The challenges of balancing safety and security in implantable medical devices

Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel

Designing the Health-related Internet of Things: Ethical Principles and Guidelines

The conjunction of wireless computing, ubiquitous Internet access, and the miniaturisation of sensors have opened the door for technological applications that can monitor health and well-being outside of formal healthcare systems. The health-related Internet of Things (H-IoT) increasingly plays a key role in health management by providing real-time tele-monitoring of patients, testing of treatments, actuation of medical devices, and fitness and well-being monitoring. Given its numerous applications and proposed benefits, adoption by medical and social care institutions and consumers may be rapid. However, a host of ethical concerns are also raised that must be addressed. The inherent sensitivity of health-related data being generated and latent risks of Internet-enabled devices pose serious challenges. Users, already in a vulnerable position as patients, face a seemingly impossible task to retain control over their data due to the scale, scope and complexity of systems that create, aggregate, and analyse personal health data. In response, the H-IoT must be designed to be technologically robust and scientifically reliable, while also remaining ethically responsible, trustworthy, and respectful of user rights and interests. To assist developers of the H-IoT, this paper describes nine principles and nine guidelines for ethical design of H-IoT devices and data protocols

Cybersecurity Vulnerabilities in Medical Devices: A Complex Environment and Multifaceted Problem

The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat

Mobihealth: mobile health services based on body area networks

In this chapter we describe the concept of MobiHealth and the approach developed during the MobiHealth project (MobiHealth, 2002). The concept was to bring together the technologies of Body Area Networks (BANs), wireless broadband communications and wearable medical devices to provide mobile healthcare services for patients and health professionals. These technologies enable remote patient care services such as management of chronic conditions and detection of health emergencies. Because the patient is free to move anywhere whilst wearing the MobiHealth BAN, patient mobility is maximised. The vision is that patients can enjoy enhanced freedom and quality of life through avoidance or reduction of hospital stays. For the health services it means that pressure on overstretched hospital services can be alleviated

A framework to detect cyber-attacks against networked medical devices (Internet of Medical Things):an attack-surface-reduction by design approach

Most medical devices in the healthcare system are not built-in security concepts. Hence, these devices' built-in vulnerabilities prone them to various cyber-attacks when connected to a hospital network or cloud. Attackers can penetrate devices, tamper, and disrupt services in hospitals and clinics, which results in threatening patients' health and life. A specialist can Manage Cyber-attacks risks by reducing the system's attack surface. Attack surface analysis, either as a potential source for exploiting a potential vulnerability by attackers or as a medium to reduce cyber-attacks play a significant role in mitigating risks. Furthermore, it is necessitated to perform attack surface analysis in the design phase. This research proposes a framework that integrates attack surface concepts into the design and development of medical devices. Devices are classified as high-risk, medium-risk, and low-risk. After risk assessment, the employed classification algorithm detects and analyzes the attack surfaces. Accordingly, the relevant adapted security controls will be prompted to hinder the attack. The simulation and evaluation of the framework is the subject of further research.</p

Security and privacy issues in implantable medical devices: A comprehensive survey

Bioengineering is a field in expansion. New technologies are appearing to provide a more efficient treatment of diseases or human deficiencies. Implantable Medical Devices (IMDs) constitute one example, these being devices with more computing, decision making and communication capabilities. Several research works in the computer security field have identified serious security and privacy risks in IMDs that could compromise the implant and even the health of the patient who carries it. This article surveys the main security goals for the next generation of IMDs and analyzes the most relevant protection mechanisms proposed so far. On the one hand, the security proposals must have into consideration the inherent constraints of these small and implanted devices: energy, storage and computing power. On the other hand, proposed solutions must achieve an adequate balance between the safety of the patient and the security level offered, with the battery lifetime being another critical parameter in the design phase. (C) 2015 Elsevier Inc. All rights reserved.This work was partially supported by the MINECO Grant TIN2013-46469-R (SPINY: Security and Privacy in the Internet of You)

Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

Background: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results: Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions: Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware

Strengthening Privacy and Data Security in Biomedical Microelectromechanical Systems by IoT Communication Security and Protection in Smart Healthcare.

Biomedical Microelectromechanical Systems (BioMEMS) serve as a crucial catalyst in enhancing IoT communication security and safeguarding smart healthcare systems. Situated at the nexus of advanced technology and healthcare, BioMEMS are instrumental in pioneering personalized diagnostics, monitoring, and therapeutic applications. Nonetheless, this integration brings forth a complex array of security and privacy challenges intrinsic to IoT communications within smart healthcare ecosystems, demanding comprehensive scrutiny. In this manuscript, we embark on an extensive analysis of the intricate security terrain associated with IoT communications in the realm of BioMEMS, addressing a spectrum of vulnerabilities that spans cyber threats, data manipulation, and interception of communications. The integration of real-world case studies serves to illuminate the direct repercussions of security breaches within smart healthcare systems, highlighting the imperative to safeguard both patient safety and the integrity of medical data. We delve into a suite of security solutions, encompassing rigorous authentication processes, data encryption, designs resistant to attacks, and continuous monitoring mechanisms, all tailored to fortify BioMEMS in the face of ever-evolving threats within smart healthcare environments. Furthermore, the paper underscores the vital role of ethical and regulatory considerations, emphasizing the need to uphold patient autonomy, ensure the confidentiality of data, and maintain equitable access to healthcare in the context of IoT communication security. Looking forward, we explore the impending landscape of BioMEMS security as it intertwines with emerging technologies such as AI-driven diagnostics, quantum computing, and genomic integration, anticipating potential challenges and strategizing for the future. In doing so, this paper highlights the paramount importance of adopting an integrated approach that seamlessly blends technological innovation, ethical foresight, and collaborative ingenuity, thereby steering BioMEMS towards a secure and resilient future within smart healthcare systems, in the ambit of IoT communication security and protection

Design of a Customized multipurpose nano-enabled implantable system for in-vivo theranostics

The first part of this paper reviews the current development and key issues on implantable multi-sensor devices for in vivo theranostics. Afterwards, the authors propose an innovative biomedical multisensory system for in vivo biomarker monitoring that could be suitable for customized theranostics applications. At this point, findings suggest that cross-cutting Key Enabling Technologies (KETs) could improve the overall performance of the system given that the convergence of technologies in nanotechnology, biotechnology, micro&nanoelectronics and advanced materials permit the development of new medical devices of small dimensions, using biocompatible materials, and embedding reliable and targeted biosensors, high speed data communication, and even energy autonomy. Therefore, this article deals with new research and market challenges of implantable sensor devices, from the point of view of the pervasive system, and time-to-market. The remote clinical monitoring approach introduced in this paper could be based on an array of biosensors to extract information from the patient. A key contribution of the authors is that the general architecture introduced in this paper would require minor modifications for the final customized bio-implantable medical device