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Patient Just Wants To See Data From His Implanted Medical Device 262

An anonymous reader writes "Hugo Campos got an implanted cardiac defibrillator shortly after collapsing on a BART train platform. He wants access to the data wirelessly collected by the computer implanted in his body, but the manufacturer says No. It seems weird that a patient can't get access to data about his own heart. Hugo and several medical device engineers are responding to live Q/A on Sunday night on such topics via ACM MedCOMM webcast at ACM SIGCOMM."
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Patient Just Wants To See Data From His Implanted Medical Device

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  • by OverlordQ ( 264228 ) on Saturday August 11, 2012 @01:39PM (#40959005) Journal

    Here's a link [blogspot.com] to the actual post.

  • Unsurprising (Score:5, Insightful)

    by girlintraining ( 1395911 ) on Saturday August 11, 2012 @01:40PM (#40959019)

    It seems weird that a patient can't get access to data about his own heart.

    No more weird than your stem cells and DNA being patented. In fact, according to intellectual property law, you don't own your body, or any of the parts implanted in it... it's all covered by a patchwork of patents on genetic materials and derived medical uses. You should be careful with yourself... it's a felony to damage government property... Or was that corporations? I confuse the two so much these days... (-_-)

    • Wasn't it ruled that natural genetic sequences can't be patented, only the specific modifications biotech companies implement? And where ever did you get that stem cells are patentable, they're not even an idea to be patented. There was that case about the HeLa-line, but in that case, it was ruled that since the cells were considered medical waste, it was the hospital's responsibility to see to their disposal as they see fit, granting ownership over the cells, and their descendants (since they are identical

    • It seems weird that a patient can't get access to data about his own heart.

      On the other hand... How much data do people w/o implanted devices have? Seems he's still in the same boat.

    • >>>No more weird than your stem cells and DNA being patented. In fact, according to intellectual property law, you don't own your body,

      Does this mean if I want an abortion, I need permission from whoever owns the genetic material of my womb? I guess that would be the fertility pill corporation.

      • Does this mean if I want an abortion, I need permission from whoever owns the genetic material of my womb? I guess that would be the fertility pill corporation.

        No, that would mean your son/daughter; and as soon as they are old enough to legally grant you permission to do so, you can get that abortion.

        • by jc42 ( 318812 )

          No, that would mean your son/daughter; and as soon as they are old enough to legally grant you permission to do so, you can get that abortion.

          Reminds me of the old Jewish joke, to the effect that Jews believe abortion should be legal until the fetus gets its law or medical degree.

          (This has gotta work for a few other ethnic groups, too, but I've only heard it from Jewish sources. ;-)

        • Re: (Score:3, Funny)

          by BluBrick ( 1924 )

          Does this mean if I want an abortion, I need permission from whoever owns the genetic material of my womb? I guess that would be the fertility pill corporation.

          No, that would mean your son/daughter; and as soon as they are old enough to legally grant you permission to do so, you can get that abortion.

          No, that would be an aggressive uterine tumour which should be excised as early as possible in order to prevent many years of mental, emotional and financial trauma. Such tumours are the primary cause of many chronic social ills, including SUV's, sitcoms and stick-figure-family rear window stickers.

    • Re:Unsurprising (Score:5, Informative)

      by ceoyoyo ( 59147 ) on Saturday August 11, 2012 @02:33PM (#40959401)

      You cannot patent someone's stem cells or genes. That's a pop journalism myth. You CAN patent treatments, given to other people, based on those stem cells or genes. It's okay though, if you have kids you won't be guilty of patent or copyright infringement.

  • by Havenwar ( 867124 ) on Saturday August 11, 2012 @01:43PM (#40959047)

    While security through obscurity isn't a good approach I figure with something such as a that you'd want to take every step you can to make sure as little information gets out about it as possible.

    Next year on defcon - learn how to hotwire your neighbour! Literally! From your android device! (or iphone, but you have to be jailbroken and pay 99c for the app. But it comes with a jump-o-meter to measure how high he jumps.)

    • Re: (Score:2, Insightful)

      by Anonymous Coward

      While security through obscurity isn't a good approach I figure with something such as a that you'd want to take every step you can to make sure as little information gets out about it as possible.

      Next year on defcon - learn how to hotwire your neighbour! Literally! From your android device! (or iphone, but you have to be jailbroken and pay 99c for the app. But it comes with a jump-o-meter to measure how high he jumps.)

      Access to data doesn't have to mean code review or access to command and control functions.

      I have access to the event logs on my MS Windows O/S, doesn't mean I have the Windows code base.

      /posting A/C because I work for one of the ICD manufacturers mentioned in the blog

      • I'm aware of that, but as any hacker knows the more you know about something the more chances are of spotting something you can use to get into it. It might not be much of a risk, say one chance in a trillion that it lead to an exploit... but this is a defibrillator built in to some guys chest we're talking about here. You heard about the hackers that raped some guys icloud account just for the lulz on their way to take over his twitter? Yeah that. I don't want those kinds of people to have a one in a trill

  • by Immostlyharmless ( 1311531 ) on Saturday August 11, 2012 @01:50PM (#40959091)
    Any entity that collects medical data on you MUST provide a way to get you copies of that information. If he really wants the data that badly, I'd contact a lawyer and pursue it from the HIPAA angle. Chances are very good there's probably not a hell of a lot of information in it. If he's really worried about it, he should contact his cardiologist and have them order an interrogation the pacer. Pretty simple stuff really and that way its covered under insurance..(probably unless there's no medical reason to do so). They probably aren't going to come out and interrogate it in the home, because they fiddle with the settings to make sure its working right and for that reason it needs to be done only in a setting where he's on telemetry and has medical staff standing by.
    • by tomhath ( 637240 ) on Saturday August 11, 2012 @03:01PM (#40959583)
      True, but there's no definition of "data" in HIPAA. Suppose you get a cholesterol test, all you see is the final number, not the inner workings of the instrument that made the measurement. If they're recording the measurements and making them part of a medical record I agree that should be shared, but this is less clear.
    • The summary isn't clear (and the link is just to a blog that seems to have moved on...) about whether he's requesting copies of his medical data, vs. technical information that would allow him to interoperate with the device such as extracting data from it himself. I would imagine they are treated differently under the law.
    • Ironically, the last time I went for a blood test the lab told me that HIPAA prevented them from sending me a copy of my test results, and that I would have to get a approval from my doctor for them to do so. The doctor's office gave me a copy, but the whole thing still confuses me. I mean, I'm attached to the arm they're drawing the blood from, so there's no doubt I'm the person the test results pertain to. I should be able to decide where the test results go, right?
  • by Anonymous Coward on Saturday August 11, 2012 @01:51PM (#40959107)

    the dude is probably thinking of tampering with the device's firmware settings and increasing his own pulse so he can go on a rampage around town like in that movie "Crank"

    • by rvw ( 755107 )

      the dude is probably thinking of tampering with the device's firmware settings and increasing his own pulse so he can go on a rampage around town like in that movie "Crank"

      Computer says no. [youtube.com]

    • by cvtan ( 752695 )
      Defibrillator app error message: "Your heart has unexpectedly quit. OK?"
  • by davidwr ( 791652 ) on Saturday August 11, 2012 @01:57PM (#40959145) Homepage Journal

    There are legitimate medical reasons why some patients shouldn't have access to all raw medical data.

    This is particularly true in psychiatric medicine, where past therapists are required to pass on notes to future therapists, but patients don't necessarily have the right to read the notes themselves.

    Now, if the company is refusing to share the raw data with the patient's doctor, that's just plain wrong and it should be illegal. Likewise, if they are refusing to share it with the patient's attorney, then the attorney should have an absolute right to subpoena it.

    Likewise, if the doctor doesn't have a bona fide medical reason for refusing to pass that data on to the patient, that should be called medical malpractice.

    • Re: (Score:2, Insightful)

      by Anonymous Coward

      There are legitimate medical reasons why some patients shouldn't have access to all raw medical data.

      This is particularly true in psychiatric medicine, where past therapists are required to pass on notes to future therapists, but patients don't necessarily have the right to read the notes themselves.

      Now, if the company is refusing to share the raw data with the patient's doctor, that's just plain wrong and it should be illegal. Likewise, if they are refusing to share it with the patient's attorney, then the attorney should have an absolute right to subpoena it.

      Likewise, if the doctor doesn't have a bona fide medical reason for refusing to pass that data on to the patient, that should be called medical malpractice.

      He is not a psych patient so all his healthcare info legally belongs to the him...

    • by Hatta ( 162192 ) on Saturday August 11, 2012 @03:21PM (#40959749) Journal

      This is particularly true in psychiatric medicine, where past therapists are required to pass on notes to future therapists, but patients don't necessarily have the right to read the notes themselves.

      I don't see how that would help a paranoiac.

    • There are legitimate medical reasons why some patients shouldn't have access to all raw medical data.

      You never know, he could get stuck in a feedback loop. He sees that his heart is beating a little fast because he's anxious about what his heart rate is. This causes more anxiety which causes his heart to beat faster. Seeing that it is out of control sends him into a panic and pushes the rate even higher, etc. Eventually he has a heart attack and sues the company.

  • by FudRucker ( 866063 ) on Saturday August 11, 2012 @02:04PM (#40959227)
    so his heart will go pitter-patter like a 20 year old in love
  • Kramer at doctor's

    Kramer : I like what you've done with that .

    Attendant : May I help you ?

    Kramer : Yes , yes . I am Dr. Vanostran from the clinic . I need Elaine Benes

    chart . She's a patient of mine and she's not going to make it . It's uh very

    bad very messy .

    Attendant : I see and what clinic is that again ?

    Kramer : That's correct .

    Attendant : Excuse me .

    Kramer : From The Hoffer-Mandale Clinic in Belgium .

    Attendant : Really ?

    Kramer : The Netherlands ?

  • by seven of five ( 578993 ) on Saturday August 11, 2012 @03:05PM (#40959619)
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    20120420 08:00:24 VENTRICLE TEST OK
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    20120420 08:00:26 BATTERY TEST OK
    20120420 08:00:27 0MG GR0W B1GG3R P3N1$ 1N 3 W33K$!
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  • by flogger ( 524072 ) <non@nonegiven> on Saturday August 11, 2012 @04:10PM (#40959997) Journal
    I usually avoid hospitals and the medical profession in general unless it is needed, ie, broken bones or donating a kidney (Which I did recently.) A couple years ago while camping my some broke a bone. I put it in a splint then took him to the hospital to get a get it set and placed in a cast. This was on a Saturday in a very "out-in-the-boonies" location. Before the staff would even look at my son, I had to sign a patient's "Bill of Rights." indicating that I had read the items on their list... There were around a dozen items and I don't remember what they were except for the first one. "The Patient has a Right to all medical records assembled during the visit." Maybe this is enforced in other hospitals. I don;t know.

    Anyway, My son was X-Rayed and dealt with and released.

    On the way out, I asked the secretary, who made me sign the "Patient's Bill of Rights," for a copy of my sons X-Rays and a print out of the Vitals they recorded. I was told "No, Those are not for you." I put on my "Contrary-Old-Bastard Hat" and stated that I have a "right" to those and read back the 1st item on theh "Patient's Bill of Rights." I explained that the X-Ray and vitals were records of the visit and that the hospital, before my son was allowed any medical attention, made me sign a form to acknowledge that I have a right to those records. I was told that I had to go through the Records department and Billing in order to get the records. These offices would not be open until the following Tuesday (due to a Holiday.) Not wanting to get mad at the secretary for doing her job, I asked to talk to her boss or whoever was in charge of the hospital that day. She informed to me with all of her arrogance that since it was the weekend, she was in charge. So I ranted to her for a while and then read the entire "Patient's Bill of Rights" to her. I strongly emphasized that nowhere in this document, which we both signed, did is mention that I should go through Billing and records. After ranting a bit more she let me know that my son's doctor can request the records and the records will be sent without charge. I explained more how I am his parent/Guardian and in charge of his primary care and that I want the records to that I can hand deliver the records when I can return and set an appointment for cast removal. Again I read the entire "Patient's Bill of Rights" to her and then explained that nowhere on it did it say that my doctor was to get the records. I asked her bluntly to obtain a copy of the records. She actually stomped her foot and said, "No."

    "OK," I said, "since I have been forced to acknowledge that I have a right to my son's records, I am going to sit right here in the middle of this hallway until I get them." And I did; I sat down in the middle of the hallway. (My son was looking at me in a state of shock -- He was at that Jr. High age when anything a parent does is considered embarrassing .)

    The secretary stared at me for about 30 seconds. then left. A minute after that she came out with a doctor and he asked what was up. I mentioned that I was waiting for a copy of my son's medical records. He nodded, went behind the counter and gave me the X-Rays and vitals papers. I said "Thank you" and left.

    This anecdote is not so that I can say I am an old cantankerous fart, it it to illustrate that even though people have rights to information, the ones that hold the information feel compelled not to give it up. THis is true with software, medical data, music... I don;t know where this attitude comes from.

    [off my soapbox]
    • by VortexCortex ( 1117377 ) <VortexCortex AT ... trograde DOT com> on Saturday August 11, 2012 @05:22PM (#40960377)

      This anecdote is not so that I can say I am an old cantankerous fart, it it to illustrate that even though people have rights to information, the ones that hold the information feel compelled not to give it up. THis is true with software, medical data, music... I don;t know where this attitude comes from.

      Emboldening mine. I know where the attitude originates, and so doe Sid Meier...

      "Beware of he who would deny you access to information, for in his heart he dreams himself your master."
      - Commissioner Pravin Lal, Alpha Centauri

  • Companies want to see data from fheir patients?

    Why? Only make money? No.

    Still, it is a serious moral contender to why Romney is so very much morally wrong.

    For once, let the Moral Majority speak up - Dont Put A Price On My Child's Life.

    How much is a Texan child worth compared to someone from Massachusetts?

  • HIPPA [hhs.gov]

    U.S. Department of Health and Human Services
    Office of Civil Rights
    200 Independence Avenue, S.W.
    Washington, D.C., 20201
    Phone: (866) 627-7748
    Web: www.hhs.gov

    The Center for Medicare & Medicaid Services
    toll free HIPAA Hotline: 1-866-282-0659

  • you can't even see the raw data from the water temperature gauge, so of course we are all too dumb to see complex health data. The temp data is manipulated so the gauge needle stays in the middle nearly all the time. Exceptions are when the engine is very cold or when it overheats. Normal fluctuations are not shown because they cause unnecessary service calls. There was a recall on Jag sedans to put a resistor in series with the temp sender to damp out needle fluctuations. My MINI does the same thing
    • My MINI does the same thing (checked with data from the OBDII port).

      I thought you said you didn't have access to this info? What this guy wants is exactly like an ODBII port for his heart. Most people don't care if their gauge fluctuates some. That's normal. If you care, do like I do and leave a Bluetooth reader hooked up and get the android app torque that let's you pull that up whenever.

  • "Hugo Campos got an implanted cardiac defibrillator shortly after collapsing on a BART train platform. He wants access to the data wirelessly collected by the computer implanted in his body, but the manufacturer says No.

    If he wants information about his heart, why isn't he talking to his cardiologist?

    Someone who knows his medical history? Someone who can interpret the data correctly?

    Does the manufacturer have the data he wants?

    What Is Follow-Up Like with ICDs?

    After your ICD is implanted, the doctor will want to see you four to six weeks after surgery to make sure the surgical site is fully healed and to answer any additional questions that may have occurred to you in the interim. Afterward, the doctor will usually want to see you in the office two to four times per year. During all these visits, your ICD will be wirelessly "interrogated" using the programmer. This interrogation gives the doctor vital information on how the ICD is functioning, the status of its battery, the status of the leads and whether and how often the ICD has needed to deliver therapy - both pacing therapy and shocking therapy.

    Some modern ICDs have the capacity to wirelessly send this kind of information to the doctor from your home, through the Internet. This "remote interrogation" feature allows the doctor to evaluate your ICD whenever needed, without requiring you to come to the office. Even if your ICD has this remote feature, however, the doctor will want to see you in the office at least once a year.

    The Implantable Defibrillator [about.com]

  • This is a nonstory (Score:4, Insightful)

    by Stickerboy ( 61554 ) on Saturday August 11, 2012 @07:34PM (#40960995) Homepage

    Disclosure: I am a doctor, and I work with patients with pacemakers on a frequent basis.

    If he wants a raw printout of the data generated, he should make an appointment, stop by his cardiologist's office, and ask the cardiologist. I've been asked a few times by curious patients to see the readouts. I always show it to them, give them the clinical interpretation of the data, and let them keep it if they want. Most don't; it's several hundred small pages of gibberish to an untrained eye, linked together like the old dot matrix printer pages.

    If he feels uncomfortable with having a machine in his body that he can't check out himself every second of every day, he can ask to have it turned off ("turned off" being simplistic) or for a surgeon to remove it. [Insert belief system here] didn't give him the pacemaker growing in him when he was born - he can choose to use it as designed or choose not to use it, which is a valid choice. There are real potential harms to widely propogating machines that could decrypt the data; the exact same machines allow us to reprogram the device, including settings that could harm or kill the patient. The encryption IS the security on implantable, reprogrammable medical devices; password, 2 step authorization or the like is not possible due to the existence of medical emergencies in which prompt access by medical personnel not normally involved in his care to the input and output of the device can mean the difference between life and death.

In the long run, every program becomes rococco, and then rubble. -- Alan Perlis

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