Introduction
The Quality Healthcare and Patient Safety Bill, 2025 (the Bill) seeks to fundamentally reshape the governance of healthcare delivery in Kenya. Against a backdrop of rising patient complaints against medical malpractice and delayed resolution of medical negligence claims—some stretching nearly two decades—this Bill introduces institutional, legal, and regulatory innovations aimed at enhancing the enforcement of patient rights and health system accountability.
A striking example is the recent High Court decision awarding Kshs. 157 million to a woman who suffered permanent harm due to medical negligence. The matter was filed in 2006, with judgment delivered in 2025—a 18-year ordeal emblematic of the delays plaguing patient rights enforcement in Kenya. The Bill seeks to bridge this gap through more accessible, pro-active and responsive mechanisms.
1. Who Is Affected?
The Bill has far-reaching implications across Kenya’s healthcare ecosystem:
- Healthcare Providers – Doctors, nurses, and pharmacists face greater accountability, mandatory adherence to standards, and risk of disciplinary action for rights violations or negligence.
- Hospitals, medical centres and clinics – Must implement internal complaint systems, undergo regular audits by the Authority, and ensure compliance or risk suspension and sanctions.
- Patients – Gain stronger rights enforcement, direct access to redress via the new Tribunal, and assurance of safer, quality-driven healthcare.
- Risk & Compliance Officers – Required to develop systems for legal compliance, documentation, and staff training to manage regulatory exposure.
- Insurers – May face increased medical liability claims, requiring reassessment of coverage models and pricing.
- Regulators – Need to coordinate with the new Authority to harmonize oversight functions and minimize duplication.
2. Establishing the Quality Healthcare and Patient Safety Authority
The Bill provides for the establishment of the Quality Healthcare and Patient Safety Authority, a statutory body responsible for:
- Developing and enforcing healthcare quality and patient safety standards;
- Accrediting health facilities;
- Investigating adverse medical events and patient complaints;
- Issuing directives, notices, and public health safety alerts.
The Authority will play a preventive and oversight role, designed to identify risks early and support health facilities in implementing corrective actions.
3. Enforcement Through a Specialized Tribunal
A key feature of the Bill is the creation of the Quality Healthcare and Patient Safety Tribunal, an independent body with quasi-judicial powers to:
- Hear complaints related to violations of patient rights;
- Investigate instances of unsafe or substandard care;
- Make binding orders, including compensation, injunctions, and disciplinary sanctions.
This framework is meant to introduce a faster, more accessible dispute resolution process than the traditional court-based litigation. It is hoped that this will reduce the time and cost of pursuing claims, benefiting both patients and providers.
4. Codification of Patient Rights and Provider Duties
The Bill affirms and expands the Patient Rights Charter, including:
- The right to dignity, informed consent, and privacy;
- The right to participate in healthcare decisions;
- The right to lodge complaints and seek redress;
- The right to emergency medical treatment.
At the same time, healthcare providers are mandated to:
- Uphold standards of professional care;
- Maintain accurate records and ensure continuity of care;
- Maintain adequate professional indemnity covers;
- Establish standardized internal complaints reporting and quality assurance mechanisms.
Facilities will be required to embed these rights in their day-to-day protocols, training, and communication practices.
5. Risk and Compliance Considerations for Healthcare Providers and Facilities
With the enactment of this Bill, healthcare providers must adopt a compliance-focused culture aligned with risk management and patient safety. Key considerations include:
✅ Governance and Internal Structures:
- Establish internal Quality and Safety Committees;
- Designate a compliance officer or risk lead;
- Implement regular audits and risk assessments.
✅ Patient Consent and Documentation:
- Review consent protocols to ensure they meet the legal thresholds of being informed, voluntary, and recorded;
- Maintain clear, contemporaneous medical records that can serve as evidence in regulatory proceedings.
✅ Complaint Handling and Redress Mechanisms:
- Develop formal patient grievance procedures, dispute resolution mechanisms and feedback loops, consistent with standards to be developed by the Autthority ;
- Train frontline staff in patient rights and how to respond to complaints lawfully.
✅ Emergency Preparedness and Safety Protocols:
- Ensure facilities are compliant with minimum emergency care standards;
- Report adverse events to the Authority as required.
✅ Training and Legal Awareness:
- Conduct regular legal compliance and ethics training;
- Ensure clinical and administrative staff understand their obligations under the new framework.
Failure to proactively engage with these risk areas could expose facilities to fines up to KES 50 million, imprisonment for up to 10 years, and potential civil liability before the Tribunal or in Court.
6. Public Policy Implications
The Bill attempts to respond to a growing public concern: delayed justice and fragmented accountability in Kenya’s health sector. By providing alternative dispute resolution pathways and stronger enforcement institutions, it seeks to rebalance the relationship between patients and providers.
However, its success will depend on:
- Adequate funding and staffing of the Authority and Tribunal;
- Coordination with existing regulatory bodies (e.g., the Kenya Medical Practitioners and Dentists Council, the );
- Political and professional buy-in from both public and private sector providers.
It also raises critical questions about the scope of liability, the balance between learning and punishment, and how best to support providers in delivering safer care without creating a climate of fear.
Conclusion
The Quality Healthcare and Patient Safety Bill, 2025 marks a bold legislative step toward improving patient care and systemic accountability. Healthcare providers, hospitals, and policymakers must begin preparing for a compliance-focused healthcare environment, one that centres patient safety while protecting clinical autonomy and quality improvement.
Legal teams should review internal policies, consent processes, and documentation practices in light of the proposed changes, and monitor developments as the Bill progresses through public participation and potential enactment.
For more updates regarding this Bill and more, reach out to Patrick Kimani via pkimani@andegogachagua.com