Medico-legal aspects of Artificial Intelligence, their current trends, and its

future perspectives.
Dr Aathithya J1
1.
Research Officer Medicine, Siddha Central Research Institute, Central Council for Research in Siddha(Ministry of Ayush),
Government of India, Anna Government hospital campus, Arumbakkam, Chennai-600106, Tamil Nadu, India

Abstract
Artificial intelligence is the ever-evolving deep learning processing in the healthcare sector,
like in radiology, the gastrointestinal system, cancer diagnostics, personalized medicine, etc.
AI can ease the workflow of doctors in early diagnostics of diseases, cardiac issues, etc.
Reduces the time by automation. The major diseases that are prevailing in the population
with large data would be considered for training a deep learning model, but in cases where
the prevalence is rare, the model would not have sufficient data for the diagnosis. The data
collected from specific populations would lead to the misdiagnosis of common symptoms.
The patient information imparts a high level of confidentiality, and certain ethical issues
about the same should be taken into consideration. Up to date, there have been no specific
regulatory statutes for AI. The responsibility for the misdiagnosis would be taken up either by
the person who developed the module, the doctor using it, or the product manufacturer. The
regulatory authority for the technology should have proper checks on its updates periodically
to prevent misdiagnosis. So, considering all these factors, a definitive law for the protection
of patient information and also the moral and ethical issues related to AI should be
formulated for using the technology safely and judiciously.
Keywords
Automation technology, Deep model, medical practice, Regulation, Ethics, medical decision.
About the technology
Artificial Intelligence (AI) is a computer-based deep learning process with software programs
used to build up a technology that is more or less equivalent to the processing of the human
brain and its intelligence. As the human brain has various capabilities like logical reasoning,
thinking, and problem-solving, the model has to be trained in such a way as to exhibit all the
similar functions that humans are capable of so that it can be comparable to the real-world
scenario.1 The computer in the olden days had mathematical solutions with certain rules and
formulas in which when an input is given to the system it is possible to generate output only
1
Amisha, Malik P, Pathania M, Rathaur VK. Overview of artificial intelligence in medicine. J Family Med Prim
Care. 2019 Jul;8(7):2328-2331. doi: 10.4103/jfmpc.jfmpc_440_19. PMID: 31463251; PMCID: PMC6691444
in a specified manner. Whereas in the present-day situation, the algorithms of the systems are
designed based on the available large volume of data so that it is processed and trained in
every batch to minimise the errors in the program and algorithm by logically and sensibly
analysing the given data to propagate better AI-based applications for various fields. 2 AI is
used in various industries like healthcare, the agriculture sector, production units, for
maintaining the health
records of the patient, manufacturing companies, automobile industries, analysis of sports and
evaluating it, and also used widely in the medical field in numerous possible ways. The brain
of humans has several neurological connections for handling complex tasks, in the same
manner, AI should also be equipped with the knowledge to handle more complicated tasks
with neural networks that are interconnected by the channels of communication. The deep
learning models rectify the mistakes by learning from the available data sources so that an
effective product can be launched in the market. AI is a growing technology, but it is to be
used safely and legally to prevent errors from happening then and there. The analysis of the
technology from ethical, legal and patient perspectives should be explained briefly and the
suggestions given need to be incorporated to safeguard the lives of the patient.3
Artificial Intelligence and its Benefits in Healthcare
AI is an emerging technology in global healthcare that demonstrates how the technology will
deliver good health in future. The development of AI in healthcare started in the 1960s but a
sudden drift in the technology has occurred in recent times. The healthcare industry has
enlisted wide uses with AI, which include identifying the disease, screening, medical imaging
the production of drugs, manufacturing AI-based diagnostic tools, implementing maintenance
of patient records, and progress towards a personalized treatment plan. The technology in the
initial stage starts with an experiment but now it has reached the level where the models
developed coincide with real-world clinical practice. 4 The surgical sector is where the robots

2
Drukker L, Noble JA, Papageorghiou AT. Introduction to artificial intelligence in ultrasound imaging in
obstetrics and gynecology. Ultrasound Obstet Gynecol. 2020 Oct;56(4):498-505. doi: 10.1002/uog.22122.
PMID: 32530098; PMCID: PMC7702141.

3
Guoguang Rong, Arnaldo Mendez, Elie Bou Assi, Bo Zhao, Mohamad Sawan,Artificial Intelligence in
Healthcare: Review and Prediction Case Studies,Engineering, Volume 6, Issue 3, 2020,Pages 291-301,ISSN
2095-8099.

4
Miller DD, Brown EW. Artificial Intelligence in Medical Practice: The Question to the Answer? Am J Med.
2018 Feb;131(2):129-133. doi: 10.1016/j.amjmed.2017.10.035. Epub 2017 Nov 7. PMID: 29126825.
are being introduced in assisting the surgery along with the doctors. AI assesses the survival
rate of the patient even with dreadful diseases like cancer. In traditional medicine, the role of
AI helps in the evolution of drug discovery by creating a chemical database. It also helps in
exploring the knowledge of ancient literature, the major components of the herbal formula
could be screened, developing the molecular mechanism for the drugs like decoction.
Deploying AI tools to propagate personalised medicine by identifying different
pulsations(naadi) for assessing the individual's body constitution(udaliyal) and identifying the
features like Vali, Azhal, and Aiyam for diagnostic purposes. The potential targets of the
drug delivery could be identified.5
Research Sector
The research sector receives the advantage of AI in clinical trials and drug discovery
processes. The progression of the tech would be useful in public health surveillance and
management.
Clinical sector
The hospitals use technology for analysing the information of the patient, and the insurance
company needs the assistance of the AI in delivering the health benefits on time. The decision
in the clinical practice takes the support of the machines to reduce the time, encountering
queries related to the compliance of the patients to specific drugs. For example, in
tuberculosis, the ATT drugs induce certain adverse reactions in the patients, so that they
avoid taking the drug which will lead to relapse and resistance to the specific drug in due
course. Here the technology can be used to elicit the difficulty faced by the patient side and
tackle it by monitoring them with special wearables that could inform the health provider so
that the health professional will help in increasing the adherence of the person to take the
medicine without fail. The chest X-ray could benefit earlier diagnosis. A detailed analysis
based on the preceding experience recommends employing Talk Bot for enhancing client
relations, measuring public well-being, regular care, and diagnosis with the existing data and
image.
Bridging the Gap based on resource availability.
The challenges faced by the healthcare department in India viz the number of doctors
available for the patient i.e. the patient-doctor ratio is low i.e. the distribution of experts are
more concentrated in the corporate cities when compared with the villages, the expertise and

5
Khan SR, Al Rijjal D, Piro A, Wheeler MB. Integration of AI and traditional medicine in drug discovery. Drug
Discov Today. 2021 Apr;26(4):982-992. doi: 10.1016/j.drudis.2021.01.008. Epub 2021 Jan 18. PMID:
33476566.
resources are very minimal in the countryside. Staff of the rural area have to be trained on par
with the urban staff. So, AI in India, may fasten the diagnosis and treatment and make it
available for every individual equally. Technology helps bridge the gap and copes with the
lack of skilled resources so, a new way would be created for the era of personalised medicine.
The AI-based tools provide a cutting edge in diagnosing the disease. There is a hope to tackle
the diagnosis and screening burden on the health system. Diagnostic errors are one of the
possible causes of death and account for the adverse events that happen in the medical field
which could be prevented by the developing technology. AI paves the way for reducing
human resources by identifying the gaps in medical care and improving the guidance for
evidence-based treatment. Vaccine development is one peculiar area where it helps in
identifying the epitope for vaccine production. Analysis based on the genetic make-up of the
individual and specific therapy for the defined disease conditions. The AI-based tools are
used for self-care by assessing nutritional uptake, monitoring BP and other parameters to
diagnose high-risk cases before health status deteriorates.6,7
Patient care, privacy, and integrity
Improved patient care:
The sufferer who is about to receive care expects the best possible care from the health care
providers. By using AI the patient can be afforded with better treatment that is personalised
for him based on the nature of his body, in recent times doctors have focused on the gut
microbiota, in which the bacteria present in the individual, help in deciding the specific
prescription for effective management. AI extracts the patient data with different patterns of
diseases, the specific bacteria present in the gut and specific conditions enabling the diagnosis
of a disease and treatment. The patient data which is obtained from concerned hospitals or the
health sectors should be checked whether approval has been acquired from the stipulated
authority, before using it for the analysis of the disease prevalence and management. The data
procured must be decentralised and the personal information and vital status of the patient has
to be masked to prevent organ trafficking as well.
Earlier diagnosis of diseases:

6
Rudin C. Stop Explaining Black Box Machine Learning Models for High Stakes Decisions and Use
Interpretable Models Instead. Nat Mach Intell. 2019 May;1(5):206-215. doi: 10.1038/s42256-019-0048-x. Epub
2019 May 13. PMID: 35603010; PMCID: PMC9122117.

7
Doran D, Schulz S, Besold TR. What does explainable AI really mean? A new conceptualization of
perspectives. ArXiv171000794 Cs. 2017. http://arxiv.org/abs/1710.00794. Accessed 3 Sept 2019.
AI can help doctors detect diseases at an earlier stage to facilitate treatment easier. For
example, AI-based diagnostic tools are being developed that can detect cancers at a much
earlier stage than traditional methods.
The different forms of AI adopted by the medical field are
Machine learning (ML):
The process where the system is trained using the datasets that are exported from the
hospital's electronic health record to predict the treatment outcomes of the disease and to
segregate the particulars accordingly.
Deep learning (DL):
DL is one of the advanced forms of ML where a large volume of data and layers of ML
algorithms are used to create neural networks to handle complex tasks. The DL when
compared with ML, in ML the features are selected manually, and the machines are trained to
develop a model but in DL the system on its own segregates the features from the available
data and learns on its own by minimising the corrections from the source data obtained and
gives us an excellent model to use it in the health industry. A main disadvantage is overfitting
which needs to be watched for to obtain the expected results.
Robotics:
The Robots are designed to assist the doctors in their tasks wherever it is essential. To
enhance the efficiency of patient care.
Natural Language Processing (NLP): The NLP is a process which deals with the interaction
between computers and the human being. The machines are unaware of the language used by
the humans, unable to recognise emotional behaviour and speech recognition. The ML trains
the system by modifying the algorithm to understand and identify different communication
recorded by humans and specify them as verbal or written formats. The NLP teaches the
algorithm and develops the model to group the specific data into documents, physician
clinical notes, reports, and published research articles and to acknowledge the speech,
emotions etc.
Integration/delegation of workflow between the engineer who develops the module, the
doctors who utilise it for patient care and the manufacturer who is about to produce the
product should have wide knowledge and basic ideology of both the systems which will lead
to the production of the best / required product that would favour the patient care. The laws
protecting patient privacy and safety have to be enabled and ensured. AI is underdeveloped in
the following domains of healthcare which are Telemedicine, the virtual communication
between the clinician and the cases gets strengthened so that the confidence that the
individual gains about the treatment is ensured, the individual from the remote places would
be recommended with the treatment required post-surgery to avoid complications due to
travel. Patient consultation is another field in healthcare wherein AI development is not
pinged into. The inpatients and the outpatients are still in direct contact with the doctors. 8
Acceptance of the Society
Although most patients are ready to accept AI-based therapy due to its efficiency, when
compared with the decision of AI the patients trust the doctor's decision in situations where
the decision of AI differs from that of the doctor. Moreover, doctors from less developed
areas could be concerned about whether AI could replace their job opportunities.9
Figure: 1 challenge faced by different disciplines (healthcare professionals, technologist,
legal experts, manufacturers, healthcare receiver) for integrating AI in healthcare and
possible solutions to be adhered by different disciplines and framing laws accordingly.

Major Challenges
 Collection of data from various sources
 Optimization of the data process
 Development of AI model
 Liability of each stakeholder
 Patient care
 Misdiagnosis due to limited /specific data resources.
 Lack of integration between the disciplines.
 Unintended outcome of the AI model due to the impact of the different
locations

8
Weng SF, Reps J, Kai J, Garibaldi JM, Qureshi N (2017) Can machine-learning improve cardiovascular risk
prediction using routine clinical data? PLoS ONE 12(4): e0174944.
https://doi.org/10.1371/journal.pone.0174944

9
Chen, Z. Ethics and discrimination in artificial intelligence-enabled recruitment practices. Humanit Soc Sci
Commun 10, 567 (2023). https://doi.org/10.1057/s41599-023-02079-x
Solutions for Consideration
 Addressing the patient safety, data privacy & autonomy, security.
 Authentication & prevention of duplication of data
 Guidelines / recommendation for developing the technology.
 Product manufactured should be in synchronous with the recommended
standards
 Addressing the responsibility for each department at every stages of the
technology development
 Involving the healthcare recipients of all the societies for precise diagnosis
 Improving the societal acceptance by engaging them in every step of
processing.
 Formulation of the detailed guidebook of the algorithm developed
 Human interpretation to be ensured in training and processing the model.

Suggestion for Formulating Law

 Protecting the patient’s ownership, safety, and rights
 Adopting the suggestion of the ethics committee
 Considering/ accepting the guidance from the quality management team
 Concerns raised by each developer to be taken for consideration.
 Redressal mechanism to be framed, to report the problems arising at any stage of
the process of the AI development to the ethics committee.
 Regulatory authority for AI must formulate standard guidelines.
 Compensation to be guaranteed for unintended harm /Injury occurred to the
patient.
 The formulated laws to be upgraded periodically based on the technological
growth.

Figure 1
Data breach
The personal information gathered from the health recipient is prone to misuse, hence the
handling of data has to be restricted for use. A committee has to be formed which has the
power to decide who is allowed to handle the data of the patient, if not the data fraud might
happen. The committee should include the ethical team and the quality management team.
There is a chance of duplication of data i.e. information about the patient collected from
different hospitals without knowing the fact that the data are already received. The detailed
guidelines have to be decided by the committee that which level of data has to be accessed
and by whom under the supervision of whom. The data breach can be prevented in the
following ways by improving the planning capacity, by setting high quality standards and the
users who are allowed to process the data need to be trained accordingly. The data obtained
from the individual and the communities of other foreign countries and industries have to be
processed by the central data controller and to confirm whether the gathered information is
safeguarded.
Lack of datasets:
For AI to be used effectively in healthcare, large amounts of data are needed. However, due
to privacy concerns and other factors, such data is not often readily available in India. As a
result, many AI applications are developed using data from other countries, which may not be
representative of the Indian population, and that also affects the decision about specific
diseases in conjugation with specific geographical locations. 10The stats obtained from one
country for example in the case of genetic diseases, and epidemic diseases will not be similar
to other countries due to their dietary habits, climate change, culture etc.
Human factors and their errors
The errors due to human handling occur in two ways, the first one is where the engineers can
commit inevitable mistakes in coding due to continuous workload. The model developers
would pay more attention to developing an effective model rather than concentrating on the
security aspect. The second error occurs with the doctors, the doctors at times commit faults,
as the analysis of the disease is anticipated by machines. As the model developed is capable
of assessing the disease and as the clinicians are occupied with heavy work, they will not be
in a position to think of other available alternatives. These errors which are bound to appear
10
Varkey B. (2021). Principles of Clinical Ethics and Their Application to Practice. Med Princ Pract, 30:17–
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happen due to misuse of technology would explicitly endangers the life of the health care
recipient.
Bias and Discrimination
The bias of data to a certain extent happens between gender, sexual orientation, race,
sociological, environmental, and economic factors. Automation machinery and advancement
in economic status comment on the ambiguity between countries with high socioeconomic
status and countries with low socioeconomic status. Regardless of a lot of difficulties, AI tries
to provide the facilities to all the residents of the country, but the improved treatment
facilities are still not approachable for the residents belonging to all the societies. The
allocation of service to the inhabitants in the poverty-stricken society with a long stay in the
ward will be rejected by the model because the particular figures are not exposed to the
system, so the disproportionate allocation of resources transpires between the wealthier
communities and the poorer communities. Prediction of the system would not be determined
whether it is going to be beneficial or harmful in the context of patient care. The developing
countries are in the start-up phase of the technology buildout. If the inputs obtained from the
authenticated seedbed are not sufficient then the data would be liable for prejudice. AI-based
decisions with indigenous peculiarity that humans are not familiar with, can exacerbate the
actual case scenario in the health sector. The contemporary blueprint may look impartial but
can injure secured class members, pretending the risk. Improper management of the AI
algorithms increases the discrimination against low socioeconomic groups. The main aim of
the system is that AI-assisted platforms should be available for the common people with the
best possible precision and safety. The unsupervised data leads to lots of bias as there is
human interference during the model development and deployment. This bias can be reduced
by involving people from various communities and industries that might represent the entire
target population thereby preventing discrimination among people. The health status of the
participant/ patient has to be masked to prevent discrimination and stigma in society. Before
deploying the AI model, the possible biases are to be identified, screened and scrutinized.
The training data need to be screened for sample bias. 11 The developers of AI and the
authorities in this regard should ensure fairness in the AI deployment. The data collected has
to be reported properly to the concerned body and also if there is a requirement for data for

11
Liu T, Fan W, Wu C. A hybrid machine learning approach to cerebral stroke prediction based on imbalanced
medical dataset. Artif Intell Med. 2019 Nov;101:101723. doi: 10.1016/j.artmed.2019.101723. Epub 2019 Oct
23. PMID: 31813482.
future use pre-consent needs to be obtained, when it is not needed the data has to be
surrendered back.
Quality and standardisation
Lack of standardization: There is currently no agreed-upon set of standards for developing
and deploying AI applications in healthcare. This lack of standardization makes it difficult to
compare and evaluate different AI solutions and makes it more difficult to ensure that they
are safe and effective. They should consider the patient safety on data, and deep learning
modules to which extent the module is reliable. It should not replace the opinion or decision
of the doctor, as the module is the only background idea developed by a doctor based on the
available big data. So, the opinion of the doctor is to be considered final, not the module
because in certain rare cases where the data availability is few / minimal, the module could
lead to misdiagnosis and treatment. The module should be revived periodically for
upgradation and doctors and users have to be trained and updated with the current technology
as and when required.12 A committee has to be formed which may consist of the experts from
the engineering field, the doctor, the manufacturer and the one who developed the technology
to analyse the product and come up with the decision on who can operate the technology and
utilise the product. They should also clarify the basic qualifications required for doctors who
are planning to utilise AI for their patients in providing effective personalised treatment. The
engineers should be educated about the medical problems and how they develop to create
models accordingly, their integration with the medical field has to be encouraged for the
effective utilisation of the available and forthcoming technological development. A
committee needs to be assigned to give clearance to the doctors and engineers who are
granted permission to develop AI for clinical practice. The standard rules and regulations for
AI could be set by the Quality assessment team at various levels like, when the data is
collected, the model is developed, and problems prior to the manufacturing and before the
clinical use to minimise errors and conflicts.
Challenges faced in the healthcare industry due to AI.
The AI-based tools in health care would be flourishing within India. Computational
technology is evidence-based technology that has many inherent moral risks which would
comprise the translucency in the algorithm designed, self-explainability of the model, clarity
on the problem, responsibility, and error due to carelessness, bias, and discrimination. The
12
Prince AE, Schwarcz D (2019) Proxy discrimination in the age of artificial intelligence and big data. Iowa
Law Rev 105:1257
targets of the technology are humans, which leads to the complexity of the goal and increases
the demand. The quality of the data, the rights of the individual, the trustworthy patient-
doctor relationship on AI software’s efficiency, and accepting the risk happening due to AI
by the doctors, the patient and the ethicist are some of the challenges that need to be
considered by the medical professionals who handle more AI-based solutions.
Security of AI
Security is a grave issue while handling AI-based medical technology warrants a review. The
intricacy and expertness gained from the medical realm and the technology sector pose an
unexplainable situation for the medical practitioner and machinator to operate AI. The
leakage of the information crops up as the access of the data was lent to the engineer, so they
should be educated to prevent the outflow of the facts. The doctors are not always exposed to
the usage of algorithms previously, which might create some confusion for them in carrying
out the tasks and comparing them with the realistic scenario which leads to reduced
efficiency and shooting up the flaws. Authority needs to be instigated to assess the safety
measures taken to protect against the complications arising due to improper network security.
The operation of AI is not up to the expectation in the large conformation though it is
successful in its initial phase of trial. The AI algorithm is viable for the attack at its design
level itself, attacks can emerge when handled without any idea about the basic constitution
and model, and when the attacker finds the path of the AI development then the entire AI will
collapse. Errors can also happen without any external hindrance, the primordial algorithm
will choose an alternate path from that of the actual one due to variations in the disease
pattern, non-availability of the previous data and errors due to delays in the update of
automation processes.
Regulatory statutes for AI
Regulatory hurdles:
The questions that necessitates attention are the regulatory environment surrounding AI in
healthcare. Currently, there are no specific regulations governing the use of AI in this
domain. As a result, there is a risk that inappropriate or even harmful applications could be
deployed without adequate oversight. The financial status of AI is enriched by combining
alignment, reducing the dependency towards AI, clarification and obtaining approval from
the regulatory authority.
Ethical Concerns of AI
There is a risk that personal health data could be used for discrimination or other nefarious
purposes. In addition, here are certain impacts that could arise due to decisions made by the
technological tools that would exacerbate existing social inequalities. The notable challenges
that arise while upgrading ourselves to the technology have to be acknowledged as follows,

● protection and transparency in obtaining the data and maintaining it,

● the basic knowledge to be fed to the beneficiaries that your health data is being

utilised for a good purpose in the written form, in their native language and other
common language used in that locality,

● the difference of belief between the people has to be taken up for consideration,

● the consultation of a patient with the doctor needs to be addressed,

● ethics and moral values of the society have to be appreciated.

Before collaborating with AI in the medical industry, clinicians and experts should think of
the four main ethics that are mentioned not only for the clinical setup but also for the
biomedical research which are as follows, Explaining to the patient the medications that are
prescribed to them during the clinical trial or as treatment in usual clinical setup, allowing
them to decide according to their ideology without any external influences with their high
level of consciousness, securing every tasks that, no harm is being done to the patient and by
sharing out the goodness of the healthcare industry to its utilisers. 13 The present-day
machinery approaches may bury the thoughts at the backbone of the processing that happens
in the technology, preventing the careful examination of the algorithm impractical. The
technology through which the AI system engenders its output is "impervious". The processes
of the AI system are proposed in a way that the clinical user, whose technical knowledge is
minimal will not be able to understand the process but the techie highly skilled will catch up
with the idea easily. The patient who is considered the owner of the data has the right to
know about to what extent his data is recorded and used. Historic data leads to the capture of
equalities in health care but the machines which are already fed with previous information,
accelerate the inequality.14 This can also lead to errors and imperfections in designing,
employment, and valuation of the system. While catering health care services, the clinician
13
Farhud DD. (2019). Epigenetic and Ethics: How are Ethical Traits Inherited? International Journal of Ethics
& Society (IJES), 1:1–4. [Google Scholar] [Ref list]

14
Scalzo FL. Tommy the robot nurse helps keep Italy doctors safe from coronavirus: Reuters: Healthcare &
Pharma; April 1, 2020. https://www.reuters.com/article/us-health-coronavirus-italy-robots-
idUSKBN21J67Y [Ref list]
stops services to the extreme findings where the sources available are insufficient. These
differences that are learned by AI on its own, lead to serious errors that can be fatal for the
patient. An Ethical committee has to be formed which may consist of the experts from the
engineering field, the doctor, the manufacturer and the one who developed the technology to
analyse the product to follow the basic ethics that are bound in patient care. The committee
devises standard guidelines that need to be adopted and abided by the manufacturers of AI to
access the medical field and conclude that the care given to the patient does not deny their
ethics. The guidelines framed by the ethics committee help in developing the technologically
developed tools for the medical service sector which will be useful for every participant
including patient role, industrialists, technical teams, medical institutions, researchers,
developers, healthcare professionals, ethics committee, and the agencies which sponsor the
fund for developing the technology related to biomedical research and healthcare field. A
robust ethical standard is needed to be adopted during AI development in India. The main
purpose of the ethics framework is to formulate guidelines that could help in developing,
positioning, and adopting evidence-based technology into biological study and outpatient
care. Solutions designed for AI will help to identify and negotiate the forthcoming challenges
that can arise in healthcare. The EC and the stakeholders should ensure the benefit-risk
assessment. The benefits should outlay the risk. The risk must be at the acceptable range
considering the scientific value. If any unintended harm arises at the time of development or
during the implementation or any time after the implementation the manufacturer, doctor and
other experts should throw light on the issue and intimate it to the ethics committee for
necessary action. Internal and external audits have to be encouraged for assessing the
potential risks and the reports to be furnished in front of the EC and stakeholders. The
redressal mechanism is to be formulated before initiating the model development. The Ethics
committee should be independent to prevent bias.15
Legal aspects of AI
As of now, there is no definitive law available for AI. Though there is an Information and
Technology Act which abides by all the technology-related issues but there is no specific
clause for AI as such. So, the authority should consider the concerns in this regard and the
influence of AI in healthcare. The laws should be framed for AI-based medical solutions.

15
Pasquale F. When medical robots fail: Malpractice principles for an era of automation The
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There should be a clear demarcation of the extent of the answerability by individual
stakeholders. Once the intricate situation arises, who would take the responsibility has to be
doubtlessly determined and a committee for supervision must be nominated in rotation to
prevent conflicts of interest. The laws once formulated must be upgraded as on par with the
development of the technology. The following suggestions would be taken up for discussion
before the formulation of law and regulation are,

● To specifically assign the responsibilities to stakeholders,

● Data privacy has to be maintained, though the concern of the doctor and government

lies with better diagnosis and treatment for the patient,

● The basic consent from the patient has to be secured and also from the hospital to

clarify that the data obtained is authenticated,

● A screening committee before the model is proposed for the development,

● Quality and standards have to be fixed before launching the product in the market,

● Ethical committee approval is required to verify whether the basic ethics are

maintained in clinical application and also confirms that morality is being maintained,

● AI Regulatory authority to finalise all the standards and regulations fixed by the

government based on the recommendations provided by the committees to prevent

errors that happen with AI16.
The AI technology developed and adopted from foreign countries should comply with Indian
laws and maintain transparency, abide by Indian ethical principles. The compensation for the
patient has to be mentioned while framing the law.
Solutions for Consideration

16
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection
of natural persons with regard to the processing of personal data and on the free movement of such data, and
repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance)
AI is a great source of development in all industries, especially medical practitioners. 17 The
biological data collected from the institutions must be supervised by the ethics committee
before processing data. The consent form has to be obtained from the health receiver and user
regarding the details of the data collected. Technology has to be developed with experts from
IT, medical professionals, technicians, patients, and manufacturers. The doctor and patients
should be explained about the benefit-risk ratio of the product developed. The patient should
be given the liberty to withdraw his data at the recruitment or even during the process. The
algorithm has to be tested and validated in different circumstances. Once the product is
developed it has to be tested at different sites where it is going to be used. The manufacturer
has to provide manuals and pamphlets regarding the workflow of the algorithm developed,
how to utilize it for the healthcare providers and at a new site where it benefits the healthcare
receiver. The Detail of the model has to be circulated among the general public to receive
their input on design, development, deployment etc. The data has to be obtained from the
marginalized population and population located in remote areas. The pre-deployment testing
and validation could prevent major issues. Alternate solutions are to be readily availed in case
any unintended error occurs in the AI. The training to be provided on data collection,
selecting the training and testing population to ratify the errors. Compensation for the patients
has to be provided if any injury is incurred due to AI.
Conclusion
AI specific to the medical field possesses many benefits but there are a few pitfalls which
need intense attention to enhance the utilisation of AI facilities and increase the availability of
resources to all communities equally. The laws of AI should not be more robust because that
will inhibit the development of technology, so the law should be framed liberally so that the
development of the technology is not affected at the same time, accounting for the concerns
emerging in the different disciplines. The policymakers in framing the law, could consider
the ethics, regulations, quality, safety, and data privacy to prevent major disruption that could
be incurred due to AI in healthcare. In unforeseen circumstances, the legal responsibilities
regarding the errors that occurred have to be demarcated by relevant authorities. Patients have
to be justly compensated for the losses incurred on the verge of the advancement of
technology. The legal authorities should delineate the responsibilities to prevent the errors

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Kakadiaris IA, Vrigkas M, Yen AA, Kuznetsova T, Budoff M, Naghavi M. Machine Learning Outperforms
ACC / AHA CVD Risk Calculator in MESA. J Am Heart Assoc. 2018 Nov 20;7(22):e009476. doi:
10.1161/JAHA.118.009476. PMID: 30571498; PMCID: PMC6404456
that occur in patient care. Thus, AI which is developed as per the rules and regulations may
provide better patient care in the future which is promising.
Conflicting Interest
There are no disagreements on this subject matter for the narrator.