bewest edited this page Jul 29, 2012 · 9 revisions

Previous writings:

Status Quo

Scott Hanselman offers a nice overview of how industry priorities have played out over time. I actually disagree with him. I want everyone to have access to the safest and most robust choices for them, and I want vendors to compete on features not related to safety. Safety is not a choice, features are.


To the FDA


advocacy/OpenHardware on the need to simulate operating devices, on the web of things.

Response to WSJ's interview with Elizabeth Hoff.

SPM List

On control, framed as Asimov's First Law:

On "security", tracking active insulin or insulin on board

Discussing multiple uses of the device:

a.) a remote hacker killing me with radio waves telling my insulin pump to go crazy b.) misunderstanding therapy and accidentally dying as a result

The FDA report seems to indicate that B is much more likely.

For agents of malice, there are far easier ways to attack me, so this mystifies me. I've talked extensively with Radcliffe and we've been studying the protocol together. :-) I've shared with him my feelings on this subject. He has played his role, and now I will have to play mine.

No one but Medtronic and the FDA knows how to decode the data.

Without independent access, there is no access. Remember when you could not buy a new computer that worked with their software?

On the need for human involvement reasoning about automatic downloads versus removal of human involvement,

On whether or not HIPAA protects my right to access my medical records,

Responding to buying more Medtronic solutions.

I already have it. Those leave chemical burns with 4 inch diameters. It is excruciating and I have no access to the logs, which is the fundamental problem. What good is it if you cannot empirically analyze the data to the best of your ability?

Connecting the dots, explaining how access to the protocol would enable me to work around bugs in "insulin on board" algorithms by deferring that work to "the cloud," using a small end-user product recently available on for $100.

Framing it in terms of Thucydides to help explain industry motives,

Thucydides explains it well: "Right, as the world goes, is only in question between equals in power, while the strong do what they can and the weak suffer what they must."

More connecting the dots, lengthy.

Explaining about some of the technology I use.

Intro letter to the list, plus letter to the FDA

On incentives for safety versus profit,

When it comes to getting it right, no one is going to be more incentivized than the software engineer whose pump is connected to him, regardless of what you pay him. TODO: this deserves a better response, quote the FDA documentation on deaths due to adverse events and the July leap second adjustment crash of 2012.

More on who should have access to technology

On creating a standards org to protect IP-free technology, like the W3 or WHATWG.

On the nature of technology, remembering the printing press.

My core point is that I don't believe that most patients or doctors have to learn about technology implementation in order to get what they need from the industry vendors.

Maybe. I'm not sure what to believe. I suspect this is like arguing that no one would need to get a book from any where except a library shortly after the printing press was invented, because homes were not accommodated with the shelves necessary to house them. But, I'm biased. I work for a tech company who, like many tech companies, cannot hire enough technical people. How many code-literate people will the Earth need? Do you have enough engineers to implement all of the features being slung around?

Fellow diabetics

Fellow diabetics are not always the most understanding group. Note how they argue with me even as they provide concrete evidence of the kind of harm I'm talking about. I've seen Hugo attacked similarly. My responses were actually modeled after his.

Summarizing what the FDA seems to recommend, issue is not about safety or liability. Holger has done excellent work implementing this prototype which relies on him manually typing all of his data in or going through a complicated CSV conversion process.