Abstract
Reinforcement learning (RL) marks a fundamental shift in how artificial
intelligence is applied in healthcare. Instead of merely predicting outcomes,
RL actively decides interventions with long term goals. Unlike traditional
models that operate on fixed associations, RL systems learn through trial,
feedback, and long-term reward optimization, introducing transformative
possibilities and new risks. From an information fusion lens, healthcare RL
typically integrates multi-source signals such as vitals, labs clinical notes,
imaging and device telemetry using temporal and decision-level mechanisms.
These systems can operate within centralized, federated, or edge architectures
to meet real-time clinical constraints, and naturally span data, features and
decision fusion levels. This survey explore RL's rise in healthcare as more
than a set of tools, rather a shift toward agentive intelligence in clinical
environments. We first structure the landscape of RL techniques including
model-based and model-free methods, offline and batch-constrained approaches,
and emerging strategies for reward specification and uncertainty calibration
through the lens of healthcare constraints. We then comprehensively analyze RL
applications spanning critical care, chronic disease, mental health,
diagnostics, and robotic assistance, identifying their trends, gaps, and
translational bottlenecks. In contrast to prior reviews, we critically analyze
RL's ethical, deployment, and reward design challenges, and synthesize lessons
for safe, human-aligned policy learning. This paper serves as both a a
technical roadmap and a critical reflection of RL's emerging transformative
role in healthcare AI not as prediction machinery, but as agentive clinical
intelligence.
School of Electrical and Electronic Engineering, University Of Galway
Abstract
As deep learning (DL) technologies advance, their application in automated
visual inspection for Class III medical devices offers significant potential to
enhance quality assurance and reduce human error. However, the adoption of such
AI-based systems introduces new regulatory complexities--particularly under the
EU Artificial Intelligence (AI) Act, which imposes high-risk system obligations
that differ in scope and depth from established regulatory frameworks such as
the Medical Device Regulation (MDR) and the U.S. FDA Quality System Regulation
(QSR). This paper presents a high-level technical assessment of the
foresee-able challenges that manufacturers are likely to encounter when
qualifying DL-based automated inspections within the existing medical device
compliance landscape. It examines divergences in risk management principles,
dataset governance, model validation, explainability requirements, and
post-deployment monitoring obligations. The discussion also explores potential
implementation strategies and highlights areas of uncertainty, including data
retention burdens, global compliance implications, and the practical
difficulties of achieving statistical significance in validation with limited
defect data. Disclaimer: This publication is in-tended solely as an academic
and technical evaluation. It is not a substitute for le-gal advice or official
regulatory interpretation. The information presented here should not be relied
upon to demonstrate compliance with the EU AI Act or any other statutory
obligation. Manufacturers are encouraged to consult appropriate regulatory
authorities and legal experts to determine specific compliance pathways.