Geetank Kamboj, Dr. Rajpal Singh, Hemant Rathi
NICE outlines essential guidelines for responsibly integrating artificial intelligence into health technology assessment processes and evidence generation.

The integration of artificial intelligence (AI) into Health Technology Assessment (HTA) has become a focal point in the evolving landscape of evidence generation. The National Institute for Health and Care Excellence (NICE) has published a detailed position statement on the integration of AI in evidence generation for HTA. This guidance arrives at a pivotal time when AI’s potential to enhance evidence generation is being keenly explored across healthcare sectors. Below, we delve into the essential facets of NICE’s position and what it means for the future of HTA.
Table 1 summarizes the key points of NICE’s position on AI integration in HTA.
Aspect | Description |
AI's Role in Healthcare | NICE acknowledges AI's ability to quickly process large datasets and identify patterns, aiding better decision-making in healthcare technology assessments. |
Balancing AI's Pros and Cons | NICE emphasizes that AI should be used only when it adds clear value and its transparency, fairness, and security risks are carefully managed. |
What NICE Expects When Using AI | NICE expects organizations to justify AI use, consult early, and adhere to ethical and technical guidelines in healthcare assessments. |
AI Should Assist, Not Replace, Humans | AI should be used to help, not replace, human decision-making. Any organization using AI must be clear about how it's used and ensure that people are still in control and making the final decisions. |
Following Rules and Being Clear | Organizations using AI must follow rules, ensure transparency, report risks, and explain how they address them. |
AI in Different Areas of Healthcare | AI can aid in research, clinical trials, data analysis, and cost-effectiveness, but its use must be clear, justified, and follow best practices. |
NICE Will Keep an Eye on AI Use | NICE will monitor AI in healthcare, update guidelines as needed, and may train staff to enhance AI understanding and use. |
Maintaining Trust and Transparency | NICE is committed to keeping its guidelines trustworthy and clear. AI should be used to support and improve decision-making, not complicate it or make it less transparent. |
AI’s potential to transform evidence generation in HTA is undeniable. From automating literature reviews to enhancing the design of clinical trials, AI can significantly streamline processes. However, NICE emphasizes the importance of balancing these innovations against inherent risks, such as algorithmic bias, cybersecurity vulnerabilities, and transparency challenges. NICE suggests that AI should only be employed when it clearly adds value, ensuring that the benefits outweigh the potential downsides.
AI should augment human decision-making, not replace it. NICE stresses the importance of keeping humans in the loop, ensuring that AI tools are used to enhance, rather than supplant, human expertise. This approach is crucial for maintaining ethical standards and ensuring the reliability of the evidence produced.
NICE insists that organizations using AI in evidence generation must prioritize transparency. This means clearly justifying the use of AI, documenting methodologies, and ensuring that AI-driven results are understandable and accessible to all stakeholders. Transparency is vital to maintaining trust in the AI-generated evidence.
Organizations considering the use of AI in their evidence generation processes are encouraged to engage with NICE early in the development process. This proactive approach can help ensure that AI methodologies are aligned with NICE’s expectations and regulatory standards from the outset, minimizing potential issues later on.
Any AI methods used must align with existing UK Government frameworks and ethical guidelines. This includes adherence to data protection laws and ensuring that AI applications are both scientifically and technically sound. Organizations are responsible for ensuring that all AI tools and methodologies meet these stringent standards.
Given the rapidly evolving nature of AI technology, NICE plans to continually review and update its guidelines to reflect new developments and evidence. This commitment ensures that AI’s integration into HTA remains both innovative and responsible, ultimately supporting improved healthcare outcomes.
NICE’s position on AI in HTA emphasizes the need for responsible, transparent, and ethical integration of AI technologies. While AI holds significant potential to transform HTA, NICE advocates for a cautious approach that safeguards the integrity of evidence generation and decision-making. By adhering to these guidelines, organizations can harness the power of AI to support and enhance evidence generation, ensuring that AI’s benefits are fully realized without compromising the quality or integrity of healthcare decisions.
National Institute for Health and Care Excellence. (2024). Use of AI in evidence generation: NICE position statement. Retrieved from https://www.nice.org.uk/about/what-we-do/our-research-work/use-of-ai-in-evidence-generation–nice-position-statement