1. Introduction

The Cognitive Biomarker Accountability Governance Doctrine is a proposed legal and regulatory framework for ensuring that organisations, governments, healthcare providers, researchers, employers and technology developers are accountable when they collect, analyse, interpret or use biomarkers associated with human cognition.

It concerns biomarkers that may provide information about cognitive functions such as:

Memory, attention and concentration.

Cognitive fatigue, alertness and sleep-related impairment.

Neurological conditions and changes in cognitive functioning.

Stress responses and certain emotional or behavioural states.

Cognitive performance inferred from brain signals, physiological measurements or biological samples.

Examples include electroencephalography (EEG) signals, neurological measurements, certain blood-based biomarkers and algorithmic predictions generated from biological data.

A cognitive biomarker does not necessarily reveal a person's thoughts, intentions or mental capacity with certainty. Many measurements are probabilistic, context-dependent or scientifically limited. Consequently, legal accountability must cover both the collection of the data and the conclusions drawn from it.

The doctrine is not a formally established, independently named doctrine in existing law. Rather, it is a proposed analytical framework derived from established principles of privacy, informed consent, medical ethics, equality, data protection, scientific reliability and procedural fairness. Contemporary neurotechnology research similarly highlights the challenges of governing inferences derived from neural signals.

Sage Journals+1

2. Meaning and legal foundations

The doctrine can be divided into three connected elements.

Cognitive biomarker protection

Protecting biological, neurological and health-related information that can reveal or help predict aspects of a person's cognitive functioning.

Accountability

Requiring those who collect, process or rely on biomarker data to justify their actions, demonstrate reliability and accept responsibility for unlawful or harmful uses.

Governance

Establishing oversight, consent procedures, security standards, independent review, safeguards against discrimination and effective remedies.

The central proposition is that the more sensitive the cognitive inference and the more consequential its use, the stronger the legal justification and safeguards should be.

For example, using a validated biomarker to assist a consenting patient in clinical diagnosis is materially different from using an unvalidated cognitive score to reject a job applicant or determine a person's eligibility for insurance.

3. Essential principles of the doctrine

3.1 Right to cognitive privacy

Cognitive privacy concerns protection against unjustified collection, disclosure or use of information that reveals or permits inferences about a person's cognitive functioning.

A brain scan or biological test may initially be collected for medical purposes. Later, an organisation might use the same information to estimate concentration, memory performance or susceptibility to fatigue. Such secondary uses can create privacy risks that were not apparent when the data were first collected.

The governance doctrine therefore requires consideration of:

Whether the information identifies, or can reasonably be linked to, an individual.

Whether the data reveal health-related or other sensitive information.

Whether the proposed use is lawful, necessary and proportionate.

Whether secondary use was adequately disclosed and authorised.

Whether the information could be used to manipulate, stigmatise or discriminate against a person.

Relevant case: Justice K.S. Puttaswamy (Retd.) v. Union of India (2017) 10 SCC 1.

The nine-judge bench of the Supreme Court of India recognised privacy as a fundamental right protected under Article 21 and other provisions of Part III of the Constitution. The judgment linked privacy with dignity, liberty and individual autonomy, and articulated legality, legitimate State purpose and proportionality as requirements for assessing certain invasions of privacy.

Indian Kanoon+1

Application: If a public authority collects cognitive biomarker information for a surveillance programme, the constitutional questions include whether the programme has legal authority, pursues a legitimate aim and uses proportionate means with appropriate safeguards.

The case did not specifically decide the legality of cognitive biomarker systems. Its constitutional principles provide the foundation for analysing them.

3.2 Informed consent and cognitive autonomy

Consent is central when a person participates in cognitive biomarker research, undergoes testing or receives treatment involving the collection of sensitive biological information.

Valid consent should ordinarily explain:

What data will be collected.

Why the data are being collected.

What conclusions the test can and cannot reliably support.

Who will receive the information.

Whether the information may be retained, shared or used in further research.

The material risks, available alternatives and applicable withdrawal procedures.

Consent to a clinical test should not automatically be treated as consent to employment screening, commercial profiling or unrelated AI training. The precise legal requirements depend on the context and applicable law.

Relevant case: Samira Kohli v. Dr. Prabha Manchanda (2008) 2 SCC 1.

The Supreme Court of India examined the scope of patient consent in a medical procedure. It held, in substance, that consent for a diagnostic procedure does not ordinarily authorise a materially different therapeutic procedure, subject to the recognised emergency exception. The Court emphasised the patient's right to make informed decisions about treatment.

Indian Kanoon+1

Application: A patient who consents to a neurological examination for diagnosis has not necessarily authorised unrelated cognitive profiling, commercial disclosure of the results or additional procedures.

The case concerns medical consent, not algorithmic biomarker governance directly, but its principles are relevant to defining the boundaries of authorisation.

3.3 Scientific validity and reliability

A cognitive biomarker should not be treated as definitive proof of intelligence, honesty, competence, future behaviour or mental capacity merely because a scientific instrument generates a score.

Accountable governance should distinguish among:

Analytical validity: Does the system measure the intended biological signal accurately?

Clinical validity: Is the signal reliably associated with the relevant clinical condition or cognitive characteristic?

Clinical utility: Does using the result improve a meaningful clinical decision or outcome?

Contextual validity: Has the system been appropriately validated for the population and setting in which it will be used?

For instance, a fatigue indicator validated under controlled laboratory conditions may not be reliable enough to determine whether an individual is fit to perform a safety-critical job without further evidence and appropriate assessment.

A defensible governance framework requires validation, documentation of uncertainty, independent testing where warranted and qualified human interpretation for consequential decisions.

3.4 Accountability for automated decisions

When an algorithm converts biomarker measurements into a decision, responsibility should not disappear behind the claim that the decision was generated by software.

Relevant actors may include the biomarker developer, the laboratory, the data controller, the model provider, the organisation deploying the system and the professional relying on its output. Their respective legal duties depend on their actual roles and the applicable liability regime.

Accountability mechanisms should include:

Traceable records of how data were collected and processed.

Documentation of the model's intended use and limitations.

Procedures for correcting inaccurate information.

Human review of high-impact decisions.

A process for challenging adverse outcomes.

Investigation of errors and allocation of responsibility.

Relevant case: State v. Loomis (2016), 881 N.W.2d 749.

The Wisconsin Supreme Court considered the use of the COMPAS risk-assessment tool during criminal sentencing. It permitted the use of the assessment under specified limitations and cautions, including concerns about proprietary methodology and the risks of relying on risk scores.

Application: A court or public authority considering a cognitive biomarker score should not treat it as an infallible or self-explanatory conclusion. The decision-maker must consider reliability, limitations, the individual's circumstances and the applicable procedural protections.

The case concerned criminal risk assessment rather than biological cognitive biomarkers, so it is an analogy about algorithmic accountability, not a direct biomarker precedent.

4. Case-law analysis: privacy, surveillance and sensitive information

European Court Finds in Favor of Investigative Journalists NGO; Armenian Government Must Pay 1,500 Euros

S. and Marper v. United Kingdom

Applications nos. 30562/04 and 30566/04 · Judgment of 4 December 2008

The European Court of Human Rights held that the blanket and indiscriminate retention of fingerprints, cellular samples and DNA profiles of persons who had not been convicted violated Article 8 of the European Convention on Human Rights.

Relevance: The judgment supports scrutiny of the retention of sensitive biological information, including whether indefinite or indiscriminate storage is justified. Cognitive biomarker repositories may raise similar proportionality and privacy questions, although the judgment did not concern cognitive testing.

ECHR upholds racial profiling complaint against Switzerland - SWI swissinfo.ch

Bărbulescu v. Romania

Application no. 61496/08 · Judgment of 5 September 2017

The Court considered workplace monitoring and the protection of an employee's private life and correspondence under Article 8. Its reasoning highlighted the importance of notification, the extent of monitoring, legitimate reasons, less intrusive alternatives and safeguards against abuse.

HUDOC+1

Relevance: An employer introducing cognitive monitoring should not assume that ownership of the workplace or equipment eliminates employee privacy. Monitoring should have a legitimate basis and be limited to what is justified.

Oral hearing – a step towards respecting European values and protecting Ljubljanska Banka's rights | GOV.SI

López Ribalda and Others v. Spain

Applications nos. 1874/13 and 8567/13 · Judgment of 17 October 2019

The Court examined covert workplace video surveillance in the context of suspected theft. It assessed the justification and proportionality of monitoring, including its scope and the safeguards available.

Relevance: Even when an organisation has a legitimate operational concern, intrusive monitoring requires contextual scrutiny. The case does not establish a general right to conduct covert cognitive or neurological testing.

These authorities support a common proposition: sensitive information and intrusive monitoring require justification, safeguards and meaningful oversight. Their binding effect differs by jurisdiction; European Convention judgments and Indian constitutional judgments should not be treated as interchangeable sources of law.

5. Statutory framework in India

The proposed doctrine can be analysed through several existing Indian legal frameworks. The precise outcome depends on the purpose of the testing, the institution involved, the type of data and the law in force.

5.1 Constitution of India

Article 21 — Life and personal liberty

The right to privacy recognised in Puttaswamy provides a constitutional basis for challenging unjustified State collection or use of sensitive cognitive information.

Article 14 — Equality before the law

If a public authority uses cognitive biomarker scores to classify individuals, unexplained or arbitrary classifications may raise Article 14 concerns.

Article 19 — Fundamental freedoms

Depending on the facts, cognitive monitoring or profiling may also interfere with protected freedoms. A claimant must establish the relevant constitutional connection rather than assume that every biomarker use violates Article 19.

These constitutional protections are especially important when government agencies use cognitive testing for policing, public employment, education, security or access to public benefits.

5.2 Digital Personal Data Protection Act, 2023

India's Digital Personal Data Protection Act, 2023 establishes a framework for processing digital personal data. Its provisions address grounds for processing, notice, consent, obligations of data fiduciaries, individual rights and grievance redressal.

India Code+1

Relevant provisions include:

A cognitive biomarker linked to an identifiable person may fall within the Act's scope when processed digitally, subject to its application provisions and exceptions. The Act does not create a separate, comprehensive statutory category called “cognitive biomarkers.” Nor does every biomarker automatically qualify as a separately defined category of sensitive personal data under this Act.

For a real-world deployment, the applicable commencement notifications, rules and any relevant exemptions must also be checked.

5.3 Medical consent and professional responsibility

Where cognitive biomarkers are collected for diagnosis or treatment, medical consent principles, professional standards, applicable clinical rules and other relevant laws may apply.

Under Samira Kohli, consent for one medical procedure does not ordinarily authorise a substantially different procedure. Similarly, a cognitive biomarker programme should clearly distinguish between diagnostic testing, experimental research and secondary commercial use.

5.4 International data-protection framework

The European Union's General Data Protection Regulation (GDPR) provides a useful comparative model.

Article 5: Principles including purpose limitation, data minimisation, accuracy and storage limitation.

Article 6: Lawful bases for processing.

Article 9: Additional restrictions on specified special categories of personal data, including health data.

Article 22: Safeguards concerning certain solely automated decisions with legal or similarly significant effects.

Article 35: Data-protection impact assessments for processing likely to result in high risks.

Not every neurological measurement automatically falls within every special category under Article 9. Classification depends on the nature of the data and the processing involved. Similarly, Article 22 is not a universal prohibition on automated biomarker analysis.

Sage Journals+1

6. Governance duties under the proposed doctrine

A practical accountability framework should distribute responsibilities across the entire biomarker lifecycle.

Duty 1 — Lawful collection

Establish an appropriate legal basis, explain the purpose and obtain valid consent where required. Avoid collecting more information than necessary.

Duty 2 — Scientific validation

Test accuracy, reliability, reproducibility and limitations. Assess whether the model is appropriate for the intended population and decision.

Duty 3 — Security and confidentiality

Restrict access, secure storage and transfers, maintain appropriate retention periods and address unauthorised disclosure.

Duty 4 — Fairness and non-discrimination

Examine whether cognitive scores unfairly disadvantage people because of disability, medical conditions, demographic differences or measurement limitations.

Duty 5 — Review and remedies

Provide appropriate explanations, human review and routes to challenge significant decisions. Preserve records for audits and investigations.

These are proposed governance duties, not a claim that every item already exists as an independent statutory obligation in every jurisdiction.

7. Liability for misuse of cognitive biomarkers

Liability should be assessed according to the conduct, harm, applicable law and role of each actor.

An erroneous result does not automatically establish liability. A claimant may need to prove the relevant duty, breach, causation, harm and other elements required by the applicable legal regime.

For example, if an employer rejects an applicant because an unvalidated cognitive score supposedly predicts poor concentration, the relevant questions include whether the test was reliable, whether it was job-related, whether the process was discriminatory or otherwise unlawful, and whether the applicant had an effective opportunity to challenge the result.

8. Hypothetical case study

Consider a company that requires workers to wear EEG monitoring devices. An AI system estimates their concentration levels and produces a daily cognitive-performance score. Workers with low scores receive fewer shifts.

The following analysis illustrates how the proposed doctrine could operate.

Legality and purpose

The company must establish the applicable legal basis and explain why collecting neural information is necessary for the stated workplace purpose.

Consent and power imbalance

A signed consent form may not resolve every issue, particularly if workers face pressure to participate or cannot meaningfully refuse. Applicable law and the circumstances determine whether consent is valid or another legal basis is available.

Scientific evidence

The employer must not assume that an EEG-based concentration score accurately measures productivity or fitness for work. Validation for the actual setting is critical.

Fairness and proportionality

The company should consider whether less intrusive measures could achieve the same legitimate aim and whether the scoring system disadvantages particular workers.

Accountability and remedy

Workers should have appropriate access to information, a way to contest materially inaccurate results and human reconsideration of significant decisions where required.

In India, Puttaswamy could inform the constitutional analysis if the State were involved or the relevant constitutional conditions were satisfied. Data-protection and employment rules would require separate analysis. Bărbulescu and State v. Loomis could provide comparative guidance, but neither directly determines the legality of this hypothetical EEG programme.

9. Limitations and challenges

The doctrine faces several unresolved legal and technical difficulties.

First, uncertain scientific interpretation. Biomarkers may correlate with cognitive characteristics without reliably measuring an individual's abilities in every context.

Second, inferred information. A system can generate a cognitive prediction that the individual never supplied directly. Governance must consider both the source data and consequential inferences.

Third, fragmented legal regulation. Medical research, employment, consumer technology, criminal justice and public surveillance may be governed by different laws.

Fourth, consent limitations. Consent alone may not adequately protect people where bargaining power is unequal or where an inference has serious consequences.

Fifth, competing public interests. Clinical benefits, patient safety, legitimate research and operational needs may justify some forms of testing, but do not automatically justify every collection or use.

Sixth, the risk of excessive claims. Recognising the sensitivity of cognitive information does not mean every cognitive inference is accurate, every use requires identical safeguards, or every individual has an absolute veto over all processing.

10. Proposed judicial test for the doctrine

A court or regulator applying this proposed framework could examine seven questions:

Legal authority: Was the collection or use authorised by applicable law?

Legitimate purpose: Was there a sufficiently legitimate and clearly defined objective?

Necessity and proportionality: Was the data use necessary, and was a less intrusive alternative reasonably available?

Scientific reliability: Was the biomarker validated for the intended use, with its limitations properly considered?

Autonomy and transparency: Was consent required and valid, and was the individual adequately informed?

Fairness and accountability: Were discrimination risks assessed, responsibility assigned and appropriate human oversight provided?

Effective remedy: Could the individual challenge an inaccurate inference, unlawful processing or harmful decision?

This is a proposed analytical test, not an existing seven-part test formally adopted by a court.

11. Conclusion

The Cognitive Biomarker Accountability Governance Doctrine can be understood as a proposed framework that combines constitutional privacy, informed consent, scientific reliability, responsible data processing, non-discrimination and effective remedies.

The most significant supporting authorities include:

Justice K.S. Puttaswamy (Retd.) v. Union of India (2017) — privacy, dignity, autonomy and proportionality.

Samira Kohli v. Dr. Prabha Manchanda (2008) — informed consent and the limits of medical authorisation.

S. and Marper v. United Kingdom (2008) — retention of sensitive biological information.

Bărbulescu v. Romania (2017) — workplace privacy and monitoring safeguards.

López Ribalda and Others v. Spain (2019) — proportionality in workplace surveillance.

State v. Loomis (2016) — limitations and safeguards in algorithmic risk assessment.

These cases do not establish a single, freestanding doctrine specifically governing cognitive biomarkers. They provide distinct legal principles from which such a framework may be developed.

The core objective is to ensure that biological measurements and AI-generated cognitive inferences remain scientifically defensible, lawfully obtained, fairly used and open to meaningful scrutiny.

For further legal research, a useful next step would be to develop this framework into a jurisdiction-specific analysis of Indian constitutional law, data protection, medical consent and employment discrimination, with case citations and relevant statutory provisions.