Kenya Introduces New Rules to Regulate AI and Medical Software in Healthcare

The Pharmacy and Poisons Board (PPB) has introduced a new guideline to regulate Medical Device Software (MDSW) as Kenya responds to the rapid growth of digital health technologies.

The framework sets out clear rules for software used in healthcare, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

According to the guideline, it provides a framework for the regulation of Medical Device Software (MDSW), including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

“The Framework also provides guidance on AI-powered Medical Devices in responding to innovative technologies which are rapidly evolving in the Kenyan market,” it stated.

Focus on Safety and Performance

“The framework will strengthen oversight of digital health tools used in diagnosis, treatment, and patient monitoring. It requires developers and manufacturers to meet set standards before they introduce software into the healthcare system,” PPB said.

As a result, the Board aims to improve the safety, quality, and performance of medical software. This comes as hospitals and health providers increasingly rely on digital systems to support clinical decisions.

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Addressing Fast-Growing AI Health Tools

Moreover, the guideline responds to the rise of artificial intelligence in healthcare. AI-powered tools now support diagnostics, treatment planning, and patient monitoring in many health systems.

However, the PPB warns that such tools must undergo strict checks before use. This helps reduce risks such as inaccurate results, system failure, or misuse in clinical settings.

Aligning with Global Standards

In addition, the Board says the framework aligns Kenya with global best practices on medical software regulation. It introduces clear requirements for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

Through this approach, PPB aims to support innovation while ensuring patient safety remains a priority. It also strengthens trust in digital health technologies entering the Kenyan market.

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Supporting Safe Digital Health Growth

Finally, the framework guides developers, manufacturers, and healthcare institutions. It outlines how they should comply with regulatory requirements before deploying medical software.

Overall, the PPB guideline marks a key step in regulating AI-driven and software-based medical technologies in Kenya. It balances innovation with safety as the digital health sector continues to expand.

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Pharmacy and Poisons Board Entrance Gate in Nairobi. PHOTO/ PPB