RESUME JOURNAL

Artificial intelligence as a medical device in radiology: ethical and

regulatory issues in Europe and the United States

To Fulfill One of the Diagnostic Imaging Course Assignments

Health Ethics Law
Lecturer :Dr. Rr. Sri Endang Pujiastuti, SKM, MN

M. Sofyan
P1337430423017

APPLIED DIAGNOSTIC IMAGING MASTER PROGRAM

HEALTH POLYTECHNIC MINISTRY OF HEALTH SEMARANG
2023/2024

i
 FOREWORD

Artificial intelligence (AI) has become a promising innovation in the medical field,
especially in radiology. The use of AI in radiology has had a significant impact on patient
data privacy and security. Therefore, it is important to understand and address the ethical
and regulatory issues associated with the use of AI as a medical tool in Europe and the
United States.

In this study, we will analyze the differences in regulation of the use of AI as a

medical tool between Europe and the United States. We will also evaluate the impact of
using AI in radiology on the privacy and security of patient data, and determine who is
responsible for the decisions made by AI in the medical field. In addition, we will consider
how regulation regarding the use of AI as a medical tool can keep up with rapid
technological developments. Finally, we will discuss how the protection of patient
medical data can be guaranteed in the use of AI in radiology.

It is hoped that this research will provide a better understanding of the implications
of using AI in radiology for patient data privacy and security, as well as provide insight
into regulatory differences between Europe and the United States. Thus, this research can
form the basis for developing effective regulations and ensuring the safe and ethical use
of AI as a medical tool.

ii
 LIST OF CONTENTS

cover ………………………………………………………...... i
Foreword ………………………………………………………….. ii
List of contents ………………………………………………………….. iii
Reasons for Choosing ………………………………………………………….. iv
a Journal

CHAPTER I INTRODUCTION
A Background ……………………………………. 1
B Problem of Formulation ……………………………………. 1
C Problem Objectives ……………………………………. 2
D Benefits of Papers ……………………………………. 3
CHAPTER II DISCUSSION
1 Use of AI in Radiology ……………………………………. 5
2 Differences About AI ………………………………….… 5
Regulations
3 Who Is Responsible For ……………………………………. 5
AI Decisions
4 Regulation About AI ……………………………………. 6
5 Medical Data Protection ……………………………………. 6
CHAPTER III CLOSING
A Conclusion ………………………………………………… 8
B Suggestion ………………………………………………… 9

iii
 REASONS TO CHOOSE THIS JOURNAL FOR RESUME

1. I chose this journal for resume because this article addresses ethical and regulatory
issues that are highly relevant in the use of artificial intelligence (AI) as a medical
device in the field of radiology. This article provides a comprehensive overview of
AI regulation in Europe and the United States, and discusses the challenges and
potential benefits of AI in medicine and radiology.
2. This journal also reviews data protection and cybersecurity which are important
considerations in the use of AI in the health sector. The author also discusses the legal
implications of AI and accountability in medicine.
3. By reading this journal, I can gain a better understanding of the ethical and regulatory
issues associated with the use of AI as a medical device in radiology. This article
provides important insights for me as a future healthcare professional to understand
the importance of proper regulation of the use of AI technology in medical practice.

iv
 1

CHAPTER I

INTRODUCTION

A. Background

Artificial intelligence (AI) has become an increasingly important field in computer

science, with its ability to perform tasks without explicit instructions. In the field of
radiology, AI has been applied as a medical tool that can help in diagnosis and
treatment. However, the use of AI as a medical device in radiology also raises several
ethical and regulatory issues that need attention.

One of the ethical issues that arises is the security and privacy of patient data. The
use of AI in radiology involves the collection and processing of patient medical data.
Therefore, it is important to ensure that this data is secure and protected in accordance
with applicable regulations in Europe and the United States.

In addition, regulations related to the use of AI as a medical device are also a

concern. In Europe, there are regulations such as the General Data Protection
Regulation (GDPR) that govern the use and protection of personal data. In the United
States, the Food and Drug Administration (FDA) is responsible for regulating the use
of AI as a medical device.

In this article, we will discuss more about ethical and regulatory issues related to
the use of AI as a medical device in radiology in Europe and the United States. We will
identify challenges and differences in regulation in these two areas, as well as provide
insights on how these issues can be addressed.

B. Problem Formulation

In the journal "Artificial intelligence as a medical device in radiology: ethical and

regulatory issues in Europe and the United States", there are several problems
discussed related to the use of artificial intelligence (AI) as a medical device in the
field of radiology in Europe and the United States.

1
 2

1. How does the use of AI in radiology affect the privacy and security of patient data?
2. How does the regulation of the use of AI as a medical device differ between Europe
and the United States?
3. Who is responsible for the decisions generated by AI in the medical field?
4. How can regulations related to the use of AI as a medical device keep up with the
rapid development of technology?
5. How can patient medical data protection be guaranteed in the use of AI in
radiology?

C. Problem Objectives

The purpose of the article "Artificial intelligence as a medical device in radiology:

ethical and regulatory issues in Europe and the United States" is to identify and discuss
ethical and regulatory issues related to the use of artificial intelligence (AI) as a
medical device in radiology in Europe and the United States. This article aims to
provide a better understanding of the challenges faced in the use of AI in radiology, as
well as the differences in regulation between the two regions. Thus, this article is
expected to provide useful insights for medical professionals, regulators, and
researchers in the face of the development of AI technology in the field of radiology.

Here is the purpose of the problem statement on "Artificial intelligence as a

medical device in radiology: ethical and regulatory issues in Europe and the United
States"

1. The purpose of this problem formulation is to evaluate the impact of the use of AI
in radiology on the privacy and security of patient data. It is important to
understand the risks associated with using AI technology in collecting, storing, and
processing patients' medical data, as well as to identify steps that can be taken to
protect the privacy and security of such data.
2. The purpose of this problem formulation is to compare the regulatory differences
in the use of AI as a medical device between Europe and the United States. By
understanding the differences in regulatory approaches between these two regions,
 3

we can identify the strengths and weaknesses of each approach, as well as

opportunities to improve regulation of the use of AI as a medical device.
3. The purpose of this problem statement is to determine who is responsible for the
decisions generated by AI in the medical field. In this context, it is important to
consider the legal and ethical aspects related to accountability and responsibility
in the use of AI technology in medical decision making.
4. The purpose of this problem formulation is to evaluate how regulations related to
the use of AI as a medical device can keep up with rapid technological
developments. In this context, it is important to consider the challenges associated
with AI regulation in a constantly changing and unpredictable environment, as well
as to identify strategies that can be used to ensure relevant and effective regulation.
5. The purpose of this problem formulation is to determine how the protection of
patient medical data can be guaranteed in the use of AI in radiology. In this context,
it is important to consider the implications related to data protection and
cybersecurity, as well as to identify measures that.

D. Benefits Of Papers
1. Provide ethical and regulatory guidance: This study addresses ethical and
regulatory issues related to the use of artificial intelligence (AI) in radiology. This
can help in developing appropriate guidelines and policies to regulate the use of AI
in the medical field.
2. Improve disease detection: This research highlights the potential of AI in improving
disease detection through medical image analysis. With the help of AI, disease
detection can be done more accurately and quickly.
3. Reduce human error: The use of AI in radiology can help reduce human error in
analyzing medical images. This can improve the accuracy of diagnosis and
treatment.
4. Improve examination efficiency: This study discusses the use of AI in reducing MRI
examination time. With the help of AI, the time required to perform examinations
can be reduced, thereby increasing efficiency and reducing patient waiting time.
 4

5. Optimizing resource usage: This study highlights the potential of AI in optimizing

the use of radiology staff and equipment. This can help reduce operational costs and
increase the efficiency of radiology services.
 5

CHAPTER II

DISCUSSION

1. The use of AI in radiology can affect the privacy and security of patient data:

In the collection and processing of patient medical data, it is necessary to ensure

that the patient's personal data and privacy are well protected. The use of AI in
radiology involves collecting and processing patient medical data, which can include
sensitive information such as medical history, test results, and medical images.
Therefore, it is important to ensure that this data is safe and protected in accordance
with applicable regulations. Personal data protection and patient privacy should be a
priority in the use of AI in radiology.

2. Regulatory differences in the use of AI as a medical device between Europe and

the United States:

In Europe, there are regulations such as the General Data Protection Regulation
(GDPR) that govern the use and protection of personal data. The GDPR gives
individuals the right to control the use of their personal data and requires organizations
to protect that data. In the United States, the Food and Drug Administration (FDA) is
responsible for regulating the use of AI as a medical device. The FDA has strict
requirements for testing and approval of AI medical devices before they are used
commercially. These differences in regulation could affect the development and use of
AI in radiology between the two regions.

3. Who is responsible for decisions generated by AI in the medical field:

Until now, it is still a debate. AI-generated decisions are still difficult to predict,
raising questions about legal and ethical accountability. In a medical context, this
question becomes important because AI decisions can have a significant impact on
patient diagnosis and treatment. Although AI can provide recommendations or
suggestions, ultimately legal and ethical responsibility remains with those who use the
AI. However, in some cases, responsibility can be shared between AI developers,

5
 6

medical care providers, and doctors who use AI in medical decision-making. A clear
legal framework is needed to determine responsibility for the use of AI in the medical
field.

4. Regulations related to the use of AI as a medical device need to be able to keep up

with rapid technological developments:

AI technology continues to evolve rapidly, and regulations must be able to keep

up with these developments in order to remain relevant and effective. This is a
challenge because regulations usually take a long time to be drafted and implemented.
To overcome this, there needs to be cooperation between the government, regulatory
agencies, and the technology industry to accelerate the regulatory process. In addition,
regulations also need to be designed with flexibility so that they can adapt to the rapid
development of AI technology. Thus, regulations related to the use of AI as a medical
device can remain relevant and effective in regulating the use of AI technology that
continues to grow.

5. Protection of patient medical data in the use of AI in radiology:

A few steps. First, there needs to be clear policies and regulations regarding the
collection, use, and storage of patient medical data. Regulations such as the General
Data Protection Regulation (GDPR) in Europe and regulations issued by the Food and
Drug Administration (FDA) in the United States have regulated the protection of
patients' personal data in the context of using AI as a medical device.

In addition, it is necessary to carry out technical measures to ensure the safety of

the patient's medical data. This includes the use of data encryption, the use of strong
security protocols, and the use of secure authentication systems. In addition, it is
necessary to conduct regular monitoring and audits to ensure that patients' medical
data is not misused or accessed by unauthorized parties.

In addition, it is important to involve patients in decision-making regarding the

use of their medical data in the development of AI in radiology. Patients should be
provided with clear information about how their medical data will be used, their right
to give consent or object to the use of their data, and their right to access and control
 7

their own medical data. In this case, transparency and patient participation are key in
maintaining the privacy and security of patient medical data.

In addition, it is also important to involve data security and privacy experts in the
development and implementation of AI systems in radiology. These experts can assist
in identifying security and privacy risks that may arise, as well as providing advice
and solutions to address those risks. Collaboration between medical experts,
technologists, and data security and privacy experts is important in ensuring the
protection of patients' medical data in the use of AI in radiology.
 8

CHAPTER III

CLOSING

A. Conclusion
The conclusion of the journal "Artificial intelligence as a medical device in
radiology: ethical and regulatory issues in Europe and the United States" is that the
use of artificial intelligence (AI) as a medical device in radiology has ethical and
regulatory challenges that need to be addressed. Current regulations in Europe and
the United States are undergoing changes to accommodate the use of AI in the
medical field. Good regulation is needed to ensure safety, privacy protection, and
ethical use of AI in healthcare.
Regulations in Europe, such as the General Data Protection Regulation
(GDPR) and Medical Devices Regulation (MDR), aim to improve the responsibility,
transparency and protection of medical data. In the United States, the Food and Drug
Administration (FDA) has strict requirements for the approval of AI medical devices.
Data protection and cybersecurity are also important concerns in the use of AI in
healthcare.
In addition, legal liability and liability are also important implications of the
use of AI in the medical field. Although AI can help in data analysis, the final decision
should involve the expertise and values of the physician. Accountability for AI results
can be addressed through insurance and multidisciplinary institutions. It is important
to address challenges such as policy initiatives, data protection, cybersecurity, and
the ethical use of sensitive information. AI must be built with ethical standards in
mind and finding a balance to ensure responsible patient management.
In conclusion, proper regulation is needed to ensure the use of AI in radiology
and other medical fields can provide substantial benefits. With good regulation.

8
 9

B. Suggestion

Advice taken from the journal "Artificial intelligence as a medical device in

radiology: ethical and regulatory issues in Europe and the United States" is as
follows:

There needs to be a clear and comprehensive regulation regarding the use of

AI as a medical device in radiology. This regulation must cover security, privacy,
and ethical aspects in the use of patient medical data.

It is important to involve data security and privacy experts in the

development and implementation of AI systems in radiology. These experts can
assist in identifying security and privacy risks that may arise, as well as providing
advice and solutions to address those risks.

Cooperation between governments, regulatory agencies, and the technology

industry is needed to accelerate the regulatory process related to the use of AI as
a medical device. Regulations must be designed with flexibility in order to keep
up with the rapid development of AI technology.

Patients should be provided with clear information about how their medical
data will be used, their right to give consent or object to the use of their data, and
their right to access and control their own medical data. Transparency and patient
participation are key in maintaining the privacy and security of patient medical
data.

In developing AI as a medical tool in radiology, it is important to ensure that

the final decision still involves the expertise and values of the physician. Although
AI can provide recommendations or suggestions, the final responsibility remains
with the party using the AI

These suggestions are expected to help in addressing the ethical and

regulatory challenges associated with the use of AI as a medical device in
radiology.
 10

LITERATURE

1. Pesapane, F., Sardanelli, F. M., &; Di Leo, G. (2018). Artificial intelligence as a

medical device in radiology: ethical and regulatory issues in Europe and the United
States. Insights into Imaging, 9(5), 745-753.

2. Christenses, H. I., Carnegie, C., Krovi, V., &; Smart, B. (2016). From Internet to
Robotics. Available via http://jacobsschool.ucsd.edu/contextualrobotics/docs/rm3-
final-rs.pdf. Accessed 42 7.

3. Molteni, M. (2017). Wellness apps evade the FDA, only to land in court. WIRED.
Available via https://www.wired.com/2017/04/wellness-apps-evade-fda-land-court/.

4. Majambere, E. (2011). Clarity, precision and unambiguity: aspects for effective

legislative drafting. Commonwealth Law Bulletin, 37, 417-426.

5. Zittrain, J. I. J. (2017). Ethics and governance of artificial intelligence. Available via

https://www.media.mit.edu/groups/ethics-and-governance/overview/.

6. Tsang, L., Mulryne, J., Strom, L., et al. (2017). The impact of artificial intelligence
on medical innovation in the European Union and United States. Available via
https://www.arnoldporter.com/~/media/files/perspectives/publications/2017/08/the-
impact-of-artificial-intelligence-on-medical-innovation.pdf.

7. Thierer, A., O'Sullivan, A., &; Russel, R. (2017). Artificial intelligence and public
policy. Mercatus Research Paper. Available via.
https://www.mercatus.org/system/files/thierer-artificial-intelligence-policy-mr
Mercatus-V1.pdf.

8. Scherer, M. U. (2016). Regulating artificial intelligence systems: risks, challenges,

competencies, and strategies. Harvard Journal of Law &; Technology, 29, 354-400.

9. Christenses HI, Carnegie C, Krovi V, Smart B (2016) From Internet to Robotics.

Stone et al. Supra note. Available via. http://
jacobsschool.ucsd.edu/contextualrobotics/docs/rm3-final-rs.pdf. Accessed 42 7.

10. Molteni, M (2017) Wellness apps evade the FDA, only to land incourt. WIRED.
Available via https://www.wired.com/2017/04/wellness-apps-evade-fda-land-court/