JMIR Publications

ABSTRACT

Background:

Long-term care (LTC) facilities operate within complex regulatory environments that require continuous compliance with federal and state standards governing resident safety, care quality, documentation, staffing, infection prevention, medication management, and quality assurance. Although health information technologies (HITs) have become widely adopted in LTC settings, evidence suggests that these systems primarily improve documentation quality and information accessibility without consistently producing corresponding improvements in regulatory compliance, workflow reliability, care coordination, or resident outcomes. Existing LTC HIT architecture remains predominantly documentation-centered, functioning as repositories for retrospective recordkeeping rather than as active mechanisms for regulatory execution and operational coordination.

Objective:

This study aimed to develop a standards-based socio-technical framework for engineering workflow-integrated, regulatory-embedded health information systems capable of translating regulatory requirements into computable workflow logic and operational processes within LTC environments.

Methods:

A theory-driven conceptual synthesis methodology was used to integrate literature from health informatics, socio-technical systems theory, implementation science, workflow engineering, interoperability research, human factors engineering, governance, process mining, and long-term care regulatory science. Literature published between 2015 and 2026 was identified through iterative searches of PubMed/MEDLINE, CINAHL, Scopus, Web of Science, IEEE Xplore, and Google Scholar. Concepts were synthesized using the Systems Engineering Initiative for Patient Safety (SEIPS 2.0), Consolidated Framework for Implementation Research (CFIR), Policy-as-Code principles, and workflow engineering approaches. Framework development was guided by the Socio-Technical Regulatory Decomposition Protocol (STRD), a structured methodology for translating narrative regulatory requirements into computable workflow artifacts.

Results:

The resulting framework consists of six interrelated layers: regulatory translation, workflow orchestration, decision support and adaptive logic, interoperability infrastructure, workflow monitoring and telemetry, and governance and lifecycle management. Regulatory requirements are translated into executable workflow logic, escalation pathways, and monitoring mechanisms embedded directly within care delivery. Technical implementation pathways incorporate HL7 Fast Healthcare Interoperability Resources (FHIR), Clinical Quality Language (CQL), Decision Model and Notation (DMN), Business Process Model and Notation (BPMN), CDS Hooks, SMART-on-FHIR, AuditEvent, and Provenance resources. The framework further incorporates governance controls, Policy-as-Code concepts, process mining, interoperability profiles, and audit-ready telemetry mechanisms. An illustrative implementation based on CMS F880 Infection Prevention and Control requirements demonstrates technical feasibility through executable workflow artifacts and synthetic workflow evaluation.

Conclusions:

This framework advances LTC informatics beyond documentation-centered architecture by conceptualizing regulation as an operational workflow process rather than a retrospective documentation activity. By integrating socio-technical theory, implementation science, interoperability standards, workflow engineering, and computational governance approaches, the framework provides a foundation for designing regulatory-embedded HIT systems capable of supporting compliance, care coordination, audit readiness, and organizational resilience.