The government targets to transform the healthcare system with the Quality Healthcare and Patient Safety Bill 2025, as part of its Universal Health Coverage (UHC) initiative.
This legislation imposes significant requirements on healthcare providers, including mandatory accreditation and penalties for non-compliance.
For the private sector, the Bill introduces a new regulatory framework that demands greater accountability and adherence to national standards, under Article 43(1)(a) of the Constitution, which guarantees every citizen the right to the highest attainable standard of health.
A key feature is the establishment of a unified Healthcare Tribunal to resolve disputes between patients, healthcare workers, and providers, to enhance access to justice and oversight.
The Business Daily unpacks what the Bill means for health providers, insurers, and the public.
Will this Bill change the way public and private sectors collaborate in healthcare delivery?
The Bill establishes a new public-private engagement model based on quality and compliance. Previously, partnerships between counties and private facilities were often based on informal arrangements or political connections.
Under the new law, however, only facilities that meet national accreditation standards will be eligible to treat patients under government-funded programmes, such as the Social Health Insurance Fund (SHIF). Non-compliant facilities will be excluded, regardless of capacity.
“Patients are too often exposed to substandard conditions, with services offered in poorly built facilities and by unqualified staff. The Quality of Health and Patient Safety Bill will be a game-changer. It aims to restore dignity and safety within Kenya’s healthcare system,” said Health PS Nancy Muthoni.
How will accreditation process work, and who oversees it?
The newly proposed Quality Healthcare and Patient Safety Authority will oversee accreditation. All health facilities, whether public or private, will undergo a structured evaluation based on safety, clinical effectiveness, infrastructure, staffing, and patient rights standards.
Facilities will be scored and potentially rated using a star or tier system. Accreditation will not be permanent and will require regular reviews, inspections, and proof of continuous quality improvement. Facilities may also be subject to unannounced aud its, data reporting obligations, and corrective action plans.
A facility’s accreditation status will directly impact its ability to receive SHIF reimbursements, participate in emergency response systems, and operate legally.
“Never again will we have substandard health facilities or rogue healthcare providers. Whether private, public, or faith-based, the quality of healthcare will be uniform,” said Ms Muthoni.
How will mandatory registration and licensing impact private clinics and hospitals?
The Bill introduces a stringent three-tier compliance structure. This comprises approval before setting up a health facility (including submitting physical plans and intended services), registration in a national health facility database, and annual licensing to operate. This licence is renewable upon meeting updated criteria.
All health facilities, from rural dispensaries to multispecialty hospitals, will have to pass all three stages. Licences will be granted based on the facility’s scope of services, infrastructure, human resources, and track record.
Those found to be operating outside their licensed scope—for example, performing surgeries without the necessary approval—will face severe penalties.
What financial or legal risks do providers face under the new penalties?
Providers who fail to comply with quality standards or operate unlicensed facilities may face fines of up to Sh50 million, imprisonment for up to 10 years, revocation or denial of licences and accreditation, exclusion from government insurance contracts (including SHIF), and civil liability, particularly if patients are harmed.
What will compliance cost health facilities, and are there funding options?
Depending on its size and complexity, a facility may require upgrades, including retrofitting buildings to meet safety and infrastructure codes, hiring additional qualified staff or retraining existing personnel, procuring digital systems for reporting and inspections, establishing and maintaining quality management units, and paying annual registration and accreditation fees.
Although the Bill does not mention government subsidies or compliance grants explicitly, it allows for private-sector solutions, such as leasing medical equipment, impact investing, and third-party compliance consultancy.
What are the implications of the Bill for health insurance providers?
The Bill significantly reshapes the operating environment for insurers by linking the accreditation of healthcare facilities to their eligibility for public insurance contracts, such as the SHIF.
Only facilities that meet quality benchmarks and maintain active accreditation will be permitted to treat SHIF patients and claim reimbursements.
For private insurers, this creates a more structured and transparent provider ecosystem, thereby reducing the risk associated with inconsistent service quality. It also paves the way for risk-based premium models, bundled products tied to facility ratings, and value-based coverage arrangements.
Insurers will need to align their provider networks with the Bill’s compliance standards, potentially collaborating with accredited facilities on data integration, claims digitisation, and joint quality monitoring frameworks.
How does the Bill align with Kenya’s Universal Health Coverage (UHC) agenda?
The Bill is a key pillar of the implementation of UHC. It ensures that only facilities that meet quality benchmarks can participate in Kenya’s new national health insurance scheme, SHIF.
By making accreditation a prerequisite for participation in SHIF, the government is establishing a clear link between quality and financing. This will discourage facilities from offering substandard services and encourage professionalisation across the board.
For the public, this promises improved care. For providers, access to growing government healthcare funds will be performance-based. Facilities that fail to meet accreditation standards will lose a major source of income.
What operational changes will health facilities need to make?
To meet the demands of the Bill, health facilities will have to overhaul their operations in several areas, including implementing evidence-based clinical guidelines for all services, setting up quality improvement programmes with internal audits and reporting systems, digitising service records, interfacing with national data platforms such as the Comprehensive Integrated Health Information System (CIHIS), conducting staff capacity assessments, retraining workers and validating all licences.
They must also display and adhere to a patient rights charter within the facility and respond to patient complaints within defined timeframes.
How could this legislation affect Kenya’s regional medical tourism ambitions?
The Bill introduces uniform accreditation and transparent facility ratings. If properly implemented and publicised, this could establish Kenya as a trusted destination for specialised care, such as oncology, dialysis, fertility treatment, and complex surgeries.
Top-rated hospitals could attract regional insurance partnerships, establish referral networks, and boost foreign investment in tertiary care.
Kenya's proximity, English-speaking workforce, and relatively low costs could be leveraged more effectively once quality is visible and verified.
