The Quality Healthcare and Patient Safety Bill, 2025

Background

The Quality Healthcare and Patient Safety Bill, 2025, sponsored by Kimani Ichung'wah, seeks to give effect to Article 43(1)(a) of the Constitution of Kenya, which guarantees the right to the highest attainable standard of health. The Bill establishes a unified regulatory structure to enforce strict clinical standards, coordinate quality assurance between national and county governments, and protect patients from clinical malpractices and unsafe medical environments.

Key Amendments

The Bill introduces extensive consequential amendments under its Second Schedule to align Kenya's healthcare statutes with the new quality and safety standards. This ensures structural integration by amending the following Acts:

• Health Act (Cap. 241): Aligns definitions of healthcare services and coordinates complaint-handling with the new Authority.
• Public Health Act (Cap. 242): Repeals Section 153 to prevent regulatory overlap.
• Pharmacy and Poisons Act (Cap. 244): Replaces references to the 'Supreme Court' with the new Health Care Tribunal.
• Mental Health Act (Cap. 248): Standardizes definitions of mental health facilities.
• Medical Practitioners and Dentists Act (Cap. 253): Updates professional liability cover mandates and disciplinary appeal pathways.
• Social Health Insurance Act (No. 16 of 2023): Repeals Part VIII and transitions its dispute functions to the new Health Care Tribunal.
• Professional Registry Acts: Consequential amendments are also made to the following Acts to harmonize licensing, registration, and disciplinary pathways with the new Tribunal and quality requirements:
  • Medical Laboratory Technicians and Technologists Act (Cap. 253A)
  • Nutritionists and Dieticians Act (Cap. 253B)
  • Counsellors and Psychologists Act (Cap. 253C)
  • Physiotherapists Act (Cap. 253D)
  • Clinical Officers (Training, Registration and Licensing) Act (Cap. 253E)
  • Radiographers Act (Cap. 253F)
  • Public Health Officers (Training, Registration and Licensing) Act (Cap. 253G)
  • Occupational Therapists (Training, Registration and Licensing) Act (Cap. 253H)
  • Nurses and Midwives Act (Cap. 257)
  • Health Records and Information Managers Act (Cap. 539)

New Obligations

• Licensing Requirements: Any individual or entity constructing or operating a health facility, ambulance, or medical camp must seek prior approval (Section 42), register the facility (Section 43), and acquire an annual licence expiring on the 31st of December each year (Section 51).
• Continuous Quality Audits: Every health facility must audit its clinical safety annually and submit a report to the Authority (Section 21(2)). Healthcare providers must report adverse events and near-misses through a standardized, anonymous reporting template (Section 21(5)).
• Professional Indemnity: Health facilities must maintain a valid professional indemnity cover to protect patients against professional negligence, acts, or omissions (Section 24).
• Patient Rights Charter: Facilities must prominently display a standardized charter outlining patients' rights to dignity, information, and timely emergency care (Section 17).

Penalties

• Patient Safety Failures: A health facility that fails to implement required quality and safety measures faces a fine of up to KSh 50 million, a 10-year prison sentence for its directors, or both (Section 18(2)).
• Operating Without a Licence: Operating an unlicensed health facility carries a fine of up to KSh 10 million or imprisonment for up to 5 years (Section 48(3)). Operating under a revoked licence carries a fine of up to KSh 20 million or imprisonment for up to 10 years (Section 55(5)).
• Obstructing Inspectors: Hindering an inspector, denying entry, or presenting falsified records to the Authority is an offence carrying a fine of up to KSh 2 million or imprisonment for up to 2 years (Section 78(2)).
• Non-Compliance with Record Requests: Failing to make required clinical or inspection records available to the Authority carries a fine of up to KSh 1 million or imprisonment for up to 1 year (Section 82(2)).

Transitional Provisions

• Existing Facilities: Health facilities registered before the commencement of the Act are deemed registered but must fully comply with the new licensing and safety standards within one year of the Act's commencement (Section 99).
• Tribunal Disputes: Any dispute proceedings pending before the Dispute Resolution Tribunal under the Social Health Insurance Act will transition directly to the new Health Care Tribunal upon commencement (Section 83(3)).