Judicial biomarker governance

Introduction

Judicial biomarker governance refers to the legal regulation and judicial oversight of biomarkers used in healthcare, research, forensic investigations, employment, insurance, and other decision-making systems. A biomarker is a measurable biological characteristic that can indicate a physiological process, disease, exposure, response to treatment, or other biological condition.

Examples include blood-based indicators, genetic markers, imaging indicators, protein measurements, and other biological measurements. As biotechnology develops, biomarkers may increasingly influence decisions about diagnosis, treatment, criminal investigations, employment, insurance, and eligibility for particular services.

The central legal problem is that biomarkers can provide valuable information while simultaneously creating risks concerning privacy, discrimination, informed consent, scientific reliability, bodily autonomy, and due process. Judicial governance therefore requires courts to determine when biomarker evidence is legally reliable and when its collection or use violates individual rights.

Biomarkers and legal evidence

A biomarker should not automatically be treated as conclusive proof of a particular condition or behaviour. Scientific markers frequently indicate probability rather than certainty.

Courts should therefore examine:

• scientific validity;
• sensitivity and specificity;
• error rates;
• methodology;
• reproducibility;
• laboratory standards;
• chain of custody;
• expert interpretation; and
• whether the marker actually establishes the fact alleged.

This is particularly important in criminal proceedings, where unreliable biological evidence could contribute to wrongful conviction.

Privacy and biomarker information

Biomarker information can constitute highly sensitive personal information. Genetic biomarkers may reveal information about an individual's health and biological characteristics, while neurological or physiological biomarkers may disclose information about mental or physical conditions.

In India, the Supreme Court's decision in Justice K.S. Puttaswamy (Retd.) v. Union of India (2017) recognised privacy as a fundamental right under Article 21.

The judgment's recognition of informational privacy and bodily autonomy provides a significant constitutional foundation for regulating biomarker collection and use.

A biomarker should therefore generally be collected and processed for a legitimate purpose and under appropriate safeguards.

Biomarkers in criminal investigations

Biological evidence has long been used in criminal investigations. DNA profiles, blood analysis, toxicological testing, and other biological measurements can assist law enforcement.

However, courts must distinguish between obtaining physical evidence and obtaining information that may reveal highly private biological characteristics.

The Indian Supreme Court's Selvi v. State of Karnataka (2010) is particularly relevant. The Court considered narco-analysis, polygraph examination, and Brain Electrical Activation Profile techniques and held that their involuntary administration violates constitutional protections against self-incrimination and personal liberty.

Although those techniques are not conventional biomarkers, the case establishes an important principle: biological information cannot be extracted from an individual without regard to constitutional protections.

Scientific reliability

Judicial biomarker governance also requires courts to determine whether scientific evidence is sufficiently reliable to be admitted.

In Daubert v. Merrell Dow Pharmaceuticals, Inc. (U.S. Supreme Court, 1993), the Court established important considerations for evaluating expert scientific evidence, including testability, peer review, error rates, and general acceptance.

This framework is highly relevant where biomarkers are introduced as evidence because courts must distinguish scientifically established biomarkers from experimental or inadequately validated indicators.

In General Electric Co. v. Joiner (1997), the U.S. Supreme Court further recognised that courts may examine whether the expert's conclusions are adequately connected to the underlying scientific evidence.

Biomarkers and discrimination

Biomarkers may potentially be used to classify individuals according to disease susceptibility, genetic characteristics, neurological conditions, or predicted health outcomes.

Such uses could create discrimination in:

• employment;
• insurance;
• education;
• healthcare;
• criminal justice; and
• access to public services.

Legal systems should therefore distinguish legitimate medical use from discriminatory decision-making.

For example, an employer should not automatically exclude a worker merely because a biomarker suggests an increased statistical risk of developing a particular condition.

Genetic biomarkers

Genetic biomarkers raise particularly sensitive concerns because genetic information may reveal information not only about the individual but also about biological relatives.

The UNESCO Universal Declaration on the Human Genome and Human Rights 1997 provides an international ethical framework emphasising human dignity and protection of individuals in genetic research.

The Genetic Information Nondiscrimination Act (GINA) in the United States provides another legislative model by restricting certain uses of genetic information in employment and health insurance.

Relevant case law concerning biological information

In S. and Marper v. United Kingdom (ECtHR, 2008), the European Court of Human Rights examined government retention of fingerprints and DNA profiles. The Court recognised the sensitivity of biological information and held that indefinite retention could violate Article 8 of the European Convention on Human Rights.

This case is highly relevant to biomarker governance because it demonstrates that even when biological information is lawfully collected, long-term retention and secondary use remain subject to privacy safeguards.

In Gaughran v. United Kingdom (ECtHR, 2020), the Court similarly examined the continued retention of biometric information and emphasised the need for proportionality and safeguards.

Biomarkers in healthcare

Clinical biomarkers can improve diagnosis and personalised treatment. However, regulatory authorities must establish standards concerning analytical validity, clinical validity, and clinical utility.

A biomarker may accurately measure a biological characteristic but still have limited clinical value. Courts should therefore avoid treating statistical association as proof of medical causation.

Medical professionals should also communicate material uncertainties to patients, particularly when biomarker results could influence major medical decisions.

Judicial review of regulatory decisions

Courts may be asked to review decisions by medical or regulatory authorities concerning approval or use of biomarkers.

Judicial review may examine whether authorities:

• acted within statutory powers;
• considered relevant scientific evidence;
• followed procedural requirements;
• provided adequate reasons;
• respected constitutional rights; and
• acted proportionately.

Courts generally should not replace specialised scientific regulators' expertise with their own scientific judgment, but they can intervene where decision-making is irrational, procedurally defective, unlawful, or unsupported by evidence.

Data governance

Biomarker databases should be governed by principles of:

Purpose limitation: information should be collected for specified legitimate purposes.

Data minimisation: only necessary information should be collected.

Security: biological information should receive strong technical and organisational protection.

Retention limitation: information should not be retained indefinitely without justification.

Access controls: only authorised persons should access sensitive biomarker information.

Biomarkers in employment and insurance

Employers and insurers may have incentives to use biomarkers to predict future health risks. This creates a conflict between legitimate risk assessment and individual privacy.

A regulatory framework should prevent decisions based solely on speculative biological predictions. Where biomarker information is used, authorities should require evidence that the marker is scientifically validated and relevant to the particular decision.

Conclusion

Judicial biomarker governance concerns the intersection of scientific evidence, privacy, constitutional rights, medical regulation, and judicial decision-making. Biomarkers can provide valuable evidence, but they should not automatically be treated as definitive proof.

Cases such as Puttaswamy, Selvi, S. and Marper, Daubert, and Joiner establish important principles concerning privacy, bodily autonomy, scientific reliability, and the use of sensitive biological information.

The central principle is that biological measurability does not eliminate legal rights. Courts and regulators should therefore require scientifically reliable evidence, lawful collection, informed consent where applicable, proportionality, secure data handling, and safeguards against discrimination. This approach allows biomarkers to contribute to medicine and justice without permitting biological information to become an unrestricted instrument of surveillance or decision-making.