Health Facility Accreditation Compared: The Health Act 2017 Versus the Incoming Patient Safety Authority

Kenya’s Health Act 2017 already promised a single national regulator for health products and facilities, but seven years later that promise still runs through a patchwork of professional regulators and county facilitation rather than one dedicated authority. Comparing today’s facility accreditation framework against the pending Quality Healthcare and Patient Safety Bill shows exactly how much would change if that Bill passes.

How Facility Licensing Actually Works Today

Section 89 of the Health Act 2017, in Part XIII, permits private entities to operate hospitals, clinics, laboratories, and other health institutions subject to licensing by the appropriate regulatory bodies. The Act does not create one central facility-licensing authority; instead, licensing runs through whichever professional regulator has jurisdiction over the relevant service, such as the Kenya Medical Practitioners and Dentists Council for private hospitals and clinics. Public facilities are addressed separately under Part III, sections 22 to 25, alongside the First Schedule’s classification of care into Levels 1 through 6. This structure means a facility offering multiple types of service can find itself dealing with more than one regulator rather than a single accrediting body.

The Kenya Health Professions Oversight Authority’s Limited Role

The Health Act 2017 did establish a coordinating body, the Kenya Health Professions Oversight Authority, under Part VI, sections 45 to 61. Its role is oversight and coordination rather than direct facility licensing: it maintains a duplicate register of health professionals, arbitrates disputes between regulatory boards such as the Pharmacy and Poisons Board, the Medical Practitioners and Dentists Board, the Nursing Council, and the Radiation Protection Board, and monitors how those boards carry out their mandates under sections 48 and 60. It does not itself inspect, register, or accredit health facilities.

Where Counties Fit Under Devolution

Sections 19 and 20 of the Health Act 2017 give each county a health executive department and a County Director of Health, with counties implementing national policy and, under section 20(d), facilitating the registration, licensing, and accreditation of providers and facilities according to standards set nationally. The word “facilitating” is doing real work here: counties do not set their own independent facility-licensing standards, they help apply nationally set ones, while national government retains responsibility for national referral facilities and health-products regulation under section 24.

Section 62 Already Anticipated a Single Regulator, and It Still Hasn’t Arrived

Part VII, sections 62 to 67, of the Health Act 2017 states that a single regulatory body for health products and technologies shall be established by a separate Act of Parliament. This is the gap the Health Products and Technologies Regulatory Authority Bill would finally fill for products, and it explains why the Pharmacy and Poisons Board has continued operating under Chapter 244 for so long after the Health Act 2017 came into force: the Act promised consolidation but never delivered it itself. The Quality Healthcare and Patient Safety Bill addresses the facility-licensing side of the same underlying problem, proposing the dedicated accrediting authority that section 89’s reference to “appropriate regulatory bodies” never actually created.

What Changes If the New Bill Passes

If the Quality Healthcare and Patient Safety Bill is enacted, a facility operator would move from today’s fragmented system, licensing through whichever professional regulator applies plus county facilitation, to a three-step national gate of approval, registration, and annual licensing, with a separate two-year accreditation certificate layered on top. The penalty structure would also change sharply: the Health Act 2017’s general penalty provision under section 111 caps at KES 2 million or three months where no other penalty is specified, while the pending Bill’s penalties run as high as KES 50 million or ten years for patient-safety non-compliance. A facility operator comparing the two regimes should understand that the new Bill does not replace the Health Act 2017 wholesale; it adds a dedicated accrediting authority into a structure the 2017 Act left deliberately open for exactly this kind of follow-on legislation.

The First Schedule’s Level 1 to Level 6 facility classification would likely remain relevant even after the new Bill passes, since that classification describes the type and complexity of care a facility is authorized to provide rather than the licensing process itself. A dispensary classified at Level 2 and a referral hospital classified at Level 6 would both move through the same new three-step gate and accreditation track, but the standards applied at each step would still need to reflect that underlying classification, much as they do today under the current fragmented system.