Implications for Australia & IT-014
2
Engineers Australia
(EA) perspective
• EA was instrumental in establishment of SA –
key contributor for 91+ years
• EA supports SA as Australia’s peak
independent standards body
• EA supports voluntary consensus standards particularly in technical regulation
• Interest in work of IT-014, HE-003 etc from:
– College of IT & Electronics Engineers (+ NCSWE)
– College of Biomedical Engineers
– College of Electrical Engineers
• Supports “digital hospital” initiative
3
Global perspectives
on HI standards
eHealth has the potential to contribute to better
health outcomes
Health Informatics (HI) standards are an
essential part of any effective eHealth strategy
• World Economic Forum, Global Health Charter, 2011
• WHO & ITU. National e-Health Strategy Toolkit, 2012
• ISO/TR 14639 Health informatics - Capacity-based
eHealth architecture roadmap
• WHO resolutions: WHA58.28 (2005)
& WHA66.24 (2013)
4
From:
ISO/TR 14639
Health
informatics Capacity-based
eHealth
architecture
roadmap
5
Global perspectives
on HI standards
• Health Informatics sits at the intersection of:
– Information & Communications Technology (ICT)
– Health & health care
• Intensely multi-disciplinary
• Multiplicity of SDOs cover the ICT, health &
health informatics fields
• Interest groups form new SDO’s in attempt to
capture ground in emerging fields
6
ICT Standards
Community
ISO
IEC
JTC1
UN/CEFACT (& EDIFACT)
DICOM
CEN
EIA etc
HL7
CENELEC
ITU-T
WSC Group
OASIS
OMG
W3C / IETF
GS1
EU/ICTSB etc
National Standards Bodies
Governments & Agencies
IEEE
ETSI
ANSI
Suppliers/Consortia
7
Health Informatics
SDOs (1)
• Hammond [2007] identified >50 SDOs, including:
–
–
–
–
–
–
–
–
ISO (TC 215) 132
CEN (TC 251) 93
ASTM (E31)
66
HL7
63
CHF
20
NCPDP
18
ADA
15
X12N
15
IEEE
CDISC
ICH
IHE
DICOM
caBIG
HIPAA
Medbiquitous
8+
8
5+
5+
5+
5
4+
2+
• Terminology & content: WHO, IHTSDO, LOINC,
WONCA, CIMI etc (150+ standards)
• Overlaps – IEC/TC62, ITU-T, W3C/IETF, OASIS,
GS1, JTC 1, Continua Alliance, mHealth Alliance
8
Global perspectives
on HI standards
Challenges
• Overcoming complexity
health information and health information systems are
complex, diverse & evolving fields
• Overcoming barriers to sharing of knowledge:
problems of bandwidth/expertise  silos
• Availability & continuity of resources for standards
development & maintenance
• Global standards –vs– local needs
• Implementation investment  low ROI for upgrades
• Conflicting business models & IP policies across &
between SDOs & stakeholder communities
• Strategies to foster, promote & support community
interest ahead of individual & sector interests
9
JIC
Joint Initiative Council on SDO Global Health Informatics
Standardization. Formed in 2007 to foster:
• Greater collaboration across SDOs
– to facilitate achievement of coherent, coordinated and
usable global health informatics standards
• Coordinated standards approach, process and work
programs
• Resolution of gaps, overlaps and counter-productive
standardization efforts across SDOs
• Making standards available through multiple SDO
communities with preference to ISO
• Greater communication and engagement with
stakeholder communities
10
JIC (2)
• Current JIC members:
–
–
–
–
–
–
–
–
ISO/TC 215 Health informatics [2007]
CEN/TC 251 Health informatics [2007]
HL7 (Health Level Seven International Inc) [2007]
CDISC (Clinical Data Interchange Standards Consortium) [2009]
IHTSDO (International Health Terminology SDO) [2010]
GS1 [2010]
IHE (Integrating the Healthcare Enterprise) [2013]
DICOM Standards Committee [2014]
• Future?? IEEE; IEC/TC62; ITU/T; Continua Alliance
11
ISO/TC 215
Health Informatics
• Significant role - international endorsement
– HL7, CEN, DICOM, IHE (process), IEEE, JIC
– Methodologies & architectural frameworks
• Difficulties with changing business models
 challenge to traditional TC215 role ??
• Considering provision of “recognition” – defining
where & when to use what standards
• Leadership team seeking:
 “fewer, better quality” standards
 stronger stakeholder engagement
 means to identify/manage gaps & overlaps
12
HL7 International (1)
• Operating for 25+ years
• US-based, global, health informatics SDO
– HL7 version 2.x messaging
– HL7 version 3 messaging & methodology
– HL7 Clinical Document Architecture (CDA)
– Templates & “Consolidated CDA” methodology
– SOA specifications (with OMG/HSSP)
– EHR/PHR System Functional Models & profiles
 FHIR (Fast Healthcare Interoperability Resources)
13
HL7 International (2)
Pressures & issues
• Balancing top-down (esp. US-govt) and
bottom-up needs
– Delivering standards for Meaningful Use, clinical
quality, S&I Framework – accelerating timelines
– Agreeing and articulating HL7 standards strategy
• Balancing the books – managing changes in
IP policy, membership & business model
• Balancing global & US domestic interests
• Keeping major stakeholders engaged
14
Other global factors
• EU-US collaboration & EU projects
– Seeking to define the markets of the future
– Effective HI solutions involve standards from many sources
– Code sets, terminology and differences in usage/meaning
pose continuing challenges
– MU + epSOS + many XDS sites  ongoing role for
constrained CDA in shared EHRs
– ISO proposal for International Patient Summary template
– Need for “boots-on-the-ground” - priming the pump
• The debate on standardized clinical content
– CIMI etc
• Impact of FHIR resources – diversity & governance
of extensions? How will they be adopted?
15
Future of HI standards
work in Australia
• HI standards are a global game – involving:
 global engagement and input
 local implementation guidance
 significant understanding to apply
• How do we achieve effective collaboration
around the need for Australian HI standards ?
• What is the role of the existing IT-014 in
moving forward ?
16
Future of HI standards
work in Australia
An effective approach to Australian HI standards
development, adoption and maintenance should:
• Be collaborative and open - accessible to all potential contributors
• Be based on applying mainstream global eHealth standards
– recognising their diversity & evolution
• Support both bottom-up and top-down needs:
– Provide generic framework compatible with the national eHealth program
– Allow specific needs widely-supported by industry to be addressed
– Support customisation by profiling to specific needs
• Both inform and be informed by meaningful engagement in all
relevant international forums
• Involve sufficient dedicated resources to support critical functions
• Have the ability to resolve conflicting interests promptly & fairly
• Support compliance, conformance and interoperability testing
• Be supported by extensive education, training & outreach
17
Future of HI standards
work in Australia
• Smart international engagement based on:
– Gathering & active sharing of intelligence
(all forums)
– Broader understanding of “local adoption”
– Collaborative focus on HI community needs to
influence international standards development
– Avoid pet projects & “research as standards”
• Potential international contributions:
– Continued SKMT, terminology (IHTSDO) work
– eHIF/eHAP architecture
– Standards for services-based packaging &
communication of clinical information
18
Future of HI standards
work in Australia
• IT-014 potentially has a key role – but needs
to be part of a much wider discussion
• Role of AeHC is pivotal
– as yet, relatively undefined
– hopefully a facilitator, rather than a dictator
• Essential HI support & maintenance roles
must continue
19
Future of HI standards
work in Australia
• The extent of IT-014’s role will largely depend
on SA’s flexibility and how far it can go in
facilitating & maintaining:
– A pro-active, customer-focussed approach to HI
standards adoption & development
– Broad stakeholder engagement – including
government and potential individual contributors
– Collaboration with relevant HI interest groups
– Momentum in progressing relevant work
– Access to and use of IP from various sources
– Balance between various competing interests
20
Questions?
21
Engineers Australia
(EA) perspective
Role of standards
• Protect health, safety, environment &
consumer
• Deliver economic benefits
- facilitate market transactions
- reap economies of scale
- foster competition
- aid diffusion of knowledge & technology
• Support regulatory & policy processes
• Ensure compatibility of products
24
Global perspectives
on HI standards
Health Informatics (e-health) – seeks to enable:
• Improved health outcomes and quality of care for
both individuals & populations
• Improved access to care
• Efficiency, productivity & cost-effectiveness
• Evidence-based practice
• Informed health service planning
• Informed health policy
Adapted from: ISO/TR 14639 Health informatics - Capacity-based eHealth architecture roadmap
25
ICT – an industry based
on standards
1. Information representation & coding
2. Information structures – databases,
messages, documents, images
3. Programming & modelling tools
4. Application processes & semantics
5. ICT management – IT security, software
engineering, accessibility, network control
6. Standards-based development cycle
26
eHealth Standards (1)
- Communication
• Sharing clinical documents
– HL7 v3 CDA r2, CCD, IHE XDS
• Messaging – HL7 v2.x, HL7 v3, EDIFACT, SMD
 Patient administration, orders & observations
 Diagnostic test requests & results, ePrescription, eReferral,
eDischarge summaries, specialist letters, health summaries,
care plans, immunisation etc.
 Supply chain
 Biosurveillance, clinical trial data, pharmacovigilance
• DICOM - Diagnostic imaging and reporting
• TeleHealth – processes and technology
• Medical device interfaces and outputs
27
eHealth Standards (2)
•
•
•
•
•
•
•
•
Patient & provider identification
Privacy, security and access control
Health cards (particularly in EU)
Health concepts and terminology
– SNOMED CT, LOINC etc
Information models and representation
System functional models for EHR + PHR
SOA & web services definitions – SOA/HSSP
eHealth software safety
28
ISO/TC 215
Health Informatics (1)
• Operating for 15+ years
• 35 member countries + 24 observers
• Recently re-structured and re-focussed
Updated scope: Standardization in the field of health informatics to
facilitate the coherent and consistent interchange and use of
health‐related data, information, and knowledge to support and
enable all aspects of the health system.
•
•
•
•
125 standards publications
68 current projects
Provided collaborative tools e.g. SKMT
IT-014 is Australian mirror committee
29
ISO/TC 215
Health Informatics (2)
Current structure
...
WG 3
WG 4
CAG2: Co-ordination Group (CG)
Joint WG w
ISO/TC249
WG-D
WG 2
WG-D
Ad hoc group
Ad hoc group
WG 1
...
WG 1 Architecture,
Frameworks and Models
Domain-specific
portfolio of items
Permanent underpinning
standards work
Joint WG7
w IEC/62A
Specific
ad hoc tasks
JIC
Technical Committee Plenary (TC Plenary)
NMB
NMB
NMB
….
NMB
WG 3 Semantic Content
WG 4 Security, Safety and
Privacy
WG 6 Pharmacy and
Medicines Business
JWG 7 Joint w IEC/CS62A
CAG3- xSDO
Co-ordination Group
CAG1: Executive Council (EC)
WG 2: Systems and Device
Interoperability
Other liaisons
ISO/TC 249/JWG 1
Informatics of TCM
eHealth Standards
- Opportunities &
challenges (1)
• FHIR – Fast Healthcare Interoperability Resources
http://wiki.hl7.org/index.php?title=FHIR
• CIMI – Clinical information modelling initiative
http://informatics.mayo.edu/CIMI/index.php/Main_Page
• eHealth interoperability framework & architectures
– conceptual, logical, implementation layers
– enterprise, information, conceptual, engineering, technology
viewpoints
• Standards versioning & change management
• Management of eHealth risks
eHealth Standards
- Trends & challenges (2)
• Clinical quality and safety measures
- ARRA/Hitech & “Meaningful Use” (USA)
• Genomics/genetics & personalised medicine,
• Mobile technologies & mHealth
• New models for care delivery & information
sharing
• Biosurveillance & public health
• Information needs of small biotech, big pharma
& clinical research