Health Policy and Technology 10 (2021) 16–20

Contents lists available at ScienceDirect

Health Policy and Technology

journal homepage: www.elsevier.com/locate/hlpt

Commentary

Integrating technology, innovation and policy: COVID-19 and HTA

Kanchan Mukherjee∗
Centre for Health Policy, Planning and Management, School of Health Systems Studies, Tata Institute of Social Sciences, India

a r t i c l e i n f o a b s t r a c t

Article history: Scientific abstract: The ongoing pandemic of the corona virus disease 2019 (COVID-19) has adversely af-
Available online 4 February 2021 fected the health and wealth of nations worldwide. While this negative impact is very visible, it has
also resulted in subtle positive growth of innovative health technologies. This article identifies the critical
Keywords:
FELUDA role of Health Technology Assessment (HTA) in analyzing innovations in health technology, using a case
Institutional voids study from India. The first HTA on COVID-19 health technology from India, using the framework from
SARS-CoV-2 the recent HTA definition, conducted on the innovative FNCAS9 Editor-Limited Uniform Detection Assay
Public health (FELUDA) diagnostic test shows the potential of HTA in health innovations in low and middle-income
Health innovation system country (LMIC) settings. Hence, while COVID-19 has opened windows of opportunities for health innova-
Health technology assessment tion and entrepreneurship worldwide, HTA can play a critical role in ensuring the smooth confluence of
India technology, innovation and policy to ensure the positive impact of health innovation in addressing this
Entrepreneurship
pandemic and beyond. An integrated systems framework linking HTA with health innovation ecosystem
Startups
Science
is presented to conceptualize this link.
Cost effectiveness Public interest abstract: The use of HTA for assessing impact of health innovations has been extremely
Health system low in India and other LMICs. The World Health Organization (WHO) in its definition of health inno-
Diagnostic test
vations considers optimizing or improving performance of the health systems as the overarching goal of
Testing policy
health innovation. The new definition of HTA also explicitly links the goals of HTA with that of the health
LMIC
Healthcare systems objectives of efficiency, equity and quality. Technology embodies applicable knowledge that arises
Disruptive technology out of science, but not all technologies add value to health systems. In this case study, innovation was
Integrated systems framework applied to create a novel technology (FELUDA) to address a void in testing capacity, while HTA was a tool
used to assess the impact of this technology for health system and provide evidence for policy. This case
study shows the potential for HTA to guide efficient, equitable and ethical policies for societal benefit.
It is important that policy makers in LMICs recognize the role of HTA in assessing the value of health
innovations and streamline policies based on evidence. A systems approach to HTA and health innovation
is needed for optimizing the use of HTA in health innovations.
© 2021 Fellowship of Postgraduate Medicine. Published by Elsevier Ltd. All rights reserved.

Context 3. Enforcement/recourse mechanisms

The corona virus disease 2019 (COVID-19) has widened the
chasm of institutional voids already existing within the Indian so-
ciety. A void is essentially a roadblock to buyer-seller interaction
[1]. While these voids cut across all sectors, in the context of
healthcare sector, it would include gaps in patient/consumer – doc-
tor/provider interactions. Some of the key healthcare voids exposed
through the COVID-19 pandemic include [1]:
1. Absence or missing reliable, accessible, credible information
2. Information on quality and availability of providers
∗
Corresponding author at: Centre for Health Policy, Planning and Management,
School of Health Systems Studies, Tata Institute of Social Sciences, V.N. Purav Marg,
India.
E-mail address: kanch@tiss.edu
4. Quality of facility, test, equipment, medicines, etc.
Although institutional voids are impediments to effective trans-
actions and the spread of beneficial services (such as reliable
healthcare), they are also opportunities for entrepreneurship and
innovations. Health innovation is to develop and deliver new or
improved health policies, systems, products and technologies, and
services and delivery methods that improve people’s health and
wellbeing [2]. Health innovation has the potential to respond to
unmet public health needs by creating new ways of thinking and
working with a focus on the needs of vulnerable populations.
COVID-19 has opened a window of opportunity for innova-
tions across multiple sectors. One of the biggest drivers of this
innovation is health technology, which is very broadly defined.
Within this technology dimension lies the spectrum of health sys-
tem interventions, which include prevention or health promotion

https://doi.org/10.1016/j.hlpt.2021.01.003
2211-8837/© 2021 Fellowship of Postgraduate Medicine. Published by Elsevier Ltd. All rights reserved.
K. Mukherjee
strategies, diagnostic and therapeutic strategies, as well as com-
plex strategies such as organization of healthcare delivery. How-
ever, all technologies may not be safe, efficient or sustainable. With
a plethora of technologies being developed to address the COVID-
19 situation, the role of Health Technology Assessment (HTA) in
addressing medical, ethical, economic and social implications of a
policy decision becomes even more important. A new definition
of HTA has emerged recently, which provides a framework with
a global consensus. It defines HTA as a “multidisciplinary process
that uses explicit methods to determine the value of a health tech-
nology at different points in its lifecycle with the purpose to in-
form decision-making in order to promote an equitable, efficient,
and high-quality health system” [3]. However, while the use of HTA
to inform policy decisions is well established in the high- income
and upper-middle- income countries, its use and application in
health systems has been limited in low and middle-income coun-
tries (LMICs) [4,5]. In the above context, this commentary aims to:
1. Describe the role of HTA in assessing health innovations, using
a case study from India of an innovative COVID-19 diagnostic
test.
2. Discuss the use of technologies and HTAs in health systems of
LMICs
3. Present an integrated systems framework of HTA within a coun-
try’s health innovation ecosystem to address health system
challenges and voids.
Health innovations to address COVID-19 in India
With the COVID-19 pandemic hitting India hard especially in
economic hotspots like Mumbai, [6] and health systems strug-
gling to cope, innovation and entrepreneurship have emerged as
hotspots of action. There has been a number of initiatives to en-
courage and fast track startups innovating to address the dimen-
sions of care associated with COVID-19. The Department of Science
and Technology (DST) launched the Centre for Augmenting War
with COVID-19 Health Crisis (CAWACH) in April 2020 to source and
support startups offering solutions to fight the pandemic. CAWACH
along with its affiliated and satellite centers have selected 51 star-
tups for funding [7]. The Centre for Cellular and Molecular Plat-
forms (C-CAMP), conceptualized by the Department of Biotechnol-
ogy (DBT), initiated its COVID-19 Innovations Deployment Acceler-
ator (CCIDA), a day into the national lockdown, in partnership with
multiple partners [8]. CCIDA has selected 30 startups to help In-
dia fight COVID-19. Venture Centre (India’s largest inventive enter-
prises and science business incubator), an initiative of the Coun-
cil of Scientific and Industrial Research (CSIR), as part of its ‘war
against COVID-19’ has identified 25 startups [9]. The selected star-
tups from all these agencies function in a plethora of domains
such as rapid diagnostics, therapeutic approaches, assisted venti-
lation, cold chain viral transport, peripheral medical devices, per-
sonal protective equipments, air and surface sterilizers and dis-
infectants, digital technology, automated face masks manufactur-
ing and control of viral contamination in waste water. Although
not exhaustive, the above examples indicate that favourable policy
initiatives can create the necessary creative collaboration among
stakeholders for a common cause. However, identifying and vali-
dating innovations in a laboratory isn’t enough. It is important to
understand whether, and how, these innovations can add value to
the health system in an efficient and equitable manner. Hence, the
bigger question remains whether these innovations can address the
challenges of implementation, scalability and sustainability in the
health system. It is in this specific area that HTA can play a criti-
cal role in linking science, innovation, technology and policy. In the
subsequent sections, using the learnings from a case study in India
and examples from other LMICs, a systems framework is presented
17
Health Policy and Technology 10 (2021) 16–20
to describe how HTA can be leveraged to create this link and ad-
dress long-term health system challenges and voids.
The FELUDA case study
There is a big gap in the use of HTA for health innovations to
guide policy decisions in India. Among the large number of innova-
tions mentioned above, till date, HTA has been conducted on only
one COVID-19 innovation to assess its implications on the health
systems. This first HTA on a COVID-19 health technology innova-
tion from India was conducted on FNCAS9 Editor-Limited Uniform
Detection Assay (FELUDA) diagnostic test [10]. Using the frame-
work from the recently developed HTA definition described above,
[3] the available data was used to do a comparative assessment of
the potential impact of the FELUDA test on health systems in the
dimensions of efficiency, equity and quality as well as the impact
on ethical and social issues raised by the current testing strategy
in India. Three testing scenarios in India were compared in this as-
sessment [11].
Scenario I: Earlier testing policy through RT-PCR (Reverse
Transcriptase-Polymerase Chain Reaction)
Scenario II: Current testing policy (RADT + RT-PCR) (Rapid anti-
gen detection test +RT-PCR)
Scenario III: FELUDA as a new testing policy
While RT-PCR is the gold standard and was the only testing
strategy from the beginning of the pandemic in India, an advi-
sory on new additional strategies for COVID-19 testing was issued
on June 23, 2020, which allowed Indian states and union territo-
ries (UT) to do a rapid point-of-care antigen detection test (RADT)
for SARS-CoV-2 [12]. The RADT approved in India has shown to be
highly specific, but only moderately sensitive [12]. Hence, the test-
ing protocol [12] included a RT-PCR test to be performed for all the
symptomatic negatives of the RADT in order to avoid false nega-
tives, which can be very high in this rapid test. Since the RADT
requires much less resources and can be done faster, a large num-
ber of states and UT have shifted to this mode of testing after the
issue of this advisory. However, there are reports, studies and ad-
visories to show that compliance with doing the RT-PCR to rule
out false negatives is extremely low and the use of RT-PCR has
either stagnated or fallen during this period [13,14]. Hence, by re-
porting SARS-CoV-2 negative cases only on the basis of the RADT, a
large proportion of actual cases (false negatives) are being missed,
which has affected the quality of the testing. This has also raised
social and ethical concerns in two ways. First, infected individuals
are given a false sense of security through a negative RADT and re-
main outside of the test-isolate-trace/treat strategy with the poten-
tial to further spread the infection. Second, due to the current un-
derestimation of actual cases, the data used for future decisions on
lockdown/unlock policies will not be an accurate one [11]. Given
the above context, and the availability of the FELUDA test in Oc-
tober 2020, the HTA was conducted on the FELUDA test. The as-
sessment showed FELUDA to be less costly and equally effective as
compared to the RT-PCR (Table 1) [11]. Hence by incorporating it
in the testing strategy, the health system would save costs, ensure
effectiveness, improve quality of testing and be more efficient. The
FELUDA test being much cheaper than RT-PCR and not requiring
specialized labs (Table 1), would be more affordable and accessible,
and hence would help decrease the inequity in testing that exists
in the context of the current testing policy. By avoiding the need
to do a follow-up RT-PCR, it would address the ethical and social
issues arising out of the improper implementation of the current
testing protocol. The assessment also recommended future HTAs
in the lifecycle of FELUDA using field -level effectiveness data to
inform future decisions on the use of this technology [11].
K. Mukherjee Health Policy and Technology 10 (2021) 16–20

Table 1
HTA key findings on COVID-19 diagnostic tests in India [11].

Cost of testing per day

based on new tests/day Sensitivity and
Testing policy and smoothed and current Time taken to give Specificity
diagnostic tests average market price results (Lab data) Additional findings Comparative Analysis

Requires expensive equipment and

RT-PCR∗ INR 2.2 Billion 90 minutes Sensitivity- 95% reagents, skilled personnel and High on cost and high
test (USD 30 million) Specificity-99% specialized laboratories. Imports on effectiveness
(Previous testing policy) involved.
Requires less specialized chemicals,
RAT∗∗ INR 1.3 Billion 30 minutes Sensitivity- equipment and skills. Imports High on costs and low
+ RT-PCR (USD 17.7 million) 50-84% involved initially. Field sensitivity on effectiveness
(Current testing policy) Specificity- reported to be 50-60%. Adjunct
99-100% RT-PCR required to rule out false
negatives, but implementation of
follow up RT-PCR is poor, thereby
increasing societal costs, social and
ethical issues
Quicker turnaround time, less
FELUDA INR 0.5 billion 45 minutes Sensitivity- 96% expensive equipment and reagents Low on cost and high
(Innovative technology) (USD 6.8 million) Specificity- 98% involved. Does not require on effectiveness
specialized lab or skilled personnel
Not dependent on imports
∗
RT-PCR= reverse transcriptase polymerase chain reaction.
∗∗
RAT= rapid antigen test.

Although limited in scope due to data constraints, this HTA
case study provided evidence to policy makers on the value of in-
novative health technologies to health systems. The RADT (which
was also an innovative technology) was costlier, less effective and
poorly implemented. This affected the testing quality and relia-
bility of information, and thus contributed to institutional voids
rather than addressing it. With its scaling up and increasing use
across India, it was inefficient and in the long run would be less
sustainable for the health systems. The FELUDA test was cheaper,
more effective and could be easily implemented. The current data
suggests that its scaling-up would lead to efficiencies of scale and
would be more sustainable for the health system in the long run
to address voids.
HTA and technologies in LMICs
With the COVID-19 pandemic and the increasing number of
technologies being developed, a large number of technologies
are expected to reach the LMICs. The World Health Organization
(WHO) through its Access to COVID-19 tools (ACT) accelerator has
facilitated a global collaboration with over 30 global health ex-
pert partners for availability of affordable, high-quality COVID-19
rapid tests for six months to enable expansion of testing in coun-
tries where implementation of RT-PCR tests is difficult [15]. Also,
efforts are being made to increase local manufacturing capacity
for COVID-19 and other diagnostics in these countries. In resource
constrained settings, such innovations are a response to an unmet
public health need, and HTA becomes a useful tool to assess the
value of these and future technologies holistically for the health
systems. The use of HTA, though currently limited, is increasing in
LMICs, and HTA agencies in these countries are being represented
in international HTA networks like HTAsia link, Health technology
Assessment International (HTAi), International Network of agencies
for HTA (INAHTA), etc. Ten HTA agencies from six LMICs in Asia
(Bhutan, India, Indonesia, Philippines, Sri Lanka and Vietnam) are
currently members of HTAsia link [16]. HTA for interventions in
health systems have been conducted in India for diseases like HIV,
[17] TB, [18] Haemophilia [19] and hospital information systems
technology [20]. Afghanistan has reported the use of HTA for reg-
ulatory and reimbursement decisions, [21] while informal HTA has
been reported from Vietnam [21].
Among the LMICs in the African region, HTA on the relevance
of rapid diagnostic test and its possible role in COVID-19 manage-
ment strategy was performed to provide recommendations to the
Ministry of Health in Tunisia [22]. While Tanzania used HTA for
revision of its essential medicine list, [23] Rwanda and Ethiopia
have used HTA for regulatory, formulary and reimbursement activ-
ities [21]. LMICs are faced with limited healthcare budgets. Hence,
policies based on evidence-based prioritization of healthcare needs
and HTA help to improve the functioning of health systems and
progress towards Universal Health Coverage (UHC) [24,25]. Hence,
it is important that policy makers and health system leaders rec-
ognize the important role of creating an equitable, efficient, and
high-quality health system, which can face the threat of pandemics
as well as ensure optimum performance at other times.
Addressing the voids: integrated systems framework of health
innovation and HTA
The health innovation working group of the WHO [2] has
closely aligned the objectives of health innovation with the di-
mensions of UHC, i.e. efficiency, effectiveness, quality, sustainabil-
ity, safety, and affordability of healthcare. Hence, optimizing or im-
proving performance of the healthcare system becomes the over-
arching goal of health innovation [26]. Also, the world is witness-
ing the strengthening of a global health innovation system with
the purpose of filling gaps in science and public health in poor
countries through the affirmation of industrial development net-
works and partnerships that extend beyond national borders [27].
The health innovation system includes the network of institutions
from academia, industry and government, along with the policies
and regulations with a focus on health innovations, in dynamic in-
teraction with the health system [28, 29]. The integration of HTA
into this health innovation ecosystem makes it possible to address
the purpose of filling gaps in health systems performance, and
also the challenges of implementation, scalability and sustainabil-
ity in the health system. The integrated systems framework con-
ceptualizes the interactions between innovative health technolo-
gies, health systems and policies through HTA to address health-
care voids in a health innovation ecosystem within a country con-
text (Fig. 1). Being a part of the larger health innovation ecosystem,
HTA would provide evidence for health policies to adopt or scale

18
K. Mukherjee
Fig. 1. Integrated systems framework of HTA and health innovation.
innovations adding value to health systems or reject innovations,
which do not add value.
While many medical and health technologies create value rel-
ative to costs, the present case study demonstrated that it is not
always true and there is wastage in health spending due to ineffi-
ciency. Noting that the efficient use of resources is a crucial factor
in the sustainability of health systems, the 67th World Health As-
sembly passed a resolution urging member countries to use and
develop capacities to adapt HTA within their national frameworks
in order to reduce such inefficiencies and enhance rational use of
technology [25]. A systems approach to assess the value of heath
innovations would help policy makers to identify if innovations
add value to the health system and reduce voids. One way of
adding value is doing more with existing resources (efficiency),
and HTA is an existing tool for policy makers to prioritize based
on efficiency. The other way to enhance value is by reducing the
wastage in resources, which would have harmful effects on equity.
In that case, evidence from HTA would be able to identify ineffec-
tive health innovations causing ethical and social concerns, for ex-
clusion from the health systems. Both, efficiency and equity gains
would effectively contribute to sustainability by reducing its trade-
offs.
It should also be acknowledged that HTA is not an easy pro-
cess. The process of institutionalizing HTA in a health innovation
ecosystem is dependent upon the social, political, economic, in-
stitutional and cultural context of a particular country, and given
the limited capacities, it is even more challenging in LMICs. How-
ever, the new definition of HTA, with its flexible framework and
scope, provides the potential to adapt it to local contexts and in-
clude relevant actor interfaces (stakeholders), financial interfaces
(cost and funding) and ecosystem interfaces (policies and regula-
tions). The latest definition of HTA [3] links the goals of HTA with
that of health systems objectives (efficiency, equity, quality) and
complements existing models like the TISS university model [5] in
India, which streamlines linkages between research and policy us-
19
Health Policy and Technology 10 (2021) 16–20
ing HTA as a tool for operations research and strategic planning
in health systems. By making equity an explicit goal, HTA would
foster more use of methods and frameworks, which capture equity
dimensions. In addition, the lifecycle approach makes HTA a dy-
namic and evolving process responding to contextual and informa-
tion changes to assess the impact of technology on health systems
over time.
COVID-19 has opened a window of opportunity to make health-
care and health systems a priority in the agenda for policy formu-
lation and implementation in LMICs. However, this window will
close with time and hence, it is imperative that researchers in re-
gional academic and research institutes and health system lead-
ers work together and fast towards addressing the deeper sys-
temic issues and voids exposed by this pandemic. The world is see-
ing an unprecedented movement towards collaboration between
academia, industry and government for development of vaccines,
medicines and diagnostics. A similar movement is needed, focused
towards addressing the systemic issues contributing to institutional
voids and HTA is an existing tool, which could be leveraged for this
purpose through its integration within the national health innova-
tion ecosystem.
Conclusions
The COVID-19 pandemic has exposed the weaknesses in health
systems worldwide. These weaknesses are systemic in nature and
manifest as voids, as described in the beginning of this com-
mentary. The FELUDA technology was the result of an innovation
emerging from an urgent collaboration between public research
institute and private industry facilitated by government policies
within the national innovation ecosystem to address a new void
(testing capacity) created during this pandemic, while the HTA was
able to provide evidence on the value of this technology to the
health system. Hence, the integration of HTA within the health in-
novation ecosystem of a country would help policy makers to shift
K. Mukherjee
from the narrow focus of cost containment to the larger picture of
exploring the potential of adding value to the health system. This
would help address the pre-existing systemic voids of affordability,
accessibility and quality affecting the health systems of countries.
With social distancing norms and lockdown protocols in place,
direct face to face consultations between doctors and patients are
going to be events of the past. Disruptive technologies driven by
technology platforms linking doctors and patients, low-cost med-
ical devices, technology-enabled diagnostics, artificial intelligence
and telemedicine will become the norm rather than exception,
and will shape the future of healthcare. The potential and reach
of technology is enormous, and if tapped constructively and ef-
fectively, it could address issues of efficiency, equity and quality
within health systems. Policy makers and health system leaders
in this region (LMICs) should provide a simple, coherent and au-
tonomous ecosystem of evidence to policy translation across all
stages of policy making (formulation, implementation, monitor-
ing and evaluation), for improving health system performance. The
success of HTA is not in the number of reports or publications pro-
duced, but by its real life application to decisions and actions. HTA
is not just economic evaluation for approval of devices, medicines,
pricing or reimbursement. It is a multidisciplinary approach for
evidence informed decisions in health systems and bridges the
gap between science and policy, a much needed bridge in times
of COVID-19 and beyond. While COVID-19 has integrated public
health and economics in a destructive manner, it also provides an
opportunity to learn the lessons and use this integration construc-
tively by using HTA as an instrument for transformation of health
systems and improving public health, which in turn creates value
for society at large.
Author’s statement
I am the sole author of this manuscript. I have conceptual-
ized, designed, written and revised this manuscript myself. This
manuscript was developed from my PhD research.
Funding
None.
Ethical approval
Not required.
Declaration of Competing Interest
None declared
Acknowledgement
The author thanks Prof. Satyajit Majumdar, Centre for Social En-
trepreneurship, School of Management and Labour Studies at TISS,
Mumbai for his insightful comments and discussions on health in-
novations in India. The author acknowledges the three anonymous
reviewers for their valuable suggestions, which helped in improv-
ing the manuscript.
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