1

UNIVERSITY SCHOOL OF LAW AND LEGAL STUDIES

GURU GOBIND SINGH INDRAPRASTHA UNIVERSITY

ASSIGNMENT LAW AND EMERGING TECHNOLOGY

RESEARCH PAPER ON

LEVERAGING ARTIFICIAL INTELLIGENCE IN MEDICINE

SUBMITTED TO

MR. YASH GUPTA

FACULTY OF LAW AND EMERGING TECHNOLOGY

SUBMITTED BY:

DEVAN DOGRA (03516503521)

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INDEX

1. Abstract…………………………………………………………………………...03

2. Introduction……………………………………………………………………….03

A. Context and Background…………………………………………03

B. Why technology in healthcare is important………………………04

3. Use of AI in healthcare……………………………………………………………04

A. Diagnostics………………………………………………………04

B. Wearable Healthcare Technology………………………………..05

C. Robotic Surgery and Automation………………………………..06

D. Biotechnology and Genetic Engineering………………………..07

4. Challenges in adoption in healthcare sector……………………………………….08

5. Solution to challenges faced……………………………………………………….15

6. Conclusion…………………………………………………………………………19
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ABSTRACT
Patient care, diagnosis, and treatment results could all be completely transformed by
the application of artificial intelligence (AI) in the healthcare industry. However, there
are a number of issues that must be resolved as a result of the broad use of AI
technologies in healthcare. This essay examines the main problems with AI in
healthcare, such as worries about data security and privacy, biases in AI algorithms,
opaque decision-making, and the moral ramifications of using AI in patient care. The
study also looks at accountability issues and regulatory frameworks related to AI-
driven medical practice decisions.
It also looks into how accessible AI technologies are, particularly in healthcare
settings with limited resources, and how AI affects healthcare inequities. The study
suggests ways to solve these problems, including creating uniform regulatory
standards, guaranteeing data diversity and openness in AI training models, improving
communication between AI developers and medical professionals, and putting strong
data security measures in place. In order to guarantee the efficient and moral
application of AI systems, it also promotes ongoing education and training for
healthcare professionals. The necessity of a well-rounded strategy that protects patient
rights, fosters innovation, and reduces the hazards of AI in healthcare is emphasized
in the paper's conclusion.

INTRODUCTION

Context and Background:

If we want to embed AI in society, we need to understand what it is. What do
we mean by artificial intelligence? How has the technology developed? Where do we
stand now?
It is difficult to define artificial intelligence (AI); in fact, the term has no widely
recognized definition. Confusion might easily result from the use of so many distinct
ones. Therefore, it is crucial that we define the phrase. We begin by going over a
number of definitions of artificial intelligence before outlining the one we have
chosen.
The goal of the computer science discipline of artificial intelligence (AI) is to build
machines that are capable of carrying out tasks that ordinarily call for human
intelligence, like comprehending natural language, identifying objects and images,
and making decisions. Fundamentally, artificial intelligence (AI) is the replication of
human intelligence in computers that have been designed to think and learn similarly
to people.1

1
Rudra Tiwari, AI 101 an Introduction to Artificial Intelligence 6-7 (2023).
 4

AI is often defined as a technology that allows machines to mimic a variety of

intricate human abilities.2
Simply simply, artificial intelligence (AI) is the field of computer science that deals
with building intelligent machines that can replicate human cognitive processes.
Through the use of deep learning models and machine learning algorithms, this
technology allows computers to learn from data, adjust to new inputs, and carry out a
number of intricate activities that normally call for human intellect.
Understanding natural language, identifying patterns, coming to conclusions,
resolving issues, and even forecasting future events based on historical data are some
examples of these jobs. AI systems are useful tools in sectors like healthcare, banking,
and customer service because they can continuously improve their performance by
utilizing enormous volumes of data.
Why studying technology in healthcare is important?
In today's healthcare system, technology is revolutionary, greatly improving
the accuracy and efficiency of diagnosis. Compared to previous ways, clinicians can
now detect and diagnose major illnesses earlier and more correctly because to
advanced tools like medical imaging technologies, machine learning algorithms, and
artificial intelligence (AI). Improved detection rates for diseases like cancer, heart
disease, and neurological disorders can result from AI-powered diagnostic system’s
ability to analyze complex medical data, such as radiology scans and pathology slides,
to spot subtle patterns that the human eye might miss.
Healthcare technology not only increases the accuracy of diagnoses but also optimizes
workflows, saving medical workers a significant amount of time. Doctors can
concentrate more on patient care and less on administrative duties thanks to
automated systems and electronic health records (EHRs). This effectiveness not only
expedites the diagnostic procedure but also improves patient satisfaction by cutting
down on wait times.
Additionally, technology reduces the possibility of human error, which is crucial for
patient safety. Healthcare professionals can reduce errors in diagnosis, treatment
planning, and execution by utilizing technologies such as robotic-assisted surgeries,
wearable health monitors, and decision support systems. These developments help
produce more dependable and consistent medical results, which eventually enhance
patient care and health outcomes.

How can AI be used in Healthcare?

1. AI in diagnostics:
With its ground-breaking discoveries that greatly increase diagnostic accuracy,
allow for early disease identification, and ultimately better patient outcomes,

2
Haroon Sheikh, Corien Prins, et.al., Mission AI 1-3 (Springer, 2023).
 5

artificial intelligence (AI) is radically changing the healthcare industry. AI systems

are able to evaluate enormous volumes of medical data, from imaging and
pathology reports to genetic information, with previously unheard-of speed and
accuracy by utilizing machine learning, deep learning, and natural language
processing. As a result, diagnosis accuracy has significantly increased, enabling
medical professionals to spot illnesses early on, when less invasive and more
effective treatments are available.
When it comes to complicated and potentially fatal illnesses like cancer, heart
disease, and neurological problems, artificial intelligence's contribution to early
disease identification is especially revolutionary. Artificial intelligence (AI)
systems are able to spot minute patterns in diagnostic pictures, such MRIs, CT
scans, and mammograms, that the human eye might overlook. By enabling prompt
intervention and more individualized treatment strategies, this early detection
capability has the potential to save lives. AI's capacity to process and analyze
medical data also aids in the detection of uncommon illnesses that doctors might
not notice right away, increasing the precision of diagnosis.
The potential of AI to democratize access to healthcare services is among its most
important effects. Patients often struggle to get prompt and correct diagnoses
because of limited access to specialist healthcare experts, especially in rural or
disadvantaged locations. This gap is being closed by AI-powered diagnostic tools,
such as telemedicine platforms, smartphone apps, and diagnostic equipment, which
allow medical practitioners to deliver precise and effective care from a distance. AI-
powered tools can help general practitioners understand complicated diagnostic
data, provide second opinions, and even suggest treatments based on the most
recent findings in medicine. By doing this, AI is enabling a wider range of patients
to have access to early detection and precise diagnostics, so bringing healthcare
closer to disadvantaged groups.
To sum up, AI is changing the healthcare industry by enabling improved patient
outcomes, earlier disease identification, and more precise diagnostics. Its promise
to level the playing field by facilitating access to healthcare, particularly in
impoverished areas, could guarantee that people from all backgrounds can receive
high-quality medical treatment. But to fully utilize AI in healthcare, technological
specialists and medical professionals must work together to create morally sound,
dependable, and fair AI solutions that put patients' needs first.3
2. Wearable Health Technologies:
Customers now consider wearable technology to be a normal aspect of their lives.
According to a recent Research and Markets estimate, wearable technology sales
are expected to reach over $60 billion worldwide by 2025.

These widely accessible and frequently affordable tools are becoming more and
more popular among doctors and in many aspects of healthcare delivery. According
3
Weronika Dorocka, World Economic Forum, “How AI is Improving Diagnostics and Health Outcomes,
Transforming Healthcare” (September 25, 2024)
 6

to a recent study by researchers at Johns Hopkins Medicine, wearable

accelerometer—which measure acceleration forces and are frequently found in
consumer smartwatches—offer a more accurate indicator of physical activity than
self-reporting.
In a statement, Jacek Urbanek, an assistant professor of medicine at the Johns
Hopkins University School of Medicine and a member of the research team, said,
"People can overestimate or underestimate how much and when they move on
surveys, but wearable devices provide accurate data that cuts through the bias and
guesswork."

Wearables are producing personalized data that gives physicians new insights into
patient treatment that go far beyond a patient's degree of physical activity. Modern
wearable technology allows doctors to keep a close eye on their patients from a
distance by monitoring everything from blood pressure to oxygen saturation.4
In conclusion, people may now effortlessly monitor vital health indicators like heart
rate, blood oxygen levels (SpO2), ECG, and more right from their fingers thanks to
wearable medical technology. By giving consumers immediate feedback, these
gadgets enable them to take charge of their health and identify possible problems
before they become serious. Wearable technology is a useful tool for medical
personnel to remotely monitor patients, particularly those who need constant
supervision or have chronic diseases. Wearable technology gives physicians access
to real-time data, allowing them to intervene promptly, modify treatments as
necessary, and provide more individualized care, all of which improve patient
outcomes and raise the standard of healthcare delivery.
3. Robotic Surgery and Automation:
Possibly the most advanced medical technology of our day is robotic surgery,
commonly known as robotic-assisted surgery.
A camera and tiny surgical instruments mounted on robotic arms make up the most
popular system in use today. Usually located in the same room as the operating
table, a viewing screen allows a specially trained surgeon to direct the robotic arms.
However, the viewing screen might be placed far away, enabling doctors to conduct
telesurgery from far-off places. The screen is a component of a device known as a
console, which enables surgeons to do surgeries while seated and observe a
magnified three-dimensional image of the patient's operating site.5
Advantages of Robotic Surgery:
 Increased Control and Precision:
By removing hand tremors, robotic systems provide increased precision through
more precise and controlled movements. This is particularly helpful for delicate

4
Andrew Steger, “Weighing the Pros and Cons of Wearable Health Technology” Health Tech Magazine (April
17, 2020).
5
Sherry Christiansen, “Robotic Surgery: Everything You Need to Know” Verywellhealth (September 22, 2024).
 7

surgeries like urological or gynecological procedures that involve small or

difficult-to-reach locations.
 Very Minimal Invasion:
Compared to open surgery, robotic surgery usually involves smaller incisions.
This less invasive method results in less blood loss, less bodily damage, and a
decreased chance of problems like infections.6
 Quicker Recuperation Times:
Patients frequently have shorter hospital stays and quicker healing times as a
result of smaller incisions and less tissue damage. Compared to patients
undergoing standard surgery, this allows them to resume their regular activities
sooner.
 Enhanced Field of Vision:
A magnified picture of the surgical site is provided by the 3D high-definition
camera used in robotic surgery, which helps the physician examine finer
anatomical details. Making accurate surgical judgments and avoiding important
nerves and arteries is made easier by this enhanced visibility.7
 Decreased Inflammation and Scarring:
Patients who have smaller incisions experience less discomfort and scars after
surgery. Better cosmetic results and a more pleasant recuperation are the results
of this.
 Greater Availability of Complex Surgeries:
Surgeons can execute delicate and complicated surgeries with robotic devices that
would not be possible with conventional methods. The variety of conditions that
can be surgically addressed with minimally invasive techniques is increased by
this capability.8
4. Biotechnology and Genetic Engineering:
Numerous forms of genetic engineering have produced definite advantages with
negligible dangers. For instance, few would contest the usefulness of the human
insulin that is currently widely available and manufactured by bacteria that have
undergone genetic engineering. The potential advantages of many new genetic
engineering uses, however, are frequently weighed against serious hazards, either
actual or imagined, making them far more contentious. This is undoubtedly true for
gene therapy, a therapeutic use of genetic engineering that is presently mostly an
experimental treatment method but may one day heal a variety of illnesses.9

6
ntuitive Surgical. "The da Vinci Surgical System." Intuitive, https://www.intuitive.com/en-us/about-
us/company/da-vinci-surgical-system.
7
Dakin, G. F., et al. (2011). "Robotic surgery: A current perspective." Annals of Surgery, 253(5), 735-743.
8
Lanfranco, A. R., et al. (2004). "Robotic Surgery: A Current Perspective." Annals of Surgery, 239(1), 14-21.
9
Admin-Science, “Genetic Engineering – the Ethical Debate and Potential Risks of a Brave New World” 4-7
(December, 2023).
 8

There are many advantages to genetic engineering. It enables scientists to improve

the traits of organisms, including crops and animals. This can lead to better disease
resistance, higher food yields, and potentially the production of pharmaceuticals.
Furthermore, by fixing defective genes, genetic engineering may be able to treat
hereditary illnesses like Huntington's disease and cystic fibrosis.
In conclusion Numerous developments in environmental protection, agriculture,
and medicine are fueled by biotechnology and genetic engineering. By using the
power of living things and genetic engineering to produce novel goods and
procedures that enhance quality of life, they provide answers to urgent global issues
including food security, sustainable development, and illness treatment.

Challenges of Technology Adoption in the Healthcare Sector:

1. AI in diagnostics:
Even though AI in diagnostics has many advantages, there are several drawbacks
and restrictions that make it hard for medical professionals and researchers to fully
rely on AI-generated results. Some of the major challenges faced by the doctors and
the scientists are mentioned below:
A. Accuracy and bias:
Although AI in diagnostics has many benefits, there are a number of obstacles and
restrictions that keep medical professionals and researchers from completely
depending on AI-generated outcomes. The accuracy and dependability of AI
diagnoses can be impacted by problems like data quality, algorithm bias, decision-
making opaqueness (sometimes referred to as the "black box" problem), and the
requirement for large amounts of training data. Concerns have also been raised over
the moral use of patient data and the possibility of an excessive dependence on
technology, which may lessen the value of human judgment and clinical knowledge.
As a result, rather than entirely replacing conventional diagnostic techniques,
healthcare practitioners frequently employ AI as an additional tool.
However, a significant disadvantage of increased sensitivity is the ability to notice
minute changes of unclear significance. An investigation of screening
mammography, for instance, revealed that while artificial neural networks
consistently had a better sensitivity for abnormal results, particularly for small
lesions, they are no more reliable than radiologists at detecting cancer.10 The
medical community must foresee the possible unknowns of this technology at the
outset of an AI-assisted diagnostic imaging revolution in order to assure its safe and
efficient integration into clinical practice.
B. Accountability:

10
Ohad Oren, MD, Prof Bernard J Gersh, DPhil, et.al., “Artificial Intelligence in Medical Imaging: Switching
from Radiographic Pathological Data to Clinically Meaningful Endpoints” The Lancet Digital Health (September,
2020).
 9

When an AI system makes a diagnostic mistake, who bears the blame—the

software developer, the hospital, or the doctor? There is currently no consensus or
clear solution to the major problem of liability in the event of AI faults, even
though the examined articles address a variety of liability theories in connection
with AI use.
Determining who is responsible for mistakes is one of the major obstacles to
incorporating AI into healthcare diagnosis. It's not obvious who should be held
accountable if an AI system makes a diagnostic error—the software developer, the
hospital utilizing the tool, or the doctor using it. Liability in these situations is
frequently not well defined by current legal systems, which could result in
controversies. For example, although physicians are supposed to use clinical
judgment, their dependence on AI-generated suggestions may transfer some of the
accountability to the technology or its developers. Establishing precise rules for
accountability is crucial since this ambiguity raises concerns around legal liability.11
The idea of "shared accountability," according to which all parties involved—
including developers, healthcare organizations, and healthcare providers—bear
common responsibility, has been discussed. However, putting such a framework
into practice is difficult and necessitates a strong legal and regulatory framework in
order to successfully manage risk and responsibility.12
C. Ethical Concerns:
Many ethical concerns are raised by the use of AI in healthcare decision-making,
especially those pertaining to patient permission, openness, and trust. To guarantee
that they can provide appropriate consent, patients must be made aware that AI
techniques are being utilized in their diagnosis and treatment. However, patients
and even healthcare professionals may find it challenging to completely
comprehend how these technologies work due to the complexity of AI systems,
particularly those built on deep learning. The "black box" problem, which is the
lack of transparency, erodes confidence in suggestions produced by AI.13
Potential biases in AI systems are also a source of worry, since they could arise
from unbalanced training datasets that are not representative of the patient
population. This can exacerbate already-existing healthcare inequities by resulting
in unequal treatment outcomes.14 To guarantee that AI systems are created and
applied in ways that respect patient autonomy, offer clear information, and avoid
introducing new forms of prejudice, ethical principles are required. Experts stress

· Char, D. S., Shah, N. H., & Magnus, D. (2018). Implementing Machine Learning in Health Care —
11

Addressing Ethical Challenges. New England Journal of Medicine, 378(11), 981-983.

12
· Grote, T., & Berens, P. (2020). On the ethics of algorithmic decision-making in healthcare. Journal of
Medical Ethics, 46(3), 205-211.
13
· Morley, J., Floridi, L., & Kinsey, L. (2020). From What to How: An Initial Review of Publicly Available AI
Ethics Tools, Methods and Research to Translate Principles into Practices. Science and Engineering Ethics, 26(4),
2141-2168.
14
· Reddy, S., Fox, J., & Purohit, M. P. (2019). Artificial intelligence-enabled healthcare delivery. Journal of the
Royal Society of Medicine, 112(1), 22-28.
 10

the necessity of a multidisciplinary strategy including ethicists, AI developers, and

healthcare practitioners to address these ethical issues and produce transparent,
intelligible, and equitable AI systems that adhere to ethical norms and medical
standards.15
2. Wearable Health Technologies:
Wearable health technology, which includes gadgets like activity trackers,
biosensors, and smartwatches, has completely changed how people keep an eye on
their health. These gadgets give users access to real-time information on a range of
health indicators, including blood oxygen levels, heart rate, physical activity, and
sleep quality, enabling them to actively manage their health. Wearable technology
has the potential to improve healthcare beyond personal usage by facilitating
remote monitoring, early health issue detection, and customized medical
interventions. Wearable health devices do, however, confront several obstacles in
the areas of data protection, accuracy, integration with healthcare systems, and
regulatory control, despite their increasing popularity and many advantages. To
guarantee the efficient, moral, and safe application of wearables in the healthcare
industry, these problems must be resolved.
A. Data Ownership and User Rights:
Who controls the health information gathered by wearable technology, such fitness
trackers and smartwatches, is still a controversial topic. Because businesses usually
keep and process the data, even while users create it, data ownership might be
unclear legally. Through terms of service agreements, many businesses claim
ownership or broad usage rights over the data, frequently without the express
knowledge or consent of users.16 Because individuals might not be completely
aware of how their personal health data is being used or shared, this presents
privacy and control problems. For instance, information may be utilized for product
development or sold to outside advertisers without the user's express consent.
Users are intended to have greater control over their data, including the ability to
access, amend, and remove personal data, according to recent regulatory
frameworks like the General Data Protection Regulation (GDPR) in the EU.17
However, consumers find it difficult to exercise complete control over their data
due to the inconsistent implementation of such rights, particularly outside of states
like the EU.
B. Reliability and Certification of Wearable Devices:
Since many wearable health gadgets are promoted for wellbeing rather than as
approved medical devices, their dependability is a major worry. Although
15
Shaban, N. (2019). AI in healthcare: Navigating ethical and regulatory hurdles. Healthcare Management
Review, 44(2), 123-130.
16
· Alam, M. M., Siddiqui, F., & Uddin, M. Z. (2021). Wearable healthcare: A review of digital health solutions.
Journal of Medical Systems, 45(8), 1-15.
17
· Li, M., Godwin, C., & Roggen, D. (2019). Data Integration in Wearable Healthcare Technology. IEEE
Internet of Things Journal, 6(4), 7154-7161.
 11

wearables like smartwatches can measure blood oxygen levels, heart rates, and
steps, their accuracy might vary based on user activity, sensor quality, and outside
variables like skin tone or ambient light.18 According to research, these devices
might not always offer accurate health information, especially when used outside of
controlled settings.
Furthermore, there is no certainty that these devices will be approved for medical
use by regulatory bodies like the U.S. Food and Drug Administration (FDA). The
majority of wearables fall under the category of "general wellness devices," which
are exempt from stringent clinical testing requirements. Their application in clinical
settings, where precision and dependability are crucial for decisions about patient
care, is restricted by their lack of certification.19 Because of this, healthcare
providers frequently view wearable’s data as supplemental rather than diagnostic,
even when they provide insightful information about overall health patterns.
C. Integration with heathcare systems:
There are various obstacles to overcome when integrating wearable technology
with conventional healthcare systems. Even though a lot of wearables may gather a
lot of health data, there are still challenges in efficiently communicating and
analyzing this data with medical professionals. It can be challenging to seamlessly
integrate data into electronic health records (EHRs) due to interoperability concerns,
which arise because different platforms and devices may employ different
standards for data collection and transmission.20
Additionally, because wearable data is unstructured and lacks context, healthcare
providers may have trouble analyzing it. For example, a smartwatch-detected
increase in heart rate may be the result of stress or activity, making it difficult for
medical professionals to make firm judgments without more data.21 Another worry
is data overload, which could result in inefficiencies in patient treatment since
doctors might not have the time or resources to sort through the massive amounts of
data produced by wearables.
Standardized procedures and better data analytics tools are required to facilitate the
integration of wearable data into healthcare systems. Better utilization of wearable
data in clinical decision-making and personalized healthcare can be made possible
by cooperation between technology developers and healthcare practitioners.22

18
· Lupton, D. (2016). The Quantified Self: A Sociology of Self-Tracking. Polity Press.
19
· Nelson, B. W., & Allen, N. B. (2019). Accuracy of wearable heart rate monitors in research settings. Journal
of the American Medical Association, 322(2), 115-116.
20
· Piwek, L., Ellis, D. A., & Andrews, S. (2016). The rise of consumer health wearables: Promises and barriers.
PLoS Medicine, 13(2), e1001953.
21
· Swan, M. (2012). Sensor mania! The internet of things, wearable computing, objective metrics, and the
quantified self 2.0. Journal of Sensor and Actuator Networks, 1(3), 217-253.

·
22
Wang, L., Gao, Y., & Min, J. (2020). Wearable sensors for non-invasive health monitoring. Journal of
Biomedical Research, 34(5), 345-359.
 12

3. Robotic Surgery and Automation:

With improved accuracy, less trauma, and faster recovery times for patients, robotic
surgery and automation have drastically changed the healthcare industry. Surgeons
may carry out minimally invasive surgeries with more control and visualization
than they could with conventional techniques because to sophisticated robotic
equipment. Despite these encouraging advantages, there are still a number of major
obstacles in the way of robotic surgery's broad implementation. Unresolved legal
and liability difficulties generate confusion regarding accountability in the case of
surgical errors, high costs restrict access to wealthy patients and well-funded
medical facilities, and specialized training needs present obstacles for healthcare
personnel. To fully realize the potential of robotic-assisted operations in enhancing
patient outcomes and increasing access to state-of-the-art medical technologies,
these issues must be resolved.

A. Cost and Accessibility:

With improved precision and shorter recovery times, robotic surgery—which uses
cutting-edge technologies like the da Vinci Surgical System—has emerged as a
major advancement in minimally invasive operations. However, only large, well-
funded hospitals are able to use these systems because to their exorbitant cost,
which can surpass $2 million per unit, and significant maintenance expenses.23
Because this cost frequently results in increased expenses for patients, robotic
surgery is primarily available to people who are richer or have full insurance
coverage. Healthcare inequities are made worse by the cost barrier, which also
prevents robotic systems from being widely used in rural and low-income areas.
Increased manufacturer competition, design advancements to lower production
costs, and possible government subsidies or insurance incentives for implementing
cost-effective robotic solutions are all necessary to lower the cost of this technology.
Furthermore, smaller institutions may be able to provide this cutting-edge therapy
option if more affordable, portable, and adaptable robotic systems are developed.24
B. Training and Skill Requirements:
Surgeons must be trained to operate intricate interfaces and precisely control robotic
tools in order to employ robotic surgical systems effectively. Robotic systems require
a different skill set that can take months or even years to learn because they involve
hand controls and 3D imaging, in contrast to traditional surgical approaches. For
healthcare professionals and institutions, this specialized training poses a major
obstacle because it is frequently expensive and time-consuming.25

23
· Childers, C. P., & Maggard-Gibbons, M. (2018). Estimation of the acquisition and operating costs for
robotic surgery. JAMA Network Open, 1(4), e180535.
24
Moustris, G. P., Hiridis, S. C., Deliparaschos, K. M., & Konstantinidis, K. M. (2011). Evolution of
autonomous and semi-autonomous robotic surgical systems: A review of the literature. International Journal of
Medical Robotics and Computer Assisted Surgery, 7(4), 375-392.
25
· Hung, A. J., & Kuo, J. (2019). Advances in training for robotic surgery: Simulation and beyond. Current
Urology Reports, 20(11), 76.
 13

The high learning curve is one of the main obstacles, especially for more experienced
surgeons used to traditional methods. To guarantee that surgeons acquire the required
abilities without endangering patient safety, training programs must be thoughtfully
created to incorporate simulation-based learning, supervised practice, and assessment.
26
Furthermore, to stay up with the quick changes in robotic systems and technology,
continuous training is necessary. Partnerships between robotic system makers and
medical institutions are one example of a collaborative training endeavor that could
provide access to high-quality training and boost proficiency.
C. Legal and Liability Issues:
Complex legal and responsibility issues are brought up by the growing use of robotic
technology in surgery, particularly when mistakes or difficulties arise. Liability
usually lies with the surgeon or healthcare provider in traditional operations. The
surgeon, the hospital, and the equipment maker may all have some of the liability in
robotic-assisted surgeries, nevertheless.27 If an error is caused by a software bug, a
robotic system malfunction, or inappropriate surgeon use, determining liability
becomes difficult.
Current legal frameworks often lack clear guidelines on who should be held
accountable in such cases. For example, if a robotic system fails during a procedure, it
might be unclear whether the manufacturer should be liable for a defect, the hospital
for inadequate maintenance, or the surgeon for improper handling. This ambiguity can
lead to complex legal disputes and may hinder the adoption of robotic surgery due to
concerns over potential lawsuits.28 To address these issues, it is crucial to establish
comprehensive legal standards and insurance policies that clearly define liability, as
well as stringent regulatory requirements for the approval and monitoring of surgical
robotic systems.
4. Biotechnology and Genetic Engineering:
Modern medicine has undergone a revolution thanks to biotechnology and genetic
engineering, which have produced novel methods for illness prevention, diagnosis,
and treatment. Precision gene editing has been made possible by technologies such as
CRISPR-Cas9, which have increased crop resilience, opened the door to treating
genetic illnesses, and even prevented inherited diseases before birth. But these
developments also present important obstacles, such as moral conundrums, legal
restrictions, and worries about fair access. In order to fully utilize genetic technologies
and guarantee their equitable and responsible use in healthcare, these problems must
be resolved.
A. Ethical issues in Genetic Editing:

26
· Huang, R., Chen, L., Li, J., & Zhang, X. (2020). Challenges in training for robotic surgery: Approaches and
strategies. Annals of Surgery, 272(4), 670-676.

· Duffy, S., & Mychaskiw, M. (2021). Legal implications of robotic-assisted surgery: An overview. Journal of
27

Robotic Surgery, 15(3), 567-573.

28
· Miller, S., Lapar, D. J., LaPar, L., & Stone, C. J. (2019). Understanding liability in robotic-assisted surgery.
American Journal of Surgery, 217(5), 869-874.
 14

Thanks to gene editing technologies like CRISPR, human DNA can now be changed
with previously unheard-of accuracy. This poses serious ethical issues even while it
offers a chance to eradicate inherited illnesses like sickle cell anemia and cystic
fibrosis. The use of genetic editing to improve non-medical traits like intelligence,
physical prowess, or attractiveness is one of the primary topics of discussion. These
applications, which are frequently called "designer babies," give rise to concerns
about escalating social injustices and establishing novel genetic discrimination.29
Furthermore, there are worries regarding the unforeseen repercussions of genetic
editing, including off-target impacts, in which unwanted genes might be changed and
pose unknown health hazards. There are concerns over permission and the possibility
of unanticipated adverse effects because the long-term effects of changing the human
genome are still mostly unknown and any modifications performed could be inherited
by subsequent generations.30 Because of the ethical ramifications of modifying human
DNA, there must be a thorough public discussion and explicit ethical standards
established to control the application of such potent technology.
B. Regulation of gene therapy:
Regulating gene therapy technology is essential to guaranteeing safe, efficient, and
morally sound therapies. Gene therapy research in the US is regulated by the Food
and Drug Administration (FDA), which demands thorough clinical trials to verify
safety and effectiveness before approving therapies for general use. Likewise, gene
treatments are subject to stringent regulations by the European Medicines Agency
(EMA) in the European Union.31
In spite of these frameworks, regulatory standards vary throughout the world, with
other nations having more lax laws or no complete restrictions at all. This discrepancy
may result in "medical tourism," where patients travel to nations with laxer rules in
search of experimental or unapproved cures, perhaps exposing them to hazardous and
untested procedures. In order to solve these problems, there is an increasing demand
for global cooperation to standardize gene therapy regulation, guaranteeing uniform
safety requirements and moral behavior around the globe.32
C. Impact on healthcare disparities:
Although hopeful, genetic technology advancements run the risk of exacerbating
already-existing healthcare inequities. Gene editing and gene therapy treatments are
frequently costly and complicated, requiring specialized equipment and knowledge
that are usually only available in affluent nations or institutions. As a result, only

29
· Doudna, J. A., & Sternberg, S. H. (2017). A crack in creation: Gene editing and the unthinkable power to
control evolution. Houghton Mifflin Harcourt.
30
· Greely, H. T. (2019). CRISPR People: The science and ethics of editing humans. MIT Press.
31
Sherkow, J. S. (2020). Regulating gene editing: Lessons from the past and opportunities for the future. Annual
Review of Genomics and Human Genetics, 21, 255-274.
32
· Kohn, D. B., & Candotti, F. (2019). Gene therapy: The challenge of global regulatory harmonization.
Human Gene Therapy, 30(12), 1445-1453.
 15

wealthy patients may have access to these cutting-edge treatments, depriving those in
low-income areas of potentially life-saving treatment.33
Another factor limiting gene treatments' accessibility is their high development and
implementation costs. For instance, one of the priciest medications in the world is
Zolgensma, a gene therapy used to treat spinal muscular atrophy, which costs more
than $2 million each treatment. The exorbitant price of these treatments begs the
questions of fair access and whether or not healthcare institutions should foot the bill.
To stop genetic discoveries from becoming instruments of inequality, measures like
public funding, international subsidies, or tiered pricing schemes are necessary to
make genetic treatments more accessible and cheap.34

Solutions to Challenges Faced:

1. AI in Diagnostics:
Artificial Intelligence (AI) in diagnostics holds the promise of improving accuracy
and efficiency in healthcare. However, challenges like accuracy, bias, accountability,
and ethical concerns must be addressed to harness its full potential. Here are
potential solutions for each:
A. Accuracy and Bias
 Solution:
Diverse and representative datasets are one method to improve the precision of AI
diagnostic tools and lessen bias. AI models can be better trained to manage
differences across different populations by combining data from different
demographic groupings. Federated learning techniques, for instance, allow
researchers to train models on several datasets without sharing private patient
information. This facilitates the aggregation of heterogeneous data while
maintaining privacy.35 Furthermore, it is essential to continuously monitor and
update AI systems in order to detect and address biases that may develop over
time.36
B. Establishing Accountability in Diagnostic Errors
 Solution:
A system of shared responsibility between software developers, regulatory
agencies, and healthcare providers should be constructed in order to address

33
· Shen, C. (2021). The global divide in gene therapy: Challenges and strategies to address healthcare
disparities. Journal of Global Health, 11, 03007.
34
· Hernandez, I., Bott, S. W., Patel, A. S., Wolf, C. G., Hospodar, A. R., & Sampathkumar, S. (2020). Pricing
of Zolgensma: A cost-effectiveness analysis of the world's most expensive drug. Journal of Market Access &
Health Policy, 8(1), 1818001.
35
Ghassemi, M., Naumann, T., & Schulam, P. (2020). "Practical Guidance on Artificial Intelligence for Health
Care Data." The Lancet Digital Health, 2(10).
36
Obermeyer, Z., Powers, B., Vogeli, C., & Mullainathan, S. (2019). "Dissecting racial bias in an algorithm
used to manage the health of populations." Science, 366(6464), 447-453.
 16

accountability. It is crucial to put in place explicit rules on the obligations of

every stakeholder. In order to regulate AI systems, the European Union is
proposing the AI Act, which would place greater responsibility on individuals
who create high-risk AI applications, like those used in medical diagnostics.37
Additionally, hospitals and healthcare providers can implement a human-AI
collaboration system in which AI technologies support doctors rather than take
their place, guaranteeing that a certified professional makes the final choice.38
C. Addressing Ethical Concerns: Patient Consent, Transparency, and Trust:
 Solution:
Ethical challenges can be tackled by implementing stringent consent protocols
and ensuring transparency in the use of AI systems. Patients should be informed
about the role of AI in their diagnosis and given the option to opt-out if they
prefer a purely human assessment.39 Furthermore, the use of explainable AI (XAI)
techniques can help demystify AI decision-making processes, making them more
transparent and understandable to both clinicians and patients. This could
increase trust in AI systems by providing clear explanations of how conclusions
are reached.40
2. Wearable Health Technologies:
A. Addressing Data Ownership Issues:
 Solution:
To define data ownership for wearable health device users, clear policies and
regulations are required. Businesses ought to embrace a user-centric data
paradigm in which people are granted authority over the sharing and use of their
health data while maintaining ownership of it. The European Union's General
Data Protection Regulation (GDPR) offers a framework that gives users the
ability to see, update, and request the deletion of personal data.41 Furthermore,
creating clear consent procedures that notify users about data usage and providing
user-friendly privacy settings can increase user control and confidence.42
B. Enhancing the Reliability of Wearable Health Devices:

37
European Commission. (2021). "Proposal for a Regulation of the European Parliament and of the Council
laying down harmonized rules on Artificial Intelligence (Artificial Intelligence Act)."
38
Reddy, S., Fox, J., & Purohit, M. P. (2020). "Artificial Intelligence in Healthcare: Insights from Predictive
Analytics in Clinical Medicine." Nature Medicine, 26(1), 47-54.
39
Shinners, L., Coughlan, M., & Gavin, B. (2020). "The Use of Artificial Intelligence in Healthcare:
Implications for Healthcare Practitioners." Journal of Medical Ethics, 46(12), 800-805.
40
A., Carrington, A., & Müller, H. (2019). "Measuring the Quality of Explanations in Explainable Artificial
Intelligence (XAI)." Journal of Artificial Intelligence Research, 67, 261-282.
41
Voigt, P., & Bussche, A. (2017). "The EU General Data Protection Regulation (GDPR): A Practical Guide."
Springer International Publishing.
42
Mathews, E., & George, A. (2020). "User Privacy in the Age of Wearable Health Technologies: Navigating the
Data Ownership Landscape." Journal of Privacy and Confidentiality, 10(2).
 17

 Solution:
Companies should go through stringent testing and validation procedures in line
with medical standards to guarantee wearable gadgets deliver reliable health data.
Frameworks for confirming the medical-grade accuracy of these devices are in
place at regulatory agencies such as the European Medicines Agency (EMA) and
the U.S. Food and Drug Administration (FDA).43 Through practical clinical trials,
partnerships between digital firms and healthcare organizations can also help
improve measurement accuracy and refine algorithms.44
C. Improving integration with healthcare systems:
 Solution:
Interoperable standards such as HL7 FHIR (Fast Healthcare Interoperability
Resources), which enable smooth data exchange between devices and electronic
health records (EHRs), can help integrate wearable health data into healthcare
systems in an effective manner.45 With user-friendly interfaces, healthcare
professionals can be trained to efficiently evaluate data from wearables.
Furthermore, doctors can access patient data in real-time while ensuring privacy
by putting in place secure data-sharing networks.46
3. Robotic Surgery and Automation:
A. Reducing Cost and Increasing Accessibility:
 Solution:
Creating more affordable and open-source robotic systems is one way to reduce
the price of robotic surgery. Instead of rebuilding complete systems, companies
can concentrate on scalable and modular designs that enable hospitals to replace
individual components. In order to make these technologies available to
underfunded and smaller healthcare facilities, government subsidies and public-
private partnerships might also be very important.47 Additionally, when more
reasonably priced robotic systems hit the market, competitive marketplaces and
higher research expenditures can aid in cost reduction.48

43
FDA. (2021). "Digital Health: Policies and Guidelines." U.S. Food and Drug Administration.
44
Wang, X., Markham, S., & Singh, H. (2020). "Evaluating the Accuracy of Wearable Health Devices in
Clinical Settings." Nature Biotechnology, 38(11), 1240-1247.

· Mandel, J. C., Kreda, D. A., Mandl, K. D., Kohane, I. S., & Ramoni, R. B. (2016). "SMART on FHIR: A
45

Standards-Based, Interoperable Platform for EHR Apps." Journal of the American Medical Informatics Association,
23(5), 899-908.
46
Dorsey, E. R., Yvonne, L. C., & Rosenthal, D. (2020). "Optimizing Data Integration from Wearable Devices
for Clinical Use." The Lancet Digital Health, 2(7).

Mahmood, S. S., & Dunn, W. R. (2020). "Robotic Surgery: Cost Analysis and Solutions for Broader Access."
47

Healthcare Technology & Innovation Journal, 5(3), 145-153.

48
Darzi, A. (2019). "Technological Innovations in Surgery: Reducing Costs and Improving Access." Journal of
Surgical Innovations, 41(2), 97-101.
 18

B. Addressing Training and Skill Requirements:

 Solution:
Standardized training programs and simulations can be used to address training
obstacles. Before performing actual procedures, doctors can obtain practical
experience in a risk-free setting by using virtual reality (VR) and augmented
reality (AR) technologies.49 Furthermore, medical practitioners can acquire the
required skills early in their careers by creating dedicated robotic surgical training
facilities and including these programs in medical school curricular.50 The
learning curve can also be accelerated through mentoring programs, in which
seasoned robotic surgeons instruct newcomers.
C. Navigating Legal and Liability Issues:
 Solution:
Clear guidelines and legal frameworks are needed to address liability concerns in
robotic surgery. A shared responsibility model can be adopted, where the surgeon,
hospital, and manufacturer each have defined roles and liabilities. For instance,
the surgeon may be responsible for the procedural aspects, the hospital for
ensuring the equipment is maintained, and the manufacturer for addressing
software or hardware defects.51 Implementing comprehensive informed consent
processes, where patients are educated about the potential risks of robotic surgery,
can also mitigate legal disputes. Additionally, insurers and regulatory bodies can
develop specific policies tailored to robotic surgeries to clarify accountability.52
4. Biotechnology and Genetic Engineering:
A. Addressing Ethical Issues in Genetic Editing:
 Solution:
Strong ethical frameworks and norms that put safety and human rights first are
necessary to handle moral conundrums involving technology like CRISPR. By
separating the acceptable uses of genetic editing into medicinal and enhancing
reasons, international bioethics committees can aid in reaching a consensus. To
guarantee openness and ethical supervision, for example, the World Health
Organization (WHO) has suggested creating a worldwide register for human
genome editing research.53 In order to collect a variety of viewpoints and promote

49
Khan, M. S., Ahmed, K., & Dasgupta, P. (2021). "Enhancing Robotic Surgery Training: The Role of
Simulation and Virtual Reality." Annals of Surgery, 273(4), 742-749.
50
Martin, J. A., Regehr, G., & MacRae, H. (2020). "Training in Robotic Surgery: A New Paradigm for Surgical
Education." Journal of Medical Education, 55(7), 615-622.
51
Di Nucci, E. (2018). "Robotic Surgery and the Question of Liability: An Ethical Perspective." Ethics &
Medical Practice, 12(3), 145-153.
52
Brougham, R., & Horsburgh, T. (2019). "Legal Considerations in Robotic-Assisted Surgery: Defining
Accountability." Medical Law Review, 27(1), 23-42.
53
WHO. (2021). "Human Genome Editing: Recommendations." World Health Organization.
 19

knowledgeable discussions regarding the societal ramifications of genetic editing,

public involvement and education are also essential.54
B. Enhancing Regulation of Gene Therapy:
 Solution:
Strict regulatory frameworks are needed to guarantee gene therapy's efficacy and
safety. In order to evaluate risks and benefits, regulatory bodies such as the
European Medicines Agency (EMA) and the U.S. Food and Drug Administration
(FDA) have set standards for clinical trials that call for staged trials and
comprehensive preclinical testing.55 Additionally, multinational partnerships like
the multinational Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH) strive to promote harmonized rules and
standardize regulatory practices worldwide.56 Improving post-market surveillance
can also aid in resolving unanticipated concerns and tracking long-term impacts.
C. Mitigating Impact on Healthcare Disparities:
 Solution:
Implementing fair access measures is necessary to stop genetic technology from
exacerbating healthcare inequities. To guarantee that low-income patients have
access to life-saving treatments, governments and international health groups can
advocate for laws that support gene therapies. Initiatives such as tiered pricing
models, which modify treatment costs according to a patient's financial capacity,
can also be used.57 Additionally, by funding regional healthcare facilities and
training, public-private partnerships can lower costs and improve access to
genetic medicines in underprivileged populations.58

CONCLUSION:
The application of artificial intelligence (AI) in medicine is revolutionizing the
field and providing encouraging answers to persistent problems. Numerous uses
of AI in the fields of drug development, customized medicine, treatment planning,
diagnostics, and patient management have been investigated in this study.
According to the research, AI-powered technologies like neural networks,
machine learning algorithms, and natural language processing have the potential

54
Berg, J. M., Taylor, P. L., & Hurlbut, J. B. (2020). "Ethical Considerations in the Use of CRISPR
Technology." Journal of Bioethics, 24(6), 567-574.
55
FDA. (2022). "Guidelines for Gene Therapy Clinical Trials." U.S. Food and Drug Administration.
56
ICH. (2021). "International Harmonisation of Gene Therapy Regulations." International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
57
Ginsburg, G. S., & Phillips, K. A. (2020). "Precision Medicine and Health Disparities: Mitigating the Gaps."
Journal of the American Medical Association, 323(2), 169-170.
58
Zhang, Y., & Zhao, R. (2019). "Addressing Healthcare Inequities in the Era of Genetic Medicine." Global
Health Policy Journal, 7(3), 203-210.
 20

to improve patient outcomes by increasing accuracy, lowering human error, and

delivering timely interventions.
The use of AI in medicine is not without difficulties, despite its benefits. To
realize its full potential, issues including algorithmic biases, data privacy, the
requirement for high-quality datasets, and ethical considerations must be resolved.
Furthermore, in order to guarantee the security and dependability of AI-driven
healthcare solutions, legal frameworks and guidelines must change to keep up
with the quick advances in technology.
In conclusion, artificial intelligence (AI) is a potent augmentation tool for
medical practitioners, but it cannot completely replace human skill. AI has the
ability to completely transform medical practice by enhancing clinical judgment
with data-driven insights, resulting in more accurate, individualized, and easily
accessible healthcare. To fully realize the advantages of AI in medicine and
eventually create a more effective and efficient healthcare system, further study,
cooperation between technologists and medical practitioners, and an emphasis on
ethical implementation are essential.