Based on the recommendations of a committee set up by the Government of India, this document briefly present a set of guidelines of standard practice in Telemedicine in India.
2. Content
1. Objectives
2. Need for Telemedicine standards
3. Scope
4. Definitions & Concepts
5. Process Guidelines
6. Security
7. Software
8. Data exchange standards
9. Clinical Protocol
3. Key Objectives in defining the standards
1. To promote the growth of Telemedicine
2. To Increase availability of quality medical service to those in need
3. To Improve quality of medical services, as it facilitates access to expert opinion leading to better diagnosis, treatment
and prognosis
4. To define usage of Telemedicine technology that is appropriate to the Indian environment
5. To identify the mechanisms for protecting the privacy & confidentiality of individuals’ health data.
6. To define processes for scientific practice of Telemedicine
7. To contribute to broad international cooperation in the scientific, legal and ethical aspects of the use of Telemedicine.
8. To encourage continued support for the advancement of Telemedicine and its applications globally to keep the
standards contemporary
9. To provide a framework for interoperability and scalability across Telemedicine services within the country and outside.
4. Need for Telemedicine standards
▪ The full potential of Telemedicine can be harnessed without clinical and technical standards and guidelines.
▪ Standardization is needed for interoperability and interconnection. Older equipment often will not connect with
newer versions of the same machine; different brands do not operate with one another, making networking across
projects and sometimes within a project expensive and frustrating.
▪ Clinical protocols for telemedicine practice are needed which will include preliminary scheduling procedures, actual
consult procedures and telemedicine equipment operation procedures (such as telecommunications transmission
specifications).
▪ The clinical technical standard for image quality in a video transmission would specify the technical standards
needed by a specialist such as a dermatologist to achieve the high levels of image clarity and color required to correctly
diagnose a patient.
5. Scope of the Standards
Infrastructure Data Exchange Standards
• Telemedicine Plateform
• Clinical Services
• Video Conferencing Unit
• Communication Hardware
• Operating Software
• Licensed Medical S/W
• Database
• Connectivity
• Universal Identifier
Of Patients
• Telemedicine Consulting
Center
• Telemedicine Specialist
Center
6. Definitions and Concepts
Telemedicine
The World Health Organization defines Telemedicine as, “The delivery of healthcare services, where distance is a critical
factor, by all healthcare professionals using information and communication technologies for the exchange of valid
information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing
education of healthcare providers, all in the interests of advancing the health of individuals and their communities”.
Telehealth
Telehealth is the use of electronic information and telecommunications technologies to support long-distance clinical
health care, patient and professional health-related education and training, public health and health administration
Teleconsultation
Teleconsultation is the use of information and communications technology to enable clinical consultation between
geographically separated individuals such as health care professionals and their patients or health care professionals
engaged in diagnostic, mentoring, or other clinical decisionmaking activities related to the delivery of health care services.
7. Definitions and Concepts
Telemonitoring
A real time and live interactive monitoring (evaluation) of technique(s) or procedure(s) of an applicant seeking privileges, or
a surgeon seeking to certify or document his competence in a specific technique or procedure(s). The Telemonitor is in
one location and the surgeon to be evaluated is in another. The Telemonitor must have the ability to see the performance
of the procedure or technique being executed by the student in real time. The Telemonitor and the applicant must have the
ability to verbally communicate during the session. Telemonitoring may be used as an adjunct to proctoring in the
privileging process but should not alone be a substitute for proctoring to determine competency. Integration of
Telemonitoring into the proctoring process may reduce, but not eliminate, the number of on-site proctored cases required.
Telemonitoring assumes that the ability of the Telemonitor to physically intervene at the site of the primary procedure is
not possible without the telecommunications interface.
Teletreatment
Treatment provided to the patient through Telemedicine. The specialist at the Specialty Centre could advise the consulting
doctor at the Consulting Centre about the course of treatment to be taken.
8. Definitions and Concepts
Patient Information Record (PIR) –
All information pertaining to the patient for providing care using telemedicine. This included clinical as well as non-clinical
information. Clinical Information includes history of the illness, associated signs and symptoms, clinical observations,
clinical interventions, diagnostics and treatments etc., relevant for providing care, using telemedicine. Non-clinical
Information include information about the patient's environment, demographic information, life style, occupation or
about related people, etc., where this is relevant for providing care using telemedicine.
Telemedicine Consultation Centre (TCC)
Telemedicine Consulting Centre is the site where the patient is present. In a Telemedicine Consulting Centre, equipment
for scanning /converting, transformation, communicating for medical information of the patient can be available but it is
not essential. A Telemedicine Consulting Centre usually has a General Practitioner or in very remote locations a Registered
Medical Practitioner who will be able to communicate to the TSC the symptoms/problems of the patient.
Telemedicine Specialty Centre (TSC)
Telemedicine Specialty Centre is a site, where the specialist is present. He can interact with the patient present in the
remote site and view his reports and monitor his progress. A Specialty Centre is generally located in a Specialty or Super
Specialty hospital catering to specific specialties or all specialties.
9. Definitions and Concepts
Health care network
Communications network designed to suit the health sector and the provision of health information via an assortment of
electronic devices (computers, printers, scanners, etc.) connected for mutual exchange of digital information.
Telemedicine System
Telemedicine system consists of an interface between hardware, software and communication channel to eventually bridge two
geographical locations to exchange information and enable teleconsultancy between two locations. The hardware consists of
computer, printer, scanner, video conferencing equipment etc. The software enables the acquisition of patient information
(images, reports, films etc.). The communication channel enables the connectivity whereby two locations can connect to each
other.
Telediagnostics
Telediagnostics is the use of information and communications technologies to enable the diagnosis of a patient between
geographically separated individuals. Telediagnostics is usually a real time and live dialogue between the specialist and the doctor at
the remote site with regard to the diagnosis of the patient’s illness. The specialist is in one location and the consulting
doctor/patient is in another. But it is also possible that Telediagnostics could be of a Store and forward type where the patient’s
information is transmitted to the TSC and the specialist gives his expert opinion after a specific period of time. This could happen
in circumstances where the specialist was not available at the time of receipt of patient information at the TSC or there was a
communication breakdown and it was not possible to give the opinion in real time.
10. Definitions and Concepts
Store and Forward
The method by which the medical images and data of patients are captured and stored locally in the TCC
(Telemedicine Consultation Centre) and/or at a central location n and subsequently forwarded/ transmitted to
the TSC (Telemedicine Specialty Center). In this method the Teleconsultation is carried out after the medical
data is received at the TSC
Real time transmission
It is the method of transmission of medical images and wave-forms (images from CT Scan, Cath Lab, Color
Doppler, Ultrasound, X-ray, PFT, ECG etc.) from TCC to the TSC as it is being acquired. In this method the
Teleconsultation is carried out along with the medical data while being acquired at the TCC and rendered at
the TSC.
11. Definitions and Concepts
Still Medical Images
These include still images of diseases, pathological slides, X-rays, CT, MRI, etc. Each image represents a single projection.
Series of images represent volumetric data. Diagnostic Imaging and Communication in Medicine (DICOM 3) is the
accepted standard for these image data storage and transmission. ACR (American College of Radiology) and NEMA
(National Electronic Manufacturer Assoc.) are forming relationships with pathology and cardiology groups to extent the
standard for additional types of images and photographs, including pathology slides, medical photographs, microscopy,
Angiography, Endoscopy, Laproscopy, full motion heart and blood vessel images and ultrasound images. As standards
become available they should be incorporated. The following are the standards formats for storing of several still images,
which are applicable in Telemedicine.
1. JPEG
2. GIF
3. TIFF
Moving Medical Images
These include ultrasound, some nuclear medical images, etc. basically, ultrasound image is a series of images represented a
temporal sequence. For moving image, MPEG and MPEG2 can be used in non-medical applications are applicable in
telemedicine
12. Process Guideline
Patient Criteria: Indicative guidelines
▪ Informed written consent must be obtained from the patient before beginning the use of video visits
▪ Patients cannot be viewed through the video without their knowledge or prior written consent. If other agency
personnel or visitors come into the viewing site, the patient must be made aware of their presence, and the patient's
approval must be obtained for such personnel to participate in the video visit.
▪ On initializing the video conferencing the patient should verbally identify himself or herself to the specialists at the
TSC. Similarly, the specialist at the TSC identifies himself or herself to the patient.
▪ If a third remote site is participating in the video visit, the patient must again be aware and approve of such
participation.
▪ Patient satisfaction regarding video visits should be a part of the protocol
Ensuring quality of Consultation
▪ Separate consultation forms need to be evolved for each specialty eg. The data needed from patient for cardiology case
is very different from a neurosurgery one
13. Process Guideline
Confidentiality of Records
▪ Information regarding a person’s physical condition, psychological condition, healthcare and treatment
shall not be released without the patient’s consent.
▪ Stricter verification of identity of each person logging into the telemedicine system using new technologies.
Telemedicine Consultation Centre (TCC): Indicative guidelines
▪ The staff should demonstrate the ability to correctly use the technology and troubleshoot common problems and
should have written troubleshooting guidelines to follow and a method for follow-up if problems are not quickly
resolved.
▪ Patients must be given clear written instructions as to who to call in case problems arise.
14. Process Guideline
Telemedicine Specialty Centre (TSC): Indicative guidelines
The documentation of the consultation can be done by the specialist in one of following ways:
1. The specialist doctor dictates the details and verifies the input done by operator
2. The specialist doctor inputs the details himself
3. The specialist doctor records the comments by audio
4. The diagnosis for each patient needs to be properly coded
5. The case report needs to be electronically signed by the specialist, sent to the consulting center, printed out and handed
over to patient
6. Monitoring of each case needs to be done to closure
7. In case the patient comes to the Specialty center the previous details of the patient from the Telemedicine system need
to be uploaded to hospital system
15. Process Guideline
Ensuring quality of Consultation
▪ The transmission of medical information, including, but not limited to electronic transmissions of telemedical records to
and from telemedical facilities, should be done in a secure manner.
▪ Stricter verification of identity of each person logging into the telemedicine system using new technologies.
Telemedicine Consulting Centre (TCC) Process Overview
▪ At Telemedicine Consulting Center (TCC) end, the patient details are given to Telemedicine Coordinator by the TCC
doctor on paper in a prefixed format
▪ Any PFT report, TMT/ ECG report of the patient are captured into the Telemedicine PC attached to the patient record
by the TCC Coordinator
▪ Any X-rays of the patient are scanned and stored. Any images/clips from the Ultra sound/ Doppler/ Digital
Microscope/ Digital Camera are also stored.
▪ Video conferencing will be used for face-to-face interaction. Live Doppler and Ultra-sound images will be transferred, if
required using Video Conferencing.
▪ The agency personnel providing telemedicine-based consultation must document each video visit in the patient's chart.
16. Process Guideline
▪ Patients must be given clear written instructions as to who to call in case problems arise.
▪ The medical practitioner must inform the patient before hand that he is free to withdraw his consent at any time
without affecting his right to future care or treatment
▪ The medical practitioner must inform the patient of the potential risks, consequences and benefits of telemedicine
▪ The medical practitioner must inform the patient that all existing confidentiality protection apply to any information
about the patient obtained or disclosed in the course of the telemedicine interaction
Telemedicine Specialty Centre (TSC) Process Overview
▪ Any PFT report, TMT/ ECG report of the patient are captured into the Telemedicine PC attached to the patient record
by the TCC Coordinator Any X-rays of the patient are scanned and stored.
▪ Any images/clips from the Ultra sound/ Doppler/ Digital Microscope/ Digital Camera are also stored.
▪ Video conferencing will be used for face-to-face interaction. Live Doppler and Ultra-sound images will be transferred, if
required using Video Conferencing.
17. Security
The following are some examples of security measures that must be built-in or addressed in any telemedicine application
system: -
1. Who can have access to individuals’ health information?
2. What kind of security technology is used for the above authentication, such as password, fingerprint and smart card?
3. What kind of encryption is used for storing medical data?
4. What kind of encryption is used for transmitting medical information?
Security elements include storage security, network security, data encryption, audit trails etc. Networks should be reliable
and secured to ensure user confidence, system and data integrity, and robust system operation. Some aspects are beyond
the scope of the current document eg. Security Policies, Physical Security, etc. The security standards should be in
conjunction with the IT Act of India as may be current at the time. Issues relating to the Digital Signatures are to be
referred to the relevant sections of the act
18. Security Services and their enforcing Security Mechanisms
Threat Security Services
Security Measures
(Asymmetric Tech)
Security Measures
(Symmetric Tech)
Unautherized Use of
Service
Principal Identification
and authentification
Digital signature TVP Encryption TVP
Data origin authentication Digital signature DN Encryption DN
Data manipulation Integrity
Digital signature
Cryptographic check
Encryption Cryptographic
check
Disclosure of Data Confidentiality Encryption
Concealment or
manipulation of origin of
data
Accountability Security audit
Repudiation of receipts Non repudiation
Digital signature, time
stamp
Encryption
19. Security
User Authentication, Entity Authentication
▪ User Authentication, Entity Authentication It is necessary to authenticate the users of the system. This is to be done by
the Telemedicine System. This should be done by using mechanisms such as Passwords, Smart card authentication, any
Biometric devices such as Thumb scanners, Iris Scanners, etc.
▪ Further the Telemedicine System itself has to be authenticated. It is recommended that this be done using Digital
Certificates; this is covered later as a part of the Secure Channel Establishment.
Security Profile
▪ Once the identity of the user has been established by the Telemedicine System, using an Authentication mechanism, the
Telemedicine System must determine the User Profile. The user profile includes the kind of rights the user has work
with data eg. create, add, view, etc. depending on the identity of the User, the roles the user plays.
20. Software
Telemedicine S/W with appropriate User Interface (UI)
The telemedicine software should be capable of performing the following functions:
▪ Acquisition of Patient related information
▪ Storage of the patient information
▪ Display of patient information
▪ Transmission of the Patient information over a communication link
▪ Scheduling of doctor appointments
Following additional functionalities, though not mandatory, are highly recommended in the software (to support multiple
formats and facilitate interfacing capability).
▪ Capturing of images/document from a scanner
▪ Capturing of video/ other data from the output of the medical equipment and conversion to DICOM
▪ Conversion from DICOM to non-DICOM formats
21. Software
Patient Information Records (PIR) to be supported by the software
The PIR created as part of the data acquisition process can be in terms of both structured and unstructured information. It
may also involve different files like - audio, video, graphics, text etc. The typical data captured as part of the PIR are as
defined below:
▪ PATIENT DEMOGRAPHICS such as name & patient Id, and address etc. ( as per the formats given in ),
▪ PATIENT HISTORY such as Past Illness, Present Illness, Treatment Details etc
▪ Details of EXAMINATIONS, INVESTIGATIONS and DIAGNOSIS conducted so far including General/Physical
Examination and Systemic Examination (as relevant).
▪ ATTACHMENT OF VIDEO/ IMAGES. Images captured from various imaging sources – eg directly through medical
equipment, scanned images etc. These can be either DICOM Images (lossless / lossy) or Non DICOM Images.
▪ ATTACHMENT OF FILES (other than audio and video images) related to patient examination and history. This can
be in various formats such as Word document, Excel sheet, PDF etc.
▪ REPORT(S) based on examinations. This can also potentially involve graphical representations. The report can be
either structured (depending on the clinical protocol involved) or unstructured. Report Generation could be various
types. For example, Report for a certain period of time, Report of Individual doctors, Report of individual
Specializations etc.
22. Software
Some of the important information relating to the Telemedicine Consultation, that the software should be capable of
capturing are as follows:
▪ Details such as time, date, details of doctor(s) attending the conference etc.
▪ Case brief and areas of discussion
▪ Diagnosis and expert opinion
▪ Case management plan including diagnostic procedures recommended, treatment to be followed, Prescription, follow
up actions to be taken etc.
23. Data Interchange/exchange Standards
DICOM
DICOM (Digital Imaging and Communications in Medicine) is an industry standard from the National Electrical
Manufacturers Association (NEMA), facilitating the exchange and processing of medical images in digital form. Image
acquisition devices (e.g. Computer Tomography), image archives, hardcopy devices and diagnostic imaging workstations
from different vendors can be connected into a common information infrastructure and integrated with other information
systems (e.g. PACS, HIS/RIS). The DICOM Standard addresses the semantics of Commands and associated data. For
devices to interact, it provides standards on how devices are expected to react to Commands and associated data, not just
the information which is to be moved between devices;
▪ The DICOM Standard is explicit in defining the conformance requirements of implementations of the Standard. In
particular, a conformance statement must specify enough information to determine the functions for which
interoperability can be expected with another device claiming conformance.
▪ The DICOM Standard facilitates operation in a networked environment, without the requirement for Network
Interface Units.
▪ The DICOM Standard is structured to accommodate the introduction of new services, thus facilitating support for
future applications
24. Clinical Protocols
Clinical Protocol
Clinical protocols for telemedicine practice include preliminary scheduling procedures, actual consult procedures and
telemedicine equipment operation procedures (such as telecommunications transmission specifications).
Protocol 1:
The protocol given below is of the store and forward type whereby the patient information is first transmitted and the
expert opinion is given later.
25. Clinical Protocols
Protocol 2:
The protocol given below is of the store and forward type but the transmission of the patient information is done during
the teleconsultation and the specialist gives his expert opinion
26. Clinical Protocols
Protocol 3:
The protocol given below is a combination of store and real time where the patient information is not stored at the TCC
but is straightaway transmitted to the TSC where it is stored and then the teleconsultation takes place and the expert
opinion is given.
27. Clinical Protocols
Protocol 4:
The protocol given below is real time where the patient information is acquired, transmitted to the TSC during the
teleconsultation and then the expert opinion is given. In this Telemedicine process, the workflow begins only during the
teleconsultation. All the necessary functions like the acquisition of patient information, transmitting to the TSC, storing at
the TSC and the expert opinion is during the time of teleconsultation. The patient’s live images (CT Scan, Doppler,
Ultrasound etc.) are being transmitted on a real time basis.
28. Clinical Protocols
Protocol 5:
The protocol given below is real time where the patient information is acquired, stored, transmitted to the TSC and stored
at TSC during the teleconsultation and then the expert opinion is given. In this Telemedicine process, the workflow begins
only during the teleconsultation. All the necessary functions like the acquisition of patient information, storing of patient
information at TCC, transmitting to the TSC, storing at the TSC and the expert opinion is during the time of
teleconsultation. The patient’s live images (CT Scan, Doppler, Ultrasound etc.) are being transmitted on a real time basis.
29. Clinical Protocols
Protocol 6:
The protocol given below is real time where the patient information is acquired, stored, transmitted to the TSC during the
teleconsultation and then the expert opinion is given. In this Telemedicine process, the workflow begins only during the
teleconsultation. All the necessary functions like the acquisition of patient information, storing of patient information at
TCC, transmitting to the TSC and the expert opinion is during the time of teleconsultation. The patient’s live images (CT
Scan, Doppler, Ultrasound etc.) are being transmitted on a real time basis.
30. Clinical Protocols
Protocol 7:
The protocol given below is store and forward but the teleconsultation commences after the acquisition of the
patient information at the TCC and the storage at TCC, transmissions done during the teleconsultation and finally the
expert opinion is given.
31. References
Recommended Guidelines & Standards for Practice of Telemedicine in India - Technical working group for Telemedicine
Standardization Department of Information Technology (DIT), Ministry of Communications and Information
Technology (MCIT)