Standardisation: why and how
Context, fundamental problems, strategies, and examples of solutions for Electronic Health Records (and maybe a bit of time-travel)
11+18 Dec 2024 + Q&A session 10 Mar 2025 @ Karolinska Institutet,
Course 5HI001 - Computer Applications in Health Care and Biomedicine
Erik Sundvall,
PhD Medical Informatics, MSc Information Technology / Computer Science
Information architect & CDR product owner @ Karolinska University Hospital, Region Stockholm (Main job)
Adjunct Senior Lecturer in Medical Informatics @ IMT, Linköping University
Affiliated researcher @ HIC, LIME, Karolinska Institutet
AGREE WHERE?
Agree where - inside or outside the EHR systems?
The difference between interoperability and intraoperability
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Agree where?
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HL7 FHIR etc.
openEHR etc.
openEHR etc.
Interoperability vs Intraoperability
Source: Grieve, G. Good Exchange Specifications: Interoperability vs Intraoperability. �Health Intersections. http://www.healthintersections.com.au/?p=820
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Interoperability vs Intraoperability
Typically, at this point, the system designers (often vendors) get the blame. But – it’s not as simple as that – vendors do whatever sells, which is whatever the purchaser wants to buy…
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Based on a post by Grahame Grieve (member of FHIR-core team) on February 28, 2012: http://www.healthintersections.com.au/?p=820. A more descriptive name for this kind of open intraoperability approach might be something like ”shared model driven strategy” Note that the positive view of intraoperability described above is concerning vendor neutral models, there is also another different (risky, lock-in-prone) definition of intraoperability focused around dominating market actors described at http://www.ecis.eu/intraoperability/)
Exploring categories of reinterpretation problems.
Some conversions are possible to do automatically with an algorithm, some others are possible with a human in the loop (manually reinterpreting every transfer) and yet some other conversions are impossible.
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What can conversion/reinterpretation solve?
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Reinterpretation problems, Type I, II & III
Example | System A | System B |
Type I�A <-- --> B �Can be done with algoritm/program | Birth weight: 3300g�Date: 1954-03-13 | Body weight: 3,3 kg�Timepoint: 13 Mar 1954 |
Type II A --> B�Semantic loss and distortion �due to reinterpretations. Hard, dangerous or impossible with algorithm/program… …but often done manually �by medically skilled staff�over and over for each transfer… B --> A�Missing information�impossible with algorithm/program | Needs surgery at latest: 2018-01-30�Surgery scheduled: 2018-01-20 15:30�Main diagnose*: 323291000119108 | Osteoarthritis of left hip joint|�Other Diagnosis*: �25343008 | Secondary localized osteoarthrosis of pelvic region|�299308007 | Hip joint painful on movement | �Procedure*: �19954002 | Reconstruction of hip with use of methyl methacrylate|�Surgery type**: Lubinus SP II �Preferred anesthesia*: 18946005 | Epidural anesthesia |�NEWS2-score at admission: 1�Anesthesia assessment:�- Fitness: can handle light physical exercise�- Cardiovascular: OK�- Lungs: OK�- Throat: OK�- Gastrointestinal*: 16331000 | Heartburn | Surgery date: 2018-01-20�Diagnosis code: M16.7 | Other secondary coxarthrosis�Surgery code***: NFB49 | Primär total höftledsplastik med cement (Primary total hip arthroplasty with cement)�Anesthesia code***: ZXH50 | Epiduralanestesi (epidural anestesia)�ASA-classification: ASA I = normal healthy patient� *) Codes from Snomed CT�**) special kind of hip replacement� with cement�***) Codes from the Swedish ”KVÅ”� terminology |
Type III�Reinterpretaion impossible (even for skilled humans) due to aggregations etc. | Number of cigarettes smoked per week: 6-10�…specified in a system with the options:�0, 1-5, 6-10, 11-15, 16-30, 31-50, 51-100, 101+ | Number of cigarettes per week: ?�…specified in a system with the options: 0, 1-3, 4-7, 8-14, 15-28, 29-69, 70+ |
�
Reinterpretation problems, Type I, II & III
Example | System A | System B |
Type I�A <-- --> B �Can be done with algoritm/program | Birth weight: 3300g�Date: 1954-03-13 | Body weight: 3,3 kg�Timepoint: 13 Mar 1954 |
Type II A --> B�Semantic loss and distortion �due to reinterpretations. Hard, dangerous or impossible with algorithm/program… …but often done manually �by medically skilled staff�over and over for each transfer… B --> A�Missing information�impossible with algorithm/program | Needs surgery at latest: 2018-01-30�Surgery scheduled: 2018-01-20 15:30�Main diagnose*: 323291000119108 | Osteoarthritis of left hip joint|�Other Diagnosis*: �25343008 | Secondary localized osteoarthrosis of pelvic region|�299308007 | Hip joint painful on movement | �Procedure*: �19954002 | Reconstruction of hip with use of methyl methacrylate|�Surgery type**: Lubinus SP II �Preferred anesthesia*: 18946005 | Epidural anesthesia |�NEWS2-score at admission: 1�Anesthesia assessment:�- Fitness: can handle light physical exercise�- Cardiovascular: OK�- Lungs: OK�- Throat: OK�- Gastrointestinal*: 16331000 | Heartburn | Surgery date: 2018-01-20�Diagnosis code: M16.7 | Other secondary coxarthrosis�Surgery code***: NFB49 | Primär total höftledsplastik med cement (Primary total hip arthroplasty with cement)�Anesthesia code***: ZXH50 | Epiduralanestesi (epidural anestesia)�ASA-classification: ASA I = normal healthy patient� *) Codes from Snomed CT�**) special kind of hip replacement� with cement�***) Codes from the Swedish ”KVÅ”� terminology |
Type III�Reinterpretaion impossible (even for skilled humans) due to aggregations etc. | Number of cigarettes smoked per week: 6-10�…specified in a system with the options:�0, 1-5, 6-10, 11-15, 16-30, 31-50, 51-100, 101+ | Number of cigarettes per week: ?�…specified in a system with the options: 0, 1-3, 4-7, 8-14, 15-28, 29-69, 70+ |
�
Reinterpretation problems, Type I, II & III
Example | System A | System B |
Type I�A <-- --> B �Can be done with algoritm/program | Birth weight: 3300g�Date: 1954-03-13 | Body weight: 3,3 kg�Timepoint: 13 Mar 1954 |
Type II A --> B�Semantic loss and distortion �due to reinterpretations. Hard, dangerous or impossible with algorithm/program… …but often done manually �by medically skilled staff�over and over for each transfer… B --> A�Missing information�impossible with algorithm/program | Needs surgery at latest: 2018-01-30�Surgery scheduled: 2018-01-20 15:30�Main diagnose*: 323291000119108 | Osteoarthritis of left hip joint|�Other Diagnosis*: �25343008 | Secondary localized osteoarthrosis of pelvic region|�299308007 | Hip joint painful on movement | �Procedure*: �19954002 | Reconstruction of hip with use of methyl methacrylate|�Surgery type**: Lubinus SP II �Preferred anesthesia*: 18946005 | Epidural anesthesia |�NEWS2-score at admission: 1�Anesthesia assessment:�- Fitness: can handle light physical exercise�- Cardiovascular: OK�- Lungs: OK�- Throat: OK�- Gastrointestinal*: 16331000 | Heartburn | Surgery date: 2018-01-20�Diagnosis code: M16.7 | Other secondary coxarthrosis�Surgery code***: NFB49 | Primär total höftledsplastik med cement (Primary total hip arthroplasty with cement)�Anesthesia code***: ZXH50 | Epiduralanestesi (epidural anestesia)�ASA-classification: ASA I = normal healthy patient� *) Codes from Snomed CT�**) special kind of hip replacement� with cement�***) Codes from the Swedish ”KVÅ”� terminology |
Type III�Reinterpretaion impossible (even for skilled humans) due to aggregations etc. | Number of cigarettes smoked per week: 6-10�…specified in a system with the options:�0, 1-5, 6-10, 11-15, 16-30, 31-50, 51-100, 101+ | Number of cigarettes per week: ?�…specified in a system with the options: 0, 1-3, 4-7, 8-14, 15-28, 29-69, 70+ |
�
Agree on what, where?
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Type I can be �solved here
Type II & III must �be solved here�also solves type I
Type II & III must �be solved here�also solves type I
Agree on what, where?
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Type I can be �solved here
Type II & III must �be solved here�also solves type I
Type II & III must �be solved here�also solves type I
Fax is a common workaround today
Agree on what, where?
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Type I can be �solved here
Type II & III must �be solved here�also solves type I
Type II & III must �be solved here�also solves type I
Many reinterpretation problems remain even if fax is replaced by PDF sharing…
…but may become less visible
Also within the same organisation…
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”swivel chair integration”
Type I can be �solved here
Type II & III must �be solved here�also solves type I
Type II & III must �be solved here�also solves type I
Agree on what, where? - Repetition
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Type I can be �solved here
Type II & III must �be solved here�also solves type I
Type II & III must �be solved here�also solves type I
Best of Breed vs Best of Suite
Historical attempts to solve integration.
Is a Best of Breed 2.0 emerging?
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Source: Tomaž Gornik, Marand /Better. Presentation at Vitalis conference, Gothenburg, Sweden
Source: Tomaž Gornik, Marand /Better. Presentation at Vitalis conference, Gothenburg, Sweden (Black text added by Erik Sundvall)
WordPerfect
+ Lotus 1-2-3
+ dBASE?
Microsoft Office?
Cooperating and competing web applications?
Comparison with productivity/office applications?
”best of suite”
A Series of posts regarding "post-modern EHR"
Image source: Tomaž Gornik, Marand /Better Presentation at Vitalis conference, Gothenburg, Sweden
WordPerfect
Lotus 1-2-3
dBASE
Microsoft Office
Cooperating and competing web applications?
Ecosystem paradigm
Source: Martin Grundberg, Cambio, https://www.cambio.se/
Source: Martin Grundberg, Cambio, https://www.cambio.se/
Let’s compare!
Best of Breed 2.0 already partially done for medical images (PACS) etc
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The way it used to be…
Documents�(Scanned, fax, PDF etc)
Image data�(X-ray, ultrasonic imaging, �MR, photos etc.)
Structured data�(from EHR forms etc)
Illustrations based on images from Better, https://www.better.care/
The way it used to be…
Illustrations based on images from Better, https://www.better.care/
Then we shared image and document storage…
Structured data�(from EHR forms etc)
often still not standardised
and thus stuck in
each different system
Illustrations based on images from Better, https://www.better.care/
A goal
Illustrations based on images from Better and Cambio
(mainly for clinical EHR content)�+
facade or storage for administrative PMI & ”PAS” data, but also supporting lab logistics/investigations, e.g. ”genomic study”
Different knowledge and assumptions of possible…�standardisation & integration strategies� …enable different procurement strategies
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Agree on what, where?
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Type I can be �solved here
Type II & III must �be solved here�also solves type I
Type II & III must �be solved here�also solves type I
Data capture�(openEHR etc)
Data transfer�(HL7 FHIR etc.)
Data capture�(openEHR etc)
Standardisation strategies 🡪 procurement assumptions
Source: The Swedish ”StandIN”-projects
Data capture�(openEHR etc)
Data transfer�(HL7 FHIR etc.)
Supplier’s proprietary models
1. Core system strategy
Buy the same system, install the same way at all organizations that will share or exchange information. Pretend “there is no system B”
Consequence: Causes vendor dependency and anti-competitive effects at the level where the strategy is applied. A single system rarely does everything well.
It is a common strategy locally/regionally: Large systems exist, but they are not comprehensive and thus need to be combined with other strategies �… and then the interoperability problems usually reappear!
Example: A region procures large EHR system + encourages municipalities and others within the geographic area to use the same system for the information to be shared.
Stockholm started but cancelled a core system procurement, but now in practice started a �”smaller” core system procurement again.... VGR (Gothenburg etc) and Skåne (Malmö etc) �have bought and are now installing Cerner Millenium as a core system but will also use �other systems.
2. Mapping/conversion based strategy
Translate, where possible (only works for ”type 1” differences), from system specific semantics and structures to a standardized exchange format (message format, API, etc.).
Consequences:
It is a common strategy today in national cross-regional information exchanges.
Examples: HL7 v2, HL7 v3 CDA, HL7 FHIR, certain applications of ISO 13606, Swedish national "service contracts" in the service platform coordinated by SKR/Inera.
3. Shared model-driven strategy
Handle data (semantics and information structure) the same way �within systems using open standardization of the content.
Consequences:
Used today in the Nordic region in components of several EHR systems (but is rarely a requirement in procurements). Further development is underway at several suppliers, including open-source alternatives
Main example: openEHR
Will Region Stockholm choose this? Karolinska University Hospital already uses an openEHR based system for some use cases and will change openEHR- system supplier soon.��Most Swedish regions use or will use Cambio Cosmic that is piece by piece converting�modules to openEHR (Norwegian DIPS started such a transition several years ago.)
The three integration strategies combined
Not mutually exclusive and can be combined depending on e.g.
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Source: Martin Grundberg, Cambio, https://www.cambio.se/
Data capture�(openEHR etc)
Supplier’s proprietary models
Data transfer?�(HL7 FHIR etc.)
Supplier’s proprietary models
+
#1. Core system strategy
(”Monolith”/all-inclusive)
#2. Mapping/conversion based strategy
#3. Shared model-driven strategy
Catalonia, Spanish region, 8 million inhabitants
Procurement-related activities
Catalan 25-year retrospective https://preprints.jmir.org/preprint/58933
#3. Shared model-driven strategy
Introducing a ”core system” (strategy #1) and making it even worse by using the ”big bang” method – a recipe for potential disaster regarding user experience
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Alla ”big bang”-införanden utan bra och välbekant samexistens-stöd ökar risk för kaos liknande VGRs försök till Millenium-införande - oavsett vilket journalsystem man köper och inför.
(”SUSSA”-regionerna som nu inför Cambio Cosmic får själva välja grad av Big Bang kontra samexistensperiod, men den som tror och föreslår att något åt ”Big bang”-hållet funkar bra i Stockholm bara för att det gått ganska OK i mindre regioner kommer nog ångra eventuellt sådant förslag)
Möjligheter till förebyggande om man har en öppen standardiserad vårddataplattform på plats som ”sidovagn” både innan och under systembyte: (Alltså en touch av strategi #3)
#1. Core system strategy
(”Monolith”/all-inclusive)
Migrating many integrations at once when replacing EHRs – another recipe for potential disaster
Att ändra hundratals integrationer tar tid!
Ny journalsystems-leverantör kan inte göra detta själv, det behövs mycket lokal/regional kompetens med process- och system-kännedom. (Det är brist på sådan personal och att ta in konsulter hjälper inte så mycket.)
Möjligheter till förebyggande åtgärder:
2025-03-19
Exempel:
Möjligheter till förebyggande om man har en öppen standardiserad vårddataplattform på plats som ”sidovagn” både innan och uinder systembyte (en touch av strat #3)
Möjligheter till förebyggande om man har en öppen standardiserad vårddataplattform på plats som ”sidovagn” både innan och uinder systembyte (en touch av strat #3)
A TRAVEL THROUGH TIME
Discovery of some problems, useful sulutions and modeling formalisms��“Those who cannot remember the past are condemned to repeat it.“�- George Santayana
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The future is already here — it's just not very evenly distributed
William Gibson
�
Clinical decision support (AAPHelp etc.)
Diagnostic error rate -40%
Mortality -22%
1972
Decision support languages for clinicians were created and successfully used, and rules/programs were intended to be shared…
…but lack of shared data structures hampered sharing, see next slide. �(Often a problem still today)�
Kap. 1 i: Taylor P. From patient data to medical knowledge: the principles and practice� of health informatics. Malden, MA: Blackwell Publishing; 2006
“Desperatly seeking data”
Linking a knowledge-based system (KBS) to a clinical database.
Used Arden Syntax Medical Logic Modules (MLMs)
KBS-database links consumed a lot more resources than the medical logic in the MLMs in terms of coding, maintenance, and performance.��Hripcsak G, Johnson SB, Clayton PD. �Desperately seeking data: knowledge base-database links. �Proc Annu Symp Comput Appl Med Care. 1993:639-43.�http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2850654/ �
1993
1996
[Kirby 1996] Kirby J, Rector AL.
The PEN&PAD data entry system: from prototype to practical system. Proc AMIA Annu Fall Symp.1996:709--‐13.�
Context dependent data entry (Pen & Pad , Clinergy etc.)
PEN&PAD from the 90:s
PEN & PAD used a compositional approach combining features to describe patients, rather than picking from long lists of precoordinated terms.
The PEN&PAD data entry system: from prototype to practical system - PubMed (nih.gov)
”
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Note: laterality selection to select left or right arm.
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Note: NO laterality selection → prohibits “left nose”-nonsense etc.
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Learn more
Illustration based on content from:�Rector AL, Rogers J, Taweel A. �Models and inference methods for clinical systems: a principled approach. �Stud Health Technol Inform. 2004;107(Pt 1):79-83
2004
Generally applicable knowledge
Terminology systems. �ICD-10, SNOMED CT etc.
Documentation of what has been done, observed, planned etc.
Decision support rules, AI etc.
Design experiences gained from �PEN & PAD, Clinergy, GALEN etc.
ICD-10 from WHO, an example of a monohierarhchy.
Treestructure where every concept has at maximum one ”parent”
Type I can be �solved here
Type II & III must �be solved here�also solves type I
Type II & III must �be solved here�also solves type I
SNOMED CT, an example of a polyhierarchy, where every concept can have multiple ”parents”.
>300 000 concepts currently…
SNOMED CT, an example of a polyhierarchy, where every concept can have multiple ”parents”…
…and many other kinds of relations between concepts
SNOMED CT, an example of a polyhierarchy, where every concept can have multiple ”parents”…
…and many other kinds of relations between concepts
For example openEHR (or proprietary model) for storage +� HL7 FHIR etc. for exchange (more about this later)
Form builder
openEHR ”template”
For specific use case, e.g. local, regional or national.
Free archetype and editing tool at https://tools.openehr.org/designer/
openEHR ”archetypes”
Clinical data models.
Found in internatioinal repository
Maximi-datasets, intended for many use cases. Multilingual
”Form renderer”
Web-component that can be included in any webapp. It displays forms and submits validated data to openEHR backends via standardized API.
Conditional logic
Reinterpretation problems, Type I, II & III
Example | System A | System B |
Type I | Birth weight: 3300g�Date: 1954-03-13 | Body weight: 3,3 kg�Timepoint: 13 Mar 1954 |
Type II | Needs surgery at latest: 2018-01-30�Surgery scheduled: 2018-01-20 15:30�Main diagnose*: 323291000119108 | Osteoarthritis of left hip joint|�Other Diagnosis*: �25343008 | Secondary localized osteoarthrosis of pelvic region|�299308007 | Hip joint painful on movement | �Procedure*: �19954002 | Reconstruction of hip with use of methyl methacrylate|�Surgery type**: Lubinus SP II �Preferred anesthesia*: 18946005 | Epidural anesthesia |�NEWS2-score at admission: 1�Anesthesia assessment:�- Fitness: can handle light physical exercise�- Cardiovascular: OK�- Lungs: OK�- Throat: OK�- Gastrointestinal*: 16331000 | Heartburn | Surgery date: 2018-01-20�Diagnosis code: M16.7 | Other secondary coxarthrosis�Surgery code***: NFB49 | Primär total höftledsplastik med cement (Primary total hip arthroplasty with cement)�Anesthesia code***: ZXH50 | Epiduralanestesi (epidural anestesia)�ASA-classification: ASA I = normal healthy patient� *) Codes from Snomed CT�**) special kind of hip replacement� with cement�***) Codes from the Swedish ”KVÅ”� terminology |
Type III� | Number of cigarettes smoked per week: 6-10�…specified in a system with the options:�0, 1-5, 6-10, 11-15, 16-30, 31-50, 51-100, 101+ | Number of cigarettes per week: ?�…specified in a system with the options: 0, 1-3, 4-7, 8-14, 15-28, 29-69, 70+ |
�
Exempel i två olika IT-system
Exempel | System A | System B |
Typ I | Födelsevikt: 3300g�Datum: 1954-03-13 | Kroppsvikt: 3,3 kg�Tidpunkt: 13 Mar 1954 |
Typ II | Opereras senast: 2018-01-30�Preliminär operationstid: 2018-01-20 15:30�Huvuddiagnos*: 323291000119108 | osteoartrit i vänster höftled |�Övriga diagnoser*: �25343008 | sekundär lokaliserad osteoartros i bäckenregion |�299308007 | smärta i höftled vid rörelse | �Åtgärd*: �33788003 | insättning av total protes eller protetisk utrustning i höft med metylmetakrylat |�Operationstyp**: Lubinus SP II med klack �Önskad anestesi*: 18946005 | epiduralanestesi |�NEWS2-score vid inskrivning: 1�Anestesibedömning:�- Kondition: klarar lättare fysisk träning�- Hjärta/kärl: u.a. (u.a. = utan anmärkning)�- Lungor: u.a.�- Svalg: u.a.�- Mag/tarm*: 162030005 | halsbränna med sur eller vattnig uppstötning *) Koder från Snomed CT�**) en särskild typ av höftledsplastik med cement | Operationsdatum: 2018-01-20�Diagnoskod: M167; Annan sekundär koxartros�Operationskod: NFB49; Primär total höftledsplastik med cement�Anestesikod: ZXH50; Epiduralanestesi�ASA-klass: 1 – Frisk patient
|
Typ III | Antal rökta cigaretter per vecka: 6-10�…angivna i ett system med alternativen:�0, 1-5, 6-10, 11-15, 16-30, 31-50, 51-100, 101+ | Antal rökta cigaretter per vecka: ? …angivna i ett system med alternativen: 0, 1-3, 4-7, 8-14, 15-28, 29-69, 70+ |
�
Focus, strengths and weaknesses for ontologies and information models
Ontology/terminology | What, How and Why |
+++ | Disease, Symptom, Sign, Procedure, Body structure, Morphology, Substance, Drug, Equipment, Organism |
++ | Semantic constraints, �Refinement of concepts (e.g. laterality) |
+ + | Context-dependent clinical situations, Present / absent / uncertain, Family history, Previous history, Referred / planned / completed |
++ | Structural constraints of classes and attributes,�Relationships between journal notes |
+++ | Date, Time, Duration, Quantity, Text, �Instance (e.g. of people, organization and place), Context |
Information model | Who, When and Where |
Example: openEHR
Example: SNOMED CT
Souorce: Slight modification of a slide by Mikael Nyström, Cambio
Decision support rules etc
Illustration from CDS in Cambio Cosmic
2007
Evidence-Based Medicine and the Changing Nature of Healthcare: Workshop Summary (IOM Roundtable on Evidence-Based Medicine) �Mark B. McClellan, Michael McGinnis, Elizabeth G. Nabel, and LeighAnne M. Olsen, Institute of Medicine. ISBN: 0-309-11370-9�https://www.nap.edu/catalog/12041/evidence-based-medicine-and-the-changing-nature-of-health-care Fig 5-1. page 116
2007
Evidence-Based Medicine and the Changing Nature of Healthcare: Workshop Summary (IOM Roundtable on Evidence-Based Medicine) �Mark B. McClellan, Michael McGinnis, Elizabeth G. Nabel, and LeighAnne M. Olsen, Institute of Medicine. ISBN: 0-309-11370-9�https://www.nap.edu/catalog/12041/evidence-based-medicine-and-the-changing-nature-of-health-care Page 16
2007
Guessed 2007
2007
Guessed 2012
2012
Källa, © Gartner:
Why so slow progress?
Integration problems?�Not proprely dealing with complexity?
Waste of resouces?
Guessed 2007
HINTS TO OVERCONFIDENT �IT-PEOPLE
End of historical time travel. Let’s look forward, remembering history
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What’s the thing about Health IT?
Bra intro för IT-folk m.fl. https://youtu.be/FbgohflFzo8 (18 min) �Silje Ljosland Bakke
Region Östergötland
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Region Östergötland
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Region Östergötland
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HOW HARD CAN IT BE?
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Hur svårt kan det vara?
Share the workload – internationally. Thousands of collaborators
How long time would it take to structure ”everything” well in healthcare?�Guesstimates range between tens to hundeds of person years initially, + some percentage of that annually for new needs and maintenance. (Probably longer if you also invent a new standard)
Table incl. references reachable via https://bit.ly/es-pres, [direct link here]
Att skapa och underhålla ett eget modellbibliotek utan internationell arbetsdelning är ett resursslukande högriskprojekt! �Detta gäller även svenska myndigheter och stora regioner. �Risken blir ännu större om man hittar på egna standarder…
Att hitta på ett eget svenskt Snomed CT vore dumt, detsamma gäller dokumentationsmodeller!
Table available via https://bit.ly/es-pres, sources:
https://oskarthunman.wordpress.com/2015/03/10/vad-kostar-fullstandig-interoperablitet/
http://wolandscat.net/2014/12/15/semantic-scalability-the-core-challenge-in-e-health/
http://files.himss.org/2015Conference/handouts/PHY7.pdf http://openehr.org/ckm/ http://arketyper.no/ckm/
Deteiled modeling takes time! Coooperate internationally & vendor independent
Mission possible but never ending (if done right together)�Mission expensive and likely impossible if done wrong.
QUESTIONS & THOUGHTS
…up to this point of the presentation…
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openEHR, a bit more in depth + �HL7 FHIR + some practical examples from Karolinska University Hospital�
(Material mainly intended for part 2, we might have some time to start during part 1)
Quick repetition �from last lecture
Reinterpretation problems, Type I, II & III
Example | System A | System B |
Type I�A <-- --> B �Can be done with algoritm/program | Birth weight: 3300g�Date: 1954-03-13 | Body weight: 3,3 kg�Timepoint: 13 Mar 1954 |
Type II A --> B�Semantic loss and distortion �due to reinterpretations. Hard, dangerous or impossible with algorithm/program… …but often done manually �by medically skilled staff�over and over for each transfer… B --> A�Missing information�impossible with algorithm/program | Needs surgery at latest: 2018-01-30�Surgery scheduled: 2018-01-20 15:30�Main diagnose*: 323291000119108 | Osteoarthritis of left hip joint|�Other Diagnosis*: �25343008 | Secondary localized osteoarthrosis of pelvic region|�299308007 | Hip joint painful on movement | �Procedure*: �19954002 | Reconstruction of hip with use of methyl methacrylate|�Surgery type**: Lubinus SP II �Preferred anesthesia*: 18946005 | Epidural anesthesia |�NEWS2-score at admission: 1�Anesthesia assessment:�- Fitness: can handle light physical exercise�- Cardiovascular: OK�- Lungs: OK�- Throat: OK�- Gastrointestinal*: 16331000 | Heartburn | Surgery date: 2018-01-20�Diagnosis code: M16.7 | Other secondary coxarthrosis�Surgery code***: NFB49 | Primär total höftledsplastik med cement (Primary total hip arthroplasty with cement)�Anesthesia code***: ZXH50 | Epiduralanestesi (epidural anestesia)�ASA-classification: ASA I = normal healthy patient� *) Codes from Snomed CT�**) special kind of hip replacement� with cement�***) Codes from the Swedish ”KVÅ”� terminology |
Type III�Reinterpretaion impossible (even for skilled humans) due to aggregations etc. | Number of cigarettes smoked per week: 6-10�…specified in a system with the options:�0, 1-5, 6-10, 11-15, 16-30, 31-50, 51-100, 101+ | Number of cigarettes per week: ?�…specified in a system with the options: 0, 1-3, 4-7, 8-14, 15-28, 29-69, 70+ |
�
Agree on what, where?
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Type I can be �solved here
Type II & III must �be solved here�also solves type I
Type II & III must �be solved here�also solves type I
The three integration strategies combined
Not mutually exclusive and can be combined depending on e.g.
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Example on next slide
Catalonia, Spanish region, 8 million inhabitants
Procurement-related activities
Catalan 25-year retrospective https://preprints.jmir.org/preprint/58933
#3. Shared model-driven strategy
P.S. Karolinska University Hospital is also following a similar path for internally developed applications based on an openEHR CDR + FHIR Server
Illustration based on content from:�Rector AL, Rogers J, Taweel A. �Models and inference methods for clinical systems: a principled approach. �Stud Health Technol Inform. 2004;107(Pt 1):79-83
2004
Generally applicable knowledge
Terminology systems. ICD-10, SNOMED CT etc.
Documentation of what has been done, observed, planned etc.
Decision support rules, AI etc.
Design experiences gained from �PEN & PAD, Clinergy, GALEN etc.
OPENEHR
The inventors of the standard pronounce it like ”open air”
EHR = Electronic Health Record (Swedish: Journalsystem)
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What is openEHR? Formally...
A technology for e-health �– open specifications + clinical models (archetypes and templates)�– software (tools etc.)
…to build information and interoperability solutions for healthcare.
Artefacts of openEHR are produced by the openEHR community and managed by openEHR International, a non-profit organisation established in 2003
https://openehr.org/about/what_is_openehr�EHR = Electronic Health Record = Elektronisk Patientjournal
What is openEHR? Organisational parts
What is openEHR? People! Collaboration!
International community with clinicians, informaticians, technicians, researchers and others working together
Discussions: https://discourse.openehr.org/
http://openehr.se/
ärende 4260283
Speed! ..by sharing the workload�Information models take time to create - if they are to work well for everyone.
88
Library and collaboration portal for archetypes, templates, etc. https://ckm.openehr.org/
Positive side effects:
Reuse!�Share the requirements gathering, analysis and information modeling. (globally!
Archetypes (arketyper)�Reusable documentation patterns
Template (mall)�Specific to a use case.�Combines and configures multiple archetypes.
Form (formulär/gränssnitt)�Autogenerated from template, then manually adjusted
Exempel på en ”arketyp” från openEHR
Kliniskt intressanta saker angående blodtrycksmätning?
”Maximi-tänk” istället för minsta gemensamma nämnare.
Det finns metod/formalism/verktyg att fånga och krav i, och forum att diskutera i.
”Template” (mall) väljer ut & anpassar från arketyper, exempelvis:
= inmatning/datafångst
= ställer in passande default-värde (kan ändras vid behov)�utan pil = fält som inte behövs i just detta exempel/användningsfall, syns då ej i formulär m.m.
Se norsk video: https://youtu.be/JW8pBJvdsHQ
Region Östergötland
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Exempel på en ”arketyp” från openEHR
Kliniskt intressanta saker angående blodtrycksmätning?
”Maximi-tänk” istället för minsta gemensamma nämnare.
Det finns metod/formalism/verktyg att fånga och krav i, och forum att diskutera i.
”Template” (mall) väljer ut & anpassar från arketyper, exempelvis:
= inmatning/datafångst
= ställer in passande default-värde (kan ändras vid behov)�utan pil = fält som inte behövs i just detta exempel/användningsfall, syns då ej i formulär m.m.
Se norsk video: https://youtu.be/JW8pBJvdsHQ
Region Östergötland
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”Adoptera” de arketyper du vill följa och t.ex. få inbjudan till review för.
Stöder olika språk. Flera arketyper finns redan på svenska.
Versionshanterat! Föra bilden var v1 denna bild visar v2
Ordentlig Sökfunktion
Begränsad namnsökning
Versionshistorik
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”Adoptera” de arketyper du vill följa och t.ex. få inbjudan till review för.
Stöder olika språk. Flera arketyper finns redan på svenska.
Versionshanterat! Föra bilden var v1 denna bild visar v2
Ordentlig Sökfunktion
Begränsad namnsökning
Versionshistorik
Region Östergötland
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Context for openEHR, Image from: https://www.openehr.org/about/what_is_openehr
Can also include patients!
Other (non-EHR) server functions
Non-EHR storage
openEHR API
API
How do openEHR parts fit together?
Archetypes, Templates, �CDS rules etc.
SNOMED CT, �ICD, ICF etc.
Archetype Designer tools etc.
Clinical Knowledge Manager (CKM),
GitHub etc.
Upload template to platform
Open template in a tool
API
openEHR API
Archetype Designer tools etc.
Archetypes, Templates, �CDS rules etc.
API
openEHR API
CKM, GitHub etc
Free to use. Search, visualisation, review/versioning, adoption, and translation archetypes and templates
Archetype
CKM = Clinical Knowledge Manager |
�
Context for openEHR, Image from: https://www.openehr.org/about/what_is_openehr
openEHR API
API
How do openEHR parts fit together?
Archetypes, Templates, �CDS rules etc.
SNOMED CT, �ICD, ICF etc.
Archetype Designer tools etc.
CKM, GitHub etc
Upload template to platform
Open template in a tool
🡨 Focus of next slide
openEHR modeling toolchain
Form builder
openEHR ”template”
For specific use case, e.g. local, regional or national.
Free archetype and editing tool at https://tools.openehr.org/designer/
openEHR ”archetypes”
Clinical data models.
Found in internatioinal repository
Maximi-datasets, intended for many use cases. Multilingual
”Form renderer”
Web-component that can be included in any webapp. It displays forms and submits validated data to openEHR backends via standardized API.
Conditional logic
Exempel: �Patologisvar Bröstcancer
Mer om detta exempel under utbildningsdag 2.
Se även rapport om modellering av patologisvaren: �http://liu.diva-portal.org/smash/get/diva2:1343958/FULLTEXT01.pdf
Formuläreditor
openEHR ”template”
…för specifikt användningsfall
Ofta nationellt, regionalt eller lokalt.
Har laddats in i formuläreditorn.
openEHR ”arketyper”
Kliniska datamodeller.
Maximi-dataset, många användningsfall
Internationella, översätts.
”Form renderer”
Web-komponent som�Visar formulär & skickar data till openEHR API.
Vilkorsstyrning av formulär
Teknikfokus: referensmodell
Figure 20. High-level Structure of the openEHR EHR
Byggbitarna ärver från LOCATABLE, när man lagrar ner motsvarande journaldata så är:
openEHRs
”allt-i-allo”
Spårbarhet från import etc.
Länka mellan journalinnehåll
Extra ID för ev. speciella behov
Examples of openEHR use from�different parts of the world
…not complete, for example missing some providers, missing recent projects and missing China!
2012
2010
2010
2016
Covid-19 Guideline 🡪 openEHR GDL�Source: Xudong Lu @ openEHR 2020 Digital event 24 Nov. https://openehr2020.com/oehrf2020/�https://discourse.openehr.org/t/chinese-covid-19-diagnosis-and-treatment-decision-support-openehr-templates-and-rules/516
HiGHmed (Nästa generations kvalitetsregister?)�https://www.highmed.org/ - https://youtu.be/x4sZQpjxP5A
National German COVID-19 research hub
Open source stack�The openEHR-based open source plattform https://ehrbase.org/ in large scale deployment
Source: openEHR 2020 Digital event 24 Nov. https://openehr2020.com/oehrf2020/
Svenska exempel och experiment
Cambio Cosmic, vissa (hårdkodade) arketypbaserade sökord�
CDS - Stroke Prevention
Cambio CDS Beslutsstöd – baserat på GDL
StandIN3, projektseminarium, infopass 4, 2019-03-05. https://github.com/modellbibliotek/standin/tree/master/ehr-form-config
"Configuration of input forms in EHR systems using spreadsheets, openEHR archetypes and templates" http://dx.doi.org/10.3233/SHTI190645
Delat detaljerat informatikarbete i exsiterande system? Standin3 testade med CGM TakeCare!�Komplement/alternativ till kvalitetsregister?
HL7 WITH FOCUS ON HL7 FHIR
Briefly…
HL7 - http://www.hl7.org/
Health Level Seven International
Messaging & API examples:
Other examples:
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HL7 FHIR�Here we had a look at https://hl7.org/fhir/ during the lecture
Karolinska Institutet – A medical university
openEHR tool & modeling demo
We had a look at these.
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This is where we ended 18 dec 2024
openEHR in practice + FHIR + Q&A
[Future] Extra seminar for 5HI020 - Standardisation within healthcare
?? ??? 2025 @ Karolinska Institutet
Erik Sundvall,
PhD Medical Informatics, MSc Information Technology / Computer Science
Information architect @ Karolinska University Hospital, Region Stockholm (Main job)
Adjunct Senior Lecturer in Medical Informatics @ IMT, Linköping University
Affiliated researcher @ HIC, LIME, Karolinska Institutet
HL7 FHIR AND OPENEHR COMBINED?
Material mainly for part 2 (Thursday)
How Karolinska University Hospital views standards in the data life cycle. �Any may be useful for a given purpose, depending on the need and relevant constraints.
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“Gartner believes that truly effective and sustainable open architectures will need a capability for vendor-neutral data persistence, such as utilizing a common schema or set of openEHR archetypes and rules for managing structured and unstructured data (for example, a VNA, openEHR or IHE XDS repository in combination with services for trust/consent, ecosystem governance and oversight, and reuse of data and processes for secondary purposes, such as research and population health).
Providing open messaging standards (for example, FHIR, HL7) for data exchange in specific use cases will only go so far in meeting the architectural challenges of digital citizen-centric care delivery”
Healthcare Provider CIOs Need to Rally Their Enterprise Architects Around Citizen-Centric Care Delivery, Gartner 2017
Extended from a slide by Patrik Georgii-Hemming, CMIO at Karolinska University Hospital
OMOP etc.
Most of the proprietary �EHR internal models
All these standards can be combined with
Recent example of lacking understanding of what can be solved where/how
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Responses from four organisations that use openEHR (and FHIR) https://discourse.openehr.org/t/synpunkter-pa-pm-vagval-for-en-nationell-digital-infrastruktur-for-halsodata-baserad-pa-standarder/4744
| HL7 FHIR | openEHR |
Main focus |
”FHIR is not written for clinicians, it's written for software developers” [2a] �(and other implementation experts) |
”openEHR … working at the clinical semantics level with implementation as a downstream activity” [2b] |
Clinical content selection |
|
|
Technical focus |
|
|
Local and speciality-specific adjustments | Extensions & Profiling Only non-extended FHIR resources guarantee easy international interoperability/similarity. (Extensions can be retrieved and analyzed. Data entered using previously unseen extensions follow the FHIR model and can thus be transferred and read by any system.) | Templates & Archetypes Only templates and archetype specializations based on international archetypes guarantee easy interoperability/similarity. �(Local archetypes etc. can be retrieved and analyzed. Data entered using previously unseen archetypes follow the openEHR model and can thus be transferred and read by any system.) |
Final decisions | HL7 member balloting | Clinical: mainly consensus in online review rounds – mostly clinicians Technical: Specifications Editorial Committee (SEC) – mostly EHR system implementers |
[1] Open internal clinical models as in Grahame Grieve’s: Interoperability vs Intraoperability http://www.healthintersections.com.au/?p=820 � (Above we do not mean intraoperability around a dominating proprietary vendor as in the definition at http://www.ecis.eu/intraoperability/) �[2a] Lloyd McKenzie 2016 March 28 and [2b] Thomas Beale at March 29, both in https://chat.fhir.org/#narrow/stream/openehr
[3] Grahame Grieve, FHIR and confusion about the 80/20 rule, http://www.healthintersections.com.au/?p=1924
OPTIONS WHEN USING FHIR AND OPENEHR TOGETHER
No alignment (just mapping)
Partial alignment (giving better mapping possiblilities)
Encapsulate one in the other
When to use what? Inter- vs Intra-operability?
WHEN TO USE WHAT? INTER- VS INTRA-OPERABILITY?
Egna hälsodata + Digital tvilling + Egenmonitorering�
(Webb)app:�filtrering, aggregering data-standardisering, berikning, kopiering/flytt. �+ Ev inmatning via formulär
Självvald
lagring
Tvilling använder:
- Data delad med vården (aggregerad?)
- Vårdgivarens data (PDL)
Tvilling använder:�- Privat data (detaljerad)
- Kopia av vårdgivarens data
”Wearables”, mätare, smartklockor m.m.
Mobiltelefon
Lagringsalternativ:�- Valfri server/molnleverantör
- Lokal lagring på egen mobil
- Egen server (open source?)
- Förening, klubb etc
- …någon du litar på
Linköpings Universitet, IMT (Gunnar Cedersund m.fl.) + Region Östergötland
In English https://www.youtube.com/watch?v=MvWPHM7wWV4�Longer in Swedish; Part 1: https://www.youtube.com/watch?v=8geMW5lpSs4 Part2: https://www.youtube.com/watch?v=SxtxhjR-lAU
Regionens lagring.
Lagring�- Regionens openEHR-plattform
- Överföring till/från befintligt
journalsystem
Ofiltrerat
Filtrerat &�berikat
REST API
REST API
Ofiltrerat (?)
& berikat
inbyggda sensorer
Google Fit was used as bridge since it works on both iOS and Android
Upphandlad plattform för egenmonitorering
�
TODO: Add many more example slides here + possibly live demos
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LET’S WORK TOGETHER TO SUPPORT BETTER HEALTH
Medical informatics is very interesting and can be challenging
Collaborate
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Bonus tracks
Extra material for possible discussioins/questions
Technical debt (Teknisk skuld)
Ward Cunningham used the metaphor of debt to explain to his boss that if the design team failed to continuously update the design to become aligned with increased updated knowledge of the problem at hand, than they were continually going to stumble over that disagreement. That would slow the team down, which was like paying interest on a loan.
‘Loans’ in the form of rushed solutions can be well motivated by business needs or by wanting to get initial experience. If you keep borrowing and never repay by refactoring and updating the design then ‘eventually all your income goes to interest and your purchasing power goes to zero’. Only adding features and never reorganizing programs to reflect your understanding of those features, then eventually work on it take longer and longer, the interest is total, zero progress.
Bildkälla: http://kirstenfeldbrugge.nl/?p=85
Bra förklarande video (8:38) med David Snowden: http://youtu.be/N7oz366X0-8
Förklarande artikel: Snowden, David; Boone, Mary (November 2007). "A Leader's Framework for Decision Making". �Harvard Business Review: 69–76. Nås från t.ex. http://scholar.google.se/scholar?cluster=16946851987297242719
Bildkälla: https://plus.google.com/117688908424964690672/posts/PWYxcYJENWk �Fler Cynefin-relaterade länkar: http://frectal.com/book/ �http://blog.jackvinson.com/docs/Systems-Thinking-and-the-Cynefin-Framework-Final.4.pdf
AGILITY AND EFFICIENCY?
Towards interoperable and knowledge-based electronic health records using archetype methodology Rong Chen (PhD thesis), http://urn.kb.se/resolve?urn=urn%3Anbn%3Ase%3Aliu%3Adiva-54822
Region Östergötland
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144
years
months
Health IT organizations & vendors are often slower than Gartners average system examples (perhaps due to complexity, regulations etc?)
Region Östergötland
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Reliability+Agility? Quality+Speed/Innovation? Bimodal IT (1+2)�Finding suitable abstraction layers and suitable management (people+process)…�
Specifications, e.g.: XML,
XML Schema (the ”language”),
XPath & XQuery
General XML database systems
XML Schema V (national?)
XML Schema U
General XML Tools (editors, processors etc)
XML Schema Y using V+W
X instances
Software manipulating/using X instances
XML Schema X using U+V
XML Schema W (international?)
Y instances
Rule engines
Rules & data flows
Spreadsheet
Software
(e.g. Excel)
Spreadsheet
template, e.g.
time report
for company X
Mr Smith’s
time report
for June
(an instance)
Specifications, e.g.:
-Reference Model (RM),
-Archetype Model (AM),
-AQL (query language)
-GDL (decision support lang.)…
EHR storage system RM+AQL+…
Archetype V (national?)
Archetype U
Archetype W (international?)
Template Y using V+W
Template X using U+V
Tools, editors…
http://www.gartner.com/it-glossary/bimodal/
GUIs generating/reading/querying instances
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”Bimodal IT” �2x ”modes”
Mode 1
Stabilt
Effektivt
”Maratonlöpare”
Mode 2
Agilt
Snabbt
”Sprinter”
Bimodal IT
Väsensskilda modus
Båda är viktiga
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Tell the truth!�Listen to science!
Solutions are possible!
Support
Sys. admin
Customer group
Delivery
Release mgmnt. Programming
Test
Configuration
Roll-out (during planned service ”windows”)
Find/create archetypes�Create template
Create form/GUI and ”task planning” �incl. dynamic w/ ”low code”
Sometimes: Modify or create CDS rules
Upload to system�(”live” in an active system)
Test and quality control
Sometimes: Extra programming & optimisations
Mode 1
”Marathonl”
Mode 2
”Sprint”
Adjusting related systems (integrations
Statistical reports etc)
Custromer repr.�Investigation
Prioritisation
Pre-study
GUI/client-design
API-design
Database design
Objekt-modelling
Mode 1
”Maratonlöpare”�Stabil informatik och teknisk grundplattform
Tech sys. administration and improvement�of CDR and tools
Mode 2
”Sprinter”, delar�konfigurerbara av verksamhet
Support
Förvaltning
Kundgrupp
Leverans
Releasehantering�Programmering
Test
Konfiguration
Utrullning (servicefönster för planerade driftstopp)
Leta/skapa arketyper�Skapa template
Skapa formulär/GUI och ”task planning” �inkl. dynamik m. ”low code”
Ev. Modifiera/skapa beslutsregler
Ladda in i system�(”live” i aktivt system)
Test/granskning�Ev. kompletterande programmering och optimering
Mode 1
”Maratonlöpare”
Mode 2
”Sprinter”
Anpassning av kringsystem
(integrationer
Statistik, uppföljning)
Kundkontakt�Utredning
Prioritering
Förstudie
GUI/klient-design
API-design
Databasdesign
Objekt-modellering
Mode 1
”Maratonlöpare”�Stabil informatik och teknisk grundplattform
Teknisk förvaltning av grundplattform och ”verktygslåda”
Mode 2
”Sprinter”, delar�konfigurerbara av verksamhet
https://youtu.be/RYTmMQJFpAc?t=718
"...still many organizations choosing ... traditional route and we know that this will be the last cohort adopting this… already a legacy technology… not going to be what we use in the future"
https://youtu.be/RYTmMQJFpAc?t=718
DEMO OF TOOLS? +�QUESTIONS & DISCUSSION
Q & A
CDR
Mottagande system
Labb/Patologi-�system
Journalsystem �+ ev remiss- & svarssystem
RIS/PACS
system
Kvalitetsregister X
Svarsmallar
Remittent
BMA
Patolog
Radiolog
Källsystem
Svarsmallar
Svars-mottagare
Svarsmallar
Svarsmallar
Regional del av INCAS vårddatalager
'���
Cancerregistret
Nat. modellbibliotek
T.ex. GitHub och andra tjänster för att dela filer versionshanterat, t.ex. eHälsomyndighetens “NGS”
NAG Patologi, �KVAST-grupper, �Sv. openEHR-förvaltning
Vårdgivare/regioner m.m.
openEHR CKM
Verktyg�för templates, �forms, AQL mm
Exempel-�formulär
Kvalitetsregister Y
Kundgruppers systemspecifika
formulär
Patologiformulär
Kvalreg-app Y
IPÖ-app
Kvalreg-app X
Lokala patientöversikter etc.
Användare i regioner som vill fortsätta jobba som idag
Kirurg
OpenEHR
Templates �för patologi
Gula pilar är informationsstruktur, terminologiurval, formulär, etc �(Alltså konfiguration, inte patientdata.)
Narrativ-genererande�algoritmer
Förenklad bild
CDR
DB
...
Standardisation: why and how
Context, fundamental problems, strategies, and examples of solutions for Electronic Health Records (and maybe a bit of time-travel)
11+18 Dec 2024 + Q&A session 10 Mar 2025 @ Karolinska Institutet,
Course 5HI001 - Computer Applications in Health Care and Biomedicine
Erik Sundvall,
PhD Medical Informatics, MSc Information Technology / Computer Science
Information architect & CDR product owner @ Karolinska University Hospital, Region Stockholm (Main job)
Adjunct Senior Lecturer in Medical Informatics @ IMT, Linköping University
Affiliated researcher @ HIC, LIME, Karolinska Institutet
//Alex Alfarone
// Pamela Castillo
// Htet Wai
160
// Stefano
161