Howdy!
I'm a type 1 diabetic patient, diagnosed shortly before my 22nd birthday. I was quickly guided towards the insulin pump as the golden standard of therapy, only to learn I'm just likely to die of side-effects from the treatment as the disease itself.
If I could access and control my pump, I could work around known design flaws, such as incorrect calculations of insulin on board, as well as better tailor my therapy to my lifestyle.
I've talked with the FDA about this, but they were unable to give me a clear answer, since they never made an endorsement, and ignored my questions.
Your queries have been vetted through subject matter experts in the Center for Devices and Radiological Health, in addition to Mr. Watson. It has been determined that your request for information may be best fulfilled through CMS (Centers for Medicaid and Medicare Services) , ONC (Health and Human Services Office of the National Coordinator for Health Information Technology) and OS (Health and Human Services Office of the Secretary) who handles data issues relative to access, security and privacy, for FDA does not regulate patient access to medical records. However, when the time arises your inquiry may allow the FDA to express its opinion about the importance of patient-centric care, which begins with patients having access to information about themselves. Even though we are not the driver for the specific area of patient data access, we can take advantage of the opportunity your inquiry has presented us to have the discussion with our HHS counterparts.
Howdy Helene et al,
Thank you for your support and help in locating additional ways for me to pursue getting access to my data with some immediacy.
I have tried quoting various FDA resources authored by all three of you to show people that the FDA more or less recommends access to the technical details and the scientific principles ruling therapy, that the vendor is on the hook for claiming how their device is safe. However, the wording is so vague that I received quite a bit of feedback arguing whether or not the FDA recommends being able to do simple things, such as auditing logs. I would love to see the FDA clarify its position here so that I can build a broader base of support for what I feel is a rather conservative safety stance.
Just to confirm,
best fulfilled through:
- CMS (Centers for Medicaid and Medicare Services) http://www.cms.gov/
- ONC (Health and Human http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__home/1204
- Services Office of the National Coordinator for Health Information Technology) and OS (Health and Human Services Office of the Secretary) http://www.hhs.gov/
I could approach them with an inquiry to access to my records framed through ownership, security and privacy, more or less?
I've been reading up on Toulmin and several of Richard's and Tony's guidance on insulin pumps on the web. I find this work very interesting; finally a practical use for the epistemology I was so interested in during college. I would love to be able to discuss those areas which you do find relevant and perhaps understand how open source can collaborate to provide tools to verify safety. I suppose I have a number of questions along these lines, I think Adrian does as well, but I don't necessarily want to bother anyone.
I hopefully look forward to fine tuning our collaboration,
-bewest Ben West