MEDTECH: Digital Health

What does digital medicine mean to you?

There are many different kinds of health monitoring devices. However, not all devices on the
market are considered to be medical devices. Consider the examples below – which of the two
do you think is a medical device?

Wearable fitness tracker – This is a device used to track physical activity. It can also track
heart rate, food intake, weight and sleep to help users stay fit and motivated. In the See Also
section, there is a link to a case study which shows the outcome of an individual reflecting on
the readings of their fitness tracker’s heart rate monitor.

Continuous Glucose Monitor (CGM) – This small device, which is placed under the skin,
measures glucose levels throughout the day and night. It enables the user to observe glucose
levels trends and notifies the user of high and low glucose levels.

What does digital medicine mean to you?

There are many different kinds of health monitoring devices. However, not all devices on the
market are considered to be medical devices. Consider the examples below – which of the two
do you think is a medical device?

Wearable fitness tracker – This is a device used to track physical activity. It can also track
heart rate, food intake, weight and sleep to help users stay fit and motivated. In the See Also
section, there is a link to a case study which shows the outcome of an individual reflecting on
the readings of their fitness tracker’s heart rate monitor.

Continuous Glucose Monitor (CGM) – This small device, which is placed under the skin,
measures glucose levels throughout the day and night. It enables the user to observe glucose
levels trends and notifies the user of high and low glucose levels.

Understanding digital medicine

Who uses digital medicine and why is it important for patients?

“Digital medicine can be defined as digital technologies and products that directly impact
diagnosis, prevention, monitoring and treatment of a disease, condition or syndrome. This
includes telemedicine, wearables, digital diagnostic tests, bionanotechnology, digital
therapeutics and immersive technologies such as virtual and augmented reality.” (Topol Report,
2019)

Traditional medicine
Traditionally clinical practice involves an assessment of the patient by a physician in order to
diagnose, prognose, treat and prevent a disease, condition or syndrome using clinical
judgement. This judgement is established through an examination of the patient’s medical
history, followed by a medical interview and physical assessment to identify signs and
symptoms.

Various methods of diagnosis are used to help rule out conditions. These are based on
information provided from the patient and from diagnostic tests. During the diagnostic process,
the patient is required to develop a level of trust in the doctor’s judgement and proposed
treatment. The outcome is based on a patient thoroughly informing the doctor of their
symptoms, and the doctor’s interpretation.

Second opinions are rare as they depend on the complexity of the patient’s condition and the
availability of a specialist. It can also be a time consuming and costly process. This means that
the diagnostic process is mostly between the patient and doctor.

Digital medicine

Digital medicine aims to use 21st century technology to transform the healthcare system for the
better. It uses portable devices and applications which make it easy to track a patient’s
condition. This data can then be collated and communicated with clinicians from an array of
specialisms. Previously, this would have been difficult to do.

The aim of digital medicine is to enhance the delivery of services to patients by monitoring
illnesses to create personalised disease management and care processes. This can be
achieved through various types of technology and devices such as implantable and wearable
technology. The use of digital technology enables constant monitoring of patients to identify the
early onset of an illness, as well as the patient’s daily behaviour.

Digital medicine can be used for preventative purposes, showing problems that will develop
unless corrective action is taken. This can be achieved through the use of DNA sequencing to
identify and diagnose diseases in humans. Big data can also be used to assist in diagnosis and
treatment.

As technology brings the world closer together, it can be used to actively engage patients with
clinicians. Patients and clinicians are now able to communicate with other healthcare
professionals around the world to gain a second opinion. The use of digital technology also
means that doctors are able to collect a substantial amount of information to detect disease
patterns. These could lead to early treatment and prevention of outbreaks.

All of the above can be made possible by transforming the healthcare system into a digital
network. Technology can then be utilised to initiate a much-needed change in providing care
and practising medicine.
It is important that medical practitioners, patients and engineers work closely together when
designing digital health systems. This ensures that all stakeholders understand the complex
healthcare challenges involved. End users, such as medical practitioners and patients, also
need to have an input in the design process to create an efficient solution which meets their
needs.

Digital tools not only record clinical data, they also have the ability to transform the information
as well as generating medical information. In doing so, digital technology potentially creates a
more precise, more effective, more experimental and more widely distributed medical practice
than before. As with any new technology, there are critical steps to ensure that the impact of the
technology is carefully analysed and assessed. This is necessary to ensure that it will create a
new way of working in medical care with minimal disruption.

What drives digital medicine?

Technological advancements have assisted with the transformation of the healthcare system in
many ways. For example, robot assisted surgeries, and digital records and databases.

Change is constant within the healthcare system. It is a growing network which is always
looking for ways to improve. Recent technological advancements have led to a drive in the
healthcare system to enhance patient care. This has been achieved through:

 the prevention of disease

 early diagnosis and efficient treatment
 improved rehabilitation procedures.

Such enhancements to patient care all need to be done in a time- and cost-efficient manner.

Key drivers

In order to improve patient care, the key drivers that digital medicine aims to address are:

Prevention of disease

This is achievable through the use of mobile technology such as wearables, implantable devices
and smartphones that collect and analyse data to prevent future diseases and illnesses.
Preventative action can help people to stay well for longer and use NHS services less, and later,
in life. Digital medicine can help individuals monitor and proactively manage their health before
a condition worsens.

Early diagnosis

This is possible by using technology to monitor a patient’s health. As you saw in the case study
in the See Also section in Step 1.2, wearable technology can be used to track conditions before
a diagnosis. In the example, a heart rate monitor informed the user of changes in their heart
rate, prompting them to speak to a medical professional. This led to the treatment of a
previously undiagnosed condition.

Another example of how digital medicine can enable an early diagnosis is software that can be
used to digitally observe a tissue sample. This can then be shared online with practitioners
globally, providing a second opinion. Both examples can result in quick and efficient diagnoses.
Diagnosing a patient earlier means that the necessary steps to improve the outcome of their
condition and modify its progression can be made sooner. This can help people to self-manage
more effectively, reducing the need for hospital admission.

Efficient treatment

Not all consultations are required in a clinic. Rather than being constrained to surgery hours and
GP availability, technology can be used to provide remote consultations at a time more suitable
for the patient. This has the potential to reduce the number of A&E visits and admissions by
remotely monitoring patients. As such, the pressure on overburdened hospitals, clinicians and
medical professionals is reduced.

Rehabilitation

Smartphone apps and remote technologies can be used to track rehabilitation and recovery of
patients. This enables the patient and healthcare professional to monitor the patient’s recovery,
ensuring that the patient is performing the correct rehabilitation exercises. These processes can
improve the recovery rate of the patient.

User expectation and need

Technology can be used as a support mechanism to help patients stay well and manage
illnesses. It can also enhance care for people with chronic or complex conditions.

Time and cost

Introducing digital medicine into the healthcare system can lead to benefits which save patients’
and healthcare professionals’ time and money. Some of these benefits include:

 reduced hospital admissions

 less adverse reactions to prescribed drugs and medications
 reduced medical errors.

How is technology transforming healthcare?

What did the healthcare system do before digital technology?

Throughout history technological advancements have impacted healthcare. Recent

advancements such as smartphones provide access to thousands of health apps. They also
connect a user to the internet, with a host of sensors to track movement through an easily
accessible interface.
These internet-enabled devices also give users access to peer-to-peer support networks and
communities. These contribute to research through a shared identity, social movement or even
a hashtag. This has assisted in facilitating the development of the healthcare sector in many
countries.

Stakeholder interactions with digital medicine

Stakeholder engagement paves the way for the development of technology. It identifies the
need for a product and clarifies the users and infrastructures that it would assist and benefit.

Digital medicine is a vast array of technological systems. These systems assist in diagnosis and
treatment without the constant assistance and guidance from a healthcare professional, such as
a doctor, surgeon and nurse. In doing so, they provide patients with independence and enable
them to actively monitor their own health.

The rising cost of healthcare has created the need to make the healthcare system more efficient
and cost effective. Appointments, referrals, missed appointments, misdiagnoses and ambulance
call outs all cost the healthcare system a considerable amount of time and money. Value-based
medicine aims to provide cost effective, science-based healthcare that incorporates patient
values that improves life expectancy and quality of life for patients. This approach could assist in
monitoring individuals remotely, prevent the likelihood of illness and disease, and provide
precise medication and treatment. This not only benefits patients, but also clinicians, nurses and
other stakeholders within the healthcare system.

Below are examples of how digital medicine aids the healthcare system alongside a brief
overview of how this affects the various stakeholders.

Empowering the general public and clinicians with mobile technology

In today’s world, many services can be accessed from devices connected to the internet. It’s
possible to order food for delivery, check a gas bill or book a flight online. If the gas bill has
increased it is possible to log in online and check usage to identify where the fluctuation
occurred. However, can the same be said to check fluctuations in your health?

It is surprising that, in this technological age, people do not have instant access to healthcare.
Patients are still required to book appointments, perform a variety of diagnostic tests and
discuss symptoms to determine the cause of a problem. If patients can monitor their own health
and wellbeing, it allows them to become active and responsive to their health. This can increase
their quality of life and encourage them to take preventative actions against illnesses. Digital
medicine aims to encourage this.

Efforts in digital medicine are aimed at developing technology to provide patients with instant
access to healthcare. Not only does this enable a quicker diagnosis, it also relieves clinicians of
pressure as the public can now play a more active role in monitoring their health.
Revolutionary technology is transforming the healthcare system through the development of
devices and software which can prevent, diagnose and treat symptoms and illnesses. These
include mHealth, genome sequencing and smartphone connected electrocardiograms (ECG).

So, other than patients and clinicians, do these devices benefit anybody else?

A shift towards remote diagnosis and treatment

Recent advances in the way information and images are digitally stored and shared enables
users to access and store substantial amounts of data remotely. They provide real-time
information through image sharing platforms.

Instant sharing of, and access to, data can ignite innovative ideas and discussions from different
parts of the world. It can assist with obtaining a second opinion when there is uncertainty, and
provide support. All of this can be achieved from the comfort of an individual’s own home.

Online platforms that host doctors and medical social networks give patients access to experts
and communities which can help to empower them. This can help them to address their
conditions and concerns at an early stage.

Citizens and patients as stakeholders in digital medicine

You’ve seen how technology is empowering the general public to monitor its health. Now you’ll
explore how digital medicine impacts screening, diagnosis and treatment.

When a treatment plan is being decided, patients need to feel like they are involved in the
decision-making process. Healthcare professionals must be adaptable to address the patient’s
issues and tailor the course of treatment to suit the patient, rather than the other way around.
Digital medicine facilitates healthcare becoming more people-centric, focusing on the
requirements of the individual instead of the requirements of the service.

MyGiHealth

An example of digital medicine supporting citizens and patients as stakeholders is MyGiHealth.

MyGiHealth is a mobile application that helps patients collect gastrointestinal (GI) symptom
information. You’ll now look at how this app is helping patients to have more control over their
health and better inform the care they receive.

Screening

To begin, the patient records their symptoms and emotions by using the app. This helps them to
learn more about their body and symptoms. This record can be used to help a patient prepare
for a consultation with a physician.
The app also uses National Institute of Health’s Patient Reported Outcomes Measurement
Information System (PROMIS®) scores – just as the patient would do in the physician’s clinic.
PROMIS is a set of patient-centred measures that evaluate and monitor physical, mental, and
social health in adults and children. It can be used with the general population and with
individuals living with chronic conditions.

PROMIS® is a registered trademark of U.S. Department of Health and Human Services

Diagnosis

Further to the screening process, the information that the patient gathered about their symptoms
is condensed and a report is sent to the physician. The physician reads the report prior to
observing the patient so they can quickly understand why the patient is visiting, and what
treatment options are available. Reviewing this information prior to the visit leaves additional
time during the appointment for the clinician to educate the patient on their health issues and
provide counselling.

Treatment

After the clinic visit, patients can continue using the application to monitor their symptoms. After
some time, patients can check whether they are responding well to the medications prescribed
by their doctor.

Healthcare professionals and the systems they work in

In this step, you consider the experiences and impact of digital medicine on the roles of
healthcare professionals.

As you have seen previously, digital medicine assists healthcare professionals (HCPs) in
practising medicine proficiently, providing improved patient care and enhanced clinical
outcomes. This is achieved using digital tools which collate and synthesize information obtained
through technology. This allows for more time to be spent with the patient in order to build a
rapport, evaluate the patient’s response to the illness and show empathy.

The impact of digital medicine on HCPs

Digital medicine can impact the roles of HCPs in different ways:

Doctors

Digital technology can be used to constantly monitor patients and provide remote rehabilitation.
This has the possibility to provide doctors with more time to engage with their patients. As such,
this can lead to an enhanced quality of care and improved patient outcomes.
Nurses

Digital technologies can perform repetitive tasks, for example, taking blood pressure. They can
also perform administrative functions such as scheduling appointments and referrals. This can
free up the time of nurses, allowing them to tend to patients in a more meaningful way and
provide greater emotional care and support.

Care assistants

Technology-enabled care has the potential to support face-to-face and remote care. This can be
done using technology to enable constant patient monitoring and communication, helping care
assistants to provide a personal touch to those who need it.

Clinicians

An example of digital medicine assisting clinicians at St James’s Hospital in Leeds is the Digital
Pathology Lab. Digital pathology is used for analysing tissue samples to diagnose diseases
such as cancer. Instead of using traditional microscopes and glass slides, slides are scanned
into a computer and available to review wherever the clinician is. The pathology team at St
James’s has reported that over 99% of cases are assessed using digital pathology, only
reverting to microscopes for exceptional cases.

Using such technology enables clinicians to share opinions and collaborate on complex cases
promptly, without having to be in the same location as a glass slide. This provides internal and
external consultation in a time-efficient manner. Clinicians can give answers immediately due to
having access to the images. In addition, digital images limit the danger and delay of
transferring fragile, irreplaceable glass slides in packages.

Summary

Access to clinicians working remotely could be an answer to the current unsustainable demand
on the health care system. It could also aid the implementation of more personalised patient
care by giving doctors the time to support longer appointments through patient consultations by
phone and video. In turn, this could reduce waiting times at hospitals and clinics.

How interdisciplinary action is making a difference

Digital medicine creates different challenges and opportunities in healthcare.

The healthcare system in the UK is currently facing several key challenges, including:

 an aging population
 a growing population
 evolving healthcare needs
 closure of services due to centralisation.
As a result of these factors, the healthcare system requires efficient methods and processes to
improve the quality of healthcare whilst keeping costs to a minimum. Technology is helping to
achieve this. Combining healthcare and technology enables healthcare professionals to access
premium tools and resources. This can help them to make appropriately informed diagnoses
and deliver efficient results.

An interdisciplinary approach towards innovation can help to develop an effective end product.
The teams involved contain members from different backgrounds, medical fields and
professions. Typically they will include the user(s), designer, engineer and a representative of
the funding body. They can share their expertise, knowledge and skills to develop an innovative
product to benefit a patient’s diagnosis, treatment and care.

Patient and clinician involvement is key when developing a product to be used in a healthcare
setting. Both stakeholders will determine what they require and their needs will create the
usability requirements of the product. The design team will then develop a product based on the
needs of the patient and clinician. The design team also needs to ensure that the product meets
the requirements of the funding source. Therefore, the involvement of an end user in this
process is beneficial. Without this, there is the potential for designers to overlook basic elements
which could have a huge benefit to the clinician and patient.

Opportunities

Digital medicine has created opportunities where a convergence of interests, opinions and ideas
have resulted in a readily-available product in the market. The combination of different fields
merging together, for example, medicine and computing, has created many opportunities to
share expertise. By doing this, specialists can develop innovative devices which would not be
possible without interdisciplinary collaboration.

An example of this approach is the Leeds Virtual Microscope (LVM) which was introduced in
Step 1.9. The LVM is a combined project between Dr Darren Treanor, a Consultant at St
James’s Hospital in Leeds, and Professor Roy Ruddle, a Professor of Computing at the
University of Leeds. Dr Treanor identified several issues with visualising tissue samples on a
glass slide using a traditional microscope. These included the following:

The method was uncomfortable for the pathologist viewing the sample.

The task was highly repetitive.

Some areas of the sample were difficult to measure.

The interdisciplinary approach between Dr Treanor and Professor Ruddle led to the
development of the LVM. This method digitises tissue samples to view on either a desktop
screen or a ‘powerwall’ (a collection of multiple high resolution screens that create a wall sized
display). This enables pathologists to:
  view the sample at any location on a high-quality display
 zoom in and out of the sample
 measure areas using a digital ruler.

As the technology and health sectors unite more readily, patients are certain to benefit from
more of these advances in health and medicine.

The technology behind the devices

In this step, you are introduced to the software and hardware behind digital medicine.

Software

Software consists of a set of instructions written by computer programmers that has been
compiled into a computer program. It is ‘virtual’, not physical like hardware.

Medical software converts biometric data into an actionable and informative user interface that
can be shared with health care providers, researchers, family members, or an individual’s social
network. One example of this is the software on a wearable fitness tracker.

Fitness tracker software processes the data collected by the device’s sensors and presents it to
the user using its screen. This can be in the form of a number representing the user’s pulse
rate. In more advanced cases, a graphical representation of a heart rhythm similar to that of an
ECG trace is available. An example of this software is available in the See Also section.

Hardware

The term ‘hardware’ refers to the physical and tangible parts of a computer or digital device.
These include sensors, smartphones and screens.

Medical hardware consists of any physical product that is used for medical purposes in patients,
such as diagnosis, therapy or surgery. An example of this hardware is available in the See Also
section. These devices include a broad range of products, including the following:

 Tongue depressors
 Thermometers
 Blood glucose meters
 Artificial hearts
 Stents
 Sonogram machines
 X-ray machines
 Stethoscopes
 Wheelchairs.
Digital medicine combines hardware with smart sensors that make use of an internet
connection, usually using Bluetooth or Wi-Fi to connect wirelessly to smartphones.

Sensor technology (hardware) provides software with the biometric data by continuously
monitoring human physiology and biology. The ability to measure millions of physiological and
other health related data points makes sensor technology one of the most intriguing areas in
digital medicine.

Internet of Things

The Internet of Things (IoT) is a network of sensor enabled physical devices connected to each
other through the internet. This connection makes it possible for devices to collectively gather
and analyse data. The data obtained provides opportunities for patients to self-manage their
care.

The fitness watch is an example of a wearable device that combines software, hardware and an
internet connection. It may use an accelerometer, gyroscope, compass, ambient light sensor
and an optical heartbeat sensor. The sensors on the wearable device enable the user to
observe feedback of their daily activity. They enabling monitoring of the:

 Heartbeat
 number of calories burnt throughout the day
 hours of quality sleep
 number of steps taken during a day.

The fitness watch could also use Wi-Fi to sync wirelessly to portable devices, allowing the user
to view their health information on a larger screen. This allows the user to monitor their daily
activity and observe how their interactions affect particular body functions. As a result, users
can actively monitor their health for fitness purposes.

Summary

Developments in software, hardware and the IoT have opened up new opportunities and
avenues in healthcare. However, due to the current limitations of technology, there are
constraints in enabling innovation. Other constraints include users’ ability and comfort in
operating such devices, safety considerations and the accessibility of current technologies.

What does the regulatory landscape look like?

You may be aware that there are many ‘health’ apps available, but how can you trust them?
Regulations are essential as they help to understand the difference between a medical device
and a commercial device.

The development of hardware, software and Internet of Things has led to many innovative
healthcare devices which can assist a user in disease diagnosis, treatment and rehabilitation.
However, there are many challenges surrounding these devices, including safety, accuracy and
user interpretation.

Many healthcare devices are easily accessible to users as they are readily available. These
devices can monitor a patient’s behaviour such as heart rate and blood pressure. The
information obtained is then relayed to the user, leaving the user to interpret their own results
without the presence of a health care professional.

Since the user has open access to their health information without the presence of a qualified
healthcare professional, the device needs to be accurate and misinterpretation must be limited.
As the device collates a substantial amount of personal data, safety measures must also be put
in place to ensure that the data obtained is stored in a safe and secure way. These are all key
challenges surrounding digital medicine, and regulations must also be adhered to when
developing a registered medical device.

Regulating a device provides a framework for the development of the device to minimise the risk
to the patient. In addition, it provides a framework for the innovator to adhere to. Regulations
can present challenges to the innovator as they can limit innovative ideas. However, regulations
are put in place to ensure patient safety, therefore, it is critical that they are adhered to.

Regulations and legislation

Regulations are rules that derive their authority from legislation. Legislation establishes the
general ‘laws of the land’ and regulations provide specific ways in which those laws are
interpreted and applied. Regulations have the same legal effect as laws and can provide
guidelines for the classification of healthcare devices as medical devices or technology.

Regulations are implemented to:

 protect the public

 maintain public confidence in the profession
 declare and uphold professional standards.

Without regulations there would be no standardized procedure in which a device is classified as

a medical device. As such, any product or material could be placed within the human body
without sufficient medical testing. The case study below highlights a device that was not
medically regulated and was implanted within the human body. As a result, there were severe
side effects for the patient.
Case study: Nanostim pacemaker

The Nanostim pacemaker was the first leadless pacemaker used in the UK. It sits inside the
heart to deliver the electrical pulses needed to keep the heart beating regularly. The design of
the Nanostim was beneficial due to a key limitation of a traditional pacemaker: the lead can
break.

Maureen McCleave was the first to receive the implant in the UK due to her irregular heartbeat.
Three years after the device was fitted, the battery failed. Surgeons were unable to remove the
device and Maureen now has a traditional pacemaker fitted to keep her alive. Although it no
longer works, the Nanostim is remains implanted.

In addition, there were two reported patient deaths and 90 events where patients were seriously
harmed by the Nanostim device. An investigation discovered that there was only one clinical
trial before the Nanostim was approved for use on the public. The study had followed 33
patients for 90 days.

Definition of medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring
that medicines and medical devices function and are acceptably safe to use in the UK. This is
the equivalent to the Food and Drug Administration (FDA) in the USA.

The MHRA define a ‘medical purpose’ of a hardware or software to be something that can
include monitoring, diagnosing and preventing a disease, injury or handicap. Other uses of
hardware or software in healthcare that are not specifically used for a medical purpose include
apps that do the following:

 Monitor fitness, health and wellbeing instead of disease.

 Support clinical decision-making rather than diagnosis.
 Store data.
 Provide general medical advice.
 Provide administrative functions (eg appointment bookings).

Therefore, if a device hasn’t been approved by a regulatory body it isn’t classified as a medical
device, it is a commercial device.

Why should we think about ethics?

Ethical considerations are a challenge which need to be considered. If something breaches

ethical boundaries it is less likely to reach a mass market. Designers need to be clear around
the ethics of their practice. They need to make sure that what they develop not only meets
patient needs, but also meets their expectations in line with their ethical frameworks.
Digital health has the ability to collate a substantial amount of data about an individual’s:

 Lifestyle
 Habits
 clinical history
 pathophysiological characteristics.

This data can be collected through commonly-used technological tools such as smartphones,
apps, social media and wellness brands. As these tools contain patient data it is important to
understand how the data is stored. It is also important to understand what safety and ethical
considerations are implemented to ensure it is handled appropriately.

Ethics are based on moral principles which apply values to the practice of clinical medicine.
These values include respect for autonomy, beneficence, non-maleficence and justice.

When an individual is qualified to practice medicine they are required to take the Hippocratic
Oath, of which a classic and modern version exists. In both of these oaths a doctor swears to
do the following:

 Share knowledge.
 Aim to benefit the patient at all measures.

Be aware that sympathy and understanding may outweigh the surgeon’s knife or the chemist’s
drug.

Adequately care for a patient and remember to respect the privacy of all patients.

Ethical concerns

There are many ethical and policy challenges in digital medicine, including the following three
considerations:

1. Privacy and security

Using digital medicine for health purposes has caused a great debate around the privacy of the
user’s data. As more data sources become available, protecting the privacy of the user
becomes an increasingly complex challenge.

The standard mechanisms of protection are:

 Consent
 Anonymisation
 Notice.

There are, however, concerns with using these methods. Consent for using an individual’s data
can be obtained easily; the difficulty is in informing the user when their data can be used in the
future. Anonymisation of the user’s details is a robust method to use, however, there is still a
possibility of re-identification. Data security is another challenge as cyber attacks, hacking of
databases and data kidnapping are reported frequently.

As a result of this, security will continue to evolve. Data safety will become more demanding and
require more technical skills, responsive policies and regulatory oversight. The user needs to be
reassured that robust security measures are mandated and enforced.

User concerns can be addressed with the adoption of:

 appropriate technologies
 monitoring and evaluation of security systems
 transparency and accountability mechanisms such as legal remedies and compensation
for privacy breaches.

2. Trust

A trustworthy digital health service requires more than privacy protection. It needs transparency,
accountability, benefit sharing, and clarity about data ownership and data control. Users having
clarity on how individuals and communities will benefit from digital health developments can
help to build trust in the use of digital technology in healthcare.

3. Accountability

A promising feature of digital medicine is the way in which many services can be automated by
using data mining and artificial intelligence (AI) as decision-making tools. These new
approaches can increase the speed and accuracy of health monitoring and lead to more
targeted and effective intervention. However, accountability is of critical importance.

As digital medicine becomes autonomous, fewer human operators will be able to override
decisions made by machines, devices and software. Therefore, these devices have the potential
to jeopardise current norms of professional accountability in clinical practice. This could make it
more complicated to trace responsibility back to individual practitioners. Therefore, it is critical
that there are robust standards to guide the adoption of digital medicine technologies in clinical
practice.

Key Points

Digital Health

Digital Health is the convergence of digital technologies with healthcare, lifestyles, and society
to enhance the efficiency of healthcare delivery and make medicines more personalized and
precise.

Drivers

Drivers are factors that encourage the development of a product by identifying the need. You
saw how the different drivers including improving patient care, earlier diagnosis, efficient
treatment, time and cost impact different stakeholders.
Regulations

Regulations are in place to monitor a device’s performance, detect potential device-related

safety issues and contribute to benefit-risk assessments of these products. As digital medicine
can accumulate a vast amount of patient sensitive information, it is important to regulate patient
data to ensure that it is collected and stored in a safe and secure manner.

Ethics

One aspect of digital medicine the IoT; where a vast amount of information and data is stored in
the cloud. Ethical considerations in digital medicine consist of who is in control of patient data,
and how much control they have. Another concern is how sensitive patient data is controlled
and protected from hacking.