Artificial Intelligence Surge in Healthcare—Can the Law Keep Up with the Algorithm?

Phenomenologists can very well understand how the term Artificial intelligence has gained popularity and is found to be associated with variable concepts, predictions, social, political, economic, military and legal implications along with a threat to human intelligence, across communities globally [1].A global shift from human intelligence to artificial intelligence can be seen so fast that Gen X can claim to experience and witness this transformational change in their lives.Gen X, being tech-savvy not tech dependent, must face the burden of this paradigm shift [2].Artificial intelligence can be explained as the simulation of human intelligence and programming and training machines to think, analyze, interpret and perform tasks specific to human cognition like problem solving, recognizing patterns and improving over time and with changing scenarios and complexity level [3,4].AI is no longer a future rather it is our present now.It reads X-rays, MRI, scans, automates triage, flags early-stage cancers, offers mental health, nutrition and lifestyle chatbots [5][6][7].Celebrating the success of AI in medicine and healthcare, the question looms are whether our laws evolving fast enough to ensure accountability, safeguard patients and healthcare clients, preserve human dignity and ethical standards across communities are inclusive and equitable [8,9,10].Globally, the AI adoption has risen from 20% in 2020 to 47% in 2024-2025.The pace of growth in clinical AI tools market is entering mainstream workflows [11].The challenges of data governance, algorithm training, robustness, consensus, legal and ethical liability are in debate from 2017 onwards resulting in formulation of regulations and laws in various regions and countries globally [12,13].WHO and FDA published ethical AI technology regulatory framework and continuously issuing guidance documents and frameworks to ensure safety of the AI system [14,15].Pakistan is not behind in the race of AI technology in healthcare, but development of regulations and laws is not fast enough to encounter and tackle the emerging ethical, legal, privacy and liability dilemmas.There is a growing generation gap between tech-savvy and tech-dependent populations (Figure 1).Pakistan lacks a dedicated AI regulations targeting the healthcare sector innovations.In 2023 the Digital health Policy was launched offering vague guidelines, leaving large healthcare organizations (hospitals) to navigate ethical, explainability, responsibility, traceability and governance dilemmas ad hoc [16].A study in 2025 reviewed the FDA documentation on AI healthcare product approval processes for the transparency and evidence rigor in terms of clinical benefit, bias reduction, procedures for testing, and validation etc., and many found to be missing.The procedure for approving these technologies was inadequately mentioned.Based on these shortcomings, strengthening the regulatory review and ensuring equity and inclusivity [17].The critical concepts of systematic error the 'Algorithmic Bias' and 'Black Box AI', are important topics while discussing AI regulations.The Algorithmic Bias means the algorithms are applied to a population on which it is not trained or in other words it is inadequately informed and trained.The Black Box AI is the concept that deep learning AI and other complex models when used are difficult for humans to understand, interpret or give reasoning [18].