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Pier Angelo Sottile Milano 08/05/2014 Pag. 1
Pier Angelo Sottile
Presidente Commissione UNINFO d’Informatica Medica
Vice-convenor WG1, CEN TC251
Coordinating Advisory Group 2, ISO TC215
GESI Gestione Sistemi per l’Informatica
Viale degli Ammiragli 67, - 00136 Roma
Tel +39-0639743413 Fax +39-0639743346
gesi@gesi.it
http://www.gesi.it
Activating Standards Developing
Organizations around Apps
Milano, Politecnico di Milano
Laboratorio di Informatica Biomedica e Sanità Digitale
eHealth Lab
8 Maggio 2014
Commissione UNINFO
“Informatica Medica”
Pier Angelo Sottile Milano 08/05/2014 Pag. 2
Agenda
Brief overview on SDOs in general and with respect to eHealth
This conference is about Apps
Overview
Issues around Apps
The need
Standardisation around Apps: what is being done here and now
Getting back to standardisation development
What is a standard
The overall process
Who writes standards
Pier Angelo Sottile Milano 08/05/2014 Pag. 3
Where do Standards come from?
CENELEC
National
Bodies
ISOISO
CEN
IEC
J T C 1
National
Bodies
ITU
ETSI
National
Committees
CEN/CLC Forum
Standards Developing Organizations acknowledged by WTO
Italian SDOs acknowledged at European (CEN-CENELEC) and
International (ISO-IEC) levels:
• CEI → “electric and electronic sectors”
• UNI → “Everything else”
In ICT, several Fora and Consortiums are very active
Pier Angelo Sottile Milano 08/05/2014 Pag. 4
European and International SDOs Regarding Health
SDOs regarding eHealth/Health Informatics aspects (in Joint Initiative
Council):
CDISC - Clinical Data Interchange Standards Consortium
CEN TC 251 – Health Informatics
GS-1 - Supply chain standards system
HL7 – Health level 7
IHTSDO - Not-for-profit association that owns and maintains SNOMED CT
ISO TC215 – Health Informatics
But more:
ISO TC 12 Quantities and units (also for use in healthcare)
International Electrotechnical Commission (IEC) - International Standards and Conformity
Assessment for all electrical, electronic and related technologies – TC62
Integrating the Healthcare Enterprise (IHE), promoting the coordinated use of established
standards though profiles
…
Pier Angelo Sottile Milano 08/05/2014 Pag. 5
Structure of ISO TC215
Technical Committee Plenary (TC) which acts as the formal decision-making body
CAG Advisory Group 1: Executive Council (EC) which provides strategic oversight
CAG Advisory Group 2: Coordinating Group (CG) responsible for operational matters
CAG Advisory Group 3: Cross-SDO Co-ordination Group
Working Groups (WGs 1-4) which have an on-going role across an underpinning area
Working Groups for a domain (WG-Ds) specific to defined business domains
Ad-hoc groups constituted for a specific purpose
WG1: concentrate on the
underpinning modelling structures,
processes and contexts
WG2: focus on data and device
interoperability
WG3: concentrate on underpinning
standards for terminologies
(excluding specific content) and
aspects of ‘semantics’, e.g. decision
support, metrics, user interfaces
WG4: represent Privacy, Safety and
Security, as an aggregation of a
number of diverse Enterprise
portfolios
Pier Angelo Sottile Milano 08/05/2014 Pag. 6
Structure of ISO TC215
Technical Committee Plenary (TC) which acts as the formal decision-making body
CAG Advisory Group 1: Executive Council (EC) which provides strategic oversight
CAG Advisory Group 2: Coordinating Group (CG) responsible for operational matters
CAG Advisory Group 3: Cross-SDO Co-ordination Group
Working Groups (WGs 1-4) which have an on-going role across an underpinning area
Working Groups for a domain (WG-Ds) specific to defined business domains
Ad-hoc groups constituted for a specific purpose
WG1: concentrate on the
underpinning modelling structures,
processes and contexts
WG2: focus on data and device
interoperability
WG3: concentrate on underpinning
standards for terminologies
(excluding specific content) and
aspects of ‘semantics’, e.g. decision
support, metrics, user interfaces
WG4: represent Privacy, Safety and
Security, as an aggregation of a
number of diverse Enterprise
portfolios
UNINFO eHealth Committee
“Commissione Informatica
Medica”
Official Liaison to HL7,
CEN, etc., apart from
participating to JIC
Pier Angelo Sottile Milano 08/05/2014 Pag. 7
The UNI Picture
UNICHIM
Chimica
CIG
Gas
UNINFO
Informatica
CTI
Termotecnica
UNSIDER
Ferro e Metalli
UNIPLAST
Materie Plastiche
CUNA
Automobili
“UNINFO è una libera Associazione
a carattere tecnico-scientifico e
divulgativo senza fine di lucro
(diretto o indiretto) che si prefigge di
promuovere, realizzare e diffondere
la normazione tecnica nel settore
delle tecnologie dell'informazione e
delle comunicazioni (in breve ICT) e
delle loro applicazioni, sia a livello
nazionale che europeo ed
internazionale.”
Estratto dallo Statuto UNINFO
Commissione
“Informatica Medica”
Pier Angelo Sottile Milano 08/05/2014 Pag. 8
Many Examples of Apps in the Medical and Health & Fitness fields
Used for:
Improving or facilitating communications between clinicians and patients
Used for monitoring clinical parameters
Informative on pathologies, drugs, interactions, available services, etc.
AND MUCH MORE!
What do they do and where are they to get? See for yourself:
Several shall be presented in this international conference
iMedicalApps.com for manyexamples and reviews
Itunes Store
Google Store
Microsoft Store
… all running on ever more powerful smartphones and tablets!
Pier Angelo Sottile Milano 08/05/2014 Pag. 9
Issues around Apps in Healthcare
BIG numbers (as seen in May 2014 on appbrain.com and 148apps.biz)!
Apps on Google Store: 1.203.791, of which 33.905 regarding Health & Fitness
and 16.316 regarding Medical topics
Apps on Itunes: 1.555.944, of which 31.737 regarding Health & Fitness and
24,836 regarding Medical topics
…
But what about App:
documentation (technical, about the provider, promoter, testing, and correct
use)?
quality and safety (risks)?
data protection?
integration of App data with other patient/person data?
scientific/expert review of the app?
accreditation of the apps?
regulatory aspects?
usage in health organisations?
…
Pier Angelo Sottile Milano 08/05/2014 Pag. 10
A note Regarding Data Protection
It’s today’s news (6th of
May 2014) that national
body responsible for the
protection of data will
investigate privacy with
respect to Medical Apps!
Pier Angelo Sottile Milano 08/05/2014 Pag. 11
The need regarding Apps in Healthcare
There is a need for the proper identification of the apps in the eHealth
arena in order to allow:
proper use and deployment in healthcare
delivery organisations
accreditation of apps
application of regulatory aspects
awareness and confidence in the app user
…
Use of standards and new ad-hoc norms to obtain:
conformity assessment procedures
assess manufacturer’s obligations
support the implementation of regulatory frameworks, accreditation,
qualification, etc.
…
Pier Angelo Sottile Milano 08/05/2014 Pag. 12
The need regarding Apps in Healthcare
There is a need for the proper identification of the apps in the eHealth
arena in order to allow:
proper use and deployment in healthcare
delivery organisations
accreditation of apps
application of regulatory aspects
awareness and confidence in the app user
…
Use of standards and new ad-hoc norms to obtain:
conformity assessment procedures
assess manufacturer’s obligations
support the implementation of regulatory frameworks, accreditation,
qualification, etc.
…
This is where SDOs
should start!
Pier Angelo Sottile Milano 08/05/2014 Pag. 13
What is being done
In the UNINFO eHealth Committee a working group has been
activated, the scope of which is to prepare a document (technical
specification or report) regarding apps and relevant characteristics
that need to be provided by the manufacture/provider. A sort of
standard ID Document for apps in healthcare, containing, for
example:
Promoters of the apps
Services provided
Sector of application
Intended use
Intended user population
Conformance (to standards/regulations/...) statements
…
The topic has also been brought up at European (CEN TC 251) and
international (ISO TC 215) eHealth Committees, to which the Italian
result may be escalated.
Pier Angelo Sottile Milano 08/05/2014 Pag. 14
Many activities already being carried out
Reference and evaluate
Pier Angelo Sottile Milano 08/05/2014 Pag. 15
Many activities already being carried out
Reference and evaluate
Pier Angelo Sottile Milano 08/05/2014 Pag. 16
European Medical Device Directive and MEDDEV
Where the intended use of the app falls under the Medical Device
Directive’s prescription, the following directives need to be taken into
consideration:
1. 90/385/EEC Active Medical Devices
2. 93/42/EEC Medical Devices Directives (General devices)
3. 98/79/EC In-vitro Diagnostic Medical Devices
Amended by 2007/47/EC, to be seen with among others MEDDEV 2.1.6
Qualification and Classification of Stand Alone SW, released in 2012
Qualification and classification of a product as Medical Device with
the consequent CE marking!
Expecting new regulation on topic? in 2015? Open question…
Pier Angelo Sottile Milano 08/05/2014 Pag. 17
Risk management is important, of course, but…
All of the previous examples deal with sole Medical Devices Directive
aspects –fundamental and highly important due to risk management-
but this however does not cover all apps dealing with Health and all
other Healthcare-related aspects.
In order to recognise when to apply the Medical Device directives and
anyhow implement a sound regulatory framework for apps dealing
with health, it is necessary to
inform and educate manufactures, providers, and users
require that the relevant characteristics of the apps be documented as to
easily identify where the app falls in terms of categorisation
This facilitates the application of regulatory frameworks in all cases
Pier Angelo Sottile Milano 08/05/2014 Pag. 18
Many activities already being carried out to reference and
evaluate
But also other
scientific literature
Pier Angelo Sottile Milano 08/05/2014 Pag. 19
EN ISO 13485 Quality Systems
EN ISO 14971 Risk management
EN ISO 12967 Health Informatics – Service Architecture
ISO/IEC 25012 Systems and software engineering -- Systems and
software Quality (and others in the 25000 series like: ISO/IEC 25010,
ISO/IEC 25051:2014)
…
Also existing standards as reference!
Pier Angelo Sottile Milano 08/05/2014 Pag. 20
‘Standard’ means a technical specification, adopted by a recognised
standardisation body, for repeated or continuous application, with which
compliance is not compulsory, and which is one of the following:
‘international standard’ means a standard adopted by an international
standardisation body;
‘European standard’ means a standard adopted by a European
standardisation organisation ;
‘harmonised standard’ means a European standard adopted on the basis of a
request made by the Commission for the application of Union harmonisation
legislation;
‘national standard’ means a standard adopted by a national standardisation
body;
Regulation (EU) No 1025/2012, OJEU L 316 14 November 2012
What is a standard?
Pier Angelo Sottile Milano 08/05/2014 Pag. 21
What is a standard?
Transparency Consensus
Voluntary Democracy
Pier Angelo Sottile Milano 08/05/2014 Pag. 22
CONSENSUS: approval through consensus of working group
members
DEMOCRACY: all interested parties may participate to the
task
TRASPARENCY: The SDO signals the steps of the approval
process, sharing the project itself with the interested parties
VOLONTARY: standards are the reference that all parties take
on spontaneously.
What is a standard?
Pier Angelo Sottile Milano 08/05/2014 Pag. 23
What is a standard?
Standardisation
Process
Durata Max 18 mesi
Editing of document
Publication
Final Ballot
Need
Initial Work Item Public Ballot
Pier Angelo Sottile Milano 08/05/2014 Pag. 24
Standards Development
Who writes standards?
You and me! ☺
Pier Angelo Sottile Milano 08/05/2014 Pag. 25
Thank you...
Pier Angelo Sottile
Presidente Commissione UNINFO d’Informatica Medica
Vice-convenor WG1, CEN TC251
Coordinating Advisory Group 2, ISO TC215
____________________________________
GESI Gestione Sistemi per l’Informatica
Viale degli Ammiragli 67, - 00136 Roma
Tel +39-0639743413 Fax +39-0639743346
gesi@gesi.it
http://www.gesi.it
… Questions? ...
This work is licensed under the
Creative Commons Attribution- NonCommercial-NoDerivs 3.0 Unported License.
To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/
uninfo@uninfo.it

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Intervento Pier Angelo Sottile dell'8 maggio ...

  • 1. Pier Angelo Sottile Milano 08/05/2014 Pag. 1 Pier Angelo Sottile Presidente Commissione UNINFO d’Informatica Medica Vice-convenor WG1, CEN TC251 Coordinating Advisory Group 2, ISO TC215 GESI Gestione Sistemi per l’Informatica Viale degli Ammiragli 67, - 00136 Roma Tel +39-0639743413 Fax +39-0639743346 gesi@gesi.it http://www.gesi.it Activating Standards Developing Organizations around Apps Milano, Politecnico di Milano Laboratorio di Informatica Biomedica e Sanità Digitale eHealth Lab 8 Maggio 2014 Commissione UNINFO “Informatica Medica”
  • 2. Pier Angelo Sottile Milano 08/05/2014 Pag. 2 Agenda Brief overview on SDOs in general and with respect to eHealth This conference is about Apps Overview Issues around Apps The need Standardisation around Apps: what is being done here and now Getting back to standardisation development What is a standard The overall process Who writes standards
  • 3. Pier Angelo Sottile Milano 08/05/2014 Pag. 3 Where do Standards come from? CENELEC National Bodies ISOISO CEN IEC J T C 1 National Bodies ITU ETSI National Committees CEN/CLC Forum Standards Developing Organizations acknowledged by WTO Italian SDOs acknowledged at European (CEN-CENELEC) and International (ISO-IEC) levels: • CEI → “electric and electronic sectors” • UNI → “Everything else” In ICT, several Fora and Consortiums are very active
  • 4. Pier Angelo Sottile Milano 08/05/2014 Pag. 4 European and International SDOs Regarding Health SDOs regarding eHealth/Health Informatics aspects (in Joint Initiative Council): CDISC - Clinical Data Interchange Standards Consortium CEN TC 251 – Health Informatics GS-1 - Supply chain standards system HL7 – Health level 7 IHTSDO - Not-for-profit association that owns and maintains SNOMED CT ISO TC215 – Health Informatics But more: ISO TC 12 Quantities and units (also for use in healthcare) International Electrotechnical Commission (IEC) - International Standards and Conformity Assessment for all electrical, electronic and related technologies – TC62 Integrating the Healthcare Enterprise (IHE), promoting the coordinated use of established standards though profiles …
  • 5. Pier Angelo Sottile Milano 08/05/2014 Pag. 5 Structure of ISO TC215 Technical Committee Plenary (TC) which acts as the formal decision-making body CAG Advisory Group 1: Executive Council (EC) which provides strategic oversight CAG Advisory Group 2: Coordinating Group (CG) responsible for operational matters CAG Advisory Group 3: Cross-SDO Co-ordination Group Working Groups (WGs 1-4) which have an on-going role across an underpinning area Working Groups for a domain (WG-Ds) specific to defined business domains Ad-hoc groups constituted for a specific purpose WG1: concentrate on the underpinning modelling structures, processes and contexts WG2: focus on data and device interoperability WG3: concentrate on underpinning standards for terminologies (excluding specific content) and aspects of ‘semantics’, e.g. decision support, metrics, user interfaces WG4: represent Privacy, Safety and Security, as an aggregation of a number of diverse Enterprise portfolios
  • 6. Pier Angelo Sottile Milano 08/05/2014 Pag. 6 Structure of ISO TC215 Technical Committee Plenary (TC) which acts as the formal decision-making body CAG Advisory Group 1: Executive Council (EC) which provides strategic oversight CAG Advisory Group 2: Coordinating Group (CG) responsible for operational matters CAG Advisory Group 3: Cross-SDO Co-ordination Group Working Groups (WGs 1-4) which have an on-going role across an underpinning area Working Groups for a domain (WG-Ds) specific to defined business domains Ad-hoc groups constituted for a specific purpose WG1: concentrate on the underpinning modelling structures, processes and contexts WG2: focus on data and device interoperability WG3: concentrate on underpinning standards for terminologies (excluding specific content) and aspects of ‘semantics’, e.g. decision support, metrics, user interfaces WG4: represent Privacy, Safety and Security, as an aggregation of a number of diverse Enterprise portfolios UNINFO eHealth Committee “Commissione Informatica Medica” Official Liaison to HL7, CEN, etc., apart from participating to JIC
  • 7. Pier Angelo Sottile Milano 08/05/2014 Pag. 7 The UNI Picture UNICHIM Chimica CIG Gas UNINFO Informatica CTI Termotecnica UNSIDER Ferro e Metalli UNIPLAST Materie Plastiche CUNA Automobili “UNINFO è una libera Associazione a carattere tecnico-scientifico e divulgativo senza fine di lucro (diretto o indiretto) che si prefigge di promuovere, realizzare e diffondere la normazione tecnica nel settore delle tecnologie dell'informazione e delle comunicazioni (in breve ICT) e delle loro applicazioni, sia a livello nazionale che europeo ed internazionale.” Estratto dallo Statuto UNINFO Commissione “Informatica Medica”
  • 8. Pier Angelo Sottile Milano 08/05/2014 Pag. 8 Many Examples of Apps in the Medical and Health & Fitness fields Used for: Improving or facilitating communications between clinicians and patients Used for monitoring clinical parameters Informative on pathologies, drugs, interactions, available services, etc. AND MUCH MORE! What do they do and where are they to get? See for yourself: Several shall be presented in this international conference iMedicalApps.com for manyexamples and reviews Itunes Store Google Store Microsoft Store … all running on ever more powerful smartphones and tablets!
  • 9. Pier Angelo Sottile Milano 08/05/2014 Pag. 9 Issues around Apps in Healthcare BIG numbers (as seen in May 2014 on appbrain.com and 148apps.biz)! Apps on Google Store: 1.203.791, of which 33.905 regarding Health & Fitness and 16.316 regarding Medical topics Apps on Itunes: 1.555.944, of which 31.737 regarding Health & Fitness and 24,836 regarding Medical topics … But what about App: documentation (technical, about the provider, promoter, testing, and correct use)? quality and safety (risks)? data protection? integration of App data with other patient/person data? scientific/expert review of the app? accreditation of the apps? regulatory aspects? usage in health organisations? …
  • 10. Pier Angelo Sottile Milano 08/05/2014 Pag. 10 A note Regarding Data Protection It’s today’s news (6th of May 2014) that national body responsible for the protection of data will investigate privacy with respect to Medical Apps!
  • 11. Pier Angelo Sottile Milano 08/05/2014 Pag. 11 The need regarding Apps in Healthcare There is a need for the proper identification of the apps in the eHealth arena in order to allow: proper use and deployment in healthcare delivery organisations accreditation of apps application of regulatory aspects awareness and confidence in the app user … Use of standards and new ad-hoc norms to obtain: conformity assessment procedures assess manufacturer’s obligations support the implementation of regulatory frameworks, accreditation, qualification, etc. …
  • 12. Pier Angelo Sottile Milano 08/05/2014 Pag. 12 The need regarding Apps in Healthcare There is a need for the proper identification of the apps in the eHealth arena in order to allow: proper use and deployment in healthcare delivery organisations accreditation of apps application of regulatory aspects awareness and confidence in the app user … Use of standards and new ad-hoc norms to obtain: conformity assessment procedures assess manufacturer’s obligations support the implementation of regulatory frameworks, accreditation, qualification, etc. … This is where SDOs should start!
  • 13. Pier Angelo Sottile Milano 08/05/2014 Pag. 13 What is being done In the UNINFO eHealth Committee a working group has been activated, the scope of which is to prepare a document (technical specification or report) regarding apps and relevant characteristics that need to be provided by the manufacture/provider. A sort of standard ID Document for apps in healthcare, containing, for example: Promoters of the apps Services provided Sector of application Intended use Intended user population Conformance (to standards/regulations/...) statements … The topic has also been brought up at European (CEN TC 251) and international (ISO TC 215) eHealth Committees, to which the Italian result may be escalated.
  • 14. Pier Angelo Sottile Milano 08/05/2014 Pag. 14 Many activities already being carried out Reference and evaluate
  • 15. Pier Angelo Sottile Milano 08/05/2014 Pag. 15 Many activities already being carried out Reference and evaluate
  • 16. Pier Angelo Sottile Milano 08/05/2014 Pag. 16 European Medical Device Directive and MEDDEV Where the intended use of the app falls under the Medical Device Directive’s prescription, the following directives need to be taken into consideration: 1. 90/385/EEC Active Medical Devices 2. 93/42/EEC Medical Devices Directives (General devices) 3. 98/79/EC In-vitro Diagnostic Medical Devices Amended by 2007/47/EC, to be seen with among others MEDDEV 2.1.6 Qualification and Classification of Stand Alone SW, released in 2012 Qualification and classification of a product as Medical Device with the consequent CE marking! Expecting new regulation on topic? in 2015? Open question…
  • 17. Pier Angelo Sottile Milano 08/05/2014 Pag. 17 Risk management is important, of course, but… All of the previous examples deal with sole Medical Devices Directive aspects –fundamental and highly important due to risk management- but this however does not cover all apps dealing with Health and all other Healthcare-related aspects. In order to recognise when to apply the Medical Device directives and anyhow implement a sound regulatory framework for apps dealing with health, it is necessary to inform and educate manufactures, providers, and users require that the relevant characteristics of the apps be documented as to easily identify where the app falls in terms of categorisation This facilitates the application of regulatory frameworks in all cases
  • 18. Pier Angelo Sottile Milano 08/05/2014 Pag. 18 Many activities already being carried out to reference and evaluate But also other scientific literature
  • 19. Pier Angelo Sottile Milano 08/05/2014 Pag. 19 EN ISO 13485 Quality Systems EN ISO 14971 Risk management EN ISO 12967 Health Informatics – Service Architecture ISO/IEC 25012 Systems and software engineering -- Systems and software Quality (and others in the 25000 series like: ISO/IEC 25010, ISO/IEC 25051:2014) … Also existing standards as reference!
  • 20. Pier Angelo Sottile Milano 08/05/2014 Pag. 20 ‘Standard’ means a technical specification, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following: ‘international standard’ means a standard adopted by an international standardisation body; ‘European standard’ means a standard adopted by a European standardisation organisation ; ‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation; ‘national standard’ means a standard adopted by a national standardisation body; Regulation (EU) No 1025/2012, OJEU L 316 14 November 2012 What is a standard?
  • 21. Pier Angelo Sottile Milano 08/05/2014 Pag. 21 What is a standard? Transparency Consensus Voluntary Democracy
  • 22. Pier Angelo Sottile Milano 08/05/2014 Pag. 22 CONSENSUS: approval through consensus of working group members DEMOCRACY: all interested parties may participate to the task TRASPARENCY: The SDO signals the steps of the approval process, sharing the project itself with the interested parties VOLONTARY: standards are the reference that all parties take on spontaneously. What is a standard?
  • 23. Pier Angelo Sottile Milano 08/05/2014 Pag. 23 What is a standard? Standardisation Process Durata Max 18 mesi Editing of document Publication Final Ballot Need Initial Work Item Public Ballot
  • 24. Pier Angelo Sottile Milano 08/05/2014 Pag. 24 Standards Development Who writes standards? You and me! ☺
  • 25. Pier Angelo Sottile Milano 08/05/2014 Pag. 25 Thank you... Pier Angelo Sottile Presidente Commissione UNINFO d’Informatica Medica Vice-convenor WG1, CEN TC251 Coordinating Advisory Group 2, ISO TC215 ____________________________________ GESI Gestione Sistemi per l’Informatica Viale degli Ammiragli 67, - 00136 Roma Tel +39-0639743413 Fax +39-0639743346 gesi@gesi.it http://www.gesi.it … Questions? ... This work is licensed under the Creative Commons Attribution- NonCommercial-NoDerivs 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/ uninfo@uninfo.it