Legal Issues and Challenges of Artificial Intelligence Technology in

International Healthcare System: What Doctors and Patients Say

Isroni Muhammad Miraj Mirza

, Agit Yogi Subandi and Ananda Melania Prawesti

Faculty of Law, Universitas Lampung, Bandar Lampung,

Indonesia

Keywords: AI, Medical, Innovation.

Abstract: Medical advancements are a major source of hope for the community. Nevertheless, for society to profit from

medical advancements and minimize their risks, comparable advances are probably needed in governance

domains including law, policy, and ethics. Researchers from a range of disciplines are voicing concerns about

the possible legal ramifications of health-related breakthroughs that might call for governmental responses as

AI develops quickly. As a result, the purpose of this essay is to investigate how physicians and patients view

that specific issue. This study employs a social-legal framework and the systematic review method to examine

the application of AI. in the medical industry in an appropriate and fair way. More precisely, in an effort to

search for and establish international standards surrounding the use of artificial intelligence in the healthcare

system, this research examines the literature that is already available using a combination of social,

technological, and legal review technique based on the existing legislative instruments. These viewpoints

could offer insightful information on the most pressing problems that will impact and enable upcoming

regulatory reform. Regretfully, there isn't a thorough summary of the research on legal issues pertaining to

innovations in the health sector at this time. Put another way, the findings of this research indicate that, despite

continued advancements in technology, there isn't a single, cohesive worldwide regulatory framework that

regulates the application of AI in the medical domain. As such, the international community still faces

problems and difficulties. The study's findings demonstrate the necessity for a common legislation controlling

AI in healthcare to be more precisely tailored so as to at least safeguard the interests of all participating

governments.

1 INTRODUCTION

Artificial intelligence (AI) in medicine has the

potential to revolutionize medicine, but regulations

must be in place to ensure proper implementation and

minimize risk. Health-related AI has been one of the

most discussed areas of AI in medicine. People are

discussing how AI could improve healthcare systems

by improving diagnoses, streamlining healthcare, or

reducing human bias (E Topol, 2019). Artificial

intelligence (AI) is emerging as a highly influential

tool in the health sector that can not only address the

need but also make it easier for people working in

these fields where the lack of service towards society

becomes the main focus. AI can analyze large

volumes of medical data, recognize patterns, and

provide relevant insights (Sanhaji, 2023). One of the

AI technologies that can take over the role of CRM

can’t serve 24 hours, but this can be done with AI,

which is known as Chatbot technology. Chatbots can

automatically respond to questions asked by AI

technology (Devianto Y, 2020).

Yet, there are also worries that AI could

exacerbate preexisting racial or social biases,

undermine transparency, make it more difficult to

deskill healthcare professionals, harm the relationship

between the patient and the provider, or produce

algorithmic bias that will be difficult to identify.

Naturally, there are differing perspectives on the

matter. Artificial intelligence (AI) has many potential

applications, but many people are cautious about its

broad adoption. These concerns highlight the

necessity of regulatory or other governance structures

(legal, political, ethical) that allow nations to

maximize AI's advantages while minimizing its risks.

Artificial Intelligence (AI) tailored to the health

sector will engage with the legal system in a number

of ways. First, there are concerns about whether

current laws will address the problems linked with AI

Mirza, I. M. M., Subandi, A. Y. and Prawesti, A. M.

Legal Issues and Challenges of Artiﬁcial Intelligence Technology in International Healthcare System: What Doctors and Patients Say.

DOI: 10.5220/0013087100003873

Paper published under CC license (CC BY-NC-ND 4.0)

In Proceedings of the 1st International Conference on Medical Science and Health (ICOMESH 2023), pages 11-16

ISBN: 978-989-758-740-5

that are specific to health, such as the following (Da

Silva, 2022):

1. AI is not immune to error, whether in the areas

of self-regulation or accreditation, medical

device regulation, monitoring the observance

of product liability rules, or medical

malpractice laws.

2. It is appropriate to think about the suitability of

current rules for assigning blame for medical

errors in which an AI tool suggests—or even

performs—a course of treatment that is

harmful to health. It is also important to think

about how liability should be distributed

among medical professionals, AI developers,

and manufacturers.

3. Can the problem of AI algorithms that

arbitrarily provide different results to groups

that have historically been less prosperous

truly be addressed by the laws now in place

against discrimination and human rights?

4. Are there enough privacy laws in place to

protect patients, considering the need for AI to

analyze massive quantities of data and

machine learning systems, for example, that

gather data in real time?

5. Will the laws and regulations governing data

governance already in place be adequate to

give AI inventors representative training data

sets that accurately represent historically

underrepresented populations?

6. Will the regulations governing informed

consent today be adequate to protect people

when medical professionals choose to use

artificial intelligence (AI) to diagnose and treat

patients?

There is a dearth of thorough knowledge

regarding the legal obstacles presented by health-

related artificial intelligence (AI), despite the fact that

law is essential to the effective application of AI in

healthcare settings.

2 RESEARCH METHOD

In this study, systematic review methods are used

with a qualitative approach and a mix of technical,

sociological, and juridical normative approach.

During this method, relevant research will be

analysed by looking at whether there are existing laws

that specifically regulate the use of AI within the

healthcare system to ensure justice and its

implementation on the ground. If there are no existing

laws, then how can the existing law regarding the use

of AI in the case of a medical science legal dispute be

applied? In this context, from the sociological, legal,

and cultural perspectives, researchers will collect data

on problems, difficulties, conditions and behaviours

in society, and the lawfulness of AI in order to have

effective law enforcement within the medical field.

3 RESULT

3.1 Aritificial Intelligence

The phrases "problem solving" and "search" in

artificial intelligence refer to a group of concepts

pertaining to inference, conclusion, planning,

common sense reasoning, proof theorems, and

associated procedures. Programs for natural language

comprehension, information retrieval, robotics,

automatic programming, text analysis, game play,

expert systems, and mathematical theorem proof are

common uses for this concept. Artificial intelligence

is a field of study that uses intelligence agents to

perceive their surroundings and display relevant

actions (Astuti, 2020).

3.2 Digital Transformation

When multiple digital innovations come together,

new actors (and actor constellations), structures,

practices, values, and beliefs are introduced into

organizations, ecosystems, industries, or fields. These

new actors alter, threaten, replace, or supplement the

established rules of the game. This process is known

as digital transformation (Kraus, 2021). There is a

significant chance that artificial intelligence (AI) may

help achieve the Sustainable Development Goals

(SDGs). Some people are concerned that their human

rights, including the freedom of speech, the right to

privacy, the right to data protection, and the right to

discrimination, are being violated, even while

technology is being used to address many of society's

most urgent issues. AI-based technologies provide

tremendous opportunities if they are developed in line

with global norms, ethics, and standards and are

founded on principles that prioritize human rights and

sustainable development.

3.3 Artificial Intelligence and

Healthcare

Artificial intelligence has aided in the development of

wearables and medical gadgets that track vital signs

and gather patient data in real time. These gadgets

provide early health issue detection and remote

ICOMESH 2023 - INTERNATIONAL CONFERENCE ON MEDICAL SCIENCE AND HEALTH

patient monitoring when paired with AI algorithms.

AI can assist medical professionals in anticipating

issues and recommending the best course of action for

a patient. For example, AI can more quickly and

accurately recommend to a patient the best course of

action or prescription. Healthcare professionals can

now identify previously unidentified relationships

between diseases and healthcare data, or they can

identify minute changes in a patient's vital signs that

may be a symptom of an issue, thanks to artificial

intelligence in the form of machine learning.

3.4 Legal Issues of Artificial

Intelligence in Healthcare System

The future of human civilization could be influenced

by the exponential expansion of artificial intelligence

(AI) in a number of ways. Artificial intelligence (AI)

has the ability to perpetuate or even worsen bias and

discrimination in the decision-making process, even

though it is a machine created by human intelligence.

Laws and regulations will be required to guarantee

the fairness and impartiality of AI systems, and those

who have experienced prejudice will have redress

options. One of the disadvantages of AI in this

context is that it can give rise to privacy and ethical

concerns when applied to healthcare systems.

The data suggests that AI models have the power

to significantly introduce and magnify social and

human biases. But rather than the algorithm itself, the

underlying data is ultimately to blame for this. Data

reflecting human decision-making or the second-

order effects of historical or societal inequality can be

used to train models. Furthermore, bias may also be

influenced by the way that data is gathered and used.

Moreover, bias could arise from the feedback

mechanism that user-generated data uses. Although

there aren't any official criteria or guidelines for

reporting and comparing these models just yet, future

study should take this into account to help researchers

and doctors (Nelson GS, 2019).

In the context of regulatory control of AI

interactions, the question of legal liability for AI

operations is critical. The example of IBM Watson, a

supercomputer, prescribing wrong cancer therapies

and exacerbating the patient's condition, highlights

the importance of this issue.

The ramifications of giving Artificial Intelligence

(AI) access to patient data at the municipal, state, or

federal levels rather than the international level must

also be taken into account. This calls for taking into

account biological differences across patient groups

(older adults, children, etc.) as well as medical ethical

requirements (Laptev, 2021).

All citizens—including doctors—are entitled to

equal treatment under the law, even though they can

face criminal charges. Nevertheless, criminal activity

by itself does not provide enough evidence to prove

criminal responsibility. It's simple to use artificial

intelligence (AI). Criminal conduct will continue if a

system acts in a way that encourages it or if there is a

legal requirement (Hallevy, 2010).

There must be a criminal mindset associated with

it. The essence of criminal guilt is directly addressed

by criminal attempt. Since no doctor is expected to

purposefully damage a patient, the issue of "mens

rea" has come up for debate in medical malpractice

cases. For instance, in Indonesia, criminal

prosecution will only occur for actions that are

deemed unlawful under a criminal code or other

criminal legislation (Hall, 1940).

3.5 Challenges and Future of Artificial

Intelligence in International Health

Care System

As artificial intelligence (AI) progresses from a "nice

to have" to a vital part of contemporary digital

systems, it is more crucial than ever to make sure that

AI is capable of making morally correct decisions that

are free from bias. We acknowledge the need for

transparent, intelligible, and responsible (Responsible

Artificial Intelligence (Rabi) systems). AI systems

will probably eventually outperform humans in some

areas as they are used more and more to improve

surgical outcomes and patient guidance. AI is likely

to surpass, coexist with, or replace current systems,

ushering in the AI era of healthcare; failing to do so

could be unethical and unscientific (Parikh, 2019).

In order to ensure the correctness and objectivity

of AI applications, medical legal customs must be

systematized and made available to AI services. The

rules and regulations governing the application of

artificial intelligence (AI) technology, including

robots, AI hospitals, and cyborg-AI doctors, will

mostly depend on national legal customs. The

development of transnational AI (such as an AI-

Cloud-Doctor) will thus require the establishment of

an international repository of medical legal treaties

that have been ratified by all participating nations.

The legislation governing the use of artificial

intelligence (AI) technology is still being developed

at this time. The creation and acceptance of strategic

(legal) guidelines for the widespread deployment of

AI technology is the main priority for states. When

creating, implementing, and using AI technology, it

is appropriate to take into consideration the following

principles, given the legal framework for its use in

Legal Issues and Challenges of Artiﬁcial Intelligence Technology in International Healthcare System: What Doctors and Patients Say

healthcare has not yet been established (Parikh,

2019):

1. Individuals should be allowed to make decisions

about their own health;

2. Sensitive information and patient privacy need

to be protected.

3. When applying AI in healthcare, developers of

the technology should ensure that it satisfies

specific safety, accuracy, and efficiency

requirements.

4. It is important to apply Artificial Intelligence

(AI) technologies in a fair and equitable manner.

5. The enforcement of educational initiatives

aimed at providing medical staff with the know-

how and abilities required to apply artificial

intelligence technologies.

6. The rationale behind the use of artificial

intelligence (AI) technology in transparency.

The problem of human resources will be the

biggest obstacle to the application of artificial

intelligence in medical practice. The entity that will

communicate with robotic systems and artificial

intelligence is the human. The goal of AI and

emerging technologies is to make human activities

easier. Artificial Intelligence can solve a range of

Human Resource problems when used to the medical

field (Hakim, 2021).

At least three significant HR challenges will face

medical professionals in the next years: a worldwide

physician shortage, an aging and overburdened

medical workforce, and a rise in long-term care

needs. The caliber of the system's medical personnel

is essential to its effectiveness. An further significant

concern is the aging of medical professionals, with an

estimated 17.4 million medical practitioners needed

globally.

Quality healthcare cannot be delivered without a

skilled medical practitioner, as the world's people

resources continue to grow. Many human resource

problems can be resolved in the healthcare industry

by implementing state-of-the-art technologies

(Devianto, 2020).

Better treatment delivery will result from the

presence of top-notch medical specialists. Medical

professionals will find it easier to do their jobs with

the help of Artificial Intelligence (AI) as a "cognitive

assistant" that can analyze and understand data and

has a broad range of clinical experience. AI as a

cognitive assistant, for instance, might be able to

recognize medical disorders by analyzing radiology

pictures (Hiadayat, 2021).

Artificial Intelligence (AI) has the potential to

help medical professionals make more accurate

diagnoses, streamline administrative processes,

improve decision-making, and analyze vast amounts

of data. Additionally, using AI could offer ways to

improve healthcare accessibility. Artificial

intelligence does not, however, fully replace human

intervention; empathy, clear communication, and

human connection are still crucial components of

treatment. In the end, nothing—not even apps or

technology—can replace interpersonal relationships

and trust.

The human doctor will always be necessary, but

artificial intelligence (AI) has the potential to be a

very useful cognitive helper. Furthermore, the

emergence of digital health holds promise for

changing the conventional doctor-patient dynamic

into an equal collaboration (Huss, 2018).

While it can be challenging to get AI models to

function in medical settings, the clinician interacting

with the robot and AI has much greater challenges.

There are two main difficulties that arise when it

comes to the risk of AI in healthcare: first, using AI

in healthcare or medical practice can be dangerous.

Negligent insiders are healthcare professionals who

disregard the law when it comes to gaining access to

and using patient data, whereas hackers are outside

hackers.

There is a technological barrier to the application

of artificial intelligence (AI) in the healthcare

industry. AI needs to be controlled and supervised by

a qualified healthcare practitioner and technologist in

order to be effective. An human with health

understanding should oversee AI operations to ensure

correct data entry and appropriate health practice

monitoring. The main goal of healthcare automation

should not be obscured by the possibility that it falls

under the category of AI or healthcare data

technology. Humans have historically formed

intimate bonds with people who are thought to have

more or less knowledge or competence (Terry, 2017).

Currently, there isn’t any international treaty or

convention that establishes a set of broad guidelines

for the application of AI technology, especially in the

medical field. Only a small number of

recommendatory texts have been ratified to serve as

the foundation for international legal supervision in

the field of artificial intelligence. Among these

documents are:

1. The "Okinawa Charter" on the Global

Information Society was released during the G8

Kyoto Summit Meeting (G8 2000) in Kyushu-

Osaka, Japan. It called for the establishment of

a regulatory framework to encourage

cooperation in order to enhance international

networks and reduce the digital divide.

ICOMESH 2023 - INTERNATIONAL CONFERENCE ON MEDICAL SCIENCE AND HEALTH

2. At the Council's Ministerial Level on May 22,

2019, the World Economic Forum (WEF) and

the Council of the European Economic and

Social Council (ECOSOC) agreed the first

Intergovernmental Standard on Artificial

Intelligence, also known as the OECD Council

Recommendation (Artificial Intelligence 2019).

The statement offers suggestions for national

governments to consider while developing

artificial intelligence and lays out broad rules for

its deployment.

3. At the G20 Trade and Digital Economy

Ministerial Statement (2019, Japan), the G20

Secretary-General adopted the principles for the

advancement of artificial intelligence (AI) on

behalf of the member states of the Group of

Twenty (G20).

The significance of international technological

standards in relation to international legal regulation

must also be emphasized. The work of the

international standardization bodies (ISO, IEC, and

ITU) leads to the creation and publication of

international standards. These groups develop and

distribute technical papers, standards, guidelines, and

recommendations.

4 CONCLUSION

Healthcare workers can now provide care more

effectively, with greater awareness, precision in

identifying potential problems, early disease

diagnosis, and use of the most recent interventions

thanks to the use of cutting-edge Artificial

Intelligence (AI) tools. Nevertheless, in an effort to

establish worldwide standards on the use of AI in the

healthcare system and minimize risks—particularly

health risks—legal issues also need to be addressed

concurrently on a global scale.

Artificial Intelligence (AI) has to be held to a

very high standard of moral accountability as it is

used in healthcare even more these days. To prevent

data bias, appropriate algorithms that are based on

objective real-time data must be used. It is imperative

to carry out regular audits of the algorithms, including

their integration into the system, and to promote

diversity and inclusion in programming groups.

While AI might not completely replace clinical

judgment, it might help doctors make wiser choices.

AI can be used, for instance, to conduct screening and

assessment in situations when medical expertise is

scarce.

In contrast to human decision-making, all AI

decisions—even the quickest ones—are methodical

since algorithms play a part in the process. As a result,

even in cases where the activities have no legal

ramifications (since effective legal frameworks are

still lacking), they inevitably lead to accountability—

not for the machine itself, but for the people who

created it and the people who use it. Artificial

Intelligence is likely to replace or coexist with current

systems, even though there are ethical and scientific

concerns. This will bring about the era of AI in

healthcare, and it would be regarded as being

unethical and unscientific for not using AI.

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