We've lost our patience.
We want unrestricted access to our medical data, regardless of what it is called. Devices such as insulin pumps, pacemakers, and ICDs generate and collect information about us. However, we have no way to verify the behavior of operation of these devices, and thus we are prevented from using these devices to properly care for our health. Industry initiatives have guaranteed that in the case of device malfunction, the patient is the last to know, if ever. The binary logs, the historical records of our devices, are our property and we need access to them in order to stay safe.
- FDA
- Congress
- San Francisco: Nancy Pelosi
- Senate
- Al Franken
Individuals have tried contacting various agencies in an ad-hoc fashion, in an attempt to access information needed for therapy. These solo efforts have failed.
This effort is about finding a common voice and building a narrative that is consistent with everyone's experience, and allows.
See our past work in many places on the web:
In chronological order,
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Hugo's presentations
- videos
- blogs
- useful forums
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Ben has engaged the FDA and engineers around the world.
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Amanda has had terrific success getting responses from Medtronic.
Are we sure CLIA would govern the data collected by device companies? What is the process wrt the CLIA amendment- what is taking so damn long? When did the HIPAA lawyer and Adrian start pressing the ONC to stop sitting on it? And what was their response?
Are there certain legislators who are supporting the CLIA amendment and others who are against it? Who is educated on the Washington insider view of this? Who can we start letter campaigns to? How can we get traction? Query FDA, Office of Civil Rights, specifically because they enforce HIPAA) about Medtronic's role as a BA (business associate).
What is the procedure for this? Whom do we write? What should the request say?
http://en.wikipedia.org/wiki/Form_FDA_483
We use a medical device.