Guidelines and Standards for Telemedicine Dr.B.S.Bedi* R.L.NMurthy"".

Introduction

of health

Telemedicine Adherence

is here to to standards

facilitates realization 1 di.. S 'T' .le eme cme. cope 0 o. Telemedicme related and technologies in

standards software some for

and

eqUIpment,

this

for

facility. addresses

This

sub-systems

Messaging storage

other

PICOM);

IT

lnteroperability

and

guidelines. "Guide~es

Department

in

that

Telemedicine

covers

standards

Data

medical

briefly

Exchange

image

capture,

standards

(HL 7,

Technical

scalability;

and

India"

of Information

published

of

to the needy

process

by the

Technology

are

that

envisaged

for the benefit remote

con

fid

I I

enti

in the provision

oali

the

services economic

disparities; the

Telemedicine

services

should

be available

located

places,

in rural,

and to further

capability;

t he ng°

ht

to

privacy .

an d

° ty In h e alth matters; the

communication

aspects

medical

of all people

Recognizing

in India,

of to

of socio

its end-to-end

advancement

in

and information

which

is the

the

technology

forerunner

for

its

in Telemedicine; to contribute

cooperation advances

quality

and inaccessible

Desiring

by recent

contribute

in the country

adaptation

Preamble

Inspired

through

promotion

irrespective

Recogmzlng oo

presented.

1.0

high

geographical

enhance

0° Interconnectivity,

the will

availability

Believing

it

The highlights of the document and standards for practice of

Telemedicine

Believing

education

and communications

common interest of the ° health and commuruty welfare of the people ° of India;

things,

Infrastructure for

the

and

transmission

..0 Standards

Recognizing

of a Telemedicine

Standards;

Standards, and

article

typical

care and medical

the use of Information technology;

facility

includes

traJlsmission,

hardware.

to Data

care and

electronic

Among

practices

by health service

of the recommended

different

and grow. guidelines

of full potential of this f th d d 0 e stan ar s covers

used

participating

stay and

of

to broad

in the scientific,

international

legal, and ethical

the use of Telemedicine;

* Senior Director, Dept. of Information Technology, New Delhi, & Member Secretary,TWG e-mail, bbedi@mi~govJn ** Manager, Business Development, Antrix Corporation, Bangalore, & Member, TWG e-mail: murdty@antrixoorg

~

r;

Believing

that

such cooperation

will

The committee is supported by a Technical

contribute to the development of mutual

Working

understanding and strengthen the friendly relations between states and people;

members drawn from different government;,. and private agencies/institutions with a

° d o od ncouragmg to proVl e continue support

d

f T 1 do 0 / 0 e erne icme

vancement

on suitable

1 h alth 0 li 0 d o le e e , its app cations an its greater relevance to Indiao' 'T'

c Realizing the importance of Information and r

Commuon~cation Technology

(TWG) , consisting

of

mandate to evolve and submit a document

E

h clor tea

Group

(~C~) in

standards

and guidelines

for

Telemedicine practice in Indiao

d fior .,. oLe 1erne di CIne . stan d ards

11..eeN

With the advances in technology the deliverya of healthcare otoeven remote locations ~as

Telemedicme programs, a set of gwdelines/ standards will go a long way in optimally

become feasible through methods Telemedicine interoperability

leveraging existing

m o become difficul t to achioeve. ° t erconnection

technologies,

while

ensuring its continuity to the evolving and advancing technical innovations; h . f d li ° ea Zing t e necessity 0 e vermg cost

R li ° eff ec

ti ° ve

1 so

u

t o ion

f

T or

1 e erne

d o 0 icme

like! and

With Telemedicine services being developed into multiple and disparate networks in an operational

mode

in

the

country,

there

is an

technology and indigenous enterprise for

imminent

providing

guidelines to facilitate growth of practice of

software/hardware

for

need to evolve standards and

Telemedicine;

Telemedicine that is uniform and scientific.

Government of India is convinced that a set

Standards imply technical compliance with

of standards

rigid and defined criteriao

and

guidelines

on

Telemedicine be defined, that will further the goal 0f proVlOdin g all peop1eWloth apractic0 ally attainable standard of health care, which is

00 0 00 In addition to techrucal standards, clinical .0 00 . protocols and guidelines are needed. Clinical

sustainable in an integrated mannero

protocols for Telemedicine practice include

As part of this endeavor, Department I c ° nlormation

T

h 1 (D11) 0 ° ec no ogy , Ministry

-preliminary of f

0

commurucations oo dl f 0 an n ormation Technology (MCI1), has taken initiative on

0

consultation 0

scheduling procedures, actual .0 procedures

equipment

operation

specifications).

for practice of Telemedicine, under the aegis 0 f the " C omffi1 ott ee Clor Stan d ar diz a ti° on 0 f

1.2.

information

implementation

to

facilitate

Key

Objectives

transmission

in

definin

g

standards

systems

.To

promote the growth of Telemedicine

using information technology (11) enabled

.To

Increase availability of quality medical

serviceso"

of Telemedicine

procedures

(such as telecommunications

the evolution and adaptation of standards

digital

and Telemedicme

0

service to those in need

.To

Improve quality of medical services,

.To

as it facilitates accessto expert opinion leadingto better diagnosis,treatmentand prognosIs .To define usage of Telemedicine technology that is appropriate to the identify

for

protecting the privacy & confidentiality of individuals' health data. .To

1.3. Framework

0

.To

for

in

defining

the

and standards

Key considerationsin Defining Guidelines & Standards include -Interoperability, P bl C bl S 1 bl ompati

define processes for scientific f

framework

and outside.

guidelines

the mechanisms

a

interoperability and scalability across Telemedicineserviceswithin the country

Indian environment .To

provide

o

o

o

o o

I Ity,

ca a I Ity,

O O

orta

I Ity

has

been

practice

1 di 0 .Le eme ClOe

and

contribute to broad international

so adopted to ensure -Inclusion

'T'

cooperation in the scientific, legal and ethicalaspectsof the useof Telemedicine. .To encouragecontinued support for the advancement of Telemedicine

and its

1.. 1 b 11 k h app ICatlOnS g 0 a y to eep t e standards contemporary

Reliability.

This

framework

of all

the stakeholders,Making recommendations vendor

neutral,

Making

standards

tec h no 1ogy neutra. 1 F or a b etter

complete understanding of these concepts, please refer Annexure-1.

,, FRAMEWORK

in defining the guidelines and standards

.Hardware .Sofrware

.Security

00

.ConnectiVIty

dicine

Providers

Process Guidelines

.Telemedicine Protocols .Minimum .Identifiers

Data Sets

an d

.MedicalEquipment .VideoConferencing

1.4. Scope of the Standards

, for home use,the hardwareplatform can also

The scope of the standards include the

be a laptop or palmtop computer, a PDA

standardsand guidelines for Telemedicine

(Personal Digital Assistant) or even aI

Infrastructure,

Data

dedicatedbox (set-top-box)with a processor.

Interchange and Exchange along with

This alsoincludes the softwarerequirements

Minimum Data sets and security.

like

connectivity,

1.5. Classification of Telemedicine C entres f "" The Telemediclne Centres can be broadly t. classified into three classes- Primary

the

operating

system, licensed

Telemedicinesoftware with appropriate user £ d B k d d b " " lnter ace an ac -en ata ase W1th the mandatory tables / fields as applicable.: 1.6.2. Clinical devices

Telemedicine Centre (PTC), Secondary

These include digital ECG, X-ray Digitiser,

Telemedicine Centre (STC) and Tertiary

Ultra

TelemedicineCentre (ITC).

Glucometer,

Thesecould be further subclassifiedasthree

Pulmonary Function Test (PFI) machine, Feta1 H eart Rate (FHR) morutor, " Te1e-

~ f major levels Ll, L2 and L3 depending on

Pathalogy Microscope(and Tnnoc " ular tube)

..the size and facilities available,the smallest beingLl.

Ii " £ " diffi etc., or use In erent app cationsIlk e te1eradiology,tele-cardiology,tele-pathologyand~

The Hardware requirements/standards are

tele-~phthalmology etc.

fr

sound

(Sonography

Machine),

Portable X-ray machine,

SpecialistCentre (fSC).

.. umts 1...1 6 4 V ' deo-co nfierencmg ffi d " £ ' V "d £ " " 1 eo-con erenclnguruts are 0 ere In our 1ernediClne " di Stlnct " confi19utations " "th the 'T'J.e W1 .

1.6. Details about the recommended

systems.One is a stand-alone box with a

referred in the context of Telemedicine , ConsultingCentre (fCC) and Telemedicine

standards

network interface with camera,microphone

This section provides the specifications

and display and may be sharing the same

recommended.

communication channel.The secondtype is

1.6.1. Telemedicine platform

PC add-on card, with Codec implemented

The hardware platform in most of the

using a dedicated hardware on the add-on

Telemedicinesystemsconsists of a personal

card,pluggedinside the Telemedicinesystem

computer-PC/workstation. Depending on

with accompanyingsoftware for control and

the application and space constraints, the

configuration. The third type is the one

platform can also be of different typeslike

where a small camerawith built-in encoder,

mobile system,handheld system or system

and accompanying software for decoding,

control and configuration is used, Also,

1.6.6. Patient (PIR)

another

type"

Software

based

be

Records

supported

by

the

desktop

software

videoconferencing using web camera is an .,

Informa~ion to

,

economlcal option when low bit rate channel less than 64 kbps are used, The standards arerecommendedfor all thesetypes of units.

The

PIR created

as part of

the data

, ,, b acqUISItIonprocesscan e m terms 0f b0th d d d £ structure an unstructure m ormation. I t al m r may so vo1ve diEIeren t ill es lik e- audi0, '

'

'

'

1.6.5. Communication hardware:

video, graphics, text etc,

Connectivity is required to enable the

The

typical

data captured

transmission/exchange of diagnostic datal

of

the

PIR

images between Telemedicine systems.To

DEMOGRAPHICS, PATIENT HISTORy'

.

provide connectivity, communication hardware is used, Various co?nectivity

Details of EXAMINATIONS INVESTIGATIONS and DIAGNOSIS,

I

options

ATTACHMENT

are available

for

Telemedicine

services. Based on these options, the

are

OF

as part PATIENT

AUDIO

,

FILES ,

A1TACHMENT

OF VIDEO/

communication hardware c~ be terrestrial

ATTACHMENT

OF FILES (other than

links or wireless/satellite links,

audio and video images),REPORT(S)based

The hardware for terrestrial links can be

on examinations,This can also potentially

"

..

further divided into three major categories-involve

IMAGES,

graphical representations.,

PSTN/POTS, ISDN and LAN,

Some of the important information relating

For

links , standards are recommended for PSTN/POTS (which are

to the Telemedicine Consultation that the

used when the Telemedicine data transfer/

also identified & deEmed.

exchangedoes not require very high bit rate,

1.6.7. Storage

terrestrial

software should be capableof capturing are

or no other option is available),ISDN (which

and

Transmission

Formats for PIR:

is usedwhen the Telemedicinedatatransfer/

Storage and Transmission Formats for the

exchange requires higher speed terrestrial link) and LAN (when connectivity is mostly

PIR are to be supported by the Telemedicine Systems,

required between various Telemedicine

G

Systems

within

a hospital).

'

dlin

Ul e

es are proVl

'

d d£ e

or

the

enco -

din .. go

f

The hardware for wireless/satellite links

the data structures for exchange. Some guidelines are also provided for actual

consists of -wireless LAN, CDMA, GSM/

interchange of the data in terms of the

GPRS/G3. The standardsarerecommended

Transport

for all of these devices,

recommended that not only should the

'1(\

mechanisms. Further,

it is

technologies

be

compatible

interoperability

between

different

i

r

in

vendors,

these

SjW

with

earlier

Data

newer

must

versions

also

of

be

the

',1

1.6.8.

Exchange

from

versions

of

HL

7

products. exchange

of

the

Communica~ons ,

standard

;

Imaging

Imaging

in widely

Medi~ine)

and

is

recogmzed

an

for

Communication.

It

was

i~terchange

Medical

disparate

to

storage

facilitate

of

X-ray

subsequently variety

the "

images

of

medical

standard

image

network

for imaging "" mformatlon

to

interface

devices,

It

and

which ., mtegratlon.

systems

DICOM

standard

acquisition, and

display

defmes

data can

HL

dia gn

osis,

medium

for

DICOM

is

because

of

Long the

a

model

"

its

key

(e.g.

archives, imaging can

with

workstations

from

HISjRIS).

other

connected infrastructure

information

it

Admi

Transier

results, master

The

a and

systems

to

among

Systems.

addresses systems

(AD

l"

the

interfaces d

at

"

sen

or

j registration, ..

1')

update

receive

D .lSC h arge

d ata,

.

quenes,

qbservations,

standard

or

d ers,

billing

and

evolving

and

information.

. mter

continuously

integrated

PACS,

versions

T e 1 eme

. ace

to

be

the

define

The XML

it.

HL7 and

g

r

es

version is

the

the

7 "

of

between a

matter

of

specifications

presentation

of

refers

of to

the

certain

HL7

strings

th e

of

errors

the

HL ul

timing

as

f

application.

communication

like

din

0

b y th e HL7

d

the

the

the

represent enco

esse

However,

information

"

a ddr

of

necessity

in may

"

specific

pragmatic

standard

verSions

exchanged, and

the

S ystems

l" Ierent

-definitions

applications;

also

of d lcme ,.

Th e .1 ssues

are

data

dif

usmg

s t an d ar d s.

application

common

various

£

from

vendors

(e.g.

is

Vanous"

use.

exchanges,

diagnostic

different into

d

ar

Messages

sslons .

file

allows

image

and

ANSI Clinical~

dd stan

"

clinical

standard

acquisition

Tomography), devices

information

archive

equipment

hardcopy

be

that

Image

Computer

reporting

standard

between

th e 1d entile " fi

Standard

patient"

are

compatibility.

advantage

an

the

,

image

an

and

manufacturers.

devices

for

recommended

interoperability different

term

for

facilitate

g e transmission,

ima

7

vanous

Essentially

images

7,

in

Cli~i~al

among

or

a wide

enables

of

HL

Telemedicme

.there the

Organisation

Messaging is

of

(OSI)

th

was

with

types.

level

Interconnection

and. but

deal

The

originally,

transmission

generalized

Seven; highest

(ISO). for

indu~try

the

International

enVtronments, ."

The developed

to

Standardization standard

(Digital

Level

refers

System

messagesI

-HL7:r

Health

7"

Open

model

-DICOM

for

"Level

the

clinical

systems

stands

term

l DICOM

of

among

compatible

SjW

interchange/

Standards

of

applications

but

products

terms

text

these

the that

as

the

.

3.0

encodes

recommended

messages ~tandard.

using

1.6.9. Identifiers -ITIH

Initiatives:

of

TWG

Report

for'J Practice

of

The identifiers to be used by different

Telemedicine. However it is essential to

persons/ entities would be as per the

know the local conditions of a particular

identifier standards defmed by the ITIH

Hospital especially the hospitals in the

initiative. The currendy proposed identifiers

rural areaswhen applying certain standards.

are -Unique

For example in many hospitals the X Ray/

Patient Identifier & Unique

Provider Identifier.

CT/MR may not have DICOM in the older

1.7.

versions of the machine. In this case

Security

The following are someexamplesof security

methods of provision

measuresthat must be built-in or addressed

the image are possible. That is, image &

in any Telemedicine application system: -patient .Who

can have access to individuals'

h alth e

.at

Wh

.L '", mlormatlonr

kind

0

f

. ch I . d securlty te no ogy 1Suse h tl h

th b . . lor e a ove aut entl~a on, suc as password, fingerprint and smart card? L

.What

kind of encryption is used for

storing medical data? .What

kind of encryption is used for

transmitting medical information? Security elements to address these issues

information

for Dicomising

are integrated as a

singleimage so that no body can changethe image

of

patient

data.

With

HL- 7 it is to be noted

adaptation

that

aspects

of

of

Admission Discharge Transfer (ADT) & Clinical Data architecture (CDA) in the form of basic minimum essentialfields need to used. References 1. Digital Imaging and Communications in Medicine, version 3.0

include storage security, network security,

2. Health Level 7, version 2.3

data encryption, audit trails etc. Networks

3. Health Level 7, version 2.4

sho~d be reliableand securedto ensureuser

4. Clinical Document Architecture, Health

confidence, system and data integrity, and

Level 7, version 2.0

robust systemoperation.

5. Indian Information TechnologyAct 2000

1.8.

6. TWG

Conclusion

It is important

to follow the required

standardsas delineatedin various chapters

Report

on "Recommended

Guidelines and Standardsfor practice of Telemedicinein India"