Enabling tomorrow s Healthcare

Transcription

1 Enabling tomorrow s Healthcare Standardisation and certification requirements ETSI ehealth workshop on telemedicine 6 7 May 2014 Karima Bourquard, IN SYSTEM, IHE Europe Philippe Cousin, EGM Samuel Fricker, BTH Franck Le Gall, EGM

2 The context The European Commission has launched the Future Internet Public Private Partnership program (FI PPP) : Shared vision for harmonised European scale technology platforms and their implmentation Integration and harmonisation of the relevant policy, legal, political and regulatory frameworks

3 What is FI STAR? FI STAR is a FI PPP Phase 2 early trial project in the healthcare domain Based on Future Internet technologies in the context of the FI PPP Delivers a robust technology framework based on FI WARE Generic Enablers (GEs) Specialised Core Platform Instance using GEs and incorporating Specific Enablers Introduces paradigm shift Software to Data

4 LEGAL Directives and regulation Introduction of eprescription (2001) EU regulation on European standardisation (2012) Patient s rights in cross border healthcare (2011) ehealth Context Organisation ehealth Network ehealth lthati Action Plan ( ) Multi Stakeholders Platform ehealth Governance Initiative ORGANISATION SEMANTIC AND TECHNICAL Report/Frameworks Mandate M403 ehealth European Interoperability Framework Patient Summary guidelines epsos ANTILOPE EXPAND Projects FI STAR National/regional Projects Trillium bridge DEPLOYMENT

5 Objectives Standards are of vital interest for competitveness ofsmes inehealthbutsometimes consideredas limitations. Standards allow Quality of the interfaces between components Ability to exchange medical data with healthcare platform or other applications ability to interoperate and to exchange data, semantically understood Identification of such European standards or technical specifications i that are not developed d following the European standards processes

6 ehealth Interoperability Based on the general process described in Mandate M403 Use cases 5 Use cases inn two categories (monitoring and identification ifi i of objkects) Standard selection Profiles Specifications Test strategy and quality process Deployment and Best practises Connectivity, messages and protocols, terminology and coding systems, security IHE profiles and Continua Alliance guidelines Certification processes definition requirements to be met, quality control Projects

7 Use cases ehealthand 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 selection Profiles Specifications Test strategy and quality process Deployment and Best practises

8 Standards Five groups of standardized aspects where analyzed: Development eeop etof a software product Usability (usage of the product by an end user) Safety, resilience and trust Interoperability of the product with other products Data security Use cases Standard selection Profiles Specifications Test strategy and quality process Deployment and Best practises

9 Profiles and underlying standards Profiles provide to developers a clear implementation path for communication standards, carefully documented, reviewed and tested. Profiles fl reduce the complexity of the communication implementation or use cases by specifying a subset of 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 semantic.

10 Semantic Terminologies: terms and uses to report observations in specific context SNOMED/CT:clinical terms for EHR(clinical findings, diagnosis, body structures, devices, ) ICD10:International Classification of diseases LOINC: generally used to describe observations in laboratory report Rosetta Terminology Mapping (RTM):vendor neutral neutral harmonised mapping for patient care device observations based on the ISO/IEEE Medical Device Communications (MDC) Nomenclature UCUM: unified codes for measures units Use cases Standard selection Profiles Specifications Test strategy and quality process Deployment and Best practises

11 Profiles, standards and content Content Prof 1 Prof 1 Content Prof 2 Prof 2 Terminologies Content t Profiles Profiles Standards d

12 ehealth European Interoperability Framework epsos example Use cases Standard selection From EU study Profiles Specifications i Test strategy and quality process Deployment and Best practises

13 Continua Alliance architecture From Continua Alliance guidelines 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; Health Reporting Network (HRN) Interface for reporting to enterprise systems (hospitals, telehealth service providers, etc).

14 FI Star Use cases study

15 Medical devices and Platform standard comparison Devices Standards used Standards recommended

16 Selection of profiles and Standards Personal Area Network (WAN) and local network Interface (LAN Wide Area Network Interface Health Reporting Network Interface

17 Testing strategy State of art Best practises in software development (ISTQB, IEC 62304, ) In ehealth, Connectathon and projectathon are widely deployed. Use cases Standard selection Profiles Specifications Test strategy and quality process Deployment and Best practises

18 Testing strategy Recommendations Quality label and certification processes are starting to be implemented in several national and regional programs as well as Eu projects in ehealth Main reference: IHE Connectathon using Gazelle Test Bed. Organised by IHE Services using a ISO/IEC testing laboratory CHA certification for medical devices

19 Testing strategy Best practises Step 1: the sensors and applications are invited to pass IHE Connectathon (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 Profiles Specifications Test strategy and quality process Deployment and Best practises

20 Other requirements Dataprotection certification schemes Euro PriSe(European Privacy seal): volontary data protection certification scheme) Electronic signature Security requirements for mobile apps

21 Validation approach in FI STAR

22 Conclusion Current standardisation and certification requirements 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 PPP required more attention with close relation between the two.