Op-Ed: Health tech innovators must consider regulation from day one

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Technology is transforming access to healthcare across Africa, with innovations such as mobile apps and digital platforms tackling genuine medical challenges. However, regulation often falls behind. Mike Adeyemi-Lawal, a Malaria and Infectious Diseases Specialist at Médecins Sans Frontières, warns that health technology must comply with local laws from the outset.

• Health innovation is not akin to building a social network; it involves lives and sensitive data and climate-sensitivity, necessitating strict compliance. Startups must recognise that regulations differ between African countries. A solution approved in Kenya may be non-compliant in Nigeria.

• Viewing regulation as a guide rather than an obstacle can facilitate safer, scalable innovation. Engaging regulators early fosters trust and enhances the likelihood of success.

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By Mike Adeyemi-Lawal

Malaria and Infectious Diseases Specialist Advisor at Médecins Sans Frontières

(This article was first published on LinkedIn on May 04, 2025)

Technology is changing the way people access healthcare across Africa. From mobile apps that connect patients with doctors to digital platforms that deliver medications or monitor chronic conditions, African innovators are building bold solutions to real health challenges. 

But as exciting as this is, one critical area often gets overlooked: regulation and local health policy. Many health startups jump straight into development (coding, designing, and launching) without asking a vital question: Is what we're building aligned with existing laws and regulations? This simple oversight can make or break a startup. In the health space, innovation must walk hand-in-hand with policy from the very beginning.

Health tech isn’t like building a ride-hailing app or a social network. When you work in healthcare, you’re dealing with people’s lives, personal information, and sometimes even critical medical decisions. Because of that, health is a tightly regulated space. These regulations exist to protect patients, ensure safety, and hold innovators accountable. 

Whether your platform provides telemedicine, diagnostics, prescriptions, or collects sensitive data, it likely falls under a regulated category. Failing to follow these rules could lead to serious legal trouble or even put patients at risk. That's why innovators must consider the regulatory framework from day one, not as an afterthought.

One common mistake startups make is assuming that regulations are the same across Africa. In reality, each country has its unique health policies and digital regulations. A solution that’s fully operational in Kenya might run into legal challenges in Nigeria or Uganda. 

For example, some countries have specific rules for who can offer telemedicine services, how electronic health records should be handled, or what licenses are needed to distribute pharmaceuticals online. Understanding these rules early allows startups to plan wisely, reduce legal risk, and scale effectively across borders.

Many startups view regulation as a roadblock. But in truth, good regulation provides clarity, safety, and opportunity. When innovators follow clear guidelines, they contribute to building trust in health technology. 

Regulators themselves are becoming more open to engaging with startups and creating environments that support innovation when it’s done responsibly. In fact, startups that help shape policy by engaging constructively can open new doors not just for themselves but for the entire ecosystem.

Data is at the heart of many health tech platforms, but patient information is among the most sensitive data there is. In an era of growing digital rights awareness, data privacy laws are tightening. 

Countries like Nigeria, South Africa, and Kenya now have clear policies around data collection, storage, and sharing. If your innovation collects or stores patient health data, you need to understand who owns that data, how it’s protected, and what your legal responsibilities are. Mishandling data could result in massive fines, legal battles, and destroyed user trust. That’s why data protection must be built into your innovation from the ground up.

Health tech is full of promise. But to deliver real, lasting impact, innovators must think beyond code and funding. Understanding and aligning with local health regulations and policies from the start is essential. Engaging regulators from the beginning also sends a powerful message: we want to do this the right way. This builds public and government trust and avoids costly delays or shutdowns later in the process.