Fostering a Culture of Health Innovation: A Review of Regulation and Integration of AI, Genomics, and Digital Therapeutics by the Ministry of Health

Background: The global health landscape is being redefined by a new era of emerging technologies, including artificial intelligence (AI), genomics, and digital therapeutics (DTx). The technologies hold the promise to shift healthcare from an episodic, reactive, and hospital-based system to a predictive, personalized, and participatory system. However, their incorporation in healthcare systems raises severe problems for regulation, ethics, equity, and implementation. The national Ministry of Health (MoH) is at the center of coordinating this transition, but its role must change beyond traditional roles such that it actively encourages a culture of responsible innovation. Aim: The purpose of this narrative review is to synthesize existing literature for critically analyzing the multidimensional role of the MoH in spearheading the integration of AI, genomics, and DTx. Methods: Systematic peer-reviewed and grey literature search between 2010-2024 on PubMed, Scopus, Web of Science, and WHO, FDA, and other regulatory sources. Thematic analysis with results structured around three core domains: governance, infrastructure, and adoption. Results: The review suggests that holistic strategies are necessary for successful integration. In regulation, MoHs must implement flexible, risk-appropriate regulatory frameworks for adaptive AI and DTx that ensure ethical exploitation of genomic information. State investment in underlying infrastructure, such as national data governance arrangements and genomic biobanks, is needed. New value-based payment models, upskilling of human resources, and national clinical guidelines need to be fostered to drive adoption. Conclusion: MoH is the indispensable conductor of health innovation. Through adopting a pro-reform, integrated stewardship strategy, MoHs can unlock the power of AI, genomics, and DTx to build more equitable, efficient, and resilient health systems, ultimately to speed progress towards Universal Health Coverage.