{ "docId": "019dd923-622c-750b-8b96-76efb5813bae", "docSlug": "8ff52fe302da", "documentTitle": "St. Jude Medical (STJ)", "authorId": "51_Muddy_Waters", "authorName": "Carson C. Block", "documentKindSlug": "research-note", "documentKindLabel": "Research note", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2016-08-25 00:00:00", "orientation": "portrait", "aspectRatio": 0.77272725, "pageNumber": 34, "pageCount": 34, "prevPage": 33, "nextPage": null, "slideType": "quote_slide", "function": "summarize", "density": "overcrowded", "nDataPoints": 0, "notes": "This is a formal letter/statement from a physician regarding medical device security.", "elementsJson": [ "paragraph" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b96-76efb5813bae/34", "deckHref": "/decks/019dd923-622c-750b-8b96-76efb5813bae", "deckJsonHref": "/decks/019dd923-622c-750b-8b96-76efb5813bae.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b96-76efb5813bae#slide-34", "components": [ { "bbox": null, "kind": "callout", "text": "In my mind, this CIED cybersecurity issue is first and foremost, a patient safety issue.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-1ac3-70f9-8551-41081befb3f9", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.035, "w": 0.588, "x": 0.206, "y": 0.565 }, "kind": "paragraph", "text": "MedSec has performed security assessments of CIEDs manufactured by other companies and while not perfect, has not found serious vulnerabilities. As an electrophysiologist, I have stopped implanting CIEDs manufactured by St. Jude Medical but continue to use other companies.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "266015ea-f758-42ed-a69d-a9552c4adf07", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.035, "w": 0.588, "x": 0.206, "y": 0.511 }, "kind": "paragraph", "text": "For patients who don’t currently have CIEDs but are considering device therapy, I advise them to discuss this cybersecurity issue involving St. Jude Medical with their physician. Device therapy saves lives and a patient should not refuse recommended device therapy based on this issue alone.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "2ec753c5-295b-440a-a1c6-197e8f70fbdb", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.035, "w": 0.588, "x": 0.206, "y": 0.619 }, "kind": "paragraph", "text": "For most of us, the topic of CIED cybersecurity is something “out of left field”. As such, it is scary and unsettling. MedSec is working diligently and is confident that solutions to these vulnerabilities will be found and risks to patients mitigated.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "33f5eb48-f383-4b12-9830-0a471ab0b5fa", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.05, "w": 0.25, "x": 0.206, "y": 0.683 }, "kind": "paragraph", "text": "Respectfully,\nHemal Nayak, MD, FACC, FHRS\nCardiac Electrophysiology", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "39ab337e-97e3-473e-9688-753ff63dff53", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.055, "w": 0.588, "x": 0.206, "y": 0.277 }, "kind": "paragraph", "text": "First, I would like to stress that patients with implanted CIEDs manufactured by St. Jude Medical should not worry about the immediate function or performance of their devices. MedSec has not released detailed information about the vulnerabilities publically and will not do so and the details remain confidential. That being said, there may be individuals actively trying to maliciously “hack” into CIED networks.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "5d753f65-097e-4cfc-81f6-0912095f017d", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.035, "w": 0.588, "x": 0.206, "y": 0.163 }, "kind": "paragraph", "text": "While I am hopeful that the FDA will give patients and physicians guidance on what to do in light of this research, I am writing this statement to give my opinion and provide a medical perspective on what the findings mean for patients with these devices and for physicians who care for these patients.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "9805abcc-d42e-4a82-ba60-8cf207e55836", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.065, "w": 0.588, "x": 0.206, "y": 0.418 }, "kind": "paragraph", "text": "Unfortunately, discontinuing home monitoring does not remove all of the vulnerabilities. Because some of the threats involve the RF or wireless communication scheme (which cannot be reduced by discontinuing home monitoring) MedSec has identified temporary solutions while the larger issues are being addressed. MedSec believes that this information will be shared with St. Jude Medical. I would encourage patients to accept any corrective patches or software from the FDA or St. Jude Medical that may reduce these risks.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "99fc951f-370a-426a-87b5-cdc254112c9e", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.045, "w": 0.588, "x": 0.206, "y": 0.353 }, "kind": "paragraph", "text": "Until the cybersecurity issues with the Merlin home monitoring network are remedied, I have recommended to my patients that they discontinue home monitoring. Unplugging the Merlin unit from the electrical outlet will effectively turn off that function. Patients can have their CIEDs checked or interrogated in person at the office or device clinic as necessary.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "dc85fba3-d818-4a8a-9d48-4be15a7aba16", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.055, "w": 0.588, "x": 0.206, "y": 0.213 }, "kind": "paragraph", "text": "In my mind, this CIED cybersecurity issue is first and foremost, a patient safety issue. Based on what I have seen and the results from the experiments conducted, I feel compelled to bring this issue up to the electrophysiology community at large especially since this is the first time an issue like this has come up. Additionally, I believe that patients with these CIEDs have the right to know.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "fa5232c3-bc94-4fb1-b81a-6a36cae54736", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "In my mind, this CIED cybersecurity issue is first and foremost, a patient safety issue. — Hemal Nayak, MD, FACC, FHRS", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-1ac3-70f9-8551-457eec8f51bc", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }