A Legal Analysis of Informed Consent in AI-Driven Healthcare in Nigeria

A Legal Analysis of Informed Consent in AI-Driven Healthcare in Nigeria

Introduction

The rapid integration of Artificial Intelligence (AI) in healthcare has transformed medical diagnosis, treatment, and patient care, offering unprecedented opportunities for improved health outcomes globally. However, this technological advancement also raises critical ethical concerns, particularly regarding informed consent and patient autonomy. Informed consent is a fundamental principle of medical ethics, ensuring patients understand the benefits, risks, and alternatives of medical interventions. The complexity of AI-driven healthcare decisions necessitates re-examining informed consent frameworks to safeguard patient autonomy.

 

In Nigeria, where healthcare infrastructure and patient education vary significantly, ensuring patients comprehend AI-driven healthcare decisions is crucial. The country's diverse cultural landscape, limited health literacy, and inadequate healthcare infrastructure create unique challenges for implementing effective informed consent processes. Therefore, research is needed to determine how Nigerian patients comprehend AI-driven medical decisions and how they affect their autonomy. To guarantee the protection of patients' rights, this article examines these problems within the framework of Nigeria, stressing the challenges posed and suggesting ways forward.

 

Understanding Informed Consent in AI-Driven Healthcare

Informed consent is a key ethical tenet in healthcare, which guarantees that patients understand and consent to the treatments they receive. It involves providing patients with comprehensive information about the nature, benefits, risks, and alternatives of a proposed intervention. And this is the basic foundation of patient autonomy, a core medical principle, emphasizing the right of patients to make informed decisions about their healthcare.

 

This principle has long been governed by the National Health Act 2014 and the practice is well established among healthcare providers. The Act mandates that healthcare providers obtain informed consent from patients before any medical intervention, emphasizing the need for clear communication and understanding. Failure to obtain such consent can constitute a violation of legal rights.

 

For instance, Section 37 of the Constitution guarantees and protects the data privacy rights of citizens with patients inclusive. In addition, Nigerian courts have interpreted this part of the Constitution broadly and thoroughly, holding that it is against an individual's right to privacy to reveal their personal information without that individual's consent. In MTN Nigeria Communications Ltd Vs. Godfrey Nya Eneye, the Court of Appeal held that the defendant's unauthorized disclosure of the claimant's mobile phone number breached his basic right to privacy.

 

In the medical palace, the Nigeria Data Protection Regulation (NDPR) 2019 and the Nigeria Data Protection Act 2023 ensure the confidentiality of healthcare user information, including health status, treatment, and stay in health establishments. This law supports the National Health Act and Patients Bill of Rights (PBoR) 2018, requiring consent, privacy and confidentiality unless public health or law enforcement requires disclosure, and it must be in the best interests of the patient or general public.

 

The apex court of the land - Supreme Court of Nigeria, in the notorious case of Medical and Dental Practitioners Disciplinary Tribunal Vs. Dr. John Emewulu Nicholas Okonkwo reaffirmed this principle, where the court held that the right of a patient to consent to medical treatment must be respected.

“The patient’s consent is paramount…the patient’s relationship with a doctor is based on consensus,… the choice of an adult patient with a sound mind to refuse informed  consent to medical treatment, barring state intervention through judicial process, leaves the practitioner helpless to impose a treatment on the patient.”

Likewise, Justice Cardozo of the New York Court of Appeal, while validating how important informed consent is, in Schloendorff Vs Society of New York Hospital, held thus:

"Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages." 

 

However, AI-driven healthcare encompasses a range of technologies, including machine learning algorithms, predictive analytics, and robotic surgery. These technologies offer significant benefits, such as improved diagnostic accuracy, personalized treatment plans, and enhanced operational efficiency. Nevertheless, they also present unique challenges for informed consent, particularly in terms of patient understanding and legal accountability. Thus, informed consent becomes more complex due to the opacity and complexity of AI algorithms. 

 

Knowing how AI systems operate is one of the main obstacles to getting patients' informed consent for AI-driven healthcare. The complexity and opaqueness of AI algorithms, especially those based on machine learning, might make it challenging for patients to understand how decisions are made. The ability of patients to make knowledgeable decisions regarding their care may be hampered by this lack of transparency.

 

Likewise, it is a known fact that most AI systems rely on massive datasets, which frequently include patient's private data. Hence, this calls for the security and privacy of sensitive data to be guaranteed. In the same vein, AI-driven healthcare systems can inadvertently perpetuate biases present in the data they are trained on, leading to unequal treatment of patients based on factors such as race, gender, or socioeconomic status. Thus, customizing AI use of disclosure to meet patient preferences and ethical norms is crucial, ensuring informed consent for diagnosis beyond legal requirements.

 

The Way Forward

To address these issues, there is a need for specific legal provisions that address informed consent in AI-driven healthcare. This includes guidelines on explaining AI systems to patients, ensuring transparency, and safeguarding data privacy. Currently, Nigeria lacks comprehensive regulations specifically addressing AI in healthcare. Existing laws, such as the National Health Act, Nigeria Data Protection Act and its Regulation, Cybercrime Act and Nigerian Communication Commission Act among others provide some guidance on patient’s medical and health records, data privacy and security but do not fully address the unique challenges posed by AI.

 

In contrast, the recently released National Artificial Intelligence Strategy 2024 Draft, hopes to offer more specific regulations therein as it aims to set a course for Nigeria "to be a global leader in harnessing the transformative power of AI through responsible, ethical, and inclusive innovation, fostering sustainable development through collaborative efforts.” Unfortunately, it does not provide for how the implementation plan will be developed or executed. Nevertheless, it is still a stone in the right direction.

 

Aside from the above, healthcare providers must also develop strategies to explain AI processes in a way that is accessible and comprehensible to patients. This might involve using simplified explanations, visual aids, or interactive tools that help patients understand the role of AI in their treatment. Ensuring that patients have a clear understanding of how AI systems function is crucial for maintaining their autonomy and trust in the healthcare system.

 

Additionally, healthcare providers must ensure that patients are given meaningful choices and that their preferences are respected. This includes providing alternatives to AI-driven interventions and ensuring that patients understand the potential implications of their choices. By prioritizing patient autonomy, healthcare providers can foster a more ethical and patient-centred approach to AI integration.

 

Moreso, ethical guidelines should require regular audits of AI systems to identify and mitigate biases, ensuring that AI contributes to equitable healthcare delivery. Similarly, ethical standards ought to require strong data security protocols and open data usage rules. Patients should have the choice to consent or opt-out, and they should be informed about how their data will be used, stored, and shared.

 

As a result, effective informed consent in AI-driven healthcare requires patients to comprehend the benefits, risks, and limitations of AI-generated medical decisions, enabling them to make autonomous and informed choices about their care. This involves healthcare providers disclosing clear explanations of AI-driven decisions, respecting patients' voluntariness to accept or refuse AI-driven care, and ensuring patients have the capacity to make informed decisions.

 

Conclusion

Ultimately, effective informed consent in AI-driven healthcare in Nigeria requires a multifaceted approach. While existing laws provide some guidance, comprehensive regulations addressing AI's unique challenges are essential. At the same time, healthcare providers must prioritize patient autonomy - explaining AI processes clearly and respecting patient preferences. Regular audits to identify biases, robust data security protocols, and transparent data usage rules are crucial.

 

By doing this, Nigeria can harness the transformative power of AI while ensuring that patient rights and dignity are upheld. Meanwhile, continuous education and training for healthcare providers on the ethical and legal aspects of AI-driven healthcare are necessary. This will equip them with the knowledge and skills needed to effectively communicate with patients about AI technologies and obtain informed consent.

 

By addressing these concerns, in the end, policymakers, healthcare providers, and stakeholders can collaborate to establish clear guidelines and ensure informed consent remains a cornerstone of patient-centred care in Nigeria's evolving healthcare landscape.

Image Source : https://nextgeninvent.com/blogs/use-cases-of-generative-ai-in-healthcare/

 

DISCLAIMER NOTICE
This is a free educational site for your general information and enlightenment ONLY. This site, by itself, does not create a Client/Attorney relationship. Recipients are therefore advised to seek professional legal counselling to their specific situations when they do arise. Questions, comments, criticisms, suggestions, new ideas, contributions, etc are welcome. The articles here, are protected by Intellectual Property Law and Regulations and is reproduced by Medical Law Hub under permission for the Medical Law Hub community.