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PoweringtheFuture
of Healthcare
in Asia Pacific
How technology will change
healthcare delivery
Powering the Future
of Healthcare in Asia Pacific
The HealthTech Report
Chapter
3
Funding
Data driven
Healthcare
Chapter
2
Big Data and Analytics
Benefits
Legal Point of View:
Data-driven Healthcare
5 Ways Big Data is
Changing Healthcare
Legal Point of View:
Genomics
Legal Point of View:
Telemedicine
What Does Following
Investment Funding
Tell Us?
Opportunities in
Asia Pacific
Biosensing Wearables
Mobile Devices Health
Legal Point of View:
mHealth
Legal Point of View:
Assessing Whether New
Technology is Subject to
Regulatory Compliance
Looking Forward
Legal Point of View:
Funding
Legal Point of View:
Intellectual Property
Why have we commissioned
the report?
The Creative
Destruction
of Healthcare
Chapter
1
Moore’s Law
The Innovator’s
Dilemma
The Healthcare
Revolution
Dramatic Changes in
Healthcare: A Tectonic
Shift
Healthcare’s New
Paradigm
What are the Legal
Consequences of the
Healthtech Revolution?
NEXT ISSUE
Chapter
4
Disruption
in Healthcare
Key trends and innovation momentum
drivers in Asia Pacific healthcare
Preface
The delivery of healthcare is poised for a radical change.
The unparalleled ability to collect, mine and analyse health
data, the increasing sophistication of bio-sensors, and the
exponential rise in the use of smart phone devices provides
opportunities for a radical re-think in how to economically
and efficiently provide healthcare solutions for populations
across Asia Pacific. This will affect healthcare systems
providers as well as individuals. Healthcare resources that
have been constructed largely to treat disease will need
to be re-thought, to take advantage of technologies that
monitor to prevent illness and to intervene early.
Countries across the
region in various stages of
development are grappling
with the possibilities of
this healthtech revolution
and the legacy issues of
twentieth-century healthcare
infrastructure for twenty-
first-century healthcare
solutions. In doing so, many
issues are raised about the
use of new technologies in
healthcare that regulators
lag behind in answering. It is
these issues that we seek to
address.
This digital revolution of
medicine will not only
significantly benefit
developed health systems, but will also allow developing
economies to leapfrog over expensive development
stages to establish better, effective health systems. For
Asia Pacific’s developing economies, following the same
evolutionary steps of developed economies is neither
feasible nor required. It will prove too costly, take too
long and lead to falling into the same pitfalls experienced
by developed health systems. Above all, it fails to take
advantage of the technology innovation that is disrupting the
delivery of healthcare.
The provision of modern-day healthcare across Asia Pacific
concerns all stakeholders such as physicians, patients,
hospitals, investors and ministries of health. The region
faces a considerable public health challenge which is
driving healthcare spending growth faster than GDP growth
and will continue to negatively impact productivity. By 2030,
India stands to lose approximately 18 million potentially
productive years of life due to non-communicable disease-
caused deaths.
Asia Pacific healthcare is a paradox of significant unmet
medical needs compounded by an under-invested and
immature health system infrastructure. It has a large
population that mostly pays for its own healthcare and is
experiencing fast-growing power of purchase, driving the
desire for greater choice and access to health services.
In this era of radical technological change and innovation,
the legal and regulatory landscape is undergoing gradual
transformation and harmonisation. The ASEAN Medical
Device Directive is an example of this. The healthcare
industry now faces the issue of “law lag,” as laws are a
number of steps behind technological advances.
We are seeing common themes emerge across Asia Pacific
in legal developments, with a focus on data protection
laws, the regulation and promotion of medical devices,
and the ability to protect, enforce and commercialise
intellectual property. Governments and legislatures are
charged with the challenging task of balancing the need for
effective regulatory compliance with the need to foster and
accelerate innovation and development, as well as to reduce
overall healthcare costs.
The opportunity to power the future of healthcare in Asia
Pacific through technology innovation will transform the
delivery of better healthcare.
In these pages, we illustrate why we believe Asia Pacific
stakeholders have an unprecedented opportunity and we
propose how this could be achieved.
Ben McLaughlin
Head of Asia Pacific Healthcare Group
Baker & McKenzie
Julien de Salaberry
Founder and CIO
The Propell Group
The Creative
Destruction
of Healthcare
Chapter
1
Considered one of the most
influential economists of the
twentieth century, Joseph
Schumpeter served as Austria’s
finance minister and became a
professor at Harvard University.
In the mid-twentieth century,
Joseph Schumpeter, the
noted Austrian economist,
popularised the term
“creative destruction” to
denote transformation
that accompanies radical
innovation. Over the past
few years, our lives have
been radically transformed
through digital and technology
innovation. But the most
precious part of our existence—
our health—has thus far been
largely unaffected—insulated,
and almost separated from this
digital revolution. Until now.
Medicine is about to go
through its biggest
shakeup in history.
Asia Pacific’s developing
economies face a significant
and growing challenge to
their ambitions to build an
OECD standard of healthcare
infrastructure and delivery. Two
main challenges face these
economies:
The prohibitive cost
of building such a
healthcare system
The increasing disease
burden ranging from
preventable communicable
diseases to the growing
trend in non-communicable
diseases brought on by
ageing and lifestyles
Asia Pacific’s policy makers must
therefore choose between
two options:
The conventional, long,
expensive and unsustainable
road which developed
economies have been
following
Taking full advantage of the
health technology innovations
and new operating models
which are transforming and
will continue to transform
healthcare across the globe
A founding father of Silicon
Valley, Gordon Moore co-founded
chipmaker Intel in 1968.
You can interpret the term
Moore’s Law in two ways. There is
its original meaning, which refers
to the speed at which transistors
on integrated circuits double.
Alternatively, you can use the
term as a metaphor to describe
any form of rapid technological
advancement. In its metaphorical
sense, Moore’s Law is now one
of the most important rules in
business and the economy today.
To borrow words used by
consultancy firm McKinsey:
Moore’s Law
Today, a human genome
can be sequenced in a few hours
and for a few thousand dollars,
a task that took 13 years
and $2.7 billion to accomplish
during the Human Genome Project.
Or to quote Craig Venter—
one of the leading scientists in
the world today—in a lecture he
gave at the BBC in 2007:
The Innovator’s
Dilemma
First published in 1997,
Christensen’s book suggests
that successful companies
can put too much emphasis on
customers’ current needs, and
fail to adopt new technology or
business models that will meet
their unstated or future needs.
He argues that such companies
will eventually fall behind.
Christensen calls the anticipation
of future needs “disruptive
innovation,” and gives examples
such as the personal computer.
Harvard Business School
Professor Clayton Christensen
is the world’s authority on
disruptive innovation and
was named the World’s Most
Influential Business Management
Thinker in 2011 and 2013.
The innovator’s “dilemma” comes
from the idea that organisations
will reject innovations based on
the fact that customers cannot
currently use them, thus allowing
these ideas with great potential
to go to waste.
Asia Pacific has a broad spectrum
of health systems and challenges,
with Myanmar at one end after
decades of under investment,
and Japan the opposite end of the
spectrum, with an OECD-standard
health system.
Whatever the level of maturity
of any Asia Pacific economy’s
health system, we advocate that
all of Asia Pacific’s healthcare
stakeholders need to overcome
their innovator’s dilemma
and take full advantage of the
technological advances that
are shaping the new healthcare
paradigm powered by Moore’s
Law.
Over a short period of time
genome projects, which,
10 years ago required
several years to complete,
now take only days.
He suggested that within half a
decade “it will be commonplace
to have your own genome
sequence, something that just
a decade ago required billions
of pounds and was considered a
monumental achievement.” He
said, “Our ability to read genetic
code is changing even faster than
changes predicted by Moore’s
Law.”
Metaphorical Moore’s Law may
yet prove to be even more extreme
in numerous medical disciplines
such as nanotechnology or
synthetic biology.
Two factors enabling
transformation
of healthcare
Factor 1
Factor 2
1
2
1
2
The innovator’s ‘dilemma’
comes from the idea that
organisations will reject innovations
based on the fact that customers
cannot currently use them, thus
allowing these ideas with great
potential to go to waste.
All figures in this report are in US dollars, unless specified otherwise.
CREATIVE
DESTRUCTION
MOORE’S LAW
1950S 1965
Popularised by Austrian
economist Joseph
Schumpeter, this refers
to the transformation
accompanying radical
innovation.
Intel founder Gordon
Moore’s observation
that computing speeds
double every two years,
an idea that can also be
applied to technology and
economics.
INNOVATOR’S DILEMMA THE HEALTHCARE
REVOLUTION
Coined by Harvard
professor Clayton
Christensen, this refers
to companies rejecting
innovations based on
the fact that they cannot
currently be used, with
the ideas ending up going
to waste.
Dramatic changes of
medicine brought about
by mobile connectivity
and bandwidth, Internet,
social networking,
increasing computing
power and data universe,
information systems,
imaging, genomics and
wireless sensors.
1997 2015
The
Healthcare
Revolution
We are set to see a truly radical
change. Healthcare will focus on
prevention. Up to now, healthcare
has always concentrated on
diseases. We only tend to receive
medical attention if we are ill and
usually rely on symptoms to drive
us to seek a qualified medical
opinion. Technology will be used
to prevent us from becoming
sick. It will enhance us all in
ways that were once thought
to be the exclusive domain of
science fiction.
mobile connectivity
and bandwidth
social networkingInternet increasing computing
power and the data
universe
genomics wireless sensorsinformation systems imaging
Dramatic changes
in healthcare—a tectonic shift
Technologies that will create this
transformation include wearable
technology, genome sequencing,
collection, mining and analysis
of big data, 3-D printing,
nanotechnology, regenerative
medicine, bionic technologies,
and exoskeleton technology, to
name but a few. We will, however,
only consider the most relevant
to Asia Pacific in this report.
Nowadays, diseases that kill us
are rarely epidemics as medicine
has been very good at solving
these; instead, each one of us is
at risk of diseases of lifestyle,
e.g.,Type 2 diabetes (T2D). If
we could only make better
decisions about our lifestyle, we
could eliminate a substantial
number of deaths from modern
conditions. This is even more
applicable in an era where good
and comprehensive information is
available.
Technology is set to enable us to
make these decisions. It will also
enable us to enjoy better, more
customised care and live longer
in the future.
The creative destruction of
healthcare is being driven by
the convergence of the following
factors:
Healthcare, which has to date
been exclusively disease centric,
is now becoming prevention
centric or outcomes driven. In
other words, a health system,
which has so far been entirely
focused and geared to curing
or managing a disease, will
transform into one focused
on prevention of disease. This
type of health system is gaining
increasing traction here in Asia
Pacific with economies such
as Australia, Korea and Taiwan
following the lead of economies
such as the UK, Canada and
Japan where health outcomes,
daily average treatment costs
and cost per QALY (qualified
adjusted life years, which is a
generic measure of disease
burden, including both the quality
and quantity of life lived, and
used to assess the value for
money of a medical intervention)
are being assessed as part of the
holistic healthcare consideration.
These advances can be
categorised into three categories
as follows:
One additional non-data-driven
technology innovation which will
have a positive impact on the
delivery of healthcare in Asia
Pacific is 3-D printing. We will
consider its impact in a later
chapter.
DATA
SHARED
INFORMATION
CLOUD
DEVICES
BIO-SENSORS
The variety, veracity,
velocity and volume
of health data that
is being collated and
analysed to define
actionable insights
The ability of the
computing power
and software on
devices to address
both consumer and
medical needs
The ability to monitor
our bodies and
continuously gather
data about human
biology suggests new
possibilities for both
biomedical research
and clinical practice
Healthcare’s
New Paradigm
In this era of the creative
destruction of medicine, we
are also seeing a gradual
transformation of the legal
landscape in response to radical
innovation in medical and
health technology. Traditionally,
the relationship between
technology and the law has been
underscored by the notion of “law
lag,” meaning that legal cultures
are generally a number of steps
behind technological advances.
This is no different for healthcare,
and is particularly relevant to
big data. The ever-increasing
methods of collecting data,
from mobile phone applications
to biosensing wearables to
telemedicine, will challenge the
traditional concepts of “personal
information,” “consent” and
“medical devices.”
Balancing the desire to
unlock potential against the
requirements for regulatory
compliance is another component
of the Innovator’s Dilemma.
Privacy laws regulate how
organisations collect, store,
use and potentially disclose
“personal information” identifying
individuals. Organisations
must ensure that they comply
with these laws, as the legal
consequences of non-compliance
can be substantial, not to mention
the risk of damage to reputation
in the case of a serious data
breach.
In some cases, the regulatory
compliance regime may restrict
or even prevent innovators from
pursuing new ideas, concepts or
technologies. In the alternative,
it is argued that if individuals
do not trust the effectiveness of
data protection laws, they will
be less likely to engage in digital
healthcare, which could threaten
the highly beneficial applications
of technological advances.
Legal regulation must address
these concerns by adopting
appropriate measures
to protect privacy.
We will introduce our readers
to key regulatory compliance
matters, from data protection
laws to the regulation and
promotion of medical devices.
Moreover, we will consider how
companies can add value to
their assets and businesses
by understanding and utilising
intellectual property rights
protection.
What are the Legal Consequences
of the Healthtech Revolution?
Promoting innovation should be
a central objective of data regulation,
yet the unprecedented ability to
collect, analyse and store vast
amounts of data raises new concerns
about individual privacy rights.
The traditional barriers, created
by the lack of inter-operability
(people, process, information)
between stakeholders, are being
dramatically removed or lowered
by advances in technology.
Ben McLaughlin on key implications of
healthtech for healthcare stakeholders
Data-driven
Healthcare
Chapter
2
Thomas Goetz, author of The
Decision Tree: Taking Control of
Your Health in the New Era of
Personalized Medicine, once said:
He is right. Data is of extreme
importance in the delivery of
a more efficient and effective
healthcare system, and healthcare
is becoming even more accessible
like never before in the history of
humanity.
Firstly, it can be small data,
specific to an individual and used
solely to help people manage their
own health, or enable the doctor,
nurse or caregiver to support them
directly. Wearable technology and
advances in genome sequencing
are creating information that can
ensure that we apply healthcare
technology in the most effective
way.
Alternatively, it can be big data,
used by doctors, health insurers,
hospitals and governments in
the planning and execution of
healthcare.
We can use this data to diagnose
diseases more effectively,
implement superior preventive
healthcare, allocate resources
more efficiently and provide
statistics for epidemiological
analysis.
Big data is being made possible in
part by Moore’s Law, as computers
are able to process more and more
information. The cloud is emerging
as a massive repository of medical
data, which can be accessed
by doctors and other medical
professionals. Supercomputers,
such as IBM’s Watson, are now
enabling deep analysis and
evidence-based reasoning for
more precise diagnosis and clinical
decision-making. IBM’s Watson
is capable of reading millions
of unstructured papers in a few
seconds, which will enable it to
process patients’ electronic health
records, genomics, clinical data
and healthcare professionals’
peer-reviewed publications. It is
also able to monitor real-time
data and new articles as they are
published.
Health insurers are using Watson
to speed pre-approval processes
for patients. Leading teaching
hospitals, such as Mayo Clinic in
the US, began working with IBM
Watson to improve medical school
training, in which they collaborate
to offer doctors real-time analysis
of patient records to improve care.
Mobile applications that allow
doctors and medical practitioners
to look up databases containing
information on thousands
of diseases, including signs,
symptoms and lab findings, are
now a reality. The physician often
has to make a diagnosis based on
patient responses to particular
questions and personal knowledge.
This cannot be infinite, resulting in
a need for additional data points.
These are usually laboratory tests
and/or second opinions from a
peer or a referral. In the future, the
access to a wealth of data, artificial
intelligence (AI) analysis, as well as
peer to peer (P2P) will enable more
accurate diagnosis. For example,
uploading a photo of a skin rash
will generate a more accurate
diagnosis through comparison with
other patient cases and research
databases.
It won’t be long before
technology breakthroughs such
as advanced voice recognition
are used in surgeries and other
medical procedures. MindMeld
has developed an application
that enables doctors or other
healthcare professionals such as
nurses to spend less time behind
their computers, encoding or
retrieving data from electronic
health records, thus allowing more
time to counsel their patients.
Combine this with apps that
support a doctor’s diagnosis by
efficiently and quickly analysing
data from the big data cloud and
the patient’s own sensors and
trackers, and the relevance and
accuracy of diagnosis will improve.
Data gives us information.
Information is vital in the war
against disease and in creating
a healthier society and a more
effective health system. But we
need technologies to implement
the findings of data.
Big Data and
Analytics
“Healthcare isn’t a
science problem, it’s an
information problem.”
Advances in computer
technology have created
major possibilities.
Just as the Internet of Things (IOT)
will provide data to transform
our homes, and just as big data
is revolutionising the world of
marketing, both are providing
mankind with the information
required to radically transform
healthcare.
It will provide doctors with the
tools for predictive analysis.
Natural language processing will
also turn the data into insights
about compliance and behaviour,
and doctors will take data from
individual departmental or
hospital silos and use it to gain
a much deeper insight into the
incidence of a particular disease.
Governments can plan better,
allocating resources according
to need and demand, and budget
more effectively. The result will
be significant. Singapore’s Smart
Nation Vision, which aims to
improve lives and businesses
through technology, comes to
mind. The initiative pulls together
world-ranked universities and
medical facilities, multi-billion-
dollar annual research and
development (R&D) investments,
a fast-growing community of
tech start-ups and large pools of
investment capital to bring about
better lives and greater business
opportunities. Health insurance
companies will be able to define
customised policies and premiums
according to individual risk profile.
Equally, consumers and patients
will gain greater visibility within
the complex health system, giving
them greater access to better-
suited and more affordable health
services. That empowerment will
eventually contribute to reducing
the enormous burden on essential
providers such as hospitals.
McKinsey’s recent analysis of the
potential impact of known big
data and analytics advances on
US healthcare spending estimates
potential savings of up to USD450
billion.
Benefits
The shift in the balance between
disease management and early
intervention will very likely have a
broad beneficial economic impact
on healthcare systems across the globe.
In the age of data-driven
healthcare, the ways in which
organisations can collect, store,
use and potentially disclose
personal or sensitive information
are growing exponentially. The
aggregation and analysis of this
data can have substantial economic
value to those who collect it, and as
we can see in the healthcare space,
even society benefits if it is used
properly. Conversely, this push
towards data-driven healthcare
raises significant privacy concerns,
particularly where there is the
potential for an individual’s
sensitive health information to be
disclosed (e.g., in the case of a
serious data breach).
The use of this sensitive
information is typically baselined
against the consent of the
individual to whom the data
relates, being obtained before it
is used for analytical purposes.
This consent requirement is not
necessarily complementary to the
vision of the benefits flowing from
the use of big data in healthcare.
There are, however, some
examples of health information
being exempt from the privacy laws
for purposes relating to research
and development.
Data protection and privacy laws
across Asia Pacific regulate how
organisations use “personal
data” or “personal information”
identifying individuals. Most
businesses now collect, store,
use and potentially disclose
personal information in some
way. Asia Pacific has experienced
solid development in privacy
laws in recent times; however,
each country has its own
implementation and enforcement
systems.
Failure to comply, or responsibility
for a serious data breach, can
also damage an organisation’s
reputation in the market and may
affect their standing with the
relevant government regulatory
body or agency.
There may also be specific
laws or regulations that govern
the collection and handling of
individuals’ health information.
There may be a legally enforceable
right for individuals to access their
health information contained in
records held by private and public
sector healthcare providers. The
application of these laws may
have a broader scope than the
regulation of “medical devices,”
and may apply to health and fitness
mobile apps, wearable devices
and associated software. These
requirements restrict the potential
benefits flowing from the use of big
data in healthcare. However, there
are examples of carve-outs being
created for the collection and use
of big data for specific purposes.
Some jurisdictions (such as
Singapore via the National Registry
of Diseases Act) regulate the
compilation of information relating
to certain diseases for use in
disease prevention. There may be
a duty for healthcare institutions
or practitioners who prescribe
medical devices to patients to
notify the relevant registrar of
reportable diseases (e.g., cancer).
Internal audit
As a company, you must
understand what personal data is
being collected and how it is being
used. In particular, the following
questions must be answered:
Legal Point of View:
Data-driven Healthcare
1. If you collect and use
personal information, have
you checked the regulatory
requirements on consent? If
you have collected the data
from an individual for one
purpose, but now seek to
use it for another, are you
required to seek “fresh”
consent from that individual?
1
2. Do you have appropriate
measures in place to
securely store personal
information and destroy or
de-identify this information
when it is no longer
required?
2
3. Does your company have a
privacy policy, and is it up to
date with your practices?
3
4. If you store personal
information offshore,
have you conducted a due
diligence-style assessment
of the privacy laws of the
recipient country?
4
5. Can you ensure that the
overseas recipient is also
bound by the same laws? Or
will you be liable if there is a
breach in that country, even
if it is completely out of your
control?
5
6. Are you able to negotiate
a data transfer agreement
with the recipient that
addresses matters such as
a data breach response and
notification plan?
6
7. Have you considered using a
data security firm to assist
in protecting the integrity of
the personal information that
you store or use?
7
1. To what extent is personal
information or personal data
being collected? Examples of
personal information include
a patient’s name, address,
medical records and bank
account details.
1
2. Is any “sensitive” information
collected? Some jurisdictions
place strict requirements
on collection and use of
sensitive information,
including health information.
2
3. For what purpose is this
information collected?
The issue of consent by
individuals arises in multiple
jurisdictions. Where an
individual has consented
to the use of his personal
information for a purpose
(or multiple purposes), an
organisation should not use
that information for any
other purpose.
3
4. Is personal information
stored overseas? Some
jurisdictions include
restrictions on disclosing
or transferring personal
information outside of the
“home jurisdiction.” This is a
particularly important issue
for cloud service providers,
which often provide services
to customers in one country,
while basing their operations
in another.
4
Assessing compliance
Based on your answers to the
above questions, you must now
determine the extent of any data
protection compliance issues.
Remember, your company may
be held accountable for serious
data breaches involving personal
information.
The advantages of data-driven
healthcare are clear. However,
individuals and organisations
operating in the healthcare industries
must be aware that, as a general rule,
“health information” is regarded
as sensitive and is more heavily
regulated under the various data
protection regimes.
It is imperative that big data
initiatives and products in
healthcare or otherwise comply with
data protection laws, as the
consequences of non-compliance
range from fines to criminal offences
and enforcement actions.
Privacy Concerns: Regulating
the Collection of Data
What are the key data protection
and privacy considerations for
big data in healthcare?
Case Example: Data Aggregators
in Healthcare
1. Are you required to notify
individuals when a data
breach occurs?
8
Human genome sequencing
provides scientists with a
roadmap of the human body. It is
probably easier to equate this to
understanding the computer code
that governs our body. Just as
computer code can contain bugs,
the human body equivalent would
be a defective protein, which would
leave it predisposed to a disease
such as cancer.
Advances in sequencing the
genome mean that in the next
ten years many rare diseases will
likely be downgraded to becoming
curable diseases. Healthcare
scientists agree that the genomic
breakthrough in cancer treatments
is already underway and
transforming the treatment of the
disease.
Genomics is becoming more
accessible and affordable through
technology advances. A process
that used to cost millions per
person now costs just a few
thousands. Novel business models,
which, for example, just focus on
a specific therapy area such as
breast cancer, are able to provide
a service to women at a fraction of
the cost of a full DNA sequencing
procedure.
This new area of medicine will have
fundamental impact on how each
one of us will be able to manage
our health, starting with prevention
through disease management.
It will impact most stakeholders
from the patient to the healthcare
professional, drug discovery and
health insurance provider, to name
a few.
5 Ways Big Data is
Changing Healthcare
Genomics1
“Chemotherapy is just medieval,”
says Eric Topol, a leading American
cardiologist, geneticist and researcher.
“It’s such a blunt instrument.
We’re going to look back on it like
we do the dark ages. Tumours can
now be sequenced and drugs tailored
to the individual. It’s the dawn of
personalised medicine.”
With groundbreaking developments
around the world in treating
and curing cancer and rare
diseases, genomics is elevated
above big data initiatives for its
transformative potential. However,
it is not without challenges both
from commercial and medical
perspectives. From a commercial
perspective, there is a need to have
adequate intellectual property right
(IPR) enforcement and protection
systems in place to protect genome
sequencing (via patent registration)
and, by extension, to encourage
R&D investment in this space.
Conversely, the medical
perspective can be a competing
consideration for genomics.
The very concept of obtaining
patent protection over human
genome sequencing and thereby
monopolising rights to methods
of medical treatment could be an
impediment to the full realisation
of genomics’ potential.
The Human Genome Project is a
practical example of the inherent
conflict between genomics and
intellectual property. The project
was designed to generate a
resource that would be freely
available in public databases
and used for a broad range of
biomedical studies. This is in
conflict with the very nature of
the legal monopoly granted by
patent protection. Equally, it is
clear that considerable time,
effort and funding are required
to translate discoveries in the
laboratory to treatment methods in
a medical clinic. Thus, patents are
an important way of encouraging
private funding in science, as they
allow investors the opportunity
to maximise the profit from their
investment.
The patentability of gene
sequences in developed IPR
governance systems such as
those in Australia, the USA and
Europe varies. In late 2015, the
Australian High Court determined
that nucleic acid isolated from
human cells was not patentable
subject matter under Australian
law (see D’Arcy v Myriad Genetics
Inc. (2015) 325 ALR 100). This is
consistent with the position in the
USA where the US Supreme Court
ruled that naturally occurring
nucleic acid is a “product of
nature” and therefore cannot be
patented (see Association for
Molecular Pathology v. Myriad
Genetics Inc. 569 US - (2013)). In
Europe, however, there is no bar
to patenting gene sequences.
The European Union Directive
(98/44/EC) expressly provides
that biological material (including
gene sequences) can be patented
provided the gene sequence
is useful (i.e., susceptible to
industrial application) and this is
disclosed in the patent application.
While patenting gene sequences or
naturally occurring isolated nucleic
acids per se is not permitted in
Australia, the patentability of
gene-related inventions remains
possible. In Myriad, the High Court
of Australia expressly left open the
possibility that, where there is a
new or improved process of nucleic
acid isolation or where an invention
consists of the application of
isolated nucleic acid to a particular
use, that method of isolation or use
may be patentable.
Legal Point of View:
Genomics
Legal Point of View:
Telemedicine
The increasing use and availability
of telemedicine (or telehealth) is an
important example of how big data
is changing the face of healthcare.
Telemedicine refers to the
systematic provision of healthcare
services over physically separate
environments via an electronic
communications network. This
exchange of healthcare information
between patients and healthcare
providers (for diagnostic and
clinical purposes) can be over the
telephone, through text messaging,
email, smart phone application
or other telecommunications
technology.
Telemedicine has been used in
Asia Pacific for close to a decade,
and the regulatory environment is
finally catching up. For example,
in Singapore, new National
Telemedicine Guidelines (NTG),
covering a wide scope of services,
were recently issued by the
Singapore Ministry of Health.
The NTG distinguishes between
healthcare organisations and
healthcare professionals involved
in the provision of telemedicine and
imposes different obligations on
each group.
From a legal perspective, the
development of telemedicine as a
viable method of providing medical
services raises various regulatory
issues. For example, in the future,
will we see telecommunication/
Internet service provider (ISP)
companies face liability for
failing to adequately facilitate
these services? Or will the
telecommunications industry
also be required to comply with
laws regulating the provision of
therapeutic services?
Given the potential for vast
amounts of personal and/or
sensitive health information
to be transferred using
telecommunications technology,
telemedicine also raises concerns
in relation to privacy and data
protection. As with conventional
medicine, a clinician practicing
in telemedicine has the same
duties to safeguard a patient’s
medical records and maintain
confidentiality. However, the
unique challenge for telemedicine
clinicians is to manage the
increasing number of people
who will potentially have access
to a patient’s records and to
ensure that protocols are strictly
followed to ensure the integrity of
data and images transmitted for
the purposes of a telemedicine
consultation.
However, telemedicine raises
several legal issues, such as data
privacy and licensing for cross-
border services, that each jurisdiction
must confront and develop a
framework for.
2 Data Analytics
Healthcare data analytics
makes extensive use of data,
statistical and qualitative analysis,
explanatory and predictive
modelling. It is the process of
working with and mixing data
sets so as to transform data into
useful insights to support decision-
making.
This is being compounded by rapid
growth of data with some 90% of
the data available today having
been created in the last two years
alone, according to IBM.
Digitising the files from the
hospitals’ or physicians’ notes is
the core of the electronic health
(or medical) record (a.k.a. EHR
or EMR). The ideal EHR would
be a comprehensive file that
includes all laboratory data as
well as reports from procedures,
operations, diagnostic tests,
hospital discharges and visits with
all healthcare practitioners. The
launch of smart phone applications
will allow the patient to have their
own personal health record (PHR),
which would ensure it is accessible
everywhere or when needed.
Initiatives in the US to digitise
these records have delivered
impressive results such as a 41%
reduction in error rate and a 51%
reduction of adverse drug events in
just one hospital.
If we consider the enormous
burden placed on hospitals in most
countries across the world, using
big data and predictive analytics
tools will provide much needed
decision support tools to reduce
cost, improve the quality of care
and improve outcomes through
smart operational improvements
in hospitals through focus on the
following:
1. Reducing readmissions by
identifying high-risk patients
and readmission time
2. Workforce planning for
optimal nurse scheduling
3. Maximising hospital
resources such as bed and
operating rooms
4. Optimising elective
admissions schedules to
reduce midweek congestion
and bed block
5. Scheduling operating rooms
efficiently to coordinate
patient care paths
1
2
3
4
5
The single greatest challenge
facing healthcare data analytics is
fragmentation of the available data.
3 Public Awareness: Planning & Preventing
One of the biggest causes of
disease in developing economies is
a lack of awareness of the diseases
(both communicable and non-
communicable) and their causes.
For example, diabetes prevalence
in India is as high as 10% of the
population (WHO) but fewer than
1% seek counsel from a healthcare
professional. Often enough,
they seek consultation once the
symptoms are quite advanced.
Current costs prevent routine
health checks for the majority
of the population in developing
economies.
Mobile device penetration is
extremely high in Asia Pacific,
facilitating both push-and-pull
health and wellness information to
be communicated or exchanged.
In many Asia Pacific economies,
the presence of counterfeit
medicine further reduces the
effectiveness of the healthcare
system. For example, up to 50% of
anti-malarial drugs in Cambodia
are fake, leading to many patients
being poisoned. Mobile devices
provide a simple solution to
verifying the authenticity of the
medicine being purchased similar
to countering credit card fraud.
The use of mobile technology
in collaboration with a well-thought-
through disease awareness
campaign would enable the effective
use of data to reduce and prevent
disease.
4
The power of today’s computers
combined with the major advances
in analytics, such as machine
learning, is making it possible to
blend a greater variety of data to
generate clinical and non-clinical
intelligence.
IBM’s Watson supercomputer
has the capability to analyse vast
amounts of data on a cloud-based
platform that puts the power
of the analysis in the hands of
physicians, researchers, insurance
actuaries and other non-technical
users. Using advanced technical
capabilities, such as artificial
intelligence and machine learning
algorithms, the system responds to
clinical queries in natural language
and comes up with responses
based on medical evidence that is
gathered and constantly analysed
in the system.
In May 2015, IBM Watson Health
announced a major push into
the healthcare analytics space
through strategic partnerships
with Mayo Clinic, one of the leading
hospitals and medical research
institutions in the US, and Epic,
a provider of Electronic Health
Record (EHR) systems with access
to vast amounts of patient medical
records. IBM has been aggressively
pursuing access to patient data
to feed the Watson engine, more
recently through the acquisition
of Explorys and Phytel. These
acquisitions and partnerships
deepen IBM’s commitment
to extend Watson’s cognitive
computing power to advance the
quality of healthcare, specifically
in areas such as cancer prediction
and treatment.
Similarly, new entrants in
healthcare such as Google or
Flatiron Health are focused on
linking and analysing all the patient
and research data of a specific
disease area such as oncology to
develop insights to significantly
improve research and treatment.
Support Providers
5 Support Self-Care/Digital Therapeutics
The rapidly expanding ownership
of smart devices (over 1 billion
Android devices worldwide)
equipped with a growing number
of built-in sensors and the growing
versatility of wearables (which
we discuss in the next section)
are making patient-empowered
disease and pre-disease
management a reality through the
combination of customised apps
and the increasing variety and
frequency of patient-centric data.
In the past few years, a handful
of medically minded visionaries
have put real clinical rigor into
every aspect of their disease
management application design.
For instance, David Van Sickle,
a former CDC epidemiologist
intelligence officer, and now the
CEO and co-founder of Propeller
Health, built a GPS-enabled sensor
for asthma inhalers that links to
a mobile device app — every puff
is mapped and time-stamped,
allowing patients and doctors to
spot patterns in “random” attacks
and identify previously unknown
triggers.
For the first time in its history,
the World Health Organization’s
Centers for Disease Control and
Prevention (CDC) has recognised
digital therapeutics as meeting
the evidence-based standards for
the agency’s National Diabetes
Prevention Program (DPP) when
it listed Omada Health as an
effective diabetes management
aid in March 2015.
We will likely see physicians
prescribing regulation-approved
apps not just to monitor and
manage chronic disease but also
to pre-empt acute disease events.
Preventing individuals from
progressing to more advanced
diabetes status through device-
based therapies or behavioural
change would have a significant
impact.
We should also consider the
beneficial impact of this type of
technology on improving disease
awareness in a region where a
small fraction of individuals at risk
or with a chronic disease actually
consult a healthcare professional.
The high prevalence of chronic
diseases in Asia Pacific warrants
the need for similar behavioural
change digital programs
customised to be appropriate to
differing levels of income and device
sophistication, among others.
First-generation consumer
wearables were built with just one
sensor (accelerometer), and they
are already making a difference.
Wearable devices from Fitbit or
Jawbone can, for example, tell us
how active we are in a day, or a
week or a month. They can also
estimate the quality of our sleep.
More to the point, such products
encourage us to improve our
habits and/or behaviour through
gamification. This can involve
incentivising and rewarding
people to meet pre-set goals
using techniques often used in
games, for example, rewards, or
a progress bar, in addition to peer
pressure via social media.
Next-generation wearable
biosensors such as smart
watches, smart clothing, jewelry,
patches and wearable tattoos
are emerging and are able to
capture physiological data such as
movement, respiration, hydration,
glucose, skin conductivity, heart
rate, temperature, posture, oxygen
level, muscle activity and blood
pressure.
Next-generation wearable
biosensor technologies will be
embedded in our clothes, homes
and cars, and other places we
regularly frequent or use.
Biosensing
Wearables
Biosensors
Devices that convert a
biological element into
a signal output
Activity
Trackers
e.g., Fitbit, Misfit
Smart
Watches
e.g., Garmin
Patches and
Tattoos
e.g., Zio, MC10
Smart
Clothing
e.g., Athos
Ingestibles and
Smart Implants
e.g., Proteus
Wearables
On- or in-body devices
that enable user
experience
Chronic diseases, such as
diabetes, can also be better self-
managed with apps, in tandem
with specific wearable biosensors
such as a glucose meter that helps
to measure carb intake, calculate
administered insulin quantity and
receive tips on diet and lifestyle
modifications essential for slowing
down the progress of the disease.
The combination of biosensors
and advanced data analytics is
rapidly democratising the access
to personal health data as well as
access to complex computational
capability and placing it in people’s
hands. They are effectively
transferring power from the hands
of scientists and academics to
ordinary citizens.
A very similar revolution is taking
place in the medical device
environment. Take for example
AliveCor, a peripheral attached to
a smart phone that enables users
to record and share their own
electrocardiograms (ECG/EKG).
Amongst other things, this device
will probably spell the demise of
the stethoscope. Doctors prescribe
the device for at-home use so that
they can regularly monitor patients
remotely. Today, if patients do
not have the symptoms of heart
disease it is generally assumed
that they don’t have the disease.
Home use would enable a doctor
to track whether a patient’s at-
rest heart rate is rising over a
prolonged period of time and
therefore tackle potential heart
disease early. This way, patients
can also determine whether the
therapy they have been prescribed
is effective.
Imagine slapping a sticker on
your arm that could measure a
wide array of medical indicators
— heart rate, body temperature,
blood pressure and more — and
transmitting that data wirelessly
to your smartphone. MC10 is
developing products that can be
used both on and inside the body,
that monitor head impact, heart
rate, brain activity, muscle function,
body temperature and hydration.
It is also developing an entirely
new class of intelligent medical
device with embedded sensors for
enhanced sensing and therapeutic
capabilities. Looking forward
a few more years, combine this
with advances in nanotechnology,
and the same sticker will also be
able to release drugs stored inside
nanoparticles when data from the
sensors suggest it is required.
This technology will fundamentally
change the way in which medicine
is administered and how chronic
diseases such as Parkinson’s are
managed.
We have deliberately not addressed
other significant scientific
advances such as regenerative
medicine, stem cell research and
nanotechnology, as these are
regarded to not be sufficiently
advanced to have an impact on Asia
Pacific’s health system in the short
to medium term.
Thanks to advances in the
computing power of handheld
devices, combined with an
increasing number of sensors
built into them, it is becoming both
practical and realistic for patients
to manage their own healthcare in a
way that was never possible before.
What data privacy and compliance
issues arise from biosensing
wearables?
Mobile Devices
Health
Recently published research
estimates mobile phone
penetration in Asia Pacific to reach
70% of the population by 2019. This
will continue to grow as countries
such as Myanmar build their
mobile phone network and their
population comes online. Smart
phone adoption is also growing fast
as new handset manufacturers
(e.g., Xiaomi in China or Micromax
in India) enter the market with
state-of-the-art devices for
USD250 or less.
Tablet ownership has also recorded
significant growth in many Asia
Pacific countries.
As Thomas Goetz put it, healthcare
is about information. We are
all looking for data to inform
our personal and professional
decisions, e.g., shopping, dining
out and booking taxis. Delivering
better healthcare in Asia Pacific
should be no different. Mobile
devices enable this by giving the
health system the ability to do the
following:
1. Provide health information
and education
2. Communicate broadly and
directly with the population
on health matters
3. Engage directly with the
population on health matters
related to them
It has the power to break down the
barrier between healthcare and the
consumer/patient-democratising
healthcare.
A poignant example of its impact
relates to infant mortality in the
region. Countries such as India
and Indonesia have failed to meet
their United Nations Millenium
Development Goal (MDG) to
reduce infant mortality. The infant
mortality rate in India is three
times higher than China’s and
seven times greater than that
of the US. There are numerous
causes of infant mortality, but
an important one is insufficient
maternal health.
A leading consumer goods
manufacturer launched a program
that works with mothers and
community leaders to educate
them on basic health practices
such as washing hands with soap
daily, particularly before handling
newborn infants.
This very successful program
provided mothers of newborn
infants with free-of-charge
awareness and education modules
via their mobile phones specifically
designed to address rural areas
where most handsets are still
unsophisticated. The company also
adjusted its soap pack size to cater
to the daily cash flow limitations
that exist in rural areas.
Overall mothers and infants have
benefited and the consumer goods
company has generated revenue
and brand awareness with a new
customer segment. It is a great
template for other healthcare
stakeholders as we aim to improve
healthcare in the lower echelons of
the income pyramid.
1
2
3
Mobile health, now known as
“mHealth,” has been identified
by the World Health Organization
as having “the potential to
transform the face of health
service delivery across the globe.”
The rise in the use of mHealth
in developing countries presents
significant risks in countries where
privacy laws are non-existent or
inconsistent. To address these
risks, Baker & McKenzie and
Merck partnered with the United
Nations Foundation’s mHealth
Alliance and the Thomson Reuters
Foundation’s TrustLaw to develop
“Patient Privacy in a Mobile World:
A Framework to Address Privacy
Law Issues in Mobile Health” (June
2013). This pioneering initiative
covers mHealth-related privacy
and security issues around the
globe.
A key purpose of the mHealth
Alliance Report was to review
privacy and security policies
around the world and to identify
gaps in these policies that must
be addressed to protect personal
health information. The mHealth
Framework states that privacy
laws are roughly split among (1)
omnibus data protection (i.e.,
laws that regulate all personal
information, as in Europe), (2)
sectoral privacy laws that address
privacy issues in specific industries
and business sectors (as in
the US), and (3) constitutional
protections, where there is a
human right to the protection of
personal information.
The mHealth Framework sets
out a functional framework for
addressing these privacy law
gaps, and is sensitive to different
cultural, technological and
institutional contexts.
Legal Point of View:
mHealth
Notably, the results of the mHealth
Framework indicate that few existing
laws make reference to mHealth or
other technological advances in
healthcare.
The development of applications
assisting in the diagnosis and
treatment of medical conditions
can give rise to regulatory
requirements. In particular,
some jurisdictions have provided
guidance that mobile apps with
therapeutic application, or
marketed as having therapeutic
application, could be regarded
as “medical devices” under the
applicable regulatory regimes.
Is it a “medical device”?
Several jurisdictions in Asia Pacific
have extended the definition
of “medical device” to capture
a large number of healthcare
technologies, including smart
phone applications, blood pressure
monitors, diagnostic software
and disposable cell testing
devices. In some instances, these
technologies may need to be
registered with a government
body or agency before they can
be imported, exported or made
available in the market.
Generally, medical devices will
be any article or object (including
software) that is intended to
diagnose, prevent, monitor or treat
a disease or injury in humans.
Some countries, such as Malaysia,
require all medical devices to be
registered with the Ministry of
Health, while other countries, such
as Australia, may take a “risk-
based” approach to regulation. This
means that the level of scrutiny
and oversight by the government
body or agency will vary according
to the level of risk that the product
represents to the patient or
physician using it.
In some cases, whether a product
is considered to be a “medical
device” will depend on (a) the
intention of the manufacturer or
supplier, and/or (b) how they will
market (or have marketed) their
product. We see this illustrated in
the treatment of wearable devices
and other devices developed for
use in relation to “quantified self”
health information by different
regulatory regimes across Asia
Pacific. In some jurisdictions,
devices marketed as being used
for sporting activities are exempt
from regulation; however, a
largely similar device, which was
marketed as having more general
application, may not be able to
take advantage of this exemption
and could therefore be subject to
regulation (despite having similar
or identical functionality).
In contrast, in jurisdictions such
as Australia that regulate devices
having therapeutic application,
a device may be subject to
regulation if it is marketed as
having a purpose relating to
diagnosis, prevention, monitoring,
treatment or alleviation of disease,
for example. If the device is not
marketed this way, it will not
be regulated. In late 2014, the
Australian regulator clarified that
the definition of a medical device
includes “software programs or
operating instructions that control
the functioning of an electronic
device such as smart phone
apps.” The key consideration is
whether the app simply presents
information to users (in which
case it is unlikely to be a medical
device) or whether the app has a
therapeutic or diagnostic use, for
example, by way of a monitoring
or diagnostic function (in which
case it is likely to be classified as a
medical device).
However, an app regulated as a
medical device in its own right and
developed for use in conjunction
with an unregulated wearable or
quantified-self device is unlikely
to extend regulation to the device
and is likely to be seen by the
regulator as extending “beyond the
intended use” of the manufacturer,
and therefore the device itself can
still be treated as a consumer
electronic device and not a medical
device.
Promotion, advertising and
other marketing of medical and
healthcare technologies is closely
scrutinised in most jurisdictions
to protect patients, consumers
and healthcare professionals.
Generally, most countries in
Asia Pacific will prohibit any
commercial conduct that is
misleading or deceptive, in addition
to specific prohibitions relating to
the healthcare industries.
1. In Australia, the Therapeutic
Goods Advertising Code
2007 regulates the
advertising and promotion
of certain therapeutic
goods, including “medical
devices,” and contains a
number of prohibitions and
requirements.
2. In China, the Advertising
Law (administered by the
State Administration for
Industry and Commerce)
provides that advertisements
published through the
mass media should be
marked as such, and be
differentiated from other
non-advertising information,
so that consumers are
not confused or misled.
The Advertising Law also
requires all advertisements
containing drug names and
the ailment or symptoms to
undergo examination before
publication.
3. In Hong Kong, the
Undesirable Medical
Advertisements Ordinance
(Cap 231) restricts the
advertising of abortion,
medicines, surgical
equipment and treatment for
curing or preventing certain
diseases or conditions.
“Medical devices” will often be
subject to the same legislation as
medicinal or other therapeutic
products. However, the specific
prohibitions on advertising of
medicine (particularly prescription
medicine) to healthcare
professionals and consumers
generally will not extend to
medical devices. For example, a
requirement that advertisements
for prescription medicines be
pre-approved by the government
agency may not apply for medical
devices. However, this differs
between jurisdictions, and one
must carefully review applicable
advertising laws and codes before
commercialising a product. Some
countries, such as Japan, even
allow advertising of prescription
medicines on television direct
to consumers, provided such
advertising is not misleading
and encourages responsible
consumption.
Be aware that in some cases,
the advertising codes may be
developed and published by
industry bodies (such as the
Medical Technology Association of
Australia), which do not have any
formal regulatory function but can
be either binding upon members or
set the baseline for best practice in
that jurisdiction.
3
Legal Point of View:
Assessing Whether New
Technology is Subject to
Regulatory Compliance
Therefore, when dealing with any
medtech product, the key question
to ask is, is the product considered
to be a “medical device” in this
jurisdiction?
1
2
Promotion
Funding
Chapter
3
In one of the better-known scenes
from the film Jerry Maguire (1996),
Rod Tidwell has Jerry Maguire
repeatedly bellowing “Show me
the money” down the phone in
order to remain Tidwell’s agent.
Many observers of the emerging
healthtech revolution will likely
utter the same words.
A study of the flow of venture
funding into the healthtech sector,
essential to the growth of new
solutions and business models,
reveals significant activity in the
last few years.
Healthtech is among the more
exciting up-and-coming industries
these days, alongside the likes
of virtual reality/augmented
reality, artificial intelligence and
Blockchain. Not only are old
markets like health insurance
being disrupted and changed,
but new industries like digital
therapeutics have sprung to life
with the advent of biosensors.
Venture capitalists have taken
notice and have been pumping
funding to these new ventures,
totaling $13.4 billion since the
beginning of 2011.
Although venture capital firms
have been investing in this sector
for some time, the activity has
notably increased in recent years.
2014 Global Healthtech
Funding Rockets
Healthtech funding in 2014 not only
broke all records, but it quadrupled
from 2011, doubled from 2013, and
exceeded the prior three years
combined, closing at $4.1 billion.
In tandem, the number of deals
completed has tripled since 2011.
What Does Following
Investment Funding
Tell Us?
Global Overview
Key highlights:
Key investment themes are
taking shape - the top five
categories being:
» Analytics and big data -
$393 million
» Healthcare consumer
engagement - $323 million
» Digital medical devices -
$312 million
» Telemedicine - $285 million
» Personalised medicine -
$268 million
The six largest deals in 2014
saw further rounds in 2015:
» NantHealth ($375 million) -
Series B - Kuwait Investment
Authority
» Proteus ($172 million) - Series
G – undisclosed investor(s).
In previous funding rounds,
Proteus has been backed
by the Carlyle Group , Essex
Woodlands, Kaiser Permanente,
Medtronic Inc., Oracle Corp .
and ON Semiconductor Corp.,
VentureWire records show. The
company’s two main strategic
partners, Novartis AG and Otsuka
Pharmaceutical Corp., are also
investors
» Flatiron ($130 million) - Series B
- Google Ventures
» Alignment Healthcare ($125 million)
- Private equity, undisclosed
» Invitae ($120 million) - Series F -
14, different investors
There were 95 healthtech
M&A transactions in 2014,
which reflect increasing
interest from corporates and
strategics in the sector:
» 46 M&A deals in healthtech
alone, with blue-chip players
such as Aetna, GE, Medtronic,
AstraZeneca and Facebook
making acquisitions
Strong IPO trend building
with five healthtech ventures
going public in 2014
10,000+ healthtech start-ups
estimated across the globe
2015 Global Healthtech Funding
Maintains Momentum
Many healthtech investment
data sources and conclusions
exist. Much of this variance is
due to the range of different
definitions of what constitutes
healthtech. Health 2.0, a new
health technology catalyst, reports
healthtech funding numbers for
2015 at $4.75 billion. Rock Health,
a venture fund focused on digital
health, had assessed the number
at $4.3 billion; Mercom Capital
estimates it at $4.6 billion and
both CB Insights, a data analytics
company, and StartUp Health, a
leading healthtech incubator, have
pegged it at $5.8 billion.
Although these reported
numbers differ primarily driven
by definitions, they tell the story
that healthtech investment is
maintaining a steady momentum
and expected to grow in maturity in
2016.
For reference, StartUp
Health has it dropping $1.2
billion, Rock Health has it
holding steady and Health
2.0 actually records a slight
increase from $4.6 billion in
2014.
In an effort to remain conservative
and due to their definitions, we
have used Rock Health’s analysis
as our primary source.
2015 Healthtech Summary
Key highlights:
Venture capital (VC) funding
globally for healthtech
totalled an average of
$4.5 billion in 2015, which
sees 2015 edge ahead of
2014. The number of deals
completed in 2015 decreased
marginally, driven by larger
late-stage deals Series C
and beyond.
Top six healthtech themes
attracting the lion’s share of
funding include:
» Healthcare consumer
engagement – $629 million
» Wearables and biosensors –
$499 million
» Personal health tools and
tracking – $409 million
» Payer administration –
$263 million
» Telemedicine – $236 million
» Care coordination – $208 million
Among the 27 countries
with recorded healthtech
deals, 19% of funding came
from outside the US. Top
VC healthtech companies,
defined by number of deals
completed in 2015, include:
» Guahao (China) – $394 million
» NantHealth (USA) – $200 million
» ZocDoc (USA) – $130 million
» Helix (USA) – $100 million
» Practo (India) – $90 million
Close to 900 investors
participated in healthtech
deals in 2015, up 25% in
2014. Fifty-one VC firms
closed three or more deals
in 2015. Corporate/strategic
investors were increasingly
active. Top VC investors in
2015 include:
» New Enterprise Associates (NEA)
» Rock Health
» Merck GHI
» Venrock
Five healthtech IPOs in 2015
raising a combined $1.2
billion:
» FitBit – $732 million
» Teladoc – $158 million
» Invitae – $102 million
» Evolent – $195 million
» MindBody – $101 million
There were 187 healthtech
M&A transactions in 2015,
nearly doubling from 2014
and indicating an increasing
consolidation in the sector.
In the venture capital industry, each round of
financing for a new business is referred to as
a “series.” The type of series (A, B, C) helps
investors know where they are in terms of
claiming future profits for a company. To better
understand this cycle, read David Newton’s
article, “Understanding the Financial Stages,” in
https://www.enterprenuer.com/article/42336
Opportunities in Asia Pacific
One of the drivers for
entrepreneurs and investors to
start and scale a business is the
size of a market and an unmet
need within it. According to Frost &
Sullivan, total healthcare spending
in Asia Pacific is expected to
reach $2.2 trillion in 2018, which
represents a huge opportunity.
The good news is that the purchase
power of many of these individuals
is also growing fast and will
continue to do so for the next 20
to 30 years. Average GDP per
capita in developing Asia Pacific
remains significantly below OECD
economies.
Many Asia Pacific countries,
however, have very under-
developed healthcare
infrastructure, which limits access
to a good standard of healthcare.
For example, India has 0.5 doctors
per thousand of population,
whereas the US has 3. This is
compounded by largely unmet
medical needs. For example,
Indonesia has 150 coronary
disease-related deaths per
hundred thousand, whereas France
has 29.2.
Healthtech therefore represents
a substantial opportunity for
all healthcare stakeholders
and investors. Key investment
categories in healthtech include
digital therapeutics, data and
analytics, and diagnostics, to name
a few.
Going forward, in addition to the
continued growth in momentum
in the healthtech space driven by
compelling start-ups and their
products and investors hungry
for attractive deals at sensible
valuations, we will also see
increased activity from corporates,
both incumbents and new entrants,
and from governments with
initiatives such as Singapore’s
Smart Nation.
Asia Pacific Healthtech Landscape
Over the past three years,
healthtech in Asia Pacific has
evolved from a nascent one to a
thriving ecosystem. This increasing
momentum, driven by the following
key factors, reflects the hierarchy
of needs within the health
ecosystem:
Lifestyle and wellness apps
driven by growing middle-
class affluence
Chronic disease
management driven by
growing health awareness
Frugal innovation enabling
better care at an affordable
price point
Growing demand for senior
healthcare products and
services
Consumers seeking a wide
range of healthcare solutions
and value for money
When compared to its regional
neighbours, Singapore punches
above its weight in terms of the
number of healthtech start-
ups operating from the island.
Singapore represents a natural
go-to point for entrepreneurs and
investors alike due to its stable
economic and legal environment as
well as its significant investment in
biomedical facilities over the past
30 years.
We expect the enthusiasm
Singapore has demonstrated for
both biotech and medical devices
to be echoed in healthtech.
Noteworthy Asia Pacific Healthtech
Deals 2014-2015
Guahao (China) raised a
$394 million series D from
Tencent and Goldman Sachs
Practo (India) raised a
$90 million series C from
Sequoia Capital, Google and
Tencent
Portea (India) raised a
$37.5 million series B from
Qualcomm, IFC and Accel
Partners
Meet You (China) raised a
$35 million series C from
Matrix Partners and K2
Ventures
PICOOC (China) raised a
$25 million series B from
Tencent and Gobi Partners
ConnexionsAsia (Singapore)
raised an $8 million series A
from Northstar and BioVeda
These only represent a small
number of the many healthtech
venture deals completed in Asia
Pacific in the past 18 months.
Mature Asia Pacific economies such
as Japan face very similar healthcare
challenges to their fellow OECD
nations. Each one of them needs
to continue to define how they will
continue to deliver high healthcare
standards despite an ageing population
and dwindling workforce.
In contrast with the mature markets
where most healthcare costs are
reimbursed, healthcare expenses in
Asia Pacific are usually an out-of-
pocket cost for the individual who is
therefore looking for choice and cost
effectiveness.
Singapore’s commitment to become
a leading regional innovation hub
positions it as an ideal platform for
healthtech innovation leadership.
Accelerators and Incubators
Over 100 accelerators and
incubators have been launched
across Asia Pacific in the
past three years, contributing
significantly to fostering the early-
stage venture ecosystem across
the region. Until recently, virtually
none were 100% focused on
healthtech, but this is changing.
In 2015, we witnessed the launch
of three new accelerators/
incubators dedicated to healthcare.
The most advanced of these three
is the AIA Accelerator (powered by
Nest), which ran its first cohort of
eight healthtech start-ups in mid-
2015. This attracted 76 applications
from 16 countries around the
world, even though no upfront
funding was offered. Building on
this success, AIA has teamed up
with Konica Minolta to launch
another healthtech accelerator in
Singapore.
As proven by the queen of
entrepreneur ecosystems,
Silicon Valley, the development
and fostering of quality early-
stage ventures requires all
key stakeholder groups to play
a catalyst role. Corporates
and strategics have begun
stepping into the Asia Pacific
healthtech sector, with insurance
companies leading the charge.
For example, in addition to the
previously mentioned AIA, Metlife
has launched its own internal
incubator, Lumen Lab, which has
a deliberate healthtech focus.
Healthcare industry incumbents
have remained, so far, on the
sidelines in Asia Pacific despite
their activities in other regions,
such as in the USA. The boldest
amongst them have recently
started their journey to better
understand the ecosystem.
Healthtech represents a unique
opportunity for all investor types
to create sustainable social and
monetary value across Asia Pacific.
Looking Forward
“Eighty-five percent of technology
companies and venture capitalists
surveyed say disrupting healthcare is a
top strategic priority.”
– Accenture report entitled
“Silicon Valley’s New Darling: Healthcare”
(2 February 2016)
Four key drivers will continue
the convergence of tech with
healthcare:
1. Sizeable value pool – Forbes’
investment report last
September listed healthtech
as the “most profitable
industry.”
2. Technology disrupting
other sectors – New
entrant traction in public
transport (e.g., Uber) and
accommodation (e.g., Airbnb)
has attracted the attention
of established technology
players (e.g., Qualcomm) as
well as new entrants (e.g.,
Proteus).
3. Funds and credibility –
Enabling household names
such as Google to build top-
quality healthcare teams
(i.e., clinical).
4. Lowered barriers – The
FDA’s decision, in its 2014
guidelines on healthtech, to
not enforce regulations akin
to drug- or medical device-
type regulations is lowering
the entry barrier for new
entrants.
Key areas of growth for
technology’s convergence with
healthcare will likely include:
5. Access to healthcare
6. Cost control and
transparency
7. Disease management
8. Workforce shortage
9. Hospital administration and
operations
10. Population health
11. Wellness
Conclusion
The healthtech revolution in
Asia Pacific will have a massive
positive impact on everyone
in the healthcare ecosystem.
Similar needs, expectations and
challenges exist across both
developed and developing Asia
Pacific.
China’s healthcare ecosystem
will benefit greatly from its
government’s directives; however,
it is likely that, in the short term,
the remainder of developing Asia
Pacific will need to rely on private
enterprise and consumers to drive
the much-needed transformation.
Legal Point of View: Funding
Traditional funding typically
involves loans from financial
institutions, government funding
or subsidies, private funding or
going public and listing on a stock
exchange.
Bank loans require regular
repayments and smaller start-ups
may not be able to do so, especially
at the early stages where there
may be no steady streams of cash
flow, since a lot of investment
is required before there may be
any results. With the lack of a
track record and uncertain future
earnings from products that are
still works in progress, a public
offering and listing may also be
less feasible for a small start-up
firm.
In this section, we focus on
the sources of funds that are
more accessible for smaller
corporations, namely private
funding and crowdfunding.
In the case of healthtech companies
seeking funding, while many options
are available for well-established firms,
for the smaller and newer start-ups,
access to some of these methods may
be limited for various reasons.
Funding considerations for
healthtech start-ups
Private Funding
This method of funding largely
involves investments from angel
investors or venture capitalists
keen on being at the forefront
of new and innovative products,
even from untested start-ups.
The investors may involve a single
firm, or multiple firms, with a
lead investor firm running the
transaction.
Multiple series of funding could
be involved with each start-up,
and investors are willing to give
the start-up a few years to show
returns of their investment. As co-
investors, the angels or VCs may
or may not take on active advisory
roles. Investee businesses should
note that depending on the terms
of the agreements that they enter
into, certain decision-making
processes may only be made with
the approval of its co-investors.
This may affect the extent of
their autonomy in the control and
management of activities.
Some of these requirements
include the ability for the
representative of the investor to
take up a position on the board of
directors, requiring the start-up to
have a minimum paid-up capital,
having an advisor experienced in
the industry consulting with the
start-up, at least one full-time
founder tobeinvolved inthestart-up,
investments by the founder(s) in
the start-up and no or minimal
investments from other external
parties.
There is a growing number of angel
and VC funding options available
in Asia Pacific in recent years, and
millions of dollars have been made
available to start-ups through
such private funding. We note a
large interest from angels and
VCs especially in healthcare and
technology industries, and believe
that healthtech is compatible with
the general sectors of interest to
various angels and VCs.
Crowdfunding
Increasingly, several healthtech
start-ups, especially in the USA,
have turned to crowdfunding
platforms for funding, such
as Indiegogo, MedStartr,
VentureHealth and Healthfundr.
Donation-based or rewards-based
crowdfunding (also referred to
as community crowdfunding) are
generally less regulated in Asia
Pacific as there are no offers of
returns or potential returns to
donors. Various crowdfunding
platforms are accessible to the
public across Asia Pacific and
many start-ups actively utilise
these avenues for fundraising.
Such crowdfunding from a
healthcare perspective is still less
commonplace in Asia, but with the
prevalence in the USA, it would
only be a matter of time before it
gains ground in the sphere.
Crowdfunding that involves a
financial return includes lending-
based and equity-based aspects.
These methods of fundraising
would be subject to the relevant
securities laws, which would result
in various restrictions or licensing
requirements. Malaysia, Singapore,
Thailand and Indonesia have
implemented or are in the process
of implementing regulations
to facilitate the establishment
of equity crowdfunding while
ensuring investor protection.
Concerns raised by regulators
include the risks associated with
investing in start-ups, which do
not guarantee success, and the
illiquidity of these investments.
The regulations, or proposed
regulations, across Asia Pacific
generally allow institutional or
accredited investors to participate
in equity-based crowdfunding, and
some limit the amount of retail
participation, if at all.
While Asia Pacific seeks to find
its equilibrium between giving a
hand to budding entrepreneurs
and safeguarding investors in
the coming years, healthtech
organisations should engage all
avenues available to them. But
start-ups should also make sure
that they don’t fall foul of both local
laws where they are based or the
foreign securities laws that may
apply to potential investors.
Certain investors may have
requirements that must be met before
they would consider investing in the
enterprise, in order to protect their
interests and to ensure that the
start-up moves in the right direction
to minimise the chance of failure.
As crowdfunding is a relatively new
concept in Asia Pacific, crowdfunding
regulations are still being implemented
at different stages across the region,
and the legal consequences arising from
these new regulations are still untested.
Legal Point of View: How to
Utilise Intellectual Property
(IP) Laws to Add Value to
Your Technology
Innovators and organisations
alike should be alert to, and take
advantage of, the various ways in
which IP protection can add value
to their assets and businesses.
Assets such as software,
processes, business plans, client
lists, logos, designs, inventions
and others, are often considered
as mere working material and
are not protected. However, this
could lead to a loss of the immense
value they represent for innovators
and organisations alike. IP rights
give the owner the right (and in
some jurisdictions, the obligation)
to invest in, sell or licence their
innovation over a certain period of
time. In most jurisdictions, these
rights are enforceable through the
courts, which have the authority to
stop IP infringement.
It is imperative that patent and
trademark applications are made,
and registrations granted before
an invention enters the market.
In particular, if you are planning
to obtain patent protection, your
invention must not be disclosed to
anyone unless they have signed a
confidentiality undertaking (e.g.,
a non-disclosure agreement).
Otherwise, it is unlikely that your
invention will satisfy the novelty
requirement at the time of filing
at the relevant patent office. In
essence, if your product is already
available in the market, it will not
be considered novel.
Once your IP is registered or
otherwise protected, there are
various options available for
commercialising your IP (i.e.,
getting your IP to market).
Licensing (exclusive and non-
exclusive) is the most common
commercialism mechanism used.
Other ways of commercialising
IP could be a joint venture
arrangement with another
established company, or a
start-up enterprise involving
venture capital.
Furthermore, accurate IP valuation
and protection is an important
part of an organisation’s asset
management strategy, providing
better negotiating positions and
increased avenues for income
generation. Conversely, failure
to pay proper attention to the
valuation and protection of an
organisation’s intangible assets
could have a detrimental effect
in various commercial scenarios,
such as mergers and acquisitions,
licence or franchise negotiations,
purchase and sale of IP assets
and financing/investment
opportunities.
With the unprecedented influx of
health and medical technologies,
obtaining IP protection for
computer programs and software
continues to be a challenging
business issue for innovators and
organisations alike. Below is a
summary of the key types of IP
protections that may be available
for computer program rights in
Asia Pacific:
In some jurisdictions, such
as Australia, computer
software is primarily
protected by copyright as a
“literary work,” although a
computer program may also
be patentable.
Trademark law, with its
system of registration, gives
significant protection for
brand names, logos, devices
and forms of trade dress
used in relation to software
products and packaging, but
is not a source of substantive
rights relating to the content
or function of software, or its
underlying code.
Software is potentially
patentable, although claims
for mathematical algorithms
alone are generally not.
Unauthorised copying
of software may also be
actionable under laws
governing misleading and
deceptive conduct, passing
off, trade secrets (see below)
and confidential information.
Software and computer programs
are unique as they can be protected
by both copyright and patent law
in most Asia Pacific jurisdictions.
Copyright in software protects
the unique expression in the
source code, while patents protect
new and non-obvious functions.
Patents are, on the whole, far
more valuable as they protect the
implementation of the source code
(i.e., the “function”), regardless of
how this is documented. As such,
anything that may compromise
another person’s (or company’s)
patent rights should be avoided, as
enforcement proceedings can be
costly, both financially and in terms
of reputation in the market.
Both globally and within Asia
Pacific, several approaches have
been adopted to protect software
by means of patents. While
many countries grant patents for
software, computer programs
are specifically excluded from
patentable subject matter in others
(including China, Indonesia, New
Zealand, Thailand, the Philippines
and Vietnam). However, in many
of these “excluding” countries, it
may be possible to obtain patent
protection for computer program-
related inventions.
In some jurisdictions,
mathematical algorithms
in themselves are
unpatentable, except for
computer software that
produces physical effects
(for example, an improved
method for drawing a curved
image in computer graphics;
see CCOM v Jiejing (1994) 28
IPR 481(the CCOM Case)).
Similarly, business methods
may be patented if they
produce an artificial state
of affairs, in the sense of a
concrete, tangible, physical
or observable effect.
The main controversy surrounding
computer program patents can be
summarised as follows:
It is often said that software
innovation involves
cumulative, sequential
development and re-use
of other people’s work,
particularly with respect to
open source software (see
below), which preserves
interoperability between
programs, systems
and networks. This
interoperability does not fit
within the patent framework,
which limits the range of
options available to new
software innovators.
Conversely, proponents
of software patents argue
that patent protection
is necessary in order to
encourage investment in this
field. This financial support
is vital to support innovation
in various technological
areas, including medical and
health technology.
Open Source Software (OSS) is
software that is licenced on very
liberal terms to allow licencees
more than just access to the
source code of the software. As
a general overview, OSS licences
allow for the following:
free re-distribution of
software by any party without
payment of a royalty or
licence fee
programs are distributed
with their source code
the licence will allow for
modifications to the source
code and derived works
these derived works can
then be distributed on the
same terms as the original
software licencee
Patent laws give patent owners
substantial, valuable control over
who uses their invention, and
extends to any form of use (i.e.,
patent infringement is generally a
strict liability offence). Conversely,
the basic premise of OSS is that
innovators should be able to view
and use the source code of the
computer program and modify it
for their own purposes without
obtaining the consent of the
licensor/owner.
Ensure Your Competitive Advantage by
Protecting Your Ideas
Overview of IP Protection Methods for
Computer Programs/Software
Protecting Software Technology
What is Open Source Software?
The Inherent Conflict Between
OSS and Patent Rights
Intellectual property issues
in healthtech
It is worth noting that under the Patent
Cooperation Treaty (PCT), it is possible
to seek patent protection simultaneously
in several countries by filing a single
“international” patent application.
A patent is a legally enforceable
proprietary right granted to
protect a device, substance,
method or process that is new,
inventive and useful. The owner
of a patent will have the exclusive
right to commercially exploit the
invention for the duration of the
patent, which is 20 years in most
Asia Pacific jurisdictions. The
key question for most innovators
and organisations is: When is an
invention patentable?
In general terms, for an invention
to be patentable, the following
conditions should apply:
It must be a patentable
subject matter (this is often
referred to as a “manner of
new manufacture”).
It must be novel and involve
an inventive step when
compared to the prior art
base that existed before the
“priority date” of the claim.
It must be useful.
It must not have been
secretly used by the patent
holder before the “priority
date” of the claim.
[Note: “Priority date” refers to the
filing date of the first application
for a patent registration. When the
patent is accepted by the relevant
government agency, the owner
will have protection, i.e., can claim
priority, from this filing date.
What Constitutes Patentable
Subject Matter?
The types of inventions (or subject
matter) that are capable of being
the subject of patent protections
vary in different countries. In
summary, the following subject
matter will be expressly precluded
from patent protection in certain
jurisdictions:
Methods of treatment of
the human or animal body
by surgery or therapy or of
diagnosis (all Asia Pacific
jurisdictions with very few
case exceptions)
Inventions that may
encourage offensive,
immoral or anti-social
behaviour (includes
Malaysia, Thailand,
Indonesia and Taiwan)
Discoveries, scientific
theories and mathematical
methods (includes China,
Indonesia, Malaysia, the
Philippines and Thailand)
Plant or animal varieties
or biological processes for
the production of plants
or animals (other than
man-made living micro-
organisms, micro-biological
processes and the products
of such micro-organism
processes) (including China,
Indonesia, Malaysia, New
Zealand, the Philippines,
Taiwan, Thailand, Vietnam)
Schemes, rules or methods
for doing business (includes
China, Hong Kong, Indonesia,
Malaysia, South Korea and
Vietnam)
“Simple” Versus “Invention”
Patents
In several Asia Pacific jurisdictions,
inventions can also be protected
by “simple patents.” Depending
on the specific country, the name
may differ from “petty patents”
(e.g., Laos) to “utility models”
(e.g., China, the Philippines
and Cambodia). Simple patents
generally cover products and tools
and rarely extend to technologies.
This type of patent is very popular
with innovators as, generally
speaking, it provides a faster, more
affordable route for protection of
inventions. In some cases, there is
no requirement for an “inventive
step” (e.g., Indonesia, the
Philippines, Thailand and Vietnam),
or the degree of inventiveness
required may be less (e.g., China,
Malaysia and Laos). There is,
however, a reduced period of
protection, which is usually 7 to 10
years from the filing date.
Are Patents Valid in Every
Country?
Patents are territorial rights,
meaning the exclusive rights are
only available to the patent owner
in the country or jurisdiction in
which a patent has been filed and
granted. As such, it is imperative
that an application for patent
protection is applied in each of the
Asia Pacific countries in which the
technology is launched.
In Asia Pacific, only Cambodia
and Myanmar are not contracting
states of the PCT (as at July 2015).
Patent protection through the PCT
should be considered as a more
convenient, efficient and cost-
effective process.
Furthermore, Article 4 of the Paris
Convention for the Protection of
Industrial Property states that
once a patent application has been
filed in a convention country, it is
possible to claim the same priority
date for a subsequent application
made in another convention
country within 12 months. Current
Asia Pacific members include
Australia, Bangladesh, Bhutan,
Cambodia, China, Indonesia,
Japan, Laos, Mongolia, New
Zealand, Papua New Guinea, the
Philippines, South Korea, Samoa,
Singapore, Thailand, Tonga and
Vietnam.
Patents
Copyright protects the original
expression of ideas, such as art,
literature, music, broadcasts and
computer programs (“works”),
but not the ideas themselves.
It protects original works from
unauthorised copying and gives the
owners exclusive rights to licence
their work. Copyright is free
and automatic in all Asia Pacific
jurisdictions and generally lasts for
50 to 70 years after the death of the
creator/owner.
To obtain this automatic protection,
a “work” must satisfy the following
general conditions:
expression in a particular
form
originality
independent creative effort
of the author (e.g., works
created by a computer,
although original, cannot be
copyrighted)
Copyright protection provides for
moral rights aimed at protecting
the author’s reputation (for
instance, the right of attribution of
authorship) and economic rights
that give authors the exclusive
right to commercialise their work
for economic gain. A copyright
holder’s economic rights will be
infringed where the following
apply:
another person or entity
exploits the copyrighted
work without the holder’s
permission
such exploitation is not
considered “fair use” or
under a statutory licence
It is also possible to register
copyright interests in some Asia
Pacific jurisdictions. Although
copyright registration is not
required for protection, it can
assist in proving ownership
in the context of enforcement
proceedings (particularly where
a government authority required
evidence of ownership before
accepting a case).
Copyright software is expressly
protected by copyright laws in the
ASEAN region, covering the source
code, object code and written
documentation. This will prevent
anyone from running, copying,
modifying or distributing the
software without the permission of
the rights holder. However, this will
not protect the ideas behind the
computer program.
Trade secrets are a subset of the
broader category of confidential
information that is protected by
the judiciary, spanning commercial
secrets, personal secrets,
artistic secrets and state secrets.
Generally speaking, trade secrets
will be any information having
commercial value to the holder,
which, if disclosed to a competitor,
would be liable to cause real (or
significant) harm to the holder of
the secret.
Although copyright law may
protect the particular form of
document in which the information
is embedded, and patent law may
protect the subject matter of the
information (provided it discloses
a patentable invention), there is no
legislation that specifically protects
secret information. As such, it
is generally accepted that trade
secrets are simply information
to which property rights do
not attach. It is imperative that
confidentiality agreements are
signed by individuals who are party
to the trade secret.
Trade Secrets
Copyright
Baker & McKenzie’s Asia Pacific Healthcare Group
has advised global pharmaceutical, life sciences and
medical devices companies for more than 50 years.
The Firm is the sole law firm ranked in Band 1 in the
Chambers Asia Pacific Life Sciences rankings for
three consecutive years (2014-2016). In Asia Pacific,
Baker & McKenzie’s healthcare practice has more than
150 lawyers, more than 20 of whom have healthcare
and medical-related qualifications, as well as a
number of non-lawyer medical practitioners who hold
doctorate degrees in fields such as biotechnology,
pharmacology, nursing and bioethics. Our team has a
thorough appreciation of the issues facing our clients,
from compliance pressures and complex pricing and
reimbursement difficulties, to red-flag issues such as
anti-corruption.
As a trusted advisor to the world’s largest life sciences
companies, the Baker & McKenzie Asia Pacific
Healthcare Group offers cutting-edge, value-added
services to help clients stay abreast of key industry
trends.
These products include the following:
Webinars
Client seminars
Publications such as From Pills to Tablets and
Investing in the Healthcare Industry
Mobile apps such as the MapApp, which won
the Innovative Use of Technology Award at the
FT Innovative Lawyers Asia Pacific Awards 2015
(download it on the App Store)
Thought leadership reports
Ben McLaughlin
Head, Asia Pacific Healthcare Group
ben.mclaughlin@bakermckenzie.com
About the Asia Pacific
Healthcare Group
Ben McLaughlin talks about
Baker & McKenzie’s strengths
and value-added client services
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Head, Asia Pacific Healthcare Group
Baker & McKenzie
Sydney
Tel: +61 2 8922 5342
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Powering the Future of Healthcare in Asia Pacific | Funding, IP Protection | Chapter 3 (incl. 1&2)

  • 1. PoweringtheFuture of Healthcare in Asia Pacific How technology will change healthcare delivery
  • 2. Powering the Future of Healthcare in Asia Pacific The HealthTech Report Chapter 3 Funding Data driven Healthcare Chapter 2 Big Data and Analytics Benefits Legal Point of View: Data-driven Healthcare 5 Ways Big Data is Changing Healthcare Legal Point of View: Genomics Legal Point of View: Telemedicine What Does Following Investment Funding Tell Us? Opportunities in Asia Pacific Biosensing Wearables Mobile Devices Health Legal Point of View: mHealth Legal Point of View: Assessing Whether New Technology is Subject to Regulatory Compliance Looking Forward Legal Point of View: Funding Legal Point of View: Intellectual Property Why have we commissioned the report? The Creative Destruction of Healthcare Chapter 1 Moore’s Law The Innovator’s Dilemma The Healthcare Revolution Dramatic Changes in Healthcare: A Tectonic Shift Healthcare’s New Paradigm What are the Legal Consequences of the Healthtech Revolution? NEXT ISSUE Chapter 4 Disruption in Healthcare
  • 3. Key trends and innovation momentum drivers in Asia Pacific healthcare Preface The delivery of healthcare is poised for a radical change. The unparalleled ability to collect, mine and analyse health data, the increasing sophistication of bio-sensors, and the exponential rise in the use of smart phone devices provides opportunities for a radical re-think in how to economically and efficiently provide healthcare solutions for populations across Asia Pacific. This will affect healthcare systems providers as well as individuals. Healthcare resources that have been constructed largely to treat disease will need to be re-thought, to take advantage of technologies that monitor to prevent illness and to intervene early. Countries across the region in various stages of development are grappling with the possibilities of this healthtech revolution and the legacy issues of twentieth-century healthcare infrastructure for twenty- first-century healthcare solutions. In doing so, many issues are raised about the use of new technologies in healthcare that regulators lag behind in answering. It is these issues that we seek to address. This digital revolution of medicine will not only significantly benefit developed health systems, but will also allow developing economies to leapfrog over expensive development stages to establish better, effective health systems. For Asia Pacific’s developing economies, following the same evolutionary steps of developed economies is neither feasible nor required. It will prove too costly, take too long and lead to falling into the same pitfalls experienced by developed health systems. Above all, it fails to take advantage of the technology innovation that is disrupting the delivery of healthcare. The provision of modern-day healthcare across Asia Pacific concerns all stakeholders such as physicians, patients, hospitals, investors and ministries of health. The region faces a considerable public health challenge which is driving healthcare spending growth faster than GDP growth and will continue to negatively impact productivity. By 2030, India stands to lose approximately 18 million potentially productive years of life due to non-communicable disease- caused deaths. Asia Pacific healthcare is a paradox of significant unmet medical needs compounded by an under-invested and immature health system infrastructure. It has a large population that mostly pays for its own healthcare and is experiencing fast-growing power of purchase, driving the desire for greater choice and access to health services. In this era of radical technological change and innovation, the legal and regulatory landscape is undergoing gradual transformation and harmonisation. The ASEAN Medical Device Directive is an example of this. The healthcare industry now faces the issue of “law lag,” as laws are a number of steps behind technological advances. We are seeing common themes emerge across Asia Pacific in legal developments, with a focus on data protection laws, the regulation and promotion of medical devices, and the ability to protect, enforce and commercialise intellectual property. Governments and legislatures are charged with the challenging task of balancing the need for effective regulatory compliance with the need to foster and accelerate innovation and development, as well as to reduce overall healthcare costs. The opportunity to power the future of healthcare in Asia Pacific through technology innovation will transform the delivery of better healthcare. In these pages, we illustrate why we believe Asia Pacific stakeholders have an unprecedented opportunity and we propose how this could be achieved. Ben McLaughlin Head of Asia Pacific Healthcare Group Baker & McKenzie Julien de Salaberry Founder and CIO The Propell Group
  • 4. The Creative Destruction of Healthcare Chapter 1 Considered one of the most influential economists of the twentieth century, Joseph Schumpeter served as Austria’s finance minister and became a professor at Harvard University. In the mid-twentieth century, Joseph Schumpeter, the noted Austrian economist, popularised the term “creative destruction” to denote transformation that accompanies radical innovation. Over the past few years, our lives have been radically transformed through digital and technology innovation. But the most precious part of our existence— our health—has thus far been largely unaffected—insulated, and almost separated from this digital revolution. Until now. Medicine is about to go through its biggest shakeup in history.
  • 5. Asia Pacific’s developing economies face a significant and growing challenge to their ambitions to build an OECD standard of healthcare infrastructure and delivery. Two main challenges face these economies: The prohibitive cost of building such a healthcare system The increasing disease burden ranging from preventable communicable diseases to the growing trend in non-communicable diseases brought on by ageing and lifestyles Asia Pacific’s policy makers must therefore choose between two options: The conventional, long, expensive and unsustainable road which developed economies have been following Taking full advantage of the health technology innovations and new operating models which are transforming and will continue to transform healthcare across the globe A founding father of Silicon Valley, Gordon Moore co-founded chipmaker Intel in 1968. You can interpret the term Moore’s Law in two ways. There is its original meaning, which refers to the speed at which transistors on integrated circuits double. Alternatively, you can use the term as a metaphor to describe any form of rapid technological advancement. In its metaphorical sense, Moore’s Law is now one of the most important rules in business and the economy today. To borrow words used by consultancy firm McKinsey: Moore’s Law Today, a human genome can be sequenced in a few hours and for a few thousand dollars, a task that took 13 years and $2.7 billion to accomplish during the Human Genome Project. Or to quote Craig Venter— one of the leading scientists in the world today—in a lecture he gave at the BBC in 2007: The Innovator’s Dilemma First published in 1997, Christensen’s book suggests that successful companies can put too much emphasis on customers’ current needs, and fail to adopt new technology or business models that will meet their unstated or future needs. He argues that such companies will eventually fall behind. Christensen calls the anticipation of future needs “disruptive innovation,” and gives examples such as the personal computer. Harvard Business School Professor Clayton Christensen is the world’s authority on disruptive innovation and was named the World’s Most Influential Business Management Thinker in 2011 and 2013. The innovator’s “dilemma” comes from the idea that organisations will reject innovations based on the fact that customers cannot currently use them, thus allowing these ideas with great potential to go to waste. Asia Pacific has a broad spectrum of health systems and challenges, with Myanmar at one end after decades of under investment, and Japan the opposite end of the spectrum, with an OECD-standard health system. Whatever the level of maturity of any Asia Pacific economy’s health system, we advocate that all of Asia Pacific’s healthcare stakeholders need to overcome their innovator’s dilemma and take full advantage of the technological advances that are shaping the new healthcare paradigm powered by Moore’s Law. Over a short period of time genome projects, which, 10 years ago required several years to complete, now take only days. He suggested that within half a decade “it will be commonplace to have your own genome sequence, something that just a decade ago required billions of pounds and was considered a monumental achievement.” He said, “Our ability to read genetic code is changing even faster than changes predicted by Moore’s Law.” Metaphorical Moore’s Law may yet prove to be even more extreme in numerous medical disciplines such as nanotechnology or synthetic biology. Two factors enabling transformation of healthcare Factor 1 Factor 2 1 2 1 2 The innovator’s ‘dilemma’ comes from the idea that organisations will reject innovations based on the fact that customers cannot currently use them, thus allowing these ideas with great potential to go to waste. All figures in this report are in US dollars, unless specified otherwise.
  • 6. CREATIVE DESTRUCTION MOORE’S LAW 1950S 1965 Popularised by Austrian economist Joseph Schumpeter, this refers to the transformation accompanying radical innovation. Intel founder Gordon Moore’s observation that computing speeds double every two years, an idea that can also be applied to technology and economics.
  • 7. INNOVATOR’S DILEMMA THE HEALTHCARE REVOLUTION Coined by Harvard professor Clayton Christensen, this refers to companies rejecting innovations based on the fact that they cannot currently be used, with the ideas ending up going to waste. Dramatic changes of medicine brought about by mobile connectivity and bandwidth, Internet, social networking, increasing computing power and data universe, information systems, imaging, genomics and wireless sensors. 1997 2015
  • 8. The Healthcare Revolution We are set to see a truly radical change. Healthcare will focus on prevention. Up to now, healthcare has always concentrated on diseases. We only tend to receive medical attention if we are ill and usually rely on symptoms to drive us to seek a qualified medical opinion. Technology will be used to prevent us from becoming sick. It will enhance us all in ways that were once thought to be the exclusive domain of science fiction. mobile connectivity and bandwidth social networkingInternet increasing computing power and the data universe genomics wireless sensorsinformation systems imaging Dramatic changes in healthcare—a tectonic shift Technologies that will create this transformation include wearable technology, genome sequencing, collection, mining and analysis of big data, 3-D printing, nanotechnology, regenerative medicine, bionic technologies, and exoskeleton technology, to name but a few. We will, however, only consider the most relevant to Asia Pacific in this report. Nowadays, diseases that kill us are rarely epidemics as medicine has been very good at solving these; instead, each one of us is at risk of diseases of lifestyle, e.g.,Type 2 diabetes (T2D). If we could only make better decisions about our lifestyle, we could eliminate a substantial number of deaths from modern conditions. This is even more applicable in an era where good and comprehensive information is available. Technology is set to enable us to make these decisions. It will also enable us to enjoy better, more customised care and live longer in the future. The creative destruction of healthcare is being driven by the convergence of the following factors:
  • 9. Healthcare, which has to date been exclusively disease centric, is now becoming prevention centric or outcomes driven. In other words, a health system, which has so far been entirely focused and geared to curing or managing a disease, will transform into one focused on prevention of disease. This type of health system is gaining increasing traction here in Asia Pacific with economies such as Australia, Korea and Taiwan following the lead of economies such as the UK, Canada and Japan where health outcomes, daily average treatment costs and cost per QALY (qualified adjusted life years, which is a generic measure of disease burden, including both the quality and quantity of life lived, and used to assess the value for money of a medical intervention) are being assessed as part of the holistic healthcare consideration. These advances can be categorised into three categories as follows: One additional non-data-driven technology innovation which will have a positive impact on the delivery of healthcare in Asia Pacific is 3-D printing. We will consider its impact in a later chapter. DATA SHARED INFORMATION CLOUD DEVICES BIO-SENSORS The variety, veracity, velocity and volume of health data that is being collated and analysed to define actionable insights The ability of the computing power and software on devices to address both consumer and medical needs The ability to monitor our bodies and continuously gather data about human biology suggests new possibilities for both biomedical research and clinical practice Healthcare’s New Paradigm In this era of the creative destruction of medicine, we are also seeing a gradual transformation of the legal landscape in response to radical innovation in medical and health technology. Traditionally, the relationship between technology and the law has been underscored by the notion of “law lag,” meaning that legal cultures are generally a number of steps behind technological advances. This is no different for healthcare, and is particularly relevant to big data. The ever-increasing methods of collecting data, from mobile phone applications to biosensing wearables to telemedicine, will challenge the traditional concepts of “personal information,” “consent” and “medical devices.” Balancing the desire to unlock potential against the requirements for regulatory compliance is another component of the Innovator’s Dilemma. Privacy laws regulate how organisations collect, store, use and potentially disclose “personal information” identifying individuals. Organisations must ensure that they comply with these laws, as the legal consequences of non-compliance can be substantial, not to mention the risk of damage to reputation in the case of a serious data breach. In some cases, the regulatory compliance regime may restrict or even prevent innovators from pursuing new ideas, concepts or technologies. In the alternative, it is argued that if individuals do not trust the effectiveness of data protection laws, they will be less likely to engage in digital healthcare, which could threaten the highly beneficial applications of technological advances. Legal regulation must address these concerns by adopting appropriate measures to protect privacy. We will introduce our readers to key regulatory compliance matters, from data protection laws to the regulation and promotion of medical devices. Moreover, we will consider how companies can add value to their assets and businesses by understanding and utilising intellectual property rights protection. What are the Legal Consequences of the Healthtech Revolution? Promoting innovation should be a central objective of data regulation, yet the unprecedented ability to collect, analyse and store vast amounts of data raises new concerns about individual privacy rights. The traditional barriers, created by the lack of inter-operability (people, process, information) between stakeholders, are being dramatically removed or lowered by advances in technology. Ben McLaughlin on key implications of healthtech for healthcare stakeholders
  • 10. Data-driven Healthcare Chapter 2 Thomas Goetz, author of The Decision Tree: Taking Control of Your Health in the New Era of Personalized Medicine, once said: He is right. Data is of extreme importance in the delivery of a more efficient and effective healthcare system, and healthcare is becoming even more accessible like never before in the history of humanity. Firstly, it can be small data, specific to an individual and used solely to help people manage their own health, or enable the doctor, nurse or caregiver to support them directly. Wearable technology and advances in genome sequencing are creating information that can ensure that we apply healthcare technology in the most effective way. Alternatively, it can be big data, used by doctors, health insurers, hospitals and governments in the planning and execution of healthcare. We can use this data to diagnose diseases more effectively, implement superior preventive healthcare, allocate resources more efficiently and provide statistics for epidemiological analysis. Big data is being made possible in part by Moore’s Law, as computers are able to process more and more information. The cloud is emerging as a massive repository of medical data, which can be accessed by doctors and other medical professionals. Supercomputers, such as IBM’s Watson, are now enabling deep analysis and evidence-based reasoning for more precise diagnosis and clinical decision-making. IBM’s Watson is capable of reading millions of unstructured papers in a few seconds, which will enable it to process patients’ electronic health records, genomics, clinical data and healthcare professionals’ peer-reviewed publications. It is also able to monitor real-time data and new articles as they are published. Health insurers are using Watson to speed pre-approval processes for patients. Leading teaching hospitals, such as Mayo Clinic in the US, began working with IBM Watson to improve medical school training, in which they collaborate to offer doctors real-time analysis of patient records to improve care. Mobile applications that allow doctors and medical practitioners to look up databases containing information on thousands of diseases, including signs, symptoms and lab findings, are now a reality. The physician often has to make a diagnosis based on patient responses to particular questions and personal knowledge. This cannot be infinite, resulting in a need for additional data points. These are usually laboratory tests and/or second opinions from a peer or a referral. In the future, the access to a wealth of data, artificial intelligence (AI) analysis, as well as peer to peer (P2P) will enable more accurate diagnosis. For example, uploading a photo of a skin rash will generate a more accurate diagnosis through comparison with other patient cases and research databases. It won’t be long before technology breakthroughs such as advanced voice recognition are used in surgeries and other medical procedures. MindMeld has developed an application that enables doctors or other healthcare professionals such as nurses to spend less time behind their computers, encoding or retrieving data from electronic health records, thus allowing more time to counsel their patients. Combine this with apps that support a doctor’s diagnosis by efficiently and quickly analysing data from the big data cloud and the patient’s own sensors and trackers, and the relevance and accuracy of diagnosis will improve. Data gives us information. Information is vital in the war against disease and in creating a healthier society and a more effective health system. But we need technologies to implement the findings of data. Big Data and Analytics “Healthcare isn’t a science problem, it’s an information problem.” Advances in computer technology have created major possibilities.
  • 11. Just as the Internet of Things (IOT) will provide data to transform our homes, and just as big data is revolutionising the world of marketing, both are providing mankind with the information required to radically transform healthcare. It will provide doctors with the tools for predictive analysis. Natural language processing will also turn the data into insights about compliance and behaviour, and doctors will take data from individual departmental or hospital silos and use it to gain a much deeper insight into the incidence of a particular disease. Governments can plan better, allocating resources according to need and demand, and budget more effectively. The result will be significant. Singapore’s Smart Nation Vision, which aims to improve lives and businesses through technology, comes to mind. The initiative pulls together world-ranked universities and medical facilities, multi-billion- dollar annual research and development (R&D) investments, a fast-growing community of tech start-ups and large pools of investment capital to bring about better lives and greater business opportunities. Health insurance companies will be able to define customised policies and premiums according to individual risk profile. Equally, consumers and patients will gain greater visibility within the complex health system, giving them greater access to better- suited and more affordable health services. That empowerment will eventually contribute to reducing the enormous burden on essential providers such as hospitals. McKinsey’s recent analysis of the potential impact of known big data and analytics advances on US healthcare spending estimates potential savings of up to USD450 billion. Benefits The shift in the balance between disease management and early intervention will very likely have a broad beneficial economic impact on healthcare systems across the globe.
  • 12. In the age of data-driven healthcare, the ways in which organisations can collect, store, use and potentially disclose personal or sensitive information are growing exponentially. The aggregation and analysis of this data can have substantial economic value to those who collect it, and as we can see in the healthcare space, even society benefits if it is used properly. Conversely, this push towards data-driven healthcare raises significant privacy concerns, particularly where there is the potential for an individual’s sensitive health information to be disclosed (e.g., in the case of a serious data breach). The use of this sensitive information is typically baselined against the consent of the individual to whom the data relates, being obtained before it is used for analytical purposes. This consent requirement is not necessarily complementary to the vision of the benefits flowing from the use of big data in healthcare. There are, however, some examples of health information being exempt from the privacy laws for purposes relating to research and development. Data protection and privacy laws across Asia Pacific regulate how organisations use “personal data” or “personal information” identifying individuals. Most businesses now collect, store, use and potentially disclose personal information in some way. Asia Pacific has experienced solid development in privacy laws in recent times; however, each country has its own implementation and enforcement systems. Failure to comply, or responsibility for a serious data breach, can also damage an organisation’s reputation in the market and may affect their standing with the relevant government regulatory body or agency. There may also be specific laws or regulations that govern the collection and handling of individuals’ health information. There may be a legally enforceable right for individuals to access their health information contained in records held by private and public sector healthcare providers. The application of these laws may have a broader scope than the regulation of “medical devices,” and may apply to health and fitness mobile apps, wearable devices and associated software. These requirements restrict the potential benefits flowing from the use of big data in healthcare. However, there are examples of carve-outs being created for the collection and use of big data for specific purposes. Some jurisdictions (such as Singapore via the National Registry of Diseases Act) regulate the compilation of information relating to certain diseases for use in disease prevention. There may be a duty for healthcare institutions or practitioners who prescribe medical devices to patients to notify the relevant registrar of reportable diseases (e.g., cancer). Internal audit As a company, you must understand what personal data is being collected and how it is being used. In particular, the following questions must be answered: Legal Point of View: Data-driven Healthcare 1. If you collect and use personal information, have you checked the regulatory requirements on consent? If you have collected the data from an individual for one purpose, but now seek to use it for another, are you required to seek “fresh” consent from that individual? 1 2. Do you have appropriate measures in place to securely store personal information and destroy or de-identify this information when it is no longer required? 2 3. Does your company have a privacy policy, and is it up to date with your practices? 3 4. If you store personal information offshore, have you conducted a due diligence-style assessment of the privacy laws of the recipient country? 4 5. Can you ensure that the overseas recipient is also bound by the same laws? Or will you be liable if there is a breach in that country, even if it is completely out of your control? 5 6. Are you able to negotiate a data transfer agreement with the recipient that addresses matters such as a data breach response and notification plan? 6 7. Have you considered using a data security firm to assist in protecting the integrity of the personal information that you store or use? 7 1. To what extent is personal information or personal data being collected? Examples of personal information include a patient’s name, address, medical records and bank account details. 1 2. Is any “sensitive” information collected? Some jurisdictions place strict requirements on collection and use of sensitive information, including health information. 2 3. For what purpose is this information collected? The issue of consent by individuals arises in multiple jurisdictions. Where an individual has consented to the use of his personal information for a purpose (or multiple purposes), an organisation should not use that information for any other purpose. 3 4. Is personal information stored overseas? Some jurisdictions include restrictions on disclosing or transferring personal information outside of the “home jurisdiction.” This is a particularly important issue for cloud service providers, which often provide services to customers in one country, while basing their operations in another. 4 Assessing compliance Based on your answers to the above questions, you must now determine the extent of any data protection compliance issues. Remember, your company may be held accountable for serious data breaches involving personal information. The advantages of data-driven healthcare are clear. However, individuals and organisations operating in the healthcare industries must be aware that, as a general rule, “health information” is regarded as sensitive and is more heavily regulated under the various data protection regimes. It is imperative that big data initiatives and products in healthcare or otherwise comply with data protection laws, as the consequences of non-compliance range from fines to criminal offences and enforcement actions. Privacy Concerns: Regulating the Collection of Data What are the key data protection and privacy considerations for big data in healthcare? Case Example: Data Aggregators in Healthcare 1. Are you required to notify individuals when a data breach occurs? 8
  • 13. Human genome sequencing provides scientists with a roadmap of the human body. It is probably easier to equate this to understanding the computer code that governs our body. Just as computer code can contain bugs, the human body equivalent would be a defective protein, which would leave it predisposed to a disease such as cancer. Advances in sequencing the genome mean that in the next ten years many rare diseases will likely be downgraded to becoming curable diseases. Healthcare scientists agree that the genomic breakthrough in cancer treatments is already underway and transforming the treatment of the disease. Genomics is becoming more accessible and affordable through technology advances. A process that used to cost millions per person now costs just a few thousands. Novel business models, which, for example, just focus on a specific therapy area such as breast cancer, are able to provide a service to women at a fraction of the cost of a full DNA sequencing procedure. This new area of medicine will have fundamental impact on how each one of us will be able to manage our health, starting with prevention through disease management. It will impact most stakeholders from the patient to the healthcare professional, drug discovery and health insurance provider, to name a few. 5 Ways Big Data is Changing Healthcare Genomics1 “Chemotherapy is just medieval,” says Eric Topol, a leading American cardiologist, geneticist and researcher. “It’s such a blunt instrument. We’re going to look back on it like we do the dark ages. Tumours can now be sequenced and drugs tailored to the individual. It’s the dawn of personalised medicine.”
  • 14. With groundbreaking developments around the world in treating and curing cancer and rare diseases, genomics is elevated above big data initiatives for its transformative potential. However, it is not without challenges both from commercial and medical perspectives. From a commercial perspective, there is a need to have adequate intellectual property right (IPR) enforcement and protection systems in place to protect genome sequencing (via patent registration) and, by extension, to encourage R&D investment in this space. Conversely, the medical perspective can be a competing consideration for genomics. The very concept of obtaining patent protection over human genome sequencing and thereby monopolising rights to methods of medical treatment could be an impediment to the full realisation of genomics’ potential. The Human Genome Project is a practical example of the inherent conflict between genomics and intellectual property. The project was designed to generate a resource that would be freely available in public databases and used for a broad range of biomedical studies. This is in conflict with the very nature of the legal monopoly granted by patent protection. Equally, it is clear that considerable time, effort and funding are required to translate discoveries in the laboratory to treatment methods in a medical clinic. Thus, patents are an important way of encouraging private funding in science, as they allow investors the opportunity to maximise the profit from their investment. The patentability of gene sequences in developed IPR governance systems such as those in Australia, the USA and Europe varies. In late 2015, the Australian High Court determined that nucleic acid isolated from human cells was not patentable subject matter under Australian law (see D’Arcy v Myriad Genetics Inc. (2015) 325 ALR 100). This is consistent with the position in the USA where the US Supreme Court ruled that naturally occurring nucleic acid is a “product of nature” and therefore cannot be patented (see Association for Molecular Pathology v. Myriad Genetics Inc. 569 US - (2013)). In Europe, however, there is no bar to patenting gene sequences. The European Union Directive (98/44/EC) expressly provides that biological material (including gene sequences) can be patented provided the gene sequence is useful (i.e., susceptible to industrial application) and this is disclosed in the patent application. While patenting gene sequences or naturally occurring isolated nucleic acids per se is not permitted in Australia, the patentability of gene-related inventions remains possible. In Myriad, the High Court of Australia expressly left open the possibility that, where there is a new or improved process of nucleic acid isolation or where an invention consists of the application of isolated nucleic acid to a particular use, that method of isolation or use may be patentable. Legal Point of View: Genomics
  • 15. Legal Point of View: Telemedicine The increasing use and availability of telemedicine (or telehealth) is an important example of how big data is changing the face of healthcare. Telemedicine refers to the systematic provision of healthcare services over physically separate environments via an electronic communications network. This exchange of healthcare information between patients and healthcare providers (for diagnostic and clinical purposes) can be over the telephone, through text messaging, email, smart phone application or other telecommunications technology. Telemedicine has been used in Asia Pacific for close to a decade, and the regulatory environment is finally catching up. For example, in Singapore, new National Telemedicine Guidelines (NTG), covering a wide scope of services, were recently issued by the Singapore Ministry of Health. The NTG distinguishes between healthcare organisations and healthcare professionals involved in the provision of telemedicine and imposes different obligations on each group. From a legal perspective, the development of telemedicine as a viable method of providing medical services raises various regulatory issues. For example, in the future, will we see telecommunication/ Internet service provider (ISP) companies face liability for failing to adequately facilitate these services? Or will the telecommunications industry also be required to comply with laws regulating the provision of therapeutic services? Given the potential for vast amounts of personal and/or sensitive health information to be transferred using telecommunications technology, telemedicine also raises concerns in relation to privacy and data protection. As with conventional medicine, a clinician practicing in telemedicine has the same duties to safeguard a patient’s medical records and maintain confidentiality. However, the unique challenge for telemedicine clinicians is to manage the increasing number of people who will potentially have access to a patient’s records and to ensure that protocols are strictly followed to ensure the integrity of data and images transmitted for the purposes of a telemedicine consultation. However, telemedicine raises several legal issues, such as data privacy and licensing for cross- border services, that each jurisdiction must confront and develop a framework for.
  • 16. 2 Data Analytics Healthcare data analytics makes extensive use of data, statistical and qualitative analysis, explanatory and predictive modelling. It is the process of working with and mixing data sets so as to transform data into useful insights to support decision- making. This is being compounded by rapid growth of data with some 90% of the data available today having been created in the last two years alone, according to IBM. Digitising the files from the hospitals’ or physicians’ notes is the core of the electronic health (or medical) record (a.k.a. EHR or EMR). The ideal EHR would be a comprehensive file that includes all laboratory data as well as reports from procedures, operations, diagnostic tests, hospital discharges and visits with all healthcare practitioners. The launch of smart phone applications will allow the patient to have their own personal health record (PHR), which would ensure it is accessible everywhere or when needed. Initiatives in the US to digitise these records have delivered impressive results such as a 41% reduction in error rate and a 51% reduction of adverse drug events in just one hospital. If we consider the enormous burden placed on hospitals in most countries across the world, using big data and predictive analytics tools will provide much needed decision support tools to reduce cost, improve the quality of care and improve outcomes through smart operational improvements in hospitals through focus on the following: 1. Reducing readmissions by identifying high-risk patients and readmission time 2. Workforce planning for optimal nurse scheduling 3. Maximising hospital resources such as bed and operating rooms 4. Optimising elective admissions schedules to reduce midweek congestion and bed block 5. Scheduling operating rooms efficiently to coordinate patient care paths 1 2 3 4 5 The single greatest challenge facing healthcare data analytics is fragmentation of the available data.
  • 17. 3 Public Awareness: Planning & Preventing One of the biggest causes of disease in developing economies is a lack of awareness of the diseases (both communicable and non- communicable) and their causes. For example, diabetes prevalence in India is as high as 10% of the population (WHO) but fewer than 1% seek counsel from a healthcare professional. Often enough, they seek consultation once the symptoms are quite advanced. Current costs prevent routine health checks for the majority of the population in developing economies. Mobile device penetration is extremely high in Asia Pacific, facilitating both push-and-pull health and wellness information to be communicated or exchanged. In many Asia Pacific economies, the presence of counterfeit medicine further reduces the effectiveness of the healthcare system. For example, up to 50% of anti-malarial drugs in Cambodia are fake, leading to many patients being poisoned. Mobile devices provide a simple solution to verifying the authenticity of the medicine being purchased similar to countering credit card fraud. The use of mobile technology in collaboration with a well-thought- through disease awareness campaign would enable the effective use of data to reduce and prevent disease.
  • 18. 4 The power of today’s computers combined with the major advances in analytics, such as machine learning, is making it possible to blend a greater variety of data to generate clinical and non-clinical intelligence. IBM’s Watson supercomputer has the capability to analyse vast amounts of data on a cloud-based platform that puts the power of the analysis in the hands of physicians, researchers, insurance actuaries and other non-technical users. Using advanced technical capabilities, such as artificial intelligence and machine learning algorithms, the system responds to clinical queries in natural language and comes up with responses based on medical evidence that is gathered and constantly analysed in the system. In May 2015, IBM Watson Health announced a major push into the healthcare analytics space through strategic partnerships with Mayo Clinic, one of the leading hospitals and medical research institutions in the US, and Epic, a provider of Electronic Health Record (EHR) systems with access to vast amounts of patient medical records. IBM has been aggressively pursuing access to patient data to feed the Watson engine, more recently through the acquisition of Explorys and Phytel. These acquisitions and partnerships deepen IBM’s commitment to extend Watson’s cognitive computing power to advance the quality of healthcare, specifically in areas such as cancer prediction and treatment. Similarly, new entrants in healthcare such as Google or Flatiron Health are focused on linking and analysing all the patient and research data of a specific disease area such as oncology to develop insights to significantly improve research and treatment. Support Providers
  • 19. 5 Support Self-Care/Digital Therapeutics The rapidly expanding ownership of smart devices (over 1 billion Android devices worldwide) equipped with a growing number of built-in sensors and the growing versatility of wearables (which we discuss in the next section) are making patient-empowered disease and pre-disease management a reality through the combination of customised apps and the increasing variety and frequency of patient-centric data. In the past few years, a handful of medically minded visionaries have put real clinical rigor into every aspect of their disease management application design. For instance, David Van Sickle, a former CDC epidemiologist intelligence officer, and now the CEO and co-founder of Propeller Health, built a GPS-enabled sensor for asthma inhalers that links to a mobile device app — every puff is mapped and time-stamped, allowing patients and doctors to spot patterns in “random” attacks and identify previously unknown triggers. For the first time in its history, the World Health Organization’s Centers for Disease Control and Prevention (CDC) has recognised digital therapeutics as meeting the evidence-based standards for the agency’s National Diabetes Prevention Program (DPP) when it listed Omada Health as an effective diabetes management aid in March 2015. We will likely see physicians prescribing regulation-approved apps not just to monitor and manage chronic disease but also to pre-empt acute disease events. Preventing individuals from progressing to more advanced diabetes status through device- based therapies or behavioural change would have a significant impact. We should also consider the beneficial impact of this type of technology on improving disease awareness in a region where a small fraction of individuals at risk or with a chronic disease actually consult a healthcare professional. The high prevalence of chronic diseases in Asia Pacific warrants the need for similar behavioural change digital programs customised to be appropriate to differing levels of income and device sophistication, among others.
  • 20. First-generation consumer wearables were built with just one sensor (accelerometer), and they are already making a difference. Wearable devices from Fitbit or Jawbone can, for example, tell us how active we are in a day, or a week or a month. They can also estimate the quality of our sleep. More to the point, such products encourage us to improve our habits and/or behaviour through gamification. This can involve incentivising and rewarding people to meet pre-set goals using techniques often used in games, for example, rewards, or a progress bar, in addition to peer pressure via social media. Next-generation wearable biosensors such as smart watches, smart clothing, jewelry, patches and wearable tattoos are emerging and are able to capture physiological data such as movement, respiration, hydration, glucose, skin conductivity, heart rate, temperature, posture, oxygen level, muscle activity and blood pressure. Next-generation wearable biosensor technologies will be embedded in our clothes, homes and cars, and other places we regularly frequent or use. Biosensing Wearables Biosensors Devices that convert a biological element into a signal output Activity Trackers e.g., Fitbit, Misfit Smart Watches e.g., Garmin Patches and Tattoos e.g., Zio, MC10 Smart Clothing e.g., Athos Ingestibles and Smart Implants e.g., Proteus Wearables On- or in-body devices that enable user experience Chronic diseases, such as diabetes, can also be better self- managed with apps, in tandem with specific wearable biosensors such as a glucose meter that helps to measure carb intake, calculate administered insulin quantity and receive tips on diet and lifestyle modifications essential for slowing down the progress of the disease. The combination of biosensors and advanced data analytics is rapidly democratising the access to personal health data as well as access to complex computational capability and placing it in people’s hands. They are effectively transferring power from the hands of scientists and academics to ordinary citizens. A very similar revolution is taking place in the medical device environment. Take for example AliveCor, a peripheral attached to a smart phone that enables users to record and share their own electrocardiograms (ECG/EKG). Amongst other things, this device will probably spell the demise of the stethoscope. Doctors prescribe the device for at-home use so that they can regularly monitor patients remotely. Today, if patients do not have the symptoms of heart disease it is generally assumed that they don’t have the disease. Home use would enable a doctor to track whether a patient’s at- rest heart rate is rising over a prolonged period of time and therefore tackle potential heart disease early. This way, patients can also determine whether the therapy they have been prescribed is effective. Imagine slapping a sticker on your arm that could measure a wide array of medical indicators — heart rate, body temperature, blood pressure and more — and transmitting that data wirelessly to your smartphone. MC10 is developing products that can be used both on and inside the body, that monitor head impact, heart rate, brain activity, muscle function, body temperature and hydration. It is also developing an entirely new class of intelligent medical device with embedded sensors for enhanced sensing and therapeutic capabilities. Looking forward a few more years, combine this with advances in nanotechnology, and the same sticker will also be able to release drugs stored inside nanoparticles when data from the sensors suggest it is required. This technology will fundamentally change the way in which medicine is administered and how chronic diseases such as Parkinson’s are managed. We have deliberately not addressed other significant scientific advances such as regenerative medicine, stem cell research and nanotechnology, as these are regarded to not be sufficiently advanced to have an impact on Asia Pacific’s health system in the short to medium term. Thanks to advances in the computing power of handheld devices, combined with an increasing number of sensors built into them, it is becoming both practical and realistic for patients to manage their own healthcare in a way that was never possible before. What data privacy and compliance issues arise from biosensing wearables?
  • 21. Mobile Devices Health Recently published research estimates mobile phone penetration in Asia Pacific to reach 70% of the population by 2019. This will continue to grow as countries such as Myanmar build their mobile phone network and their population comes online. Smart phone adoption is also growing fast as new handset manufacturers (e.g., Xiaomi in China or Micromax in India) enter the market with state-of-the-art devices for USD250 or less. Tablet ownership has also recorded significant growth in many Asia Pacific countries. As Thomas Goetz put it, healthcare is about information. We are all looking for data to inform our personal and professional decisions, e.g., shopping, dining out and booking taxis. Delivering better healthcare in Asia Pacific should be no different. Mobile devices enable this by giving the health system the ability to do the following: 1. Provide health information and education 2. Communicate broadly and directly with the population on health matters 3. Engage directly with the population on health matters related to them It has the power to break down the barrier between healthcare and the consumer/patient-democratising healthcare. A poignant example of its impact relates to infant mortality in the region. Countries such as India and Indonesia have failed to meet their United Nations Millenium Development Goal (MDG) to reduce infant mortality. The infant mortality rate in India is three times higher than China’s and seven times greater than that of the US. There are numerous causes of infant mortality, but an important one is insufficient maternal health. A leading consumer goods manufacturer launched a program that works with mothers and community leaders to educate them on basic health practices such as washing hands with soap daily, particularly before handling newborn infants. This very successful program provided mothers of newborn infants with free-of-charge awareness and education modules via their mobile phones specifically designed to address rural areas where most handsets are still unsophisticated. The company also adjusted its soap pack size to cater to the daily cash flow limitations that exist in rural areas. Overall mothers and infants have benefited and the consumer goods company has generated revenue and brand awareness with a new customer segment. It is a great template for other healthcare stakeholders as we aim to improve healthcare in the lower echelons of the income pyramid. 1 2 3
  • 22. Mobile health, now known as “mHealth,” has been identified by the World Health Organization as having “the potential to transform the face of health service delivery across the globe.” The rise in the use of mHealth in developing countries presents significant risks in countries where privacy laws are non-existent or inconsistent. To address these risks, Baker & McKenzie and Merck partnered with the United Nations Foundation’s mHealth Alliance and the Thomson Reuters Foundation’s TrustLaw to develop “Patient Privacy in a Mobile World: A Framework to Address Privacy Law Issues in Mobile Health” (June 2013). This pioneering initiative covers mHealth-related privacy and security issues around the globe. A key purpose of the mHealth Alliance Report was to review privacy and security policies around the world and to identify gaps in these policies that must be addressed to protect personal health information. The mHealth Framework states that privacy laws are roughly split among (1) omnibus data protection (i.e., laws that regulate all personal information, as in Europe), (2) sectoral privacy laws that address privacy issues in specific industries and business sectors (as in the US), and (3) constitutional protections, where there is a human right to the protection of personal information. The mHealth Framework sets out a functional framework for addressing these privacy law gaps, and is sensitive to different cultural, technological and institutional contexts. Legal Point of View: mHealth Notably, the results of the mHealth Framework indicate that few existing laws make reference to mHealth or other technological advances in healthcare.
  • 23. The development of applications assisting in the diagnosis and treatment of medical conditions can give rise to regulatory requirements. In particular, some jurisdictions have provided guidance that mobile apps with therapeutic application, or marketed as having therapeutic application, could be regarded as “medical devices” under the applicable regulatory regimes. Is it a “medical device”? Several jurisdictions in Asia Pacific have extended the definition of “medical device” to capture a large number of healthcare technologies, including smart phone applications, blood pressure monitors, diagnostic software and disposable cell testing devices. In some instances, these technologies may need to be registered with a government body or agency before they can be imported, exported or made available in the market. Generally, medical devices will be any article or object (including software) that is intended to diagnose, prevent, monitor or treat a disease or injury in humans. Some countries, such as Malaysia, require all medical devices to be registered with the Ministry of Health, while other countries, such as Australia, may take a “risk- based” approach to regulation. This means that the level of scrutiny and oversight by the government body or agency will vary according to the level of risk that the product represents to the patient or physician using it. In some cases, whether a product is considered to be a “medical device” will depend on (a) the intention of the manufacturer or supplier, and/or (b) how they will market (or have marketed) their product. We see this illustrated in the treatment of wearable devices and other devices developed for use in relation to “quantified self” health information by different regulatory regimes across Asia Pacific. In some jurisdictions, devices marketed as being used for sporting activities are exempt from regulation; however, a largely similar device, which was marketed as having more general application, may not be able to take advantage of this exemption and could therefore be subject to regulation (despite having similar or identical functionality). In contrast, in jurisdictions such as Australia that regulate devices having therapeutic application, a device may be subject to regulation if it is marketed as having a purpose relating to diagnosis, prevention, monitoring, treatment or alleviation of disease, for example. If the device is not marketed this way, it will not be regulated. In late 2014, the Australian regulator clarified that the definition of a medical device includes “software programs or operating instructions that control the functioning of an electronic device such as smart phone apps.” The key consideration is whether the app simply presents information to users (in which case it is unlikely to be a medical device) or whether the app has a therapeutic or diagnostic use, for example, by way of a monitoring or diagnostic function (in which case it is likely to be classified as a medical device). However, an app regulated as a medical device in its own right and developed for use in conjunction with an unregulated wearable or quantified-self device is unlikely to extend regulation to the device and is likely to be seen by the regulator as extending “beyond the intended use” of the manufacturer, and therefore the device itself can still be treated as a consumer electronic device and not a medical device. Promotion, advertising and other marketing of medical and healthcare technologies is closely scrutinised in most jurisdictions to protect patients, consumers and healthcare professionals. Generally, most countries in Asia Pacific will prohibit any commercial conduct that is misleading or deceptive, in addition to specific prohibitions relating to the healthcare industries. 1. In Australia, the Therapeutic Goods Advertising Code 2007 regulates the advertising and promotion of certain therapeutic goods, including “medical devices,” and contains a number of prohibitions and requirements. 2. In China, the Advertising Law (administered by the State Administration for Industry and Commerce) provides that advertisements published through the mass media should be marked as such, and be differentiated from other non-advertising information, so that consumers are not confused or misled. The Advertising Law also requires all advertisements containing drug names and the ailment or symptoms to undergo examination before publication. 3. In Hong Kong, the Undesirable Medical Advertisements Ordinance (Cap 231) restricts the advertising of abortion, medicines, surgical equipment and treatment for curing or preventing certain diseases or conditions. “Medical devices” will often be subject to the same legislation as medicinal or other therapeutic products. However, the specific prohibitions on advertising of medicine (particularly prescription medicine) to healthcare professionals and consumers generally will not extend to medical devices. For example, a requirement that advertisements for prescription medicines be pre-approved by the government agency may not apply for medical devices. However, this differs between jurisdictions, and one must carefully review applicable advertising laws and codes before commercialising a product. Some countries, such as Japan, even allow advertising of prescription medicines on television direct to consumers, provided such advertising is not misleading and encourages responsible consumption. Be aware that in some cases, the advertising codes may be developed and published by industry bodies (such as the Medical Technology Association of Australia), which do not have any formal regulatory function but can be either binding upon members or set the baseline for best practice in that jurisdiction. 3 Legal Point of View: Assessing Whether New Technology is Subject to Regulatory Compliance Therefore, when dealing with any medtech product, the key question to ask is, is the product considered to be a “medical device” in this jurisdiction? 1 2 Promotion
  • 24. Funding Chapter 3 In one of the better-known scenes from the film Jerry Maguire (1996), Rod Tidwell has Jerry Maguire repeatedly bellowing “Show me the money” down the phone in order to remain Tidwell’s agent. Many observers of the emerging healthtech revolution will likely utter the same words. A study of the flow of venture funding into the healthtech sector, essential to the growth of new solutions and business models, reveals significant activity in the last few years. Healthtech is among the more exciting up-and-coming industries these days, alongside the likes of virtual reality/augmented reality, artificial intelligence and Blockchain. Not only are old markets like health insurance being disrupted and changed, but new industries like digital therapeutics have sprung to life with the advent of biosensors. Venture capitalists have taken notice and have been pumping funding to these new ventures, totaling $13.4 billion since the beginning of 2011. Although venture capital firms have been investing in this sector for some time, the activity has notably increased in recent years. 2014 Global Healthtech Funding Rockets Healthtech funding in 2014 not only broke all records, but it quadrupled from 2011, doubled from 2013, and exceeded the prior three years combined, closing at $4.1 billion. In tandem, the number of deals completed has tripled since 2011. What Does Following Investment Funding Tell Us? Global Overview Key highlights: Key investment themes are taking shape - the top five categories being: » Analytics and big data - $393 million » Healthcare consumer engagement - $323 million » Digital medical devices - $312 million » Telemedicine - $285 million » Personalised medicine - $268 million The six largest deals in 2014 saw further rounds in 2015: » NantHealth ($375 million) - Series B - Kuwait Investment Authority » Proteus ($172 million) - Series G – undisclosed investor(s). In previous funding rounds, Proteus has been backed by the Carlyle Group , Essex Woodlands, Kaiser Permanente, Medtronic Inc., Oracle Corp . and ON Semiconductor Corp., VentureWire records show. The company’s two main strategic partners, Novartis AG and Otsuka Pharmaceutical Corp., are also investors » Flatiron ($130 million) - Series B - Google Ventures » Alignment Healthcare ($125 million) - Private equity, undisclosed » Invitae ($120 million) - Series F - 14, different investors There were 95 healthtech M&A transactions in 2014, which reflect increasing interest from corporates and strategics in the sector: » 46 M&A deals in healthtech alone, with blue-chip players such as Aetna, GE, Medtronic, AstraZeneca and Facebook making acquisitions Strong IPO trend building with five healthtech ventures going public in 2014 10,000+ healthtech start-ups estimated across the globe 2015 Global Healthtech Funding Maintains Momentum Many healthtech investment data sources and conclusions exist. Much of this variance is due to the range of different definitions of what constitutes healthtech. Health 2.0, a new health technology catalyst, reports healthtech funding numbers for 2015 at $4.75 billion. Rock Health, a venture fund focused on digital health, had assessed the number at $4.3 billion; Mercom Capital estimates it at $4.6 billion and both CB Insights, a data analytics company, and StartUp Health, a leading healthtech incubator, have pegged it at $5.8 billion. Although these reported numbers differ primarily driven by definitions, they tell the story that healthtech investment is maintaining a steady momentum and expected to grow in maturity in 2016. For reference, StartUp Health has it dropping $1.2 billion, Rock Health has it holding steady and Health 2.0 actually records a slight increase from $4.6 billion in 2014. In an effort to remain conservative and due to their definitions, we have used Rock Health’s analysis as our primary source. 2015 Healthtech Summary Key highlights: Venture capital (VC) funding globally for healthtech totalled an average of $4.5 billion in 2015, which sees 2015 edge ahead of 2014. The number of deals completed in 2015 decreased marginally, driven by larger late-stage deals Series C and beyond. Top six healthtech themes attracting the lion’s share of funding include: » Healthcare consumer engagement – $629 million » Wearables and biosensors – $499 million » Personal health tools and tracking – $409 million » Payer administration – $263 million » Telemedicine – $236 million » Care coordination – $208 million Among the 27 countries with recorded healthtech deals, 19% of funding came from outside the US. Top VC healthtech companies, defined by number of deals completed in 2015, include: » Guahao (China) – $394 million » NantHealth (USA) – $200 million » ZocDoc (USA) – $130 million » Helix (USA) – $100 million » Practo (India) – $90 million Close to 900 investors participated in healthtech deals in 2015, up 25% in 2014. Fifty-one VC firms closed three or more deals in 2015. Corporate/strategic investors were increasingly active. Top VC investors in 2015 include: » New Enterprise Associates (NEA) » Rock Health » Merck GHI » Venrock Five healthtech IPOs in 2015 raising a combined $1.2 billion: » FitBit – $732 million » Teladoc – $158 million » Invitae – $102 million » Evolent – $195 million » MindBody – $101 million There were 187 healthtech M&A transactions in 2015, nearly doubling from 2014 and indicating an increasing consolidation in the sector. In the venture capital industry, each round of financing for a new business is referred to as a “series.” The type of series (A, B, C) helps investors know where they are in terms of claiming future profits for a company. To better understand this cycle, read David Newton’s article, “Understanding the Financial Stages,” in https://www.enterprenuer.com/article/42336
  • 25. Opportunities in Asia Pacific One of the drivers for entrepreneurs and investors to start and scale a business is the size of a market and an unmet need within it. According to Frost & Sullivan, total healthcare spending in Asia Pacific is expected to reach $2.2 trillion in 2018, which represents a huge opportunity. The good news is that the purchase power of many of these individuals is also growing fast and will continue to do so for the next 20 to 30 years. Average GDP per capita in developing Asia Pacific remains significantly below OECD economies. Many Asia Pacific countries, however, have very under- developed healthcare infrastructure, which limits access to a good standard of healthcare. For example, India has 0.5 doctors per thousand of population, whereas the US has 3. This is compounded by largely unmet medical needs. For example, Indonesia has 150 coronary disease-related deaths per hundred thousand, whereas France has 29.2. Healthtech therefore represents a substantial opportunity for all healthcare stakeholders and investors. Key investment categories in healthtech include digital therapeutics, data and analytics, and diagnostics, to name a few. Going forward, in addition to the continued growth in momentum in the healthtech space driven by compelling start-ups and their products and investors hungry for attractive deals at sensible valuations, we will also see increased activity from corporates, both incumbents and new entrants, and from governments with initiatives such as Singapore’s Smart Nation. Asia Pacific Healthtech Landscape Over the past three years, healthtech in Asia Pacific has evolved from a nascent one to a thriving ecosystem. This increasing momentum, driven by the following key factors, reflects the hierarchy of needs within the health ecosystem: Lifestyle and wellness apps driven by growing middle- class affluence Chronic disease management driven by growing health awareness Frugal innovation enabling better care at an affordable price point Growing demand for senior healthcare products and services Consumers seeking a wide range of healthcare solutions and value for money When compared to its regional neighbours, Singapore punches above its weight in terms of the number of healthtech start- ups operating from the island. Singapore represents a natural go-to point for entrepreneurs and investors alike due to its stable economic and legal environment as well as its significant investment in biomedical facilities over the past 30 years. We expect the enthusiasm Singapore has demonstrated for both biotech and medical devices to be echoed in healthtech. Noteworthy Asia Pacific Healthtech Deals 2014-2015 Guahao (China) raised a $394 million series D from Tencent and Goldman Sachs Practo (India) raised a $90 million series C from Sequoia Capital, Google and Tencent Portea (India) raised a $37.5 million series B from Qualcomm, IFC and Accel Partners Meet You (China) raised a $35 million series C from Matrix Partners and K2 Ventures PICOOC (China) raised a $25 million series B from Tencent and Gobi Partners ConnexionsAsia (Singapore) raised an $8 million series A from Northstar and BioVeda These only represent a small number of the many healthtech venture deals completed in Asia Pacific in the past 18 months. Mature Asia Pacific economies such as Japan face very similar healthcare challenges to their fellow OECD nations. Each one of them needs to continue to define how they will continue to deliver high healthcare standards despite an ageing population and dwindling workforce. In contrast with the mature markets where most healthcare costs are reimbursed, healthcare expenses in Asia Pacific are usually an out-of- pocket cost for the individual who is therefore looking for choice and cost effectiveness. Singapore’s commitment to become a leading regional innovation hub positions it as an ideal platform for healthtech innovation leadership. Accelerators and Incubators Over 100 accelerators and incubators have been launched across Asia Pacific in the past three years, contributing significantly to fostering the early- stage venture ecosystem across the region. Until recently, virtually none were 100% focused on healthtech, but this is changing. In 2015, we witnessed the launch of three new accelerators/ incubators dedicated to healthcare. The most advanced of these three is the AIA Accelerator (powered by Nest), which ran its first cohort of eight healthtech start-ups in mid- 2015. This attracted 76 applications from 16 countries around the world, even though no upfront funding was offered. Building on this success, AIA has teamed up with Konica Minolta to launch another healthtech accelerator in Singapore. As proven by the queen of entrepreneur ecosystems, Silicon Valley, the development and fostering of quality early- stage ventures requires all key stakeholder groups to play a catalyst role. Corporates and strategics have begun stepping into the Asia Pacific healthtech sector, with insurance companies leading the charge. For example, in addition to the previously mentioned AIA, Metlife has launched its own internal incubator, Lumen Lab, which has a deliberate healthtech focus. Healthcare industry incumbents have remained, so far, on the sidelines in Asia Pacific despite their activities in other regions, such as in the USA. The boldest amongst them have recently started their journey to better understand the ecosystem. Healthtech represents a unique opportunity for all investor types to create sustainable social and monetary value across Asia Pacific.
  • 26. Looking Forward “Eighty-five percent of technology companies and venture capitalists surveyed say disrupting healthcare is a top strategic priority.” – Accenture report entitled “Silicon Valley’s New Darling: Healthcare” (2 February 2016) Four key drivers will continue the convergence of tech with healthcare: 1. Sizeable value pool – Forbes’ investment report last September listed healthtech as the “most profitable industry.” 2. Technology disrupting other sectors – New entrant traction in public transport (e.g., Uber) and accommodation (e.g., Airbnb) has attracted the attention of established technology players (e.g., Qualcomm) as well as new entrants (e.g., Proteus). 3. Funds and credibility – Enabling household names such as Google to build top- quality healthcare teams (i.e., clinical). 4. Lowered barriers – The FDA’s decision, in its 2014 guidelines on healthtech, to not enforce regulations akin to drug- or medical device- type regulations is lowering the entry barrier for new entrants. Key areas of growth for technology’s convergence with healthcare will likely include: 5. Access to healthcare 6. Cost control and transparency 7. Disease management 8. Workforce shortage 9. Hospital administration and operations 10. Population health 11. Wellness Conclusion The healthtech revolution in Asia Pacific will have a massive positive impact on everyone in the healthcare ecosystem. Similar needs, expectations and challenges exist across both developed and developing Asia Pacific. China’s healthcare ecosystem will benefit greatly from its government’s directives; however, it is likely that, in the short term, the remainder of developing Asia Pacific will need to rely on private enterprise and consumers to drive the much-needed transformation.
  • 27. Legal Point of View: Funding Traditional funding typically involves loans from financial institutions, government funding or subsidies, private funding or going public and listing on a stock exchange. Bank loans require regular repayments and smaller start-ups may not be able to do so, especially at the early stages where there may be no steady streams of cash flow, since a lot of investment is required before there may be any results. With the lack of a track record and uncertain future earnings from products that are still works in progress, a public offering and listing may also be less feasible for a small start-up firm. In this section, we focus on the sources of funds that are more accessible for smaller corporations, namely private funding and crowdfunding. In the case of healthtech companies seeking funding, while many options are available for well-established firms, for the smaller and newer start-ups, access to some of these methods may be limited for various reasons. Funding considerations for healthtech start-ups
  • 28. Private Funding This method of funding largely involves investments from angel investors or venture capitalists keen on being at the forefront of new and innovative products, even from untested start-ups. The investors may involve a single firm, or multiple firms, with a lead investor firm running the transaction. Multiple series of funding could be involved with each start-up, and investors are willing to give the start-up a few years to show returns of their investment. As co- investors, the angels or VCs may or may not take on active advisory roles. Investee businesses should note that depending on the terms of the agreements that they enter into, certain decision-making processes may only be made with the approval of its co-investors. This may affect the extent of their autonomy in the control and management of activities. Some of these requirements include the ability for the representative of the investor to take up a position on the board of directors, requiring the start-up to have a minimum paid-up capital, having an advisor experienced in the industry consulting with the start-up, at least one full-time founder tobeinvolved inthestart-up, investments by the founder(s) in the start-up and no or minimal investments from other external parties. There is a growing number of angel and VC funding options available in Asia Pacific in recent years, and millions of dollars have been made available to start-ups through such private funding. We note a large interest from angels and VCs especially in healthcare and technology industries, and believe that healthtech is compatible with the general sectors of interest to various angels and VCs. Crowdfunding Increasingly, several healthtech start-ups, especially in the USA, have turned to crowdfunding platforms for funding, such as Indiegogo, MedStartr, VentureHealth and Healthfundr. Donation-based or rewards-based crowdfunding (also referred to as community crowdfunding) are generally less regulated in Asia Pacific as there are no offers of returns or potential returns to donors. Various crowdfunding platforms are accessible to the public across Asia Pacific and many start-ups actively utilise these avenues for fundraising. Such crowdfunding from a healthcare perspective is still less commonplace in Asia, but with the prevalence in the USA, it would only be a matter of time before it gains ground in the sphere. Crowdfunding that involves a financial return includes lending- based and equity-based aspects. These methods of fundraising would be subject to the relevant securities laws, which would result in various restrictions or licensing requirements. Malaysia, Singapore, Thailand and Indonesia have implemented or are in the process of implementing regulations to facilitate the establishment of equity crowdfunding while ensuring investor protection. Concerns raised by regulators include the risks associated with investing in start-ups, which do not guarantee success, and the illiquidity of these investments. The regulations, or proposed regulations, across Asia Pacific generally allow institutional or accredited investors to participate in equity-based crowdfunding, and some limit the amount of retail participation, if at all. While Asia Pacific seeks to find its equilibrium between giving a hand to budding entrepreneurs and safeguarding investors in the coming years, healthtech organisations should engage all avenues available to them. But start-ups should also make sure that they don’t fall foul of both local laws where they are based or the foreign securities laws that may apply to potential investors. Certain investors may have requirements that must be met before they would consider investing in the enterprise, in order to protect their interests and to ensure that the start-up moves in the right direction to minimise the chance of failure. As crowdfunding is a relatively new concept in Asia Pacific, crowdfunding regulations are still being implemented at different stages across the region, and the legal consequences arising from these new regulations are still untested.
  • 29. Legal Point of View: How to Utilise Intellectual Property (IP) Laws to Add Value to Your Technology Innovators and organisations alike should be alert to, and take advantage of, the various ways in which IP protection can add value to their assets and businesses. Assets such as software, processes, business plans, client lists, logos, designs, inventions and others, are often considered as mere working material and are not protected. However, this could lead to a loss of the immense value they represent for innovators and organisations alike. IP rights give the owner the right (and in some jurisdictions, the obligation) to invest in, sell or licence their innovation over a certain period of time. In most jurisdictions, these rights are enforceable through the courts, which have the authority to stop IP infringement. It is imperative that patent and trademark applications are made, and registrations granted before an invention enters the market. In particular, if you are planning to obtain patent protection, your invention must not be disclosed to anyone unless they have signed a confidentiality undertaking (e.g., a non-disclosure agreement). Otherwise, it is unlikely that your invention will satisfy the novelty requirement at the time of filing at the relevant patent office. In essence, if your product is already available in the market, it will not be considered novel. Once your IP is registered or otherwise protected, there are various options available for commercialising your IP (i.e., getting your IP to market). Licensing (exclusive and non- exclusive) is the most common commercialism mechanism used. Other ways of commercialising IP could be a joint venture arrangement with another established company, or a start-up enterprise involving venture capital. Furthermore, accurate IP valuation and protection is an important part of an organisation’s asset management strategy, providing better negotiating positions and increased avenues for income generation. Conversely, failure to pay proper attention to the valuation and protection of an organisation’s intangible assets could have a detrimental effect in various commercial scenarios, such as mergers and acquisitions, licence or franchise negotiations, purchase and sale of IP assets and financing/investment opportunities. With the unprecedented influx of health and medical technologies, obtaining IP protection for computer programs and software continues to be a challenging business issue for innovators and organisations alike. Below is a summary of the key types of IP protections that may be available for computer program rights in Asia Pacific: In some jurisdictions, such as Australia, computer software is primarily protected by copyright as a “literary work,” although a computer program may also be patentable. Trademark law, with its system of registration, gives significant protection for brand names, logos, devices and forms of trade dress used in relation to software products and packaging, but is not a source of substantive rights relating to the content or function of software, or its underlying code. Software is potentially patentable, although claims for mathematical algorithms alone are generally not. Unauthorised copying of software may also be actionable under laws governing misleading and deceptive conduct, passing off, trade secrets (see below) and confidential information. Software and computer programs are unique as they can be protected by both copyright and patent law in most Asia Pacific jurisdictions. Copyright in software protects the unique expression in the source code, while patents protect new and non-obvious functions. Patents are, on the whole, far more valuable as they protect the implementation of the source code (i.e., the “function”), regardless of how this is documented. As such, anything that may compromise another person’s (or company’s) patent rights should be avoided, as enforcement proceedings can be costly, both financially and in terms of reputation in the market. Both globally and within Asia Pacific, several approaches have been adopted to protect software by means of patents. While many countries grant patents for software, computer programs are specifically excluded from patentable subject matter in others (including China, Indonesia, New Zealand, Thailand, the Philippines and Vietnam). However, in many of these “excluding” countries, it may be possible to obtain patent protection for computer program- related inventions. In some jurisdictions, mathematical algorithms in themselves are unpatentable, except for computer software that produces physical effects (for example, an improved method for drawing a curved image in computer graphics; see CCOM v Jiejing (1994) 28 IPR 481(the CCOM Case)). Similarly, business methods may be patented if they produce an artificial state of affairs, in the sense of a concrete, tangible, physical or observable effect. The main controversy surrounding computer program patents can be summarised as follows: It is often said that software innovation involves cumulative, sequential development and re-use of other people’s work, particularly with respect to open source software (see below), which preserves interoperability between programs, systems and networks. This interoperability does not fit within the patent framework, which limits the range of options available to new software innovators. Conversely, proponents of software patents argue that patent protection is necessary in order to encourage investment in this field. This financial support is vital to support innovation in various technological areas, including medical and health technology. Open Source Software (OSS) is software that is licenced on very liberal terms to allow licencees more than just access to the source code of the software. As a general overview, OSS licences allow for the following: free re-distribution of software by any party without payment of a royalty or licence fee programs are distributed with their source code the licence will allow for modifications to the source code and derived works these derived works can then be distributed on the same terms as the original software licencee Patent laws give patent owners substantial, valuable control over who uses their invention, and extends to any form of use (i.e., patent infringement is generally a strict liability offence). Conversely, the basic premise of OSS is that innovators should be able to view and use the source code of the computer program and modify it for their own purposes without obtaining the consent of the licensor/owner. Ensure Your Competitive Advantage by Protecting Your Ideas Overview of IP Protection Methods for Computer Programs/Software Protecting Software Technology What is Open Source Software? The Inherent Conflict Between OSS and Patent Rights Intellectual property issues in healthtech
  • 30. It is worth noting that under the Patent Cooperation Treaty (PCT), it is possible to seek patent protection simultaneously in several countries by filing a single “international” patent application. A patent is a legally enforceable proprietary right granted to protect a device, substance, method or process that is new, inventive and useful. The owner of a patent will have the exclusive right to commercially exploit the invention for the duration of the patent, which is 20 years in most Asia Pacific jurisdictions. The key question for most innovators and organisations is: When is an invention patentable? In general terms, for an invention to be patentable, the following conditions should apply: It must be a patentable subject matter (this is often referred to as a “manner of new manufacture”). It must be novel and involve an inventive step when compared to the prior art base that existed before the “priority date” of the claim. It must be useful. It must not have been secretly used by the patent holder before the “priority date” of the claim. [Note: “Priority date” refers to the filing date of the first application for a patent registration. When the patent is accepted by the relevant government agency, the owner will have protection, i.e., can claim priority, from this filing date. What Constitutes Patentable Subject Matter? The types of inventions (or subject matter) that are capable of being the subject of patent protections vary in different countries. In summary, the following subject matter will be expressly precluded from patent protection in certain jurisdictions: Methods of treatment of the human or animal body by surgery or therapy or of diagnosis (all Asia Pacific jurisdictions with very few case exceptions) Inventions that may encourage offensive, immoral or anti-social behaviour (includes Malaysia, Thailand, Indonesia and Taiwan) Discoveries, scientific theories and mathematical methods (includes China, Indonesia, Malaysia, the Philippines and Thailand) Plant or animal varieties or biological processes for the production of plants or animals (other than man-made living micro- organisms, micro-biological processes and the products of such micro-organism processes) (including China, Indonesia, Malaysia, New Zealand, the Philippines, Taiwan, Thailand, Vietnam) Schemes, rules or methods for doing business (includes China, Hong Kong, Indonesia, Malaysia, South Korea and Vietnam) “Simple” Versus “Invention” Patents In several Asia Pacific jurisdictions, inventions can also be protected by “simple patents.” Depending on the specific country, the name may differ from “petty patents” (e.g., Laos) to “utility models” (e.g., China, the Philippines and Cambodia). Simple patents generally cover products and tools and rarely extend to technologies. This type of patent is very popular with innovators as, generally speaking, it provides a faster, more affordable route for protection of inventions. In some cases, there is no requirement for an “inventive step” (e.g., Indonesia, the Philippines, Thailand and Vietnam), or the degree of inventiveness required may be less (e.g., China, Malaysia and Laos). There is, however, a reduced period of protection, which is usually 7 to 10 years from the filing date. Are Patents Valid in Every Country? Patents are territorial rights, meaning the exclusive rights are only available to the patent owner in the country or jurisdiction in which a patent has been filed and granted. As such, it is imperative that an application for patent protection is applied in each of the Asia Pacific countries in which the technology is launched. In Asia Pacific, only Cambodia and Myanmar are not contracting states of the PCT (as at July 2015). Patent protection through the PCT should be considered as a more convenient, efficient and cost- effective process. Furthermore, Article 4 of the Paris Convention for the Protection of Industrial Property states that once a patent application has been filed in a convention country, it is possible to claim the same priority date for a subsequent application made in another convention country within 12 months. Current Asia Pacific members include Australia, Bangladesh, Bhutan, Cambodia, China, Indonesia, Japan, Laos, Mongolia, New Zealand, Papua New Guinea, the Philippines, South Korea, Samoa, Singapore, Thailand, Tonga and Vietnam. Patents
  • 31. Copyright protects the original expression of ideas, such as art, literature, music, broadcasts and computer programs (“works”), but not the ideas themselves. It protects original works from unauthorised copying and gives the owners exclusive rights to licence their work. Copyright is free and automatic in all Asia Pacific jurisdictions and generally lasts for 50 to 70 years after the death of the creator/owner. To obtain this automatic protection, a “work” must satisfy the following general conditions: expression in a particular form originality independent creative effort of the author (e.g., works created by a computer, although original, cannot be copyrighted) Copyright protection provides for moral rights aimed at protecting the author’s reputation (for instance, the right of attribution of authorship) and economic rights that give authors the exclusive right to commercialise their work for economic gain. A copyright holder’s economic rights will be infringed where the following apply: another person or entity exploits the copyrighted work without the holder’s permission such exploitation is not considered “fair use” or under a statutory licence It is also possible to register copyright interests in some Asia Pacific jurisdictions. Although copyright registration is not required for protection, it can assist in proving ownership in the context of enforcement proceedings (particularly where a government authority required evidence of ownership before accepting a case). Copyright software is expressly protected by copyright laws in the ASEAN region, covering the source code, object code and written documentation. This will prevent anyone from running, copying, modifying or distributing the software without the permission of the rights holder. However, this will not protect the ideas behind the computer program. Trade secrets are a subset of the broader category of confidential information that is protected by the judiciary, spanning commercial secrets, personal secrets, artistic secrets and state secrets. Generally speaking, trade secrets will be any information having commercial value to the holder, which, if disclosed to a competitor, would be liable to cause real (or significant) harm to the holder of the secret. Although copyright law may protect the particular form of document in which the information is embedded, and patent law may protect the subject matter of the information (provided it discloses a patentable invention), there is no legislation that specifically protects secret information. As such, it is generally accepted that trade secrets are simply information to which property rights do not attach. It is imperative that confidentiality agreements are signed by individuals who are party to the trade secret. Trade Secrets Copyright
  • 32. Baker & McKenzie’s Asia Pacific Healthcare Group has advised global pharmaceutical, life sciences and medical devices companies for more than 50 years. The Firm is the sole law firm ranked in Band 1 in the Chambers Asia Pacific Life Sciences rankings for three consecutive years (2014-2016). In Asia Pacific, Baker & McKenzie’s healthcare practice has more than 150 lawyers, more than 20 of whom have healthcare and medical-related qualifications, as well as a number of non-lawyer medical practitioners who hold doctorate degrees in fields such as biotechnology, pharmacology, nursing and bioethics. Our team has a thorough appreciation of the issues facing our clients, from compliance pressures and complex pricing and reimbursement difficulties, to red-flag issues such as anti-corruption. As a trusted advisor to the world’s largest life sciences companies, the Baker & McKenzie Asia Pacific Healthcare Group offers cutting-edge, value-added services to help clients stay abreast of key industry trends. These products include the following: Webinars Client seminars Publications such as From Pills to Tablets and Investing in the Healthcare Industry Mobile apps such as the MapApp, which won the Innovative Use of Technology Award at the FT Innovative Lawyers Asia Pacific Awards 2015 (download it on the App Store) Thought leadership reports Ben McLaughlin Head, Asia Pacific Healthcare Group ben.mclaughlin@bakermckenzie.com About the Asia Pacific Healthcare Group Ben McLaughlin talks about Baker & McKenzie’s strengths and value-added client services
  • 33. Contributors Ben McLaughlin Head, Asia Pacific Healthcare Group Baker & McKenzie Sydney Tel: +61 2 8922 5342 Ben.McLaughlin@bakermckenzie.com View CV Julien de Salaberry Founder and CIO, The Propell Group Singapore Tel: +65 9488 7334 julien@propellgroup.biz View CV Yee Chung Seck Partner, Baker & McKenzie Ho Chi Minh City Tel: +84 8 3520 2633 YeeChung.Seck@bakermckenzie.com View CV Toby Patten Special Counsel, Baker & McKenzie Melbourne Tel: +61 3 9617 4456 Toby.Patten@bakermckenzie.com View CV Anne-Marie Allgrove Partner, Baker & McKenzie Sydney Tel: +61 2 8922 5274 Anne-marie.Allgrove@bakermckenzie.com View CV Andy Leck Principal, Baker & McKenzie.Wong & Leow Singapore Tel: +65 6434 2525 Andy.Leck@bakermckenzie.com View CV Ren Jun Lim Local Principal, Baker & McKenzie.Wong & Leow Singapore Tel: +65 6434 2721 Ren.Jun.Lim@bakermckenzie.com James Halliday Partner, Baker & McKenzie Sydney Tel: +61 2 8922 5187 James.Halliday@bakermckenzie.com View CV Elisabeth White Partner, Baker & McKenzie Sydney Tel: +61 2 8922 5386 Elisabeth.White@bakermckenzie.com View CV Chen Yih Pong Principal, Baker & McKenzie.Wong & Leow Singapore Tel: +65 6434 2682 ChenYih.Pong@bakermckenzie.com View CV Monique Nicolle Senior Associate, Baker & McKenzie Sydney Rebekah Lam Associate, Baker & McKenzie Sydney Huiying Lin Associate, Baker & McKenzie.Wong & Leow Singapore Grace Loukides Graduate at Law, Baker & McKenzie Melbourne Le Thu Minh Legal Assistant, Baker & McKenzie Ho Chi Minh City Rosaline Chow Koo Founder and CEO, CXA Group Singapore Kae Yuan Tan Co-founder and CEO, REKA Health Singapore Francois Cadiou Co-founder and CEO, Healint Singapore
  • 35. Our difference is the way we think, work and behave — we combine an instinctively global perspective with a genuinely multicultural approach, enabled by collaborative relationships and yielding practical, innovative advice. Serving our clients with more than 4,200 lawyers in more than 45 countries, we have a deep understanding of the culture of business the world over and are able to bring the talent and experience needed to navigate complexity across practices and borders with ease. © 2016 Baker & McKenzie. All rights reserved. Baker & McKenzie International is a Swiss Verein with member law firms around the world. In accordance with the common terminology used in professional service organizations, reference to a “partner” means a person who is a partner, or equivalent, in such a law firm. Similarly, reference to an “office” means an office of any such law firm. This may qualify as “Attorney Advertising” requiring notice in some jurisdictions. Prior results don’t guarantee a similar outcome. www.bakermckenzie.com Baker & McKenzie has been global since inception. Being global is part of our DNA.