Abstract
Abstract
Advancements in technology have heralded more than a few cutting-edge benefits. Medicine is a vital sector of every nation and it has benefitted from these advancements in delivering health care services at a distance. The increasing use of Information and Communication Technology (ICT) by a vast population worldwide has been pivotal for telemedicine in recent years. Many developed and developing countries of the world have embraced telemedicine as a proactive means of delivering health care services to their citizens, although at different rates of development. The challenges associated with health care service and delivery is numerous and telemedicine has become one solution to counter some of these challenges. This paper seeks to examine the state of telemedicine in Nigeria. It identifies the gaps that ought to be filled in the Nigerian legal system and proposes relevant policies and legislation that must be formulated by government alongside appropriate authorities in order to ensure an optimum telemedicine system that meets the standards of conventional medicine.
Introduction
Medicine and technology are closely linked. The two concepts have an inseparable connection and they also share a future. They both touch the lives of people daily. Telemedicine, or “technological medicine”, is the future. It is medicine “at a distance”, medical services at an individual’s convenience and consultation from anywhere and with anyone in real time. Telemedicine, which is also referred to as “e-health”, is the use of information and telecommunication technologies to provide medical information and services from a distance. Innovation in the use of telemedicine allows for new ways of medical consultation by health care practitioners. Without doubt, telemedicine is changing the way medical practitioners deliver health care all over the globe.
Telemedicine in Africa: Its challenges and prospects
Medical practice is at present centred on the growing quest for technological advancement in health care delivery. The advent of telemedicine emanated from the need to diagnose and treat patients at low cost but effectively in an environment with limited diagnosis and treatment options, such as in Africa.
The influence of culture on the health-seeking behaviour of Africans cannot be played down. Diverse cultures in Africa have different conceptions of diseases and their causes. 1 Many people believe that diseases are caused by supernatural beings, their neighbours or vengeance from an offended “God” as a result of transgressions committed in the past by an individual or their parents. 1 Biomedicine in Africa is practised such that the traditional African healer links the cause of the patient’s ailments to a tragedy in the relationship between the patient and the natural/social environments and the spiritual realm. This greatly influences the understanding of their health issues. In an environment where poverty and ignorance are commonplace, health care delivery is often constrained by the chain of events from poor health policies and an individual’s attitude to their health-seeking behaviour. 1
Culture and religion 2 are two major factors that have an overwhelming influence on African society. The complexity of practices introduced by these factors is reflected greatly in people’s knowledge of their health issues and reaction towards them. Notwithstanding the prevalence of sundry diseases in Africa, telemedicine is still basic in most communities in which it is practised. Understanding the role of Information and Communication Technology (ICT) in health care delivery is important for the global efforts to assuage the burden of diseases and health inequalities, especially in Africa. The availability and utilisation of ICT for health care delivery, especially in rural settings where access to medical services is insufficient, presents prospects of expansion for health care access. 2
Despite the burden of infectious disease and health inequalities in Africa, telemedicine practice is still fundamental in most African societies. Some countries in Africa are making a significant impact in the use of ICT for health care delivery. In Malawi, software that allows health workers to text medical information for rural patients was developed by Josh Nesbit of Medic mobile. 3 With this software, patients could get a quick diagnosis on routine symptoms and recommended treatment instead of spending more than 1200 h commuting to the hospital. According to the report, the use of this software doubled the number of patients being treated for tuberculosis within six months of implementation. This made emergency services accessible within the region for the first time. Telemedicine not only makes doctors more efficient because they do not have to be in the physical presence of a patient to judge his or her condition, but it also helps solve health care inequality.
Telemedicine is an appealing novelty that may be beneficial to rural communities in Africa, where diseases are widespread and medical personnel and health care infrastructure are inadequate. Thus, it is crucial to develop telemedicine to guarantee quality access to health care delivery in Africa.
Nigeria as a case study
Over 207 million people live in Nigeria, 4 and a major percentage of this population live in the remote rural areas and some in these remote rural areas have very limited access to health care services as a result of geographic isolation, scarcity of physicians and hospitals, and difficulty travelling to larger cities where such care is available. Governments at federal, state and local levels have been prioritising health care in these remote rural areas over the years to enable citizens in both rural and urban areas to have equal access to medical services and clinical health care despite the geographic isolation barriers, but this effort has not been wholly successful. 5 Therefore, the establishment of an internet-based telemedicine system would be very useful in achieving the government’s aim of bringing health care to these remote rural areas. 6 Among other things, this would improve the quality of health care in the rural areas, lower the costs of delivering health care and give remotely placed physicians the opportunity to consult over a patient’s case.
A proper legal framework and guidelines must be laid down by appropriate bodies and government agencies to achieve a telemedicine system in Nigeria that meets the high standards of conventional medicine. Telemedicine involves several general legal matters, namely, consent, informed consent, contracts, medical negligence, medical ethics and specific medico-legal issues. 7
Apart from the non-availability of these computerised devices at affordable costs, the poor communication network, and the sporadic power supply, confidentiality, and privacy, ideas, and understanding of ailments are challenges to the advancement of telemedicine in Nigeria and other African societies. Telemedicine has the potential of improving Nigeria’s health indices if infrastructural and enabling laws and policy challenges are addressed and can bridge the gap between health care specialists and rural communities. 8 Telemedicine breaks the distance barrier for people living in rural and remote areas. 9
Telemedicine was incorporated in Nigeria in 2007 when NASRDA (National Space Research and Development Agency) and the Federal Ministry of Health inaugurated its pilot project in two teaching hospitals, namely, the University College Hospital, Ibadan, and the University Teaching Hospital, Maiduguri, and six Federal Medical Centers in the six geopolitical zones of the country. The Federal Medical Centres include those in Owo, Gombe, Makurdi, Yenagoa, Birnin Kebbi and Owerri. Apart from the public institutions, private organisations such as the Lagoon Hospital, Lagos, and the Igbinedion University Teaching Hospital, Benin have also embraced the use of the technology. Furthermore, a pilot project that involved mobile units or vehicles equipped with satellite receivers was unveiled. As telemedicine is currently being applied in virtually all medical domains, it can be enormously beneficial for people living in isolated communities and remote regions. Patients who live in such areas can be consulted by a general medical practitioner or specialist, who can provide an accurate and complete examination, avoiding the need for a patient to travel or wait the normal distances or times required for a conventional hospital or general practitioners’ visits. 9
A study by Adenuga et al 10 titled “Towards reinforcing telemedicine adoption amongst clinicians in Nigeria” concluded that the use of telemedicine by clinicians in the Nigerian context is perceived as a dual responsibility which requires suitable reinforcement. The study recognised other influential factors affecting the use of telemedicine in remote areas of Nigeria as performance expectancy, effort expectancy, facilitating condition and reinforcement determinants.
Regulatory issues in telemedicine
Regulatory issues are critical in telemedicine. It is essential to analyse the status of regulations at the time of implementing and developing the telemedicine service. In general, these regulatory aspects are as follows:
Protection of data. Privacy and confidentiality of data. Issues related to responsibility for data.
Comprehensive regulatory frameworks are seldom available, and they are usually based on pre-existing laws about protection of data.
Among the challenges associated with telemedicine is data security. Medical records and health-related data are confidential pieces of information, and it is important for major stakeholders in the health sector of every country to continue to acknowledge this as they always have. The formulation and implementation schemes for telemedicine ought to lay down the safety procedures and ensure strict enforcement to maintain confidentiality of health-related data as inappropriate communication about a patient’s medical condition may be detrimental to their well-being. To ensure that data security measures related to clinical issues in telemedicine operation conform with the standards for the storage of medical data, documents and information relating to the clinical condition of patients must be specifically spelt out. It is also crucial to define the degree of access that specialists have to certain information and to disclose the users that have licensed access to clinical documents. In addition, the management system of clinical data and information should be determined in terms of storage, transfer and processing. The duties and obligations of concerned personnel should be defined through the data security strategy and these personnel should be trained in line with the standards and procedures. Furthermore, patients ought to be enlightened appropriately about their rights and responsibilities although this may be an impediment to the discharge of duties by telemedicine service personnel as people have increasing awareness. It is vital to establish a strategy that allows patients to grant their consent to utilise clinical data obtained from telemedicine services and define patients’ ownership of clinical data and records.
Regulatory bodies and agencies for telemedicine in Nigeria
There is no regulatory body or agency specially formed to regulate telemedicine-related matters in Nigeria. 7 However, there are government agencies indirectly responsible for regulating some of the issues that arise. These government agencies, otherwise known as regulatory bodies, include the Nigerian Communications Commission (NCC), National Agency for Food and Drug Administration and Control (NAFDAC), National Information Technology Development Agency (NITDA), Medical and Dental Council of Nigeria (MDCN), Federal Competition and Consumer Protection Commission (FCCPC) and the Standards Organisation of Nigeria (SON). The functions of these regulatory bodies intersect with telemedicine and its related services in Nigeria.
Laws and guidelines of practice in place for telemedicine in Nigeria
Telemedicine is not just a concept that affects the lives of Nigerians. This makes it even more important for proper guidelines to be created to regulate it as it also involves international affairs.
11
As stated, there are no precise laws regulating telemedicine activities in Nigeria but various laws and provisions apply to certain sectors such as health care, data protection, etc used in telemedicine activities. The provisions are as follows:
The Constitution of the Federal Republic of Nigeria, 1999 (as amended), which stipulates the provision for the right to health and assures the privacy of Nigerians in s 17 and s 37, respectively.
12
The Nigerian Communications Commission Guidelines, Paragraph 11, which contains the guidelines that apply to all licences providing internet access services and any other internet-based telecommunications services. These guidelines are published pursuant to s 70(2) of the Nigerian Communications Act, 2003.
13
In specific circumstances, this provision permits service providers to evade liability as content agents. The Nigerian Communications Commission Guidelines, Paragraph 12, which states: “Internet Service Providers (ISPs) must have in place a procedure for receiving and promptly responding to content related complaints, including any notice to withdraw or disable access to identified content issued by the Commission or other legal authority (‘takedown notices’).”
13
The National Information Technology Development Agency established under the National Information Technology Development Agency Act, 2007, which is commissioned through s 6(c) to: “Develop guidelines for electronic governance and monitor the use of electronic data interchange and other forms of electronic communication transactions as an alternative to paper-based methods in government, commerce, education, the private and public sectors, labour, and other fields, where the use of electronic communication may improve the exchange of data and information.”
14
The Agency is empowered to constitute regulatory standards and guidelines for e-health initiatives. Section 84(1) of the Nigerian Evidence Act, 2011,
15
which legally backs up the admissibility of computer-generated documents and the obtainability of consent by electronic means for the purpose of telemedicine. The Standards Organisation of Nigeria, which is empowered to lay down standards for the technological quality of medical devices manufactured and imported into the nation. The Standards Organisation of Nigeria Act, 2015 established the Organisation and defined its functions and powers.
16
The Federal Competition and Consumer Protection Commission, which was established by the Federal Competition and Consumer Protection Act, 2018 to review economic activities and make extensive provisions for the enforcement of consumers’ rights in relation to health care services.
17
Section 8, 15, 16 and 17 of the Medical and Dental Practitioners Act, Cap M8, which contain the provisions for full registration of medical practitioners and dental surgeons, establishment of the Disciplinary Tribunal and Investigation Panel, penalties for professional misconduct, etc and offences and penalties.
18
Additionally, the Act made provisions for certain regulations, rules and orders. These are contained in s 19(1)(a) and s 19(1)(b). A shortcoming of this Act is that it created no provisions for a nexus between technology and health and it contains several gaps relating to the new trends of the country’s health sector. The National Agency for Food and Drug Administration and Control Act, s 5(a)–(t), which grants the NAFDAC autonomy to establish procedures for quality criteria, management of information and the sale of medicines and regulated health products.
19
Academic contribution
An interim dean of the School of Law at the American University of Nigeria, Professor Lawal Ahmadu, identified a connection between telemedicine, law and national development, stating that telemedicine has so far failed to impact national development due to the absence of a supportive legal framework. 20 The legal challenges of telemedicine were identified and propositions to promote telemedicine as a vital segment of the nation’s health care scheme were suggested by him. 20 He further defined telemedicine as “the practice of medicine from a distance using information and communication technology”. 20 The legal luminary opined that law is a key component of telemedicine and it is essential for the delivery of quality health care in the country. 20
He believed that the inclusion of law would enable telemedicine to meet the standards of conventional medicine. Any additional risks or limitations of telemedicine would be made known to the patient legally. Freedom of information, medical malpractice liability, etc are legal considerations with acts that should be enforced in line with the laws put in place for telemedicine practice. 20
In the professor’s critical examination, he was of the opinion that the medical curriculum ought to be reviewed as it gives no backing whatsoever to telemedicine in the country. 20 He urged legal practitioners as major stakeholders to actively participate in advocating for a proper legal framework, as he believed they were not performing as expected of them. 20 In addition, he remarked that “Law permeates all aspects of society; this is why it can be used to facilitate the development of our health sector in Nigeria.” 20
Government’s involvement in the development of e-health
Over the years, there have been several National Health Policies approved by the federal government in the form of a “Strategic Health Development Plan”. Nigeria still lacks an explicit e-health policy in spite of all this. The involvement of government in the promotion of e-health lacks a clear-cut definition by any policy or legal framework. The execution, backing and regulation of the plan at all levels are threatened owing to the lack of a policy mechanism. It is important to note that there was a stalled attempt to develop an e-health policy and legislation in 2011 when a national conference on ICT health was organised by the federal government. This brought about the decision to formulate a plan for administering e-health in the country. Unfortunately, there is currently no information on the developments that followed the national conference in December 2011.
Recommendations
The importance of telemedicine in Nigeria has been extensively discussed. The applicable laws and the gaps in the Nigerian legal system have been examined. The recommendations below are therefore necessary:
a. Enactment of legislation for telemedicine
It is necessary to establish an Act and to have proper guidelines for telemedicine. The Act should set up a body for the enforcement, regulation and control of telemedicine-related concerns all over the country. It should be clearly defined to enable medical practitioners and telemedicine service providers to provide advice online, diagnose online (e-consultations), prescribe medicine online (e-prescribing) and dispense medicine online (e-dispensing of medicine). In addition, the legislation should provide for the storage of and access to health information across geographical and health sector boundaries. Furthermore, it should stipulate requirements for the licensing or accreditation of online e-health applications, e-health or telemedicine guidelines and codes of practice.
b. Advocacy for a proactive legal framework
Legal practitioners/lawyers also need to advocate for a proactive legal framework for telemedicine and to participate in the policy process, as it is the right step towards national development.
c. Regional and international engagement
The government and relevant stakeholders must be involved in greater alliance with regional and global organisations to improve the telemedicine policies in Nigeria.
d. Active participation by national stakeholders
Committed support between the public and private sectors as well as inviting private sector telemedicine enterprises is vital to form a practicable telemedicine policy. It is also important to form regulatory bodies, including a telecommunications regulator, a data protection regulator and a cyber-crime prevention regulator to further stabilise telemedicine activities. In addition, it is important to encourage and find appropriate alternative and more pragmatic means of performing activities in a virtual environment so that the same effect as with conventional medicine can be achieved.
Conclusion
In achieving all this, it is crucial to establish a committee to develop a practical legal framework on telemedicine that would ensure that the regulations are practical, compliant and enabling. The onus is on the federal and state governments, regulatory bodies and all concerned stakeholders to promote the growth and development of telemedicine services in Nigeria.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.