Government biomarker accountability

Introduction

Government biomarker accountability refers to the legal and institutional responsibility of governments and public authorities when they collect, process, store, analyse, share, or use biological markers relating to individuals. Biomarkers may include genetic information, physiological indicators, disease markers, biochemical measurements, immune-response indicators, and other biological data capable of revealing information about a person's health or biological characteristics. Although the expression “government biomarker accountability” is not yet a universally recognised independent field of law, it can be understood through existing principles of constitutional law, privacy law, medical law, data protection, bioethics, administrative law, and human rights.

The importance of accountability arises because government agencies increasingly use biological information for public-health surveillance, disease control, forensic investigations, population health programmes, research, screening, and emergency responses. Such uses can produce significant benefits, but they also create risks of unlawful surveillance, discrimination, unauthorised disclosure, function creep, and indefinite retention. Government accountability therefore requires that biomarker collection and use have a lawful purpose, legitimate justification, appropriate safeguards, proportionality, transparency, and mechanisms for independent review.

Legal foundations of government accountability

The first requirement is legality. A government authority should not collect or process sensitive biological information merely because it considers the activity useful. There must be an appropriate legal basis authorising the collection and defining its purpose and limits. The principle is particularly important where biomarker collection interferes with privacy or bodily autonomy.

The second requirement is necessity and proportionality. Even when legislation authorises collection, the government should demonstrate that the interference with individual rights is necessary to achieve a legitimate public objective and that less intrusive alternatives are insufficient. Excessive collection can therefore become unlawful even when the underlying government objective is legitimate.

The third requirement is purpose limitation. Information collected for one purpose, such as diagnosis or disease surveillance, should not automatically be repurposed for unrelated objectives such as law enforcement, immigration control, commercial exploitation, or general population surveillance. Any secondary use should have its own legal and ethical justification.

Accountability also requires data security and retention controls. Government institutions handling biomarkers should employ appropriate technical and organisational safeguards, establish retention periods, restrict access, maintain audit trails, and provide remedies where information is misused. Independent oversight is particularly important because individuals may have limited ability to challenge government agencies possessing highly sensitive biological information.

Constitutional and human-rights dimensions

Biomarker accountability is closely connected with the right to privacy. In Justice K.S. Puttaswamy (Retd.) v. Union of India, (2017) 10 SCC 1, the Supreme Court of India recognised privacy as a fundamental right under Article 21 and other constitutional freedoms. The judgment established that privacy includes interests relating to bodily integrity, informational privacy, and decisional autonomy. Consequently, governmental collection and processing of biological information must satisfy constitutional requirements rather than being treated merely as administrative matters.

The proportionality principle was subsequently developed in K.S. Puttaswamy (Retd.) v. Union of India (Aadhaar), (2019) 1 SCC 1. The Supreme Court examined the constitutional validity of Aadhaar and considered questions involving legitimate state purposes, proportionality, information use, and privacy safeguards. The case illustrates how large-scale government collection of personal information must be assessed against constitutional rights.

International human-rights jurisprudence also provides important guidance. In S. and Marper v. United Kingdom (2008) 48 EHRR 50, the European Court of Human Rights considered the indefinite retention of fingerprints and DNA profiles of individuals who had not been convicted. The Court found that indiscriminate and indefinite retention violated Article 8 of the European Convention on Human Rights. The case is highly relevant to biomarker accountability because DNA information can reveal deeply personal biological characteristics and therefore requires strong retention safeguards.

Case law concerning bodily and genetic information

In Roe v. Wade, 410 U.S. 113 (1973), although the case concerned reproductive autonomy rather than biomarkers directly, the United States Supreme Court's privacy jurisprudence contributed to broader recognition of personal autonomy in matters involving the body. Modern biomarker governance similarly raises questions about the extent to which individuals retain control over information derived from their bodies.

In United States v. Mitchell, 652 F.3d 387 (3d Cir. 2011), the court considered constitutional issues relating to DNA collection in the context of criminal justice. DNA collection demonstrates the tension between legitimate governmental identification interests and individual privacy interests. Courts have consequently examined factors such as statutory authority, the nature of the governmental purpose, safeguards, and the degree of intrusion.

The landmark case Maryland v. King, 569 U.S. 435 (2013) upheld certain DNA collection practices from individuals arrested for serious offences under the Fourth Amendment. The decision demonstrates that biological information may sometimes be collected without traditional consent where a constitutionally sufficient governmental justification exists. However, the decision does not establish unlimited governmental authority to collect or retain biological information.

Public-health biomarker surveillance

Government biomarker programmes can be particularly important during infectious-disease outbreaks. Governments may collect laboratory results, antibody information, vaccination-related data, genomic information, and other biomarkers to identify outbreaks and protect public health. However, emergency circumstances do not automatically eliminate privacy obligations.

The European Court of Human Rights' jurisprudence concerning medical information demonstrates the sensitivity of health data. In Z. v. Finland (1997) 25 EHRR 371, the Court recognised the particularly sensitive character of medical information and emphasised the importance of confidentiality. Unauthorised disclosure of medical information can therefore constitute a serious interference with private life.

Similarly, in Avilkina and Others v. Russia (2013), the European Court considered disclosure of medical information to authorities and reinforced the importance of legal safeguards surrounding sensitive medical data.

These principles are relevant to biomarker-based public-health systems. Governments should therefore establish clear rules concerning who can access biological information, for what purpose, how long it can be retained, and under what circumstances it may be disclosed.

Indian legal framework

In India, government biomarker accountability can be derived from constitutional privacy principles, the Information Technology Act framework, the Digital Personal Data Protection Act, 2023, medical confidentiality principles, and sector-specific regulations. The constitutional framework remains particularly important because sensitive biological information can directly implicate bodily integrity and informational autonomy.

The Puttaswamy judgment is the central constitutional authority. The Supreme Court identified informational privacy as an essential component of privacy and recognised that individuals should have protection against improper use of personal information by both public and private actors.

The Aadhaar litigation further demonstrates that large government databases require strong restrictions concerning collection, authentication, disclosure, and use. The principle emerging from these cases is that technological capability cannot itself establish legal authority.

Institutional accountability

Government biomarker accountability should operate through multiple layers. Administrative agencies should establish internal data-governance policies, access controls, security procedures, retention schedules, and breach-response mechanisms. Independent regulators and courts should provide external oversight.

Parliament or the legislature also has an important role in defining the permissible purposes of biomarker programmes. Legislation should identify the categories of biological information that may be collected, authorised purposes, circumstances permitting disclosure, retention periods, individual rights, and available remedies.

Judicial review provides another safeguard. Courts can examine whether governmental biomarker programmes exceed statutory authority or violate constitutional rights. Where a programme is disproportionate, discriminatory, arbitrary, or insufficiently safeguarded, judicial intervention may be justified.

Conclusion

Government biomarker accountability represents an emerging intersection of privacy, constitutional rights, public health, biotechnology, data protection, and administrative law. Governments may legitimately use biomarkers for healthcare, epidemiological surveillance, forensic identification, and other public purposes, but such power must remain subject to legality, necessity, proportionality, purpose limitation, confidentiality, security, and independent oversight.

The strongest legal principle emerging from cases such as Puttaswamy, Puttaswamy (Aadhaar), S. and Marper, Maryland v. King, and Z. v. Finland is that biological information is not ordinary administrative data. Because biomarkers can reveal intimate information about an individual's body and health, governmental authority over them must be accompanied by heightened legal safeguards and meaningful remedies against misuse.