Legal & Regulatory News

Kenya Moves to Overhaul Healthcare with New Quality and Patient Safety Bill

Hospital Bed without person in Ward

In a landmark decision aimed at reshaping Kenya’s health sector, President William Ruto’s Cabinet has approved the Quality Healthcare and Patient Safety Bill, 2025. The proposed law, which now moves to Parliament for debate, seeks to root out longstanding malpractices, systemic failures, and institutional corruption that have plagued the sector for decades.

This reform is seen as central to the government’s promise of achieving Universal Health Coverage (UHC), restoring public trust, and delivering safe, accessible, and accountable healthcare to all Kenyans.

Kenya’s healthcare system, while boasting notable strides in infrastructure and service delivery, has been marred by widespread public mistrust, poor oversight, and a regulatory environment riddled with loopholes.

A 2023 audit by the Ministry of Health revealed:

  • A significant number of unlicensed health facilities operating illegally.
  • Collusion between regulators and practitioners to approve substandard clinics.
  • Rampant cases of medical negligence, with few held accountable.
  • Overlapping and unclear quality assurance standards.

The Quality Healthcare and Patient Safety Bill, 2025 is the boldest legislative attempt to close these gaps, enforce discipline, and set a new national standard for healthcare delivery.

The proposed legislation introduces several far-reaching reforms, including:

1. Establishment of the Quality Healthcare and Patient Safety Authority

This new, independent national body will have sweeping powers to:

  • Enforce uniform national standards of care.
  • Monitor, evaluate, and audit health facilities regularly.
  • Investigate complaints and take disciplinary action.
  • Publish transparent performance reports for all facilities.

2. Mandatory Licensing, Registration, and Accreditation

All healthcare providers, including:

  • Hospitals and clinics,
  • Diagnostic laboratories,
  • Ambulance services,

must undergo mandatory accreditation under strict new guidelines. The aim is to ensure that only facilities meeting minimum safety, hygiene, and quality benchmarks can operate.

3. Facility-Level Quality Improvement Plans

Each registered facility will be required to:

  • Submit annual quality improvement plans.
  • Demonstrate adherence to patient safety protocols.
  • Train staff regularly on evolving health standards and ethics.

4. Patient Rights Enshrined in Law

The Bill mandates:

  • Protection of patient confidentiality.
  • The right to informed consent before procedures.
  • The right to safe emergency services.
  • Mechanisms for patients to report malpractice without fear of victimization.

5. Emergency Medical Services Reform

One of the more critical components is the regulation of ambulance services, long criticized for operating like unregulated taxis. The Bill sets standards for:

  • Response times,
  • Equipment compliance,
  • Trained paramedics,
  • Central coordination during emergencies.

Perhaps the most groundbreaking element of the legislation is its direct targeting of impunity.

The Cabinet explicitly noted that systemic health failures have been driven by:

  • Conflicts of interest in licensing bodies.
  • Bribery in accreditation and inspection processes.
  • Weak disciplinary action for malpractice.

The new Authority will have prosecution referral powers and operate independently of the Ministry of Health to avoid political interference.

Moreover, health officials and practitioners found guilty of malpractice or collusion face deregistration, heavy fines, and in some cases, criminal charges.

Health providers—both private and public—will face a compliance transition window of six to twelve months once the Bill is enacted. Key changes include:

  • New licensing applications.
  • Re-inspection of existing facilities.
  • Staff retraining on new national standards.

For compliant institutions, this could enhance credibility and patient volumes. For rogue operators, it could mean permanent closure.

The government has pledged to:

  • Train 2,000 quality assurance officers.
  • Digitize the licensing and inspection process.
  • Offer capacity-building support to county health departments.

The Cabinet emphasized that the Bill supports the broader goal of Universal Health Coverage by:

  • Ensuring patients receive value for money.
  • Lowering long-term treatment costs through safer care.
  • Reducing avoidable deaths and complications.
  • Creating data systems to track health system performance.

It is also seen as a complement to the new national health insurance reforms, including the rollout of the Social Health Insurance Fund (SHIF) and primary healthcare networks.

While the Bill is comprehensive, implementation will not be easy. Key risks include:

  • Political interference in appointments to the new Authority.
  • Resistance from entrenched interests in both public and private sectors.
  • Inadequate funding for enforcement and training.
  • Legal pushback from closed or downgraded facilities.

The President has reportedly directed the Ministry of Health and Attorney General’s Office to fast-track the Bill’s tabling in Parliament and ensure cross-party support.

The Quality Healthcare and Patient Safety Bill, 2025 marks a pivotal moment for Kenya’s healthcare sector. If successfully implemented, it could usher in a new era of professionalism, accountability, and patient-centered care—restoring confidence in a system that millions depend on.