Enablingtomorrow’s Healthcaredocbox.etsi.org/.../2014/201405_EHEALTHWORKSHOP/... · eHealth...

Enabling tomorrow’sHealthcare

Standardisation and certification requirementsStandardisation and certification requirementsETSI eHealth workshop on telemedicine

6‐7 May 2014

Karima Bourquard, IN‐SYSTEM, IHE‐EuropePhilippe Cousin, EGMppSamuel Fricker, BTHFranck Le Gall, EGM

The context

• The European Commission has launched theThe European Commission has launched the Future Internet Public‐Private Partnership program (FI‐PPP) :program (FI PPP) :– Shared vision for harmonised European scale technology platforms and their implmentationtechnology platforms and their implmentation

– Integration and harmonisation of the relevant policy, legal, political and regulatory frameworkspo cy, ega , po ca a d egu a o y a e o s

07 May 2014eHealth workshop on Telemedecine

What is FI‐STAR?

• FI‐STAR is a FI‐PPP Phase 2 early trial project in S s a ase ea y t a p ojectthe healthcare domain

• Based on Future Internet technologies in the gcontext of the FI‐PPP

• Delivers a robust technology framework based on FI‐WARE Generic Enablers (GEs)

• Specialised “Core Platform Instance” using GEs d i ti S ifi E bland incorporating Specific Enablers

• Introduces paradigm shift „Software to Data”

eHealth Context DirectivesDirectivesand regulation Organisation

Introduction of ePrescription (2001) eHealth Network

H lth A ti PlEU regulation on European standardisation (2012)

Patient’s rights in cross‐border h lth (2011)

Multi Stakeholders Platform

eHealth Action Plan (2012‐2020)

healthcare (2011) eHealth Governance Initiative

R t/F k

LEGAL ORGANISATION

Projects

eHealth European

epSOS

FI‐STAR

ANTILOPE

Report/FrameworksMandate M403

Patient Summary guidelines

Interoperability Framework

ANTILOPE

EXPAND

Trillium bridge

National/regionalProjects


Trillium bridgeSEMANTIC AND TECHNICAL DEPLOYMENT

Objectives

• Standards are of vital interest for competitvenessof SMEs in eHealth but sometimes considered asof SMEs in eHealth but sometimes considered as limitations. Standards allow– Quality of the interfaces between componentsy p– Ability to exchange medical data with healthcare platform or other applications

– ability to interoperate and to exchange data– ability to interoperate and to exchange data, semantically understood

• Identification of such European standards or h i l ifi i h d l dtechnical specifications that are not developed

following the European standards processes


eHealth Interoperability

• Based on the general process described in Mandate M403

Use cases 5 Use cases inn two categories (monitoring d id ifi i f bjk )

5 Use cases inn two categories (monitoring d id ifi i f bjk )Use cases

Standard selectionStandard selection

and identification of objkects) and identification of objkects)

Connectivity, messages and protocols, terminology and coding systems, securityConnectivity, messages and protocols,

terminology and coding systems, security

Profiles Specifications


Test strategy andTest strategy and

IHE profiles and Continua Alliance guidelinesIHE profiles and Continua Alliance guidelines

Certification processes definitionCertification processes definitionTest strategy and quality processTest strategy and quality process

Deployment and Best practises


Certification processes definition requirements to be met, quality control

Certification processes definition requirements to be met, quality control

ProjectsProjects


practisespractises

Use cases

• eHealth and FI‐STAR use cases:eHealth and FI STAR use cases:– Bipolar Patient Treatment Management Solution (BPTM)( )

– Cardiac Rehabilitation (CR)– Chronic disease Treatment Assistance Solution (CDTA)– Diabetes Share Sytem (DSS)– Drug Supply Manager Solution (DSMS)– Operating Theatre monitor Solution (TMS)– Telecare Solution (TS)

Use cases

Standard selectionStandard selection

Profiles SpecificationsProfiles Specifications



Test strategy and quality process




Standards

• Five groups of standardized aspects whereg p panalyzed:– Development of a software producte e op e t o a so t a e p oduct– Usability (usage of the product by an end‐user)– Safety resilience and trustSafety, resilience and trust– Interoperability of the product with otherproductsproducts

– Data security Use cases

Standard selection








Profiles and underlying standardsstandards

• Profiles provide to developers a clear p pimplementation path for communication standards, carefully documented, reviewed and tested.

f l d h l f h• Profiles reduce the complexity of the communication implementation or use cases by specifying a subset of standards that limit and precise their usage for theof standards that limit and precise their usage for the specific needs..

• Profiles are standards‐based choices in different levels such as application interfaces, protocols for communication, security level, file format,… and semanticsemantic.


Semantic

• Terminologies: terms and uses to report observations in specific contextspecific context– SNOMED/CT:clinical terms for EHR(clinical findings, diagnosis,

body structures, devices,…)ICD10:International Classification of diseases– ICD10:International Classification of diseases

– LOINC: generally used to describe observations in laboratoryreport

– Rosetta Terminology Mapping (RTM):vendor‐neutralRosetta Terminology Mapping (RTM):vendor neutralharmonised mapping for patient care device observations basedon the ISO/IEEE 11073 Medical Device Communications (MDC) Nomenclature

– UCUM: unified codes for measures units– …

Use cases

Standard selection








Profiles, standards and content

Prof‐1

Content Prof‐1

Prof‐2

Content Prof‐2

St d dTerminologies ProfilesContent StandardsTerminologies ProfilesCo te tProfiles


eHealth European Interoperability FrameworkeHealth European Interoperability FrameworkepSOS example

Use cases

Standard selection

fil S ifi i

07 May 2014

From EU study

eHealth workshop on Telemedecine






Continua Alliance architecture

• Personal Area Network (PAN) Interface for communication around a person;

• Local Area Network (LAN) Interface for communication at a location or facility;

• Wide Area Network (WAN) Interface for communication from the home / office / facility to backend services providers;

From Continua Alliance guidelines

facility to backend services providers;• Health Reporting Network (HRN) Interface

for reporting to enterprise systems (hospitals, telehealth service providers,

)

07 May 2014

etc).

eHealth workshop on Telemedecine

FI‐Star Use casesstudystudy


Medical devices and Platformstandard comparisonstandard comparison

Devices StandardsDevices

Standards used

Standards recommended

used


Selection of profiles and StandardsStandards

Personal Area Network (WAN) and local network Interface (LAN Wide Area Network Interface

Health Reporting Network Interface


Testing strategy – State of art

• Best practises in software development (ISTQB, IEC 62304, …)

• In eHealth, Connectathon and projectathon , p jare widely deployed.

Use cases

Standard selection







Testing strategy ‐RecommendationsRecommendations

• Quality label and certification processes areQuality label and certification processes are starting to be implemented in several national and regional programs as well as Eu projects inand regional programs as well as Eu projects in eHealth

• Main reference: IHE Connectathon using• Main reference: IHE Connectathon using Gazelle Test Bed. Organised by IHE‐Services using a ISO/IEC 17025 testing laboratoryusing a ISO/IEC 17025 testing laboratory

• CHA certification for medical devices


Testing strategy ‐ Best practises

Step 1: the sensors and applications are invited to pass IHE Connectathonp(generic)Step 2: Projectathon evaluates the conformity to the project (project)

Step 3: the pre production testing session: The production environment is in place including the security aspect. Only the exchanged data are not belonging to the real world. The testing session is a virtual testing session.

Standard selection






Other requirements

• Data protection certification schemesData protection certification schemes • Euro PriSe(European Privacy seal): volontary data protection certification scheme)data protection certification scheme)

• Electronic signature• Security requirements for mobile apps


Validation approach in FI‐STAR


Conclusion

• Current standardisation and certification i t f FI STARrequirements for FI‐STAR use cases

• Methodological approach as described in M403

• IHE profiles and Continua Alliance guidelines are promoting for implementation

• Interaction between FI‐STAR and FI‐PPPInteraction between FI STAR and FI PPP required more attention with close relation between the two.


between the two.

Enablingtomorrow’s Healthcaredocbox.etsi.org/.../2014/201405_EHEALTHWORKSHOP/... · eHealth...

Documents

Transcript of Enablingtomorrow’s Healthcaredocbox.etsi.org/.../2014/201405_EHEALTHWORKSHOP/... · eHealth...