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Telemedicine, particularly tele-powered service delivery, is transforming healthcare by overcoming temporal and spatial limitations. Although Nigeria has embraced telemedicine, its regulatory framework is a work in progress. In contrast to countries like Canada, Nigeria lacks comprehensive regulations tailored to its unique challenges. This article explores the legal hurdles facing telemedicine in Nigeria and offers guidance to medical practitioners, emphasizing the need for stakeholders to engage with legal considerations and advocate for a robust regulatory framework supporting responsible telemedicine implementation.
Legal Challenges in Nigerian Telemedicine
1) Regulatory Gap and Uncertainty for Telemedicine in Nigeria:
Nigeria lacks dedicated legislation for telemedicine, causing uncertainty for operators and users. This creates an air of uncertainty that continues to define the discourse of telemedicine in Nigeria. The resulting puzzle significantly inhibits the operators from framing a clear outlook for their legal and regulatory compliance, while users are presented with a hazy rights and reliefs matrix. To successfully navigate this terrain, players in this sector are tasked not only with searching through the litany of regulatory provisions scattered across various legislations but also with positioning themselves to take the best advantage of these provisions. The key to surmounting this arduous task is to seek prior guidance from qualified legal practitioners who can effectively balance the application of local laws with the emerging best international trends. At a minimum, such guidance must reflect the multi-territorial footprint of the underlying activities and the applicable regulations to deliver solutions that best address the individual needs of the respective players.
2) Licensing and Registration Challenges:
The absence of a dedicated licensing regime and a registration framework based on a focused piece of regulation, denies operators and users the benefits of standardization, both in their operation and user experience within the sector. However, the specific requirements and processes for obtaining licenses and registrations for telemedicine are today scattered across litany of legal and regulatory provisions that govern its cellular components.
Operators and users alike are therefore charged to understand and comply with the multifarious licensing and registration requirements. This compliance duplicity is further compounded by the daunting reality of the multi-jurisdictional straddling of the rights and duties underlying these activities. A dedicated licensing and registration process will at the very least, serve to harmonise the multi-jurisdictional diversities with the sole aim of delivering clarity and certainty to operators and users alike.
3) Data Protection Complexity:
Telemedicine involves sensitive data handling such as collection, storage, and transmission of sensitive patient information and records. Ensuring the privacy and security of these data is crucial.[i] Healthcare providers offering telemedicine services should adhere to data protection regulations and take appropriate measures to safeguard patient information. A healthcare practitioner is a data processor within the context of the Nigeria Data Protection Regulation (NDPR), and its data protection obligations are clearly outlined in the extant regulation. However, following in the multi-territorial footprint of tele-medical activities, the data protection obligations and rights are likely to assume multi-jurisdictional dimensions, which require operators to seek ample guidance on the scope of their compliance and for users to understand the available rights and protection across the multiple locations of their operations.[ii]
Read also; Data privacy and protection in Nigeria’s IOT environment
4) Cross-border footprint:
The cross-border nature of telemedicine makes it difficult for operators to clearly define the specific ambit and scope of their relationships thereby raising issues of jurisdiction and care standards. Telemedicine facilitates seamless cross-border delivery of healthcare services, allowing patients located mainly in Nigeria to consult with healthcare providers located outside the country. This often gives rise to issues related to jurisdiction, professional accountability, and the standard of care, with varying implications and consequences in different jurisdictions. More advanced jurisdictions have made targeted regulatory attempts to address this challenge,[iii] but Nigeria still needs to cover this obvious jurisprudential deficit. In the meantime, every intending player within the tele-medical space should seek proper guidance on the prevalent uncertainties and the best ways to navigate them.
5) Insurance and Reimbursement coverage:
Telemedical activities may occur across multiple zones and territories, introducing a wide range of insurance claim and reimbursement challenges. Despite the growth and improved adoption of health insurance in Nigeria, the Nigerian health insurance framework is yet to provide a suitable framework for the standardization of claims and reimbursement that caters to the complex diversities of telemedicine consultations. The complexities of typical telemedicine risks go beyond the current codes of Nigerian insurance laws[iv] and require creative solutions to adapt to emerging insurance and claims-related issues associated with the rapid acceptance of telemedicine in Nigeria.
6) Jurisdictional issues:
Telemedicine even in its simplest ramifications can pose complicated jurisdictional challenges along the diverse intersections ofthe chain of activities. Determining which jurisdiction’s laws apply, especially in cross-border scenarios, can be a complex task. Given the technical composition of the service delivery model and channels, this issue can often stretch the usual discourse on conventional conflict of law to its very limit. Therefore, in the absence of a clear-cut regulatory and licensing framework to harness the respective positions, both operators and users must rely on competent advisors to guide them through the murky waters of jurisdictional uncertainties. One way to best address this challenge is to develop agreements that address jurisdictional issues and harmonize legal requirements across regions in permissible circumstances.
7) Medical liability and malpractice:
Telemedicine like conventional medical practice, naturally raises questions about medical liability and malpractice in the event of adverse outcomes or negligence. Determining accountability and liability in this intricate overlap of roles, rights, and obligations can be challenging, particularly in cases where the healthcare provider and patient are physically separated. A central feature of healthcare delivery is practice regulation and the legal framework for asserting the liability of practitioners. This seemingly simple task takes on a more complex dimension when healthcare delivery takes place across physical geographical boundaries with diverse standards of professional ethics and accountability. Telehealthcare delivery therefore suffers from the uncertainty of a legal framework and guidelines for related liability and malpractice issues. It is imperative for patients and service providers to seek help in navigating these complexities.
Conclusion
The growth of telemedicine in Nigeria hinges on the establishment of a deliberate legal and regulatory framework, a sentiment echoed by all stakeholders involved. While awaiting government intervention, industry players must proactively position themselves to leverage the potential benefits and mitigate the risks posed by the current regulatory uncertainties. This necessitates the adoption of creative measures, including strategic contractual and legal structuring, that go beyond the capabilities of the average practitioner or user within the telemedical ecosystem. To optimize their positions within this evolving landscape, interested players should seek the guidance of qualified practitioners who can navigate them through the complexities and help them make informed decisions. By taking proactive steps and engaging expert assistance, stakeholders can position themselves for success in the burgeoning telemedicine sector in Nigeria.
[i] Nigeria has data protection laws, such as the Nigeria Data Protection Regulation (NDPR) implemented by the National Information Technology Agency (NITDA).
[ii] The REGULATION (EU) 2016/679 (General Data Protection Regulation) is fast emerging as the holy grail for global data protection benchmark and every operator and user alike will do well to further familiarise themselves to the import on their multi-jurisdictional activities.
[iii] Countries like Canada, the USA, India and the United Kingdom have put in place targeted regulations to address the peculiarities of telemedicine in their zones.
[iv] The Insurance Act 2003 does not make specific provision to cover this and although the NHIA 2022 created the Third-Party Administrator to empower health insured, it still falls significantly short of what is required to cater for the challenges of telemedicine.
Written by Taye Awofiranye for The Trusted Advisors
Email us: info@cms.trustedadvisorslaw.com