Commissione UNINFO Informatica Medica

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1 Commissione UNINFO Informatica Medica Activating Standards Developing Organizations around Apps Milano, Politecnico di Milano Laboratorio di Informatica Biomedica e Sanità Digitale ehealth Lab 8 Maggio 2014 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, Roma Tel Fax gesi@gesi.it Pier Angelo Sottile Milano 08/05/2014 Pag. 1

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. 2

3 Where do Standards come from? Standards Developing Organizations acknowledged by WTO In ICT, several Fora and Consortiums are very active IEC CENELEC J T C 1 ISO CEN ITU ETSI National Bodies CEN/CLC Forum National Bodies National Committees Italian SDOs acknowledged at European (CEN-CENELEC) and International (ISO-IEC) levels: CEI electric and electronic sectors UNI Everything else Pier Angelo Sottile Milano 08/05/2014 Pag. 3

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. 4

5 Structure of ISO TC215 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 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 Pier Angelo Sottile Milano 08/05/2014 Pag. 5

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. 6

7 The UNI Picture CIG Gas CTI Termotecnica CUNA Automobili UNICHIM Chimica UNSIDER Ferro e Metalli 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. UNINFO Informatica Commissione Informatica Medica UNIPLAST Materie Plastiche Estratto dallo Statuto UNINFO Pier Angelo Sottile Milano 08/05/2014 Pag. 7

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. 8

9 Issues around Apps in Healthcare BIG numbers (as seen in May 2014 on appbrain.com and 148apps.biz)! Apps on Google Store: , of which regarding Health & Fitness and regarding Medical topics Apps on Itunes: , of which 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. 9

10 A note Regarding Data Protection It s today s news (6 th 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. 10

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. 11

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 This is where SDOs should start! 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

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. 13

14 Many activities already being carried out Reference and evaluate Pier Angelo Sottile Milano 08/05/2014 Pag. 14

15 Many activities already being carried out Reference and evaluate Pier Angelo Sottile Milano 08/05/2014 Pag. 15

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 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. 16

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 managementbut 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. 17

18 Many activities already being carried out to reference and evaluate But also other scientific literature Pier Angelo Sottile Milano 08/05/2014 Pag. 18

19 Also existing standards as reference! EN ISO Quality Systems EN ISO Risk management EN ISO Health Informatics Service Architecture ISO/IEC Systems and software engineering -- Systems and software Quality (and others in the series like: ISO/IEC 25010, ISO/IEC 25051:2014) Pier Angelo Sottile Milano 08/05/2014 Pag. 19

20 What is a standard? 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 November 2012 Pier Angelo Sottile Milano 08/05/2014 Pag. 20

21 What is a standard? Transparency Consensus Voluntary Democracy Pier Angelo Sottile Milano 08/05/2014 Pag. 21

22 What is a standard? 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. Pier Angelo Sottile Milano 08/05/2014 Pag. 22

23 What is a standard? Durata Max 18 mesi Need Standardisation Process Initial Work Item Public Ballot Editing of document Final Ballot Publication Pier Angelo Sottile Milano 08/05/2014 Pag. 23

24 Standards Development Who writes standards? You and me! Pier Angelo Sottile Milano 08/05/2014 Pag. 24

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, Roma Tel Fax gesi@gesi.it uninfo@uninfo.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 Pier Angelo Sottile Milano 08/05/2014 Pag. 25