1. Introduction

The Continuous Biomarker Accountability Doctrine is a proposed legal and regulatory framework under which healthcare institutions, pharmaceutical companies, biotechnology enterprises, clinical laboratories, medical-device manufacturers and healthcare professionals remain legally accountable for the continuous monitoring, interpretation, storage, disclosure and use of biomarker information throughout a person's healthcare journey.

Biomarkers are measurable biological indicators that provide information about normal biological processes, disease conditions, pathological developments or responses to medical interventions.

Examples include:

Blood glucose and HbA1c levels.

Cardiac troponin and other cardiac biomarkers.

Cancer biomarkers and circulating tumour DNA.

Genetic and genomic indicators.

Inflammatory markers such as CRP.

Hormonal and neurological biomarkers.

Digital biomarkers generated through wearable medical devices.

The central proposition of this doctrine is that biomarker accountability does not end when a test is performed or a laboratory report is delivered. It continues wherever a healthcare institution or other responsible entity has an ongoing legal duty to monitor, interpret, communicate or act upon clinically significant biomarker information.

The doctrine is particularly relevant to precision medicine, artificial intelligence-assisted diagnosis, predictive healthcare, continuous glucose monitoring, personalised cancer treatment and longitudinal clinical trials.

Legal status: This is a proposed analytical doctrine, not a universally recognised or independently codified legal doctrine. Its foundations can be developed from existing principles of medical negligence, informed consent, data protection, product liability, clinical-trial regulation and constitutional rights.

2. Meaning and conceptual foundations

The doctrine rests on five fundamental propositions:

Continuity: Biomarker-related responsibilities continue over time where an ongoing duty exists.

Traceability: Every clinically significant biomarker measurement should have an identifiable source, time, methodology and responsible institution.

Interpretability: Institutions must take reasonable steps to ensure that biomarker results are interpreted in their appropriate clinical context.

Responsiveness: Significant abnormalities must be communicated and acted upon within clinically appropriate timeframes.

Accountability: Negligence, manipulation, concealment, improper disclosure or failure to respond may attract appropriate legal consequences.

For example, if a hospital continuously monitors a cancer patient's biomarkers and its monitoring system repeatedly identifies a clinically significant abnormality, the hospital may face liability if it negligently fails to communicate the finding or arrange appropriate clinical review.

However, liability depends on the applicable standard of care, the scope of the institution's responsibility, causation and the circumstances of the case. Continuous measurement does not automatically create an unlimited duty to intervene.

3. Essential elements of the doctrine

A. Continuous monitoring accountability

Healthcare providers must establish appropriate procedures for monitoring biomarkers when continuous or repeated monitoring forms part of the agreed treatment or clinical protocol.

Legal responsibilities may include:

Maintaining reliable monitoring systems.

Identifying clinically significant changes.

Establishing alert thresholds.

Preventing avoidable monitoring interruptions.

Documenting abnormal findings.

Ensuring appropriate clinical escalation.

A failure to detect an abnormality may constitute negligence where reasonable monitoring would have identified it.

B. Biomarker interpretation accountability

A biomarker result cannot always be interpreted in isolation.

Its significance may depend on age, medical history, medication, underlying conditions, laboratory methodology and changes over time.

Accordingly, healthcare professionals must exercise appropriate clinical judgment rather than mechanically relying upon numerical outputs or automated predictions.

C. Disclosure and communication accountability

Patients should receive material information about their biomarker results when disclosure is required by the applicable legal and professional standards.

Particular attention should be given to:

Unexpected abnormal findings.

Clinically significant deterioration.

Findings requiring additional investigations.

Results indicating possible treatment failure.

Relevant incidental findings.

Changes that may affect future treatment decisions.

Failure to communicate important findings may create liability if the applicable duty and causation requirements are established.

D. Data integrity and traceability

Every biomarker record should, where reasonably practicable, preserve:

Date and time of collection.

Identity of the testing laboratory.

Testing methodology.

Instrument calibration information.

Reference ranges.

Relevant quality-control information.

Corrections and changes to records.

Identity of persons accessing or modifying the information.

This is especially important when biomarker information is used in litigation, clinical trials, regulatory investigations or pharmaceutical safety assessments.

E. Long-term accountability

Biomarker monitoring may extend across multiple institutions and treatment stages.

For example, a patient may move from a diagnostic laboratory to a specialist hospital, then to a clinical trial and subsequently to long-term follow-up.

The doctrine therefore raises questions concerning continuity of records, transfer of responsibility, communication of abnormal findings and preservation of patient rights.

4. Indian legal framework

The doctrine can be developed through several existing legal provisions.

Constitutional dimensions

Article 21 – Right to life and personal liberty

Article 21 provides the constitutional foundation for protecting patient dignity, bodily integrity, privacy and access to appropriate medical care.

Where continuous biomarker monitoring is part of an accepted treatment arrangement, an unjustified failure to address serious abnormalities may raise questions concerning the protection of life and bodily integrity.

Article 14 – Equality and non-arbitrariness

Healthcare institutions should not apply discriminatory or arbitrary biomarker-based classifications.

For instance, an automated risk-scoring system should not deny patients access to treatment through unexplained or irrational classifications.

Article 47 – Public health

The constitutional obligation to improve public health supports appropriate regulatory supervision of diagnostic laboratories, biotechnology facilities and healthcare-monitoring systems.

5. Important case laws and judicial principles

The following judgments do not formally establish a doctrine bearing this name. They provide the legal principles from which Continuous Biomarker Accountability can be constructed.

A. Indian Supreme Court judgments

1. Jacob Mathew v. State of Punjab (2005) 6 SCC 1

Foundational negligence authority

The Supreme Court examined the standard for establishing criminal medical negligence.

Legal principles:

Medical negligence must be assessed against the standard of a reasonably competent medical professional.

A mere error of judgment does not automatically constitute negligence.

Criminal liability requires a substantially higher degree of negligence than ordinary civil liability.

Application to biomarkers:

If a physician negligently ignores repeated, clinically significant biomarker abnormalities despite having a duty and reasonable opportunity to respond, the conduct may constitute medical negligence.

However, criminal liability would require satisfaction of the applicable criminal-negligence threshold.

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

Patient autonomy and informed consent

The Supreme Court emphasised that medical consent must be voluntary, valid and based on adequate information.

The judgment distinguishes consent for diagnostic procedures from consent for additional therapeutic interventions.

Application to biomarkers:

Patients should receive appropriate information concerning:

The purpose of repeated biomarker testing.

The medical significance of relevant findings.

Material risks associated with testing.

The intended use of biomarker information.

Relevant treatment alternatives.

Any significant additional use of collected biological material.

A patient's consent to a diagnostic test should not automatically be treated as unrestricted permission for unrelated genetic research or commercial exploitation of biological information.

VoxJuris+1

3. Kusum Sharma v. Batra Hospital and Medical Research Centre (2010) 3 SCC 480

The Supreme Court discussed the principles governing medical negligence and the importance of evaluating professional conduct in light of accepted medical standards.

Application:

A laboratory or physician should not be held automatically liable merely because a biomarker result was inaccurate or a treatment outcome was unsuccessful.

The court must examine whether reasonable professional care, appropriate testing methodology and accepted clinical standards were followed.

4. Justice K.S. Puttaswamy v. Union of India (2017) 10 SCC 1

Biomarker privacy authority

The Supreme Court recognised privacy as a fundamental right under Article 21 and Part III of the Constitution.

The judgment is especially important for sensitive biological and genomic information.

Application:

Continuous biomarker monitoring may generate highly personal information about:

Disease susceptibility.

Reproductive health.

Genetic characteristics.

Mental and physical health.

Future disease risks.

Collection, retention, processing and disclosure must therefore be examined through the constitutional principles of legality, legitimate purpose and proportionality where applicable.

5. Dr. Balram Prasad v. Dr. Kunal Saha (2014) 1 SCC 384

The Supreme Court considered medical negligence and compensation in the context of serious deficiencies in medical treatment.

Application:

Where failures in diagnostic evaluation, clinical supervision or treatment decisions cause demonstrable harm, the responsible healthcare providers may be liable under applicable negligence principles.

A biomarker-monitoring failure could be analysed through similar principles, subject to proof of duty, breach, causation and damage.

6. Yash Charitable Trust v. Union of India (2026)

This judgment is relevant to emerging biotechnology governance and the regulation of unproven treatments.

The Supreme Court's discussion of informed consent reinforces the importance of adequate information, scientific validity and protection against therapeutic misconceptions.

Application:

Biomarker-based predictions should not be represented as scientifically established medical outcomes when their predictive validity remains uncertain.

Likewise, patients should not be induced to undergo experimental biomarker-driven interventions through misleading claims about their effectiveness.

Sci API+1

B. Comparative international judgments

7. Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582

The English court developed the traditional professional-standard approach to medical negligence.

Application: The appropriateness of biomarker interpretation and monitoring can be evaluated against responsible and recognised professional medical practice, subject to subsequent developments in negligence law.

8. Montgomery v. Lanarkshire Health Board [2015] UKSC 11

The UK Supreme Court emphasised the duty to disclose material risks and reasonable alternatives in medical treatment.

Application: Clinicians should communicate material risks associated with biomarker-guided treatment where those risks are relevant to a patient's decision.

9. S. and Marper v. United Kingdom (2008) 48 EHRR 50

The European Court of Human Rights considered the retention of DNA samples and profiles by public authorities.

The Court recognised the particularly sensitive nature of genetic information and the privacy implications of retaining biological samples.

Application: Biomarker accountability must include safeguards against unnecessary retention, excessive access and unauthorised secondary use of biological information.

Bailii+1

10. Bolitho v. City and Hackney Health Authority [1998] AC 232

The House of Lords clarified that professional medical opinion must be capable of withstanding logical analysis.

Application: A hospital cannot necessarily defend an unreasonable biomarker-monitoring protocol merely by asserting that a group of professionals follows that practice. The reasoning underlying the practice must also be defensible.

6. Accountability of different stakeholders

The doctrine distributes responsibilities according to each stakeholder's role.

An important distinction is that responsibility should follow actual control, undertaking and applicable statutory duties. A software developer, for example, is not automatically responsible for every subsequent clinical decision made using its system.

7. Continuous Biomarker Accountability in clinical trials

Clinical trials are particularly important because biomarkers are frequently used to measure treatment response and predict safety outcomes.

The doctrine may require the following safeguards:

A. Baseline accountability

Researchers should establish baseline biomarker values before beginning the relevant intervention.

B. Periodic assessment

The clinical protocol should specify appropriate testing intervals and scientifically justified thresholds.

C. Adverse-event escalation

Potentially serious biomarker abnormalities should be evaluated and escalated under the approved safety protocol.

D. Independent review

Where scientifically and ethically appropriate, independent safety-monitoring mechanisms should review significant findings.

E. Participant communication

Relevant information should be communicated to participants in accordance with the consent process and applicable clinical-trial requirements.

F. Post-trial continuity

Where follow-up monitoring is required, responsibility for continuing care, communication and record preservation should be clearly allocated.

The New Drugs and Clinical Trials Rules, 2019, provide an important Indian regulatory foundation for participant safety, ethics oversight and compensation.

8. Artificial intelligence and automated biomarker accountability

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AI systems increasingly analyse biomarker information to predict disease progression, identify abnormalities and recommend personalised interventions.

This creates several legal problems.

A. Algorithmic error

An AI model may incorrectly classify a biomarker as normal or abnormal.

B. Algorithmic opacity

Patients and clinicians may be unable to understand the reasoning behind a predictive output.

C. Automation bias

Medical professionals may rely excessively on algorithmic recommendations without independent clinical assessment.

D. Model deterioration

An algorithm that performed accurately during initial validation may become less reliable when used with different patient populations, laboratory equipment or clinical environments.

E. Allocation of liability

Legal responsibility may involve multiple parties, including the manufacturer, software developer, hospital, laboratory and treating clinician.

The doctrine therefore proposes maintaining auditable records of algorithm versions, validation results, significant updates, alerts and human clinical decisions.

9. Remedies for violations

Depending on the nature of the violation and applicable law, possible remedies include:

Civil compensation: For demonstrable injury caused by negligence.

Consumer remedies: For deficiency in covered medical services.

Professional disciplinary action: For professional misconduct.

Regulatory enforcement: For breaches of applicable clinical-trial, laboratory or medical-device requirements.

Data protection remedies: For unlawful processing or breaches of applicable data-protection obligations.

Constitutional remedies: Where unlawful state action violates fundamental rights.

Criminal proceedings: Where the facts satisfy the elements of an applicable criminal offence.

A claimant would ordinarily need to establish the relevant duty, breach, causation and legally recognised harm. A biomarker abnormality alone does not prove negligence.

10. Proposed judicial test for applying the doctrine

A court examining a claim under the proposed Continuous Biomarker Accountability Doctrine could apply the following seven-stage test:

This framework should be applied flexibly. Not every biomarker requires continuous monitoring, and not every abnormal result requires immediate intervention.

11. Critical legal challenges

The doctrine also raises difficult questions:

Scientific uncertainty: Biomarkers may have imperfect sensitivity, specificity and predictive value.

False positives: Excessive monitoring may result in unnecessary investigations and treatment.

False negatives: Apparently normal results may create misleading reassurance.

Data ownership: Questions arise concerning control over biological samples, derived data and research databases.

Patient autonomy: Patients may refuse repeated testing or certain forms of monitoring.

Institutional fragmentation: Different healthcare providers may share responsibility without clearly defining their respective duties.

Over-monitoring: Continuous surveillance may become disproportionate and interfere with privacy.

Long-term liability: It may be difficult to identify which institution was responsible when a biomarker abnormality was missed over several years.

These challenges demonstrate why accountability must be proportionate to clinical responsibility, scientific reliability and legal authority.

12. Recommendations for legislative development in India

India could strengthen biomarker governance through a dedicated regulatory framework containing:

Mandatory quality standards for laboratories conducting clinically significant biomarker testing.

Standardised reporting and traceability requirements.

Clear clinical escalation protocols for critical results.

Appropriate informed-consent requirements for secondary biomarker use.

Privacy safeguards for genomic and longitudinal health information.

Independent audits of AI-based biomarker systems.

Defined responsibilities between hospitals, laboratories and technology providers.

Appropriate patient access to biomarker records and correction mechanisms.

Post-market surveillance of relevant diagnostic devices.

Effective grievance redressal and compensation mechanisms.

13. Conclusion

The Continuous Biomarker Accountability Doctrine represents a proposed evolution in medical and biotechnology law from isolated diagnostic responsibility towards continuing, traceable and scientifically justified accountability.

Its central contribution is the recognition that biomarker information has legal significance beyond the moment of testing. Where an institution undertakes continuing monitoring or assumes responsibility for interpreting and communicating results, its obligations may continue throughout the relevant period of care.

The principles developed in Jacob Mathew, Samira Kohli, Puttaswamy, S. and Marper and other medical negligence and privacy judgments provide a foundation for developing this framework.

Ultimately, the doctrine seeks to establish a balance between scientific innovation, patient autonomy, institutional responsibility, medical safety and protection of biological information.

14. Suggested academic proposition

A suitable formulation for a doctoral-level legal research paper would be:

The Continuous Biomarker Accountability Doctrine establishes a normative framework of longitudinal responsibility in which healthcare institutions, medical professionals, biotechnology enterprises and digital health-system operators remain accountable for the scientifically reasonable monitoring, interpretation, preservation, communication and lawful utilisation of biomarker information throughout the lifecycle of a relevant medical undertaking.

Research significance: The doctrine could form the basis of a separate research chapter examining the intersection of medical negligence, precision medicine, constitutional privacy, artificial intelligence and biotechnology regulation.

Which direction should the next research expansion take?

Constitutional and Fundamental Rights AI and Biotechnology Regulation Comparative International Law