THE IMPACT OF ORGANIZATIONAL CONFLICT ON THE SECURITY IMPERATIVE FOR IMPLANTABLE MEDICAL DEVICES: A CASE STUDY APPROACH

Patient safety should be the primary concern in implantable medical devices (IMD). The growing threat of security attacks on networkable IMDs is an obvious risk to patient safety, because it can involve injury or death to the patient. In the case of insulin pumps, vulnerabilities are well-documented and security frameworks have been recommended. In addition, several government bodies have issued multiple advisories about security threats to IMDs. Furthermore, there is an ISO standards initiative to promote secure design for insulin pumps and associated devices. However, device manufacturers look to the U.S. Food and Drug Administration (FDA) for guidance during the pre-market approval process, and no standards are being enforced. To date, a convincing cost/benefit analysis of the security issues has remained elusive. Structuration theory has been used as a lens to understand the organizational process and the consequences of their choices

Modelo de ciberseguridad para el sector de salud pública: 2018 -2020: una revisión de la literatura científica

Hoy en día la información de diversos centros de salud se ha visto afectada por ciberataques, estos problemas surgen debido a que a que no se cuenta con planes eficientes y consistentes de ciberseguridad. Afectando enormemente a la seguridad nacional, ya que se habla de data personal masiva, financiera e intelectual. En la actualidad se afirma que el sector de salud se sitúa entre los cinco sectores principales que se encuentran expuestos a mayores riesgos de seguridad desde el 2018. Por lo que es de vital importancia tomar medidas para proteger la privacidad datos del personal y del público. La presente revisión sistemática tiene como objetivo analizar modelos de ciberseguridad aplicado al sector salud pública. En esta revisión se sintetizaron los datos extraídos de 50 artículos, relacionados al tema de ciberseguridad y modelos de ciberseguridad. La búsqueda de la información se realizó en la base de datos de IEEEXLORE, Scopus, WOS y Science Direct. En total se encontró que el 52% de artículos (26) son analíticos y el 48% son descriptivos (24). La revisión de la literatura científica realizada nos indica que las características básicas que debe presentar un marco de ciberseguridad dirigido al sector de salud pública; entre ellas tenemos: tamaño pequeño a mediano, adaptable, componible y reusable

Threat Assessment and Risk Analysis (TARA) for Interoperable Medical Devices in the Operating Room Inspired by the Automotive Industry

Prevailing trends in the automotive and medical device industry, such as life cycle overarching configurability, connectivity, and automation, require an adaption of development processes, especially regarding the security and safety thereof. The changing requirements imply that interfaces are more exposed to the outside world, making them more vulnerable to cyberattacks or data leaks. Consequently, not only do development processes need to be revised but also cybersecurity countermeasures and a focus on safety, as well as privacy, have become vital. While vehicles are especially exposed to cybersecurity and safety risks, the medical devices industry faces similar issues. In the automotive industry, proposals and draft regulations exist for security-related risk assessment processes. The medical device industry, which has less experience in these topics and is more heterogeneous, may benefit from drawing inspiration from these efforts. We examined and compared current standards, processes, and methods in both the automotive and medical industries. Based on the requirements regarding safety and security for risk analysis in the medical device industry, we propose the adoption of methods already established in the automotive industry. Furthermore, we present an example based on an interoperable Operating Room table (OR table)

Healthcare Cyber Security Challenges and Solutions Under the Climate of COVID19: A Scoping Review

Background: COVID-19 has challenged the resilience of the health care information system, which has affected our ability to achieve the global goal of health and well-being. The pandemic has resulted in a number of recent cyberattacks on hospitals, pharmaceutical companies, the US Department of Health and Human Services, the World Health Organization and its partners, and others. Objective: The aim of this review was to identify key cybersecurity challenges, solutions adapted by the health sector, and areas of improvement needed to counteract the recent increases in cyberattacks (eg, phishing campaigns and ransomware attacks), which have been used by attackers to exploit vulnerabilities in technology and people introduced through changes to working practices in response to the COVID-19 pandemic. Methods: A scoping review was conducted by searching two major scientific databases (PubMed and Scopus) using the search formula “(covid OR healthcare) AND cybersecurity.” Reports, news articles, and industry white papers were also included if they were related directly to previously published works, or if they were the only available sources at the time of writing. Only articles in English published in the last decade were included (ie, 2011-2020) in order to focus on current issues, challenges, and solutions. Results: We identified 9 main challenges in cybersecurity, 11 key solutions that health care organizations adapted to address these challenges, and 4 key areas that need to be strengthened in terms of cybersecurity capacity in the health sector. We also found that the most prominent and significant methods of cyberattacks that occurred during the pandemic were related to phishing, ransomware, distributed denial-of-service attacks, and malware. Conclusions: This scoping review identified the most impactful methods of cyberattacks that targeted the health sector during the COVID-19 pandemic, as well as the challenges in cybersecurity, solutions, and areas in need of improvement. We provided useful insights to the health sector on cybersecurity issues during the COVID-19 pandemic as well as other epidemics or pandemics that may materialize in the future

Achieving quality medical equipment in developing countries through remanufacturing

Remanufacturing restores a used product to at least, its original equipment manufacturers (OEM) performance specification from the customer’s perspective and gives the resultant product a warranty that is at least equal to that of newly manufactured equivalent product. It is a wise option as it offers high quality products at lower price since remanufactured products are substantially cheaper than new products of equivalent quality. Remanufacturing also has social, economic, and environmental benefits since it has the potential to become a source of revenue, create jobs and reduce environmental pollution. While remanufacturing is common in industries such as automobile and aviation, its application and benefits in the medical device industry have not been investigated. Medical devices are crucial in the diagnosis and treatment of diseases and injuries but are inequitably distributed globally, such that there is acute shortage in developing countries with consequent high mortality rates over disease and adverse health conditions that could be treated if the right equipment were available. Several strategies have been considered to eliminate or mitigate this issue. However, neither has remanufacturing been considered a potential solution to this issue nor key factors in implementing medical equipment remanufacturing for developing countries been identified. This study proposes remanufacturing as a potential sustainable solution to this issue. The research was conducted in 3 phases following a multiphase mixed methods design. Questionnaires and interviews were used to gather data while pre-figured thematic analysis, Decision-making trial and evaluation laboratory (DEMATEL) technique and confirmatory factor analysis techniques were used to analyse the data. Main findings of this research include the following: (1) medical equipment remanufacturing can address 5 out of 11 causes of poor medical equipment availability accounting for 43.5% of the overall prominence. (2) A definition and decision support frameworks for medical equipment remanufacturing that could help to improve availability of quality medical equipment in developing countries (3) Major concerns in implementing medical equipment remanufacturing. (4) Impact of perception on the purchase intention for remanufactured medical equipment. This research is the first to identify the potential impact of remanufacturing in addressing medical equipment availability issues in developing countries, to characterise medical equipment remanufacturing towards this end. It is unique in its application of DEMATEL to the study of root causes of poor availability of medical equipment in developing countries and in applying behavioural science in understanding its purchase intentions.Remanufacturing restores a used product to at least, its original equipment manufacturers (OEM) performance specification from the customer’s perspective and gives the resultant product a warranty that is at least equal to that of newly manufactured equivalent product. It is a wise option as it offers high quality products at lower price since remanufactured products are substantially cheaper than new products of equivalent quality. Remanufacturing also has social, economic, and environmental benefits since it has the potential to become a source of revenue, create jobs and reduce environmental pollution. While remanufacturing is common in industries such as automobile and aviation, its application and benefits in the medical device industry have not been investigated. Medical devices are crucial in the diagnosis and treatment of diseases and injuries but are inequitably distributed globally, such that there is acute shortage in developing countries with consequent high mortality rates over disease and adverse health conditions that could be treated if the right equipment were available. Several strategies have been considered to eliminate or mitigate this issue. However, neither has remanufacturing been considered a potential solution to this issue nor key factors in implementing medical equipment remanufacturing for developing countries been identified. This study proposes remanufacturing as a potential sustainable solution to this issue. The research was conducted in 3 phases following a multiphase mixed methods design. Questionnaires and interviews were used to gather data while pre-figured thematic analysis, Decision-making trial and evaluation laboratory (DEMATEL) technique and confirmatory factor analysis techniques were used to analyse the data. Main findings of this research include the following: (1) medical equipment remanufacturing can address 5 out of 11 causes of poor medical equipment availability accounting for 43.5% of the overall prominence. (2) A definition and decision support frameworks for medical equipment remanufacturing that could help to improve availability of quality medical equipment in developing countries (3) Major concerns in implementing medical equipment remanufacturing. (4) Impact of perception on the purchase intention for remanufactured medical equipment. This research is the first to identify the potential impact of remanufacturing in addressing medical equipment availability issues in developing countries, to characterise medical equipment remanufacturing towards this end. It is unique in its application of DEMATEL to the study of root causes of poor availability of medical equipment in developing countries and in applying behavioural science in understanding its purchase intentions