Abstract
<sec> <title>BACKGROUND</title> <p>Rapid population ageing is increasing demand for long-term care (LTC), while workforce shortages threaten the sustainability of institutional care. AI- and robotics-based digital eldercare may support care delivery and mitigate staffing constraints. However, existing AI ethics and governance frameworks provide limited operational guidance for translating ethical principles into feasible, workflow-compatible practices in long-term care.</p> </sec> <sec> <title>OBJECTIVE</title> <p>To develop and validate an implementation-oriented ethical, legal, and social implications (ELSI) guideline for AI- and robotics-based digital eldercare in the Republic of Korea using a multi-method design.</p> </sec> <sec> <title>METHODS</title> <p>This multi-method study comprised three stages. Phase 1 included a rapid targeted documentary review of governance documents and technical standards and semi-structured interviews conducted between July and September 2025 in two LTC hospitals with 21 stakeholders (16 caregivers, 2 patients, and 3 administrators), analyzed using framework analysis. Phase 2 involved a two-round modified Delphi process (September-October 2025) with 28 invited experts (16 in Round 1 and 12 in Round 2), who rated entity inclusion, importance, and feasibility on 5-point Likert scales. Phase 3 consisted of a developer-facing validation workshop with 15 technical stakeholders evaluating the guideline's clarity, feasibility, and usability.</p> </sec> <sec> <title>RESULTS</title> <p>The documentary review synthesized requirements into 12 domains and 48 checklist items. Interviews emphasized (1) meaningful human oversight, (2) fail-safe operation and accountable risk governance, and (3) feasibility constraints shaping what is ethically achievable; these findings expanded the draft into 19 domains and 72 checklist items, formatted as 91 Delphi-rated entities (19 domains and 72 items). In Round 1, 34 entities (7 domains and 27 items) achieved consensus. Of 57 entities carried forward, 56 were re-rated in Round 2, and 40 entities (10 domains and 30 items) achieved consensus; 1 item omitted from re-rating was retained as a conditional recommendation. Combined with the 27 items reaching consensus in Round 1, this yielded a 57-item consensus-based core checklist. The remaining 15 items were retained as conditional recommendations within the 72-item implementation framework. Consensus was strongest for human oversight, technical safety and reliability, autonomy and privacy, and dignity protections. Equitable Access to Technology and Fair Resource Allocation had the lowest mean feasibility ratings and comparatively high variability in importance ratings, suggesting implementation challenges. Workshop participants supported the guideline's relevance but highlighted risks of regulatory framing and requested clearer intended users, lifecycle staging, and tiered recommendations.</p> </sec> <sec> <title>CONCLUSIONS</title> <p>This study delivers a stakeholder-informed, implementation-oriented ELSI guideline for digital eldercare in LTC hospitals. Findings support staged ethical governance: establishing a near-term safety-and-oversight baseline while progressively building institutional and policy capacity to operationalize equity commitments in diverse LTC settings.</p> </sec>