The pulse of global AI regulations through a life sciences lens
Where innovation races and compliance keeps the pace steady
As AI reshapes the life sciences industry, a sector where innovation moves fast and regulatory scrutiny runs deep, the global AI regulations have yet to reach a steady state. Regulators’ approach to balancing the AI duality (i.e., the tension between innovation and risk aversion) is wide-ranging and impacts global adoption. Industry leaders need to decode and keep abreast of the latest regional AI regulatory requirements and approaches for the adoption of AI. Discover how the shifting and diverse regulatory landscape will affect life sciences companies and why early alignment strategy with global AI regulations is critical for competitive advantage in life sciences. The answer lies not in waiting for regulatory clarity but in leading it by positioning AI regulations as a strategic factor—not a reactive task.
Executive summary: The new shape of global AI regulations in life sciences
The global landscape for AI in life sciences is shifting rapidly. Some regulators are moving to replace voluntary frameworks with enforceable laws, while others are adopting a non-statutory approach. AI tools that once operated globally in regulatory ambiguity—whether used in drug discovery, diagnostics, or patient monitoring—are now subject to new oversight demands that span transparency, accountability, and safety.
The approaches vary:
- The European Union’s AI Act is now partially in force and may classify some life sciences AI tools as high risk.
- China’s draft AI Law imposes state-driven guardrails on health-related AI.
- In the US, AI guidance is primarily being shaped by executive orders coming out of the White House and interpreted by multiple agencies.
- In Japan, the first AI law was officially introduced in 2025 and represents a significant step to establish a legal framework for the development and application of AI technologies but is still aligned with the “soft law” approach.
- India is advancing sector-specific guidelines and legislation.
Each framework offers a unique path, but they all are shaped by the same underlying tension and duality: the drive to lead in AI innovation while avoiding missteps that could compromise patient safety, outcomes, or public trust.
And yet, the global regulatory landscape remains in flux. No steady state has been reached. While jurisdictions are converging on some high-level principles—such as privacy, fairness, transparency, and bias mitigation—common ground on enforcement and implementation remains elusive. Health authorities in some regions have issued nonbinding guidance or industry-specific high-level regulations, offering limited clarity. Currently, life sciences companies are navigating without a globally harmonized roadmap.
The global artificial intelligence (AI) revolution has moved from theoretical potential to operational reality—especially for the life sciences sector. The AI tools reshaping how therapies and medical devices are developed, tested, and brought to market are now subject to rising and broad global regulatory oversight. The tension between innovation and risk aversion is mounting.
Every jurisdiction that the Global Regulatory Intelligence Team (GRIT) at Deloitte explored through our research spanning October 2024 through April 2025—and across six global regions: China, European Union, India, Japan, United Kingdom, and United States—is pursuing a different regulatory approach and is in a different position on the duality spectrum of innovation and risk. Governments are eager to lead in AI innovation to spur economic growth and be at the forefront of advancement. Yet, with that ambition comes a growing recognition that AI must be deployed responsibly, with safeguards that uphold human rights, safety, transparency, integrity, and public trust. Each jurisdiction may approach this duality differently, guided by broader national goals, cultural norms, and sociopolitical contexts.
As the pace of global AI regulation accelerates, one truth becomes clear: in life sciences, agility and accountability are no longer trade-offs. They are twin imperatives for the future.
Imperatives for effective AI integration
Life sciences companies should prepare for and embrace continued change by:
- Establishing processes to monitor and understand the impact of changes in global AI regulations.
- Building flexible AI governance systems that can adapt across jurisdictions, and forming a framework of AI tool development that is adaptable to global regulatory shifts.
- Executives should weigh global versus regional compliance strategies—balancing risk, cost, and speed to market.
- Companies should focus on developing auditable, explainable, and bias-mitigated AI systems to gain early regulatory trust.
- Stakeholder engagement—including proactive dialogue with regulators—will likely be critical to anticipating future guidance and reducing downstream friction.
While the path ahead is complex, it is navigable—especially for companies that treat regulation not as a barrier, but as a blueprint for market leadership, patient trust, and lasting innovation.
Life sciences companies are faced with three strategic imperatives that can shape their readiness and ability to lead effectively in the introduction of AI to their processes.
Risk-readiness: “Wait and see” is no longer a viable AI strategy. To lead in innovation and capture competitive advantage, life sciences companies need to be willing to act—despite uncertainty.
A patchwork with purpose: Smart life sciences companies are building global governance systems that adapt locally but scale universally.
From compliance to competitive edge: Companies that align early to the evolving landscape may find their competitive edge comes not from cutting corners but from building trust—at record speed.
Regional executive summary regulatory outlook: A global landscape in flux
While some countries are taking a non-statutory approach, the European Union has made headlines by becoming the first to enshrine broad-based AI regulation into law. The EU AI Act, which officially became a law in August 2024, has a gradual implementation rollout till August 2027 and represents the most sweeping statutory framework to date. In Japan, the first AI law—the Act on Promotion of Research and Development, and Utilization of AI-Related Technology—was passed in May 2025 and represents an initial step in AI governance rather than a comprehensive regulatory framework. It is primarily a policy-driven initiative designed to foster innovation, advance research and development, and promote responsible use of AI technologies. The current framework applies a light touch and is flexible, allowing room for future adjustments and stricter regulations as needed. In contrast, China balances agile regulation with state control, and other major markets—including the United States, United Kingdom, and India—are relying on a mix of nonbinding guidance, sector-specific rules, or fragmented agency-led oversight. This divergence has created a complex landscape for life sciences companies to navigate. (Table 1 provides a high-level summary of all jurisdictions discussed in this paper. While the country specific sections provide a detailed overview.)
The variation in regulatory approaches, maturity, enforcement mechanisms, and risk classifications across the six jurisdictions we highlight presents operational and strategic challenges for global life sciences firms. While there is no single pathway through this evolving regulatory environment, life sciences companies that invest now in regulatory readiness, cross-functional collaboration, and strategic foresight not only will stay compliant but also could possibly lead the next generation of AI-enabled health innovation.
Global standards organizations: Moving toward harmonization
The global AI regulatory landscape remains disparate, with no unified governance system in place. Instead, a handful of influential organizations and international bodies are advancing parallel frameworks aimed at improving alignment and interoperability—each with distinct priorities and approaches. For life sciences companies operating across borders, navigating the variety of regulatory approaches presents both a compliance challenge and a strategic opportunity.
Efforts to promote global harmonization have gained momentum, particularly around shared values such as ethical AI use, data privacy, human rights, and system safety. However, meaningful alignment has yet to emerge. Countries continue to adopt varying levels of statutory and non-statutory approaches to AI regulation, which complicates the development of universally applicable compliance guidance and standards. Several global organizations are shaping the direction of international AI standards. Although these frameworks have commonalities, a global regulatory consensus remains elusive.
Moving forward: Strategic steps for AI readiness
As the regulatory landscape evolves, life sciences firms can’t afford to wait for clarity. Proactive action is a leading path forward. Here’s some considerations for moving from reactive compliance to strategic readiness:
The last word: Embracing the new AI reality
In this sector where innovation moves fast and scrutiny runs deep, compliance is no longer the last hurdle before market entry. It’s the proving ground where credibility is won or lost. In the race to lead AI-driven health innovation, the winners won’t be those who simply comply—but those who wield responsibility as a strategic advantage. In the era of regulated intelligence, playing by the rules isn’t a burden. It’s the new power move.
