The Quality Healthcare and Patient Safety Bill: A New Facility Licensing and Accreditation Regime

The Quality Healthcare and Patient Safety Bill, 2025 would build an entirely new licensing and accreditation authority on top of Kenya’s existing facility regulation, not replace it outright. It has already passed the National Assembly and is now before the Senate Health Committee, which makes this a bill worth understanding in detail even though it is not yet law.

Where the Bill Stands and What It Creates

The Bill passed the National Assembly on 2 June 2026 and completed First Reading in the Senate on 15 July 2026. It is currently with the Senate Health Committee for public participation. It has not passed the Senate or received presidential assent, so nothing in this article should be treated as current law until that happens, and the Senate’s own copy of the text should be checked for any changes before final passage. If enacted, the Bill establishes the Quality Healthcare and Patient Safety Authority as a body corporate under section 27, governed by a board that includes a presidentially appointed chairperson, the Principal Secretaries for Health and Treasury, the Director-General for Health, a Council of Governors nominee, two nominees from a healthcare providers’ consortium and a patients’ association, a patient-quality expert, and the Authority’s CEO.

What the Authority Would Actually Do

Under section 28, the Authority would register, license, and accredit health facilities, regulate facility infrastructure development, run inspections for compliance, operate a quality scoring and rating framework, and accredit facilities for empanelment under the Social Health Insurance Fund pursuant to sections 33 and 34 of the SHIF Act. It would also advise the Cabinet Secretary and county governments on standards. The Bill layers this new facility-level Authority on top of, rather than in place of, existing professional regulators; it does not appear to abolish the Kenya Medical Practitioners and Dentists Council or the Kenya Health Professions Oversight Authority, and it continues to reference those bodies for professional licensure verification.

A New Three-Step Facility Gate, Plus Separate Accreditation

Part IV of the Bill, sections 44 to 73, sets out a facility regime built around three sequential steps: approval covering construction, operation, or decommissioning; registration, evidenced by a certificate; and an annual licence valid to 31 December each year and renewable thereafter. Accreditation sits separately from this three-step gate as a two-year certificate assessed against infrastructure, staffing, clinical-guideline conformity, health-product standards, laboratory standards, and ongoing monitoring of patient outcomes and satisfaction. This is a materially more elaborate structure than the general licensing language currently found in the Health Act 2017, and a facility operator should expect meaningfully more documentation and a longer approval runway than under the current regime if this Bill passes in its current form.

Penalties and a New Tribunal

The Bill’s penalty scale is substantially higher than the Health Act 2017’s general penalty provision. Operating an unlicensed facility would carry a fine of up to KES 10 million, imprisonment of up to five years, or both; continuing to operate under a revoked licence would carry up to KES 20 million or ten years; and non-compliance with patient-safety duties under section 19(2) would carry up to KES 50 million or ten years. Part VI of the Bill establishes a new Health Care Tribunal to hear appeals from Authority decisions, with a further right of appeal to the High Court. A facility already registered before the Bill’s commencement would be deemed registered under the new Act automatically, with a six-month window under section 101 to otherwise come into compliance.

What This Means for Facility Operators

A health facility operator should not restructure compliance processes around a bill that has not passed the Senate, but should track this legislation closely given how far advanced it is and how much higher its penalty scale runs compared to current law. The most useful preparation now is understanding the three-step approval, registration, and licensing sequence this Bill would introduce, distinguishing it clearly from the separate two-year accreditation track, and watching for the Senate committee’s public participation outcome, since that process closed for submissions on 3 August 2026 and may still produce amendments to the text summarized here.

The link to Social Health Insurance Fund empanelment under sections 33 and 34 of the SHIF Act is worth flagging separately, since it changes the practical stakes of accreditation beyond mere legal compliance. If the Bill passes in its current form, a facility that treats accreditation as optional once it already holds a basic operating licence could find itself unable to bill SHIF for insured patients, which for many private facilities is a much larger commercial consequence than the licensing penalties themselves.