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NATIONAL DIGITAL HEALTH BLUEPRINT
Presenter – Dr. Gurmeet
Singh
Moderator – Dr. Kathirvel S.
WHERE IS HEALTH CARD ?
Birth Certificate
Immunization
card
Voter Card
School Identity
Card
New Pension System
Card
Driving license
Aadhaar Card
Employment ID
card
PAN Card
Death Certificate
Passpor
t
Ration Card
Ayushman Bharat Arogya
Card
Marriage certificate
Ration card, Caste certificate, Education certificate, Degrees, Fellowships
Certificate…...
PM SPEECH ON INDEPENDENCE DAY
 Health Sector में आज से एक बहुत बड़ा अभिय़ान शुरू होने ज़ा रह़ा है और उसमें
technology क़ा िी बहुत बड़ा रोल रहेग़ा। आज से National Digital Health Mission
क़ा िी आरंि ककय़ा ज़ा रह़ा है। ि़ारत क
े Health Sector में ये एक नई क़्ांतत ले
आएग़ा... इल़ाज में आने व़ाली परेश़ातनय़ां कम करने क
े भलए technology क़ा बहुत
सुववच़ाररत रूप से उपयोग होग़ा।
PM SPEECH ON INDEPENDENCE DAY
 प्रत्येक ि़ारतीय को Health ID दी ज़ाएगी। ये Health ID प्रत्येक ि़ारतीय क
े स्व़ास््य
ख़ाते की तरह क़ाम करेगी। आपक
े हर test, हर बीम़ारी... आपने ककस डॉक्टर क
े
प़ास, कौन-सी दव़ा ली थी, उनक़ा क्य़ा Diagnosis थ़ा, कब ली थी, उनकी ररपोटट क्य़ा
थी, ये स़ारी ज़ानक़ारी आपकी इस Health ID में सम़ाहहत की ज़ाएगी। Doctor से
appointment हो, पैस़ा जम़ा करऩा हो, अस्पत़ाल में पची बनव़ाने की ि़ागदौड हो, ये
तम़ाम हदक्कतें… National Digital Health Mission क
े म़ाध्यम से अनेक मुसीबतों से
मुक्क्त भमलेगी और उत्तम स्व़ास््य क
े भलए हम़ाऱा कोई िी ऩागररक सही फ
ै सले कर
प़ाएग़ा। ये व्यवस्थ़ा होने व़ाली है।
HISTORY OF UNIQUE ID IN SOCIAL SECURITY AND PATIENT
CARE
 The first Social security card is issued in U.S.
 Social Security number became essential in
1965
 For universal patient identification for health
record and insurance plans
 The UK adopts a similar system known as NI No.
(National Insurance Number)
DIGITAL HEALTH ID IN ESTONIA
 Near Universal, Public-key Infrastructure
Identification system
 eID is mandatory for all citizens and legal
residents
 Each citizen is registered at birth in
Comprehensive Population register and issued
with a unique personal identification Code
 Estonian Health information system – 2005
 Electronic Health record – 2008
 e - Prescription – 2010
ESTONIA – A TRULY DIGITAL COUNTRY
PWC – Estonia The Digital
THAILAND: NATIONAL ID AS A DELIVERY SYSTEM FOR UHC
 Thailand’s foundational identification system established in 1984
 13 digits personal identification number
 Integrated health care delivery system with Personal identification number as
Universal Coverage Scheme (UCS) in 2001
 Achieved Universal Health Coverage in 2002
 UCS reduced the uninsured population from 29 to 5 percent in less than 2
years*
 BORA (Bureau of Registration in Thailand) linkage with health system –
National population register is accurate in real time
*Kijsanayotin, Boonchai. (2017). Thailand’s national IDs as a foundation for universal health coverage and healthcare delivery. Third meeting of
the Regional Steering Group on Civil Registration and Vital Statistics in Asia and the Pacific, 19 October 2017, Bangkok, Thailand.
ONGOING INITIATIVES IN DIGITAL HEALTH IN INDIA
 Reproductive Child Healthcare (RCH)
 Prandhan Mantri Matri Vandana Yojana (PMMVY)
 Janani Suraksha Yojana (JSY)
 Integrated Disease Surveillance System (IDSP)
 Integrated Health Information System (IHIP)
 eHospital
 e-Shushrut
 Electronic Vaccine Intelligence Network (eVIN)
 Central Government Health Scheme (CGHS)
ONGOING INITIATIVES IN DIGITAL HEALTH
 Integrated Health information Platform (IHIP)
 National Health Portal (NHP)
 Nikshay
 Online Registration System (ORS)
 Mera Aspatal (Patient Feedback system)
 Health Management Information System (HMIS)
 National Medical College Network (NMCN)
NATIONAL HEALTH POLICY 2017
 Health and wellbeing for all at all ages
 Continuum of care is a concept strongly advocated by the policy
 Citizen-centricity, Quality of care, Better access, Universal Health Coverage
and Inclusiveness are some of key principles
 Significant emphasis on leveraging the power of information and
communication technologies to strengthen the healthcare delivery system
NATIONAL DIGITAL COMMUNICATION POLICY 2018
National digital communication policy 2018
Connect India Rashtriya Broadband
Abhiyaan
Universal Broadband connectivity to every
citizen by 2022
BharatNet 1 Gbps to Gram panchayat
GramNet 10 Mbps to rural developmental institutions
JanaWifi 1million Wi-fi hotspots in urban
National Digital Grid
Propel India Investment of USD 100 Billons Dollars to expand digital ecosystem
Globally recognized IPR (Intellectual Property Right)
Secure India Data Protection Regime
Robust Digital Communication Network
Security testing
Accountability
NATIONAL DIGITAL HEALTH BLUEPRINT
HIGHLIGHTS
VISION OF NDHM
 “To create a National Digital Eco-System that supports Universal Health
Coverage in an efficient, accessible, inclusive, affordable, timely and safe
manner, through provision of a wide – range of data, information and
infrastructure services, duly leveraging open, interoperable, standards- based
digital systems, and ensuring the security, confidentiality and privacy of health
– related personal information.”*
*National digital Health blue print (Page no. 7)
VISION – UNIVERSAL HEALTH COVERAGE
DOMAIN PRINCIPLES OF NDHM
Health
and
wellness
Univers
al
inclusiv
e Security
and Privacy
by design
National
Portability
Educat
e
Think Big
Start Small
Scale fast
Performance
accountabilit
y
TECHNOLOGY PRINCIPLES OF NDHM
Architecture
Interoperabl
e
Building
Blocks
Open APIs
Leverage
Legacy
Minimalist
Design
Single
Sources of
Truth
OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT
 To establish digital health system for managing the core digital health data,
and the infrastructure required for its seamless exchange
 To establish national and regional registries to create single source of truth in
respect of clinical establishments, healthcare professionals, health workers
and pharmacies
OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT
 To enforce adoption of open standards by all the actors in the National Digital
Health Eco-system
 To create a system of Electronic Health Records based on international
standards, easily accessible to the citizens and to the healthcare
professionals and services providers, based on citizen-consent
OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT
 To promote development of enterprise-class health application systems with a
special focus on addressing the Sustainable Development Goals related of
the health sector
 To adopt the best principles of cooperative federalism while working with the
states and union territories for the realization of the vision
 To ensure that the healthcare institutions and professionals in the private
sector participate actively in the building of the NDHE, through a combination
of prescription and incentivization
OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT
 To ensure national portability in the provision of health services
 To promote the use of Clinical Decision Support (CDS) Systems by health
professionals and practitioners
 To promote a better management of health sector leveraging health data
analytics and medial research
OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT
 To provide for enhancing the efficiency and effectiveness of governance at all
levels through digital tools in the area of performance management
 To support effective steps being taken for ensuring quality of healthcare
 To leverage the information systems existing in the health sector, by ensuring
that they confirm to the defined standards and integrate with the proposed
NDHE
FEDERATED ARCHITECTURE AND BUILDING BLOCKS OF OF
NDHM
 All digital health and applications held at 3 levels – National, State and Facility
 Patient data is held at the point of care
 Citizens shall be in full control of the processing of health data relating to
them
 Systems of Record (SoR) shall hold primary data and all others IT systems,
applications or entities will have access to it through links, subject to
applicable permission and consent
FEDERATED ARCHITECTURE AND BUILDING BLOCKS OF OF
NDHM
 Large facilities and government health department shall be data fiduciaries
 Small facilities which do not have the capacity/infrastructure can take the
service of licensed health data repositories, who will perform the role of data
processors
 Data fiduciary managing the data and the data processor holding and
processing the same shall be responsible for data protection obligations and
compliances under the applicable laws
OVERVIEW OF FEDERATED
ARCHITECTURE OF NDHB
Page 14, NDHB
FLOW OF DATA IN HMIS
HMIS Orientation workshop NHM 2019
COMPARATIVE ANALYSIS OF THREE ARCHETYPES FOR UHID
Centralized
Architecture
Federated
Architecture
Decentralized
Architecture
Definition A single organization
establishes and
manages the identifier
Different stand-alone
entities, each with its own
trust anchor, establish
trust-based interactions
with each other
Multiple entities
contributes to a
decentralized digital
identity; users
controls sharing of
identity data
Strengths •Can be built with
specific purpose in
mind
•Potential for
organizational vetting
of identity data
•User can access a wider
range of services
•Efficiency for
organizations
•Increased user
control and reduced
amount of
information collected
and stored by
organizations
Challenge
s
• Generally low user
control
•Centralized risk and
•Generally low user
control
•High technical and legal
•Complex
Governance model
•Complex liability
 MyHealth App(s)
 Health Portal
 Health Locker
 Value-Added services
FEDERATED ARCHITECTURE OF NDHB WITH BUILDING
BLOCKS
(CITIZEN ACCESS)
FEDERATED ARCHITECTURE OF NDHB WITH BUILDING
BLOCKS
(LOCAL LEVEL)
Local – Public/Private
Applications Hospital Information Systems
Technology
Building
blocks
Anonymizer Consent
Manager
Telemedicine Offline tools
System of Record (SOR)
Data Electronic
Medical
records
Health
workers data
Lab/
Diagnostics
Claims
Infrastructure IT Infrastructure at the facility Access to secure health cloud
FEDERATED ARCHITECTURE OF NDHB WITH BUILDING
BLOCKS
(STATE LEVEL)
State – Distributed
Application Emergenc
y care
Public
health
Well
applications
RCH Insurance
Technology
Building
blocks
Health Analytics Consent-
Management-
as-Service
Anonymizer-as-a
service
System of Record (SOR)
Data EHR Nurse/Paramedical
Directory
NCD registries
Infrastructure Security
operations
Call centers Secure Health Networks Health
lockers
FEDERATED ARCHITECTURE OF NDHB WITH BUILDING
BLOCKS
(NATIONAL LEVEL)
National Level
Application Medical Edunet National
Programs
Health research Common Reusable
application
Technology
Building blocks
Health Analytics (N) Health
information
exchange
Clinical
Decision
Support (CDS)
GIS tools
System of Record (SOR)
Data PHI/UHID Facilities
Directory
Doctors
Directory
Repository of
standards/ APIs/
Metadata/ Data
dictionaries
Infrastructure Secure Health
Network (N)
Privacy Ops
Center
Security Ops
Center
Health App store
UNIQUE HEALTH ID (UHID)
 To standardize the process of identification of an individual at any point
 Only way to ensure medical related records are issued to correct individuals
 System will collect certain basic details
 Demographic and location, contact details
 Ability to update contact information
ELECTRONIC HEALTH RECORDS (EHR)
 The EHR is created only after consent is sought from the user
 To generate and aggregate health records for person
 Individual can share medical records with other health provider as per
consent framework
 Data related to significant medical and health conditions, episodes and events
 Digi Locker system
MISTAKES TO BE AVOIDED IN DESIGNING EHR
 Incorrect Identification
 Incorrect Medical History
 Incorrect Lab/Diagnostic results
 Incorrect Drug Info
HEALTH LOCKER
 With interoperability specification
 When a medical record needs to be issued, only a reference link shared with
the locker ecosystem
 Small clinics/ hospitals are expected to subscribe to the authorized repository
providers who can integrate with the health locker to be able to participate in
this ecosystem
HEALTH DIRECTORIES AND HEALTH REGISTRIES
 Health Directories play a key role in the health ecosystem
 They hold the mater data of various entities
 Must adhere to principle of being the “Single source of truth”
 Directories related to professionals must enable Identity and Access
Management (IAM) for health applications that adopt the blueprint
 Health applications must be able to verify the identity of a doctor using the
registries, allow them access to records that they have authorized for.
HEALTH DIRECTORIES AND HEALTH REGISTRIES
 Facilities Directory – Unique identifier for each health facility – Hospitals,
Clinics, Diagnostic centers, Pharmacies
 Doctors Directory – doctor who has registered with the medical council after
completion of their education. Provision of Update
 Nurses & Paramedical Directory – Nurses, ANMs, Ophthalmic technicians,
OT technicians etc.
 Health Workers Directory – ASHA
 Allied Professionals Directory – Health IT, Masters in Hospital Administration,
Disease Coders, Pradhan Mantri Arogya Mitras, etc.
ANONYMIZER
 Anonymization – Irreversible process of transforming or converting personal
data to a form in which a data owner/ citizen cannot be identified (One-way
process)
 De-identification – Reversible process, whereby re-identification by competent
authority is possible for specific purposes
 Data is anonymized at the primary source of its capture and retention, mostly
at the facility level, to minimize its leakage while in transit
 Facility level – Infrastructure ? / Capacity ?
 “Anonymize-as-a-Service” @ Intermediate (State) layer
CONSENT MANAGER
 Every access to each record requires explicit consent of the individuals (Data
Principal)
 Electronic consent framework specification by MeitY
 Goal – To ensure that the citizen/ patient as the data principal, is in complete
control of what data is collected, and how/ with whom it is shared and for what
purpose, and how it is processed
 Applicable both on longitudinal (Over a period of time) and vertical (relating to an
episode)
HEALTH INFORMATION EXCHANGE (HIE)
 Real time data exchange by implementation of Open APIs and other
exchange mechanism
 For application access, to submit or retrieve or access any information
registration is required with Health Information Exchange
 HIE would be responsible for responsible for authentication and authorization
of all data exchanges requests
STANDARDS AND REGULATIONS
Areas chosen to define Standards for NDHB
Consent Consent for data collection and data use
Content &
Interoperability
Standards related to exchange of Healthcare data
Privacy and
Security
Standards related to data privacy and Security of data @rest
and @motion and data immutability
Patient Safety &
Data Quality
While collecting data and quality of data captured
STANDARDS AND REGULATIONS
Standards for NDHB
Consent Management ISO/TS 17975:2015
Content Framework Electronic Consent Framework (TS v1.1) with its
subsequent revision published by MeitY
Technical
Interoperability
IndEA (Indian Enterprise Architecture ) Frame work
Structured Clinical
Information exchange
Fast Healthcare Interoperability Resource (FHIR) R4
(subject to section 3.4.2)
STANDARDS AND REGULATIONS
Standards for NDHB
Still Images/
Documents/ Audio/
Video
Still image – JPEG
Document/Scan : PDF A -2
Audio: MP3/ OGG
Video: MP4/ MOV
(embedded as binary content in relevant FHIR resource)
Diagnostic Images DICOM PS3.0-2015c
Standards for NDHB
Terminology/
Vocabulary
SNOMED CT
(for all clinical terminology requirements in health records)
Coding
System
WHO ICD-10 (for statistical classification of diseases and
related health problems)
LOINC (for observation, measurement, test-panels, test items
and units)
Security Digital Certificate, TLS / SSL, SHA – 256, AES – 256
Access
Control
ISO 22600:2014 Health informatics – Privilege Management and
Access Control
STANDARDS AND REGULATIONS
REGISTRIES FOR NCDS
 National cancer registry maintained by ICMR and other diseases registries
maintained in India are not interoperable and not integrated with HIMS
 NDHB make them integrated and interoperable
DATA ANALYTICS
 @ State and National level
 For analysis of aggregated data set
 Data will send to one or more government-controlled analytics
DISCUSSION
PUBLIC CONSULTATION
1. National health authority gave only 21 days for Public consultation on Health
data management policy in NDHM (Till 3rd September)
2. The consultation document was only available in English
3. The consultation process was entirely online. Only 54% of the Indian
population has access to internet
03/04/2020
CRITICAL REVIEW
 Health is a state subject within Federal structure of Indian Constitution
 The state would need to be consulted in it. The state would be critical actors
in hosting and using data & would also have the legal right to regulate it
 Draft is not specifying
 Who will be the “Consent Managers”
 Who are the “Health Information user” – WILL THERE BE PRIVATE PARTIES
?
 Whether the financial or benefit schemes will be linked here? Whether the
citizen need to apply separately or it will happen automatically?
DATA PROTECTION LAW IN INDIA
 India has not yet enacted specific legislation on data protection
 However Indian legislature did amend the IT Act 2000 to include section 43A
and 72A, which give right to compensation on improper disclosure of personal
information
 Puttaswami’s Judgement 2017 – Supreme court of India has recognized the
“right of privacy” as fundamental right under Article 21
 Personal Data Protection, 2019 – drafted by Justice BN Srikrishna’s
committee, Right to be forgotten, Jurisdiction of Bill - both territorial and
extra-territorial, applying both to private and governmental sector, Critical
personal data should be processed only in India, Provision of Data
protection authority
03/09/2020
CHALLENGES
AADHAAR MANDATE
LINKAGE OF AADHAAR DATA WITH BIRTH & DEATH
REGISTRATION
(HARYANA STATE)
TELEMEDICINE PRACTICE GUIDELINE (PAGE NO. 11)
25/03/2020
Data Security ?
MY UNIQUE HEALTH ID
MY 2ND UNIQUE HEALTH ID
National digital health mission- Dr. Gurmeet

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  • 1. NATIONAL DIGITAL HEALTH BLUEPRINT Presenter – Dr. Gurmeet Singh Moderator – Dr. Kathirvel S.
  • 2. WHERE IS HEALTH CARD ? Birth Certificate Immunization card Voter Card School Identity Card New Pension System Card Driving license Aadhaar Card Employment ID card PAN Card Death Certificate Passpor t Ration Card Ayushman Bharat Arogya Card Marriage certificate Ration card, Caste certificate, Education certificate, Degrees, Fellowships Certificate…...
  • 3. PM SPEECH ON INDEPENDENCE DAY  Health Sector में आज से एक बहुत बड़ा अभिय़ान शुरू होने ज़ा रह़ा है और उसमें technology क़ा िी बहुत बड़ा रोल रहेग़ा। आज से National Digital Health Mission क़ा िी आरंि ककय़ा ज़ा रह़ा है। ि़ारत क े Health Sector में ये एक नई क़्ांतत ले आएग़ा... इल़ाज में आने व़ाली परेश़ातनय़ां कम करने क े भलए technology क़ा बहुत सुववच़ाररत रूप से उपयोग होग़ा।
  • 4. PM SPEECH ON INDEPENDENCE DAY  प्रत्येक ि़ारतीय को Health ID दी ज़ाएगी। ये Health ID प्रत्येक ि़ारतीय क े स्व़ास््य ख़ाते की तरह क़ाम करेगी। आपक े हर test, हर बीम़ारी... आपने ककस डॉक्टर क े प़ास, कौन-सी दव़ा ली थी, उनक़ा क्य़ा Diagnosis थ़ा, कब ली थी, उनकी ररपोटट क्य़ा थी, ये स़ारी ज़ानक़ारी आपकी इस Health ID में सम़ाहहत की ज़ाएगी। Doctor से appointment हो, पैस़ा जम़ा करऩा हो, अस्पत़ाल में पची बनव़ाने की ि़ागदौड हो, ये तम़ाम हदक्कतें… National Digital Health Mission क े म़ाध्यम से अनेक मुसीबतों से मुक्क्त भमलेगी और उत्तम स्व़ास््य क े भलए हम़ाऱा कोई िी ऩागररक सही फ ै सले कर प़ाएग़ा। ये व्यवस्थ़ा होने व़ाली है।
  • 5. HISTORY OF UNIQUE ID IN SOCIAL SECURITY AND PATIENT CARE  The first Social security card is issued in U.S.  Social Security number became essential in 1965  For universal patient identification for health record and insurance plans  The UK adopts a similar system known as NI No. (National Insurance Number)
  • 6. DIGITAL HEALTH ID IN ESTONIA  Near Universal, Public-key Infrastructure Identification system  eID is mandatory for all citizens and legal residents  Each citizen is registered at birth in Comprehensive Population register and issued with a unique personal identification Code  Estonian Health information system – 2005  Electronic Health record – 2008  e - Prescription – 2010
  • 7. ESTONIA – A TRULY DIGITAL COUNTRY PWC – Estonia The Digital
  • 8. THAILAND: NATIONAL ID AS A DELIVERY SYSTEM FOR UHC  Thailand’s foundational identification system established in 1984  13 digits personal identification number  Integrated health care delivery system with Personal identification number as Universal Coverage Scheme (UCS) in 2001  Achieved Universal Health Coverage in 2002  UCS reduced the uninsured population from 29 to 5 percent in less than 2 years*  BORA (Bureau of Registration in Thailand) linkage with health system – National population register is accurate in real time *Kijsanayotin, Boonchai. (2017). Thailand’s national IDs as a foundation for universal health coverage and healthcare delivery. Third meeting of the Regional Steering Group on Civil Registration and Vital Statistics in Asia and the Pacific, 19 October 2017, Bangkok, Thailand.
  • 9. ONGOING INITIATIVES IN DIGITAL HEALTH IN INDIA  Reproductive Child Healthcare (RCH)  Prandhan Mantri Matri Vandana Yojana (PMMVY)  Janani Suraksha Yojana (JSY)  Integrated Disease Surveillance System (IDSP)  Integrated Health Information System (IHIP)  eHospital  e-Shushrut  Electronic Vaccine Intelligence Network (eVIN)  Central Government Health Scheme (CGHS)
  • 10. ONGOING INITIATIVES IN DIGITAL HEALTH  Integrated Health information Platform (IHIP)  National Health Portal (NHP)  Nikshay  Online Registration System (ORS)  Mera Aspatal (Patient Feedback system)  Health Management Information System (HMIS)  National Medical College Network (NMCN)
  • 11. NATIONAL HEALTH POLICY 2017  Health and wellbeing for all at all ages  Continuum of care is a concept strongly advocated by the policy  Citizen-centricity, Quality of care, Better access, Universal Health Coverage and Inclusiveness are some of key principles  Significant emphasis on leveraging the power of information and communication technologies to strengthen the healthcare delivery system
  • 12. NATIONAL DIGITAL COMMUNICATION POLICY 2018 National digital communication policy 2018 Connect India Rashtriya Broadband Abhiyaan Universal Broadband connectivity to every citizen by 2022 BharatNet 1 Gbps to Gram panchayat GramNet 10 Mbps to rural developmental institutions JanaWifi 1million Wi-fi hotspots in urban National Digital Grid Propel India Investment of USD 100 Billons Dollars to expand digital ecosystem Globally recognized IPR (Intellectual Property Right) Secure India Data Protection Regime Robust Digital Communication Network Security testing Accountability
  • 13. NATIONAL DIGITAL HEALTH BLUEPRINT HIGHLIGHTS
  • 14. VISION OF NDHM  “To create a National Digital Eco-System that supports Universal Health Coverage in an efficient, accessible, inclusive, affordable, timely and safe manner, through provision of a wide – range of data, information and infrastructure services, duly leveraging open, interoperable, standards- based digital systems, and ensuring the security, confidentiality and privacy of health – related personal information.”* *National digital Health blue print (Page no. 7)
  • 15. VISION – UNIVERSAL HEALTH COVERAGE
  • 16. DOMAIN PRINCIPLES OF NDHM Health and wellness Univers al inclusiv e Security and Privacy by design National Portability Educat e Think Big Start Small Scale fast Performance accountabilit y
  • 17. TECHNOLOGY PRINCIPLES OF NDHM Architecture Interoperabl e Building Blocks Open APIs Leverage Legacy Minimalist Design Single Sources of Truth
  • 18. OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT  To establish digital health system for managing the core digital health data, and the infrastructure required for its seamless exchange  To establish national and regional registries to create single source of truth in respect of clinical establishments, healthcare professionals, health workers and pharmacies
  • 19. OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT  To enforce adoption of open standards by all the actors in the National Digital Health Eco-system  To create a system of Electronic Health Records based on international standards, easily accessible to the citizens and to the healthcare professionals and services providers, based on citizen-consent
  • 20. OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT  To promote development of enterprise-class health application systems with a special focus on addressing the Sustainable Development Goals related of the health sector  To adopt the best principles of cooperative federalism while working with the states and union territories for the realization of the vision  To ensure that the healthcare institutions and professionals in the private sector participate actively in the building of the NDHE, through a combination of prescription and incentivization
  • 21. OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT  To ensure national portability in the provision of health services  To promote the use of Clinical Decision Support (CDS) Systems by health professionals and practitioners  To promote a better management of health sector leveraging health data analytics and medial research
  • 22. OBJECTIVES OF NATIONAL DIGITAL HEALTH BLUEPRINT  To provide for enhancing the efficiency and effectiveness of governance at all levels through digital tools in the area of performance management  To support effective steps being taken for ensuring quality of healthcare  To leverage the information systems existing in the health sector, by ensuring that they confirm to the defined standards and integrate with the proposed NDHE
  • 23.
  • 24. FEDERATED ARCHITECTURE AND BUILDING BLOCKS OF OF NDHM  All digital health and applications held at 3 levels – National, State and Facility  Patient data is held at the point of care  Citizens shall be in full control of the processing of health data relating to them  Systems of Record (SoR) shall hold primary data and all others IT systems, applications or entities will have access to it through links, subject to applicable permission and consent
  • 25. FEDERATED ARCHITECTURE AND BUILDING BLOCKS OF OF NDHM  Large facilities and government health department shall be data fiduciaries  Small facilities which do not have the capacity/infrastructure can take the service of licensed health data repositories, who will perform the role of data processors  Data fiduciary managing the data and the data processor holding and processing the same shall be responsible for data protection obligations and compliances under the applicable laws
  • 28. FLOW OF DATA IN HMIS HMIS Orientation workshop NHM 2019
  • 29. COMPARATIVE ANALYSIS OF THREE ARCHETYPES FOR UHID Centralized Architecture Federated Architecture Decentralized Architecture Definition A single organization establishes and manages the identifier Different stand-alone entities, each with its own trust anchor, establish trust-based interactions with each other Multiple entities contributes to a decentralized digital identity; users controls sharing of identity data Strengths •Can be built with specific purpose in mind •Potential for organizational vetting of identity data •User can access a wider range of services •Efficiency for organizations •Increased user control and reduced amount of information collected and stored by organizations Challenge s • Generally low user control •Centralized risk and •Generally low user control •High technical and legal •Complex Governance model •Complex liability
  • 30.  MyHealth App(s)  Health Portal  Health Locker  Value-Added services FEDERATED ARCHITECTURE OF NDHB WITH BUILDING BLOCKS (CITIZEN ACCESS)
  • 31. FEDERATED ARCHITECTURE OF NDHB WITH BUILDING BLOCKS (LOCAL LEVEL) Local – Public/Private Applications Hospital Information Systems Technology Building blocks Anonymizer Consent Manager Telemedicine Offline tools System of Record (SOR) Data Electronic Medical records Health workers data Lab/ Diagnostics Claims Infrastructure IT Infrastructure at the facility Access to secure health cloud
  • 32. FEDERATED ARCHITECTURE OF NDHB WITH BUILDING BLOCKS (STATE LEVEL) State – Distributed Application Emergenc y care Public health Well applications RCH Insurance Technology Building blocks Health Analytics Consent- Management- as-Service Anonymizer-as-a service System of Record (SOR) Data EHR Nurse/Paramedical Directory NCD registries Infrastructure Security operations Call centers Secure Health Networks Health lockers
  • 33. FEDERATED ARCHITECTURE OF NDHB WITH BUILDING BLOCKS (NATIONAL LEVEL) National Level Application Medical Edunet National Programs Health research Common Reusable application Technology Building blocks Health Analytics (N) Health information exchange Clinical Decision Support (CDS) GIS tools System of Record (SOR) Data PHI/UHID Facilities Directory Doctors Directory Repository of standards/ APIs/ Metadata/ Data dictionaries Infrastructure Secure Health Network (N) Privacy Ops Center Security Ops Center Health App store
  • 34. UNIQUE HEALTH ID (UHID)  To standardize the process of identification of an individual at any point  Only way to ensure medical related records are issued to correct individuals  System will collect certain basic details  Demographic and location, contact details  Ability to update contact information
  • 35. ELECTRONIC HEALTH RECORDS (EHR)  The EHR is created only after consent is sought from the user  To generate and aggregate health records for person  Individual can share medical records with other health provider as per consent framework  Data related to significant medical and health conditions, episodes and events  Digi Locker system
  • 36. MISTAKES TO BE AVOIDED IN DESIGNING EHR  Incorrect Identification  Incorrect Medical History  Incorrect Lab/Diagnostic results  Incorrect Drug Info
  • 37. HEALTH LOCKER  With interoperability specification  When a medical record needs to be issued, only a reference link shared with the locker ecosystem  Small clinics/ hospitals are expected to subscribe to the authorized repository providers who can integrate with the health locker to be able to participate in this ecosystem
  • 38. HEALTH DIRECTORIES AND HEALTH REGISTRIES  Health Directories play a key role in the health ecosystem  They hold the mater data of various entities  Must adhere to principle of being the “Single source of truth”  Directories related to professionals must enable Identity and Access Management (IAM) for health applications that adopt the blueprint  Health applications must be able to verify the identity of a doctor using the registries, allow them access to records that they have authorized for.
  • 39. HEALTH DIRECTORIES AND HEALTH REGISTRIES  Facilities Directory – Unique identifier for each health facility – Hospitals, Clinics, Diagnostic centers, Pharmacies  Doctors Directory – doctor who has registered with the medical council after completion of their education. Provision of Update  Nurses & Paramedical Directory – Nurses, ANMs, Ophthalmic technicians, OT technicians etc.  Health Workers Directory – ASHA  Allied Professionals Directory – Health IT, Masters in Hospital Administration, Disease Coders, Pradhan Mantri Arogya Mitras, etc.
  • 40. ANONYMIZER  Anonymization – Irreversible process of transforming or converting personal data to a form in which a data owner/ citizen cannot be identified (One-way process)  De-identification – Reversible process, whereby re-identification by competent authority is possible for specific purposes  Data is anonymized at the primary source of its capture and retention, mostly at the facility level, to minimize its leakage while in transit  Facility level – Infrastructure ? / Capacity ?  “Anonymize-as-a-Service” @ Intermediate (State) layer
  • 41. CONSENT MANAGER  Every access to each record requires explicit consent of the individuals (Data Principal)  Electronic consent framework specification by MeitY  Goal – To ensure that the citizen/ patient as the data principal, is in complete control of what data is collected, and how/ with whom it is shared and for what purpose, and how it is processed  Applicable both on longitudinal (Over a period of time) and vertical (relating to an episode)
  • 42. HEALTH INFORMATION EXCHANGE (HIE)  Real time data exchange by implementation of Open APIs and other exchange mechanism  For application access, to submit or retrieve or access any information registration is required with Health Information Exchange  HIE would be responsible for responsible for authentication and authorization of all data exchanges requests
  • 43. STANDARDS AND REGULATIONS Areas chosen to define Standards for NDHB Consent Consent for data collection and data use Content & Interoperability Standards related to exchange of Healthcare data Privacy and Security Standards related to data privacy and Security of data @rest and @motion and data immutability Patient Safety & Data Quality While collecting data and quality of data captured
  • 44. STANDARDS AND REGULATIONS Standards for NDHB Consent Management ISO/TS 17975:2015 Content Framework Electronic Consent Framework (TS v1.1) with its subsequent revision published by MeitY Technical Interoperability IndEA (Indian Enterprise Architecture ) Frame work Structured Clinical Information exchange Fast Healthcare Interoperability Resource (FHIR) R4 (subject to section 3.4.2)
  • 45. STANDARDS AND REGULATIONS Standards for NDHB Still Images/ Documents/ Audio/ Video Still image – JPEG Document/Scan : PDF A -2 Audio: MP3/ OGG Video: MP4/ MOV (embedded as binary content in relevant FHIR resource) Diagnostic Images DICOM PS3.0-2015c
  • 46. Standards for NDHB Terminology/ Vocabulary SNOMED CT (for all clinical terminology requirements in health records) Coding System WHO ICD-10 (for statistical classification of diseases and related health problems) LOINC (for observation, measurement, test-panels, test items and units) Security Digital Certificate, TLS / SSL, SHA – 256, AES – 256 Access Control ISO 22600:2014 Health informatics – Privilege Management and Access Control STANDARDS AND REGULATIONS
  • 47. REGISTRIES FOR NCDS  National cancer registry maintained by ICMR and other diseases registries maintained in India are not interoperable and not integrated with HIMS  NDHB make them integrated and interoperable
  • 48. DATA ANALYTICS  @ State and National level  For analysis of aggregated data set  Data will send to one or more government-controlled analytics
  • 50. PUBLIC CONSULTATION 1. National health authority gave only 21 days for Public consultation on Health data management policy in NDHM (Till 3rd September) 2. The consultation document was only available in English 3. The consultation process was entirely online. Only 54% of the Indian population has access to internet 03/04/2020
  • 51. CRITICAL REVIEW  Health is a state subject within Federal structure of Indian Constitution  The state would need to be consulted in it. The state would be critical actors in hosting and using data & would also have the legal right to regulate it  Draft is not specifying  Who will be the “Consent Managers”  Who are the “Health Information user” – WILL THERE BE PRIVATE PARTIES ?  Whether the financial or benefit schemes will be linked here? Whether the citizen need to apply separately or it will happen automatically?
  • 52. DATA PROTECTION LAW IN INDIA  India has not yet enacted specific legislation on data protection  However Indian legislature did amend the IT Act 2000 to include section 43A and 72A, which give right to compensation on improper disclosure of personal information  Puttaswami’s Judgement 2017 – Supreme court of India has recognized the “right of privacy” as fundamental right under Article 21  Personal Data Protection, 2019 – drafted by Justice BN Srikrishna’s committee, Right to be forgotten, Jurisdiction of Bill - both territorial and extra-territorial, applying both to private and governmental sector, Critical personal data should be processed only in India, Provision of Data protection authority
  • 56. LINKAGE OF AADHAAR DATA WITH BIRTH & DEATH REGISTRATION (HARYANA STATE)
  • 57. TELEMEDICINE PRACTICE GUIDELINE (PAGE NO. 11) 25/03/2020 Data Security ?
  • 59. MY 2ND UNIQUE HEALTH ID

Editor's Notes

  1. Population 13.2 Lakhs
  2. X – Road = Centrally managed distributed data exchange layer between information systems Block chain = Decentralized, distributed ledger that records the provenance of digital asset E-Governance = application of IT for delivering government services I voting = internet voting Mobile id = allows people to use a mobile phone as secure digital id
  3. Kijsanayotin, Boonchai. (2017). Thailand’s national IDs as a foundation for universal health coverage and healthcare delivery. Third meeting of the Regional Steering Group on Civil Registration and Vital Statistics in Asia and the Pacific, 19 October 2017, Bangkok, Thailand.
  4. PMMVY – Pradhan Mantri Matri Vandana Yojana JSY – Janani Suraksha Yojana
  5. MeitY – Ministry of Electronics and and information Technology
  6. Europe – GDPR – general data protection regulation HIPAA – Health Insurance Portability and Accountility Act