I was invited by KTN TV to discuss the medico-legal status of misdiagnosis. The producer asked us to discuss what happens in law when there is a misdiagnosis and whether the public is misinformed when interpreting adverse health outcomes. Find my preparation notes.
1. A correct diagnosis depends on a functioning health system
The starting point is the purpose of medicine: to provide the highest attainable quality of healthcare. Every doctor aims to make the correct diagnosis, offer appropriate treatment, relieve suffering and, where possible, restore health. But healthcare is not delivered by a doctor in isolation.
The World Health Organization traditionally describes six health-system building blocks: service delivery; health workforce; health information systems; medical products, vaccines and technologies; health financing; and leadership and governance. All six must work together to deliver safe, effective and high-quality healthcare.
A highly competent clinician can still be constrained by a non-functioning laboratory, unavailable medicines, delayed imaging, inadequate staffing, dysfunctional referral systems, failed information systems or insufficient financing. Therefore, after an adverse outcome, the better patient-safety question is not simply “What did the doctor do wrong?” but “What happened to this patient, why did it happen, and how can recurrence be prevented?”
2. Misdiagnosis is real — but not every bad outcome is misdiagnosis
Diagnostic error is a genuine patient-safety problem. WHO describes diagnostic error broadly to include diagnoses that are incorrect, delayed, missed or not properly communicated. Diagnosis is an iterative process involving history, examination, testing, interpretation, communication, treatment, follow-up and reassessment.
However, a bad outcome is not automatically evidence of a wrong diagnosis, and a wrong diagnosis is not automatically evidence of negligence. Medicine deals with probability, uncertainty and biological variation. Diseases evolve, tests can yield false-positive or false-negative results, and recognised complications can occur despite appropriate care.
The central medicolegal question is therefore whether the diagnostic and treatment process was reasonable and whether the accepted standard of care was followed in the circumstances.
3. Misdiagnosis or misinformed?
When a patient dies, develops disability, loses a pregnancy, suffers a surgical complication or fails to recover as expected, it is natural to seek an explanation and sometimes a person to blame. The doctor is usually the most visible person.
But the laboratory failure may be invisible. The broken machine is invisible. The medicine shortage, delayed referral, staffing deficit, financing failure and governance decisions may all be invisible to the patient.
Sometimes the doctor may indeed have made an error. Sometimes there was a wider system failure. And sometimes there was no preventable error at all: a known complication occurred despite correct diagnosis and appropriate care.
It is therefore essential to distinguish an adverse outcome, a medical error, a diagnostic error and medical negligence. They are not synonyms.
4. The standard of care and peer review
Medicine cannot guarantee a particular outcome. Healthcare professionals are expected to provide competent care, exercise appropriate clinical judgment, communicate adequately, obtain informed consent and practise within accepted professional standards and the circumstances in which care is delivered.
This is why independent professional or peer review is important. Emotion alone cannot determine negligence, and neither can a practitioner simply declare that everything was done correctly. Medical records, clinical circumstances, available resources and accepted professional standards must be objectively examined.
5. Kenya’s legal and regulatory framework
The Constitution of Kenya places healthcare firmly within a human-rights framework. Article 43(1)(a) guarantees every person the right to the highest attainable standard of health, including healthcare services and reproductive healthcare. Article 43(2) states that a person shall not be denied emergency medical treatment.
Other relevant constitutional protections include Article 53(1)(c) on children’s healthcare; Article 54 on persons with disabilities; Article 56(e) on reasonable access to health services for minorities and marginalised groups; and Article 57(d) on care and assistance for older persons.
The Kenya Medical Practitioners and Dentists Council (KMPDC) is established under Section 3 of the Medical Practitioners and Dentists Act (Cap. 253). It regulates medical and dental practice and health institutions and provides a formal complaints and disciplinary mechanism through which concerns about professional standards can be examined.
Patients must be able to question care, obtain information, seek a second opinion and lodge complaints. At the same time, healthcare professionals should not be convicted in the court of public opinion merely because an adverse outcome occurred. There must be a fair, evidence-based process.
It is also important to distinguish professional discipline from civil compensation. KMPDC’s disciplinary process addresses professional standards; claims for civil damages are pursued through the courts.
6. Patient rights and communication
One of the strongest protections against medicolegal conflict is good communication. Patients should understand the working diagnosis, the degree of certainty, investigations required, proposed treatment, important benefits and risks, alternatives, warning symptoms and circumstances requiring reassessment.A clinician should be comfortable saying: “This is our working diagnosis based on the information available today. If your condition evolves or you do not improve, we may need to reconsider it.” That is not weakness; it is good medicine and honest communication.
7. Healthcare is a shared ecosystem
A patient enters an ecosystem involving clinicians, nurses, laboratories, imaging, pharmacy, blood services, equipment, referral systems, health information, financing, facility management and government policy. Failure anywhere along this chain can affect the outcome.
WHO patient-safety thinking recognises both system factors and cognitive factors in diagnostic errors. A mature safety system therefore asks not only “Who made the error?” but also “What conditions allowed this error to occur, and how do we prevent the next patient from suffering the same harm?”
8. Social determinants of health
The environment outside the hospital also affects outcomes. Economic stability, education, healthcare access and quality, neighbourhood and built environment, and social and community context influence health.
A patient who cannot afford investigations, lacks transport, arrives after a prolonged referral delay or has limited access to specialist services presents a different clinical challenge from one with immediate access to comprehensive care. Recognising these determinants does not remove professional accountability; it makes accountability sufficiently intelligent to examine the entire causal pathway.
9. The paradox of medicolegal compensation
A patient who suffers catastrophic harm may genuinely require rehabilitation, lifelong treatment, assistive devices or income support. Society therefore has a legitimate obligation to ask how such patients should be supported.
At the same time, turning every adverse outcome into a negligence lawsuit can encourage defensive medicine, unnecessary investigations, avoidance of high-risk patients and excessive referral. The challenge is to compensate genuine injury while preserving fair professional accountability and protecting healthcare workers from unjust blame.
10. What Kenya can learn from New Zealand
New Zealand provides an important model through its government-run no-fault accident compensation system administered by the Accident Compensation Corporation (ACC). Treatment injuries that qualify can receive statutory support without requiring the patient first to prove that a doctor was negligent. For covered personal injuries, the law generally limits separate proceedings for compensatory damages arising from that injury.
Professional accountability remains separate. The Health and Disability Commissioner (HDC) protects patient rights, including appropriate standards, effective communication, information, informed choice and consent, and the right to complain. Serious professional matters can proceed through regulatory and disciplinary mechanisms.
The key lesson is that no-fault compensation does not mean no accountability. It separates two questions: How do we support the injured patient? And separately, was there a breach of professional standards?
11. Could Kenya consider a similar model?
Kenya should have a national discussion about a patient-injury compensation mechanism that can provide timely support for qualifying treatment-related injuries without forcing every injured patient into years of adversarial litigation.
A well-designed model could compensate deserving patients more quickly, reduce prolonged litigation and defensive medicine, encourage disclosure and reporting of adverse events, identify recurring system failures and strengthen patient safety. Disciplinary action would remain available where professional standards were genuinely breached.
The objective is not to protect negligent doctors. It is to protect patients while creating a fair, accountable and learning-oriented healthcare system.
12. The letter of the law and the spirit of the law
The letter of the law establishes rights, duties, standards, complaints mechanisms and remedies. The spirit of the law should ask what kind of healthcare system we want.
We should not create a culture in which clinicians hide mistakes because they fear litigation, patients spend years in court before receiving assistance, or every adverse outcome is automatically interpreted as negligence.
Patient safety and doctor protection are not opposing objectives. A fair system protects the patient from negligent practice, protects the competent practitioner from unjust blame, holds the wider health system accountable, and uses adverse events to make care safer for the next patient.
Short messages
• A bad outcome is not automatically a misdiagnosis, and a misdiagnosis is not automatically negligence.
• The question should not simply be, ‘Who is to blame?’ The better question is, ‘What happened, why did it happen, and how do we prevent it happening again?’
• A doctor does not work in isolation. Behind every diagnosis is a health system — laboratories, medicines, equipment, nurses, financing, information systems and governance.
• The doctor is often the most visible person when something goes wrong, but the cause of the failure may be much deeper in the health system.
• Medicine cannot guarantee outcomes. What it must guarantee is competent care, proper communication and adherence to accepted standards.
• Patients have a right to complain. Doctors have a right to a fair, evidence-based professional review.
• An adverse outcome, a medical error and medical negligence are different things
• The best medicolegal system should compensate genuine injury without requiring us to manufacture blame.
• No-fault compensation does not mean no accountability.
• Kenya should consider separating compensation from professional discipline.
• Patient safety and protection of healthcare workers are not competing interests. A fair system should achieve both.
• The safest healthcare system is one that identifies errors, learns from them and prevents recurrence.
SUMMARY
The medicolegal debate should move beyond the simplistic question of whether a doctor “misdiagnosed” a patient. Diagnosis occurs within a complex healthcare ecosystem, and WHO’s six health-system building blocks all influence quality and safety.
Diagnostic errors occur and must be taken seriously. Patients need information, complaints mechanisms, independent professional review and, where appropriate, compensation. But an adverse outcome does not by itself prove negligence.
Kenya already has constitutional and regulatory protections, including Article 43 of the Constitution and KMPDC’s complaints and disciplinary framework. A further national discussion is needed on how patients who suffer genuine treatment-related injuries can receive timely support without prolonged adversarial litigation being the primary route to compensation.
The New Zealand model demonstrates an important principle: compensation for injury can be separated from professional accountability.
– JUSTICE FOR THE PATIENT.
– FAIRNESS FOR THE HEALTHCARE PROFESSIONAL.
– ACCOUNTABILITY FOR THE HEALTH SYSTEM.
– LEARNING THAT MAKES THE NEXT PATIENT SAFER.
Key primary references
• World Health Organization — World Patient Safety Day 2024: Improving diagnosis for patient safety.
• World Health Organization — Everybody’s Business: Strengthening Health Systems to Improve Health Outcomes (WHO’s Action Framework).
• Constitution of Kenya, 2010 — especially Articles 43, 53, 54, 56 and 57.
• Medical Practitioners and Dentists Act (Cap. 253), Laws of Kenya, and KMPDC disciplinary framework.
• New Zealand Accident Compensation Act 2001 and Accident Compensation Corporation guidance on treatment injury.
• New Zealand Health and Disability Commissioner — Code of Health and Disability Services Consumers’ Rights.
• CDC — Social Determinants of Health framework.
Dr Simon Kigondu is a gynaecologist and a commentator on health policy in Kenya