In today’s rapid digital transformation of the clinical trials space, artificial intelligence (AI) is becoming an indispensable part of meeting business goals and improving patient care and treatment. One essential concept that bridges the evolving field of AI technology and effective human oversight required in such a regulated space is “Human in the Loop” (HITL). 

What is Human in the Loop (HITL)?

Human in the Loop refers to the integration of human governance into AI systems. In this AI adoption model, although AI performs tasks, makes predictions, or processes data, human oversight is involved to supervise, provide feedback, and make critical decisions. The objective of HITL is to leverage the strengths of both AI and human intelligence to achieve more accurate, reliable, and ethically sound outcomes.

In the context of AI software, HITL ensures that the system remains under human control and that its operations are aligned with human values and practical realities. This approach is particularly beneficial in scenarios where AI alone might not fully grasp complex or nuanced situations.

Why Should a Medical Writer Be a Human in the Loop for Clinical Documentation?

Clinical documentation involves the detailed reporting of a patient’s medical history, treatment plans, and healthcare outcomes. The accuracy and quality of these reports are paramount, as they inform regulatory decisions and impact patient safety. Integrating AI in clinical documentation can streamline data entry, reduce redundancy, and promote lean authoring concepts, and enhance information retrieval. However, the sensitive nature of medical data demands a high level of precision that AI alone might not yet guarantee. Here’s why a medical writer is ideal for this role:

1. Expert Knowledge and Understanding: Medical writers have a deep understanding of medical terminology and clinical contexts. They can ensure that the documentation captured by AI reflects accurate medical information and adheres to established standards, guidelines, and protocols.
2. Quality Control and Accuracy: A medical writer can review and validate the information processed by AI, ensuring that the data is not only accurate but also clinically relevant. This step is crucial in avoiding potentially dangerous misunderstandings or misinterpretations that could affect patient care or cause unintended harm.
3. Ethical Considerations and Patient Privacy: Medical writers are intimately familiar with ethical guidelines and legal requirements related to patient data and privacy. Their involvement ensures that the use of AI in documentation adheres to these standards, safeguarding patient information and maintaining confidentiality.
4. Adaptability to Changes: Healthcare is a dynamic field, with frequent updates in guidelines, treatments, and drug information. Medical writers can update AI systems with the latest relevant knowledge and practices, ensuring that the documentation and instructions remain current and useful.
5. Human Touch and Patient-Centric Clinical Trials: While AI can handle data efficiently, it lacks the human touch needed to make patient-centric decisions. Medical writers can interpret AI-generated data at both micro and macro levels, adding a layer of context that AI cannot achieve on its own.

Conclusion

The role of Human in the Loop is integral to harnessing the full potential of AI in healthcare, particularly in clinical documentation. Involving medical writers in this process can ensure that the integration of AI not only enhances efficiency but also upholds the highest standards and accuracy—a role that medical writers and medical communicators have been playing proudly for decades. As AI continues to advance, the human element, represented by skilled professionals like medical writers, will remain indispensable in bridging the gap between technological capabilities and human needs.

If you want to take it one step further and investigate AI medical writing software created by career-long medical writers for clinical and regulatory documents, from protocols and informed consent forms to IND and NDA submissions, check out AgileWriter™, our AI-enabled authoring platform for clinical documentation, and see in this video how we keep the human in the loop.