AI, HEALTH CARE AND LAW: PART 2 - The Daily Guardian
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AI, HEALTH CARE AND LAW: PART 2

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In the context of AI in health care, Jurisdiction plays a significant role specifically in the light of determining and adjudicating legal issues arising thereof. Given the complexities in AI Algorithms, the risk of data breaches is likely to be high. In case the AI system is developed by a party in “A” Jurisdiction and is used by the doctor in “B” Jurisdiction for analysing and predicting the health outcomes of a patients in “C” Jurisdiction and the results of such analysis and predictions are shared to the party located in “D” jurisdiction for the benefit of the patient and for getting the best possible results, then in case a data breach occurs which Jurisdiction shall adjudicate the breach will be an important aspect requiring significant consideration.

• CYBER SECURITY

Given the fact that the use of AI in healthcare by and large makes use of large data sets involving sensitive and personal data of patients for performing complex analysis and cognitive tasks instantly. While AI Algorithms can be subject to Cyber Security breaches and can also be used for committing Cyber Crimes, Medical Crimes, and other Crimes, therefore, Cyber Security in the context of AI in health care assumes significant role.

Let us consider a scenario where in AI Algorithm is compromised and data is altered erroneously in a wrong manner which can entirely change the outcome and can lead to a catastrophe. Constant monitoring of AI Algorithm becomes necessary for Cybersecurity purposes. Cyber Crimes like unauthorised access, hacking, data manipulation and tampering, man in the middle attacks, data thefts, denial of service and denial of distributed service attacks can be considered as common Cyber Crimes in the context of AI in health care. In addition to the same, Cyber murders can also take place in the context of AI in health care as explained above.

The AI Algorithms must be tested frequently for different vulnerabilities and must incorporate anti-malware, anti-spyware. Let us take another example, in case, an AI Algorithm gets unauthorizedly accessed and the data possessed by the data AI Algorithm gets into the hands of different players like Health Care Providers, Medical Equipment Sellers, Pharmacies, other Specialised Medical Hospitals, Doctors, Pharma Companies, and other Stake Holders. These Stake Holders may specifically offer services, products suitable for the patients since they are aware of their medical and health conditions.

• MEDICO LEGAL CONSIDERATIONS

DOCTOR PATIENT RELATIONSHIP-ETHICS

In case any AI Algorithm assume the role of a Doctor during the interactions with patients, the entire concept of Doctor Patient relationship becomes different. Given the fact that Doctor Patient relationship is based on trust and confidentiality, in this kind of a scenario the machine ethics assume significant consideration specifically regarding the moral behaviour of AI Algorithms. It is also imperative to note if there is a duty on Human Beings to observe ethical standards while designing, creating AI Algorithms. Even when the patient is aware that they are interacting with the machine it is still possible that such interactions may evoke intense emotions specifically during counselling and therapy related sessions. The Doctor-Patient relationship usually involves disclosure of sensitive personal data and other details of the Patient to the doctor. The patient is usually prepared with such disclosure since they believe that such information is protected by the doctor in a confidential manner and any breach of confidentiality can result in damage claims by the aggrieved patient.

Given the fact that AI Algorithm is not a person and that it possesses a lot of data of the patient after interactions, the question that has to be decided is whether the patient information held by the AI Algorithm is protected by the duty of confidentiality. Further recording of patient’s data becomes a prerequisite by the Algorithms for analysing the medical records, suggesting medical treatments, analysing the medical health conditions counselling and therapeutic sessions. In case the patient is subject to multi-disciplinary therapies there is a possibility that the AI Algorithms are likely to be in contact, in a connection, interact with the other Algorithms in order to serve the best interest of the patient. Given this scenario the question of confidentiality will have to be looked into the context of such Algorithms.

It is imperative to note that patients need to be protected beyond the Doctor-Patient relationship which otherwise might have a different impact including impact on relationships, job opportunities. Given the scenario that AI Algorithms stores lots of patient’s personal data which might be shared not just with the doctor but also with the family members and others, such kind of protection may seem challenging.

Let us take an example, that the personal and sensitive data of the patient possessed by AI Algorithm is used for increasing the health insurance premium of the patient. The predictive capability of AI brings in significant ethical concerns in health care. In case an AI is used for health and medical predictions, such information can be included in a patient’s electronic health records. Therefore, anybody accessing such health records could get access to such medical and health predictions. These kinds of access could also lead to discrimination including discrimination in employment.

Health predictions through AI can also cause psychological harms. For example, many people could be dramatized in case they come to know that they are likely to suffer with cognitive decline at the later part of their lives. Further, AI health predictions may be erroneous. There can be many factors that contribute to such errors. In case, the data that is used to develop the Algorithm is flawed and in case it uses any medical information or records that contain errors, then the output of the Algorithm shall be incorrect, therefore patients may suffer discrimination or psychological harm, when in fact they are not at the risk of such predicted ailments. In these kinds of scenarios, who will be legally accountable is an interesting question.

• ALGORITHMIC FAIRNESS AND BIAS

Algorithmic Fairness in health care usually takes place, in events where the Algorithm predictions are used to support decision making that is beneficial. It becomes important to understand that the Algorithmic Fairness also involves ethical, political, and constitutional concerns. It can be understood that machine-learning and Algorithms make predictions using mathematical models which are not programmed explicitly but are however developed using rules that associate variables with outcomes in a specified data set. The importance of Algorithm Fairness is assuming greater significance given the rapid expansion and usage of Algorithmic Prediction in health care which focuses on how the principles of Algorithmic Fairness shall be made applicable in clinical decision making. Considering the general principle of Fairness, similar individuals shall not be subject to differential treatments subject to attributes and discrimination including Race, Gender, Ethnicity, Religion, Creed or National, Origin etc., However, in the context of AI in health care it can be understood that Algorithmic Fairness is maintained, in case no differential treatment is provided as an outcome of analysing the medical and health conditions of two similar patients.

However, there is a possibility that the Algorithms used for predictions can inadvertently be biased or unfair in decision making, despite the broad Algorithmic Fairness. However, data or any other sampling issues can lead to predictions that are biased. Given the differences in both consistent and substantial treatments with regard to medical conditions in patients subject to Gender, Race, and other parameters contribute to clinical bias and disparities in health care.

In the context of AI in health care, Algorithmic Bias takes place in case different outcomes and predictions are provided in case of similar patients. Let us take an example of Thyroid, because Thyroid diagnose is an imperfect proxy for thyroid incidence and further the rates of Thyroid is considered relatively high in obese people compared to normal people. In case, the AI prediction models are developed routinely based on the above parameters to target the screening of obese people for high Thyroid levels, then this itself could lead to Bias and mistargeting.

Let us consider the example of Pregnancy test, in case the AI Algorithm is designed to predict pregnancy which is subject to gauging of Human Chorionic Gonadotropin hormone based on the urine, in this kind of scenario if the male urine also gauges the presence of this hormone, then AI Algorithm shall predict and attribute pregnancy to the male person, based on the above parameters. It can be inferred that AI Algorithm using Gender based data blindly may be less effective than the AI Algorithm that possess trained data sets including information on gender. In this context, it shall be understood that eliminating Bias from the data initially fed into the AI Algorithms shall be challenging since such training data may be subject to historical Bias. The concept of debiasing is also being developed in order to address the issue of Algorithmic Bias. These bring in huge amounts of potential challenges from a legal perspective while using AI Algorithms in health care since there is an involvement of health care data which is sensitive and personal.

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Allahabad High Court Quashes POSCO Case: If Husband/Accused Is Convicted Then Victim/Wife’s Future Would Be Ruined

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Allahabad High Court Quashes POSCO Case: If Husband/Accused Is Convicted Then Victim/Wife’s Future Would Be Ruined

The Allahabad High Court recently in the case Rajiv Kumar v. State of U.P. And 2 Others observed and has recently quashed an FIR and criminal proceedings in a POCSO case registered against a man as it noted that the accused man and victim-wife (who was a minor at the time of the incident) married the accused/ applicant out of her own sweet will and is living a happy married life with him.
The bench comprising of Justice Manju Rani Chauhan observed that to punish punish the offenders for a crime, involved in the present case, is in the interest of society, but, at the same time, the husband is taking care of his wife and in case, the husband is sentenced and convicted for societal interest, then, the wife will be in great trouble and it would ruin their future. Thus, it is also in the interest of society to settle and resettle the family for their welfare, the bench quashed the rape-POCSO case against the accused.

Facts of the Case:
The Maternal Uncle of the Victim lodged an FIR against the accused under Sections 363, 366, and Section 376 of the Indian Penal Code, 1860and Section 3/4 of the POCSO Act, alleging that the accused had raped the victim (then a 17-year-old minor).
Further, the accused moved the instant Section 482 CrPC petition seeking to quash the instant FIR. Also, the victim appeared before the Court and had submitted that her maternal uncle had lodged the FIR in an attempt to ruin her married life.
It was further stated by her that she has entered into a compromise with the accused and has married him out of her free will, and consent, and without any external pressure, coercion, or threat of any kind. Before the court, it was also submitted that that out of their wedlock, they are blessed with a male child, who is presently four and half years old and as per her date of birth and at the time of marriage she was nearly 17 and half years old.
It was submitted by the Applicant-Accused that on account of the compromise entered into between the parties concerned, all disputes between them have come to an end, and therefore, further proceedings are liable to be quashed in the present case.

Observations Made By Court:
In the present case, the court noted that though the offence under the relevant sections 363, 366 and 376 of IPC and Sections 3/4 of POCSO Act are not compoundable under Section 320 Cr.P.C, however, adding to it, the court stated that the power of the High Court under Section 482 Cr.P.C is not inhibited by the provisions of Section 320 Cr.P.C and the criminal proceedings as well as the FIR can be quashed by exercising inherent powers under provision of Section 482 Cr.P.C, if warranted in given facts and circumstances of the case for ends of justice or to prevent abuse of the process of any Court, even including the cases which are not compoundable where parties have settled the matter between themselves.
The court while considering the facts and circumstances of the case, and also the submissions made by the counsel for the parties, the court came to the considered opinion that the victim herself, has stated before this Court that out of her own sweet will, she has married the applicant and is living a happy married life and out of their wedlock, the couple are blessed with a male child. However, no useful purpose shall be served by prolonging the proceedings of the criminal case as the parties have already settled their disputes.
Accordingly, the court quashed the charge sheet and the cognizance order as well as the entire proceedings of the Criminal Case were hereby quashed. Thus, the application was allowed.

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SC likely to hear next month pleas related to Article 370

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SC to hear Manoj Tiwari’s plea on firecracker

A Supreme Court constitution bench is expected to hear a slew of petitions related to Article 370 of the Constitution, which granted Jammu and Kashmir (J&K) semi-autonomous status before it was repealed in August 2019. Chief Justice of India (CJI) Uday Umesh Lalit said on Friday that the petitions will be heard after the Dussehra holiday.

When senior advocate Prashanth Sen asked the CJI to list the matter, Justice Lalit responded, “We will certainly list that…it will be listed after Dussehra break.” From October 3 to 10, the court will be closed for Dussehra.

The petitions were last heard in March 2020, when a five-judge panel declined to refer the case to a larger panel. The reference was requested because previous court decisions on the subject were in conflict with one another. This contention was rejected by the bench.

At the time, the bench was aware of an older batch of petitions pending in the Supreme Court challenging the constitutionality of Articles 370 and 35A, which granted J&K special status. It was stated that all issues concerning Article 370 should preferably be heard together.

National Conference legislators, former bureaucrats, and some organisations are among those who have objected to the repeal of Article 370. Some petitioners cited the Supreme Court’s 2018 decision, which stated that Article 370 had gained permanent status.

Many petitions have also been filed against the Jammu and Kashmir State Reorganization Act, which calls for the division of J&K into two Union Territories.

Despite opposition from the central government, which argued that Article 370 had international and cross-border implications, the Supreme Court issued notices on the petitions on August 28, 2019. The Centre also claimed that it is a highly sensitive issue, and that whatever happens in the country will be brought up at the United Nations. While issuing notices in 2019, the court referred the case to the five-judge constitution bench.

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Supreme Court: Fixed Term Sentences Exceeding 14 Years Can Be Alternative To Death Sentence In Certain Cases

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death penalty

The Supreme Court in the case State of Haryana vs Anand Kindoo observed and stated that fixed term sentences exceeding 14 years can be awared in appropriate cases to strike a delicate balance between the victims’ petition for justice and rehabilitative justice for the convicts.
The bench comprising of Justice Sanjay Kishan Kaul, Justice Abhay S. Oka and the Justice Vikram Nath observed that this fixed term sentence can only be by the High Court or this Court and not by the trial Court.
In the present case, the trial court awarded death sentence to the accused who were ‘trusted employees’ of the deceased. However, Major General Kailash Chand Dhingra (K.C. Dhingra) and his wife Smt. Sangeeta Dhingra, who were an aged couple and were killed by the accused while they were sleeping. It was refused by the High Court to confirm the death sentence and imposed life sentence on them.
In an appeal before the Apex Court, the complainant and the state contended that given the brutality of the crime, the court should impose a fixed term sentence before which the convicts are not liable to be considered for granting of remission. Thus, it was submitted that there should be at least a fixed term sentence.
The court observed that it was a pre-planned murder for gain and greed by somebody who was in a position of trust with the family.
The bench observed that at an advanced stage in such health respect, there is always an element of trust and faith in the person by a person who employs them as well as the family members. However, the work takes other family members elsewhere and with the joint family system having broken down, the role of such trusted help becomes even more significant. Also, it is the significance of the society where a wrong signal goes if a trusted person breaches that trust to kill the person who had employed them in such a gruesome manner. It has been stated by the trial Court, the society itself demands justice, apart from an utter element on deterrence which is in any aspect of conviction. Further, the approach cannot be the vindictive but lack of appropriate sentence leaves the cry of justice of the society un-addressed apart from the fact that other persons who may have the propensity to carry out the crime feel that they will get away with the lighter sentence, if in case they are caught. While, battering two sleeping people beyond recognition who imposed trust in their employee certainly calls for something more than merely a life sentence under Section 302, IPC, even if death sentence is not to be imposed.
Therefore, the court imposed a fixed term sentence of 30 years.
The bench while allowing the appeal observed in the case Shankar Kishanrao khade vs. State of Mahrashtra (2013) 5 SCC 546, wherein it was held that if there is any circumstance favouring the accused such as lack of intention to commit the crime, young age of the accused, possibility of reformation etc., accused not being a menance to the society, no previous criminal record etc., the accused may avoid capital punishment. It was opined by the court that the crime is important but so is the criminal and hence the Supreme Court in recent past has substituted death penalty with fixed term sentences exceeding 14 years. It stated that imposing a fixed term sentence creates a possibility for the convict to re-integrate into society after serving his/her sentence. A delicate balance is strike the balance between victims’ plea for justice.

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NCLAT Upholds Dismissal Of Section 7 Petition, Corporate Debtor Willing To Pay Full Amount, Opposed By Financial Creditor

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NCLAT Upholds Dismissal Of Section 7 Petition, Corporate Debtor Willing To Pay Full Amount, Opposed By Financial Creditor

The National Company Law Appellate Tribunal (“NCLAT”) in the case Reliance Commercial Finance Limited v Darode Jog Builder Private Limited, the Principal Bench, comprising of Justice Ashok Bhushan (Chairperson), Judicial Member, Justice M. Satyanarayana Murthy and the Technical Member, Mr. Barun Mitra observed while adjudicating an appeal filed in Reliance Commercial Finance Limited v Darode Jog Builder Pvt. Ltd., has upheld the Adjudicating Authority’s decision to not admit a petition under Section 7 of IBC, despite there being a default and a debt. It was recorded by the bench the Corporate Debtor an opportunity to pay/settle the full amount of default despite the Financial Creditor’s unwillingness to enter settlement.

Background Facts of the Case:
The Appellant/ Financial Creditor, Reliance Commercial Finance Limited had sanctioned Term-Loans of Rs. 19.5 Crores to the Corporate Debtor i.e., Darode Jog Builder Pvt. Ltd. on 29.07.2013. In 2017, the Loan Accounts were declared as the Non-Performing Assets. On 04.11.2019, a petition under Section 7 of Insolvency and Bankruptcy Code, 2016 (“IBC”) was filled by Financial Creditor, wherein seeking initiation of Corporate Insolvency Resolution Process (“CIRP”) over a default of Rs. 15,79,41,658/- against the Corporate Debtor.
It was observed that in an hearing held on 06.07.2022, the Corporate Debtor acknowledged its liability to pay and made an offer of Rs. 12.75 Crores, which is to be paid within 45 days. Thus, the Adjudicating Authority directed the Counsel for the Financial Creditor to obtain appropriate instructions. Thus, the court observed that if the Settlement did not take place, the Petition would automatically be admitted on the next date of hearing.
The court on the next date of hearing i.e. 11.07.2022, it was submitted by the Corporate Debtor that it is willing to deposit the entire amount of Rs. 15,79,41,658/- within 45 days. However, the Financial Creditor expressed its unwillingness for settling the matter. The Bank account details of the Financial Creditor were obtained by the Adjudicating Authority and alongside granted liberty to the latter to file for restoration of petition in case said amount is not deposited within 45 days. The court disposed of the appeal.
The Financial Creditor filed an appeal before the NCLAT, aggrieved by the order dated 11.07.2022.

Contentions Made By Appellant:
It was submitted by the Financial Creditor that the Adjudicating Authority committed error in disposing of the Petition, as it was not willing to settle the matter. However, the Adjudicating Authority could not have permitted the Corporate Debtor to deposit amount in Financial Creditor’s account.

Contentions Made By Respondent:
It was argued by the Corporate Debtor that Financial Creditor was unwilling to settle as earlier entire amount was not offered and settlement had not taken place despite several adjournments. Further, it was submitted that the Corporate Debtor has financial capacity to deposit the entire amount.

NCLAT Decision:
The Bench placed reliance on the Supreme Court judgment in the case Vidarbha Industries Power Limited Vs. Axis Bank Limited, Civil Appeal No. 4633 of 2021.
It was observed by the bench that as per the judgment, even after debt and default is there, Adjudicating Authority has to apply its mind to assess the feasibility of initiating CIRP.
It stated that when the Corporate Debtor has complied to deposit the entire defaulted amount of the Financial Creditor as permitted by the Adjudicating Authority and no purpose and occasion shall survive to still proceed with the Corporate Debtor Insolvency Resolution.
Accordingly, the bench observed that the proceedings under Section 7 are for resolution of insolvency. Adjudicating Authority had not erred in ascertaining whether the Corporate Debtor can comply to deposit the entire defaulted amount in bank account of Financial Creditor’s. Further, the court observed that the Financial Creditor’s interest was fully protected, since liberty was already given to revive the petition in case full amount was not received within 45 days.

The bench dismissed the appeal.

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IBBI Amends Liquidation Process Regulations: COC To Function As Stakeholder’s Consultation Committee For First 60 Days

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IBBI Amends Liquidation Process Regulations: COC To Function As Stakeholder’s Consultation Committee For First 60 Days

On 16.09.2022, the Insolvency and Bankruptcy Board of India (“IBBI”) has notified amendments for a second time to the IBBI (Voluntary Liquidation Process) Regulations, 2016 (“Voluntary Liquidation Regulations”) and IBBI (Liquidation Process) Regulations, 2016 (“Liquidation Regulations”).
Detailed Overview Of the Amendments:
the IBBI has introduced the following amendments to the Voluntary Liquidation Regulations and Liquidation Process regulations, in exercise of the powers conferred by Section 196(1)(t) read with Section 240 of the Insolvency and Bankruptcy Code, 2016.
For enabling better participation of stakeholders and streamline the liquidation process to reduce delays and realize better value, the following major modifications are made for the amendment in Liquidation Regulation.
The Committee of Creditors (CoC) constituted during Corporate Insolvency Resolution Process (CIRP) shall function as Stakeholders Consultation Committee (SCC) in the first 60 days and after the adjudication of claims and within 60 days of initiation of process, the SCC shall be reconstituted with respect to the admitted claims.
It has been mandated to the liquidator to conduct the meetings of SCC in a structured and time bound manner with better participation of stakeholders.
It has been enlarged the scope of mandatory consultation by liquidator with SCC and now SCC may even propose replacement of liquidator to the Adjudicating Authority (AA) and fix the fees of liquidator, if the same during CIRP is not fixed by the CoC.
The amount of claim collated during CIRP shall be verified by the liquidator, if any claim is not fixed during the liquidation process.
Whenever it is decided by the CoC that the process of compromise or arrangement may be explored during liquidation process, an application shall be filled by the liquidator only in such cases before Adjudicating Authority for considering the proposal of arrangement or compromise, if any, within thirty days of the order of liquidation.
For Auction process, specific event-based timelines have been stipulated.
SCC b Before filing of an application for dissolution or closure of the process shall advice the liquidator, the manner in which proceedings in respect of avoidance transactions or fraudulent or wrongful trading and shall be pursued after closure of liquidation proceedings.
Further, the Amendment Liquidation Regulations and Amendment Voluntary Liquidation Regulations lays down the manner and period of retention of records relating to liquidation and voluntary liquidation of a corporate debtor or corporate person, respectively.

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Supreme Court: Setting Aside NCDRC Order Awarding Compensation To Women Who Gave Birth Despite Undergoing Tubectomy Surgery

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Supreme Court: Setting Aside NCDRC Order Awarding Compensation To Women Who Gave Birth Despite Undergoing Tubectomy Surgery

The Supreme Court in the case Civil Hospital vs Manjit Singh observed and has set aside an NCDRC order that directed a hospital to pay compensation to a woman who delivered a child despite undergoing tubectomy procedure.
In the present case, a woman underwent tubectomy procedure twice, though both the procedures remained unsuccessful. In the year 2003, she gave birth to a male child. A complaint was filled by her before the District Consumer Disputes Redressal Forum alleging medical negligence on account of failed tubectomy surgery. Thus, the court dismissed the same on the ground that the hospital is not a consumer. The order was affirmed by the State Consumer Commission (SCDRC). Later, the revision petition was allowed by the National Consumer Commission and has directed to pay compensation as per the guidelines and the policy of the State.
Before the Apex Court, two contentions were raised by the hospital (1) that hospitals and Doctors who render service without any charge to every person availing of the service would not fall within the ambit of ‘service’ under Section 2(1)(o) of the Act relying on the case Indian Medical Association Vs. V.P. Shantha And Ors., (1995) 6 SCC 651 that the failed tubectomy surgery is not a case of medical negligence as the sterilized woman can become pregnant due to natural causes. [relying on the case State of Punjab Vs. Shiv Ram and Ors., 2005, 7 SCC 1].
The bench while taking notice of the law laid down in the decisions relied on by the appellants, allowed the appeal by setting aside the NCDRC order. However, if the respondent has been paid any amount in terms of the Order of the NCDRC, the same shall not be recovered by the State, the bench said.
It was observed in In V.P. Shantha that the Hospitals and Doctors who render service without any charge whatsoever to every person availing of the service would not fall within the ambit of ‘service’ under Section 2(1)(o) of the Act. Thus, the payment of a token amount for registration purposes only would not alter the position in respect of such doctors and hospitals.
The Apex Court regarding failed tubectomy surgery in Shiv Ram (supra), had observed that the cause of action in claiming compensation in cases of failed sterilization operation arises on account of negligence of the surgeon and not on the account of child birth. Further, the failure due to natural causes would not provide any ground for claim and it is the women who has conceived the child to go or not to go for medical termination of pregnancy. Thus, having gathered the knowledge of conception in spite of having undergone sterilization operation, if the couple opts for bearing the child, it ceases to be an unwanted child and the compensation for maintenance and upbringing of such a child cannot be claimed.

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