Escolar Documentos
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November 2013
Acknowledgement
The Ministry of Health & Family Welfare and the members of MDDS Committee would like to thank Indian
& International Health Informatics professionals who have provided valuable contributions towards
development of Meta Data & Data Standards.
The MDDS Committee acknowledges and thanks Mr. Sunil Bhushan, (Senior Technical Director, National
Informatics Centre), Dr. Meenakshi Mahajan, (Senior Technical Director, National Informatics Centre)
and her team for providing necessary help in standards development. The Committee would also like
to acknowledge the help and support provided by Dr. Rattan Chand Chief Director, Statistics Division
MoHFW. Help & support provided by MCTS Division and e-Gov Consulting team in MoHFW & Rajasthan
Medical Services Corporation team in Jaipur needs to be acknowledged. A big acknowledgement goes to
Dr. B.K. Murti, Mr. Praveen Srivastava and C-DAC team for verifying & reviewing the standards.
The MDDS Committee acknowledges, the secretariat role played by National Health Systems Resource
Centre (NHSRC) for the MDDS Committee. The intensive efforts & work contributed by two partner
agencies Taurus Glocal Consulting & United Health Group and the considerable expertise they brought
to this work is greatly appreciated and acknowledged. The committee also appreciates the technical
support received from International Health Informatics Experts Prof. Sundeep Sahay & Mr. Bob Jolliffe.
The full time professional team that worked for this secretariat are: NHSRC- Dr. Amit Mishra, Taurus
Glocal Consulting -Dr. Pankaj Gupta, Mr. Krishan Bhardwaj, Dr. Savita Gupta and Ms. Anjali Nanda, United
Health Group- Mr. Ranjan Prasad, Dr. Lokesh Gupta, Mr. J. P. Pattanaik and Ms. Akanksha.
Manoj Jhalani
Chairperson
Committee on Meta Data & Data Standards in Health Domain
Ministry of Health & Family Welfare
New Delhi
iii
Member
Member
Member Secretary
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Chairperson
Member
Executive Summary
* https://egovstandards.gov.in/
# Operational Manual for formulation of Domain Specific Metadata and Data Standards
! Institutional Mechanism for formulation of Domain specific Metadata and Data standards
Executive Summary
vii
Overview Report
National Committee on Meta Data and Data Standards For Health Domain
viii
Attribute
Frequency
Concept
Frequency of Medication
Value Domain
Medication Frequency
Code Directory
List of Values
(BID, TID, QID, HS, STAT)
Data Element
Medication Frequency
Figure 1: Based on ISO/IEC 11179 Meta Model-I with an illustrative example relating to drug prescription
Executive Summary
ix
* https://egovstandards.gov.in/sites/default/files/Published_Standards/Metadata%20and%20Data%20Standards/
MDDS_Demographic_Ver_1.1.pdf
xi
Contents
iii
v
vii
xi
Section-I: Introduction
What is Common Data Element?
Why is Common Data Element Required?
Conceptual Design Principles
1
1
2
2
5
5
5
9
13
13
13
14
14
15
15
19
19
19
20
20
23
Introduction
Contents
15
17
Acknowledgement
Terms of Reference of the Domain Health Committee
Executive Summary
Note to the Reader
xiii
SECTION: 1
Introduction
* https://egovstandards.gov.in/
Introduction
Overview Report
National Committee on Meta Data and Data Standards For Health Domain
Data Element
Object
Attribute
Operational Status
Value Domain
n:1
Conceptual
Domain
n:1
Value
Domain
Introduction
Data Element
1:n
Data Element
Concept
1:n
Representational
Level
Conceptual
Level
Overview Report
National Committee on Meta Data and Data Standards For Health Domain
SECTION: 2
Principles of Design
1.
2.
3.
4.
5.
Identifiers
This effort of Health Domain MDDS Committee
includes creating an infrastructure to allow the
exchange of healthcare data at the regional, state
and national levels. To do this we must start with
the accurate identification of each person/ facility
receiving or providing healthcare services, and
also anyone accessing or using this information.
As we move away from paper-based healthcare
data that are controlled by physical access to
buildings, rooms, and files, we need to have an
infrastructure that supports strong identity and
2O
perational Manual for formulation of Domain Specific Metadata and Data Standards
3 Institutional Mechanism for formulation of Domain specific Metadata and Data standards
Principles of Design
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
vii.
Administrative Linked Facility Type
This will include Type of Facility Code
Principles of Design
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
c) Facility Human
directory Facility
Master: Indicates
resources available
designations.
Principles of Design
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
10
SN
Entity
Description*
Generic
Person
Person is an individual with certain attributes associated with it. These relates
to identity management of an individual in health care. E.g. Alternate Unique
Identification Number(UID)
Patient
A patient is any recipient of health care services. This entity list patient
attributes as data elements. E.g. Patient Age
Employee
Provider
Source of
Payment
Source of Payment in healthcare indicates who is paying for the services given to
the patient. This can be out of pocket by patient, insurance (public, private) or
provisioned through government budget, government reimbursement. Relevant
data elements are grouped under this entity. E.g. Insurance Policy Type.
Bill
Facility
Any institution which is engaged in the delivery of health care services to the
individuals, families or communities. This entity contains list of data elements
which are related to health facility identification. E.g. Unique Facility ID, Facility
Type Code.
Episode
Any health condition for which an individual is provided care by a health service
provider for a certain period of time is considered as episode of care. E.g.
Episode ID
10
Encounter
A patient encounter is a record of a patients arrival in the health facility for any
form of diagnostic and/or therapeutic event. This indicates interaction between
a patient and health service provider irrespective of place of interaction for the
purpose of diagnosis, care & treatment. An episode can contain multiple related
encounters. E.g. Encounter ID, Encounter Type.
11
Advance
Directives
12
ADT
13
Emergency
Emergency care relates to the inpatient emergency care provided to the patient
reaching to the emergency department of the health facility. E.g. Patient Status,
Ambulatory Status
* http://en.wikipedia.org
Description*
14
Outreach
15
Disaster
Response
Disaster response is the health care response to the disaster and consist data
elements which are part of rescue, first aid, triage, transport to the facility and
deceased management. E.g. Mass Casualty Incident Type.
16
Examination
17
Vital Signs
18
Allergy
19
Clinical Notes
20
Diagnosis
21
Lab
Lab entity covers data elements related for ordering laboratory services. E.g. Lab
Order Code
22
Radiology
Radiology entity covers data elements related for ordering Radiology services.
E.g. Radiology Procedure Code
23
Pharmacy
Pharmacy entity covers data elements related for ordering Pharmacy services.
E.g. Medication Frequency, Dose
24
Immunisation
Order
Orders are indication for execution of certain tasks related to patient care,
medication administration, disease prevention etc. Immunisation Order
Entity covers data elements related for ordering Immunisation services. E.g.
Immunization Administered Date, Immunisation product code
25
Clinical Order
Clinical Order Entity covers data elements related for Clinical Orders. E.g. Order
to admit date
26
Procedure
Principles of Design
Entity
SN
11
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
12
SN
Entity
Description*
27
Blood Bank
28
Nursing
29
OT
30
CSSD
31
Inventory
32
Remission
33
Complications
34
Relapse
35
Morbidity
36
Disability
37
Mortality
38
Ambulance
39
Indicator
Indicator entity is created as placeholder for the aggregate data elements and
for reporting from population-based indicators. E.g. Infant Mortality Rate etc.
SECTION: 3
Standards Rollout
Standards Rollout
Data Sets
13
Recording Systems
Historical
Systems
Upgraded
Systems
Recording of data in
EHR format. Automate
aggregation as per local
reporting requirements
National Committee on Meta Data and Data Standards for Health Domain
Clean Slate
Systems
14
Institutional Framework
For implementing Meta Data & Data Standards some
institutional mechanism needs to be put in place
which will ensure participation from stakeholders
and partners. There are various mechanism which
can enable standards roll-out in prospective and
existing systems. Standards institution role and
framework are described in section V.
SECTION: 4
Interoperability Solution
Interoperability Solution
15
Regulatory
Support
Births and
Deaths
Service
Delivery data
from HMIS
Disease
Surveillance
Epidemiology
GIS
HR and
Financial
Management
16
National
Disease/
Program
Monitoring
State Health
Information
Exchange
Hospital
Information
Systems
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
Medical
Education and
Research
Public
Information
Nutrition
Surveillance
Emergency
Response
Support
State
Health
Information
Exchange
National
Health
Information
Network
State
Health
Information
Exchange
State Health
Information
Exchange
Interoperability Solution
17
Document
Registry
Facility
Registry
Service
Registry
Payment
Registry
Provider
Registry
Disease
Registry
Directorates
Private Sector
Portal
Patient
Registry
State HQ
Meta Data
Registry
Data Warehouse
Patient
District Admin
Central
RCH
SystemsHMIS,
MCTS
National
Disease
ProgramsMalaria,
IDSP,
NACO
Private Sector
State
Health
Programs
EMRI,
DHIS,
Kala Azar
Nutrition- NRCs
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
HIS, EMR
18
Block 1
Block 2
SECTION: 5
Institutional Framework
The Mandate
The Authority shall be responsible for,
i. Maintaining the repository of standards
ii. Update and upgrade standards
iii. Ensuring compliance to standards.
iv. Facilitate adoption/ implementation
I. Managing repository of standards
Healthcare is a very diverse domain and to
address standardization, it needs a large set of
data standards. . It is an error prone and difficult
task to manage these standards manually and
would require automated management of
standards. DietY has a framework to address
this purpose and it suffices the need of health
domain as well.
II. Update & Upgrade Standards
a) Documenting specific standards request:
As an iterative process the standards
management organisation has to work
closely with the state public health
departments and private health sector to
document various standards requirements
originating with new program and with
new areas as they open up.
b) Organising standards consultations:
The organisation has to arrange specific
standards consultations with participation
from various stakeholders which will
discuss and recommend updation in the
standards list.
* http://planningcommission.gov.in/plans/planrel/12thplan/pdf/12fyp_vol3.pdf
Institutional Framework
The Need
19
c) Decision
making:
Once
thorough
deliberation is done on the prospective
standards and legitimate feedbacks are
absorbed, a decision should be made on
the shape, size and form of standards.
The decision can include the timelines
and mode of releasing the standards and
guidelines for implementation.
d) Notifying the standards: All the competent
stakeholders should be dully notified using
the prevalent mode of communication by
standards organization. The standards
once notified should be available in public
space for usage.
III. Ensuring Compliance to standards
a) Certification: Prospective health IT
applications have to undergo auditing
and testing to ensure compliance with the
standards. This task should be done by a
Standards Auditor Group in which external
empanelled experts should participate
with internal consultants. If any incentive
mechanism is put in place for standards
compliance, the applications which are not
compliant can be disqualified for incentive
schemes.
Figure 6: Standards Organization: Roles &
Functions
Publish
Advocacy
Disseminate
l Capacity
Building
FAQs
Help lines
MA
IN
T
N
AI
FA
CI
Incentive
Legislation
TE
TA
LI
20
Update
Upgrade
Identify
gaps
NA
GE
ER
TI
MA
FY
MDDS Health
Domain Standard
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
Testing &
Certification
l
Collect
Feedback
l
Accreditation
Compliance
Governance
An organisation needs to be established initially
by MoHFW, & later by an act as the apex
institution for carrying out its task as defined
in mandate. One suggestion that was discussed
that the current Health Domain MDDS Committee,
could after some changes in composition as
considered necessary, would be the National
Health Information Authority. The regular function
could be executed by constituting a secretariat,
that could be placed in one of the existing apex
public institutions or a new one created for
the same.
th Information A
l
a
e
uth
lH
a
Core Functions
or
n
o
it
i
m
r
o
F
u
l
t
ation
Policy
nt
Functional
Group (4-5
Health IT
Professionals)
Health IT Forum
Management
Group (4-5
Health Mgmt
Professionals
mplement
rds I
at i
Technical
Group (4-5
Technical
Architect)
on
Certification
Group
e
at
St alth tion
He rma ils
fo nc
In Cou
Academic
& Research
Institutions
al
on
i
t
a
s
ern dard
t
n
I tan es
S odi
B
Institutional Framework
nd a
dards Managem
Stan
e
S ta
Core Groups
Na
21
d.
The government/ MDDS committee
would accredit and rate contract suitable
testing agencies and for testing and a
f.
All existing systems which are publicly
financed and owned by MoHFW or any
statutory body under MoHFW can request any
other system for specific information that it
MDD is a pivotal
process
No
Build a case for
health domain
categories
Measure and
Maintain the master
data elements and
other resultant
datasets
This involves
indetification of
value domains
and populations
of code directory
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
Initialize
MDDS
program
22
Standardize
the meta data
of master data
elements
Chosen category
justified for the
MDDS Health
candidate?
Processes
like Data DE
duplication,
establishing
metadata
references
between data
elements and
metadata etc..
Yes
Identify the
master Data
Elements
Based on MDDS
standards
template.
It is further
customized to
meet the goal
Knowledge Resources
Vast amount of work has been globally done for the
health IT standards development by governments,
private organisation and by international NGOs.
However keeping pace with these developments
is only possible when the NHIA works closely
with these institutions through partnerships from
inception. In addition the NHIA should have
easy access to documented studies, research
publications on health IT standards. The authority
should also collaborate with the other sectors
such as insurance, IT, hospitals etc. to understand
their needs and demands.
Principles of Design
23
SECTION: 6
Concluding Remarks
Concluding Remarks
25
Definitions
Reference
Remarks
ADT
HL7
http://www.hl7.org/
implement/standards/
product_brief.
cfm?product_id=92
Adverse Event
http://en.wikipedia.org/
wiki/Adverse_event
Allergy
Wikipedia
http://en.wikipedia.org/
wiki/Allergy
Advance
Directives
http://en.wikipedia.org/
wiki/Advance_directives
Blood Bank
http://en.wikipedia.org/
wiki/Blood_bank
Wikipedia
Glossary
Terms
Glossary
27
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
28
Terms
Definitions
Reference
Remarks
Blood Donor
Registration
http://medical-dictionary.
thefreedictionary.com/
Blood+Donation+and+Registry
Blood
transfusion
Wikipedia
http://en.wikipedia.org/
wiki/Blood_transfusion
Common Data
Element
Comorbidity
Wikipedia
http://en.wikipedia.org/
wiki/Morbidity#Morbidity
Clinical/
Progress
Notes
http://medical-dictionary.
thefreedictionary.com/
progress+notes
CSSD
Wikipedia
http://en.wikipedia.org/
wiki/Central_sterile_
services_department
Disaster
Management
Wikipedia
http://en.wikipedia.org/
wiki/Disaster_relief
Disability
Wikipedia
http://en.wikipedia.org/
wiki/Disability
Data Element
Reference
Remarks
Diagnosis
Wikipedia
http://en.wikipedia.org/
wiki/Medical_diagnosis
Donor
Screening
http://en.wikipedia.org/
wiki/Blood_donation
Drug Plan
Monitoring
Direct Care
http://medical-dictionary.
thefreedictionary.com/
direct+care
Emergency
care
Wikipedia
http://en.wikipedia.org/
wiki/Emergency_care
Facility
Wikipedia
http://en.wikipedia.org/
wiki/Health_care_provider
HEENT
Wikipedia
http://en.wikipedia.org/
wiki/HEENT_examination
Identifier
Glossary
Definitions
Terms
29
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
30
Terms
Definitions
Reference
Remarks
ICD 10
http://en.wikipedia.org/
wiki/ICD-10
Immunization
Wikipedia
http://en.wikipedia.org/
wiki/Immunization
LOINC
Wikipedia
http://en.wikipedia.org/
wiki/LOINC
Mass Casualty
Wikipedia
http://www.
thefreedictionary.com/
mass+casualty
Meta Data
Wikipedia
http://en.wikipedia.org/
wiki/Data
Master Data
http://en.wikipedia.org/
wiki/Master_Data
Morbidity
Wikipedia
http://en.wikipedia.org/
wiki/Morbidity#Morbidity
Mortality
Online
Medical
Dictionary
http://medical-dictionary.
thefreedictionary.com/
mortality
Reference
Remarks
OT
Management
Wikipedia
http://en.wikipedia.
org/wiki/
Operating_room_management
Outcome
Online
Medical
Dictionary
http://medical-dictionary.
thefreedictionary.com/
outcome
Outreach
Services
Wikipedia
http://en.wikipedia.org/
wiki/Outreach
Pain
Assessment
http://medical-dictionary.
thefreedictionary.com/
pain+assessment
Physical
Examination
http://en.wikipedia.org/
wiki/Physical_examination
Wikipedia
Glossary
Definitions
Terms
31
Terms
Definitions
Reference
Remarks
Post op
recovery
monitoring
Wikipedia
http://en.wikipedia.org/
wiki/Surgical_nursing
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
32
Pre-operative
checks
http://en.wikipedia.org/
wiki/Surgical_nursing
Provider
http://en.wikipedia.org/
wiki/Health_care_provider
Wikipedia
http://en.wikipedia.org/
wiki/Palliative
Rehabilitative
Care
http://medical-dictionary.
thefreedictionary.com/
Rehabilitation
Remission
Wikipedia
http://en.wikipedia.org/
wiki/Remission
Relapse
Wikipedia
http://en.wikipedia.org/
wiki/Relapse
Recipient
Terms
Definitions
Reference
Remarks
RxNorm
Wikipedia
http://en.wikipedia.org/
wiki/RxNorm
RFID
http://en.wikipedia.org/
wiki/RFID
Sterlization
http://en.wikipedia.
org/wiki/
Sterilization_(microbiology)
Supportive
Care
Online
Medical
Dictionary
http://medical-dictionary.
thefreedictionary.com/
supportive+care
Supply Chain
Management
Wikipedia
http://en.wikipedia.
org/wiki/
Supply_chain_management
Vital Signs
Glossary
http://en.wikipedia.org/
wiki/Vital_Signs
33
References
1. E-Governance Standards Accessed from https://egovstandards.gov.in/ on 15th July 2013.
2. MDDS Demographics v1.1 Accessed from https://egovstandards.gov.in/sites/default/files/Published_
Standards/Metadata%20and%20Data%20Standards/MDDS_Demographic_Ver_1.1.pdf on 11th July
2013.
3. Website of Ministry of Health & Family Welfare (http://mohfw.nic.in/) Accessed on 20th July 2013.
4. Website of National Health Systems Resource Centre (www.nhsrcindia.org) Accessed on 1st August
2013.
5. Website of Medical Council of India (http://www.mciindia.org/) Accessed on 17th August 2013.
6. Website of Rajasthan Medical Services Corporation (http://www.rmsc.nic.in/) Accessed on 15th August
2013.
7. Website of IRDA. Accessed from www.irda.gov.in on 21st September 2013.
8. Website of National Disaster Management Authority, Government of India (http://ndma.gov.in/ndma/
index.htm) Accessed on 19th August 2013.
9. NRHM HMIS Web Portal, www.nrhm-mis.nic.in Accessed on 11August 2013.
10. NRHM Mother Child Tracking System, www.nrhm-mcts.nic.in/MCH Accessed on 18th September 2013.
11. Website of Integrated Disease Surveillance Project(IDSP), (www.idsp.nic.in/) Accessed on 9th September
2013.
12. Strategic Information Management System, National AIDS Control Organization (www.naco-sims.nic.in)
Accessed on 12th September 2013.
13. Master Facility List Guidelines, WHO 2012 Accessed from http://www.who.int/healthinfo/systems/
WHO_CreatingMFL_draft.pdf on 6th August 2013.
14. Master Facility List- Implementation Guide, Division of Health Information Systems Department of
Standards and Regulatory Services Ministry of Medical Services, Kenya February 2010 http://www.
ehealth.or.ke/facilities/ Accessed on 11 August 2013.
17. Canadian Classification of Health Interventions (CCI Codes) Accessed from http://www.cihi.ca/cihiext-portal/pdf/internet/cci_vol3_2009_en on 18th July 2013.
18. International Classification of Functioning, Disability and Health (ICF),WHO 2001, Accessed from
http://apps.who.int/classifications/icfbrowser/ on 17th August 2013.
19. LOINC Standards Accessed from https://loinc.org/ on 11th August 2013.
20. Website of Standards International Accessed from http://www.standardsinternational.net/ on 26th
August 2013.
References
16. International Statistical Classification of Diseases and Related Health Problems 10th Revision, WHO
Accessed from http://apps.who.int/classifications/icd10/browse/2010/en on 20th July 2013.
15. HITSP Data Dictionary Component, Healthcare Information Technology Standards Panel. Jan 2010.
Accessed from http://wiki.siframework.org/file/view/HITSP_V1.0_2010_C154_-_Data_Dictionary.pdf
on 8th August 2013.
35
21. Public Health Guide for Emergencies, Centre for Refugee & Disaster Response, John Hopkins Bloomberg
School of Public Health, Accessed from http://www.jhsph.edu/research/centers-and-institutes/centerfor-refugee-and-disaster-response/publications_tools/
publications/_CRDR_ICRC_Public_Health_
Guide_Book/Public_Health_Guide_for_Emergencies on 10th September 2013.
22. Additional Information Specification 0001: Ambulance Service Attachment Release 2.0, Based on HL7
CDA Standard Release 1.0, with supporting LOINC Tables, CDA Ballot, August 2003 Accessed from
http://www.hl7.org/documentcenter/public/wg/ca/AMBULANCE%20Additional%20Information%20
Specification%20(Jan%202012%20Draft%20Copy).doc 8th September 2013.
23. Management of Dead Bodies after Disasters: A Field Manual For First Responders, Pan American Health
Organization, Washington 2006. Accessed from http://www.paho.org/disasters/ on 18th August 2013.
24. Data Against Natural Disasters: Establishing Effective Systems for Relief, Recovery, and Reconstruction.
The World Bank, Washington DC 2008. Accessed from www.ipcc-wg2.gov/njlite_download.php?id=6686
on 8th September 2013.
25. Impact of Public Health Emergencies on Modern Disaster Taxonomy, Planning, and Response, Frederick
M. Gregg G, Special Focus 2008 Accessed from http://www.ncbi.nlm.nih.gov/pubmed/18562943 on
9th September 2013.
26. Special tabulation lists for mortality and morbidity, ICD-10, WHO. http://apps.who.int/classifications/
icd10/browse/2010/en on 20th July 2013.
27. Report on Medical Certification of Cause of Death 2008, Office of The Registrar General, India,
Government of India, Accessed from http://www.censusindia.gov.in/2011-Documents/mccd_Report1/
Report%20on%20Medical%20Certification%202.pdf on 8th August 2013.
28. NSSO -71- the List of ailments with codes and working definitions. NSSO.
29. Verbal Autopsy Standards: Ascertaining and attributing causes of death, The 2012 WHO verbal autopsy
instrument, WHO Accessed from http://www.who.int/healthinfo/statistics/verbalautopsystandards/
en/ on 23 August 2013.
31. The Signature Domain and Geographic Coordinates: A Standardized Approach for Uniquely Identifying
a Health Facility Health Facility Assessment Technical Working Group January 2007, WP-07-91, WHO.
Accessed from http://www.cpc.unc.edu/measure/publications/wp-07-91/at_download/document on
11 September 2013.
32. United States of America Food and Drug Administration (FDA) - Medication Physical Form http://
www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm Accessed on
12th September 2013.
33. United States of America Food and Drug Administration (FDA) - Pharmaceutical Unit of Measurement
http://www.fda.gov/forindustry/datastandards/structuredproductlabeling/ucm168397.htm Accessed
on 8th September 2013.
34. United States of America Food and Drug Administration (FDA) - Medication Package Type http://
www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162034.htm Accessed on 3rd
September 2013.
Overview Report
National Committee on Meta Data and Data Standards for Health Domain
30. Institutional Mechanism for Formulation of Domain specific Metadata and Data Standards in e-Governance,
eGSI-IM:02, Version 1.0, April 2012, Department of Electronics and Information technology Ministry of
Communications and Information Technology Government of India, Accessed from http://egovernance.
gov.in/policy/institutional-mechanism on 8th September 2013.
36
35. United States of America Food and Drug Administration (FDA) - Route of Administration http://www.
fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/
DataStandardsManualmonographs/ucm071667.htm Accessed on 3rd September 2013.
36. Rajasthan Medical Service Corporation for Equipments or Instruments http://www.rmsc.nic.in/pdf/eel.
pdf Accessed on 18th August 2013.
37. API Textbook of Medicine Volume-I & II, Ninth Edition.
on 11th
References
37