Powering the Future of Healthcare in Asia Ch.2 | The Propell Group | Baker & McKenzie

PoweringtheFuture
of Healthcare
in Asia Paciﬁc
How technology will change
healthcare delivery

Powering the Future
of Healthcare in Asia Paciﬁc
The HealthTech Report
NEXT ISSUE
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
Genomics
Telemedicine
Biosensing Wearables
Mobile Devices Health
mHealth
Assessing Whether New
Technology is Subject to
Regulatory Compliance
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?

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’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’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 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 Asian economy’s health
system, we advocate that all of
Asia’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.

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:

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:
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.
Genomics

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, facilitating
both push-and-pull health and
wellness information to be
communicated or exchanged.
In many Asian 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 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’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.
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
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

Baker & McKenzie’s Asia Pacific Healthcare Group
has advised global pharmaceutical, life sciences and
medical devices companies for more than 50 years.
The Firm ranked Band 1 in the Chambers Asia Pacific
Life Sciences rankings for two consecutive years
(2014-2015). In Asia Pacific, Baker & McKenzie 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 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 (example: Powering the
Future of Healthcare in Asia Pacific)
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

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
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
Sydney
Tel: +61 2 8922 5187
James.Halliday@bakermckenzie.com
View CV
Elisabeth White
Sydney
Tel: +61 2 8922 5386
Elisabeth.White@bakermckenzie.com
View CV
Monique Nicolle
Senior Associate, Baker & McKenzie
Sydney
Rebekah Lam
Associate, Baker & McKenzie
Sydney
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

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with a genuinely multicultural
approach, enabled by collaborative
relationships and yielding practical,
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© 2016 Baker & McKenzie. All rights reserved. Baker & McKenzie International is a
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