Nanomaterials (NMs) are having a huge impact in several domains, including the fabrication of medical devices (MDs). Hence, nanostructured MDs are becoming quite common; nevertheless, the associated risks must be carefully considered in order to demonstrate safety prior to their immission on the market. The biological effect of NMs requires the consideration of methodological issues since already established methods for, e.g., cytotoxicity can be subject to a loss of accuracy in the presence of certain NMs. The need for oversight of MDs containing NMs is reflected by the European Regulation 2017/745 on MDs, which states that MDs incorporating or consisting of NMs are in class III, at highest risk, unless the NM is encapsulated or bound in such a manner that the potential for its internal exposure is low or negligible (Rule 19). This study addresses the role of NMs in medical devices, highlighting the current applications and considering the regulatory requirements of such products.

Over the past decade, the use of telehealth has garnered increasing attention. The focus on quality aspects has seen significant growth in tandem with the telehealth expansion. Having useful indicators in this area is becoming increasingly strategic for fully integrating the technology into the health domain. These indicators can help monitor and evaluate the quality of telehealth services, guiding improvements and ensuring that these digital solutions meet the necessary standards for effective healthcare delivery. The purpose of this study is to analyze Key performance indicators (KPIs) in telehealth within institutional websites and the scientific dissemination world by means of a narrative review. A narrative review was proposed with these two specific points of view based on a standardized checklist and a quality control procedure for including scientific papers in the analysis. Results from scientific studies emphasize KPIs such as patient outcomes, operational efficiency, technical reliability, and cost-effectiveness. These include measures like improvements in condition management, patient satisfaction, consultation numbers, waiting times, and cost savings. Institutional documents from entities like the WHO also show diverse perspectives, focusing on equitable access, clinical excellence, patient prioritization, response times, and patient and staff satisfaction. The findings suggest that adopting a comprehensive set of KPIs and continuously monitoring and evaluating telehealth services can enhance their effectiveness, efficiency, and equity, ultimately improving healthcare outcomes and accessibility.

18β-glycyrrhetinic acid (GA) is a pentacyclic triterpene with promising hepatoprotective and anti-Hepatocellular carcinoma effects. GA low water solubility however reduces its biodistribution and bioavailability, limiting its applications in biomedicine. In this work we used core-shell NPs made of PolyD-L-lactide-co-glycolide (PLGA) coated with chitosan (CS), prepared through an osmosis-based methodology, to efficiently entrap GA. NPs morphology was investigated with SEM and TEM and their GA payload was evaluated with a spectrophotometric method. GA-loaded NPs were administered to HepG2 cells and their efficiency in reducing cell viability was compared with that induced by the free drug in in vitro tests. Cell viability was evaluated by the MTT assay, as well as with Electric Cells-Substrate Impedance Sensing (ECIS), that provided a real-time continuous monitoring. It was possible to correlate the toxic effect of the different forms of GA with the bioavailability of the drug, evidencing the importance of real-time tests for studying the effects of bioactive substances on cell cultures.

The expanding role of technology assessment in telemedicine is the focus of this study. An umbrella review has been proposed to delve into emerging themes within telemedicine technology assessment by scrutinizing systematic reviews gathered from PubMed and Scopus. The proposed approach was based on a standard narrative checklist and a qualification process. The selection process identified 20 systematic reviews. The main findings underscore the transformative potential of telemedicine, emphasizing technology assessments focused on systematic evaluations, stakeholder engagement, societal impact recognition, targeted interventions, and structured frameworks. While offering valuable insights, the current studies highlight certain limitations that require attention. There is a need for the following: (I) First of all, a more focused approach, primarily centered on a process-centric, multidomain, and generalizable technology assessment (TA). (II) A deeper analysis in specific healthcare areas, including a comprehensive examination of the cost–benefit ratio, peer-to-peer interactions, and a broader inclusion of diagnostic technologies. (III) Greater emphasis on the involved stakeholders, ranging from patients to stakeholders. In conclusion, this study contributes to a comprehensive and nuanced understanding of the continually evolving landscape in telemedicine technology assessment, offering valuable insights for practitioners, researchers, and policymakers alike. Researchers are encouraged to further explore both the established and emerging themes identified in this study.

Background: With the increasing use of health apps and ongoing concerns regarding their safety, effectiveness, and data privacy, numerous health app quality assessment frameworks have emerged. However, assessment initiatives experience difficulties scaling, and there is currently no comprehensive, consistent, internationally recognized assessment framework. Therefore, health apps often need to undergo several quality evaluations to enter different markets, leading to duplication of work. The CEN ISO/TS 82304‑2 health app assessment seeks to address this issue, aiming to provide an internationally accepted quality evaluation through a network of assessment organizations located in different countries. Objective: This study aimed to develop and evolve the draft CEN ISO/TS 82304-2 assessment handbook and developer guidance by testing them across organizations in several countries. Methods: Assessment organizations from 5 countries were engaged to evaluate 24 health apps using the evolving CEN ISO/TS 82304-2 assessment across 3 evaluation rounds. The information submitted by a given health app developer was evaluated by 2 assessment organizations, and interrater reliability was examined. In addition, app developers and assessors were asked to report how much time they spent on information collation or evaluation and to rate the clarity of the developer guidance or assessor handbook, respectively. The collected data were used to iteratively improve the handbook and guidance between rounds. Results: The interrater reliability between assessment organizations improved from round 1 to round 2 and stayed relatively stable between rounds 2 and 3, with 80% (55/69) of assessment questions demonstrating moderate or better (Gwet AC1>0.41) agreement in round 3. The median time required by developers to prepare the assessment information was 8 hours and 59 minutes (IQR 5.7-27.1 hours) in round 3, whereas assessors reported a median evaluation time of 8 hours and 46 minutes (IQR 7.1-11.0 hours). The draft guidance and handbook were generally perceived as clear, with a median round-3 clarity rating of 1.73 (IQR 1.64-1.90) for developers and 1.78 (IQR 1.71-1.89) for assessors (0=“very unclear”, 1=“somewhat unclear”, and 2=“completely clear”). Conclusions: To our knowledge, this is the first study to examine the consistency of health app evaluations across organizations located in different countries. Given that the CEN ISO/TS 82304-2 guidance and handbook are still under development, the interrater reliability findings observed at this early stage are promising, and this study provided valuable information for further refinement of the assessment. This study marks an important first step toward establishing the CEN ISO/TS 82304-2 assessment as a consistent, cross-national health app evaluation. It is envisioned that the assessment will ultimately help avoid duplication of work, prevent inequities by facilitating access to smaller markets for developers, and build trust among users, thereby increasing the adoption of high-quality health apps.

Background: The Telemechron project addresses critical needs in telemedicine by evaluating technology assessment frameworks and key performance indicators (KPIs), among other objectives. Effective frameworks and KPIs are crucial for assessing telemedicine services, especially in terms of their impact on patient outcomes and service efficiency. Methods: This study adopted a dual approach to assess the contributions of the Telemechron project. Firstly, it applied a technology assessment framework to quantitatively evaluate telemedicine services, focusing on measurable improvements and systematic analysis. Secondly, it investigated a set of predefined KPIs using specific metrics and parameters to evaluate their applicability and limitations in telemedicine settings. Results and Discussion: The technology assessment framework demonstrated significant utility by providing structured, quantifiable improvements across key aspects of telemedicine services. It was effective in evaluating the alignment of services with strategic goals and their integration with existing healthcare systems. The predefined KPIs, although not developed within this study and not directly used by the different operational units (OUs)—which established their own context-specific KPIs—still provided valuable insights into telemedicine performance. However, the study revealed that these KPIs highlighted a need for further customization to enhance their relevance across various contexts. While the KPIs may offer useful performance indicators, their general applicability necessitated adjustments to better address the specific needs of telemedicine applications. The analysis model for the KPI set, in terms of metrics and parameters, is exportable and generalizable to other national and international telemedicine contexts. Conclusions: The study confirms the effectiveness of the framework in delivering measurable improvements in telemedicine services and underscores the importance of adapting KPIs for specific contexts. Future research should focus on further applying and expanding the framework and metrics, refining KPI models, integrating new technologies, and conducting cross-national comparisons to enhance the applicability and effectiveness of telemedicine evaluations.