Example of Security and Safety Medical Devices Review
PLoS One. 2012; 7(vii): e40200.
Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
Daniel B. Kramer
1 Section of Medicine, Beth Israel Deaconess Medical Centre, Harvard Medical Schoolhouse, Boston, Massachusetts, United States of America,
Matthew Baker
one Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical Schoolhouse, Boston, Massachusetts, U.s.a. of America,
Benjamin Ransford
2 Department of Informatics, University of Massachusetts, Amherst, Massachusetts, United States of America,
Andres Molina-Markham
2 Department of Figurer Science, University of Massachusetts, Amherst, Massachusetts, U.s. of America,
Quinn Stewart
2 Section of Computer Science, University of Massachusetts, Amherst, Massachusetts, United States of America,
Kevin Fu
2 Section of Information science, Academy of Massachusetts, Amherst, Massachusetts, U.s.a.,
Matthew R. Reynolds
1 Department of Medicine, Beth State of israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America,
Brad Spellberg, Editor
Received 2012 February 7; Accepted 2012 Jun ane.
Abstruse
Background
Medical devices increasingly depend on computing functions such every bit wireless communication and Net connectivity for software-based control of therapies and network-based manual of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known virtually the prevalence of such risks inside the clinical setting.
Methods
We used three comprehensive, publicly available databases maintained by the Nutrient and Drug Assistants (FDA) to evaluate recalls and agin events related to security and privacy risks of medical devices.
Results
Review of weekly enforcement reports identified i,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (ane.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only 1 result with a specific connection to security or privacy. Software-related recalls were relatively mutual, 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 find signals of security and privacy issues that adversely bear on 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.
Introduction
Medical devices play a growing role in the care of millions of patients worldwide.[1], [2] Devices for diseases ranging from heart failure to diabetes better patient outcomes and may ease disease management.[3] Recent innovations in medical device blueprint include more than complex diagnostics and the storage of patient data. In many cases, this information can be transmitted directly to physicians or indirectly through a 3rd-party provider, sometimes using wireless systems, to aid with diagnosis and management of chronic medical issues. At nowadays, data flow between implanted devices and providers is predominantly unidirectional (from device to provider). Theoretically, however, current technologies could easily be modified such that remote interactions betwixt providers and medical devices (due east.g. to reprogram an insulin pump or pacemaker) would be possible. The possibility of hacking into an insulin pump was recently demonstrated by a Type 1 diabetic on his own device.[four].
The rapid broadcasting of medical devices capable of storing and transmitting patients' medical information and the theoretical possibility of remotely reprogramming implanted medical devices raise important concerns regarding security, privacy, and prophylactic.[5] Investigators have demonstrated limitations of the security functions for implantable cardioverter-defibrillators (ICDs), for example, past proving the feasibility of communicating with an ICD through an unauthorized radio-based arroyo that theoretically could interfere with appropriate device therapy.[six] While at that place are hundreds of confirmed reports of conventional figurer viruses infecting medical devices in radiology, cardiac catheterization labs, sleep labs, and other clinical departments, at that place are no known case reports of malevolent interference that specifically target medical device function.[7], [eight] A growing list of confirmed cybersecurity vulnerabilities in medical devices pose challenging risks to patients whose privacy or disease management depends on the proper functioning of devices.
In the Usa, post-market surveillance of medical devices identifies potential risks and connects device malfunction to adverse events in patients. Post-market events may trigger recalls or advisories depending on the nature of the device problem that is identified.[9] These reports may provide important data nearly prophylactic and effectiveness, and accept led to revision of regulatory practices for devices such as ICD leads and automated external defibrillators.[10], [11].
In club to improve understand the security vulnerabilities of marketed medical devices, we performed an analysis of recalls and adverse events, which we adjudicated to place post-market place actions related to security or privacy, and to identify specific features of devices at risk for recalls with security implications.
Methods
We used publicly bachelor databases maintained by the Food and Drug Administration (FDA). Effigy ane summarizes the different sources leveraged for our analysis.
Summary of Sources for Search Strategy.
FDA Enforcement Reports
In order to place a comprehensive denominator of medical device recalls, we accessed publicly bachelor weekly enforcement written report listings on the FDA website.[12] These reports are published on a weekly basis and contain data regarding deportment emerging from agency regulation. Actions include Rubber Alerts and Recalls. Prophylactic alerts are communications issued by a manufacturer, distributor, or other responsible party or the FDA to inform health professionals or other appropriate persons or firms of a risk of substantial impairment from a medical device in commercial utilize. Recalls are issued by the FDA when a reasonable likelihood of causing harm exists, and are classified according to the likelihood of causing patient damage. Class I recalls are the most serious, indicative of situations in which there is a "reasonable probability that the utilize of or exposure to a violative product volition crusade serious adverse health consequences or expiry." Class Ii and III recalls are less serious. Enforcement reports may also include notice of civil or criminal proceedings or seizures of products.
FDA Enforcement Reports from January 2009 through May of 2011 were reviewed, and all actions other than recalls related to medical devices (such as those specific to nutrient or drugs) were excluded. Reports were manually searched for bureau actions related to medical devices, and details from each written report were extracted. These features included the specific device and device type, organ system, manufacturer, date and class of call back, estimated volume of distribution, and the reason for the retrieve itself. We categorized these reasons equally follows: sterility/contamination; mechanical failure; electrical failure; software failure; figurer hardware failure; pedagogy or manual mislabeling; unapproved usage; wrong shelf life; or naming problems. We too categorized each device co-ordinate to specific features including: permanent implantation; inclusion of a computer; power to communicate wirelessly; and storage of personal data. Similarly, each recall was adjudicated as to whether or non the reason for recall was related to these specific functions (e.g. personal data storage, wireless advice, etc.).
Device Recalls
The FDA also hosts a public, searchable database of Medical and Radiation Emitting Device Recalls, which houses data related to recalls of medical devices since November 2002.[xiii] Information that tin be extracted from this database includes the date and a narrative explanation of the reason for the retrieve and details of actions taken past the manufacturer. The FDA retrieve database can be searched past date, manufacturer, recall grade or number, or the reason for recall using a complimentary-text search window. Terms such as "bombardment failure", "labeling", "sterility", etc. tin can be used to identify recalls related to specific problems or malfunctions with a device. We searched using "security" and "privacy" equally search terms to identify recalls where either of these elements were considered primal or of import.
Adverse Event Reports
Lastly, nosotros used the Manufacturer and User Facility Device Experience (MAUDE) database to look for adverse events related to security or privacy issues.[14] The MAUDE database was established through the Safe Medical Devices Act of 1990, and requires sites where medical devices are used (hospitals, nursing homes, physicians' offices, etc.) to written report device-related fatalities and serious adverse events straight to FDA besides as to the manufacturers.[15] Since 1995, these reports have been stored in a searchable, publicly available database. This database is used for FDA analysis and is as well available to independent researchers. The majority (>xc%) of these reports come up from manufacturers, with the remainder submitted by user facilities, such as hospitals and outpatient clinics or individual physicians. Manufacturers are required to report any adverse events that are communicated to them verbally or in writing. These reports include details related to the device type and model number, timing and location of agin events, clinical details, and clarification of the manufacturer'south analysis of the device (if available).
MAUDE can be searched using its advanced interface, which provides a drop-down menu of "production problems" from which to cull. The advanced interface includes approximately 1000 product trouble terms. These were manually searched and evaluated for inclusion of "security" and "privacy", and each term was also evaluated individually for a plausible human relationship to either theme. Any adverse events mapped to those search terms related to security or privacy were and then reviewed in detail. Adverse events from January i, 2000 through November 30, 2011 were included in the searches.
Software Recalls Analysis
Preliminary analysis of enforcements reports identified software related recalls equally a particularly prevalent problem with potential security and safety ramifications. Thus, all software-related recalls were identified using the searchable FDA recall database between 2002 and 2010 for those recalls that included the word "software" in their reason for retrieve. The results included Class I, II, and Three recalls. For each of these software related recalls, we determined whether the retrieve cited problems in the software itself as the reason for the call up, every bit opposed to issues with labeling lonely. We noted whether the recall mentioned that a software update was to be issued and whether this software update was mentioned as beingness bachelor online, or explicitly mentioned as non being available online. We besides recorded whether the software update, if available, involved a manufacturer representative visiting the installation site or return of a device to the manufacturer by mail.
Results
Enforcement Reports
We identified 1845 recalls issued from January 2009 to May 2011 from the weekly enforcement reports listings. Table i summarizes the categorization of recalls by organ organisation and etiology. For all recalls of the organ systems or usages involved most commonly were laboratory/pathology (294, fifteen.9%), orthopedic (279, 15.1%), cardiovascular (250, xiii.5%) and general hospital (225, 12.2%). The almost common reasons for recalls were mechanical problems (918, 49.8%) and software problems (279, xv.ane%).
Table 1
Characteristics of Weekly Enforcement Reports, 2009–2011 (N = 1845).
| Mutual organ system/usage | Laboratory/pathology (294, 15.9%) |
| Orthopedic (279,15.i%) | |
| Cardiovascular (250, 13.5%) | |
| General Hospital (225, 12.ii%) | |
| Radiology (164, 8.nine%) | |
| General Surgery (121, 6.six%) | |
| Permanent Devices | 241 (thirteen.1%) |
| Devices with reckoner functions | 605 (32.viii%) |
| Devices capable of wireless communication | 35 (1.9%) |
| Storage of personal data | 31 (1.7%) |
| Selected call back reasons | Mechanical Problem (918, 49.8%)Software problems (279, fifteen.1%)Instruction or manual mislabeling (268, fourteen.v%)Sterility/contamination (185, 10.0%)Electric failure (82, 4.4%)Calculator hardware failure (17, 0.9%) |
Permanent implants were the subject of 241 (13.1%) recalls. Of the recalled devices, 605 (32.8%) included computers, but only 35 (ane.9%) stored patient data and 31 (1.vii%) were capable of wireless communication. Though storage of patient data and wireless advice were relatively uncommon features of implanted devices, these features were often adjudicated to exist responsible for recalls of devices utilizing them. For case, 301 (49.8%) of devices with computers that were recalled had calculating functions every bit the reason for the retrieve itself. Six (17.ane%) of the 35 devices storing patient data had recalls originating from this office, and 6 (19.4%) of the 31 devices using wireless communication had recalls originating from this function.
An instance of one of the enforcement reports (from November 2010) is for a PC Unit for use with infusion and monitoring systems. The reason for the recall provided in the report is: "Under sure wireless network conditions a communication error tin occur, which freezes the PC Unit of measurement screen, which may effect in a delay of therapy. A delay of therapy may consequence in serious injury and/or death".[16]
An example of a software related enforcement report corresponds to an ultrasound system. The reason for the call back is listed as: "The production has a software problem in which previous patient measurement data gets associated with another patient's epitome". [17]
Recall Searches
"Security" as a search term for recalls returned but i finding. This was a Class II retrieve, for a radiation oncology system including a console and software to ostend proper patient positioning for therapy. The MAUDE report for this retrieve was incomplete, but alluded to a failure of security measures designed to restrict admission to the panel (incomplete sentence quoted verbatim): "The Operator Station Calibration panel provides access to view and change machine specific configuration settings. Access to these settings has e'er been restricted to individuals with advisable security rights, existence limited to only the 'Superuser' and 'Field Service engine'".[17] "Privacy" did not return any reported adverse events.
MAUDE Searches
Manually searching the advanced interface of MAUDE yielded "Computer system security problem"; "patient data event"; and "unauthorized access to reckoner system" every bit the only terms (out of most 1000) that were related by title to security and privacy features of devices. Adverse events from each of these terms from January 1, 2000 through November 30, 2011 were reviewed. Importantly, despite categorization in MAUDE under these headings, review of the specific agin events revealed that only one of them was really related to privacy or security in even a tangential style. TABLE 2 describes the exact contents of each MAUDE entry, including the device type and manufacturer narrative of the device problem. These are of variable detail (encounter TABLE 2 ), and range from no data at all (as with the "powered wheelchair" entry included nether "calculator system security trouble" and specifics of an esophageal implant problem categorized equally "patient data effect". "Computer system security problem" yielded iv reports, none of which on review was related to either computers or security. "Patient data result" yielded five reports, only one of which clearly had security and/or privacy implications. In the one pertinent "patient data upshot" instance, a remote monitoring organization for an implantable cardioverter-defibrillator routed patient data to a medico practise from which the patient no longer received follow-up care. "Unauthorized access to computer organisation" did not yield any reports.
Tabular array 2
Agin Issue Reports from MAUDE Linked to Security or Privacy Problems.
| Product Problem category | Event Appointment | Device Blazon | Device/Manufacturer | Verbatim Text | Adjudicated Security or Privacy Implications? |
| "Computer system security effect" | |||||
| 9/29/2011 | Powered wheelchair | INVACARE TAYLOR STREET POWERED WHEELCHAIR 890.3860 | None | No | |
| 4/8/2010 | Orthopedic implant | DEPUY ORTHOPAEDICS, INC. ENDURON NEUT 54OD Ten 28ID | Manufacturer Narrative | No | |
| This complaint is still under investigation. Depuy will notify the fda of the results of this investigation in one case it has been completed. | |||||
| Result Clarification | |||||
| Enduron liner has failed. Excessive wear causing all-encompassing osteolysis. | |||||
| 2/9/2010 | Orthopedic implant | DEPUY ORTHOPAEDICS, INC. AMK PATELLA 8.five 10 34MM 87 JWH | Manufacturer Narrative | No | |
| This complaint is still nether investigation. Depuy will notify the fda of the results of this investigation once information technology has been completed. | |||||
| Event Description | |||||
| Pt was revised to address femoral and tibial loosening. Poly wear and osteolysis were discovered intraoperatively. | |||||
| ane/11/2010 | Orthopedic implant | DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY DURALOC LINER Total HIP REPLACEMENT | The devices associated with this report were non returned. Review of the device history records and/or a complaint database search was not possible as the product and lot codes required were unavailable. The investigation could non draw any conclusions regarding the reported upshot with the info available. Based on the investigation, the need for corrective action is not indicated. Depuy considers the investigation closed at this time. Should the product and/or additional information be received to change the result of the performed investigation, the complaint will be re-opened. | No | |
| Effect Description | |||||
| Patient was revised to accost femoral stem loosening. Poly article of clothing and osteolysis were discovered intraoperatively. | |||||
| "Patient data effect" | |||||
| 6/3/2011 | Cardiac device monitoring system | MEDTRONIC, INC. PACEART Organization SOFTWARE | Manufacturer Narrative | Aye | |
| The information submitted reflects all relevant data received. If additional relevant data is received, a supplemental study will be submitted. | |||||
| Event Description | |||||
| It was reported that a carelink patient followed at some other practice in a dissimilar state had a transmission keep to pull into this exercise's paceart information substitution log viewer. The paceart outcome was resolved. No patient complications have been reported every bit a upshot of this event. | |||||
| three/4/2011 | Cardiac device monitoring organisation | MEDTRONIC, INC. PACEART Arrangement SOFTWARE | Event Description | No | |
| It was reported that a remote manual of a patient's device had discrepancies with the remote event in the electronic medical records system. No patient complications accept been reported every bit a effect of this event. | |||||
| Manufacturer Narrative | |||||
| The information submitted reflects all relevant data received. If additional relevant data is received, a supplemental report will be submitted. | |||||
| v/13/11 | Esophageal stent | BOSTON SCIENTIFIC - GALWAY ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM PROSTHESIS, ESOPHAGEAL | Manufacturer Narrative | No | |
| Although the exact patient age is unknown, the patient was reported to exist over 18 years of historic period. The complainant indicated that the device was implanted and will not exist returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed. If whatever farther relevant information is identified, a supplemental medwatch will be filed. | |||||
| Outcome Clarification | |||||
| It was reported to boston scientific corporation that an ultraflex esophageal covered stent was implanted during an esophageal stenting procedure on (b)(6), 2011. Co-ordinate to the complainant, the indication for the stent placement was esophageal cancer. The label on the packaging of the stent stated that the stent was 7 cm in length and covered. However, post-obit the stent placement, the user believed the stent to be uncovered. The stent position was adjusted with rat-tooth forceps and the stent was left implanted. There were no patient complications as a upshot of this event. The patient status at the conclusion of the process was reported to be stable. Attempts to obtain additional information regarding the circumstances surrounding this effect have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted. | |||||
| eleven/9/2010 | Pulmonary part test calculator | HOSPIRA POINT OF Intendance SOLUTIONS ENDO TOOD SOFTWARE | None | No | |
| 9/three/2010 | Automated white blood jail cell differential counter | ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER | Event Description | No | |
| The customer observed that occasionally, barcoded patient samples processed using a cell-dyn sapphire analyzer would be incorrectly mismatched to the specimen id number and wrong patient proper name. Sample (b)(half dozen) was replicated by the cd sapphire and potentially mismatched to an wrong patient name. The client uses a laboratory information system (lis) to farther procedure patient data. No mismatched results or incorrect reports were released from the lab. No adverse patient outcomes were reported related to this result. | |||||
| Manufacturer Narrative | |||||
| (b)(four). An investigation is in process. A follow-upward report will be submitted when the investigation is complete. | |||||
Software Related Recalls
From 2002 through 2010, 523 of the 537 recalls (97.4%) that mentioned the word "software" cited software specifically as the reason for the recall. Of these, 428 (81.8%) mentioned a software upgrade, and only 258 (49.3%) described upgrade instructions. 13 (ii.5%) of the recalls due to software mentioned that a software upgrade would be available online. Ix (1.7%) mentioned that a software upgrade would not exist available online. No Class I (high risk) recalls mentioned online updates; but five (1.0%) Class I recalls provided specific instructions for providers to upgrade software. Most Form I recalls were mitigated by manufacturer representatives upgrading software via either site visits or return aircraft.
To farther test the effectiveness of the FDA Safety Information and Adverse Upshot Reporting Program (MedWatch Form 3500) for reporting security and privacy problems, one co-writer submitted a software vulnerability written report for an automated external defibrillator on July 19, 2011.[18] As of Jan 19, 2012, the study had not even so been processed into MAUDE. In Apr 2012, MAUDE was found to comprise the study for the event under report number MW5023578. The written report processing took nine months. As the fourth dimension from discovery of a conventional computer security vulnerability to the global exploitation of the flaw is frequently measured in hours, a nine month processing filibuster may non be an effective strategy for ensuring the security of software-based medical devices.
Discussion
This study evaluated postmarket events in medical devices related to security and privacy using complementary databases compiling enforcement reports, recalls, and adverse events. Detailed review of enforcement reports revealed that recalls of devices with computers were mutual, though features such as wireless advice and storage of personal data were less common in those recalled devices. The FDA call up database did non yield any recalls related to patient security or privacy over a 9 year period of analysis. While the lack of any security or privacy concerns through these two mechanisms may be reassuring, information technology seems more likely that the electric current recall classification scheme does not adequately capture device malfunctions of this blazon. In addition, information technology is apropos that processing an agin event study may have several months, given that a global exploitation of a security and privacy vulnerability may spread in a shorter period of time.
Our results as well dissimilarity with databases that track security and privacy problems for the Section of Veterans' Diplomacy (VA). The Field Security Office in the Office of Information Security at the VA collects statistics on the prevalence of malicious software (malware) infections within its 156 medical centers. Between January 2009 and December 2011, the VA detected 142 separate instances of malware infections affecting 207 medical devices found in radiation oncology, radiology, clinical lab, GI lab, ophthalmology imaging, cardiology imaging, pharmacy, sleep lab, cardiac catheterization lab, pulmonary, dental, audiology, dictation, and neurology.[eight] A mutual outcome was the unavailability of intendance considering of reckoner outages. In one extreme instance, a calculator virus infection in a catheterization lab required transport of patients to a different hospital. Common causes of infections include use of the Internet and USB flash retentiveness drives from vendors who are paradoxically updating software on medical devices. In 1 instance, a mill-installed device arrived already infected with malware. All detected malware pertained to conventional computer viruses rather than malware customized for medical devices. The about prevalent malware converted the medical devices into condign nodes of "botnet" criminal networks. Organized law-breaking rents out botnets for others to distribute spam anonymously and for mounting targeted attacks on information infrastructure.
Nosotros believe that the inconsistency between databases is due to lack of a meaningful and convenient reporting mechanism, but we also believe that clinicians without expertise in estimator security are unlikely to recognize the departure betwixt a virus infection and a crashed or slow computer. Time pressure, lack of incentives, lack of federal safe harbor policies, and lack of clear actionable guidance probable further reduce the probability of incident reporting by clinicians and information technology staff.
Similarly, our review of the MAUDE database of agin event reports did not identify any events related to privacy or security, despite inclusion of nearly 1000 possible production bug to facilitate targeted searching. Again, the negative findings hither may be viewed in ii ways. The absence of a glaring safety indicate provides some reassurance that, for example, unauthorized access to patient information does non announced to be rampant. Yet, our manual review of the entire list of search product problems – from "abnormal" to "Y2K related problem"[14] – plant only a handful of terms with a prima facie connection to security or privacy. This again suggests that the classification of postmarket events may not be well-positioned to prospectively collect security or privacy related problems. The detailed, verbatim review of the bodily information provided in those agin reports which mapped to security or privacy terms ( TABLE ii ) raises suspicions that electric current surveillance mechanisms may be insufficiently tailored to these specific problems.
This same concern is demonstrated in part past our findings related to software recalls. Most of these recalls indicated that a software update would exist issued to correct the problem in question, but the mechanism of update itself remained unclear. These mechanisms might include web/internet based solutions, direct interventions past field engineers, or other interventions, each of which might innovate security risks. Our review of adverse events, notwithstanding, suggests that even if an event were to occur – such as failure to update properly or deliberate interference with a software update – the electric current classification of "product problems" might not categorize these events clearly.
Our report reinforces findings of a prior evaluation of agin events related to health data technology.[19] This much broader search strategy, also using MAUDE, found that only 0.1% of nearly 900,000 reports over a two-twelvemonth catamenia were related to health information technology. These problems included a mix of software malfunctions, arrangement configuration, and human errors. As with our study, these investigators suggested that the relatively low charge per unit of findings may reverberate known shortcomings of MAUDE, variability in reporting and the difficulty in even recognizing device malfunctions that are "unusual" or exterior of traditional notions of device functioning. Similarly, they identified a demand for better blueprint of prospective systems for capturing adverse events specific to the growing complexity of medical devices. Our contributions differ in two respects. First, our assay is based on information from MAUDE every bit well as the FDA's Enforcement Reports and Medical & Radiation Emitting Device Recalls. Second, our findings concern the outcome of revising the current arroyo to postmarket surveillance to adequately identify bug related to the security and privacy of medical devices.
Our report has important limitations. Every bit noted, our search strategy may not have been sufficient to identify reports or events related to privacy or security, although our manual review of search terms and reports was intentionally broad. All three databases focus on postmarket events that themselves required several links in a complex chain to become publicly known. Most importantly, device problems related to privacy and security must manifest clinically to get reportable, and by their very nature these issues may be difficult to detect. Even so, this strengthens our suggestion that better prospective mechanisms are needed to track device performance in this area.
The rapid proliferation of medical devices, and their growing composure, presents Internet-age challenges for multiple stakeholders. Without an agreement of security and privacy, it will be hard for patients and clinicians to found confidence in device safety and effectiveness. While this report provides some comfort in the lack of observed security or privacy breaches, the related adverse events or device malfunctions are not served well by the current arroyo to postmarket surveillance. This conclusion challenges regulators and manufacturers to carefully weigh the premarket evaluation of security and privacy elements of their devices and systems, and to pattern postmarket systems that enable constructive collection of cybersecurity threat indicators for medical devices. While intentional interference may be much less likely to manifest clinically than other types of traditional malfunctions, it is articulate that no effective system exists to detect signals of security or privacy problems. This decision is confirmed by the precipitous contrast of security and privacy problems tabulated by the VA and the security and privacy problems tabulated with FDA databases. To find a security or privacy problem that could harm patients, a more effective information sharing organization for medical device cybersecurity should be established.
Footnotes
Competing Interests: The authors accept declared that no competing interests be.
Funding: This piece of work was sponsored by Health and Human Services (HHS) Grant Number 90TR0003/01. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Department of Health and Human Services. The funders had no role in study pattern, data collection and analysis, decision to publish, or grooming of the manuscript. This inquiry was also supported by National Scientific discipline Foundation award CNS-0831244. Any opinions, findings, and conclusions or recommendations expressed in these materials are those of the authors and do not necessarily reflect the views of NSF.
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