1. TRA Proprietary 1/20 10/16/2009 Telecom Regulatory Aspects of e-Health Dr. Imad Y. Hoballah Commissioner, Board Member Head of Telecommunications Technologies Unit Telecommunications Regulatory Authority (TRA), Lebanon

2. TRA Proprietary 1/20 Table Of Content e-Health: definition and benefits Telecom infrastructure for e-Health applications Spectrum for radio medical devices Requirements and Type Approval for radio medical devices EMF exposure limits and EMC for radio medical devices Radiology EMC case - Lebanon TRAs role in e-Health 2

3. TRA Proprietary 1/20 e-Health: definition and benefits Healthcare is supported by electronic processes and communications Adopts the use of Internet and other communication technologies in the health care sector. Its sometimes called as Health Information Technology (HIT) Comprises all other technologies that are used in the course of medical and processes and procedures (e.g., wireless sensors) Improves the efficiency, effectiveness, cost and quality of, and access to, medical services Empowers the patient – control of e-health information ultimately rests with him/her Enables intelligent personalized information and provides patients with the opportunity to take a leading role in their own healthcare process The existence of a national broadband network that integrates the delivery of healthcare information serves as a catalyst for the standardization and integration of the various widely dispersed computerized systems that are currently used within the sector. 3

4. TRA Proprietary 1/20 4 Interference may cause malfunction of devices in close proximity WiFi router Internet Bluetooth Cordless Phone and WiFi Bluetooth Cordless Phone Microwave 2.4 GHz

5. TRA Proprietary 1/20 Telecom infrastructure for e-Health applications 5 ADSL/Fiber connection (Broadband speed) Hospital Patients home Environment sensor Health device BAN sensors IP- Network WWAN Aggregation Sensor data for fitness coach Sensor data for health provider Sensor data for family care giving Integrated personnel health view Integrated personnel health view

6. TRA Proprietary 1/20 e-Health applications Why Telecom infrastructure? Requirements Tele-consultingTo support interactive voice communication Low bandwidth (narrowband), Voice over landline network (PSTN) Tele-treatmentTo exchange pictures and large volume of data Broadband (high bandwidth), Fiber optic / xDSL technologies Tele-surgeryTo support long distance transmission of images and video Broadband, Fiber optic / xDSL technologies Tele-monitoringTo support voice and video communication Low bandwidth/ high bandwidth 6 Fixed Telecom infrastructure

7. TRA Proprietary 1/20 Wireless sensors and connectivity used for e-Health 7

8. TRA Proprietary 1/20 Short Range Wireless network technologies for e-Health services TypeApplication Bluetooth: (2.4 GHz) Up to 1 Mb/s Few Meters Patients' vital signs can be collected and transmitted over the internet to their doctors and nurses in real time When used inside hospitals sensors can be used to monitor patients in critical condition Real time video tracking for patients and staff Zigbee: (ISM band) Low speed up to 40 Kb/s Up to 50 meters WiFi: (2.4 GHz) Broadband speed up to 108 Mb/s Up to 100 meter indoor and outdoor (Radio Frequency ID) RFID: (ISM band) Less than 3 meters Used as tags in hospitals to keep track of equipment Hospitals can manage their resources properly and know in real-time the status of their supplies. Ultra Wide Band (UWB): Broadband speed up to 2Gb/s Short distance (30 meters), Indoor Wirelessly connecting medical and digital equipments 8

9. TRA Proprietary 1/20 Spectrum for radio medical devices Many low-cost applications operate in the following unlicensed frequency bands (however equipment type approval is required) ISM (Industrial, Scientific, and Medical) bands: Wireless medical applications are permitted in Region 1 in the following bands as per footnote No. 5.150 of the ITU-R RR: (13.533-13.567) MHz, (26.957-27. 283) MHz, (40.66-40.70) MHz, (2.4– 2.5) GHz, (5.725-5.875) GHz, and (24-24.25) GHz Inductive loop Ultra Low Power (ULP) active medical implants in (9-315) kHz (ETSI Standards) ULP animal implant devices in (315-600 )kHz and (12.5 -20) MHz (ETSI Standards) ULP animal implant membrane devices in (30-37.5) MHz (ETSI Standards) Several licensed (may un-license) frequency bands exist specifically for medical applications 401 – 406 MHz Medical Implant Communication Services (MICS) is permitted to operate in a portion of the band (401 – 406) MHz at an EIRP level of -16 dBm (25 microwatts) or less Interference mitigation techniques should be used by MICS UWB communications and medical imaging devices use portions of the band (3.1-10.6) GHz 9

10. TRA Proprietary 1/20 Spectrum for radio medical devices 10

11. TRA Proprietary 1/20 Requirements for radio medical devices RequirementQuestionsComments EnvironmentIs the indoor environment likely to be crowded with obstacles? A noisy environment requires robust data error detection especially in the presence of other transmitters. Data rateHow much data must be transmitted? How often? How fast? Higher data rates consume more power and require more sophisticated designs than low data rates. The radios are usually needed to transmit infrequently only a small amount of data Data rangeHow far apart will the transmitter and receiver be? Medical applications are usually indoors Longer ranges require more transmit power and sensitive receivers than short ranges Power consumption What type of batteries will be used? How many? Medical radios must consume very little power so that they can last on battery power for months or years TopologyWill data go point-to-point, or point-to-multipoint? Point to point systems are easier to develop and cheaper than point to multipoint systems Size and system cost How much room is available for antennas and external components? Medical radios must often be added to other low-cost, small-sized components such as sensors 11

12. TRA Proprietary 1/20 Type approval of radio medical devices 12 According to Telecom Law 431 – article 21: ….The Authority shall ensure that Telecom equipments does not cause any damage to the Telecommunications networks, or to safety and public health In this context, all Radio Telecom & Terminal Equipment (RTTE) require Type Approval certification from the TRA prior to importation and use in Lebanon Approvals are granted in Compliance with international standards – Mainly European standards – ETSI and IEC

13. TRA Proprietary 1/20 13 RTTE classifications Class 0Class 1Class 2Class 3 BluetoothSubscriber metersNon-Specific SRD (ISM and country specific bands) Digital PMR Radio Hearing Aids WiFi/RLAN/HiperLAN/ (indoor use only) Detection of Movement Short Range Radio Telemetry Wireless Audio Applications Wireless Applications in Healthcare (Active Medical Implants and associated peripherals)??? RTTE equipment is divided into classes according to the equipments overall level of interference, environmental/safety impact, complexity and effect on the network.

14. TRA Proprietary 1/20 How to apply for Type Approval? 14 start Importer/ Manufacturer identifies RTTE Class RTTE Class?Submit Type approval application Declaration of conformity Technical compliance file RTTE test report Additional information/ Restrictions for Class 3 TRA assesses the application and grants Type Approval Certificate end

15. TRA Proprietary 1/20 EMF for radio medical devices 15 According to the telecommunications law 431/2002 (article 23), the TRA is responsible to set standards and technical requirements applicable to all Telecom Equipment in order to prevent any harm to telecom networks and hazards to public health or safety The Human EMF Exposure Limit Regulation drafted by the TRA establishes limits on human exposure to EMF in the frequency range 0 to 300 GHz based on the recommendations of theInternational Commission of Non-Ionizing Radiation Protection (ICNIRP) adopted by WHO (the draft will be issued for consultation within two weeks) – just approved by the TRA board The Human EMF Exposure Limit Regulation drafted by the TRA establishes limits on human exposure to EMF in the frequency range 0 to 300 GHz based on the recommendations of theInternational Commission of Non-Ionizing Radiation Protection (ICNIRP) adopted by WHO (the draft will be issued for consultation within two weeks) – just approved by the TRA board This regulation does not apply to patients under long term medical care exposed to EMF from diagnostic or treatment equipment or to equipment that does not require Type Approval This regulation identifies the basic restrictions and reference levels that all Radio Medical Devices should comply with This regulation does not apply to patients under long term medical care exposed to EMF from diagnostic or treatment equipment or to equipment that does not require Type Approval This regulation identifies the basic restrictions and reference levels that all Radio Medical Devices should comply with

16. TRA Proprietary 1/20 EMC for radio and electronic medical devices EMC – Electromagnetic Compatibility: the ability to operate in the health environment without interfering with the operations of other radio systems or electronic medical devices Limited understanding and management of EMC issues within the healthcare industry Medical devices could malfunction resulting in catastrophic consequence Systems could fail to provide critical patient status and alert information Inter-device Incompatibility Coexistence of multiple wireless technologies around the point-of-care is surfacing as a major issue Guidelines to manage the EMC problems: Coordinate the purchase, installation, service, and management of all electrical and electronic equipment used in the facility to achieve EMC Educate healthcare facility staff, contractors, visitors, and patients about EMC Inform - Information must be provided on specific precautions for EMC protection (e.g., installation instructions, Faradays cage, shielded cable, etc.) Follow the EMC medical standards –Standards Organizations IEEE, ANSI, AAMI, ISO, IEC, etc –Industry groups AHA, AMA, JCAHO, etc. 16

17. TRA Proprietary 1/20 Radiology EMC case - Lebanon A radiology center reported interference on MRI equipment operating in the band below 10kHz. MRI had a Faradays cage but still interference was received and caused degradation to the quality of the images RF Scanning indicated a broadcasting station on that band (BBC at 9410) Further analysis showed that external signal is being received internally inside the chamber through UPS power Here are some general guidelines to eliminate EMC problems: Prevention: eliminate the sources of potential interference Reflection: keep internally generated signals inside the device and keep external interference outside the devices enclosure Absorption: use filter networks and filtering materials to absorb interfering signals Conduction: divert interfering signals thru RF shields 17

18. TRA Proprietary 1/20 TRAs role in e-Health 18 Define spectrum requirements for wireless medical applications and reflect them in the Lebanese National Frequency-Allocation Table (LNFT) Issue Service Provider licenses including spectrum licenses that could be used as the telecom infrastructure required for medical applications Receive and resolve user complaints (including interference complaints) filed through the TRA or the Consumer Protection Directorate (CPD) at 1739 at the Ministry of Economy and Trade. The TRA and the MoET have joined their efforts by signing an MOU to share this hotline as a first step to better serve telecom consumers Issue Import and Type Approval certificates for Radio Telecom & Terminal Equipment (RTTE) TRA -Approved label ensures Electro-Magnetic Compatibility All RTTE should comply with the guidelines and limits set in TRAs Human EMF exposure limit regulation

19. TRA Proprietary 1/20 THANK YOU 19