The technical case for AI in Bangladeshi medical imaging is compelling. Deep learning algorithms now achieve diagnostic performance comparable to expert clinicians in image-based tasks such as tumor detection, anomaly identification, and disease classification. Automated image segmentation and diagnostic prediction can compress reporting times that currently stretch for days in under-resourced facilities. For a country where the healthcare system faces pronounced urban–rural disparities, infrastructural constraints, and a thin supply of specialists, the technology offers a genuine opportunity to extend expert-level diagnostics to populations that have historically gone without. The World Health Organization has recognized this potential, defining AI in health as the use of algorithms and software to approximate human cognition in the analysis and interpretation of complex medical data.

Yet the study insists that this shift is not happening in a regulatory vacuum so much as in a regulatory void. Bangladesh’s principal digital legislation, including the Information and Communication Technology Act 2006 and the Digital Security Act 2018, was drafted for cybersecurity and digital offenses, not for the governance of algorithmic decision-making in clinical settings. The analysis identifies no clear statutory provisions governing how patient data may be used to train AI systems, how liability should be allocated when an algorithm-assisted misdiagnosis causes harm, or how transparency obligations can be enforced when diagnostic outputs emerge from opaque computational models. These are not marginal technicalities; they go to the heart of patient safety and legal recourse.

The ethical stakes are framed through the four classical principles of biomedical ethics: autonomy, beneficence, non-maleficence, and justice. Autonomy is tested when patients cannot know how their data are used or how algorithms contribute to their diagnosis. Beneficence demands that AI genuinely improve care while remaining under human oversight. Non-maleficence requires protection against algorithmic bias, data errors, and misdiagnosis, harms the study notes can be systemic and reproducible across entire populations. Justice requires that the benefits of AI not deepen existing inequalities between urban and rural, public and private healthcare. The authors argue that these principles provide both a moral compass and a practical lens through which Bangladesh’s legal instruments can be critically assessed.

The methodological approach is doctrinal, sometimes called black-letter legal research, involving the systematic identification, interpretation, and evaluation of authoritative sources: statutes, regulations, professional codes, and policy documents. The descriptive dimension maps Bangladesh’s existing legal landscape; the normative dimension asks whether that landscape aligns with international standards. The study draws on primary legal materials, secondary interpretive sources, and ethical frameworks including the WHO’s 2021 Guidance on Ethics and Governance of Artificial Intelligence for Health, the UNESCO Recommendation on the Ethics of Artificial Intelligence adopted by all 193 member states, and the European Union’s AI Act, which classifies medical diagnostic imaging systems as high-risk and imposes stringent obligations on data quality, transparency, human oversight, and post-market monitoring.

Against these benchmarks, Bangladesh’s domestic frameworks fall short in instructive ways. The Bangladesh Medical and Dental Council’s Code of Medical Ethics, while emphasizing physician competence and confidentiality, presupposes direct human decision-making and does not address algorithmic opacity, data-intensive diagnostics, or the allocation of responsibility in AI-assisted errors. The Draft Bangladesh National AI Policy 2026–2030 represents progress, acknowledging transparency, accountability, human oversight, and safeguards against fully autonomous clinical decision-making. But the study finds these provisions remain largely programmatic rather than enforceable: the policy establishes no binding liability regime, no independent oversight body, and no detailed compliance mechanisms for high-risk applications such as medical imaging.

The comparative analysis adds an important caution against simple imitation. The EU’s risk-based model works because it rests on strong institutional infrastructure, including independent supervisory authorities and robust data protection under the GDPR. The United Kingdom’s principle-based approach depends on the integrated structure of the National Health Service, which allows coordinated implementation of AI standards. The United States relies on a market-oriented FDA framework for AI and machine-learning-based Software as a Medical Device, emphasizing pre-market approval and lifecycle monitoring. Each model presupposes institutional capacity, regulatory expertise, and technological maturity that Bangladesh cannot simply import. The authors warn that uncritical transplantation of Global North frameworks risks becoming symbolic rather than functional, and may even reinforce what they describe as techno-colonialism, where standards and technologies are externally imposed without contextual adaptation.

The study’s most distinctive contribution is its insistence on explaining why regulatory gaps persist rather than merely cataloging them. It identifies structural factors: limited regulatory capacity, fragmented legal frameworks, competing political priorities that privilege digital expansion over rights-based governance, and heavy reliance on externally developed technologies trained on datasets from high-income countries. That last point carries direct clinical consequences. Imaging algorithms trained on foreign demographic and epidemiological data may embed systematic biases that produce diagnostic inaccuracies disproportionately affecting vulnerable Bangladeshi populations, particularly where local data infrastructure and dataset representativeness requirements are absent.

Informed consent emerges as a particularly thorny problem. The draft policy’s prohibition on AI independently making life-altering decisions addresses only a narrow slice of autonomy. The deeper difficulty is algorithmic opacity: when clinicians themselves cannot fully explain how diagnostic outputs were generated, meaningful patient consent becomes difficult to uphold. The challenge is compounded in Bangladesh by limited digital literacy and hierarchical physician–patient relationships, conditions under which consent risks degenerating into a procedural formality rather than a substantive safeguard. Similarly, the draft policy’s data protection commitments, including calls for strict safeguards against leakage of sensitive health information, are not backed by a comprehensive, sector-specific data protection regime covering anonymization, secondary use, and cross-border transfers.

The study closes with a reform agenda that links ethical principles to operational governance. It calls for comprehensive health data legislation that codifies patient rights, consent, and transparency; AI-specific ethical guidelines updating professional codes to address algorithmic accountability; a sector-specific regulatory authority to oversee validation, certification, and post-deployment monitoring of clinical AI; clearly defined liability frameworks spanning developers, deployers, and clinicians; and sustained investment in regulatory capacity and AI literacy among healthcare professionals. The authors argue that without this shift from aspirational policy-making to enforceable, institutionally grounded regulation, AI adoption in Bangladesh risks exacerbating existing inequalities rather than curing them. Their message to policymakers is ultimately optimistic but firm: the country can harness AI to transform diagnostic medicine, but only if its legal and ethical infrastructure evolves as fast as the technology it is meant to govern.

Subject of Research: Ethical and legal governance of artificial intelligence in medical imaging and diagnostics in Bangladesh

Article Title: Regulating AI in medical imaging and diagnostics in Bangladesh through ethical and legal doctrinal analysis

Article References: Basu, B. K., Sarker, M. F. R., Akter, R., Amin, M. B., Hassan, M. S., Debnath, G. C., & Sony, M. M. A. A. M. (2026). Regulating AI in medical imaging and diagnostics in Bangladesh through ethical and legal doctrinal analysis. Discover Artificial Intelligence, 6(1), Article 1324. https://doi.org/10.1007/s44163-026-02197-w

Image Credits: AI Generated

DOI: 10.1007/s44163-026-02197-w

Keywords: artificial intelligence, medical imaging, Bangladesh, health law, medical ethics, data protection, informed consent, algorithmic bias, EU AI Act, WHO guidance, regulatory policy, digital health