Audio By Vocalize
It is barely the second quarter of the year, yet the Kenyan healthcare regulatory landscape is being redrawn.
Two documents released in 2026 will be major determinants of how pharmacies, clinics, hospitals, and businesses in the digital health space deploy AI in their operations. The AI Bill 2026 received its first reading in the Senate on April 2, 2026, while the lesser-known document, already in force, was issued by the Pharmacy and Poisons Board in February as guidelines for regulating medical device software in Kenya (MDSW). Together, they will define compliance for digital health in Kenya, though not necessarily in a single voice.
The AI Bill applies across every sector, from finance and public administration to security and agriculture. It establishes the office of the AI Commissioner, a new independent state office. The Bill classifies AI-assisted medical devices as high-risk AI. It creates obligations for pre-deployment risk assessments, human rights impact assessments, transparency, five-year data retention and performance metrics, annual compliance reporting to the AI Commissioner, and explicit consent requirements for AI-generated content. Penalties for breach can be as high as Sh5 million or two years’ imprisonment.
