The National Health
Policy 2017 (NHP-2017) of India correctly identified the need for creating many new institutions
like the National Digital Health Authority (NDHA). However, the ground realities don’t
appear to have been considered well enough. Early setting up of a functional
NDHA is essential for India to avoid a digital health mess in future. The first
job for the proposed NDHA will be to formulate a robust National Digital Health
Strategy / Policy, in consultation with all the stakeholders. Caution needs to
be exercised before cross referrals and sharing disparate information among
different systems of medicine. Health informatics education must be embedded as
an integral part for health and hospital management. It may be prudent to include
Health in the Concurrent list of the Constitution of India. That will ensure a
smooth adoption of digital health in India. Seeking comments on the Draft Bill
DISHA (Digital Information Security in Healthcare Act) is a good start.
It has been now more than a year that the (third
edition of the) National Health Policy 2017 (NHP-2017) of India has been notified.
While the accompanying Situation Analysis didn’t mention anything about Digital
Health, the Policy correctly identified the need for creating many new institutions like the National
Digital Health Authority (NDHA).
Now, let us look at where do we stand one year later,
regarding the ushering in of Digital Health in India.
First let us glance at some of the key provisions of
the NHP-2017 as mentioned in the various sections. Just beneath the quotes from
the relevant sections of the NHP-2017, I’m commenting on certain issues for
thought.
2.4.3.3 Health Management Information
a.
Ensure district-level electronic database of information on health system
components by 2020.
b.
Strengthen the health surveillance system and establish registries for diseases
of public health importance by 2020.
c. Establish
federated integrated health information architecture, Health Information Exchanges
and National Health Information Network by 2025.
Comments: The NHP-2017 focuses on Digital technology, right from the beginning.
Some timelines are also proposed here. However, while some states have been
doing very well, some others are lagging. We would further elaborate on this
aspect towards the end.
3.3 Organization
of Public Health Care Delivery:
For effectively handling medical disasters and health security, the policy
recommends that the public healthcare system retain a certain excess capacity
in terms of health infrastructure, human resources, and technology which can be
mobilized in times of crisis.
In order to leverage the pluralistic health care
legacy, the policy recommends mainstreaming the different health systems. This
would involve increasing the validation, evidence and research of the different
health care systems as a part of the common pool of knowledge. It would also
involve providing access and informed choice to the patients, providing an
enabling environment for practice of different systems of medicine, an enabling
regulatory framework and encouraging cross referrals across these systems.
Comments: Here there is a need for more caution since the other streams of
medicine – viz., Ayurveda, Yoga and Naturopathy, Siddha, Unani and Homeopathy,
follow entirely different principles from those followed by modern medicine.
Therefore, cross referrals may add to the complexity and confusion, ultimately
harming the patient.
11.1
Medical Education:
The policy recognizes the need to revise the under graduate and post graduate
medical curriculum keeping in view the changing needs, technology and the newer
emerging disease trends.
Comments: There have been a lot of issues regarding the Medical Council of India
and the National Board of Examinations in the past, followed by a proposed
revamping through the National Medical Commission. Despite all the proposed
changes, one of the essential features that is amiss is the incorporation of
health informatics essentials in all branches of health professional education.
Without doing that, a smooth adoption of digital health is extremely difficult.
11.8 Public Health Management Cadre: The
policy proposes creation of Public Health Management Cadre in all States based
on public health or related disciplines, as an entry criteria.
Comments:
In continuation of
the previous section, health information management must be embedded as an
integral part for health and hospital management. Health Informatics weds both
health information technology and health information management. Scaling up,
public health informatics combines health informatics and population
demographics.
13.12: Health
Information System: The objective of an integrated health information
system necessitates private sector participation in developing and linking
systems into a common network/grid which can be accessed by both public and
private healthcare providers. Collaboration with private sector consistent with
Meta Data and Data Standards and Electronic Health Records would lead to
developing a seamless health information system. The private sector could help
in creation of registries of patients and in documenting diseases and health events.
Comments:
Most of the times
various health information systems don’t talk to each other and therefore there
is a dire need of Standards for interoperability. I would discuss this issue in
greater details this issue towards the end, where I would talk about the
Clinical Establishments Act.
14.2: Regulation
of Clinical Establishments: A few States have adopted the Clinical
Establishments Act 2010. Advocacy with the other States would be made for
adoption of the Act. Grading of clinical establishments and active promotion
and adoption of standard treatment guidelines would be one starting point.
Protection of patient rights in clinical establishments (such as rights to
information, access to medical records and reports, informed consent, second
opinion, confidentiality and privacy) as key process standards, would be an
important step. Policy recommends the setting up of a separate, empowered
medical tribunal for speedy resolution to address disputes /complaints
regarding standards of care, prices of services, negligence and unfair
practices. Standard Regulatory framework for laboratories and imaging centers,
specialized emerging services such as assisted reproductive techniques,
surrogacy, stem cell banking, organ and tissue transplantation and Nano Medicine
will be created as appropriate.
Comments:
Discussed below
separately.
14.5: Medical
Devices Regulation: The policy recommends strengthening regulation of
medical devices and establishing a regulatory body for medical devices to
unleash innovation and the entrepreneurial spirit for manufacture of medical
device in India. The policy supports harmonization of domestic regulatory
standards with international standards. Building capacities in line with
international practices in our regulatory personnel and institutions, would
have the highest priority. Post market surveillance program for drugs, blood
products and medical devices shall be strengthened to ensure high degree of
reliability and to prevent adverse outcomes due to low quality and/or
refurbished devices/health products.
Comments: Medical
Devices Rules, 2017 that has come into force with effect from 1st day
of January, 2018, has included in the Part-I of the first schedule Parameters for classification of medical
devices other than in vitro diagnostic
medical devices. There, Software as Medical Device (SaMD) is defined as:
(iii) Software, which drives a device or influences the use of a device,
falls automatically in the same class. This
is indeed a very forward looking and welcome legislation, ahead of the times in
our country.
22: Health
Technology Assessment: Health Technology assessment is required to ensure
that technology choice is participatory and is guided by considerations of
scientific evidence, safety, consideration on cost effectiveness and social
values. The National Health Policy commits to the development of institutional
framework and capacity for Health Technology Assessment and adoption.
Comments:
We can combine
these aspects with the digital health technology, described in the next
section.
23:
Digital Health Technology Eco - System: Recognising the integral role of
technology(eHealth, mHealth, Cloud, Internet of things, wearables, etc) in the
healthcare delivery, a National Digital Health Authority (NDHA) will be set up
to regulate, develop and deploy digital health across the continuum of care.
The policy advocates extensive deployment of digital tools for improving the
efficiency and outcome of the healthcare system. The policy aims at an
integrated health information system which serves the needs of all
stake-holders and improves efficiency, transparency, and citizen experience.
Delivery of better health outcomes in terms of access, quality, affordability,
lowering of disease burden and efficient monitoring of health entitlements to
citizens, is the goal. Establishing federated national health information
architecture, to roll-out and link systems across public and private health
providers at State and national levels consistent with Metadata and Data
Standards (MDDS) & Electronic Health Record (EHR), will be supported by
this policy. The policy suggests exploring the use of “Aadhaar” (Unique ID) for
identification. Creation of registries (i.e. patients, provider, service,
diseases, document and event) for enhanced public health/big data analytics,
creation of health information exchange platform and national health
information network, use of National Optical Fibre Network, use of
smartphones/tablets for capturing real time data, are key strategies of the
National Health Information Architecture.
23.1 Application of Digital Health: The
policy advocates scaling of various initiatives in the area of
tele-consultation which will entail linking tertiary care institutions (medical
colleges) to District and Sub-district hospitals which provide secondary care
facilities, for the purpose of specialist consultations. The policy will
promote utilization of National Knowledge Network for Tele-education, Tele-CME,
Tele-consultations and access to digital library.
23.2 Leveraging Digital Tools for AYUSH: Digital
tools would be used for generation and sharing of information about AYUSH
services and AYUSH practitioners, for traditional community level healthcare
providers and for household level preventive, promotive and curative practices.
Comments: This
is a very correct decision and the first job for the proposed NDHA will be to
formulate a robust National Digital Health Strategy / Policy, in consultation
with all the stakeholders. The first constituents of the Authority will lay
down the rules of the game as to how will digital health be adopted in India.
The earlier the NDHA is set up and functional, the better it will be for India
to avoid a digital health mess in future. Any delay in the process might make
us deal with non-interoperable legacy systems, as has been the case in many
developed nations. However, cross referrals and sharing disparate information
among different systems of medicine may add to the complexity and confusion,
ultimately harming the patient. Currently, the MoHFW is seeking comments on the
proposed DISHA (Digital Information Security in Healthcare Act) that will be
the Bill setting up the NDHA / NeHA.
25.
Health Research: The
National Health Policy recognizes the key role that health research plays in
the development of a nation’s health. In knowledge based sector like health,
where advances happen daily, it is important to increase investment in health
research.
25.1
Strengthening Knowledge for Health: The
policy envisages strengthening the publicly funded health research institutes
under the Department of Health Research, the apex public health institutions
under the Department of Health & Family Welfare, as well as those in the
Government and private medical colleges. The policy supports strengthening
health research in India in the following fronts- health systems and services
research, medical product innovation (including point of care diagnostics and
related technologies and internet of things) and fundamental research in all
areas relevant to health- such as Physiology, Biochemistry, Pharmacology,
Microbiology, Pathology, Molecular Sciences and Cell Sciences. Policy aims to
promote innovation, discovery and translational research on drugs in AUSH and
allocate adequate funds towards it. Research on social determinants of health
along with neglected health issues such as disability and transgender health
will be promoted. For drug and devices discovery and innovation, both from
Allopathy and traditional medicines systems would be supported. Creation of a
Common Sector Innovation Council for the Health Ministry that brings together
various regulatory bodies for drug research, the Department of Pharmaceuticals,
the Department of Biotechnology, the Department of Industrial Policy and
Promotion, the Department of Science and Technology, etc. would be desirable.
Innovative strategies of public financing and careful leveraging of public
procurement can help generate the sort of innovations that are required for
Indian public health priorities. Drug research on critical diseases such as TB,
HIV/AIDS, and Malaria may be incentivized, to address them on priority. For
making full use of all research capacity in the nation, grant- in- aid
mechanisms which provide extramural funding to research efforts is envisaged to
be scaled up.
25.2 Drug
Innovation & Discovery: Government
policy would be to both stimulate innovation and new drug discovery as
required, to meet health needs as well as ensure that new drugs discovered and
brought into the market are affordable to those who need them most. Similar
policies are required for discovering more affordable, more frugal and
appropriate point of care diagnostics as also robust medical equipment for use
in our rural and remote areas. Public procurement policies and public
investment in priority research areas with greater coordination and convergence
between drug research institutions, drug manufacturers and premier medical
institutions must also be aligned to drug discovery.
25.3
Development of Information Databases: There
is also a need to develop information data-bases on a wide variety of areas
that researchers can share. This includes ensuring that all unit data of major
publicly funded surveys related to health, are available in public domain in a
research friendly format.
25.4 Research Collaboration: The
policy on international health and health diplomacy should leverage India’s
strength in cost effective innovations in the areas of pharmaceuticals, medical
devices, health care delivery and information technology. Additionally
leveraging international cooperation, especially involving nations of the
Global South, to build domestic institutional capacity in green-field
innovation and for knowledge and skill generation could be explored.
Comments: For
health research and innovation the government’s role of encouraging Standards
for interoperability and allowing open data for analysis will go a long way.
Apart from the NHP-2017, there are certain existing
legislations that affects the adoption of digital health in India. The first
and foremost is the 2012 Amendments of the Clinical Establishments Act 2010.
The other guidance comes from the Constitution of India. Both of these are
discussed below.
Clinical Establishments
(Registration and Regulation) Act (CEA): In 2012, the MoHFW
amended the CEA (2010) and added Clause “9 (iv): the clinical establishments
shall maintain and provide Electronic Medical Records (EMR) or Electronic
Health Records (EHR) of every patient as may be determined and issued by the
Central Government or the State Government as the case may be, from time to
time”.
Comments: The
Act has taken effect in the four states namely, Arunachal Pradesh, Himachal
Pradesh, Mizoram, Sikkim, and all Union Territories since 1st March,
2012 vide Gazette notification dated 28th February, 2012. The states of Uttar
Pradesh, Uttarakhand, Rajasthan, Jharkhand, Bihar and Assam have adopted the
Act under clause (1) of article 252 of the Constitution.
The
Ministry has notified the National Council for Clinical Establishments and the
Clinical Establishments (Central Government) Rules, 2012 under this Act vide
Gazette notifications dated 19th March, 2012 and 23rd May,
2012 respectively.
The
Act is applicable to all kinds of clinical establishments from the public and
private sectors, of all recognized systems of medicine including single doctor
clinics. The only exception will be establishments run by the Armed forces.
The
good point is the enactment of the necessity for EMR / EHR. The Ministry of
Health and Family Welfare has been notifying Standards for EHR since August
2013 and the second edition of the Guidelines were notified in December 2016. That is the right way to move forward. However,
Health being a State subject, not all the states are equally keen to adopt it.
Concurrent
List:
The seventh schedule of the Constitution of India lists “Health” (Public health
and sanitation; hospitals and dispensaries) under the Item 6 of List-II (State
list). As expected, like the Union ministry, health ministers of various states
have also agreed to equipping PHCs and CHCs with
latest technology.
Comments: However, as seen in the previous
section, the CEA has not yet been adopted by most of the states of India.
Therefore, although the CEA mandates EMR / EHR, most of the states are not yet
bound to follow it. Since Health is neither in the Union list, nor in the
Concurrent list, it may be prudent to include it in the Concurrent list. In
that case adoption of digital health would be much smoother.
Conclusions:
While the NHP-2017 is
bold in its thoughts and foresight, for facilitating digital health, the ground
realities don’t appear to have been considered well enough. Early setting up of
a functional NDHA is essential for India to avoid a digital health mess in
future. Inordinate delays might make us deal with non-interoperable legacy
systems. The first job for the proposed NDHA will be to formulate a robust
National Digital Health Strategy / Policy, in consultation with all the
stakeholders. Caution needs to be exercised before cross referrals and sharing
disparate information among different systems of medicine. Health informatics
education must be embedded as an integral part for health and hospital
management. Since Health is neither in the Union list, nor in the Concurrent
list of the Constitution of India, it may be prudent to include it in the
Concurrent list. In that case adoption of digital health would be much
smoother. Seeking comments on the Draft Bill DISHA (Digital
Information Security in Healthcare Act) is a good start.
References:
- Ministry
of Health and Family Welfare, Government of India, National Health Policy 2017:
https://www.nhp.gov.in//NHPfiles/national_health_policy_2017.pdf
(Accessed 19th February 2018)
- Ministry of Health and Family
Welfare, Government of India. Situation Analyses: Backdrop to the
National Health Policy – 2017, New Delhi. Available from : https://mohfw.gov.in/sites/default/files/71275472221489753307.pdf
- Sundararaman
T, National Health Policy 2017: A Cautions Welcome, Indian J Med Ethics. 2017 Apr-Jun;2(2):69-71
- Sarbadhikari
SN. A farce called the National Board of Examinations. Indian J Med Ethics.
2010 Jan-Mar;7(1):20-2
- Thomas G, Medical education in India – the way forward, Indian J Med Ethics. 2016 Oct-Dec;1(4):200
- Government of India, The Gazette
of India, dated 31/01/2017: http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E(1).pdf (Accessed 19th February 2018)
- Government of India, The
Gazette of India, dated 19/8/2010, Clinical Establishments (Registration and
Regulation) Act 2010: http://clinicalestablishments.nic.in/WriteReadData/969.pdf (Accessed 19th
February 2018)
- Government of India, The
Gazette of India, dated 23/5/2012, Clinical Establishments (Registration and
Regulation) Act, (Amendments) 2012: http://clinicalestablishments.nic.in/WriteReadData/386.pdf (Accessed 19th February 2018)
- Ministry of Health and
Family Welfare, Government of India. http://clinicalestablishmentstraining.nic.in/cms/Home.aspx (Accessed 19th February 2018)
- National
Health Portal, Ministry of Health and Family Welfare, Government of India, EHR
Standards: https://www.nhp.gov.in/electronic-health-record-standards-for-india-helpdesk_mty (Accessed 19th February 2018)
- Government of India, The Constitution
of India http://lawmin.nic.in/olwing/coi/coi-english/coi-4March2016.pdf (Accessed 19th
February 2018)
- Press Information Bureau, Government of India, Shri J P Nadda chairs 12th Conference of the Central Council
of Health and Family Welfare to discuss Draft National Health Policy, dated 27/02/2016: http://pib.nic.in/newsite/PrintRelease.aspx?relid=136961 (Accessed 19th February 2018)
- Ministry of Health and
Family Welfare, Government of India. https://mohfw.gov.in/newshighlights/comments-draft-digital-information-security-health-care-actdisha
(Accessed 28th March 2018)
- National Health
Portal, Ministry of Health and Family Welfare, Government of India, EHR
Standards: https://www.nhp.gov.in/ehr-standards-helpdesk_ms
(Accessed 28th March 2018)