10/16/2009

1. 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. 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 • TRA’s role in e-Health

3. 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. It’s 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.”

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

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

6. Fixed Telecom infrastructure

7. Wireless sensors and connectivity used for e-Health

8. Short Range Wireless network technologies for e-Health services

9. 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 devicesuse portions of the band (3.1-10.6) GHz

10. Spectrum for radio medical devices

11. Requirements for radio medical devices

12. Type approval of radio medical devices

13. RTTE classifications RTTE equipment is divided into classes according to the equipment’s overall level of interference, environmental/safety impact, complexity and effect on the network.

14. How to apply for Type Approval?

15. EMF for radio medical devices 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 the “International 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

16. 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 • Limitedunderstanding 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, Faraday’s cage, shielded cable, etc.) • Follow the EMC medical standards • Standards Organizations • IEEE, ANSI, AAMI, ISO, IEC, etc • Industry groups • AHA, AMA, JCAHO, etc.

17. Radiology EMC case - Lebanon • A radiology center reported interference on MRI equipment operating in the band below 10kHz. • MRI had a Faraday’s 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 device’s enclosure • Absorption: use filter networks and filtering materials to absorb interfering signals • Conduction: divert interfering signals thru RF shields

18. TRA’s role in e-Health 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 TRA’s “Human EMF exposure limit regulation”

19. THANK YOU