HELIX: Human-Agent Embedded Lifecycle for Healthcare Integration Engineering

Abstract

The increasing complexity of healthcare integration engineering—managing hundreds of HL7 and FHIR interfaces across distributed integration engine environments—demands development methodologies that scale beyond traditional manual workflows. While general-purpose agent-driven software development lifecycle (SDLC) frameworks have been proposed for software engineering, no formal framework exists for systematically embedding AI agents across every phase of the healthcare integration development lifecycle under the clinical safety, regulatory compliance, and semantic precision constraints unique to this domain. This paper introduces HELIX (Human-Agent Embedded Lifecycle for Healthcare Integration Engineering)—a formal framework for AI-driven development lifecycle (AI-DLC) in healthcare integration engineering, defined as a 6-tuple comprising lifecycle phases, a 12-role agent taxonomy, an institutional knowledge architecture, orchestration protocols, constitutional constraints, and evaluation metrics. The framework positions specialized AI agents as embedded participants in every lifecycle phase—from requirements analysis through operations—with the human engineer as the authoritative decision-maker. Six of twelve defined agent roles are retrospectively validated through published healthcare-specific empirical research, three are partially validated by general-domain AI and DevOps research requiring healthcare adaptation, and three are identified as open research gaps requiring new investigation. A preliminary empirical evaluation using a within-subjects counterbalanced design with eight integration analysts developing 48 healthcare interfaces (24 per condition) demonstrates that HELIX orchestration reduces mean development time by 57.1% (paired t-test: t(7) = 8.33, p < 0.001, Cohen's d_z = 2.95), analyst cognitive workload by 33.4% (NASA-TLX: t(7) = 7.78, p < 0.001), and defect density by 30.6% (t(7) = 3.84, p < 0.01) compared to manual baseline. HELIX provides the first domain-specific formal foundation for a research program advancing AI-embedded healthcare integration engineering.