<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD Journal Publishing DTD v2.0 20040830//EN" "journalpublishing.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" dtd-version="2.0" xml:lang="en" article-type="research-article"><front><journal-meta><journal-id journal-id-type="nlm-ta">JMIR Diabetes</journal-id><journal-id journal-id-type="publisher-id">diabetes</journal-id><journal-id journal-id-type="index">23</journal-id><journal-title>JMIR Diabetes</journal-title><abbrev-journal-title>JMIR Diabetes</abbrev-journal-title><issn pub-type="epub">2371-4379</issn><publisher><publisher-name>JMIR Publications</publisher-name><publisher-loc>Toronto, Canada</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">v11i1e79166</article-id><article-id pub-id-type="doi">10.2196/79166</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Paper</subject></subj-group></article-categories><title-group><article-title>Privacy-Preserving Collaborative Diabetes Prediction in Heterogeneous Health Care Systems: Algorithm Development and Validation of a Secure Federated Ensemble Framework</article-title></title-group><contrib-group><contrib contrib-type="author"><name name-style="western"><surname>Hasan</surname><given-names>Md Rakibul</given-names></name><degrees>MSc</degrees><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author" corresp="yes"><name name-style="western"><surname>Li</surname><given-names>Juan</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="aff1"/></contrib></contrib-group><aff id="aff1"><institution>Department of Computer Science, Faculty, North Dakota State University</institution><addr-line>258 Quentin Burdick Bldg, Computer Science Department, NDSU, 1320 Albrecht Blvd</addr-line><addr-line>Fargo</addr-line><addr-line>ND</addr-line><country>United States</country></aff><contrib-group><contrib contrib-type="editor"><name name-style="western"><surname>Li</surname><given-names>Sheyu</given-names></name></contrib></contrib-group><contrib-group><contrib contrib-type="reviewer"><name name-style="western"><surname>Gheisari</surname><given-names>Mehdi</given-names></name></contrib><contrib contrib-type="reviewer"><name name-style="western"><surname>Patel</surname><given-names>Shreyaskumar</given-names></name></contrib></contrib-group><author-notes><corresp>Correspondence to Juan Li, PhD, Department of Computer Science, Faculty, North Dakota State University, 258 Quentin Burdick Bldg, Computer Science Department, NDSU, 1320 Albrecht Blvd, Fargo, ND, 58105, United States, 1 701-231-9662; <email>J.Li@ndsu.edu</email></corresp></author-notes><pub-date pub-type="collection"><year>2026</year></pub-date><pub-date pub-type="epub"><day>26</day><month>1</month><year>2026</year></pub-date><volume>11</volume><elocation-id>e79166</elocation-id><history><date date-type="received"><day>16</day><month>06</month><year>2025</year></date><date date-type="rev-recd"><day>13</day><month>12</month><year>2025</year></date><date date-type="accepted"><day>17</day><month>12</month><year>2025</year></date></history><copyright-statement>&#x00A9; Md Rakibul Hasan, Juan Li. Originally published in JMIR Diabetes (<ext-link ext-link-type="uri" xlink:href="https://diabetes.jmir.org">https://diabetes.jmir.org</ext-link>), 26.1.2026. </copyright-statement><copyright-year>2026</copyright-year><license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/"><p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">https://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Diabetes, is properly cited. The complete bibliographic information, a link to the original publication on <ext-link ext-link-type="uri" xlink:href="https://diabetes.jmir.org/">https://diabetes.jmir.org/</ext-link>, as well as this copyright and license information must be included.</p></license><self-uri xlink:type="simple" xlink:href="https://diabetes.jmir.org/2026/1/e79166"/><abstract><sec><title>Background</title><p>Diabetes prediction requires accurate, privacy-preserving, and scalable solutions. Traditional machine learning models rely on centralized data, posing risks to data privacy and regulatory compliance. Moreover, health care settings are highly heterogeneous, with diverse participants, hospitals, clinics, and wearables, producing nonindependent and identically distributed data and operating under varied computational constraints. Learning in isolation at individual institutions limits model generalizability and effectiveness. Collaborative federated learning (FL) enables institutions to jointly train models without sharing raw data, but current approaches often struggle with heterogeneity, security threats, and system coordination.</p></sec><sec><title>Objective</title><p>This study aims to develop a secure, scalable, and privacy-preserving framework for diabetes prediction by integrating FL with ensemble modeling, blockchain-based access control, and knowledge distillation. The framework is designed to handle data heterogeneity, nonindependent and identically distributed distributions, and varying computational capacities across diverse health care participants while simultaneously enhancing data privacy, security, and trust.</p></sec><sec sec-type="methods"><title>Methods</title><p>We propose a federated ensemble learning framework, FedEnTrust, that enables decentralized health care participants to collaboratively train models without sharing raw data. Each participant shares soft label outputs, which are distilled and aggregated through adaptive weighted voting to form a global consensus. The framework supports heterogeneous participants by assigning model architectures based on local computational capacity. To ensure secure and transparent coordination, a blockchain-enabled smart contract governs participant registration, role assignment, and model submission with strict role-based access control. We evaluated the system on the PIMA Indians Diabetes Dataset, measuring prediction accuracy, communication efficiency, and blockchain performance.</p></sec><sec sec-type="results"><title>Results</title><p>The FedEnTrust framework achieved 84.2% accuracy, with precision, recall, and <italic>F</italic><sub>1</sub>-score of 84.6%, 88.6%, and 86.4%, respectively, outperforming existing decentralized models and nearing centralized deep learning benchmarks. The blockchain-based smart contract ensured 100% success for authorized transactions and rejected all unauthorized attempts, including malicious submissions. The average blockchain latency was 210 milliseconds, with a gas cost of ~107,940 units, enabling secure, real-time interaction. Throughout, patient privacy was preserved by exchanging only model metadata, not raw data.</p></sec><sec sec-type="conclusions"><title>Conclusions</title><p>FedEnTrust offers a deployable, privacy-preserving solution for decentralized health care prediction by integrating FL, ensemble modeling, blockchain-based access control, and knowledge distillation. It balances accuracy, scalability, and ethical data use while enhancing security and trust. This work demonstrates that secure federated ensemble systems can serve as practical alternatives to centralized artificial intelligence models in real-world health care applications.</p></sec></abstract><kwd-group><kwd>blockchain</kwd><kwd>decentralized health care</kwd><kwd>diabetes prediction</kwd><kwd>ensemble learning</kwd><kwd>federated learning</kwd><kwd>knowledge distillation</kwd><kwd>privacy-preserving AI</kwd><kwd>artificial intelligence</kwd><kwd>AI</kwd></kwd-group></article-meta></front><body><sec id="s1" sec-type="intro"><title>Introduction</title><p>Diabetes continues to pose a growing global health burden, requiring timely prediction and proactive management to reduce complications and improve quality of life [<xref ref-type="bibr" rid="ref1">1</xref>]. While machine learning has emerged as a powerful tool for diabetes prediction, conventional approaches often rely on centralized data repositories [<xref ref-type="bibr" rid="ref2">2</xref>-<xref ref-type="bibr" rid="ref4">4</xref>]. This reliance introduces serious challenges related to patient privacy, regulatory compliance (eg, Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and susceptibility to cyberattacks [<xref ref-type="bibr" rid="ref5">5</xref>]. Moreover, centralized data aggregation is increasingly impractical due to fragmented data ownership across institutions and regions [<xref ref-type="bibr" rid="ref6">6</xref>].</p><p>Real-world health care systems are inherently heterogeneous, encompassing a wide range of contributors&#x2014;from large hospitals and urban clinics to wearable health devices in remote settings [<xref ref-type="bibr" rid="ref7">7</xref>]. These entities vary significantly in data volume, quality, and computational capacity. The data are often nonindependent and identically distributed (non-IID), reflecting demographic, clinical, and behavioral diversity [<xref ref-type="bibr" rid="ref8">8</xref>]. As a result, models trained within a single institution or on homogeneous datasets often struggle to generalize across settings, limiting their effectiveness and scalability.</p><p>To address these limitations, collaborative federated learning (FL) has emerged as a compelling solution [<xref ref-type="bibr" rid="ref9">9</xref>]. However, applying FL to real-world diabetes prediction presents several unresolved challenges. In particular, current FL frameworks often struggle with:</p><list list-type="bullet"><list-item><p>security vulnerabilities, such as model poisoning and adversarial manipulation [<xref ref-type="bibr" rid="ref10">10</xref>]</p></list-item><list-item><p>lack of coordination and trust, especially in decentralized, multiparty settings [<xref ref-type="bibr" rid="ref11">11</xref>]</p></list-item><list-item><p>performance degradation due to client heterogeneity and non-IID data distributions [<xref ref-type="bibr" rid="ref12">12</xref>]</p></list-item></list><p>While several FL frameworks [<xref ref-type="bibr" rid="ref13">13</xref>-<xref ref-type="bibr" rid="ref16">16</xref>] have been explored for decentralized health care analytics, most assume homogeneous model architectures, single global models, or idealized trust environments and do not explicitly address lightweight or resource-constrained participants at the edge [<xref ref-type="bibr" rid="ref17">17</xref>,<xref ref-type="bibr" rid="ref18">18</xref>]. Existing systems, such as Biscotti [<xref ref-type="bibr" rid="ref19">19</xref>] and Chang et al [<xref ref-type="bibr" rid="ref20">20</xref>], rely on gradient sharing and therefore require structurally aligned models and consistent computational resources, while recent blockchain-enabled FL frameworks incorporate differential privacy but still assume homogeneous models or centralized coordination [<xref ref-type="bibr" rid="ref21">21</xref>,<xref ref-type="bibr" rid="ref22">22</xref>]. Furthermore, blockchain [<xref ref-type="bibr" rid="ref23">23</xref>], a promising technology for ensuring integrity, transparency, and access control in decentralized systems, has seen limited integration with FL, especially in diabetes prediction contexts. Other blockchain-enabled approaches, such as Shalan et al [<xref ref-type="bibr" rid="ref24">24</xref>], provide secure access control but do not incorporate mechanisms for interoperable knowledge sharing across heterogeneous local models.</p><p>In contrast, FedEnTrust introduces an integrated design that simultaneously addresses model heterogeneity, non-IID data, trust and identity verification, and secure update submission. By combining soft-label knowledge distillation with blockchain-verified RBAC, FedEnTrust enables robust collaboration across diverse health care systems while preventing unauthorized or malicious updates. FedEnTrust introduces a novel integration of:</p><list list-type="bullet"><list-item><p>ensemble learning, allowing clients to train diverse local models best suited to their data and computational constraints</p></list-item><list-item><p>soft-label knowledge distillation, enabling effective model aggregation across non-IID participants</p></list-item><list-item><p>blockchain-based smart contracts, which provide tamper-proof coordination, role-based access control, and participant accountability</p></list-item></list><p>FedEnTrust represents a step forward in secure and collaborative artificial intelligence (AI) for health care, with the following key contributions:</p><list list-type="order"><list-item><p>Heterogeneity-aware ensemble design: Each participant trains a model tailored to its resource level, supporting real-world deployment across varied health care nodes.</p></list-item><list-item><p>Knowledge distillation-based aggregation: We introduce a soft-label ensemble mechanism that improves convergence and generalization across non-IID data.</p></list-item><list-item><p>Blockchain-enabled trust layer: Our smart contract system enforces participant registration, access control, and secure model submissions without a centralized authority.</p></list-item><list-item><p>Comprehensive evaluation: Using the PIMA Indians Diabetes Dataset, we demonstrate that FedEnTrust improves prediction accuracy; maintains privacy; and ensures secure, low-latency collaboration.</p></list-item></list><p>By addressing the intersection of privacy, trust, heterogeneity, and security, FedEnTrust provides a practical and deployable framework for AI-powered diabetes prediction in real-world, decentralized health care systems.</p></sec><sec id="s2" sec-type="methods"><title>Methods</title><sec id="s2-1"><title>Overview of FedEnTrust</title><p>FedEnTrust is a secure, privacy-preserving federated ensemble learning framework designed to address the challenges of decentralized diabetes prediction across heterogeneous health care environments. It enables collaborative learning without centralizing sensitive patient data, accommodates diverse computational resources, and defends against malicious behaviors through a blockchain-coordinated trust infrastructure. The core modules of FedEnTrust include (1) heterogeneity-aware local model training, (2) knowledge distillation via soft label sharing, (3) blockchain-based secure coordination, and (4) adaptive ensemble aggregation.</p><p>These modules work together to realize 3 key objectives: maintaining patient privacy, enabling equitable participation across institutions with varying capacities, and ensuring secure collaboration in a decentralized system.</p><p><xref ref-type="fig" rid="figure1">Figure 1</xref> illustrates the end-to-end data flow across the 4 modules. Local raw data remain strictly on the device. Each participant trains a heterogeneous local model and generates soft-label probability vectors. These soft labels, along with accuracy metadata, are sent off-chain to the aggregator but must first pass through blockchain-based role-based access control (RBAC) validation, where the smart contract verifies participant identity, role permissions, and submission metadata. Validated soft labels are incorporated into an adaptive weighted aggregation mechanism, producing global pseudo-labels that are redistributed to all participants. The blockchain records transaction hashes and role enforcement events, ensuring traceability without revealing sensitive data.</p><fig position="float" id="figure1"><label>Figure 1.</label><caption><p>Overview of the FedEnTrust architecture. Soft labels generated by local models are authenticated through blockchain-based role-based access control and combined using adaptive weighted aggregation to produce pseudo labels for continued local training. ML: machine learning.</p></caption><graphic alt-version="no" mimetype="image" position="float" xlink:type="simple" xlink:href="diabetes_v11i1e79166_fig01.png"/></fig></sec><sec id="s2-2"><title>Architectural Novelty and Comparison With Existing FL Frameworks</title><p>Real-world health care environments exhibit substantial diversity in computational capacity, data distributions, trust requirements, and security risks. To contextualize the design of FedEnTrust within this landscape, we compare its architectural capabilities against representative FL and blockchain-enabled frameworks in <xref ref-type="table" rid="table1">Table 1</xref>.</p><table-wrap id="t1" position="float"><label>Table 1.</label><caption><p>Architectural comparison of FedEnTrust with representative federated learning frameworks.</p></caption><table id="table1" frame="hsides" rules="groups"><thead><tr><td align="left" valign="top">Challenge in real-world health care FL</td><td align="left" valign="top">FedEnTrust (Our work)</td><td align="left" valign="top">Hasan et al [<xref ref-type="bibr" rid="ref15">15</xref>]</td><td align="left" valign="top">Biscotti [<xref ref-type="bibr" rid="ref19">19</xref>]</td><td align="left" valign="top">Chang et al [<xref ref-type="bibr" rid="ref20">20</xref>]</td><td align="left" valign="top">Microcontroller FL<sup><xref ref-type="table-fn" rid="table1fn1">a</xref></sup> [<xref ref-type="bibr" rid="ref17">17</xref>]</td></tr></thead><tbody><tr><td align="left" valign="top">Heterogeneous compute environments (hospitals, clinics, kiosks, wearables)</td><td align="left" valign="top">Heterogeneity-aware model assignment; each node trains model matching its device capacity; ensemble aggregation aligns knowledge across disparate models</td><td align="left" valign="top">Supports ML<sup><xref ref-type="table-fn" rid="table1fn2">b</xref></sup> models but generally assumes similar capacity clients</td><td align="left" valign="top">Assumes all clients run comparable gradient-sharing deep models</td><td align="left" valign="top">Single model structure required; difficult for low-resource clients</td><td align="left" valign="top">Designed for ultra-low-power devices; not suitable for multitier health care</td></tr><tr><td align="left" valign="top">Non-IID<sup><xref ref-type="table-fn" rid="table1fn3">c</xref></sup> and imbalanced data across institutions</td><td align="left" valign="top">Soft-label knowledge distillation + weighted aggregation improve cross-site generalization</td><td align="left" valign="top">Local models trained independently; static averaging struggles with non-IID distributions</td><td align="left" valign="top">Gradient aggregation without distillation; non-IID data reduces convergence</td><td align="left" valign="top">DP<sup><xref ref-type="table-fn" rid="table1fn4">d</xref></sup>-sanitized gradients reduce signal strength on non-IID data</td><td align="left" valign="top">Very limited support for complex non-IID medical data</td></tr><tr><td align="left" valign="top">Cross-institution trust and secure participation</td><td align="left" valign="top">Smart contract&#x2013;driven RBAC<sup><xref ref-type="table-fn" rid="table1fn5">e</xref></sup>; on-chain validation of model submissions; rejects malicious or unauthorized updates</td><td align="left" valign="top">Minimal security; no on-chain validation</td><td align="left" valign="top">Uses blockchain only as consensus layer, not for role-level access control</td><td align="left" valign="top">Smart contract manages DP gradients, not participation permissions</td><td align="left" valign="top">No trust or participation assurance mechanism</td></tr><tr><td align="left" valign="top">Protection against malicious updates (poisoning, fake uploads)</td><td align="left" valign="top">On-chain validator roles + metadata checks prevent poisoned soft labels before aggregation</td><td align="left" valign="top">No defense against malicious gradient or model uploads</td><td align="left" valign="top">Consensus prevents tampering but not model poisoning</td><td align="left" valign="top">DP reduces leakage but not poisoning</td><td align="left" valign="top">No adversarial defense features</td></tr><tr><td align="left" valign="top">Interoperability across model types</td><td align="left" valign="top">Soft labels unify outputs of RF<sup><xref ref-type="table-fn" rid="table1fn6">f</xref></sup>, XGB<sup><xref ref-type="table-fn" rid="table1fn7">g</xref></sup>, DT<sup><xref ref-type="table-fn" rid="table1fn8">h</xref></sup>, SVM<sup><xref ref-type="table-fn" rid="table1fn9">i</xref></sup>, KNN<sup><xref ref-type="table-fn" rid="table1fn10">j</xref></sup> into comparable probability space</td><td align="left" valign="top">Homogeneous ML models; limited interoperability</td><td align="left" valign="top">Requires same model structure for gradient fusion</td><td align="left" valign="top">Single-model FL; weights must match</td><td align="left" valign="top">No model interoperability</td></tr><tr><td align="left" valign="top">Scalability across distributed health care networks</td><td align="left" valign="top">Lightweight soft-label sharing reduces communication overhead and suits mixed-resource environments</td><td align="left" valign="top">Local model averaging; moderate scalability</td><td align="left" valign="top">Heavy blockchain consensus overhead limits scalability</td><td align="left" valign="top">DP gradient exchange increases bandwidth needs</td><td align="left" valign="top">Limited to microcontroller networks</td></tr><tr><td align="left" valign="top">Auditability and traceability for compliance (HIPAA<sup><xref ref-type="table-fn" rid="table1fn11">k</xref></sup> or GDPR<sup><xref ref-type="table-fn" rid="table1fn12">l</xref></sup>)</td><td align="left" valign="top">Full on-chain audit log of registrations, updates, and permissions</td><td align="left" valign="top">Centralized coordination; limited auditability</td><td align="left" valign="top">All gradient updates stored on-chain&#x2014;high cost</td><td align="left" valign="top">Stores only gradient summaries; limited audit transparency</td><td align="left" valign="top">Not designed for regulated health care settings</td></tr></tbody></table><table-wrap-foot><fn id="table1fn1"><p><sup>a</sup>FL: federated learning.</p></fn><fn id="table1fn2"><p><sup>b</sup>ML: machine learning.</p></fn><fn id="table1fn3"><p><sup>c</sup>IID: independent and identically distributed.</p></fn><fn id="table1fn4"><p><sup>d</sup>DP: differential privacy. </p></fn><fn id="table1fn5"><p><sup>e</sup>RBAC: role-based access control.</p></fn><fn id="table1fn6"><p><sup>f</sup>RF: random forest.</p></fn><fn id="table1fn7"><p><sup>g</sup>XGB: extreme gradient boosting.</p></fn><fn id="table1fn8"><p><sup>h</sup>DT: decision tree.</p></fn><fn id="table1fn9"><p><sup>i</sup>SVM: support vector machine.</p></fn><fn id="table1fn10"><p><sup>j</sup>KNN: k-nearest neighbors.</p></fn><fn id="table1fn11"><p><sup>k</sup>HIPAA: Health Insurance Portability and Accountability Act.</p></fn><fn id="table1fn12"><p><sup>l</sup>GDPR: General Data Protection Regulation.</p></fn></table-wrap-foot></table-wrap><p>Unlike approaches such as Hasan et al [<xref ref-type="bibr" rid="ref15">15</xref>], Biscotti [<xref ref-type="bibr" rid="ref19">19</xref>], and Chang et al [<xref ref-type="bibr" rid="ref20">20</xref>], which rely on homogeneous model structures or gradient-based updates, FedEnTrust supports heterogeneity-aware model assignment. Each participant trains a locally suitable model (eg, random forest, extreme gradient boosting, decision tree, support vector machine [SVM], k-nearest neighbors [KNN]) based on its available resources, enabling participation from hospitals, clinics, kiosks, and wearable devices.</p><p>FedEnTrust also differs from blockchain-enabled systems such as Shalan et al [<xref ref-type="bibr" rid="ref24">24</xref>] and TinyFL [<xref ref-type="bibr" rid="ref25">25</xref>]. While these frameworks integrate blockchain for logging or access control, they do not incorporate soft-label knowledge distillation or adaptive ensemble aggregation to unify heterogeneous model outputs. FedEnTrust introduces a unique coupling of soft-label&#x2013;based distillation with blockchain-enforced RBAC, enabling secure verification of participant identity and role prior to model update submission, on-chain logging of update hashes to ensure auditability, prevention of malicious or unauthorized contributions before they influence aggregation, and interoperability of predictions across diverse model architectures.</p><p>This integration ensures that only authenticated, validated soft labels contribute to the global model. This design is particularly effective for non-IID and imbalanced health care data settings, where traditional gradient-averaging approaches struggle.</p></sec><sec id="s2-3"><title>Module 1: Decentralized Local Training With Heterogeneous Models</title><p>FedEnTrust begins with a network of decentralized health care participants, including large hospitals, regional clinics, kiosks, and personal health trackers, each training its own machine learning model locally. These models are tailored to each participant&#x2019;s computational capabilities and data volume. For example, high-resource hospitals may use deep neural networks, while low-resource settings use shallow learning such as KNN or support vector classifier (SVC) to support real-time inference with minimal memory demands.</p><p>This heterogeneity-aware model assignment ensures that all participants, regardless of scale or technical capacity, can contribute meaningfully. Local training is performed privately using internal datasets, aligning with privacy regulations such as HIPAA and GDPR.</p></sec><sec id="s2-4"><title>Module 2: Knowledge Distillation via Soft Labels</title><p>To facilitate collaborative learning without exposing raw data, participants generate soft labels, probability distributions over prediction classes (eg, diabetic, nondiabetic). These soft labels encode richer information than binary outputs and are shared with a central aggregator, enabling cross-site knowledge transfer.</p><sec id="s2-4-1"><title>Soft Label Generation</title><p>Each participant generates soft labels, probability distributions reflecting its model&#x2019;s confidence across classes, and transmits these predictions to the aggregator. Unlike gradient-based approaches, soft labels create an interoperable representation across heterogeneous model types. Before being used for ensemble aggregation, every soft label submission is paired with metadata including local validation accuracy, model identifier, and round number. For an input instance <italic>x</italic>, the participant&#x2019;s model outputs a probability vector:</p><disp-formula id="E1"><label>(1)</label><mml:math id="eqn1"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mrow><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:msub><mml:mi>P</mml:mi><mml:mi>i</mml:mi></mml:msub><mml:mo stretchy="false">(</mml:mo><mml:mi>x</mml:mi><mml:mo stretchy="false">)</mml:mo><mml:mo>=</mml:mo><mml:mo stretchy="false">[</mml:mo><mml:msub><mml:mi>p</mml:mi><mml:mn>1</mml:mn></mml:msub><mml:mo>,</mml:mo><mml:msub><mml:mi>p</mml:mi><mml:mn>2</mml:mn></mml:msub><mml:mo>,</mml:mo><mml:mo>&#x2026;</mml:mo><mml:mo>,</mml:mo><mml:msub><mml:mi>p</mml:mi><mml:mi>c</mml:mi></mml:msub><mml:mo stretchy="false">]</mml:mo><mml:mo>&#x2208;</mml:mo><mml:msup><mml:mrow><mml:mi mathvariant="double-struck">R</mml:mi></mml:mrow><mml:mi>c</mml:mi></mml:msup><mml:mo>,</mml:mo><mml:mtext>&#x00A0;</mml:mtext><mml:mtext>where&#x00A0;</mml:mtext><mml:munderover><mml:mo>&#x2211;</mml:mo><mml:mrow><mml:mi>c</mml:mi><mml:mo>=</mml:mo><mml:mn>1</mml:mn></mml:mrow><mml:mrow><mml:mi>C</mml:mi></mml:mrow></mml:munderover><mml:msub><mml:mi>p</mml:mi><mml:mi>c</mml:mi></mml:msub><mml:mo>=</mml:mo><mml:mn>1</mml:mn></mml:mstyle></mml:mstyle></mml:mrow></mml:mstyle></mml:math></disp-formula><p>These soft labels encapsulate the model&#x2019;s confidence across the <inline-formula><mml:math id="ieqn1"><mml:mi>C</mml:mi></mml:math></inline-formula>classes and support knowledge transfer without sharing raw patient data or internal model parameters.</p><p>To address differences in how heterogeneous models calibrate probability outputs, FedEnTrust applies temperature scaling, which smooths the probability distribution by dividing logits <inline-formula><mml:math id="ieqn2"><mml:msub><mml:mrow><mml:mi>z</mml:mi></mml:mrow><mml:mrow><mml:mi>i</mml:mi></mml:mrow></mml:msub><mml:mo>(</mml:mo><mml:mi>x</mml:mi><mml:mo>)</mml:mo></mml:math></inline-formula>by a temperature parameter <inline-formula><mml:math id="ieqn3"><mml:mi>T</mml:mi></mml:math></inline-formula>:</p><disp-formula id="E2"><label>(2)</label><mml:math id="eqn2"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mrow><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mtable rowspacing="4pt" columnspacing="1em"><mml:mtr><mml:mtd><mml:msubsup><mml:mi>P</mml:mi><mml:mrow><mml:mi>i</mml:mi></mml:mrow><mml:mrow><mml:mrow><mml:mo>(</mml:mo><mml:mi>t</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow></mml:msubsup><mml:mrow><mml:mo>(</mml:mo><mml:mi>x</mml:mi><mml:mo>)</mml:mo></mml:mrow><mml:mo>=</mml:mo><mml:mtext>s</mml:mtext><mml:mtext>o</mml:mtext><mml:mtext>f</mml:mtext><mml:mtext>t</mml:mtext><mml:mtext>m</mml:mtext><mml:mtext>a</mml:mtext><mml:mtext>x</mml:mtext><mml:mtext>&#x00A0;</mml:mtext><mml:mrow><mml:mo>(</mml:mo><mml:mfrac><mml:mrow><mml:msub><mml:mi>z</mml:mi><mml:mrow><mml:mi>i</mml:mi></mml:mrow></mml:msub><mml:mrow><mml:mo>(</mml:mo><mml:mi>x</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow><mml:mi>T</mml:mi></mml:mfrac><mml:mo>)</mml:mo></mml:mrow><mml:mo>,</mml:mo><mml:mtext>&#x00A0;</mml:mtext><mml:mi>T</mml:mi><mml:mo>=</mml:mo><mml:mn>2</mml:mn></mml:mtd></mml:mtr></mml:mtable></mml:mstyle></mml:mrow></mml:mstyle></mml:math></disp-formula><p>A temperature of <inline-formula><mml:math id="ieqn4"><mml:mi>T</mml:mi><mml:mo>=</mml:mo><mml:mn>2</mml:mn></mml:math></inline-formula> was selected because values greater than 1 produce smoother, less overconfident probability distributions, which improves the stability of aggregation across models with different calibration characteristics. A small temperature (eg, <inline-formula><mml:math id="ieqn5"><mml:mi>T</mml:mi><mml:mo>=</mml:mo><mml:mn>1</mml:mn></mml:math></inline-formula>) can lead to overly sharp probabilities that amplify noise, while excessively large values dilute useful predictive signals. Empirical testing showed that <inline-formula><mml:math id="ieqn6"><mml:mi>T</mml:mi><mml:mo>=</mml:mo><mml:mn>2</mml:mn></mml:math></inline-formula> offers an optimal balance.</p></sec><sec id="s2-4-2"><title>Dynamic Weight Updates Across Federated Rounds</title><p>Once soft labels are generated by each participant model, the system proceeds to combine these distributed outputs into a unified global prediction. This ensemble consensus represents a key step in transferring collective intelligence across all nodes while respecting the constraints of data privacy and computational diversity.</p><p>&#x2003;The ensemble aggregation process employs adaptive weighted soft voting, where more reliable and accurate models are given stronger influence. For example, a well-resourced clinic with consistently high validation performance will contribute more to the global prediction than a basic kiosk with limited data. However, no participant is excluded; each contributes according to its validated strength, ensuring fairness and inclusivity in the learning process. FedEnTrust adaptively updates the influence of each participant during communication round <inline-formula><mml:math id="ieqn7"><mml:mi>t</mml:mi></mml:math></inline-formula>. Each participant evaluates its model using a shared public validation subset to compute <inline-formula><mml:math id="ieqn8"><mml:msubsup><mml:mrow><mml:mtext>Acc</mml:mtext></mml:mrow><mml:mrow><mml:mi>i</mml:mi></mml:mrow><mml:mrow><mml:mfenced separators="|"><mml:mrow><mml:mi>t</mml:mi></mml:mrow></mml:mfenced></mml:mrow></mml:msubsup></mml:math></inline-formula>, which is the validation accuracy of participant <inline-formula><mml:math id="ieqn9"><mml:mi>i</mml:mi></mml:math></inline-formula> at round <inline-formula><mml:math id="ieqn10"><mml:mi>t</mml:mi></mml:math></inline-formula>. The ensemble assigns each participant a normalized contribution weight:</p><disp-formula id="E3"><label>(3)</label><mml:math id="eqn3"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mrow><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mtable rowspacing="4pt" columnspacing="1em"><mml:mtr><mml:mtd><mml:msubsup><mml:mi>W</mml:mi><mml:mrow><mml:mi>i</mml:mi></mml:mrow><mml:mrow><mml:mrow><mml:mo>(</mml:mo><mml:mi>t</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow></mml:msubsup><mml:mo>=</mml:mo><mml:mfrac><mml:msubsup><mml:mtext>Acc</mml:mtext><mml:mrow><mml:mi>i</mml:mi></mml:mrow><mml:mrow><mml:mrow><mml:mo>(</mml:mo><mml:mi>t</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow></mml:msubsup><mml:mrow><mml:munderover><mml:mo movablelimits="false">&#x2211;</mml:mo><mml:mrow><mml:mi>j</mml:mi><mml:mo>=</mml:mo><mml:mn>1</mml:mn></mml:mrow><mml:mrow><mml:mi>N</mml:mi></mml:mrow></mml:munderover><mml:msubsup><mml:mtext>Acc</mml:mtext><mml:mrow><mml:mi>j</mml:mi></mml:mrow><mml:mrow><mml:mrow><mml:mo>(</mml:mo><mml:mi>t</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow></mml:msubsup></mml:mrow></mml:mfrac></mml:mtd></mml:mtr></mml:mtable></mml:mstyle></mml:mstyle></mml:mrow></mml:mstyle></mml:math></disp-formula><p>To prevent dominant institutions (eg, large hospitals with more data) from exerting disproportionate influence, FedEnTrust applies weight clipping, capping <inline-formula><mml:math id="ieqn11"><mml:msubsup><mml:mrow><mml:mi>W</mml:mi></mml:mrow><mml:mrow><mml:mi>i</mml:mi></mml:mrow><mml:mrow><mml:mfenced separators="|"><mml:mrow><mml:mi>t</mml:mi></mml:mrow></mml:mfenced></mml:mrow></mml:msubsup></mml:math></inline-formula>at an upper bound. This ensures contribution fairness and reduces the risk of bias toward specific demographic subpopulations.</p></sec><sec id="s2-4-3"><title>Justification for Heterogeneous Model Assignment</title><p>The model architectures listed in <xref ref-type="table" rid="table2">Table 2</xref> were selected to reflect realistic resource constraints and deployment contexts:</p><list list-type="bullet"><list-item><p>Random forest (hospitals): Hospitals possess sufficient computational capacity and large datasets; random forest models capture nonlinear relationships and perform well on tabular clinical data.</p></list-item><list-item><p>XGB (regional clinics): XGB provides strong performance under moderate computational resources, making it suitable for mid-sized clinics.</p></list-item><list-item><p>Decision trees and KNN (community clinics or kiosks): These models require minimal training cost and support real-time inference in low-power environments.</p></list-item><list-item><p>Linear SVM (wearables or personal trackers): Linear SVM has a lower memory footprint than logistic regression and offers more stable performance on small, noisy physiological samples typically produced by wearables.</p></list-item></list><table-wrap id="t2" position="float"><label>Table 2.</label><caption><p>Simulated decentralized participants and their models.</p></caption><table id="table2" frame="hsides" rules="groups"><thead><tr><td align="left" valign="top">ID</td><td align="left" valign="top">Participant</td><td align="left" valign="top">Model architecture</td><td align="left" valign="top">Key parameters</td><td align="left" valign="top">Resource level</td><td align="left" valign="top">Weight</td><td align="left" valign="top">Remarks</td></tr></thead><tbody><tr><td align="left" valign="top">1</td><td align="left" valign="top">Large hospital</td><td align="left" valign="top">Random forest</td><td align="left" valign="top">n_estimators=130max_depth=15max_features=0.75 data_use=50%</td><td align="left" valign="top">Very high</td><td align="left" valign="top">0.50</td><td align="left" valign="top">Trains complex models on large datasets; serves as a high-capacity node</td></tr><tr><td align="left" valign="top">2</td><td align="left" valign="top">Urban health kiosk</td><td align="left" valign="top">K-nearest neighbors</td><td align="left" valign="top">n_neighbors=5 algorithm='auto'data_use=5%</td><td align="left" valign="top">Low</td><td align="left" valign="top">0.05</td><td align="left" valign="top">Designed for low-resource environments using simple, efficient models</td></tr><tr><td align="left" valign="top">3</td><td align="left" valign="top">Regional clinic</td><td align="left" valign="top">XGBoost</td><td align="left" valign="top">learning_rate=0.01max_depth=10n_estimators=180data_use=30%</td><td align="left" valign="top">High</td><td align="left" valign="top">0.30</td><td align="left" valign="top">Supports moderately complex modeling on medium-sized datasets</td></tr><tr><td align="left" valign="top">4</td><td align="left" valign="top">Community health clinic</td><td align="left" valign="top">Decision tree</td><td align="left" valign="top">max_depth=Nonecriterion='gini'data_use=10%</td><td align="left" valign="top">Medium</td><td align="left" valign="top">0.10</td><td align="left" valign="top">Runs interpretable tree-based models with moderate resource needs</td></tr><tr><td align="left" valign="top">5</td><td align="left" valign="top">Personal health tracker</td><td align="left" valign="top">Support vector machine</td><td align="left" valign="top">kernel='linear'C=1.0data_use=5%</td><td align="left" valign="top">Very low</td><td align="left" valign="top">0.05</td><td align="left" valign="top">Uses lightweight models suitable for wearables and embedded devices</td></tr></tbody></table></table-wrap><p>This heterogeneity-aware mapping allows each participant to train a model aligned with its resource profile while still contributing to a unified ensemble.</p></sec><sec id="s2-4-4"><title>Enhanced Knowledge Distillation and Pseudo-Label Generation</title><p>In each communication round <inline-formula><mml:math id="ieqn12"><mml:mi>t</mml:mi></mml:math></inline-formula>, participant models generate calibrated soft probability vectors <inline-formula><mml:math id="ieqn13"><mml:msubsup><mml:mrow><mml:mi>P</mml:mi></mml:mrow><mml:mrow><mml:mi>i</mml:mi></mml:mrow><mml:mrow><mml:mi>t</mml:mi></mml:mrow></mml:msubsup><mml:mo>(</mml:mo><mml:mi>x</mml:mi><mml:mo>)</mml:mo></mml:math></inline-formula>, which are aggregated using dynamically updated participant weights to produce a global soft prediction.</p><p>Our proposed model aggregates the calibrated soft labels using the dynamic weights to produce a global soft prediction:</p><disp-formula id="E4"><label>(4)</label><mml:math id="eqn4"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mrow><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mtable rowspacing="4pt" columnspacing="1em"><mml:mtr><mml:mtd><mml:msup><mml:mi>P</mml:mi><mml:mrow><mml:mi>t</mml:mi></mml:mrow></mml:msup><mml:mrow><mml:mo>(</mml:mo><mml:mi>x</mml:mi><mml:mo>)</mml:mo></mml:mrow><mml:mo>=</mml:mo><mml:munderover><mml:mo movablelimits="false">&#x2211;</mml:mo><mml:mrow><mml:mi>i</mml:mi><mml:mo>=</mml:mo><mml:mn>1</mml:mn></mml:mrow><mml:mrow><mml:mi>N</mml:mi></mml:mrow></mml:munderover><mml:msubsup><mml:mi>W</mml:mi><mml:mrow><mml:mi>i</mml:mi></mml:mrow><mml:mrow><mml:mi>t</mml:mi></mml:mrow></mml:msubsup><mml:mo>&#x2217;</mml:mo><mml:msubsup><mml:mi>P</mml:mi><mml:mrow><mml:mi>i</mml:mi></mml:mrow><mml:mrow><mml:mi>t</mml:mi></mml:mrow></mml:msubsup><mml:mrow><mml:mo>(</mml:mo><mml:mi>x</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mtd></mml:mtr></mml:mtable></mml:mstyle></mml:mstyle></mml:mrow></mml:mstyle></mml:math></disp-formula><p>Because aggregation operates entirely on probability distributions rather than gradients or model parameters, FedEnTrust naturally supports heterogeneous machine learning architectures across hospitals, clinics, kiosks, and personal wearable devices while preserving data locality and privacy.</p><p>To improve the reliability of knowledge transfer, each participant&#x2019;s soft predictions undergo normalization followed by temperature scaling (with <inline-formula><mml:math id="ieqn14"><mml:mi>T</mml:mi><mml:mo>=</mml:mo><mml:mn>2</mml:mn></mml:math></inline-formula>) to smooth overconfident outputs. The ensemble output is then evaluated using a confidence-based filtering mechanism, where pseudo-labels are generated only if the maximum ensemble probability satisfies:</p><disp-formula id="E5"><label>(5)</label><mml:math id="eqn5"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mrow><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mtable rowspacing="4pt" columnspacing="1em"><mml:mtr><mml:mtd><mml:mo movablelimits="true" form="prefix">max</mml:mo><mml:mrow><mml:mo>(</mml:mo><mml:mrow><mml:msup><mml:mi>P</mml:mi><mml:mrow><mml:mi>t</mml:mi></mml:mrow></mml:msup><mml:mrow><mml:mo>(</mml:mo><mml:mi>x</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow><mml:mo>)</mml:mo></mml:mrow><mml:mo>&#x2265;</mml:mo><mml:mi>&#x03C4;</mml:mi></mml:mtd></mml:mtr></mml:mtable></mml:mstyle></mml:mrow></mml:mstyle></mml:math></disp-formula><p>With <inline-formula><mml:math id="ieqn15"><mml:mstyle><mml:mrow><mml:mstyle displaystyle="false"><mml:mi>&#x03C4;</mml:mi><mml:mo>=</mml:mo><mml:mn>0.7</mml:mn></mml:mstyle></mml:mrow></mml:mstyle></mml:math></inline-formula> Predictions failing this criterion are discarded to prevent the propagation of uncertainty or noise. Accepted pseudo-labels are normalized and redistributed to participants, where they are appended to local datasets and used for continued training in the subsequent round. This feedback loop enables low-resource participants to benefit from globally distilled knowledge while retaining local autonomy.</p><p>All soft-label submissions are validated through the blockchain-based RBAC mechanism described in Module 3. Only soft labels originating from authenticated and authorized roles (eg, model-provider) are accepted. Validated submissions are incorporated into an adaptive weighted soft-voting process, where participant weights are updated based on observed local performance across rounds. The resulting global outputs are then redistributed as pseudo-labels for the next training iteration, ensuring robustness against non-IID data distributions, preventing malicious or fabricated updates, and enhancing cross-site generalization across heterogeneous health care environments.</p></sec></sec><sec id="s2-5"><title>Module 3: Blockchain-Based Secure Coordination</title><sec id="s2-5-1"><title>Overview</title><p>Module 3 employs an Ethereum-based smart contract to authenticate participants, enforce role permissions, and log immutable update metadata. When a node attempts to upload soft labels, the smart contract verifies the participant&#x2019;s role, identity, timestamp, and declared accuracy. The contract then generates and stores a hashed representation of the update, which validator nodes review. Only soft labels that receive approval from multivalidators are admitted to the aggregation pool. This ensures tamper resistance, prevents poisoning attacks, and provides end-to-end traceability for health care compliance requirements. When a participant attempts to contribute soft labels, the smart contract performs the following checks:</p><list list-type="order"><list-item><p>Identity verification: Confirms that the contributor is a registered network participant.</p></list-item><list-item><p>Role validation: Ensures the contributor holds a permitted role to submit model outputs.</p></list-item><list-item><p>Metadata verification: Confirms the integrity of reported metrics (eg, accuracy, round number).</p></list-item><list-item><p>Hash logging: Stores a transaction hash to provide auditability without exposing any data.</p></list-item></list><p>Only after passing these checks is the soft label included in the aggregation pool. This design prevents poisoned or fabricated updates from influencing the global model and eliminates single points of failure in participation management. By integrating RBAC directly with knowledge distillation, FedEnTrust establishes a secure and transparent trust layer that coordinates collaborative learning across diverse health care nodes.</p></sec><sec id="s2-5-2"><title>Blockchain Platform Selection and Justification</title><p>FedEnTrust is implemented on an Ethereum-compatible private blockchain network. Ethereum was selected due to its deterministic smart contract execution, robust security guarantees, and mature tooling ecosystem. The platform supports Solidity-based smart contracts, Remix IDE integration, and widely adopted standards for access control and event logging. These characteristics make Ethereum well suited for privacy-preserving health care collaboration, where verifiable execution and auditability are required.</p><p>To justify this choice, we compared Ethereum with 2 commonly used permissioned blockchain platforms: Hyperledger Fabric and Corda. <xref ref-type="table" rid="table3">Table 3</xref> presents a feature-level comparison of Ethereum, Hyperledger Fabric, and Corda across network type, decentralization, smart contract support, privacy mechanisms, ecosystem maturity, and application alignment. Given the need for flexible smart contract logic, verifiable coordination, and broad compatibility with Internet of Things (IoT) and health care prototypes, Ethereum provides the most practical platform for FedEnTrust.</p><table-wrap id="t3" position="float"><label>Table 3.</label><caption><p>Comparison of blockchain platforms.</p></caption><table id="table3" frame="hsides" rules="groups"><thead><tr><td align="left" valign="middle">Feature</td><td align="left" valign="middle">Ethereum</td><td align="left" valign="middle">Hyperledger fabric</td><td align="left" valign="middle">Corda</td></tr></thead><tbody><tr><td align="left" valign="middle">Network type</td><td align="left" valign="middle">Public or private</td><td align="left" valign="middle">Permissioned</td><td align="left" valign="middle">Permissioned</td></tr><tr><td align="left" valign="middle">Decentralization</td><td align="left" valign="middle">Highly decentralized</td><td align="left" valign="middle">Semi-decentralized</td><td align="left" valign="middle">Semi-decentralized</td></tr><tr><td align="left" valign="middle">Smart contracts</td><td align="left" valign="middle">Solidity, robust tooling</td><td align="left" valign="middle">Chaincode (Go/Java/Node.js)</td><td align="left" valign="middle">Contract flows for financial logic</td></tr><tr><td align="left" valign="middle">Privacy</td><td align="left" valign="middle">Extensible via Layer-2/private networks</td><td align="left" valign="middle">Strong privacy (channels, private collections)</td><td align="left" valign="middle">Strong bilateral privacy</td></tr><tr><td align="left" valign="middle">Ecosystem</td><td align="left" valign="middle">Very large developer ecosystem</td><td align="left" valign="middle">Enterprise-focused</td><td align="left" valign="middle">Financial institutions</td></tr><tr><td align="left" valign="middle">Use alignment</td><td align="left" valign="middle">Decentralized coordination across heterogeneous nodes</td><td align="left" valign="middle">Consortium-style enterprise networks</td><td align="left" valign="middle">Regulated financial workflows</td></tr></tbody></table></table-wrap></sec><sec id="s2-5-3"><title>Adversarial Threat Model and Security Resilience</title><p>FL deployments in real-world health care environments may be exposed to adversarial participants attempting to manipulate the global model, disrupt training, or infer sensitive information. To address these risks, we construct a structured threat model covering three primary attack categories: (1) model poisoning; (2) collusion among compromised participants; and (3) malicious soft-label injection, where adversaries submit manipulated pseudo-probabilities to bias the aggregation process.</p><p>FedEnTrust incorporates multiple, tightly coupled defense mechanisms across its blockchain coordination and ensemble aggregation layers to provide resilience against these threats.</p><list list-type="order"><list-item><p>Model poisoning and malicious soft-label injection: A compromised participant may attempt to submit adversarial or fabricated soft labels to influence global predictions. FedEnTrust mitigates this risk through smart contract&#x2013;enforced RBAC, which restricts update submission exclusively to authenticated participants holding an authorized model-provider role. Each submission is accompanied by metadata including round number, reported validation accuracy, and timestamp, which are verified for internal consistency before acceptance. To ensure integrity and prevent replay or tampering, all submissions are cryptographically hashed and logged on-chain. Furthermore, FedEnTrust employs validator redundancy, requiring approval from multiple trusted validator nodes (eg, lead hospitals within the consortium) before a submission is incorporated into aggregation, preventing single-node compromise.</p></list-item><list-item><p>Collusion and validator compromise: To reduce the impact of colluding or compromised participants, FedEnTrust adopts a consortium-style multivalidator approval mechanism. No single validator can independently approve a model update; instead, a quorum of validators must jointly authorize submissions. The validator set itself is managed through governed smart contract functions, allowing secure updates to validator membership over time and eliminating static trust assumptions.</p></list-item><list-item><p>Blockchain-specific threats: Public blockchain deployments may be vulnerable to front-running, transaction reordering, or gas manipulation attacks. FedEnTrust avoids these risks by operating on a private Ethereum-compatible consortium network without a public mempool, eliminating front-running opportunities. Smart contracts use fixed gas budgets and sequential transaction counters to ensure deterministic execution and prevent reordering attacks.</p></list-item><list-item><p>Privacy leakage through on-chain metadata: Although raw data and model parameters are never shared, metadata leakage can still pose privacy risks. FedEnTrust minimizes exposure by storing only hashed identifiers and role-verification logs on-chain. No patient-level attributes, raw predictions, or model parameters are recorded. All soft labels remain strictly off-chain and are exchanged only between authorized participants and the aggregator over secure channels.</p></list-item><list-item><p>Aggregation-level safeguards: Beyond blockchain enforcement, the adaptive ensemble layer further mitigates adversarial influence by applying temperature scaling, confidence thresholds, and weight clipping. These mechanisms limit the amplification of extreme or adversarial soft-label probabilities and restrict the maximum influence any single participant can exert, even if it reports high accuracy.</p></list-item></list><p>Collectively, these mechanisms establish a multilayered security architecture that protects FedEnTrust against common poisoning, collusion, and manipulation attempts at the coordination and authorization layers while preserving decentralized operation and data privacy. The empirical results demonstrate that unauthorized and malicious submissions are consistently detected and rejected through blockchain-enforced RBAC and validator checks. While this study focuses on secure enforcement and system robustness rather than controlled adversarial learning simulations, the framework is explicitly designed to support future evaluation against targeted and untargeted attacks, including label-flipping, probability-shifting, and adaptive adversarial strategies.</p></sec></sec><sec id="s2-6"><title>Module 4: Adaptive Model Aggregation and Feedback Loop</title><p>After soft labels are aggregated into a global ensemble prediction, FedEnTrust redistributes this consensus to participants as pseudo-labels for retraining. This adaptive aggregation ensures that high-performing models contribute more to the global prediction, while low-resource nodes still benefit from the collective knowledge.</p><p>This module enables faster convergence across non-IID data, fair and inclusive participation, and improved generalization without data sharing.</p><p>The result is a balanced feedback loop: local models become more aligned with the ensemble, improving personalization and global performance over time.</p></sec><sec id="s2-7"><title>System Implementation and Evaluation Setup</title><p>We evaluated FedEnTrust using the publicly available PIMA Indians Diabetes Dataset [<xref ref-type="bibr" rid="ref26">26</xref>], which includes 768 records of female patients with 8 clinical attributes and a binary diabetes outcome. Data were preprocessed using the following steps:</p><list list-type="order"><list-item><p>Outlier detection with IQR and local outlier factor</p></list-item><list-item><p>Feature engineering (eg, binning glucose, insulin levels)</p></list-item><list-item><p>Normalization using <italic>z</italic> scores</p></list-item><list-item><p>Class balancing using the synthetic minority oversampling technique [<xref ref-type="bibr" rid="ref27">27</xref>]</p></list-item></list><p>As shown in <xref ref-type="table" rid="table1">Table 1</xref>, to simulate a real-world heterogeneous environment, the dataset was split across 5 simulated participants with varying data volumes and models. Each participant&#x2019;s computational weight was reflected in the aggregation process, mimicking operational conditions ranging from large hospitals to low-power personal devices.</p></sec><sec id="s2-8"><title>Ethical Considerations</title><p>This study exclusively used publicly available, deidentified secondary datasets. No new data were collected, and no interaction with human participants occurred. According to institutional policy and US federal regulations (45 CFR 46), research involving publicly available, deidentified data does not constitute human participant research and is therefore exempt from institutional review board review. As a result, institutional review board approval was not sought, and informed consent was not required. All datasets used in this study were fully deidentified prior to public release. The data contained no direct or indirect identifiers, and no attempt was made to reidentify individuals. Data were accessed and analyzed in accordance with the terms and conditions specified by the data providers. No participants were recruited for this study, and no compensation was provided.</p></sec></sec><sec id="s3" sec-type="results"><title>Results</title><sec id="s3-1"><title>Model Performance</title><p>We evaluated the FedEnTrust framework across 5 heterogeneous participants over 15 communication rounds, focusing on prediction accuracy, precision, recall, and <italic>F</italic><sub>1</sub>-score. The results highlight how collaborative learning and adaptive aggregation significantly enhance performance, especially for participants with limited data and computational resources.</p><p><xref ref-type="fig" rid="figure2">Figure 2</xref> shows the accuracy trajectories of each participant over the FL rounds. Participant 1 (random forest), equipped with the largest dataset and the highest computational power, consistently achieved the highest accuracy, acting as a de facto &#x201C;teacher&#x201D; during knowledge distillation. Its influence helped guide improvements in lower-resource nodes, such as participant 5 (SVC) and participant 2 (KNN), which showed steady gains over time.</p><fig position="float" id="figure2"><label>Figure 2.</label><caption><p>Global model accuracy improves over ensemble federated round. DT: decision tree; KNN: k-nearest neighbors; RF: random forest; SVC: support vector classifier; XGB: extreme gradient boosting.</p></caption><graphic alt-version="no" mimetype="image" position="float" xlink:type="simple" xlink:href="diabetes_v11i1e79166_fig02.png"/></fig><p><xref ref-type="fig" rid="figure3">Figure 3</xref> presents the corresponding model loss curves. All participants experienced substantial loss reduction early on, with convergence observed by round 15. Participant 1 maintained the lowest loss throughout, while participants 4 and 5 showed marked improvement from higher initial losses, demonstrating the benefit of federated collaboration.</p><fig position="float" id="figure3"><label>Figure 3.</label><caption><p>Federated model losses over rounds. DT: decision tree; KNN: k-nearest neighbors; RF: random forest; SVC: support vector classifier; XGB: extreme gradient boosting.</p></caption><graphic alt-version="no" mimetype="image" position="float" xlink:type="simple" xlink:href="diabetes_v11i1e79166_fig03.png"/></fig><p>Table 5. Federated Models Performance after 15 rounds</p><p>Comparing the initial and federated performance results (<xref ref-type="table" rid="table4">Tables 4</xref> and <xref ref-type="table" rid="table5">5</xref>) reveals substantial gains for all participants after collaborative training. Accuracy improvements of up to 28% are observed in lower-resource participants, and <italic>F</italic><sub>1</sub>-scores increase consistently across all models, demonstrating the effectiveness of knowledge distillation and adaptive aggregation in heterogeneous environments. For example, participant 4 (decision tree) improves its <italic>F</italic><sub>1</sub>-score from 0.71 to 0.88, while participant 3 (XGBoost) improves from 0.64 to 0.85, highlighting the benefits of ensemble-driven knowledge transfer.</p><table-wrap id="t4" position="float"><label>Table 4.</label><caption><p>Initial models&#x2019; performance.</p></caption><table id="table4" frame="hsides" rules="groups"><thead><tr><td align="left" valign="top">Participant</td><td align="left" valign="top">Accuracy</td><td align="left" valign="top">Precision</td><td align="left" valign="top">Recall</td><td align="left" valign="top"><italic>F</italic><sub>1</sub>-score</td></tr></thead><tbody><tr><td align="left" valign="top">1</td><td align="left" valign="top">0.78</td><td align="left" valign="top">0.85</td><td align="left" valign="top">0.84</td><td align="left" valign="top">0.83</td></tr><tr><td align="left" valign="top">2</td><td align="left" valign="top">0.71</td><td align="left" valign="top">0.73</td><td align="left" valign="top">0.71</td><td align="left" valign="top">0.72</td></tr><tr><td align="left" valign="top">3</td><td align="left" valign="top">0.65</td><td align="left" valign="top">0.63</td><td align="left" valign="top">0.65</td><td align="left" valign="top">0.64</td></tr><tr><td align="left" valign="top">4</td><td align="left" valign="top">0.70</td><td align="left" valign="top">0.73</td><td align="left" valign="top">0.71</td><td align="left" valign="top">0.71</td></tr><tr><td align="left" valign="top">5</td><td align="left" valign="top">0.67</td><td align="left" valign="top">0.67</td><td align="left" valign="top">0.68</td><td align="left" valign="top">0.67</td></tr></tbody></table></table-wrap><table-wrap id="t5" position="float"><label>Table 5.</label><caption><p>Federated models&#x2019; performance after 15 rounds.</p></caption><table id="table5" frame="hsides" rules="groups"><thead><tr><td align="left" valign="top">Participant</td><td align="left" valign="top">Accuracy</td><td align="left" valign="top">Precision</td><td align="left" valign="top">Recall</td><td align="left" valign="top"><italic>F</italic><sub>1</sub>-score</td></tr></thead><tbody><tr><td align="left" valign="top">1</td><td align="left" valign="top">0.93</td><td align="left" valign="top">0.92</td><td align="left" valign="top">0.94</td><td align="left" valign="top">0.93</td></tr><tr><td align="left" valign="top">2</td><td align="left" valign="top">0.81</td><td align="left" valign="top">0.80</td><td align="left" valign="top">0.86</td><td align="left" valign="top">0.83</td></tr><tr><td align="left" valign="top">3</td><td align="left" valign="top">0.84</td><td align="left" valign="top">0.85</td><td align="left" valign="top">0.86</td><td align="left" valign="top">0.85</td></tr><tr><td align="left" valign="top">4</td><td align="left" valign="top">0.83</td><td align="left" valign="top">0.87</td><td align="left" valign="top">0.90</td><td align="left" valign="top">0.88</td></tr><tr><td align="left" valign="top">5</td><td align="left" valign="top">0.80</td><td align="left" valign="top">0.79</td><td align="left" valign="top">0.87</td><td align="left" valign="top">0.83</td></tr></tbody></table></table-wrap><p>To further characterize performance stability across communication rounds, <xref ref-type="table" rid="table6">Table 6</xref> reports both the final accuracy at round 15 and the mean (SD) of accuracy over all 15 federated rounds. The relatively low SDs indicate stable convergence behavior for all participants, even for lightweight models such as KNN and SVC. These results confirm that FedEnTrust effectively accommodates device and data heterogeneity while maintaining strong predictive performance, privacy preservation, and decentralized operation. Tailored model architectures, aligned with participant resource constraints, ensure balanced contribution and efficient deployment across the collaborative learning process.</p><table-wrap id="t6" position="float"><label>Table 6.</label><caption><p>Federated model accuracy and variability across 15 rounds.</p></caption><table id="table6" frame="hsides" rules="groups"><thead><tr><td align="left" valign="top">Participant</td><td align="left" valign="top">Model</td><td align="left" valign="top">Final accuracy</td><td align="left" valign="top">Accuracy, mean (SD)</td></tr></thead><tbody><tr><td align="left" valign="top">1</td><td align="left" valign="top">RF<sup><xref ref-type="table-fn" rid="table6fn1">a</xref></sup></td><td align="left" valign="top">0.93</td><td align="left" valign="top">0.91 (0.04)</td></tr><tr><td align="left" valign="top">2</td><td align="left" valign="top">KNN<sup><xref ref-type="table-fn" rid="table6fn2">b</xref></sup></td><td align="left" valign="top">0.81</td><td align="left" valign="top">0.79 (0.03)</td></tr><tr><td align="left" valign="top">3</td><td align="left" valign="top">XGB<sup><xref ref-type="table-fn" rid="table6fn3">c</xref></sup></td><td align="left" valign="top">0.84</td><td align="left" valign="top">0.81 (0.05)</td></tr><tr><td align="left" valign="top">4</td><td align="left" valign="top">DT<sup><xref ref-type="table-fn" rid="table6fn4">d</xref></sup></td><td align="left" valign="top">0.83</td><td align="left" valign="top">0.80 (0.03)</td></tr><tr><td align="left" valign="top">5</td><td align="left" valign="top">SVC<sup><xref ref-type="table-fn" rid="table6fn5">e</xref></sup></td><td align="left" valign="top">0.80</td><td align="left" valign="top">0.76 (0.03)</td></tr></tbody></table><table-wrap-foot><fn id="table6fn1"><p><sup>a</sup>RF: random forest. </p></fn><fn id="table6fn2"><p><sup>b</sup>KNN: k-nearest neighbors.</p></fn><fn id="table6fn3"><p><sup>c</sup>XGB: extreme gradient boosting.</p></fn><fn id="table6fn4"><p><sup>d</sup>DT: decision tree.</p></fn><fn id="table6fn5"><p><sup>e</sup>SVC: support vector classifier.</p></fn></table-wrap-foot></table-wrap><p>To assess whether the performance differences between FedEnTrust and baseline models were statistically meaningful on the PIMA Indians Diabetes Dataset, we conducted a nonparametric bootstrap significance analysis using the same held-out test set as the main evaluation. Because accuracy, precision, recall, and <italic>F</italic><sub>1</sub>-score are bounded metrics that may deviate from normality, bootstrap resampling provides a distribution-free and robust alternative to parametric methods such as the <italic>t</italic> test. We used a 2-tailed <italic>t</italic> test, as no directional assumption was imposed a priori and the objective was to assess whether there was any statistically significant difference between the compared methods.</p><p>We generated B=1000 bootstrap resamples by sampling test instances with replacement from the held-out evaluation set. For each bootstrap resample, we evaluated FedEnTrust and the decentralized baseline from Blockchain-FL with Differential Privacy [<xref ref-type="bibr" rid="ref20">20</xref>], which represents the closest methodologically comparable prior work under similar privacy and decentralization constraints. This procedure produced 1000-sample empirical distributions for both models&#x2019; accuracy. To quantify comparative performance, we computed the bootstrap metric difference for each resample:</p><disp-formula id="E6"><label>(6)</label><mml:math id="eqn6"><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mrow><mml:mstyle displaystyle="true" scriptlevel="0"><mml:mtable rowspacing="4pt" columnspacing="1em"><mml:mtr><mml:mtd><mml:msup><mml:mrow><mml:mi mathvariant="normal">&#x0394;</mml:mi></mml:mrow><mml:mrow><mml:mrow><mml:mo>(</mml:mo><mml:mi>b</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow></mml:msup><mml:mo>=</mml:mo><mml:msubsup><mml:mi>M</mml:mi><mml:mrow><mml:mtext>FedEnTrust</mml:mtext></mml:mrow><mml:mrow><mml:mrow><mml:mo>(</mml:mo><mml:mi>b</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow></mml:msubsup><mml:mo>&#x2212;</mml:mo><mml:msubsup><mml:mi>M</mml:mi><mml:mrow><mml:mtext>Baseline</mml:mtext></mml:mrow><mml:mrow><mml:mrow><mml:mo>(</mml:mo><mml:mi>b</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:mrow></mml:msubsup></mml:mtd></mml:mtr></mml:mtable></mml:mstyle></mml:mrow></mml:mstyle></mml:math></disp-formula><p>where <inline-formula><mml:math id="ieqn16"><mml:msup><mml:mrow><mml:mi>M</mml:mi></mml:mrow><mml:mrow><mml:mi>b</mml:mi></mml:mrow></mml:msup></mml:math></inline-formula> represents the accuracy, precision, recall, or <italic>F</italic><sub>1</sub>-score on bootstrap resample <inline-formula><mml:math id="ieqn17"><mml:mi>b</mml:mi></mml:math></inline-formula>. We then constructed 95% CIs for each metric difference using the percentile method.</p><p>The bootstrap CI analysis indicates that FedEnTrust achieves statistically significant performance improvements over the decentralized blockchain-based FL baseline [<xref ref-type="bibr" rid="ref20">20</xref>]. Specifically, FedEnTrust attains a mean accuracy of 0.842 with a 95% bootstrap CI of 0.831-0.853, compared to 0.827 (0.814-0.839) for the decentralized baseline. The resulting accuracy difference of +0.015 yields a 95% CI of 0.004-0.027, which excludes zero, indicating statistical significance at <italic>&#x03B1;</italic>=.05. These results confirm that the performance gains observed for FedEnTrust are not due to random variation but rather stem from its integration of heterogeneous ensemble learning with blockchain-backed coordination under privacy constraints.</p><p>These findings validate that FedEnTrust&#x2019;s performance gains are not only empirical but statistically robust, reinforcing the effectiveness of combining heterogeneous ensemble learning with blockchain-backed coordination in constrained health care environments.</p></sec><sec id="s3-2"><title>Blockchain Performance</title><p>We deployed the smart contract with 6 key functions and evaluated it under a realistic configuration consisting of 5 decentralized health care participants and 1 global aggregator. These components facilitated secure collaboration, access management, and federated training. The details are shown in <xref ref-type="table" rid="table7">Table 7</xref>.</p><table-wrap id="t7" position="float"><label>Table 7.</label><caption><p>Blockchain system configuration.</p></caption><table id="table7" frame="hsides" rules="groups"><thead><tr><td align="left" valign="middle">Operation</td><td align="left" valign="middle">Count</td><td align="left" valign="middle">Description</td></tr></thead><tbody><tr><td align="left" valign="middle">Total registered participants</td><td align="left" valign="middle">5</td><td align="left" valign="middle">Registered using registerClient()</td></tr><tr><td align="left" valign="middle">Federated coordination nodes</td><td align="left" valign="middle">1</td><td align="left" valign="middle">Global aggregator for accuracy aggregation and model ensemble</td></tr><tr><td align="left" valign="middle">Smart contract functions deployed</td><td align="left" valign="middle">6</td><td align="left" valign="middle">Includes registration, role assignment, update logging, and access checks</td></tr></tbody></table></table-wrap><p>To assess computational efficiency, we monitored key metrics such as gas consumption, data size, and latency for major smart contract operations. These measurements reflect the cost-effectiveness and responsiveness of blockchain-mediated tasks.</p><p>These operations incur gas overhead beyond Ethereum&#x2019;s 21,000 base gas due to additional computation, state updates, and event emissions. The <italic>modelUpdate</italic>() function, for example, consumes about 98,560 gas (~295 bytes of encoded parameters), balancing cost with functional depth and traceability (<xref ref-type="table" rid="table8">Table 8</xref>).</p><table-wrap id="t8" position="float"><label>Table 8.</label><caption><p>Smart contract performance metrics.</p></caption><table id="table8" frame="hsides" rules="groups"><thead><tr><td align="left" valign="middle">Operation</td><td align="left" valign="middle">Average gas cost</td><td align="left" valign="middle">Data size (bytes)</td><td align="left" valign="middle">Average latency (ms)</td></tr></thead><tbody><tr><td align="left" valign="middle">Client registration</td><td align="left" valign="middle">118,073</td><td align="left" valign="middle">370</td><td align="left" valign="middle">220</td></tr><tr><td align="left" valign="middle">Role assignment</td><td align="left" valign="middle">109,820</td><td align="left" valign="middle">345</td><td align="left" valign="middle">210</td></tr><tr><td align="left" valign="middle">Model update</td><td align="left" valign="middle">98,560</td><td align="left" valign="middle">295</td><td align="left" valign="middle">195</td></tr><tr><td align="left" valign="middle">Model aggregation</td><td align="left" valign="middle">105,310</td><td align="left" valign="middle">315</td><td align="left" valign="middle">215</td></tr></tbody></table></table-wrap><p>Despite slight delays compared to traditional systems, the observed latency (195&#x2010;220 ms) remains acceptable for health care applications, considering the gains in trust, verifiability, and tamper resistance. To assess longer-term stability, we analyzed all 212 smart contract operations recorded during the training. All valid transactions executed successfully without anomalies, indicating stable performance across repeated interactions. The expanded evaluation in <xref ref-type="table" rid="table9">Table 9</xref> includes average latency, latency range, and variability across extended cycles. These findings support the suitability of the blockchain layer for multiround federated training.</p><table-wrap id="t9" position="float"><label>Table 9.</label><caption><p>Transaction integrity and enforcement metrics.</p></caption><table id="table9" frame="hsides" rules="groups"><thead><tr><td align="left" valign="middle">Category</td><td align="left" valign="middle">Values</td><td align="left" valign="middle">Description</td></tr></thead><tbody><tr><td align="left" valign="middle">Total transactions</td><td align="left" valign="middle">212</td><td align="left" valign="middle">All smart contract operations</td></tr><tr><td align="left" valign="middle">Valid transactions</td><td align="left" valign="middle">201</td><td align="left" valign="middle">Successfully executed by authorized participants</td></tr><tr><td align="left" valign="middle">Rejected transactions</td><td align="left" valign="middle">11 (5.19%)</td><td align="left" valign="middle">Unauthorized queries (6), malicious submissions (3), invalid role updates (2)</td></tr><tr><td align="left" valign="middle">Success rate</td><td align="left" valign="middle">100%</td><td align="left" valign="middle">All valid transactions completed without error</td></tr><tr><td align="left" valign="middle">Average latency</td><td align="left" valign="middle">21.4 ms</td><td align="left" valign="middle">Mean execution time for valid transaction</td></tr><tr><td align="left" valign="middle">Latency range</td><td align="left" valign="middle">14.8&#x2010;36.2 ms</td><td align="left" valign="middle">Minimum and maximum observed latency</td></tr><tr><td align="left" valign="middle">SD</td><td align="left" valign="middle">&#x00B1;4.7 ms</td><td align="left" valign="middle">Variability in execution time</td></tr><tr><td align="left" valign="middle">Latency over extended cycles (100 iterations)</td><td align="left" valign="middle">Mean: 22.1 ms; variation:&#x00B1;5.3 ms</td><td align="left" valign="middle">Long-term stability testing simulating multiround FL<sup><xref ref-type="table-fn" rid="table9fn1">a</xref></sup></td></tr><tr><td align="left" valign="middle">Finality time</td><td align="left" valign="middle">~1 block(~1 s)</td><td align="left" valign="middle">Deterministic finality in private PoA<sup><xref ref-type="table-fn" rid="table9fn2">b</xref></sup> Ethereum network</td></tr><tr><td align="left" valign="middle">Estimated throughput</td><td align="left" valign="middle">~47 tx/s</td><td align="left" valign="middle">Consistent with private Ethereum networks</td></tr></tbody></table><table-wrap-foot><fn id="table9fn1"><p><sup>a</sup>FL: federated learning.</p></fn><fn id="table9fn2"><p><sup>b</sup>PoA: proof-of-authority.</p></fn></table-wrap-foot></table-wrap><p>As illustrated in <xref ref-type="fig" rid="figure4">Figure 4</xref>, unauthorized model submissions are automatically rejected, triggering an on-chain error: &#x201C;Client not registered.&#x201D; This ensures that only authenticated nodes contribute to the learning process, strengthening data integrity.</p><fig position="float" id="figure4"><label>Figure 4.</label><caption><p>Access rejection for unauthorized participant.</p></caption><graphic alt-version="no" mimetype="image" position="float" xlink:type="simple" xlink:href="diabetes_v11i1e79166_fig04.png"/></fig><p>Throughout 15 communication rounds, the smart contract reliably supported secure, real-time exchange of soft label predictions and model aggregation updates. For instance, participant 1 improved from 78% to 93% accuracy, while participant 4 rose from 70% to 83%, all while maintaining privacy and resisting tampering.</p><p>These results underscore the effectiveness of combining blockchain with federated ensemble learning to achieve scalable, secure, and privacy-preserving AI in health care environments.</p></sec></sec><sec id="s4" sec-type="discussion"><title>Discussion</title><sec id="s4-1"><title>Principal Findings</title><p>This study presents FedEnTrust, a blockchain-enabled federated ensemble learning framework that offers a privacy-preserving and scalable solution for decentralized diabetes prediction. Our system effectively balances accuracy, privacy, and adaptability by integrating diverse machine learning models with knowledge distillation and adaptive weighted aggregation. With a predictive accuracy of 84.2%, FedEnTrust demonstrates competitive performance while maintaining strict privacy guarantees and supporting heterogeneous health care participants ranging from hospitals to wearable devices.</p><p>The framework&#x2019;s integration with blockchain smart contracts provides secure participant coordination, role-based access control, and transparent model validation without incurring substantial latency or resource overhead. Importantly, our results show that even low-resource participants benefit from collaboration through soft label exchange, enabling equitable participation in the learning process.</p></sec><sec id="s4-2"><title>Comparison With Prior Work</title><p><xref ref-type="table" rid="table10">Table 10</xref> summarizes the performance of FedEnTrust against the existing centralized and decentralized methods applied to the PIMA Indians Diabetes Dataset. While centralized deep learning approaches achieve slightly higher accuracy (eg, 95.2% with light gradient boosting machine, 96.1% with convolutional neural networks), these models require full data centralization, sacrificing privacy and increasing system vulnerability.</p><table-wrap id="t10" position="float"><label>Table 10.</label><caption><p>Comparative performance on the PIMA Indians Diabetes Dataset.</p></caption><table id="table10" frame="hsides" rules="groups"><thead><tr><td align="left" valign="middle">Model or study</td><td align="left" valign="middle">Accuracy (%)</td><td align="left" valign="middle">Precision (%)</td><td align="left" valign="middle">Recall (%)</td><td align="left" valign="middle"><italic>F</italic><sub>1</sub>-score (%)</td><td align="left" valign="middle">Notes</td></tr></thead><tbody><tr><td align="left" valign="middle">FedEnTrust</td><td align="left" valign="middle">84.2</td><td align="left" valign="middle">84.6</td><td align="left" valign="middle">88.6</td><td align="left" valign="middle">86.4</td><td align="left" valign="middle">Federated ensemble with adaptive weighted voting and blockchain smart contract integration</td></tr><tr><td align="left" valign="middle">ML<sup><xref ref-type="table-fn" rid="table10fn1">a</xref></sup> classifiers approach [<xref ref-type="bibr" rid="ref28">28</xref>]</td><td align="left" valign="middle">95.2</td><td align="left" valign="middle">N/A<sup><xref ref-type="table-fn" rid="table10fn2">b</xref></sup></td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">Centralized; evaluated multiple classifiers (LR<sup><xref ref-type="table-fn" rid="table10fn3">c</xref></sup>, XGB<sup><xref ref-type="table-fn" rid="table10fn4">d</xref></sup>, GB<sup><xref ref-type="table-fn" rid="table10fn5">e</xref></sup>, DT<sup><xref ref-type="table-fn" rid="table10fn6">f</xref></sup>, ET<sup><xref ref-type="table-fn" rid="table10fn7">g</xref></sup>, RF<sup><xref ref-type="table-fn" rid="table10fn8">h</xref></sup>, and LGBM<sup><xref ref-type="table-fn" rid="table10fn9">i</xref></sup>) on PIMA Indians dataset; best accuracy achieved by LGBM</td></tr><tr><td align="left" valign="middle">Recursive feature elimination with a gated recurrent unit RFE-GRU<sup><xref ref-type="table-fn" rid="table10fn10">j</xref></sup> [<xref ref-type="bibr" rid="ref29">29</xref>]</td><td align="left" valign="middle">90.7</td><td align="left" valign="middle">90.5</td><td align="left" valign="middle">90.7</td><td align="left" valign="middle">90.5</td><td align="left" valign="middle">Centralized; utilized RFE-GRU on PIMA Dataset</td></tr><tr><td align="left" valign="middle">Hybrid classification approach [<xref ref-type="bibr" rid="ref30">30</xref>]</td><td align="left" valign="middle">83.1</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">64.8</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">Centralized; applied SVM<sup><xref ref-type="table-fn" rid="table10fn11">k</xref></sup>, RF, DT, naive Bayes with K-means preprocessing; best accuracy achieved by SVM</td></tr><tr><td align="left" valign="middle">Three predictive algorithms [<xref ref-type="bibr" rid="ref31">31</xref>]</td><td align="left" valign="middle">77.1</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">Centralized; applied LR, RF, and ANN<sup><xref ref-type="table-fn" rid="table10fn12">l</xref></sup>; LR achieved the best accuracy (77.10%) with AUC<sup><xref ref-type="table-fn" rid="table10fn13">m</xref></sup> 0.83 over RF and ANN</td></tr><tr><td align="left" valign="middle">Soft voting ensemble [<xref ref-type="bibr" rid="ref32">32</xref>]</td><td align="left" valign="middle">79.1</td><td align="left" valign="middle">73.1</td><td align="left" valign="middle">71.6</td><td align="left" valign="middle">80.9</td><td align="left" valign="middle">Centralized; combined RF, LR, and naive Bayes classifiers</td></tr><tr><td align="left" valign="middle">Ensemble hierarchical model [<xref ref-type="bibr" rid="ref33">33</xref>]</td><td align="left" valign="middle">83.1</td><td align="left" valign="middle">25.0 (positive)/98.6 (negative)</td><td align="left" valign="middle">38.4 (positive)/90.2 (negative)</td><td align="left" valign="middle">82.8</td><td align="left" valign="middle">Centralized; applied DT and LR, fused by neural network</td></tr><tr><td align="left" valign="middle">Stacking ensemble [<xref ref-type="bibr" rid="ref25">25</xref>]</td><td align="left" valign="middle">77.1</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">Centralized; stacking ensemble of ML models; accuracy achieved using cross-validation protocol</td></tr><tr><td align="left" valign="middle">Deep learning pipeline [<xref ref-type="bibr" rid="ref34">34</xref>]</td><td align="left" valign="middle">92.3</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">Centralized; deep learning pipeline using VAE<sup><xref ref-type="table-fn" rid="table10fn14">n</xref></sup> for data augmentation, SAE<sup><xref ref-type="table-fn" rid="table10fn15">o</xref></sup> for feature augmentation, and CNN<sup><xref ref-type="table-fn" rid="table10fn16">p</xref></sup> for classification</td></tr><tr><td align="left" valign="middle">Deep CNN with correlation-based features [<xref ref-type="bibr" rid="ref35">35</xref>]</td><td align="left" valign="middle">96.1</td><td align="left" valign="middle">94.4</td><td align="left" valign="middle">94.4</td><td align="left" valign="middle">94.5</td><td align="left" valign="middle">Centralized; applied deep CNN with feature selection based on correlation</td></tr><tr><td align="left" valign="middle">Blockchain-FL with adaptive DP [<xref ref-type="bibr" rid="ref20">20</xref>]</td><td align="left" valign="middle">82.7</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">N/A</td><td align="left" valign="middle">Decentralized; implemented federated learning with differential privacy using blockchain technology</td></tr></tbody></table><table-wrap-foot><fn id="table10fn1"><p><sup>a</sup>ML: machine learning.</p></fn><fn id="table10fn2"><p><sup>b</sup>N/A: not applicable.</p></fn><fn id="table10fn3"><p><sup>c</sup>LR: logistic regression.</p></fn><fn id="table10fn4"><p><sup>d</sup>XGB: extreme gradient boosting.</p></fn><fn id="table10fn5"><p><sup>e</sup>GB: gradient boosting.</p></fn><fn id="table10fn6"><p><sup>f</sup>DT: decision tree.</p></fn><fn id="table10fn7"><p><sup>g</sup>ET: extra tree.</p></fn><fn id="table10fn8"><p><sup>h</sup>RF: random forest.</p></fn><fn id="table10fn9"><p><sup>i</sup>LGBM: light gradient boosting machine.</p></fn><fn id="table10fn10"><p><sup>j</sup>RFE-GRU: Recursive Feature Elimination with Gated Recurrent Unit.</p></fn><fn id="table10fn11"><p><sup>k</sup>SVM: support vector machine.</p></fn><fn id="table10fn12"><p><sup>l</sup>ANN: artificial neural network.</p></fn><fn id="table10fn13"><p><sup>m</sup>AUC: area under the curve.</p></fn><fn id="table10fn14"><p><sup>n</sup>VAE: variational autoencoder.</p></fn><fn id="table10fn15"><p><sup>o</sup>SAE: stacked autoencoder.</p></fn><fn id="table10fn16"><p><sup>p</sup>CNN: convolutional neural network.</p></fn></table-wrap-foot></table-wrap><p>In contrast, FedEnTrust improves over recent decentralized models, such as blockchain-integrated FL with differential privacy (accuracy&#x2248;82.7%), by incorporating ensemble learning and adaptive aggregation. Despite the constraints of data fragmentation and heterogeneity, our framework maintains robust performance across all key metrics, including precision (84.6%), recall (88.6%), and <italic>F</italic><sub>1</sub>-score (86.4%).</p><p>FedEnTrust achieves a favorable trade-off between privacy, generalizability, and computational practicality, making it well suited for real-world deployment in regulated health care environments.</p></sec><sec id="s4-3"><title>Ethical AI Considerations: Fairness, Transparency, and Accountability</title><sec id="s4-3-1"><title>Ethical Framework</title><p>Ethical concerns are central to the deployment of AI systems in health care, where unequal access to computational resources and imbalanced data distributions may inadvertently create or reinforce model biases. FedEnTrust incorporates several design principles aligned with emerging ethical AI guidelines, including those recommended by the World Health Organization and major AI governance frameworks.</p></sec><sec id="s4-3-2"><title>Fairness Across Heterogeneous Participants</title><p>Health care institutions vary substantially in data volume, demographic composition, and computational capacity, which can introduce systematic bias in collaborative learning systems. FedEnTrust is designed to mitigate such bias by supporting heterogeneity-aware participation, allowing low-resource nodes to contribute using models aligned with their capabilities without sacrificing predictive performance. Adaptive weight clipping is applied during aggregation to prevent high-resource institutions from disproportionately dominating the global ensemble. In addition, temperature-calibrated soft labels are used to reduce overconfidence from models trained on larger or more homogeneous datasets, while confidence thresholding ensures that noisy or low-confidence predictions are not propagated across participants. Together, these mechanisms promote more balanced influence across diverse health care contributors and support fairer model outcomes in heterogeneous federated environments.</p></sec><sec id="s4-3-3"><title>Transparency and Auditability</title><p>Transparency in FedEnTrust is enabled through the blockchain-based coordination layer, which provides immutable audit trails for all update submissions and verifiable records of role validation events. Each model contribution is traceably logged, allowing the system to record which institutions participated in and influenced each training round. This tamper-resistant logging mechanism enhances accountability, supports post hoc auditing, and increases trust among participating health care entities without exposing sensitive data or model parameters.</p></sec><sec id="s4-3-4"><title>Privacy and Data Minimization</title><p>FedEnTrust adheres to privacy-by-design principles:</p><list list-type="bullet"><list-item><p>Raw patient data remain strictly on the device</p></list-item><list-item><p>Only soft-label vectors and hashed metadata are transmitted</p></list-item><list-item><p>No identifiable information is stored on-chain, supporting HIPAA, GDPR, and similar regulatory frameworks</p></list-item></list><p>Role-based access ensures that only authorized clinical entities may participate.</p></sec><sec id="s4-3-5"><title>Accountability and Governance</title><p>The multivalidator consensus layer enables shared governance rather than reliance on a single coordinating institution. This creates a more accountable decision-making process and aligns with ethical expectations for distributed medical AI systems.</p></sec></sec><sec id="s4-4"><title>Blockchain Performance and Practical Considerations</title><sec id="s4-4-1"><title>Implementation Considerations</title><p>Beyond empirical accuracy and security validation, the practical deployment of blockchain-enabled FL systems in health care requires careful consideration of scalability, cost, and regulatory compliance. While the blockchain layer in FedEnTrust demonstrated stable and reliable performance under controlled experimental conditions, real-world health care environments introduce additional operational and governance challenges. This section discusses key practical considerations and outlines how FedEnTrust is designed to address them.</p></sec><sec id="s4-4-2"><title>Scalability and Throughput</title><p>Public blockchain platforms, such as the Ethereum main net, face inherent constraints related to transaction throughput, block confirmation latency, and network congestion. These limitations can lead to unpredictable delays and may not support the repeated coordination required across multiple FL rounds. To address this, FedEnTrust is designed for deployment on private or consortium-based Ethereum networks, where consensus parameters, block times, and validator participation can be tailored to health care workflows. Such configurations enable deterministic execution and consistent performance, as observed in our evaluation. Nevertheless, large-scale deployments involving many institutions may require additional enhancements, including optimized validator load balancing, hierarchical or sharded blockchain structures, and integration with layer-2 scaling mechanisms to further increase throughput.</p></sec><sec id="s4-4-3"><title>Cost Variability and Resource Requirements</title><p>In public blockchain environments, gas fees fluctuate dramatically based on network conditions, resulting in variable operational costs for smart contract execution. This variability is incompatible with cost-sensitive health care environments. Deploying FedEnTrust on a private Ethereum network eliminates transaction fees and allows institutions to control computational and storage overhead. However, operating such networks requires institutional commitment to maintain validator nodes, ensure uptime, and manage governance policies. Future work will investigate cost-benefit trade-offs between private, hybrid, and layer-2 blockchain configurations for FL.</p></sec><sec id="s4-4-4"><title>Regulatory and Compliance Constraints</title><p>Health care systems must comply with strict privacy regulations such as HIPAA, GDPR, and provincial or national data-protection laws. These frameworks introduce challenges, such as prohibiting the storage of patient data or identifiers on-chain, requiring transparent audit trails for collaborative analytics, and ensuring that cross-institution coordination adheres to data-sharing agreements.</p><p>FedEnTrust addresses these concerns by storing only hashed metadata and role-verification entries on-chain, keeping soft labels and model outputs entirely off-chain. However, real-world deployment requires integration with institutional governance mechanisms to ensure compliance documentation, legal interoperability among institutions, and formal auditing procedures.</p></sec></sec><sec id="s4-5"><title>Generalizability to Multimodal and Longitudinal Health Care Data</title><p>Although the PIMA dataset provides a controlled benchmark for evaluating prediction accuracy, it does not reflect the complexity of real-world clinical environments. Modern health care systems generate multimodal data that may include structured electronic health record fields, laboratory values, medical imaging, clinician notes, and continuous wearable sensor streams. Additionally, many health conditions, including diabetes, require longitudinal modeling to capture evolving physiological states over time.</p><p>FedEnTrust is designed to naturally extend to these scenarios. The framework&#x2019;s heterogeneity-aware model assignment allows each participant to select model architectures aligned with its data modality and computational resources. For example, hospitals could train sequence models (eg, long short-term memories or transformers) on longitudinal EHR data, while wearable devices may contribute short-term physiological features via lightweight SVM or tree-based models. The knowledge-distillation component operates on probability distributions and is therefore agnostic to model type, enabling soft-label fusion across diverse modalities and temporal structures. This capability is particularly suitable for integrating outputs from time-series models, tabular models, and sensor analytics.</p><p>The blockchain-based coordination layer also supports generalization, as its role-based validation and update logging apply to any model output regardless of modality. Future work will apply FedEnTrust to multicenter datasets such as MIMIC-IV, NHANES, and integrated wearable&#x2013;EHR cohorts to evaluate its performance under more heterogeneous and clinically realistic conditions.</p></sec><sec id="s4-6"><title>Limitations</title><p>Despite promising results, several limitations remain:</p><list list-type="bullet"><list-item><p>Dataset representativeness: The PIMA dataset is limited in scope and population diversity. Future work should evaluate FedEnTrust on broader, real-world datasets from varied demographics and geographies.</p></list-item><list-item><p>Extreme client heterogeneity: Devices with ultra-low resources may still face difficulties in real-time model adaptation. Exploring ultra-lightweight architectures and communication compression techniques is a key next step.</p></list-item><list-item><p>Controlled blockchain simulation: Our blockchain operations were simulated under stable conditions. Future deployment on public testnets or mainnets is necessary to assess real-world transaction delays, scalability, and cost variability.</p></list-item><list-item><p>Advanced threat modeling: While the smart contract blocks unauthorized actions, adversarial behaviors such as collusion or model poisoning were not addressed. Future extensions may integrate anomaly detection and audit trails to enhance system resilience.</p></list-item></list><p>Although the PIMA Indians Diabetes Dataset is a well-established benchmark for evaluating diabetes prediction models, its limited demographic diversity and relatively small size restrict the generalizability of the findings. The simulated heterogeneous environment in <xref ref-type="table" rid="table2">Table 2</xref>, while constructed to reflect realistic participant variability, does not fully replicate the complexity of multi-institution health care settings, where differences in clinical practice, sensor characteristics, and patient demographics lead to substantially wider non-IID distributions. Accordingly, the results presented here should be viewed as a controlled feasibility demonstration rather than a comprehensive real-world validation.</p></sec><sec id="s4-7"><title>Conclusions</title><p>This study presents FedEnTrust, a secure and intelligent federated ensemble learning framework for privacy-preserving diabetes prediction. Our approach addresses key challenges in decentralized health care AI, including data privacy, system trust, and participant heterogeneity, without requiring access to raw patient data.</p><p>By integrating knowledge distillation and adaptive ensemble aggregation, the framework enables resource-aware contributions from a diverse range of participants, from high-performance hospital systems to low-power personal devices. The experimental results demonstrate consistent improvements in predictive performance across all participants, validating both the effectiveness and inclusiveness of the design.</p><p>A central innovation is the blockchain-enabled coordination layer, which ensures secure registration, role-based access control, and verifiable model updates. Smart contract simulations confirm the system&#x2019;s efficiency, low latency, and robustness against unauthorized actions, supporting scalable and tamper-resistant deployment in health care environments.</p><p>In sum, FedEnTrust offers a practical, scalable solution for secure, decentralized medical AI, balancing privacy, performance, and trust. Future work will extend this framework to additional clinical domains, multisite studies, and dynamic personalization for broader impact in real-world health care.</p></sec></sec></body><back><notes><sec><title>Funding</title><p>The authors express their gratitude to the funding provided to support this study from the National Science Foundation with award number 2218046.</p></sec></notes><fn-group><fn fn-type="conflict"><p>None declared.</p></fn></fn-group><glossary><title>Abbreviations</title><def-list><def-item><term id="abb1">AI</term><def><p>artificial intelligence</p></def></def-item><def-item><term id="abb2">FL</term><def><p>federated learning</p></def></def-item><def-item><term id="abb3">GDPR</term><def><p>General Data Protection Regulation</p></def></def-item><def-item><term id="abb4">HIPPA</term><def><p>Health Insurance Portability and Accountability Act</p></def></def-item><def-item><term id="abb5">IID</term><def><p>independent and identically 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