uninfo informatica medica

Pier Angelo Sottile Milano 08/05/2014 Pag. 1

Pier Angelo SottilePresidente Commissione UNINFO d’Informatica MedicaVice-convenor WG1, CEN TC251Coordinating Advisory Group 2, ISO TC215GESI Gestione Sistemi per l’InformaticaViale degli Ammiragli 67, - 00136 RomaTel +39-0639743413 Fax [email protected]://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”


Agenda

Brief overview on SDOs in general and with respect to eHealth

This conference is about AppsOverview

Issues around Apps

The need

Standardisation around Apps: what is being done here and now

Getting back to standardisation developmentWhat is a standard

The overall process

Who writes standards


Where do Standards come from?

CENELEC

National Bodies

ISOISO

CEN

IECJ T C 1

National Bodies

ITU

ETSI

NationalCommittees

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


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

…


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


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


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”


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!


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?

…


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!


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.

…


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 SDOsshould start!


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 characteristicsthat 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.


Many activities already being carried out Reference and evaluate


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…


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


Many activities already being carried out to reference and evaluate

But also otherscientific literature


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!


‘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?


What is a standard?

Transparency Consensus

Voluntary Democracy


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?


What is a standard?

StandardisationProcess

Durata Max 18 mesi

Editing of document

Publication

Final Ballot

Need

Initial Work Item Public Ballot


Standards Development

Who writes standards?

You and me! ☺


Thank you...Pier Angelo SottilePresidente Commissione UNINFO d’Informatica MedicaVice-convenor WG1, CEN TC251Coordinating Advisory Group 2, ISO TC215____________________________________GESI Gestione Sistemi per l’InformaticaViale degli Ammiragli 67, - 00136 RomaTel +39-0639743413 Fax [email protected]://www.gesi.it

… Questions? ...

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uninfo informatica medica

Health & Medicine

pier angelo sottile

underpinning standards

apps milano

body cag advisory group

milano laboratorio

group cg responsible

health sdos

international sdos