Pacemaker and ICD Generator Malfunctions

Maisel, William H.; Moynahan, Megan; Zuckerman, Bram; Gross, Thomas P.; Tovar, Oscar H.; Tillman, Donna-Bea; Schultz, Daniel B.

doi:10.1001/jama.295.16.1901

Cited by 311 publications

(32 citation statements)

References 18 publications

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“…They identified a number of radio-based attacks that could compromise the safety and privacy of a patient. Other studies also discussed potential security and privacy risks of Implantable Medical Decives (IMDs) [27] [28]. The existing research in this category is orthogonal to our work presented in this paper, as we focus on securing BAN communications.…”

Section: Related Workmentioning

confidence: 99%

Body Area Network Security: A Fuzzy Attribute-Based Signcryption Scheme

Zhang

et al. 2013

IEEE J. Select. Areas Commun.

117

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Body Area Networks (BANs) are expected to play a major role in the field of patient-health monitoring in the near future. While it is vital to support secure BAN access to address the obvious safety and privacy concerns, it is equally important to maintain the elasticity of such security measures. For example, elasticity is required to ensure that first-aid personnel have access to critical information stored in a BAN in emergent situations. The inherent tradeoff between security and elasticity calls for the design of novel security mechanisms for BANs.In this paper, we develop the Fuzzy Attribute-Based Signcryption (FABSC), a novel security mechanism that makes a proper tradeoff between security and elasticity. FABSC leverages fuzzy Attribute-based encryption to enable data encryption, access control, and digital signature for a patient's medical information in a BAN. It combines digital signatures and encryption, and provides confidentiality, authenticity, unforgeability, and collusion resistance. We theoretically prove that FABSC is efficient and feasible. We also analyze its security level in practical BANs.

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Section: Related Workmentioning

confidence: 99%

Body Area Network Security: A Fuzzy Attribute-Based Signcryption Scheme

Zhang

et al. 2013

IEEE J. Select. Areas Commun.

117

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“…[7, 8, 10–15, 17, 18, 25, 26] The reason for CIED implantation, the severity of illness of the device patient, and the opportunity to follow high-risk CIED or field actions/safety alerts of devices appear beneficial indications. [27] For devices and/or leads with a high risk of technical malfunction or great technical complexity (e.g. ICD) remote monitoring appears favourable.…”

Section: Chapter 3: Indications Benefits and Limitations Of Remote Cmentioning

confidence: 99%

Remote monitoring and follow-up of cardiovascular implantable electronic devices in the Netherlands

et al. 2012

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Remote monitoring of cardiac implanted electronic devices (CIED: pacemaker, cardiac resynchronisation therapy device and implantable cardioverter defibrillator) has been developed for technical control and follow-up using transtelephonic data transmission. In addition, automatic or patient-triggered alerts are sent to the cardiologist or allied professional who can respond if necessary with various interventions. The advantage of remote monitoring appears obvious in impending CIED failures and suspected symptoms but is less likely in routine follow-up of CIED. For this follow-up the indications, quality of care, cost-effectiveneness and patient satisfaction have to be determined before remote CIED monitoring can be applied in daily practice. Nevertheless remote CIED monitoring is expanding rapidly in the Netherlands without professional agreements about methodology, responsibilities of all the parties involved and that of the device patient, and reimbursement. The purpose of this consensus document on remote CIED monitoring and follow-up is to lay the base for a nationwide, uniform implementation in the Netherlands. This report describes the technical communication, current indications, benefits and limitations of remote CIED monitoring and follow-up, the role of the patient and device manufacturer, and costs and reimbursement. The view of cardiology experts and of other disciplines in conjunction with literature was incorporated in a preliminary series of recommendations. In addition, an overview of the questions related to remote CIED monitoring that need to be answered is given. This consensus document can be used for future guidelines for the Dutch profession.

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“…In such cases, decisions are ‘preference sensitive’ because patients informed of risks and benefits might change their treatment preference [12]. The preference-sensitive concept is germane to the context of non-drug technologies where evidence of the safety and effectiveness of some implantable cardiovascular or orthopaedic medical devices is limited [13, 14], and they have been associated with morbidity and mortality [15, 16]. Medical devices have been defined as non-drug technologies or instruments vital to the prevention, diagnosis, cure or treatment of a disease or abnormal physical condition [17].…”

Section: Introductionmentioning

confidence: 99%

Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians

Gagliardi

Lehoux

Ducey

et al. 2017

International Journal for Quality in Health Care

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ObjectivePatient engagement (PE) is warranted when treatment risks and outcomes are uncertain, as is the case for higher risk medical devices. Previous research found that patients were not engaged in discussions or decisions about implantable medical devices. This study explored physician views about engaging patients in such discussions.DesignQualitative interviews using a basic descriptive approach.SettingCanada.ParticipantsPracticing cardiovascular and orthopaedic physicians.Main outcome measuresLevel, processes and determinants of PE in medical device discussions and decisions.ResultsViews were largely similar among 10 cardiovascular and 12 orthopaedic physicians interviewed. Most said that it was feasible to inform and sometimes involve patients in discussions, but not to partner with them in medical device decision-making. PE was constrained by patient (comfort with PE, technical understanding, physiologic/demographic characteristics, prognosis), physician (device preferences, time), health system (purchasing contracts) and device factors (number of devices on market, comparative advantage). A framework was generated to help physicians engage patients in discussions about medical devices, even when decisions may not be preference sensitive due to multiple constraints on choice.ConclusionsThis study identified that patients are not engaged in discussions or decisions about implantable medical devices. This may be due to multiple constraints. Further research should establish the legitimacy, prevalence and impact of constraining factors, and examine whether and how different levels and forms of PE are needed and feasible.

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Pacemaker and ICD Generator Malfunctions

Cited by 311 publications

References 18 publications

Body Area Network Security: A Fuzzy Attribute-Based Signcryption Scheme

Body Area Network Security: A Fuzzy Attribute-Based Signcryption Scheme

Remote monitoring and follow-up of cardiovascular implantable electronic devices in the Netherlands

Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians

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