Launching A Digital Health Platform In Nigeria: Key Legal And Regulatory Considerations For Founders

Introduction

Nigeria's digital health sector is growing rapidly as founders, investors and healthcare providers leverage technology to improve access, efficiency and patient engagement.¹ Current estimates indicate that there are over 625 active health-tech companies in the country, with the market valued at approximately $1.5 billion.² This growth is driven by increasing smartphone penetration, rising demand for more accessible healthcare services, and the growing use of artificial intelligence and machine learning to support diagnosis, patient monitoring and data-driven decision-making. In urban areas, more than 60% of residents now prefer telehealth services, reflecting a shift in healthcare delivery models.³ With over 120 million smartphone users and growing reliance on telemedicine, digital platforms are becoming an integral part of healthcare delivery.⁴

However, regulation in this sector is still evolving. Nigeria has yet to enact a single, comprehensive law governing digital health services. Several legislative proposals are currently under consideration in the National Assembly, including the Digital Health Services Bill,⁵ the Records Officers Registration and Digital Health Bill 2025, and the Electronic Health Records Bill.⁶ While there is no unified framework regulating digital health in Nigeria, existing laws remain applicable.⁷ Therefore, launching a digital health platform involves more than just a technological or product decision. Depending on the platform's business model, various legal obligations may arise, including those related to healthcare regulation, data protection, intellectual property, corporate governance, and consumer protection. Founders, operators, and investors need to understand the legal and regulatory landscape before entering the market. This article highlights key legal and regulatory considerations that stakeholders should be aware of before launching a digital health platform.

1. Corporate Formation and Governance

A digital health platform intending to operate in Nigeria must first be incorporated with the Corporate Affairs Commission. This is the primary legal requirement, as incorporation confers legal status and a distinct identity on the business. It provides the legal structure within which the platform operates. A platform may function as a telemedicine provider, appointment-booking marketplace, electronic health records solution, e-pharmacy, diagnostics facilitator, wellness platform, insurance intermediary, or a combination of these services.

This classification is important because different activities attract different regulatory obligations. Digital health platforms must ensure proper registration, clear shareholding arrangements and effective governance structures from the outset. In practice, compliance with the Companies Allied Matters Act, (CAMA), supports investor confidence, regulatory engagement and operational credibility, particularly in a highly regulated sector such as healthcare.

2. Professional Regulation

Another key area for digital health platforms is compliance with professional regulatory laws relevant to the services they provide. As noted, a platform may operate across different service areas such as telemedicine, pharmacy, diagnostics or health data management (telehealth). The applicable law will depend on the nature of the service.

For instance, the Medical and Dental Practitioners Act governs the licensing and practice of medical doctors and is relevant to telemedicine platforms. The Pharmacists Council of Nigeria Act applies to platforms involved in medicines, e-pharmacy or drug distribution. Similarly, the Medical Laboratory Science Council of Nigeria Act is relevant for platforms offering diagnostic or laboratory-related services. It is therefore important for operators to be familiar with the relevant professional laws before launching. These requirements apply regardless of whether services are delivered physically or through digital platforms.

3. Health Regulatory Landscape

Before launching a digital health platform, founders must also consider the healthcare regulatory landscape, as these platforms are subject to federal and state regulations. At the federal level, the Federal Ministry of Health plays a central role in policy and sector coordination, while agencies such as the National Agency for Food and Drug Administration and Control (NAFDAC) regulate medicines, medical products and related services that may be integrated into digital health platforms.

At the state level, the State Ministry of Health is central. Additional approvals may be required depending on where the platform operates. For example, in Lagos, the Health Facility Monitoring and Accreditation Agency oversees the registration and accreditation of private healthcare providers and has issued ‘Basic Standards for Digital Health Facility Registration'. In the FCT, the Private Health Establishments Registration and Monitoring Committee regulates private health establishments under the Health and Human Services Secretariat. Therefore, founders need to assess and comply with all relevant regulatory requirements before commencing operations

4. Patients' Rights

Protecting patient rights is central to building trust in any digital health platform. In Nigeria, several laws protect these rights. A key example is the National Health Act 2014, which contains detailed provisions on patient rights. Patients have the right to emergency medical treatment,⁸ and refusal of such treatment is prohibited. They are also entitled to adequate information about their health status and treatment options.⁹ Health establishments are required to maintain proper records, and patient information must be kept confidential except where disclosure is permitted by law.¹⁰

The Code of Medical Ethics also recognises core patient rights, which apply to telehealth services. These include the requirement to obtain informed consent before treatment,¹¹ maintain accurate medical records, ensure confidentiality, and make timely referrals where necessary. The Patients' Bill of Rights further outlines rights such as access to medical records, transparent billing, privacy, the right to decline care, and the right to raise complaints.

5. Data Protection and Privacy

Given their nature, digital health platforms must comply with the Nigeria Data Protection Act 2023, which provides the legal framework for safeguarding personal data. Platforms are required to obtain explicit, informed, and unambiguous consent from patients or rely on other lawful grounds for processing data. Only the minimum necessary patient information should be collected for the intended purpose.

The Act introduces categories of data controllers and processors known as Data Controllers and Processors of Major Importance, all of whom must register with the relevant authority. High-risk activities require conducting a Data Protection Impact Assessment (DPIA) to ensure accountability and mitigate risks. Platforms must also implement robust data security measures, establish lawful bases for processing, maintain proper consent mechanisms, and verify users' age and identity where necessary. Compliance with these obligations is essential before launching a digital health platform.

6. Tax Considerations

The recent tax reforms have significant implications for digital health platforms. Relevant laws include the Nigeria Tax Act, the Nigeria Tax Administration Act, the Nigeria Revenue Service (Establishment) Act, and the Joint Revenue Board of Nigeria (Establishment) Act. These laws introduce incentives that may benefit health-tech companies.

For example, companies engaged in research and development may claim certain expenses as deductions, subject to limits. Some healthcare products are exempt from VAT, while others may be zero-rated.¹² Medical and pharmaceutical products, health services, and equipment, may fall within this category.¹³ In addition, small companies are exempt from Company Income Tax and certain levies. A small company is defined by its turnover and asset base. Many early-stage digital health platforms may fall within this threshold and should assess their eligibility for these benefits.

7. Intellectual Property Protection

Protecting intellectual property is essential for digital health platforms. This includes patents for new technologies, copyrights for software and digital content, and trademarks for branding. Under the Trademarks Act, a trademark must be registered to enjoy statutory protection. Once registered, it grants exclusive rights to the owner and is renewable over time.¹⁴ Failure to renew may result in loss of protection.

The Copyright Act also protects digital works, including software and online content.¹⁵ The Patents and Designs Act¹⁶ further secures a platform's innovations. It allows for patents to protect eligible technological innovations or technical processes, while industrial design registration protects unique visual elements like the User Interface (UI) or physical hardware.¹⁷ Digital health platforms should ensure that their intellectual property is properly secured from the outset.

8. Electronic Pharmacy Regulations 2026

For digital health platforms offering prescription or medication services online, the new Electronic Pharmacy Regulations 2026, issued by the Pharmacists Council of Nigeria, are particularly important. The Regulations revised the Online Pharmacy Regulations 2021 and expanded the definition of an Electronic Pharmaceutical Service Provider,¹⁸ while introducing new compliance requirements. Notably, the Regulations restrict cross-border online sales of medicines, except in limited circumstances, and a licensed pharmacist in Nigeria must conduct such transactions.¹⁹ They also establish a National Electronic Pharmacy Platform, requiring all pharmaceutical service providers and electronic pharmacy aggregators to integrate with the system both legally and technically.²⁰ These requirements are central to ensuring regulatory oversight, patient safety and supply chain integrity within the digital pharmaceutical space.

9. Startup Regulation and Incentives

The Nigerian Startup Act is another important law for digital health platforms. It was enacted to support innovation and ease the process of doing business. The Act provides several incentives, including access to funding through the Startup Investment Seed Fund.²¹ Digital health platforms may apply for labelled startup status which confers additional benefits such as relief on pre-incorporation expenses for up to six years prior to incorporation²².  They may also benefit from deductions on research and development expenses and exemptions from certain statutory contributions. This framework is particularly useful for platforms in their early stages.

10. Technology Transfer and NOTAP Compliance

Technology is central to digital health platforms. The National Office for Technology Acquisition and Promotion Act regulates the transfer of foreign technology into Nigeria. Agreements involving such transfers must be registered with the National Office for Technology Acquisition and Promotion. This applies where a platform relies on foreign technology, including patents and technical services. Compliance is important to ensure the enforceability of such agreements and to avoid regulatory complications, particularly for platforms leveraging foreign-developed health technologies.

11. Advertising and Marketing

The Advertising Regulatory Council of Nigeria Act regulates advertising in Nigeria. Digital health platforms must comply with its provisions when promoting their services. Advertising must not be misleading or make unverified claims. In particular, healthcare-related advertising should not present services as diagnosing or treating illnesses without appropriate safeguards. Platforms must therefore ensure that all marketing communications meet regulatory standards.

12. Technology Regulation and Cybersecurity

The National Information Technology Development Agency Act governs the development and regulation of information technology in Nigeria. Digital health platforms fall within its scope as technology-driven businesses. As platforms grow, they may need to engage with NITDA in relation to compliance with applicable standards and guidelines. This becomes particularly relevant as the platform scales its operations.

Other relevant laws include the Federal Competition and Consumer Protection Act, which addresses unfair practices and protects consumer rights, and the Cybercrimes (Prohibition, Prevention, etc.) Act, which covers cybersecurity and system protection. Given the sensitivity of health data and services, platforms must implement strong cybersecurity measures, maintain system integrity and ensure fair treatment of users.

Conclusion

While Nigeria's digital health sector continues to expand, its regulatory framework remains fragmented. As a result, compliance requires careful consideration of multiple legal regimes. Digital health platforms that address these issues early are better placed to manage risk, build trust and achieve long-term growth. Early legal and regulatory planning should therefore be treated as a strategic priority for any digital health business entering the market.

Footnotes

1. https://www.kenresearch.com/nigeria-digital-health-and-telemedicine-market

2. https://tracxn.com/d/explore/healthtech-startups-in-nigeria/

3. https://www.researchandmarkets.com/reports/6207334/nigeria-digital-health-telemedicine-market

4. Ibid

5. https://www.techhiveadvisory.africa/insights/review-of-nigerias-digital-health-services-bill-2025

6. https://punchng.com/tinubu-transmits-24-health-bills-to-senate-for-legislative-action/

7. Ibid

8. Section 20, National Health Act 2014

9. Section 23, National Health Act 2014

10. Section 26, National Health Act 2014

11. Rule 19, Code of Medical Ethics

12. Section 186

13. Section 156

14. Section 9, Copyright Act

15. Section 108, Copyright Act

16. Section 1, Patents and Designs Act

17. Section 12, Patents and Designs Act

18. Regulations 52, Electronic Pharmacy Regulations 2026

19. Regulations 35, Electronic Pharmacy Regulations 2026

20. Regulations 36, Electronic Pharmacy Regulations 2026

21. Section 19, Startup Act

22. As per the New Tax Reforms Act

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.