ETSI IN SUPPORT OF EHEALTH

Transcription

1 ETSI IN SUPPORT OF EHEALTH Presented by Dr Saad Mezzour Medtronic ETSI TG30 Chairman ETSI All rights reserved

2 ETSI is Independent, not for profit organization, created in 1988 A recognized EuropeanStandards Organization Setting global standards for all areas of ICT More than 700 members from more than 60 countries Offering direct participation and Membership voting Organisational partner of 3GPP 2

3 ETSI produces standards for the whole Telecommunications field Applicable harmonized standards from ETSI can be used to show compliance with European legal requirements in the field ofemc and radio spectrum use. ETSI standards are also used in many countries outside Europe e.g. EN for Ultra Low Power Active Medical implants is used in Japan, Australia, New Zealand, Canada etc 3

4 European radio spectrum management The overall body is the CEPT the European Conference of Post and Telecommunications It is an organisation of 48 countries Telecommunications matters are handled by the ECC Electronic Communications Committee There are three Working Groups: Regulatory Affairs (RA) Frequency Management (FM) Spectrum Engineering (SE) 4

5 European radio spectrum management Each of the three groups have Project Teams dealing with ih particular areas. All three groups have some representation from industry, although only Administrations have voting rights. Decisions are usually reached by consensus. The Short Range Device Maintenance Group (SRD/MG) is a sub group of WGFM: it advises WGFM on frequency management matters including such matters as power, frequency assignment etc. Compatibility studies before new assignments are made are carried out by a WGSE project team. 5 5

6 European radio spectrum management The European Union has a Radio Spectrum Policy Group drawn from the espectrum administrations at s in each EU country. RSPG assists the European Commission in the development of spectrum policy throughout the EU The RSPG works with the CEPT and ETSI The Radio Spectrum Committee (RSCOM) implements RSPG policy National administrations WG FM WG/SE SRD/MG 48 CEPT Harmonizing National Frequency Allocations Harmonizing National Regulatory Authority activities Coordinating International Negotiations 28 TCAM RSPG Policy positions Legal certainty Political support MoU ETSI Industry ERM ERM RM ERM TG30 / EP ehealth Harmonized Standards and other standards & specifications to support legislation & market development 6

7 ETSI Organisation The work of ETSI is carried out in Technical Committees and ETSI Projects. TC_ERM is the technical committee responsible for EMC and radio policy matters: its various task group committees have responsibility for defined areas e.g. TG28Short Range Devices (SRD), TG30 Wireless Medical Devices etc. The Task Groups produce standards for various equipments: some standards are generic, while some are specific to a particular product. 7

8 ETSI Organisation General lassembly Operational Coordination Group OCG R&TTED ETSI Board Technical Committees Including TC_ERM ETSI Secretariat t EP ehealth TC SmartBAN ERM_RM Radio Policy Matters ERM_TG17 Wireless Audio ERM_TG28 Short Range Devices ERM_TG30 Wireless Medical Applications 8

9 ETSI ERM_TG30 organisation Officials - ERM TG30 : Chairman Secretary : Saad Mezzour (Medtronic) : Phillip Inglis (Medtronic) TG30 Participants: Medtronic St Jude Medical Biotronik Zarlink ELA/Sorin Boston Scientific Philips Healthcare Toumaz 9

10 A typical generic standard is EN , for generic short range devices in the frequency range 25 to 1000MHz. An example of a specific standard dis EN (first published in 2002) for Ultra Low Power Active Medical Implants and associated peripherals EN specifically excludes audio applications 10

11 ETSI medical SRDs Some ERM_TG30 deliverables Wireless Medical devices (ERM_TG30) Ultra Low Power Active Medical Implants (ULP AMI) 9 khz to 315 khz: EN MHz to 37,5 MHz: EN MHz to 405 MHz: EN EN ULP AMI Medical Data Service Systems in 401 MHz to 402 MHz and 405 MHz to 406 MHz; EN ULP AID 315 khz to 600 khz 11

12 Short Range Devices (SRD) SRD are devices that can have an e.i.r.p. ranging from 25 W to 400W, depending on frequency band and applications They are accepted by many Administrations i i on the basis that they must not cause any interference to, and must accept any interference from, other radiocommunication services. They have no status in the international Radio Regulations as a service in fact, they are the pariahs of the radio world! The European regulatory bible for SRD is the Recommendation ERC/REC

13 European frequencies for SRDs khz in various bands and power levels for inductive devices, some with specific applications e.g. animal implants , , , , , MHz, all inductive coupling only, and many for specific applications , , (limited to ultra low power medical implants) , MHz, GHz, GHz, GHz, GHz, GHz, and GHz 13 13

14 The European Generic SRD bands MHz and 2400MHz MHz are planned with various segments and various powers for a number of applications. With the use of either Low Duty Cycle (LDC) or Listen Before Talk (LBT) as a media access method, optimum spectrum sharing for all users is achieved. 14

15 European Medical Implant communication bands 9-315kHz for implant communication typically, a pacemaker MHz for membrane implants MHz for Ultra Low Power Active Medical Implants (ULP-AMI) MHz Low Power Active Medical Implants (ULP-AMI) 15

16 Implant receiver power requirements Depending upon the demand on the pacemaker, an implant can last between 5 and 20 years The average is about 8 to 10 years before implant replacement is required Rechargeable batteries have been used in certain implanted devices, but problemsofenergy of energy density, heat whilerecharging, and physical problems of coupling, as well as difficulties with patients forgetting to charge the battery, remain 16

17 Power management in implant receivers Because of limited power availability, implant receivers have to sleep for the majority of the time. Wake up can be achieved in several ways, and the lowest component count is with band scanning Interference during wake up sniffing can increase current consumption as the wake up system must use processing power to discriminate the interferer from a wanted signal High duty cycle interferers are particularly problematic and will adversely affect battery life 17

18 Access Protocols and Power Management 100% duty cycle applications without access protocolin ULP AMI bands are a major problem, and need to be avoided, especially with the large installed base of implants The MHz band is shared with the Primary Service meteorological aids mainly meteorological weather balloons These are rarely transmitting close enough to patients with implants to lead to extended wake up power demands No Non implant applications in these bands, especially those used close to patients, require a limitation on duty cycle and a polite access protocol to avoid prematurely discharging the implant battery and to avoid interference with implant transmissions 18

19 ISM and SRD Some frequency bands are often referred to as ISM bands (Industrial, Scientific, Medical). Although radio communications services operating in such bands must accept any interference from ISM, these bands are allocated to radio communications on a primary basis e.g to MHz is allocated to fixed and mobile services on a primary ybasis, s, and dto radiolocation ocat o on a secondary basis in some regions and on a primary basis in others These bands are convenient for use by licence exempt SRD (sometimes referred to as gadgets ) because of global harmonization and also because of the lack of protection thus afforded through RR1.15 and RR

20 ITU and Medical Implant Communication frequencies The MHz range was assigned for use by Medical Implant Communication Systems (MICS) in ITU R RecommendationSA (now RS)1346 This was as a result of sharing studies with meteorological aids, and on the basis of very limited or no outdoor use Some Administrations treat MICS as a Mobile service within the ITU terms: most others treat it as SRD, and thus an orphan Some Administrations also feel that some protection greater than that afforded to SRDs is justified for medical implants 20

21 European frequency allocation and MBANS In February 2014 CEPT published in Recommendation ERC/REC a new entry for MBANS operating in the MHz band ETSI TG30 has finalised and approved (this morning) the new draft Standard EN The Draft Standard EN will be submitted to TC_ERM pproval and is expected to be published for Public Enquiry EN is expected to be published by ETSI in January

22 Typical Medical Implant Communication System Spectrum usage scenarios Implant Streamlined implant procedure Real-time communication of critical data In-office Complete wireless follow-up Improved comfort for patient Remote Pre-scheduled device checks Replaces regularly scheduled clinic visits Physician selected alert conditions 22

23 New devices leveraging existing technologies ed Algorithms from ICD and CRT Micro-Electronics & Advanced Packaging Miniaturization Techn nology Leverag Electrode Materials & Battery Tech. Advanced Sensors Development Instruments & Data Management Interfaces Communication/ Telemetry Protocols Intra-body Communication Remote monitoring and programming New Market with advanced injectable Platform 23

24 Trends driving wireless medical innovation Device miniaturization On-body networks Leadless Pacemaker Injectable Device Remote monitoring gand dpoga programming g 24

25 Diabetes therapy system glucose sensor The pump can numerically and graphically display wirelessly transmitted data from a continuous glucose sensor glucose meter Insulin Pump The pump has the ability to wirelessly download pump data to a PC for retrospective analysis of therapy. Remote control 25 The pump can wirelessly receive and store blood glucose measurements from a paired blood glucose meter. The pump can wirelessly receive commands from a remote control device.

26 26 Technology Trends Wireless Medical Device Proliferation

27 The Expense? Taking part in Standards and Regulatory work is expensive, but Not doing Regulatory and Standards work can be even more expensive 27

28 Thank you for your attention Dr. Saad Mezzour ETSI TG30 Chairman com ETSI All rights reserved