Impact Of The New Quality Healthcare And Patient Safety Bill, 2025 On Kenya’s Healthcare System

Executive Summary

The Quality Healthcare and Patient Safety Bill, 2025, is a transformative step by the Government of Kenya to ensure all citizens receive safe, dignified, and high-standard healthcare. As part of the Universal Health Coverage (UHC) initiative, the Bill introduces mandatory accreditation, a unified dispute resolution tribunal, and a rigorous compliance framework for all health facilities. It shifts both public and private healthcare delivery towards quality-driven and transparent systems, with significant legal and financial implications for non-compliant providers. Importantly, it establishes a clear link between compliance and access to government funding, notably through the Social Health Insurance Fund (SHIF).

Overview of the Bill

The Quality Healthcare and Patient Safety Bill, 2025, aims to elevate the standards of healthcare across Kenya by implementing a comprehensive regulatory framework that prioritizes quality, safety, accountability, and justice. It is grounded in Article 43(1)(a) of the Constitution, which guarantees the right to the highest attainable standard of health. Key components of the Bill include:

• Mandatory accreditation for all healthcare facilities
• A structured evaluation and licensing process
• A new Healthcare Tribunal to address disputes
• Penalties for non-compliance and illegal operations

Key Implications for Health Insurance Providers

The Bill significantly reshapes the insurance landscape by linking healthcare facility accreditation to insurance eligibility, particularly for government-funded programs such as SHIF.

Key changes include:

• Access to SHIF: Only facilities with valid accreditation will be allowed to treat SHIF beneficiaries and claim reimbursements.
• Provider Networks: Insurers will be required to align their panels with accredited facilities, pushing them to review and restructure their existing networks.
• Transparency and Risk Reduction: A standardized compliance framework ensures consistent service quality, helping insurers mitigate risk and reduce fraudulent or inconsistent claims.
• Product Innovation: The Bill enables risk-based pricing and value-based insurance models where premiums and payouts are tied to facility quality and patient outcomes.
• Collaboration: Insurers may need to partner with providers on claims digitization, real-time data sharing, and joint quality monitoring systems to stay compliant and competitive.

Overall, the Bill pushes insurers toward a tech-enabled, quality-driven, and more accountable model of healthcare financing.

Other Key Provisions

• Public-Private Collaboration: The Bill formalizes partnerships by requiring facilities to meet national quality benchmarks before accessing government contracts like SHIF, moving away from informal or politically driven arrangements.
• Accreditation and Oversight: A new authority, Quality Healthcare and Patient Safety Authority, will evaluate health facilities based on safety and clinical effectiveness, infrastructure, staffing, and patient rights protection. Facilities will be reviewed regularly and may face audits or penalties for non-compliance.
• Mandatory Licensing: All facilities must undergo a three-stage process: Pre-approval, registration and annual licensing, to operate legally.
• Penalties: Non-compliance could lead to fines (up to KSh 50 million), imprisonment (up to 10 years), license revocation, and civil liability for patient harm.
• Cost of Compliance: Facilities must invest in infrastructure, staffing, reporting systems and quality management, without any guarantee of government subsidies, though private-sector financing options are encouraged.

Conclusion

The Quality Healthcare and Patient Safety Bill, 2025, will significantly restructure Kenya’s healthcare system by enforcing uniform standards across all health facilities. Through a mix of strict regulation, enforced accreditation, and digital oversight, the Bill seeks to improve patient safety, service quality, and access to justice. While it introduces financial and legal pressure on providers, it opens up pathways for better public-private collaboration, improved insurance models, and a higher standard of care. The implementation of this Bill marks a major step forward in achieving Universal Health Coverage in Kenya and aligns national healthcare delivery with constitutional guarantees and international health standards.