Health Technology Assessment and Biomedical Engineering: Global trends, gaps and opportunities.

The diffusion of medical devices is expanding at an astonishing rate. The increasing number of novel patents per year suggests this growth will continue. In contrast to drugs, medical devices are intrinsically dependent on the environment in which they are used and how they are maintained. This created an unprecedented global need for well-trained biomedical engineers who can help healthcare systems to assess them. The International Federation for Medical and Biological Engineering (IFMBE) is the global scientific society of biomedical engineers in official relations with the United Nations World Health Organisation (WHO) and has been very active in promoting the role of the biomedical engineer in Health Technology Assessment (HTA). The IFMBE Health Technology Assessment Division (HTAD) is the IFMBE operative branch in this field, promoting studies, projects and activities to foster the growth of this specific and very important science sector, including summer schools, training material, an HTA eLearning platform, HTA guidelines, awards and more. This article describes the vision, the mission and the strategy of the HTAD, with a focus on the results achieved and the impact this is having on global policymaking.

Hospital-based expert model for health technology procurement planning in hospitals.

Although in the last years technology innovation in healthcare brought big improvements in care level and patient quality of life, hospital complexity and management cost became higher. For this reason, necessity of planning for medical equipment procurement within hospitals is getting more and more important in order to sustainable provide appropriate technology for both routine activity and innovative procedures. In order to support hospital decision makers for technology procurement planning, an expert model was designed as reported in the following paper. It combines the most widely used approaches for technology evaluation by taking into consideration Health Technology Assessment (HTA) and Medical Equipment Replacement Model (MERM). The designing phases include a first definition of prioritization algorithms, then the weighting process through experts' interviews and a final step for the model validation that included both statistical testing and comparison with real decisions. In conclusion, the designed model was able to provide a semi-automated tool that through the use of multidisciplinary information is able to prioritize different requests of technology acquisition in hospitals. Validation outcomes improved the model accuracy and created different "user profiles" according to the specific needs of decision makers.

A queueing theory based model for business continuity in hospitals.

Clinical activities can be seen as results of precise and defined events' succession where every single phase is characterized by a waiting time which includes working duration and possible delay. Technology makes part of this process. For a proper business continuity management, planning the minimum number of devices according to the working load only is not enough. A risk analysis on the whole process should be carried out in order to define which interventions and extra purchase have to be made. Markov models and reliability engineering approaches can be used for evaluating the possible interventions and to protect the whole system from technology failures. The following paper reports a case study on the application of the proposed integrated model, including risk analysis approach and queuing theory model, for defining the proper number of device which are essential to guarantee medical activity and comply the business continuity management requirements in hospitals.

The diagnostic-therapeutic process. Workflow analysis and risk management with IT tools.

The aim of this work is to study the impact of an Information Technology (IT) tool on clinical risk management and Adverse Drug Events prevention in patient care. In this study we propose the workflow analysis and the application of Failure Modes Effects and Criticality Analysis (FMECA) as potential tools to assess the effectiveness of a specific IT tool in mitigating clinical risk. The study is made up of two different parts: the first one shows the decomposition and representation of the workflow of hospital departments using standardized tools from Project Management. The next phase shows the application of FMECA to the workflow, in order to identify critical issues and evaluate the risk reduction obtained using a specific IT tool, compared to the use of current resources.

Random Forest for automatic assessment of heart failure severity in a telemonitoring scenario.

In this study, we describe an automatic classifier of patients with Heart Failure designed for a telemonitoring scenario, improving the results obtained in our previous works. Our previous studies showed that the technique that better processes the heart failure typical telemonitoring-parameters is the Classification Tree. We therefore decided to analyze the data with its direct evolution that is the Random Forest algorithm. The results show an improvement both in accuracy and in limiting critical errors.

Heart failure analysis dashboard for patient's remote monitoring combining multiple artificial intelligence technologies.

In this paper we describe an Heart Failure analysis Dashboard that, combined with a handy device for the automatic acquisition of a set of patient's clinical parameters, allows to support telemonitoring functions. The Dashboard's intelligent core is a Computer Decision Support System designed to assist the clinical decision of non-specialist caring personnel, and it is based on three functional parts: Diagnosis, Prognosis, and Follow-up management. Four Artificial Intelligence-based techniques are compared for providing diagnosis function: a Neural Network, a Support Vector Machine, a Classification Tree and a Fuzzy Expert System whose rules are produced by a Genetic Algorithm. State of the art algorithms are used to support a score-based prognosis function. The patient's Follow-up is used to refine the diagnosis.

Telematics integrated system to perform drugs prescription and administration reducing adverse drug events.

In this paper we present PHARMA 2.0 a telematics integrated system aimed at reducing Adverse Drug Events (ADEs) in the phases of drug prescription, transcription, distribution and administration. The proposed system is grounded on three sub-systems: a CPOE (Computerized Prescription Order Entry), an RFID-based drug container and dispenser and a middleware system. The visualization and management of prescription and administration data are handled through a web application designed to comply with international usability regulation.

A methodology aimed to guarantee technology continuity in health structures.

In healthcare the importance of clinical continuity is essential for both patients life and health organization activity. Since technology continuity is having more and more importance for the service continuity, a correct management of medical devices must be guided by criteria that ensure its safe, appropriate and economical use through a well planned purchase, appropriate preventive and corrective maintenance Indeed, the aim of health technology managers is to optimize the integration of external interventions assistance and internal technical service to guarantee an efficient and cost-effective maintenance system. This paper proposes an innovative carefully thought methodology which is aimed to provide technological and procedural actions which offer support to decision makers in technology management regarding the implementation of continuity in medical services and response to technology failures and emergency events.

Medical software management: a failure analysis approach for maintenance and safety plan.

Medical software management represents one of the biggest future challenge in healthcare. Technology level is actually waiting for appropriate normative and regulatory support by including maintenance, assistance and safety. This paper aims to highlight the critical aspects in medical software management and specifically to provide a methodology in order to support decision makers responsible for medical software assistance in health structures. The results show how medical software effectiveness depends on technical, organizational and clinical aspects.