Subject: Social Justice

The Indian Council of Medical Research (ICMR) has recently released the first-ever set of ethical guidelines for the application of artificial intelligence (AI) in biomedical research and healthcare.

Ethical Guidelines for AI usage in Healthcare

• The guidelines aim to create “an ethics framework which can assist in the development, deployment, and adoption of AI-based solutions” in specific fields.
• Through this initiative, the ICMR aims to make “AI-assisted platforms available for the benefit of the largest section of common people with safety and highest precision possible”.
• It seeks to address emerging ethical challenges when it comes to AI in biomedical research and healthcare delivery.

Key features

• Effective and safe development, deployment, and adoption of AI-based technologies: The guidelines provide an ethical framework that can assist in the development, deployment, and adoption of AI-based solutions in healthcare and biomedical research.
• Accountability in case of errors: As AI technologies are further developed and applied in clinical decision making, the guidelines call for processes that discuss accountability in case of errors for safeguarding and protection.
• Patient-centric ethical principles: The guidelines outline 10 key patient-centric ethical principles for AI application in the health sector, including accountability and liability, autonomy, data privacy, collaboration, risk minimisation and safety, accessibility and equity, optimisation of data quality, non-discrimination and fairness, validity and trustworthiness.
• Human oversight: The autonomy principle ensures human oversight of the functioning and performance of the AI system.
• Consent and informed decision making: The guidelines call for the attainment of consent of the patient who must also be informed of the physical, psychological and social risks involved before initiating any process.
• Safety and risk minimisation: The safety and risk minimisation principle is aimed at preventing “unintended or deliberate misuse”, anonymised data delinked from global technology to avoid cyber attacks, and a favourable benefit-risk assessment by an ethical committee among a host of other areas.
• Accessibility, equity and inclusiveness: The guidelines acknowledge that the deployment of AI technology assumes widespread availability of appropriate infrastructure and thus aims to bridge the digital divide.
• Relevant stakeholder involvement: The guidelines outline a brief for relevant stakeholders including researchers, clinicians/hospitals/public health system, patients, ethics committee, government regulators, and the industry.
• Standard practices: The guidelines call for each step of the development process to follow standard practices to make the AI-based solutions technically sound, ethically justified, and applicable to a large number of individuals with equity and fairness.
• Ethical review process: The ethical review process for AI in health comes under the domain of the ethics committee which assesses several factors including data source, quality, safety, anonymization, and/or data piracy, data selection biases, participant protection, payment of compensation, possibility of stigmatisation among others.

Policy moves for streamlining AI in Healthcare

• India already offers streamlining of AI technologies in various sectors, including healthcare, through the National Health Policy (2017), National Digital Health Blueprint (NDHB 2019), and Digital Information Security in Healthcare Act (2018) proposed by the Health Ministry.
• These initiatives pave the way for the establishment of the National Data Health Authority and other health information exchanges.

Potential applications of AI in healthcare

Artificial Intelligence (AI) has revolutionized the healthcare industry by enabling various applications. These applications include:

• Diagnosis and screening: AI can be used to identify diseases from medical images like X-rays, CT scans, and MRIs.
• Therapeutics: AI can assist in the development of personalised medicines by analyzing a patient’s genetic makeup.
• Preventive treatments: AI can predict the risk of developing a disease, helping healthcare professionals to take preventive measures.
• Clinical decision-making: AI can analyze large amounts of data to assist healthcare professionals in making treatment decisions.
• Public health surveillance: AI can be used to monitor disease outbreaks and inform public health policies.
• Complex data analysis: AI can analyze large amounts of data from multiple sources to identify patterns and inform healthcare decision-making.
• Predicting disease outcomes: AI can predict disease outcomes based on patient data, enabling early
• Behavioural and mental healthcare: AI can help diagnose and treat mental health conditions.
• Health management systems: AI can assist in managing patient records, appointment scheduling and reminders, and medication management.

Various challenges for imbibing

• Data privacy and security: With the use of AI in healthcare, there is a significant amount of personal and sensitive data is collected. This data needs to be kept secure and protected from potential cyber-attacks.
• Regulatory and ethical issues: AI technology is still in its early stages of development and there are no clear guidelines or regulations in place for its use in healthcare. There are also ethical considerations, such as accountability, transparency, and bias that need to be addressed.
• High cost involved: The implementation of AI in healthcare requires significant investment in terms of infrastructure, software, and training. This cost can be a major challenge for healthcare organizations, especially in developing countries.
• Integration with existing systems: AI systems need to be integrated with existing healthcare systems and processes. This can be challenging, especially in cases where the existing systems are outdated or incompatible with AI technology.
• Lack of trust and acceptance: AI technology is still relatively new in healthcare and there is a lack of trust and acceptance among healthcare professionals and patients. This can be a major hurdle in the widespread adoption of AI in healthcare.

Threats posed by AI to healthcare

• Data privacy and security: The use of AI in healthcare requires the collection and analysis of vast amounts of personal health data, which could be at risk of being stolen or misused.
• Bias and discrimination: There is a risk that AI algorithms could perpetuate existing biases and inequalities in healthcare, such as racial or gender bias.
• Lack of transparency: Some AI models are complex and difficult to understand, which can make it difficult to explain the reasoning behind a particular decision.
• Medical errors: AI systems can make errors if they are trained on biased or incomplete data, or if they are used inappropriately.
• Ethical concerns: There are several ethical concerns associated with the use of AI in healthcare, including the potential for AI to replace human doctors, the impact on patient autonomy, and the implications for informed consent.

Way forward

• Develop a national AI strategy for healthcare: This strategy should include policies for data sharing, privacy, and security, as well as guidelines for the ethical and responsible use of AI.
• Invest in AI research and development: The government should invest in research and development of AI technologies that can help address the challenges in healthcare.
• Promote collaboration between stakeholders: Collaboration between stakeholders such as healthcare providers, researchers, government agencies, and industry can help accelerate the development and adoption of AI technologies in healthcare.
• Train healthcare professionals in AI: The government can work with academic institutions and the industry to create training programs and certifications for healthcare professionals.
• Address regulatory challenges: The government should work to address regulatory challenges related to the use of AI in healthcare.
• Focus on affordability and accessibility: This can be achieved by promoting innovation, encouraging competition, and ensuring that AI technologies are integrated into existing healthcare infrastructure.

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The Rajasthan Assembly passed the Right to Health (RTH), even as doctors continued their protest against the Bill, demanding its complete withdrawal.

Right to Health (RTH): A conceptual insight

• RTH is a fundamental human right that guarantees everyone the right to enjoy the highest attainable standard of physical and mental health.
• It is recognized as a crucial element of the right to an adequate standard of living and is enshrined in international human rights law.

Scope of RTH

• RTH covers various health-related issues, including-

1. Access to healthcare services, clean water and sanitation, adequate nutrition, healthy living and working conditions, health education, and disease prevention.
2. Accessible, affordable, and quality healthcare services,
3. Eliminating barriers to healthcare access
4. Informed consent to medical treatment and accessing information about their health.

What is the Rajasthan Right to Health Bill?

• Free treatment: RTH gives every resident of the state the right to avail free Out Patient Department (OPD) services and In Patient Department (IPD) services at all public health facilities and select private facilities.
• Wider scope of healthcare: Free healthcare services will include consultation, drugs, diagnostics, emergency transport, procedures, and emergency care. However, there are conditions specified in the rules that will be formulated.
• Free emergency treatment: Residents are entitled to emergency treatment and care without prepayment of fees or charges.
• No delay in treatment: Hospitals cannot delay treatment on grounds of police clearance in medico-legal cases.
• State reimbursement of charges: After emergency care and stabilisation, if patients do not pay requisite charges, healthcare providers can receive proper reimbursement from the state government.

Existing schemes in Rajasthan

• The flagship Chiranjeevi Health Insurance Scheme provides free treatment up to Rs 10 lakh, which has been increased to Rs 25 lakh in the latest budget.
• The Rajasthan Government Health Scheme covers government employees, ministers, current and former MLAs, etc.
• The Nishulk Nirogi Rajasthan scheme provides free OPD and IPD services in government hospitals and covers about 1,600 medicines, 928 surgicals, and 185 sutures.
• The Free Test scheme provides up to 90 free tests in government hospitals and has benefited 2.93 crore persons between March-December 2022.

Need for the RTH Scheme

• The state prioritizes healthcare and wants Rajasthan to be a great example of good health.
• The Health Minister has received many complaints about private hospitals asking for money from patients who have the Chiranjeevi card.
• So, they are bringing in a new law to stop this.
• The new law will make sure that future governments follow it and provide free healthcare to everyone.

Controversy with the RTH Law: Emergency Care Provisions

• Emergency care was a contentious issue in the RTH.
• The clause states that people have the right to emergency treatment and care for accidental emergency, emergency due to snake bite/animal bite and any other emergency decided by the State Health Authority under prescribed emergency circumstances.
• Emergency treatment and care can be availed without prepayment of requisite fee or charges.
• Public or private health institutions qualified to provide such care or treatment according to their level of health care can offer emergency care.

Issues raised by healthcare professionals

• Existing burden of schemes: Doctors are protesting against the RTH because they question the need for it when there are already schemes like Chiranjeevi that cover most of the population.
• Specialization concerns: They are also objecting to certain clauses, such as defining “emergency” and being compelled to treat patients outside their specialty as part of an emergency.
• Unnecessary obligations: The Bill empowers patients to choose the source of obtaining medicines or tests at all healthcare establishments, which means that hospitals cannot insist on in-house medicines or tests.

Way forward

• Given the contentious nature of the Bill, it is important for all stakeholders to come to the table and engage in constructive dialogue to resolve the issues at hand.
• It should involve liaison between government, doctors, patient advocacy groups, and other relevant stakeholders to discuss the concerns raised by all parties and identify potential solutions.
• This could be followed by a revision of the Bill, incorporating feedback and suggestions from all stakeholders, and a renewed effort to build consensus and support for the legislation.
• Additionally, greater efforts could be made to improve transparency and accountability in the healthcare system, with a focus on educating patients about their rights.

 

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Tamil Nadu has pioneered an initiative across the State to reduce the mortality rate among people with tuberculosis named: TN-KET (Tamil Nadu Kasanoi Erappila Thittam) meaning TB death-free project.

What is TN-KET?

• TN-KET aims to reduce the mortality rate among people with tuberculosis.
• This initiative, which began in April 2022, has already achieved significant reduction in the number of early TB deaths.

Unique features

• Differentiated TB Care: This is at the heart of the initiative, which aims at assessing whether people with TB need ambulatory care or admission in a health facility to manage severe illness at the time of diagnosis.
• Radiological assessment: The guidelines require comprehensive assessment of 16 clinical, laboratory and radiological parameters.
• Triage of assessment: The preliminary assessment of patients based on just three conditions — very severe undernutrition, respiratory insufficiency, and inability to stand without support — was found to be feasible for quick identification at diagnosis.

Outcome: Significant reduction in early TB deaths

• Above features vastly cut down the delay and increasing the chances of saving lives.
• The initiative has achieved the initial target of 80% triaging of patients, 80% referral, comprehensive assessment and confirmation of severe illness, and 80% admission among confirmed.
• The State’s target is to achieve 90%-90%-90% at each district.

Key challenges

• The challenge is to increase the duration of admission, especially for people with very severe undernutrition, which comprises 50% of the admitted patients.

 

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TB mukt India

 

 

In a major tweak to the organ donation policy, the Union Ministry of Health and Family Welfare said that the clause that people beyond 65 years could not receive cadaver organ transplants had been removed.

What are the changes introduced?

(1) No Age Bar

• Now an individual of any age can register for organ transplant.
• People beyond 65 years in need of an organ donation will also be eligible to get one.
• The government has decided to do away with a clause in the National Organ and Tissue Transplant Organisation (NOTTO) guidelines as the clause violates the Right to Life.

(2) Doing away with domicile compulsion

• Earlier an organ recipient could register for a prospective transplant in domicile State.
• States like Gujarat had made it mandatory for registered patients to furnish a domicile certificate to be eligible for a transplant.
• In November last year, the Gujarat High Court quashed the discriminatory policy of the State government.

Organ transplant in India: Key statistics

• According to data accessed from the Health Ministry, the number of organ transplants have increased by over three times from 4,990 in 2013 to 15,561 in 2022.
• Of the 15,561 transplants, a majority — 12,791 (82%) — are from live donors and 2,765 (18%) are from cadavers (the dead).
• Up to 11,423 of the 15,561 organ transplants are for the kidney, followed by liver (766), heart (250), lung (138), pancreas (24) and small bowel transplants (3).
• Most of these transplants occur in private hospitals, the numbers in government hospitals are relatively lower.

Challenges to Organ Donation in India

• Lack of awareness: There is a lack of awareness among the general public about the importance of organ donation, the legal framework governing it, and the procedures involved. This can limit the number of potential donors.
• Cultural beliefs and superstitions: In India, there are several cultural beliefs and superstitions that discourage organ donation. Some people believe that organ donation is against religious beliefs, or that it can impact the soul or afterlife.
• Lack of infrastructure: India faces a shortage of hospitals and medical facilities that are equipped to handle organ transplantation. This can limit the availability of organs for transplantation.
• Regulatory bottlenecks: While the legal framework exists, there is a lack of implementation and enforcement of the law. This can lead to issues such as organ trafficking and black market activities.

Way ahead

• To address these challenges, the government and other stakeholders are working to raise awareness, improve infrastructure, and strengthen the legal framework governing organ donation.
• Campaigns and initiatives are being undertaken to educate the public and healthcare professionals about the importance of organ donation, and to dispel myths and misconceptions.
• Efforts are also being made to improve the infrastructure and facilities for organ transplantation, and to enhance the regulatory framework to prevent illegal activities.
• These steps are aimed at promoting organ donation and increasing the availability of organs for transplantation, which can save lives and improve the quality of life for many people in India.

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About National Organ Transplant Programme (NOTP)

• In 2019, the GoI implemented the NOTP for promoting deceased organ donation.
• Organ donation in India is regulated by the Transplantation of Human Organs and Tissues Act, 1994.

Types of Organ Donations

• The law allows both deceased and living donors to donate their organs.
• It also identifies brain death as a form of death.
• Living donors must be over 18 years of age and are limited to donating only to their immediate blood relatives or, in some special cases, out of affection and attachment towards the recipient.

(1) Deceased donors:

• They may donate six life-saving organs: kidneys, liver, heart, lungs, pancreas, and intestine.
• Uterus transplant is also performed, but it is not regarded as a life-saving organ.
• Organs and tissues from a person declared legally dead can be donated after consent from the family has been obtained.
• Brainstem death is also recognized as a form of death in India, as in many other countries.
• After a natural cardiac death, organs that can be donated are cornea, bone, skin, and blood vessels, whereas after brainstem death about 37 different organs and tissues can be donated, including the above six life-saving organs

(2) Living donors:

They are permitted to donate the following:

• one of their kidneys
• portion of pancreas
• part of the liver

Features of the NOTP

• Under the NOTP a National Level Tissue Bank (Biomaterial Centre) for storing tissues has been established at National Organ and Tissue Transplant Organization (NOTTO), New Delhi.
• Further, under the NOTP, a provision has also been made for providing financial support to the States for setting up of Bio- material centre.
• As of now a Regional Bio-material centre has been established at Regional Organ and Tissue Transplant Organization (ROTTO), Chennai, Tamil Nadu.

 

Back2Basics: National Organ and Tissue Transplant Organization (NOTTO) NOTTO is a national-level organization set up under the Directorate General of Health Services, Ministry of Health and Family Welfare. 1.  National Human Organ and Tissue Removal and Storage Network 2.  National Biomaterial Centre (National Tissue Bank) [I] National Human Organ and Tissue Removal and Storage Network This has been mandated as per the Transplantation of Human Organs (Amendment) Act 2011. The network will be established initially for Delhi and gradually expanded to include other States and Regions of the country. Thus, this division of the NOTTO is the nodal networking agency for Delhi and shall network for the Procurement Allocation and Distribution of Organs and Tissues in Delhi. It functions as apex centre for All India activities of coordination and networking for procurement and distribution of Organs and Tissues and registry of Organs and Tissues Donation and Transplantation in the country. [II] National Biomaterial Centre (National Tissue Bank) The Transplantation of Human Organs (Amendment) Act 2011 has included the component of tissue donation and registration of tissue Banks. It becomes imperative under the changed circumstances to establish National level Tissue Bank to fulfil the demands of tissue transplantation including activities for procurement, storage and fulfil distribution of biomaterials. The main thrust & objective of establishing the centre is to fill up the gap between ‘Demand’ and ‘Supply’ as well as ‘Quality Assurance’ in the availability of various tissues. The centre will take care of the following Tissue allografts: 1.  Bone and bone products 2.  Skin graft 3.  Cornea 4.  Heart valves and vessels

 

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