Jago Grahak Jago

Team JGJ

Artificial Intelligence and Healthcare: Legal risks and mitigation strategies

Oct 9, 2024 Disruptive technologies such as AI, digital diagnostics and therapeutics, and machine learning (ML) are revolutionising healthcare by enabling unprecedented growth and innovation. 79per cent of the healthcare organisations are utilising generative AI and indust1Y is transforming at a rapid pace. AI is enhancing patient care and management, through telemedicine, drug discovery, imaging analysis, monitoring, and predictive analytics, while raising challenging questions of law relating to professional malpractice, privacy and product liability claims. Key legal risks One of the key issues facing AI arises from the limitations of uploading data into its algorithm for ML. As the quality of AI depends upon the quality of data used to train, the risk of data inputs being incomplete, selective, or manifesting a narrow understanding or unrepresentative of the total population and potential bias cannot be underestimated in healthcare. Extensive monitoring of information used for algorithm, assessment of benefit-risk profile for intended use and evaluation for potential bias is therefore pertinent to avoid legal consequences for stakeholders. AI misinformation or inaccuracy poses a considerable risk in healthcare, where precision is paramount. While AI fosters innovation, it also amplifies the risks of wrongful diagnosis or treatment, generating plausible but incorrect or misleading information, making it crucial for healthcare professionals to critically evaluate and validate outputs. AI’s inaccurate diagnosis may have multiple liability and costs ramifications. AI’s data intensive nature exposes patients’ personal and sensitive health records vulnerable to cybersecurity and privacy breaches. Healthcare organisations must implement robust security protocols to prevent data breach. Recent data breaches in India include the ransomware attack on the All India Institute of Medical Sciences and data leak from the Indian Council of Medical Research, highlight existing vulnerabilities of the Indian healthcare system. Statutory and common law compliance impacts all stakeholders. While India is yet to implement a comprehensive legislation regulating the use of AI in healthcare, experience from other matured jurisdictions may help in developing a robust and efficient legal framework. The World Health Organisation (WHO) mandates the regulation of digital and public health, the United Nations Charter and European Union’s international health regulations also require harmonisation of regulations governing AI use in healthcare. However, operators currently need to navigate complex regulatory landscapes to avoid liability based on local requirements. Most AI tools leverage preliminmy open-source content and is amenable to greater infringement claims. Understanding the ownership and licensing of AI technology is crucial to prevent infringement claims. Determining liability attributed to AI related inaccuracies, across multiple stakeholders (hospital, developer, licensor, and physicians) is challenging. Transparency in AI’s decision-making processes is vital to ensure accountability. For example, ethical issues may arise in AI driven diagnosis, which often lacks transparency, making it difficult for physicians to explain the reasoning behind a decision, and allocate responsibility for any liability particularly when disclosing the underlying AI bias to the patients. AI also raises antitrust concerns as its’ use can lead to algorithmic collusion among competitors, inadvertently fixing prices, which is closely scmtinisecl by competition law authorities. While attribution of liability in cases involving ‘algorithmic collusion’ is evolving, it is impoltant to assess this risk and consider monitoring algorithmic pricing tools to detect and prevent such situations. Medical liability Medical negligence under torts would typically consider severity of the injmy, expected standard of care and the AI tools’ causal relationship to the injmy to allocate liability. Under vicarious liability, operators may be held liable for the acts or omissions of the doctors or employees. An AI tool construed as a product, may entail strict or product liability (depending upon severity) or design defect claims against the developers, manufacturers or licensors, while wrongful operation of AI, may trigger professional malpractice claims. An AI tool deployed may be considered as an agent of the organisation or physicians using it, capable of holding the principal liable for breach. Jurispmclence is rapidly evolving with application of AI in healthcare becoming an integral part of patient care. The Texas Coult of Appeals (June 2024) held an AI based medical device manufacturer liable for a defective product, for providing an erroneous guidance to a surgeon. The U.S. Comt of Appeals (November 2022) held the developer and seller of a drug-management software liable for a product liability and negligence claim due to a defective AI user interface, leading physicians to mistakenly believe they had scheduled medication, which had not been scheduled. The Supreme Coult of Alabama (May 2023) held a physician liable for relying upon an erroneous AI software recommendation for cardiac health screening that wrongly classified a young adult with a family history of congenital healt defects as normal. Risk mitigation strategies To mitigate risks associated with AI in healthcare, stakeholders must upskill their workforce with comprehensive manuals, trainings on safe usage and troubleshooting errors. Developers must transparently disclose information around existing biases, providing mechanisms to explain decision making and develop processes for data security. Operators should also inform patients on AI usage and its role in their diagnostic or treatment decisions, obtain informed consent from patients’, providing an oppoltunity to withdraw consent, anonymise sensitive information and establish multiple layers of encryption. Appropriate risk allocation methods and strategies should be adopted by operators specifically identifying the obligations for cultailing liability, indemnification and insurance coverage in case of erroneous output or misuse. Conclusion Despite the foreseen risks, diverse benefits of using AI in healthcare, make its adoption an imperative for continued relevance and maintaining a competitive edge, unveiling a landscape brimming with potential and complexity. AI adds efficiency and innovation to the forefront, subject to its actors understanding and mitigating the risks and associated liability, to foster a transparent and ethical environment of trust. This article has been written by Aditya Patni, Paltner and Achint Kaur, Counsel at Khaitan & Co. Source: Economic Times

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Irdai to increase scrutiny of cyber security breaches after Star Health episode

Oct 11, 2024 New Delhi: The Insurance Regulat01Y and Development Authority (Irdai) is intensifying scrutiny of cyber security lapses in the insurance sector after Star Health Insurance, one of the country’s largest health insurers, suffered a major data breach. Over 31 million customers’ sensitive personal information was allegedly sold to hackers, seen as one of the most severe breaches in the insurance industry. “Irdai sees this data leak as a very serious issue,” a person said, adding that other insurers would also need to review their data security policies. “As more sensitive data flows into insurance firms, there is a need for stronger cybersecurity. The regulator wants to ensure that every insurer applies the best possible security measures, including regular audits and updates to safeguard data.” Irdai will wait for an audit report to identify the gaps and issue instiuctions. The regulator has asked Star Health to extensively audit the company’s cybersecurity framework. The audit, led by an external firm, is expected to identify control gaps and recommend compliance measures to prevent future data thefts. The breach, linked to the company’s chief information security officer (CISO) Amarjeet Khanuja, surfaced after a hacker going by the alias “xenZen” claimed Khanuja had sold the data and later tried to renegotiate for more money in exchange for continued backdoor access. Source: Economic Times

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Illegal to advertise Ayurveda, Siddha drugs claiming ‘miraculous’ effects: Ayush Ministry

Oct 8, 2024 The Union Ayush Ministry on Tuesday (October 08, 2024) said it was illegal to advertise Ayurveda, Siddha, Unani, and Homeopathy drugs claiming “miraculous or supernatural effects” for the treatment of diseases, stating such advertisements can “mislead and endanger” public health. In a public notice, the Ministry clarified it neither certifies or approves any Ayurvedic, Siddha, Unani and Homeopathic (ASU&H) company or its medicine nor grants license to manufacture for sale to any ASU&H manufacturer or company. Further, as the extant provisions of the Drugs and Cosmetics Act, 1940 and the rules thereunder, the license of manufacture for sale of any ASU&H drugs is granted by the state and Union Territory Licensing Authority of the concerned State and Union Territory. “It is illegal to advertise ASU&H drugs claiming miraculous or supernatural effects for the treatment of diseases. Such advertisements can mislead and endanger public health by promoting unverified or false claims,” the Ministry said. The Ministry further stated that The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, strictly prohibits the advertisement of drugs and magic remedies for the treatment of certain diseases and conditions. Any person found guilty of contravening this Act shall be liable for penalties as prescribed under the law. The Ayurvedic, Siddha and Unani (ASU) drugs containing Schedule El drugs are mandated to be consumed under the supervision and guidance of a registered medical practitioner of the concerned system of Ayush medicine, the public notice said. The container of such medicines will have instructions on its label — “Caution to be taken under medical supervision” — in both Hindi and English languages, it said. “General public are advised to use such medications only after consultations with registered medical practitioners/doctors of concerned Ayush systems,” the Ministry said. It further warned that self-diagnosis or self-medication with Ayurveda, Siddha, Unani & Homeopathy (ASU&H) drugs/medicines should be avoided. “Public is also encouraged to report any such objectionable advertisements, false claims, fake medicines etc to the concerned State Licensing Authority or the Ministry of Ayush for an appropriate action,” the notice stated. Source: The Hindu

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Rare diseases matter: Delhi HC directs centre to set up NRDF, says right to health is integral part of ‘right to life’

Oct 5, 2024 New Delhi: While disposing of a batch of more than 100 petitions moved on behalf of patients suffering from Rare diseases, the Delhi High Coult said that the Right to health is an integral part of the right to life. Justice Prathiba M Singh on Friday directed the Central Government to set up the National Rare Disease Fund (NRDF) for which Rs. 974 Crores will be allocated. The bench said that this fund should be utilised for the treatment of persons suffering from rare diseases. It is also directed that the disbursement of funds will be monitored by a mandat01Y monthly and to identify delays if any. The first meeting should be scheduled within 30 days. A detailed copy ofthe judgement is yet to be uploaded. The High Court has passed a number of directions. The High Court directed that the National Rare Disease Committee formed on May 25, 2023, shall continue to work for the next five years. “The Union government shall create a national fund for rare diseases and a fund of Rs. 974 Crore as per the recommendation of NRDC and pending approval of the Minist1Y of Health shall be allocated for the year 2024-25 and 2025-26,” the High Court ordered on Friday. While pronouncing the judgement on 105 petitions, the High Court said Treatment and medicine should be provided to all patients suffering from rare diseases. The fund shall not be lapse or refunded on the grounds of non-utilisation. The High Court was dealing with petitions seeking free treatment to patients suffering from Rare Diseases. (ANI) Source: Economic Times

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Consumer panels eligible to issue warrants, says HC

08 Oct 2024 NEW DELHI: In its recent ruling, the Delhi High Court has upheld consumer commissions’ power to issue arrest warrants under the Consumer Protection Act, 2019 (CP Act), stating that the State Consumer Disputes Redressal Commission (SCDRC) and the National Consumer Disputes Redressal Commission (NCDRC) have judicial powers equivalent to first- class “judicial magistrates” for enforcing compliance with their orders. Justice Sanjeev Narula, in a detailed judgment, declared the enforcement actions initiated due to VXL Realtors’ failure to comply with an order from the SCDRC, which mandated a refund and compensation to a consumer, were within the commission’s jurisdiction. ” Section 72 of the CP Act makes it abundantly clear that the objective of the provision is to enforce the orders of Consumer Commissions, by holding a company and its officers accountable for defying the directions of the Commissions, ” the court stressed. The case stems from a 2016 complaint filed by a consumer Naveen Kumar Aggarwal, who alleged unfair trade practices and deficiency in services by VXL Realtors related to a real estate deal. The SCDRC, in one of its orders, had directed VXL Realtors to refund the full amount paid by the complainant, along with interest and compensation for the inconvenience caused. Despite this, VXL Realtors failed to comply, leading Aggarwal to file an execution petition in 2022, which eventually resulted in arrest warrants being issued against the company’s directors, including Rakesh Khanna. Khanna, who was appointed director of VXL Realtors in 2020, filed a writ petition seeking to quash the arrest warrants. He contended that since the alleged deficiencies in service occurred between 2010 and 2013—prior to his appointment—he should not be held accountable for the company’s past failings. Source: New Indian Express

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Ola Electric served show-cause notice by consumer rights authority amid social media backlash

08 Oct 2024 Ola Electric was served a show-cause notice by the Central Consumer Protection Authority on Monday, October 7, for alleged violation of consumer rights, misleading advertisements, and unfair trade practices. The notice to the electric vehicle (EV) manufacturer comes amid mounting customer complaints about the functioning and service quality of Ola Electric scooters. “The Central Consumer Protection Authority has provided a timeline of 15 days to the Company to respond to the show cause notice. The Company will respond to the Central Consumer Protection Authority within the given timeframe with the supporting documents,” read a stock exchange filing by Ola Electric CFO Harish Abichandani. Shares of the Bengaluru-based firm tumbled by 9.1 per cent to Rs 89.14 on Monday, with its market capitalisation falling below $4.75 billion for the first time since Ola’s IPO listing in August. Ola Electric, which holds over 27 per cent share of the e-scooter market in India, receives over 80,000 customer complaints every month, according to a report by Mint. Recently, CEO Bhavish Aggarwal’s public spat with Indian stand-up comedian Kunal Kamra on X over Ola Electric’s service quality triggered an outpouring of anger and frustration from customers on social media. In response to Kamra’s photo purportedly showing dozens of discarded e-scooters outside an Ola showroom, Aggarwal asked him to “sit quiet and let us focus on fixing the issues for the real customers. We’re expanding service network fast and backlogs will be cleared soon.” Meanwhile, HSBC analysts who dropped by multiple Ola service stations said that most of them had “appeared overwhelmed by the service requests and were struggling to provide adequate service quality,” according to a report by Reuters. Last month, a man torched seven e-scooters at an Ola Electric showroom in Karnataka after his complaints about an e- scooter he bought last month were allegedly ignored. Source: Indian Express

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Complaints at consumer helpline doubled in last 2 years: Consumer Affairs Secy

04 Oct 2024 New Delhi: The complaints registered at the National Consumer Helpline (NCH) have seen a significant increase over the past two years, said Nidhi Khare, Secretary, Department of Consumer Affairs, Ministry of Consumer Affairs, Food and Public Distribution at a recent event. Attributing the increase in complaints to growing consumer confidence, Khare remarked, “The complaints that we are now getting registered at NCH have doubled in the past two years. And that shows the trust and confidence consumers today have at the National Consumer Helpline.” In addition to the rise in complaints, She highlighted that class action suits by the Central Consumer Protection Authority (CCPA) have been instrumental in addressing consumer issues. “Through the Central Consumer Protection Authority, the class action matters have resulted in a big way to take care of consumer needs,” she added. Looking ahead, Khare assured that in the coming months, CCPA will be taking service to consumer rights ‘velY seriously.’ Stressing the government’s sharp focus on the growing e-commerce sector, the Consumer Affairs Secretary also said that the government is working towards ensuring that consumers shopping online are better served in terms of delivery times and efficient refunds. Source: Economic Times

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New IRDAI rules: Life insurance policyholders to get higher early-exit payouts from today

01 Oct 2024 You will no longer lose your entire life insurance premium if you surrender your policy in the first year. Under a new rule by the Insurance Regulator and Development Authority of India (IRDAI) effective today, the surrender value will be available to life insurance policyholders after the first year of premium payment. Previously, policyholders could only surrender their policy after paying at least two full years of premiums, with no surrender value offered in the first year under the old guidelines. However, the increase in surrender value may result in higher costs for life insurers, which is expected to lower returns on both participating (par) and non-participating (non-par) policies. Non-par policies are likely to feel the immediate impact, while par policies may see lower bonuses announced later. Additionally, there could be a shift in commission structures from upfront payments to a trail model to offset the cost increases. In a participating policy, the policyholder shares in the profits of the insurance company in the form of bonuses or dividends. These bonuses are usually declared annually and are based on the insurer’s performance. On the other hand, non-participating policies do not offer such bonuses. Instead, they provide guaranteed benefits like a fixed sum assured, with no link to the company’s profits. Surrendering a policy refers to ending it before its full term and withdrawing from coverage. When this occurs, the policyholder receives a payout called the surrender value or early exit payouts, which is the higher of two amounts: the Guaranteed Surrender Value (GSV) or the Special Surrender Value (SSV). According to the new guidelines, insurers must ensure that the SSV equals at least the present value of the paid-up sum assured, future benefits, and any accrued or vested bonuses, while also accounting for any survival benefits already paid. The interest rate used for these calculations cannot exceed the current yield on 10-year government securities (G-Secs) plus an additional 50 basis points. For example, consider a policyholder with a IO-year policy, a sum assured of Rs 1 lakh, an annual premium of Rs 10,000, and a bonus of Rs 50,000. Under the new rules, the present value of the paid-up sum assured plus the future bonus would amount to Rs 7,823 or 78%. This is calculated as follows: {No. of Premiums Paid} / {Total Premiums to be Paid} * {Policy Returns Upon Maturity} For instance: 1 / 10 = Rs 10,000 Adding the paid-up bonus: Rs 10,000 + Rs 5,000 = Rs 15,000 Discounting this over the remaining term using the 10-year G-Sec rate plus 50 basis points: {Rs 15,000/(1.075)^9} = Rs 7,823 These new regulations will lead to an increase in the surrender value that policyholders receive but would also impact the return from these policies due to increase in costs. Source: Business Today

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Tripura CM calls for more awareness on Consumer Protection Act

30 sept 2024 Agartala, Sept 30: Chief Minister Dr. Manik Saha on Monday stressed the need for raising more awareness on the Consumer Protection Act. With the changing times, the scope of business has expanded, and consumer protection has become inevitable, he said at an event in Agartala. He was addressing a state-level consumer awareness seminar and launch of Consumer Clubs inlOO schools and 18 colleges organized by the Food, Civil Supplies and Consumer Affairs department at Rabindra Satabarshiki Bhavan. The Chief Minister also handed over smart ration cards to a few consumers and launched free distribution of Maida, Sooji and Sugar through PDS for the upcoming Durga Puja. As decided by the Food department, the Chief Minister launched distribution of puja grants of Rs. 2000 to the workers. Minister for Food, Civil Supplies and Consumer Affairs Sushanta Chowdhury, Justice Arindam Lodh of the High Court of Tripura and president of Tripura State Consumer Disputes Redressal Commission, Mayor Dipak Majumder, Special Secretary to Food department Ravel Hamendra Kumar, Director Nirmal Adhikary and other officials were present. The Chief Minister advised the consumers to collect cash memo in case of any purchase so that they could easily avail legal benefit. He also emphasized the importance of such awareness programmes in educating the people regarding relevant matters including fraud in online purchase. Justice Lodh appreciated the initiative in view of raising awareness on the Consumer Protection Act in this digital era. Chowdhury in his address said, small in size, Tripura holds a significant position in the country in terms of PDS. He highlighted the initiative of digitizing the PDS and other plans to further strengthen this sector. Source: Tripura Times

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Consumer Tips for Cybersecurity Awareness Month

08 Oct 2024 With October marking the beginning of Cybersecurity Awareness, it’s a crucial time to revisit best practices for staying safe online. Let’s look at a comprehensive set of cybersecurity strategies, aimed at helping individuals navigate the ever-evolving digital landscape with confidence. From leveraging biometric authentication to practicing good password hygiene and being cautious of phishing attempts, these practical recommendations ensure that consumers are well-equipped to protect themselves from common cyber threats. Below is a detailed guide on how to stay secure in today’s online world: Cybersecurity Pro Tips: Face Scans and Fingerprints are Safer Than Passcodes: use features like Face ID or fingerprint scans for your devices as much as possible. These are safer than passcodes and devices have good built-in protections for this sensitive information. Use Multi-Factor Authentication: Use multi-factor authentication (MFA) whenever possible. This gives an important extra layer of security that makes it harder for cybercriminals to access your accounts. If you can’t use something more secure like secure authenticator applications or physical hardware security keys, use your phone number it’s safer than using nothing. If you use MFA for only one thing, use it for your email: that’s what attackers want the most. Think Before You Share Publicly: Think twice before sharing any information publicly — cybercriminals can use it to access your accounts or to convince someone that they’re you. Think about those cute surveys on Facebook with questions about your first car, city you were born in: these are the same kinds of info cybercriminals can use to pretend they’re you and log into and take over your accounts. You Don’t Always Need (to keep) the App: Don’t feel pressured to download an app every time: you can often use the service’s website just as well. Apps collect much more data than websites, including your location, your contact list and other info you might not want to share. If you do download an app, think about deleting it when you’re done using it: you can always reinstall it next time you need it. Beware of Apps You Get Outside of the Big-Name App Stores: Apps from app stores and websites  that aren’t the official big names ones like Google Play, Apple’s App Store, Samsung’s Galaxy Store can be very risky. The official stores have security and privacy standards that can identify malicious activity. Always stick to official sources for downloading apps or, if they’re not on the official app stores, download the app from the developer’s official website or use the app’s web version. Be On Your Guard for Unexpected Q EmajJs and Text Messages: Phishing continues to be one of the most effective tactics cybercriminals use to compromise consumers. If you get an unexpected q .emaiJ or text message, ignore it or at least don’t interact with it (don’t open attachments, don’t click on links). If you think it might be legitimate, reach out directly to who you think sent it and check with them. Question Urgency in Emails and Calls: Cybercriminals use urgency to get you to let your guard down and make bad decisions. If someone contacts you saying they’re from a trusted organization like the IRS, police or your bank and need you to take action quickly or something bad will happen, stop and question it. Go to the trusted source like the number on the back of your credit card to independently validate the request. Practice Good Password Security: Every account should have its own unique complex password. A strong password is at least 12 characters long with a mix of numbers, upper- and lower-case letters, and punctuation characters. Passwords should not be based on any personal information, and the best ones use a phrase rather than single words. If these passwords are too tough to juggle, try a password manager to stay organized. Keep Everything Updated and Run Security Tools. Make sure all your apps and devices are always fully updated. Be sure to have some sort of security software on all of your phones and computers (even if you have a Mac). Get Rid of End-of-Life Devices and Software: Everything from operating systems to services to Wi-Fi routers “go stale” and must be replaced eventually. For example, it might surprise you, but your internet router is typically only supported with patches and updates for a few years after you get it. Attackers love out-of-date devices. When something is “out of support” it’s stale: get rid of it and replace it with something fresh. Back up Your Data: While ransomware groups are mostly after businesses that can pay higher ransoms, they still go after people at home. It’s still important to have your data backed up so that you don’t have to consider paying a ransom. Put Your Mind at Ease Regarding These Cybersecurity Concerns Part of staying secure requires being able to filter out the noise and prioritize the security actions that matter. Here are things not to worry about. Focus your energy on real risks, not exaggerated threats. Public Wi-Fi is Safer Than You Think: Contrary to outdated advice, public Wi-Fi is generally safe due to encryption used by most websites and apps. Use it freely at airports or coffee shops, but avoid sensitive activities. Beware of Fearmongering Around New Tech Features: Not every new technology is as risky as it’s made out to be. For example, Apple’s NameDrop feature is generally safe and requires specific conditions to function. However, if you’re concerned, you can easily turn it off in settings. Stop Stressing Over Public Chargers: The risk of “juice jacking” (data theft from public chargers) is extremely low. Don’t worry about using public phone chargers — just focus on real, more prevalent threats. Source: Cityair News

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