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

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10/16/2009

Telecom Regulatory Aspects of e-Health

Dr. Imad Y. HoballahCommissioner, Board Member

Head of Telecommunications Technologies Unit

Telecommunications Regulatory Authority (TRA), Lebanon

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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

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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.”

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Interference may cause malfunction of devices in close proximity

WiFi routerInternet

Bluetooth

Cordless Phone and WiFi Cordless Phone and WiFi Bluetooth Bluetooth

Cordless PhoneCordless Phone

MicrowaveMicrowave

2.4 GHz

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Telecom infrastructure for e-Health applications

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ADSL/Fiber connection

(Broadband speed)

Hospital

Patient’s home

Environment sensor

Health device

BAN sensors

IP- NetworkWWAN

Aggregation

Sensor data for fitness

coach

Sensor data for health provider

Sensor data for family

care giving

Integrated personnel health view

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e-Health applications

Why Telecom infrastructure?

Requirements

Tele-consulting To support interactive voice communication

Low bandwidth (narrowband), Voice over landline network (PSTN)

Tele-treatment To exchange pictures and large volume of data

Broadband (high bandwidth), Fiber optic / xDSL technologies

Tele-surgery To support long distance transmission of images and video

Broadband, Fiber optic / xDSL technologies

Tele-monitoring To support voice and video communication

Low bandwidth/ high bandwidth

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Fixed Telecom infrastructure

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Wireless sensors and connectivity used for e-Health

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Short Range Wireless network technologies for e-Health services

Type ApplicationBluetooth: (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

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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

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Spectrum for radio medical devices

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Requirements for radio medical devices

Requirement Questions CommentsEnvironment Is 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 rate How 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 range How 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

Topology Will 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

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Type approval of radio medical devices

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RTTE classifications

Class 0 Class 1 Class 2 Class 3Bluetooth Subscriber meters Non-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 equipment’s overall level of interference, environmental/safety impact, complexity and effect on the network.

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How to apply for Type Approval?

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EMF for radio medical devices

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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

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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, Faraday’s cage, shielded cable, etc.)• Follow the EMC medical standards

– Standards OrganizationsIEEE, ANSI, AAMI, ISO, IEC, etc

– Industry groupsAHA, AMA, JCAHO, etc.

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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

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TRA’s role in e-Health

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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”

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THANK YOU

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