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Earnings management literature extensively explores tax regime and debt contracting as possible incentives in financial reporting. Firms engage with aggressive financial reporting to bias earnings in periods when the need for external financing increases. Contrary to this, the tax burden represents incentive for more conserva tive reporting. We argue that the level of firm’s financial reporting aggressiveness is not constant but rather floating from period to period, directly affecting the quality of financial reports. We assume that firm’s management on its own discretion determines the level of conservatism, balancing between these two incentives. The prevailing of two incentives, the need for external financing and the tax burden, determines the level of conservatism in particular reporting period. We hypothesised that the reduction in tax burden incentive overcomes the debt contracting incentive in the years of decreasing external financing need, implying more conservative accounting to balance between economic and taxable income. The total accruals are used as a measure of earnings management reflected to working capital accruals. The data analysis conducted on financial reports of 297 firms in the time-series of five years shows a significant correlation between total accruals, external financing needs and difference between economic and taxable income. This study provides an evidence on the association between conditional conservatism and external financing needs against anticipated tax sheltering activities in the economy with rather weak legal enforcement and widely spread use of accoun-ting-based covenants in debt contracting, proposing that the conditional conservatism may rather not reduce the cost of debt with the diminishing role of accounting in the debt contracting.

Daniel Brahneborg, W. Afzal, Adnan Causevic, M. Björkman

To keep internet based services available despite inevitable local internet and power outages, their data must be replicated to one or more other sites. For most systems using the store-and-forward architecture, data loss can also be prevented by using end-to-end acknowledgements. So far we have not found any sufficiently good solutions for replication of data in store-and-forward systems without acknowledgements and with geographically separated system nodes. We therefore designed a new replication protocol, which could take advantage of the lack of a global order between the messages and the acceptance of a slightly higher risk for duplicated deliveries than existing protocols. We tested a proof-of-concept implementation of the protocol for throughput and latency in a controlled experiment using 7 nodes in 4 geographically separated areas, and observed the throughput increasing superlinearly with the number of nodes up to almost 3500 messages per second. It is also, to the best of our knowledge, the first replication protocol with a bandwidth usage that scales according to the number of nodes allowed to fail and not the total number of nodes in the system.

Šejla Cerić, Timur Cerić, N. Pojskić, N. Bilalović, J. Mušanović, E. Kučukalić-Selimović

Context Neoangiogenesis and lymphangio-genesis are essential for the growth of tumor and progression of malignancy. Objective The study examined the significance of VEGF-C expression in comparison to classical prognostic factors in differentiated thyroid carcinoma (DTC), as well as an independent prognostic marker in DTC. Design The study included 81 patients with DTC allocated in two groups according to the type of cancer (follicular versus papillary) and then compared to expression of VEGF-C and clinicopathological features. Methods Expression of VEGF-C was identified with anti-VEGF-C antibody using tris-EDTA buffer Antigen Retrieval Protocol. Each specimen was scored with a semi-quantitative score system (H-score). Results The analysis of T staging system showed a linear correlation between the size of a tumor, expression of VEGF-C and recurrence of a disease, with a statistical significance (p < 0.0001). There was a clear and significant correlation between VEGF-C expression and T stage in patients with papillary carcinoma (p = 0.0294). Analysis of invasion of a surgical margin demonstrated significant positivity in patients with papillary thyroid cancers who expressed VEGF-C (p = 0.0207) indicating the worse prognosis of a disease. Also a statistically significant correlation was between VEGF-C and extrathyroid extension, indicating the worse prognosis (p = 0.0133) in papillary cancers. The level of VEGF-C expression was statistically significant in patients with papillary thyroid cancer (p = 0.039). Conclusions This study undoubtedly demonstrates that VEGF-C expression is an evident negative prognostic factor in patients with papillary thyroid carcinoma, along with the classic prognostic factors, such as a larger tumor size, tumor margin involvement, extrathyroid extension, i.e. local aggressiveness.

Due to the development of information communication technologies (ICT), the number of medical devices (MDs) with telemetric possibilities is rising, so the concept of homecare is gaining importance. Also, new generation medical devices are equipped with artificial intelligence that is able to perform real-time analysis of measurement result and provide diagnosis prediction. This is the Industry 4.0 happening now. However, there is still traditional approach in management of medical devices. As medical devices have been sophisticated, management systems should improve so they can encompass all the important aspects regarding safety of patients and quality of care. This chapter presents how the technology of Industry 4.0 can be used to improve medical device maintenance systems by application of artificial intelligence (AI). Clinical engineering and health technology management departments benefit from such systems in terms of increase of safety and quality of patient diagnosis and treatments, and cost optimization in medical device management.

A. Badnjević, L. G. Pokvic

Abstract It has been stated multiple times that we live in modern age, where technology has a great impact on our lives. We perform a lot of tasks using technology, so we communicate much quicker, plan, organize, pay bills, and control appliances at home and all by using one application. But what is the most important thing for a human? Is it the technology, money, or something else? Are you capable of performing any task if you have increased body temperature, high blood pressure, or unbalanced heart rate? Health has always been, is, and will always be the most important thing that for sure should be taken care of.The development of medical devices has dramatically changed the way medical care is provided to patients. Nowadays, medical professionals are working with sophisticated medical devices, but the interpretation of obtained values and understanding of their function is very important. Due to the gap in this area, patient safety issue is gaining on its importance. Recently, a majority of healthcare institutions are undertaking accreditation procedures, depending on national legislation, to ensure the quality of treatment provided to their patients. The reason for such activities is increasing competitiveness on national and international markets, especially now when a major shift from public to private health care can be observed. However, even in these situations, mechanisms for ensuring patient safety, in terms of medical device reliability achieved through postmarket supervision, are not well defined. This is proven by numerous incident reports involving various medical devices including infant incubators, but importantly emphasized by recent amendments to medical device directives at the European level.

A. Badnjević, L. G. Pokvic

Abstract Medical devices (MDs) are sophisticated electronic systems whose performances vary depending on the production quality and the environmental conditions in which they are used (European Commission, n.d.-a). Safety and performance of MDs are defined by international standards issued by prominent worldwide organizations and national regulatory bodies (International Organisation for Standardization – ISO, n.d.; International Electrotechnical Commission, n.d.). Although, production process of MDs is regulated by various international and national legal frameworks and procedures (World Health Organisation, n.d.), safety and quality of MD performance in real settings are still not defined. That is the reason why, despite the existence of regulations for MDs unfortunate incidents are not uncommon around the world. Existing frameworks are mostely based on postmarket surveillance performed by manufacturers and distributors, or local health technology assessment (HTA) units. This is done through the establishment of databases for reporting incidents involving MDs. That practice is adopted in United States. The Food and Drug Administration (FDA) (n.d.) receives thousands of reports each year detailing the deaths, serious injuries, and malfunctions associated with MDs. These incidents are, in United States, reported either by healthcare institution or by manufacturer to central database of incidents called Manufacturer and User Facility Device Experience (MAUDE) (Food and Drug Administration (FDA), n.d.). In the Europe, as part of IDABC (Interoperable Delivery of European eGovernment Services to public Administrations, Businesses, and Citizens) program, information system for exchanging legal information related to the application of European Union Directives on medical devices [European Union database on Medical Devices (EUDAMED)] was established (European Commission, n.d.-c). Nowadays, most manufacturers recommend different preventive maintenance procedures for preoperative checking of MD as only method of assessment during usage. All of this suggests that evidence-based performance and safety inspection of MDs already used in health care should be adopted to ensure safety and performance reliability of MDs. Performance inspection regulations exist for other devices with measuring function (electricity meters, gas meters, scales) and it is conducted periodically based on metrological procedures so measurements are traceable to international standards. Therefore, this chapter gives an overview of key elements for legal metrology framework for inspection od MD safety and performance that can be part of various HTAs protocols.

Z. Dzemic, A. Bosnjakovic, A. Badnjević

Abstract Medical devices with a measuring function have to be periodically inspected. Periodical inspection of these devices is necessary to protect the end users as well as personnel who use them for establishing diagnoses for patient treatment. Incorrect and imprecise measuring results can lead to misdiagnosis, and therefore to wrong treatment. To avoid these unwanted situations, medical devices with the measuring function have to be regularly inspected in accordance with the prescribed inspection procedures. These procedures have to be approved by a state authorized body responsible for this area. Also, medical devices with measuring function in some countries are a part of the legal metrology system. Because of the high importance of these devices, their inspection needs to be carried out by inspection bodies with proven competences. The most reliable way of proving competences is through the fulfillment of requirements resulting from ISO/IEC 17020. This chapter briefly elaborates on the requirements arising from this standard as well as the mode for its implementation. This chapter aims to facilitate the implantation of the ISO/IEC 17020 standard for future inspection bodies for performing the inspection in a competent and impartial manner. Accurate and precise medical devices with measuring function will enable professional personnel to properly establish diagnoses for patient treatment. There are many advantages of regular inspection of medical devices, and the greatest advantage is the protection of the patient’s lives.

Abstract Cardiovascular diseases (CVD) cause an average of 17.7 million deaths each year (44% of NCD fatalities) making it one of the most deserving topics for research on prevention. CVD are a group of disorders of the heart and blood vessels which is the most significant cause of death globally. Despite the critical fatality rate 90% CVD can be prevented by taking necessary precautions.

Z. Dzemic, Haris Memic, A. Badnjević

Abstract People usually do not make any difference between laws and regulations but there is certain difference in hierarchy between laws and regulations. In the United States, e.g., Congress, and only Congress, creates laws. Federal executive departments and administrative agencies write regulations to implement the authority of laws. Regulations (as well as Executive Orders and Proclamations) are ancillary or subordinate to laws but both laws and regulations are enforceable. The US Code is the official compilation of current, codified laws by subject; the US Statutes-at-Large is the official chronological compilation of all laws; and the Code of Federal Regulations is the official compilation of regulations.

A. Badnjević, M. Cifrek, R. Magjarević, Z. Dzemic

Abstract Around the world, there are varieties of healthcare systems, each with its own characteristics and organizational structure according to national resources, requirements, and needs. Bearing this in mind it is very difficult to give a general definition for the healthcare system. Basically, it can be defined as a normatively accepted system of society and government in protecting and improving the population health, with all system factors affecting organized and constantly evolving as part of a general country social system. Each healthcare system consists of medical institutions which in addition to personnel and infrastructure must possess the necessary equipment in order to perform the correct diagnosis and treatment of their patients. In addition to the knowledge and experience of medical doctors, inpatient diagnosis and treatment, it is necessary to have the correct and tested medical apparatus. Diversity and innovativeness of medical devices, as a result of the evolving field of biomedical engineering, significantly contribute to improvement in quality and efficiency of healthcare services

A. Badnjević, L. G. Pokvic

Abstract Intensive care units are run and staffed by specialists trained in intensive care. Once a patient is admitted to the unit, the intensive care team will manage the care of the patient in consultation with the original team that admitted the patient to the hospital and any other specialists that they think can help to aid the patient’s recovery. The intensive care doctors and nurses will give the best overview and general update on the patient, but they may refer relatives to the specialist teams for discussion of certain aspects of care.

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