A proposed approach to the revision of IEC 80001-1 following annex SL

IEC 80001-1 was published in 2010 and is now undergoing revision. Feedback gathered on the adoption of the standard has revealed a number of barriers that have impacted its adoption. The standard provides requirements related to the roles, responsibilities and activities that need to be performed for the risk management of medical IT networks. One reported barrier is a lack of drivers to motivate Top Management to implement the standard. In addition, there is a lack of alignment between IT and biomedical engineering departments within hopitals. Finally, the IEC 80001-1 standard was considered to be too complicated and complex to implement. This paper presents the barriers identified in the feedback and presents an approach to the revision of the standard as a process based management system standard in accordance with ISO/IEC Directives Annex SL as a means to overcome these barriers

Improving communication in risk management of health information technology systems by means of medical text simplification

Health Information Technology Systems (HITS) are increasingly used to improve the quality of patient care while reducing costs. These systems have been developed in response to the changing models of care to an ongoing relationship between patient and care team, supported by the use of technology due to the increased instance of chronic disease. However, the use of HITS may increase the risk to patient safety and security. While standards can be used to address and manage these risks, significant communication problems exist between experts working in different departments. These departments operate in silos often leading to communication breakdowns. For example, risk management stakeholders who are not clinicians may struggle to understand, define and manage risks associated with these systems when talking to medical professionals as they do not understand medical terminology or the associated care processes. In order to overcome this communication problem, we propose the use of the “Three Amigos” approach together with the use of the SIMPLE tool that has been developed to assist patients in understanding medical terms. This paper examines how the “Three Amigos” approach and the SIMPLE tool can be used to improve estimation of severity of risk by non-clinical risk management stakeholders and provides a practical example of their use in a ten step risk management process

Study on Indirect Harms and Safety Measures of Medical Device Software

早大学位記番号:新7554早稲田大

BIG DATA IN HEALTH IOE IN EMERGENCY SITUATIONS: BETWEEN THE RIGHT TO PRIVACY AND DIGITAL HEALTH INNOV A TION

The unprecedented use of digital technologies in healthcare in the past five years in Europe has led to increased concerns regarding individual privacy and data protection. The increased use of digital health technologies in the past three years on the European continent due to the Covid-19 pandemic has exasperated these concerns, especially considering the processing and management of personal and sensitive data by public authorities in various Member States. These concerns raised a question on how individual and group privacy and related data protection rights can be adequately ensured in sensitive healthcare situations, such as a public healthcare crisis. The chapters of the thesis pursue an answer to this question, focusing on a limited variety of selected themes in EU privacy and data protection law. Chapter 1 sets out the general introduction on the research topic. Chapter 2 touches upon the methodology used in the research. Chapter 3 conceptualises the basic notions from a legal standpoint. Chapter 4 examines the current regulatory regime applicable to digital health technologies, healthcare emergencies, privacy, and data protection. Chapter 5 provides case studies on the application deployed in the Covid-19 scenario, from the perspective of privacy and data protection. Chapter 6 addresses the post-Covid European regulatory initiatives on the subject matter, and its potential effects on privacy and data protection. Chapter 7 is the outcome of a six-month internship with a company in Italy and focuses on the protection of the fundamental rights through common standardisation and certification, demonstrating that such standards can serve as supporting tools to guarantee the right to privacy and data protection in digital health technologies. The thesis concludes with the observation that finding and transposing the European privacy and data protection standards into scenarios, such as public healthcare emergencies where digital health technologies are deployed, requires rapid co-ordination between the European Data Protection Authorities and the Member States to guarantee that individual privacy and data protection rights are ensured. It observed that with the introduction of AI-based digital health technologies, the protection of the fundamental rights to privacy and data protection will remain a topical subject, with the need to work on harmonising different applicable regulatory regimes to ensure regulatory clarity

Assuring Safety and Security

Large technological systems produce new capabilities that allow innovative solutions to social, engineering and environmental problems. This trend is especially important in the safety-critical systems (SCS) domain where we simultaneously aim to do more with the systems whilst reducing the harm they might cause. Even with the increased uncertainty created by these opportunities, SCS still need to be assured against safety and security risk and, in many cases, certified before use. A large number of approaches and standards have emerged, however there remain challenges related to technical risk such as identifying inter-domain risk interactions, developing safety-security causal models, and understanding the impact of new risk information. In addition, there are socio-technical challenges that undermine technical risk activities and act as a barrier to co-assurance, these include insufficient processes for risk acceptance, unclear responsibilities, and a lack of legal, regulatory and organisational structure to support safety-security alignment. A new approach is required. The Safety-Security Assurance Framework (SSAF) is proposed here as a candidate solution. SSAF is based on the new paradigm of independent co-assurance, that is, keeping the disciplines separate but having synchronisation points where required information is exchanged. SSAF is comprised of three parts - the Conceptual Model defines the underlying philosophy, and the Technical Risk Model (TRM) and Socio-Technical Model (STM) consist of processes and models for technical risk and socio-technical aspects of co-assurance. Findings from a partial evaluation of SSAF using case studies reveal that the approach has some utility in creating inter-domain relationship models and identifying socio-technical gaps for co-assurance. The original contribution to knowledge presented in this thesis is the novel approach to co-assurance that uses synchronisation points, explicit representation of a technical risk argument that argues over interaction risks, and a confidence argument that explicitly considers co-assurance socio-technical factors

End-of-waste criteria for biodegradable waste subjected to biological treatment (compost & digestate): Technical proposals

This report is the JRC-IPTS contribution to the development of the end-of-waste criteria for biodegradable waste subject to biological treatment (compost/digestate) in accordance with Article 6 of Directive 2008/98/EC of the European Parliament and of the Council on waste (the Waste Framework Directive). This report includes a possible set of end-of-waste criteria and shows how the proposals were developed based on a comprehensive techno-economic analysis of the biodegradable waste derived compost/digestate production chain and an analysis of the economic, environmental and legal impacts when such compost/digestate ceases to be waste. The purpose of end-of-waste criteria is to avoid confusion about the waste definition and to clarify when certain waste that has undergone recovery ceases to be waste. Recycling should be supported by creating legal certainty and an equal level playing field and by removing unnecessary administrative burdens. The end-of-waste criteria should provide a high level of environmental protection and an environmental and economic benefit.JRC.J.5-Sustainable Production and Consumptio

A human factors evaluation of an electronic display system for an aircraft flight deck

This thesis describes a two and a half year study of the human factors associated with the introduction of electronic displays, i.e. cathode ray tubes, and their associated controls onto a civil transport aircraft flight deck. A simulator was constructed for the evaluation which was managed jointly by the British Aircraft Corporation Ltd. and Hawker Siddeley Aviation Ltd. (now British Aerospace) under a Ministry of Defence contract.[Continues.

Safety and Reliability - Safe Societies in a Changing World

The contributions cover a wide range of methodologies and application areas for safety and reliability that contribute to safe societies in a changing world. These methodologies and applications include: - foundations of risk and reliability assessment and management - mathematical methods in reliability and safety - risk assessment - risk management - system reliability - uncertainty analysis - digitalization and big data - prognostics and system health management - occupational safety - accident and incident modeling - maintenance modeling and applications - simulation for safety and reliability analysis - dynamic risk and barrier management - organizational factors and safety culture - human factors and human reliability - resilience engineering - structural reliability - natural hazards - security - economic analysis in risk managemen

USCID fourth international conference

Presented at the Role of irrigation and drainage in a sustainable future: USCID fourth international conference on irrigation and drainage on October 3-6, 2007 in Sacramento, California.Includes bibliographical references.The two-layer model of Shuttlerworth and Wallace (SW) was evaluated to estimate actual evapotranspiration (ETa) above a drip-irrigated Merlot vineyard, located in the Talca Valley, Region del Maule, Chile (35° 25' LS; 71° 32' LW ; 136m above the sea level). An automatic weather system was installed in the center of the vineyard to measure climatic variables (air temperature, relative humidity, and wind speed) and energy balance components (solar radiation, net radiation, latent heat flux, sensible heat flux, and soil heat flux) during November and December 2006. Values of ETa estimated by the SW model were tested with latent heat flux measurements obtained from an eddy-covariance system on a 30 minute time interval. Results indicated that SW model was able to predict ETa with a root mean square error (RMSE) of 0.44 mm d-1 and mean absolute error (MAE) of 0.36 mm d-1. Furthermore, SW model predicted latent heat flux with RMSE and MAE of 32 W m-2 and 19W m-1, respectively

USCID Fourth international conference on irrigation and drainage

Presented at the Role of irrigation and drainage in a sustainable future: USCID fourth international conference on irrigation and drainage on October 3-6, 2007 in Sacramento, California.Includes bibliographical references.Integrated regional water management -- Change of irrigation water quantity according to farm mechanization and land consolidation in Korea -- Local stakeholders participation for small scale water resources management in Bangladesh -- Water user participation in Egypt -- The man swimming against the stream knows the strength of it -- Roles and issues of Water Users' Associations for Sustainable Irrigation and Drainage in the Kyrgyz Republic and Uzbekistan in Central Asia -- Chartered Water User Associations of Afghanistan -- Updated procedures for calculating state-wide consumptive use in Idaho -- Measuring and estimating open water evaporation in Elephant Butte Reservoir in New Mexico -- Evapotranspiration of deficit irrigated sorghum and winter wheat -- Evaluation of a two-layer model to estimate actual evapotranspiration for vineyards -- Estimating pecan water use through remote sensing in Lower Rio Grande -- Estimating crop water use from remotely sensed NDVI, crop models, and reference ET -- Alfalfa production using saline drainage water -- Performance evaluation of subsurface drainage system under unsteady state flow conditions in coastal saline soils of Andhrapradesh, India -- Management strategies for the reuse of wastewater in Jordan -- Providing recycled water for crop irrigation and other uses in Gilroy, California -- Oakdale Irrigation District Water Resources Plan -- Use of information technology to support integrated water resources management implementation -- Decision-support systems for efficient irrigation in the Middle Rio Grande -- Salt management -- Ghazi Barotha Project on Indus River in Pakistan -- Field tests of OSIRI -- Water requirements, irrigation evaluation and efficiency in Tenerife's crops (Canary Islands, Spain) -- Using wireless technology to reduce water use in rice production -- Variability of crop coefficients in space and time -- Assessing the implementation of integrated water management approach in closed basins -- New strategies of donors in the irrigation sector of Africa -- Holistic perspective for investments in agricultural drainage in Egypt -- Mapping system and services for canal operation techniques -- An open channel network modernization with automated structures -- Canal control alternatives in the irrigation district 'Sector BXII del Bajo Guadalquivir,' Spain -- Hydrodynamic behavior of a canal network under simultaneous supply and demand based operations -- Simulation on the effect of microtopography spatial variability on basin irrigation performance -- Drip irrigation as a sustainable practice under saline shallow ground water conditions -- Water retention, compaction and bean yield in different soil managements under a center pivot system -- Precision mechanical move irrigation for smallholding farmers -- Wild flood to graded border irrigation for water and energy conservation in the Klamath basin -- A method describing precise water application intensity under a CPIS from a limited number of measurements -- An irrigation sustainability assessment framework for reporting across the environmental-economic-social spectrum -- Planning for future irrigation landscapes -- One size does not fit all -- Water information networks -- Improving water use efficiency -- Irrigation system modernization in the Middle Rio Grande Valley -- Relationship of operation stability and automatic operation control methods of open canal -- Responsive strategies of agricultural water sector in Taiwan -- Effect of network water distribution schedule and different on-farm water management practices on sugarbeet water use efficiency -- Variable Frequency Drive (VFD) considerations for irrigation -- Accuracy of radar water level measurements -- Transition submergence and hysteresis effects in three-foot Cutthroat flumes -- Practical irrigation flow measurement and control -- Linear anionic PAM as a canal water seepage reducing technology -- In-situ non-destructive monitoring of water flow in damaged agricultural pipeline by AE -- Reoptimizing global irrigation systems to restore floodplain ecosystems and human livelihoods -- Water management technologies for sustainable agriculture in Kenya -- Impacts of changing rice irrigation practices on the shallow aquifer of Nasunogahara basin, Japan -- Drought protection from an in-lieu groundwater banking program -- Development of agricultural drought evaluation system in Korea -- Bean yield and root development in different soil managements under a center pivot system -- Can frost damage impact water demand for crop production in the future? -- Real time water delivery management and planning in irrigation and drainage networks -- Growth response of palm trees to the frequency of irrigation by bubblers in Khuzestan, Iran -- Application of Backpropagation Neural Network to estimate evapotranspiration for ChiaNan irrigated area, Taiwan -- Increasing water and fertilizer use efficiency through rain gun sprinkler irrigation in sugar cane agriculture