Trust Before Treatment: The Ethical Questions Biotech and Healthcare Must Answer

Healthcare and biotechnology are rapidly evolving fields that are changing how we understand and treat the human body. Using advanced tools such as gene editing, artificial intelligence (AI) and large datasets, these fields are expanding what we can achieve. These advances also bring important ethical issues affecting patient rights, data privacy and the reliability of medical decisions.

This article examines the main ethical challenges in biotech and healthcare, drawing on current trends, regulatory perspectives and practical solutions.

The Foundations of Medical Ethics

In contemporary medical ethics, doctors in the USA developed a national code of ethics for physicians. The American Medical Association (AMA) adopted its Code of Medical Ethics at its founding meeting in Philadelphia in 1847, drawing primarily on Medical Ethics, published in 1803 by Thomas Percival, a British physician. The International Code of Medical Ethics of the World Medical Association, an organisation representing physicians founded in 1947, was first adopted in 1949 and was most recently revised in 2022. It sets out the ethical principles and professional duties of physicians towards patients, colleagues and society.

Healthcare organisations around the world are struggling to provide services while remaining financially stable. The quality of patient care is now in competition with the financial health of these organisations, making ethics more important than ever. Healthcare services have a unique moral dimension: their goals include saving lives, reducing or preventing pain, treating illnesses and disabilities, and improving outcomes for diseases that cannot be cured or prevented.

It is difficult for most people to accept that someone might be denied healthcare that could help them or save their life simply because they cannot afford it. In India, where the country’s health indicators remain poor, discussing ethics becomes more complicated and requires a deeper understanding of the situation.

The Indian Healthcare Sector

Public spending on health has grown: according to India’s National Health Accounts 2022–23, government health expenditure accounted for 43.7% of total health expenditure, up from 28.6% in 2013–14. Households still bear a large share of the cost. Their out-of-pocket spending made up 43.4% of total health expenditure in 2022–23, up from 39.4% the year before. Private providers also remain central to care. In the National Sample Survey conducted in 2025, public facilities accounted for 35% of outpatient care in rural areas and 25% in urban areas, and the average out-of-pocket expense per hospitalisation case was ₹50,508 in private hospitals, against ₹6,631 in public hospitals.

The Importance of Ethics in Biotechnology and Healthcare

In recent years, the terms ‘biomedical ethics’, ‘biopharmaceutical ethics’ and ‘healthcare ethics’ have gained importance. Biomedical ethics includes issues related to reproductive biology, such as stem cell research and human cloning, and the ethical questions arising from these developments. Ethics are essential in biotechnology and healthcare because their outcomes directly affect people’s lives, health and trust in society.

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In these fields, the pursuit of new ideas must work alongside ethical principles to keep the public safe and maintain trust. Strong ethical practices protect vulnerable people from potential harm and prevent the misuse of powerful technologies.

Handling New Discoveries That Raise Ethical Concerns

With groundbreaking developments such as CRISPR gene editing and AI-based medical tests, biotechnology is changing what we can do while raising important ethical questions. These advances go beyond traditional boundaries, particularly concerning human involvement and the privacy of personal health information. As these technologies develop rapidly, they need ethical guidelines that help balance potential benefits with the risks involved.

Understanding Ethics and Ethical Challenges in Biotech and Healthcare

Ethics in biotech and healthcare provide principles for decision-making and accountability, especially when it comes to respecting people’s rights and treating them fairly. These principles help ensure that new scientific ideas respect people’s choices, benefit everyone and avoid causing harm. Following them protects important human values and helps ensure that patients receive appropriate care.

Why Ethics Matter

Ethics matter because biotech and healthcare can change people’s lives profoundly, sometimes permanently. Developments in gene editing, artificial intelligence and the handling of large amounts of data can create difficult questions about privacy, consent and fair access. Ethical principles help address these questions. Following them builds trust among patients, those involved in healthcare and the wider community, helping innovation align with shared ideas of right and wrong.

Incorporating Ethics into Biotech and Healthcare

Ethics help companies and professionals make difficult decisions, including obtaining consent for gene editing and protecting patient information in AI tools. They inform regulation, compliance and clear communication, helping ensure that new developments prioritise human welfare. By considering ethical issues early in innovation and including bioethicists in decision-making, the biotech and healthcare sectors can build public trust and progress responsibly towards positive, socially responsible outcomes.

Key Ethical Challenges

Privacy and Data Security

As digital records and wearable devices become more common, more patient information is being gathered and stored than ever before. This creates ethical challenges because healthcare organisations must decide how to use data to improve services while protecting patient privacy. Strong security and clear data policies are essential to prevent leaks and the misuse of personal health information.

Informed Consent in Genetic Testing and Treatment

Genetic testing can reveal important details about a person’s health risks, making clear, informed consent essential. Patients should understand the long-term implications of genetic data, including both risks and benefits, before undergoing tests or treatment. Ethical concerns include ensuring that patients consent freely and understand what they are agreeing to, as well as addressing any pressure affecting decisions about genetic treatments.

Artificial Intelligence and Machine Learning in Healthcare

AI is increasingly used to diagnose illnesses, plan treatments and support patient care. It also brings new ethical challenges. AI systems can be difficult to understand, making their results harder to trust. Ethical concerns include ensuring that AI is fair, transparent and accountable, to avoid biases and mistakes that could harm patients’ health.

Case Studies and Real-World Examples after COVID-19

Privacy and Data Misuse in Digital Health Platforms

In 2023, the US Federal Trade Commission (FTC) took action against two digital health companies over the sharing of sensitive health data with advertisers. GoodRx, a prescription-discount and telehealth platform, was accused of sharing users’ health information with platforms such as Facebook and Google without notice or consent. Its order carried a $1.5 million civil penalty and a permanent ban on sharing health data for advertising [8]. BetterHelp, an online counselling service, was accused of sharing data, including information about mental health challenges, with Facebook and Snapchat for advertising despite promising to keep it private. Its order bans such sharing, requires express consent before disclosure to certain third parties, and requires BetterHelp to pay $7.8 million to affected consumers [9]. These cases showed the need for better data protection and greater openness about how health information is used.

Informed Consent and the Use of Genetic Data

In October 2023, the genetic testing company 23 and Me disclosed a data breach that affected 6.9 million customers. The company filed for bankruptcy in March 2025, and its customer data and samples were sold to TTAM Research Institute, a non-profit formed by its co-founder and former chief executive. California’s Attorney General argued that the sale breached the state’s Genetic Information Privacy Act, which requires explicit consent before genetic data is sold or transferred. In October 2026 he announced a $6 million settlement, pending court approval, and reminded customers that they can ask for their genetic data to be deleted. Vermont has since passed a law requiring genetic testing companies to obtain express consent before collecting, using or sharing genetic data.

Bias in Healthcare Algorithms

A 2019 study published in Science found racial bias in a widely used commercial algorithm that helps US health systems identify patients who need extra care. At the same risk score, Black patients were considerably sicker than White patients. The algorithm predicted health costs rather than illness, and less money is spent on Black patients with the same level of need. The authors estimated that this bias reduced the number of Black patients identified for extra care by more than half, and showed that reformulating the algorithm so that it no longer used cost as a proxy for need removed it. This highlighted the importance of checking what an AI tool is actually asked to predict, and of testing its results across different groups, to avoid worsening existing inequalities.

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Regulation and Compliance in Biotech and Healthcare

Important Regulatory Bodies and Recent Developments

Major organisations such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) play important roles in managing biotech and healthcare progress. The ICH develops harmonised technical guidelines, which regulatory authorities then implement. Important developments include Europe’s GDPR (Regulation (EU), which has applied since 25 May 2018 and restricts the processing of health data as a special category of personal data; the FDA’s final guidance of December 2024 on predetermined change control plans for AI-enabled device software and India’s Digital Personal Data Protection Rules, notified in November 2025, whose main obligations take effect in phases by May 2027. These developments aim to ensure that data is used ethically and transparently, while protecting patient rights.

Rules for Biotech and Healthcare Companies

Healthcare and biotech companies need to follow strict rules concerning patient consent, data security and fair treatment. Failing to follow them can lead to substantial fines, legal problems and reputational damage. India’s data protection framework, for example, allows penalties of up to ₹250 crore for failures to maintain security safeguards, and the GoodRx and BetterHelp cases above ended in a civil penalty and a payment to consumers. This underlines the importance of meeting high ethical and legal standards to maintain public trust and sustain operations.

Opportunities and Solutions in Healthcare Ethics

The healthcare industry continues to face ethical issues that need attention, particularly as technology advances. Several areas offer opportunities for improvement.

Clear Data Use

As healthcare becomes more digital, patient information is shared, analysed and sometimes used for profit. Greater transparency about how this data is gathered, stored and used can help build trust. Clear information and data-sharing policies can help patients understand the implications of sharing their health information.

Improving Consent Procedures

Consent forms, especially for genetic testing and AI-based diagnostics, are often complex and difficult to understand. Simplifying these forms and using clear, accessible language can help ensure that patients are fully informed and comfortable with how their data and biological information will be used. Improved consent procedures can give patients greater control, support their independence and reduce the likelihood of ethical problems.

Fair Access to Innovation

New healthcare technologies, including AI-based diagnostics, genetic testing and personalised medicine, can be expensive, making them difficult for some people to access. Creating affordable alternatives, providing financial assistance or working with public health systems can help close this gap. Fair access is crucial to reducing healthcare inequalities and creating a system that serves everyone.

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Training in Ethical AI and Genetic Privacy

As AI tools become essential to diagnosis, prediction and patient care, healthcare workers need training in the ethical aspects of AI and genetic information. This can help staff understand potential biases in AI and the importance of protecting genetic privacy. Such training supports informed decision-making that respects patient rights.

Innovation Guided by Ethics

Ethical innovation involves reducing risks and finding new ways to help people while ensuring that everyone is included. Businesses that prioritise ethical conduct can build trust, attract customers who value ethics and become leaders in responsible healthcare.

AI Diagnostics Using Diverse Data

An important opportunity for innovation is developing AI diagnostic tools using data from different population groups. When AI systems are trained on diverse data, they work better for people of different races, ethnicities and genders, helping make healthcare fairer. Companies following this approach aim to ensure that their technology benefits all patients equally and avoids mistakes arising from unfair AI systems.

Patient-Managed Health Data Systems

New digital health tools give patients greater control over their health information, allowing them to decide who can access it and why. Tools that prioritise data security and allow patients to move their data easily will appeal to people who value privacy. This approach can also make relationships between patients and healthcare providers more open.

The Advantages of Ethical Business Practices

Companies with strong ethical standards build public trust and gain a competitive advantage. Increasingly, consumers are seeking secure, ethical healthcare options, and companies that demonstrate transparency and a commitment to patient needs can stand out. A strong reputation can lead to partnerships, investment and a loyal customer base, supporting continued ethical innovation and growth.

By focusing on these ethical improvements and ensuring that new developments align with ethical standards, healthcare companies can create a more inclusive, transparent and trustworthy healthcare system. This approach improves patient care and strengthens the industry’s overall reputation.

Future Trends in Healthcare Innovation and Ethics

Healthcare is poised for significant change, driven by new technologies and a stronger focus on ethical practice. As these areas develop, integrating ethical principles with technology will influence how healthcare works in the future.

AI and Machine Learning with Ethical Guidelines

The use of AI in healthcare will continue to expand, supporting diagnosis, treatment planning and personalised care. However, issues such as bias and patient privacy require careful attention. Future developments may include:

• Reducing bias: Training AI models on large, varied datasets to help them work well for everyone.
• Clear explanations: Making AI decisions understandable and sharing them with healthcare workers, so patients know why particular choices are made for their care.
• Clear and open AI decisions: Ensuring that AI choices in healthcare can be explained and understood by doctors, so patients can see why they are receiving particular treatments.
• Ethical AI guidelines: Developing rules for healthcare AI that respect patient rights and align with society’s ethical expectations.

Advances in Genomics with Better Consent and Privacy

Genomics is developing rapidly and can offer treatments tailored to a person’s genes. As the field advances, genetic privacy and consent require careful consideration.

• Clear consent procedures: Using simpler, more transparent consent methods to help patients make informed choices and protect their right to decide how their data is used.
• Privacy safeguards: Using advanced encryption and decentralised systems to help patients manage genetic information securely and reduce the risk of misuse.

Telemedicine and Digital Health Access and Privacy

Telemedicine and digital health tools are now common, but they need to develop further to serve everyone, particularly people with limited access to healthcare.

• Reaching underserved communities: Improving telemedicine in places with inadequate healthcare can help more people access the care they need.
• Keeping information safe: Strong security measures are essential to protecting patient privacy as more health data is stored online.

Giving Patients More Control through Digital Health Tools

Healthcare is becoming more responsive to patients’ preferences, with people increasingly able to manage their health information and choose their treatments.

• Patient-managed health records: Digital tools that allow patients to manage records and consent to data sharing can give them greater control and improve transparency.
• Predictive tools for preventive care: With permission to use health data, predictive tools can identify potential health problems earlier and help patients make better health choices.

Ethical Standards as a Competitive Advantage

Companies that prioritise ethical behaviour, openness and patient needs are likely to gain an advantage in healthcare.

• Ethical innovation as market differentiation: Companies with strong ethical standards can attract ethically minded customers and partners, strengthening their reputation and customer loyalty.
• Setting long-term industry norms: As ethical standards become more important, companies that adopt them early can help establish industry benchmarks and influence regulation, encouraging responsible practices across the sector. So everyone should know Ethical Challenges in Biotech and Healthcare.

References

1. 1. NSS 80th Round press note (MoSPI, April 2026)
   https://static.pib.gov.in/WriteReadData/specificdocs/documents/2026/apr/doc2026420852401.pdf
2. National Health Accounts 2022–23
   https://www.pib.gov.in/PressReleasePage.aspx?PRID=2265816&lang=1&reg=3
3. Obermeyer et al., Science, 2019
   https://just-tech.ssrc.org/citation/dissecting-racial-bias-in-an-algorithm-used-to-manage-the-health-of-populations/
4. 4. California Attorney General, 23andMe settlement (19 October 2026)
   https://oag.ca.gov/news/press-releases/attorney-general-bonta-secures-6-million-settlement-23andme-litigation