Medical devices in the disclosure era and the role of medical writers (original) (raw)
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Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
2012
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.
PLOS digital health, 2024
AU : Pleaseconfirmthatallheadinglevelsarerepresentedcorrectly: Advancements in digitalisation with cardiac implantable electronic devices (CIEDs) allow patients opportunities for improved autonomy, quality of life, and a potential increase in life expectancy. However, with the digital and functional practicalities of CIEDs, there exists also cyber safety issues with transferring wireless information. If a digital network were to be hacked, a CIED patient could experience both the loss of sensitive data and the loss of functional control of the CIED due to an unwelcome party. Moreover, if a CIED patient were to become victim of a cyber attack, which resulted in a serious or lethal event, and if this information were to become public, the trust in healthcare would be impacted and legal consequences could result. A cyber attack therefore poses not only a direct threat to the patient's health but also the confidentiality, integrity, and availability of the CIED, and these cyber threats could be considered "patient-targeted threats." Informed consent is a key component of ethical care, legally concordant practice, and promoting patient-as-partner therapeutic relationships [1]. To date, there are no standardised guidelines for listing cybersecurity risks within the informed consent or for discussing them during the consent process. Providers are responsible for adhering to the ethical principles of autonomy, beneficence, nonmaleficence, and justice, both in medical practice generally and the informed consent process specifically. At present, the decision to include cybersecurity risks is mainly left to the provider's discretion, who may also have limited cyber risk information. Without effective and in-depth communication about all possible cybersecurity risks during the consent process, CIED patients can be left unaware of the privacy and physical risks they possess by carrying such a device. Therefore, cyber risk factors should be covered within the patients' informed consent and reviewed on an ongoing basis as new risk information becomes available. By including cyber risk information in the informed consent process, patients are given the autonomy to make the best-informed decision.
Medical Devices Managing the Risk.docx
National Cybersecurity Institute Journal Volume 3, No1, 2016
Medical devices are becoming a major point of attack in the healthcare industry. Most medical devices have the capability to access and transmit data on the hospital network both wired and wirelessly. These devices collect and transmit real-time Electronic Protected Health Information (ePHI) and they often rely on out-of-date software that can be susceptible to malware. The software used in medical devices is the same as in other computing devices and subject to the same vulnerabilities. Add this to the fact that healthcare is the target of choice for criminal hackers and there is a recipe for disaster. While it is possible for hackers to gain access to medical devices for nefarious purposes, a more likely scenario is that they will use this access to identify, access, and exfiltrate medical records. Hackers look for a vulnerable system, gain access to the system, and use that as a pivot point to find systems containing the information they are looking for. This paper will identify vulnerabilities and recommend a risk management framework for mitigating the risks.
IEEE Transactions on Information Technology in Biomedicine, 2005
Raising awareness and providing guidance to online data protection is undoubtedly a crucial issue worldwide. Equally important is the issue of applying privacy-related legislation in a coherent and coordinated way. Both these topics gain extra attention when referring to medical environments and thus to the protection of patients' privacy and medical data. Electronic medical transactions require the transmission of personal and medical information over insecure communication channels like the Internet. It is therefore a rather straightforward task to capture the electronic medical behavior of a patient, thus constructing "patient profiles", or reveal sensitive information related to a patient's medical history. The consequence is clearly a potential violation of the patient's privacy. We performed a risk analysis study for a Greek shared care environment for the treatment of patients suffering from beta-thalassemia, an empirically embedded scenario that is representative of many other electronic medical environments; we capitalized on its results to provide an assessment of the associated risks, focusing on the description of countermeasures, in the form of technical guidelines, that can be employed in such medical environments for protecting the privacy of personal and medical information.
Legal Requirements towards Enhancing the Security of Medical Devices
International Journal of Advanced Computer Science and Applications, 2020
Over 25 million Americans are dependent on medical devices. However, the patients who need these devices only have two choices, thus the choice between using an insecure critical-life-functioning devices or the choice to live without the support of a medical device with the consequences of the threats presented by the disease. This study therefore conducted a stateof-the-art on security requirements, concerning medical devices in the US and EU. Food, Drugs and Cosmetic Act, HIPAA, Medical Device Regulations of EU and GDPR were some of the identified regulations for controlling the security of these devices. Statutory laws such as computer Fraud and abuse Act (CFAA), Anti-Tempering Act, Panel Code as well as Battery and Trespass to Chattel in the civil law, were also identified. In analyzing the security requirements, there are less motivations on criminal charges against cyber criminals in addressing the security issues. Because it is often challenging to identify the culprits in medical device hacks. It is also difficult to hold device manufactures on negligence of duty especially after the device has been approved or if the harm on patient was as a result of a cyber attacker. Suggestions have been provided to improve upon the regulations so that both the regulatory bodies and MDM can improve upon their security conscious care.
Security and Privacy for Implantable Medical Devices
IEEE Pervasive Computing, 2008
Protecting implantable medical devices against attack without compromising patient health requires balancing security and privacy goals with traditional goals such as safety and utility. I mplantable medical devices monitor and treat physiological conditions within the body. These devices-including pacemakers, implantable cardiac defibrillators (ICDs), drug delivery systems, and neurostimulators-can help manage a broad range of ailments, such as cardiac arrhythmia, diabetes, and Parkinson's disease (see the "Pacemakers and Implantable Cardiac Defibrillators" sidebar). IMDs' pervasiveness continues to swell, with upward of 25 million US citizens currently reliant on them for lifecritical functions. 1 Growth is spurred by geriatric care of the aging baby-boomer generation, and new therapies continually emerge for chronic conditions ranging from pediatric type 1 diabetes to anorgasmia and other sexual dysfunctions. Moreover, the latest IMDs support delivery of telemetry for remote monitoring over long-range, high-bandwidth wireless links, and emerging devices will communicate with other interoperating IMDs. Despite these advances in IMD technologies, our understanding of how device security and privacy interact with and affect medical safety and treatment efficacy is still limited. Established methods for providing safety and preventing unintentional accidents (such as ID numbers and redundancy) don't prevent inten
Zenodo (CERN European Organization for Nuclear Research), 2023
She leads the PETRAS Regulation and Standardization of Connected, Intelligent Medical Devices (Reg-MedTech) project. Dr Brass specialises in the regulation of emerging technologies and the governance of responsible innovation. She has worked closely with government departments, regulatory agencies, and national and international standards-making bodies on the cybersecurity and algorithmic integrity of connected devices. Dr Brass is a member of the BSI Standards, Policy and Strategy Committee (SPSC), as well as a member and former chair of the BSI IoT-1 Technical Committee. Dr Isabel Straw is an Emergency Doctor and a PhD Candidate in Artificial Intelligence at UCL. Dr Straw specialises in the intersection of clinical medicine, Artificial Intelligence (AI) and cybersecurity. Her previous research has exposed biases in AI systems, examined issues of tech-abuse, and evaluated models for clinical training in digital emergencies. As director of the Non-profit 'bleepDigital', Dr Straw oversees the delivery of clinical education and training events focused on cybersecurity and digital healthcare technologies. She has policy experience in both domestic and international settings, having worked on the Recommendation on the Ethics of AI and Neurotechnology at the United Nations, and as a current expert on the UK Government information Commissioner's Office (ICO) Technology Advisory Panel.
SSRN Electronic Journal
New digital technologies and systems, such as the Internet of Things (IoT) or Artificial Intelligence (AI) tools that are typically implemented as software in medical devices or as medical devices themselves, are fuelling the digital healthcare sector's ongoing quest for better ways to diagnose and treat conditions proactively. When medical devices are connected to digital infrastructures such as the Internet, they can support the real-time transfer of important diagnostic data to information technology systems, where machine learning and AI can be used to quickly identify patient health patterns and anomalies. Despite the significant benefits that Connected, Intelligent Medical Devices (CIMDs) bring to the healthcare sector, different stakeholders such as manufacturers, software developers, clinicians, regulators and global standards organizations are facing several challenges around patient safety, effectiveness, transparency, accountability, and explainability of software and AI-based medical devices, as well as increased cybersecurity breaches and limited sectoral data governance frameworks necessary to ensure the safety, quality, and integrity of medical services, and ultimately patient trust. CIMDs are integrated in existing digital healthcare infrastructures in hospitals, general practice surgeries, patient care homes, and related health system services, generating new requirements to transfer, manage, store, and analyse health data. CIMDs can be wearable or implantable, acquiring physiological patient data or providing therapy outside the hospital setting, which brings new challenges for monitoring the performance, accuracy, and safety of these devices.
ProQuest Dissertations Publishing, 2022
Remote implantable or wearable medical devices (RMDs) include networking. Devices monitor important areas but are vulnerable to breaches in devices, networks, or healthcare facilities. The impact ranges from loss of privacy and exposure of personal data to disruption of critical life-sustaining systems. This study employed a qualitative exploratory method documenting medical and information technology professionals’ perceptions regarding the responsibility for security and privacy of remote implantable or wearable medical devices. Participants included personnel from medical facilities and device manufacturers, medical practitioners, and healthcare information technology. The concerns and themes were an inconsistent awareness of cyber security threats among physicians, the presumption that these devices were secured by “someone else,” networking vulnerabilities, and a lack of identified responsibility for remote medical device security and privacy. This exploratory study documented participants’ perceptions regarding who is responsible for end-to-end privacy and security of remote implantable or wearable medical devices. The findings revealed no definitive answer to this question. Additional research and recommendations are warranted. Future research analyzing medical practitioner awareness will yield additional data. The relationships between device manufacturers and medical practitioners regarding security, privacy, and risk disclosures could also yield further insight. Comprehensive research regarding regulations pertaining to RMDs will be helpful to public policy and regulatory bodies. Keywords and phrases associated with this study included: Medical Internet of Things (MIoT), cybersecurity, remote medical devices, HIPAA, healthcare privacy and security risks, implantable medical devices, patient safety, pacemaker medical device safety, wearable medical device, and security officer.