The problem is that although regulation may be necessary, the regulators incentives are different than the users. Regulators are rewarded for being overly conservative. If they are making an assessment best on the riskiness of a device versus the benefits to its users, they should say what their criteria are.

Different users are willing to accept different amounts of risk for a given quality of life improvement. Besides differing between users, the tradeoff is almost certainly in favor of accepting more risk than a regulator would approve.

I think it may help to have some specifics about what, exactly, the regulations are screwing up here.

Every type 1 diabetic has some parameters that they use to determine how much insulin they need: an insulin to carb ratio, an insulin sensitivity factor, and a basal rate (or several basal rates for different times of day). The way these parameters are traditionally managed is that your devices collect data about your carbohydrate intake and glucose at various times of day, and every 3 or 6 months you bring those devices to an endocrinologist's office where they print them out, a doctor looks at the printouts, and the doctor suggests tweaks to the parameters. This process works very poorly, first of all because 3-6 months is too infrequent, and second because calculating the correct parameter tweak requires a whole lot of math, not just looking at a printout.

The way it works in OpenAPS is that a program runs nightly, looks at historical data, figures out the correct parameter tweak, and applies it for the next day. This works much better. Much better long term health, much better quality of life, much lower short-term risk of death. But if someone dies, there's no doctor to pin it on. So device makers don't include that feature.

(This is the clearest example, but there are others as well. There are also things like where alert thresholds are set; too few alerts and you're at risk of failing to alert the user to something important, too many alerts and you cause alert fatigue and impact quality of life.)

When you say OpenAPS "works much better", while I believe that in general is probably true, how exactly do you know? Is somebody monitoring the OpenAPS fleet and its users? If something did go wrong, would you be able to recover the decision process that led to the incorrect dosing?

Deep understanding of the system, plus personal experience. There is a repository of OpenAPS users' logs, accessible to a small pool of researchers, but (for medical privacy reasons) there isn't any central fleet monitoring. Each user has detailed logs of what their own install saw and did and why, and is expected to monitor it closely. (And we do in fact monitor them--not just as a precaution, but as a necessary part of the remaining decision-making we still do ourselves. The monitoring requirement is much more manageable and less time-sensitive than it would be in the alternative, without a closed-loop system.)

I have, in fact, had incorrect dosing happen, including the worst-case scenario of an incorrect large bolus at night. (That happened because of a bug on the git head branch, not a release version, which is much riskier. As a developer of the system that's a risk I knowingly accept.)

And that's not actually that bad. The important thing to realize is that the point of comparison isn't a zero error rate, it's the error rate a human would make. The worst-case scenario is quite well understood: excess insulin, up to a configured dosage limit. And that's an error which humans definitely make--it's not even a rare mistake, it's a mistake that a human doing everything manually will make multiple times per year, every year.

When you say The worst-case scenario is quite well understood: excess insulin, up to a configured dosage limit.

Is the configuration software controlled? IE, if you had a bug in your configuration or in your microcontroller, could that bug lead to exceeding the configured dosage limit? Or is there a hard limiter (fixed amount of insulin, a physical limit switch, etc) that prevents that.

There's a software limit, selected by the user, in the microcontroller. There's a per-bolus limit, selected by the user, in the pump. There's a physical limit, in the amount of insulin that is loaded into the pump at a time (typically 2-5 days worth).

OK. Based on what you said, I see numerous situations in which a user could receive very large doses simply due to software errors. Have you had external auditors test your design from an adversarial point of view?

Well, the bloomberg article mentions that Medtronic has accepted this new uprising (which is great), but there's nothing mentioned about if the new relationship has meant the DIYers have a clear path to controlling pumps that doesn't rely on hacks.

The chances are this is unlikely, for legal reasons: Medtronic creates regulated medical devices. I wonder whether it would be possible to add something along the lines of "push this (software/hardware) button to allow non-regulated 3rd-party hardware and software to begin controlling your medical device, but doing so will bind you to <insert waiver here>" and get such functionality to pass FDA approval. I somehow suspect not, although I would be very happy to hear otherwise.

As things stand now, though, it sounds like (as the article suggests, with the picture of a "hacked pump") people are still relying on methods and techniques that it sounds like anyone can use. So yes, unfortunately everyone's in a situation where any adversary within Bluetooth range could probably take the device over, and (depending on the severity of the vulnerability being used) perhaps modify the pump itself to pump too much or too little regardless of inputs, or similar.

Quite an uncomfortable situation from a security perspective. :/

Chiming in to say that some data is available to the public as well, as these Open Humans users have shared their Nightscout data publicly: https://www.openhumans.org/api/public-data/?source=direct-sh...

These two explanations seem entirely compatible to me.

For better or for worse, in an environment where "root cause attribution" is such a preoccupation, it's not such a stretch to think that the agents acting in it would be strongly incentivized to minimize their opportunities to be the root cause - in other words, "be blamed if something goes wrong".

I don't think that needs to be interpreted as nefarious. It might just be that everyone looked at making them more automatic, and just decided that the costs to do all the research that would be necessary for CYA and regulatory purposes would be too great.

Yes. It is the "ensuring the manufacturer can't be blamed if something goes wrong" mindset that says, "it's necessary ... if somebody did something illegal or dumb, they can be sanctioned".

Another approach would be to focus on patients and ignore punishments. Which is what the hackers are doing: ignoring rewards and punishments that are driving professionals in the field.

Not necessarily even illegal or dumb.

One of the things about testing drugs and medical devices is, you really can't cover all your bases. It would be too expensive to construct a clinical trial with the statistical power necessary to reliably detect very rare side effects. I don't think anyone wants to delay releasing all new drugs to the market by 40 years so that we can be sure about what happens if you take it over a lifetime. Even post-release monitoring for these things is potentially tricky, due to the poor interoperability of EHR systems and also, in many jurisdictions, unintended consequences of health care privacy laws.

Meaning that there is no amount of due diligence that will guarantee you can't get sued. Which is fine, you can always go for proportionality instead. But then, the amount of due diligence that's necessary is driven by what costs the legal system is willing and able to impose, and, at least in the legal regime I live under (USA), they've got their own entirely other set of procedures and incentive structures that they're working with.

Insulin is incredibly expensive and is manufactured by some of the companies making these devices. I wonder how much less insulin people use with these devices?

There is no overlap between companies that manufacture insulin and companies that manufacture diabetes-related devices. (Not for any fundamental reason, it just happened to work out that way.)

Also, the amount of insulin used is not significantly different with a closed-loop system vs. not. Although closed-loop systems do increase the benefit of faster-acting insulin relative to slower insulin, and the fastest-acting insulins are more expensive (especially inside the US).

Somehow I can't help but read you've smuggled endorsement for: It's ok if the product is more dangerous when bundled with the benefit that we can blame it on some organization.

The more generous interpretation is: We value life and try to reduce the risk of severe damage when making drugs. And regulatory bodies exist to combat the incentive to just ship whatever works without adequate regard for what could go wrong

Yes, this is what I meant.

Thanks for being generous.

And what do you suggest we do when an open-source "biohack" results in something like this ?

https://en.wikipedia.org/wiki/Thalidomide

Note the mistake made, and just how subtle it was. During testing a somewhat more ad-hoc process was used to produce the drug that did not result in the bad isomere, and then it was sold with multiple isomeres in the actual drug. Regulators at the time thought that isomeres did not matter and it took years for the effects to become clear. Of course regulators did not test for things they didn't know about. Neither did the companies (not just one). Crucially the drug was NOT tested for the effect on pregnancies (and was therefore not to be taken by pregnant women, like many drugs and even some non-drug products like famously alcohol).

Furthermore: there is at least some amount of "guilt" on the part of some of the mothers: the medicine was NOT approved for use during pregnancy, and stated this.

Result: >10.000 crippled children.

Where is the guilt to be placed for this incident ? I would argue that the primary guilt is with the regulator (government) and a small amount with (most of) the mothers for taking unapproved medicine, with the rest of the mothers following doctors' prescriptions (which of course means those doctors prescribed unapproved medicine). Needless to say, the company was blamed, and forced to pay (essentially in trade for not going to prison). The German government denied any responsibility, and several other governments (famously Spain) went further: they denied anything had happened at all.

So let's say there is a timing bug in this "open source pancreas", and it starts pumping insulin into the patients bodies without cause, say at the unix epoch transition. I would guess that at least half of them won't survive.

What happens next ? Given the Thalomide incident we can make an educated guess: whatever the law says, and despite patients "accepting the risk", even when the patients explicitly make mistakes in the treatment, you can bet the government will go after whoever they can arrest, and force them to pay millions of euros, or throw them in jail for the rest of their life.

People cannot be trusted to accept responsibility for the result of picking their own treatments, even when fully informed about the risks.

I actually don't care about anyone else's opinion of what I may do to manage my chronic, lifelong, slog of a disease. This is merely my chosen alternative to doing math and jabbing myself with a needle manually, which any reasonable person can conclude is perfectly capable of killing me within minutes. This is already delegated to all T1Ds in the normal state.

Your scary hypothetical is not possible. As if to agree, my pump just beeped at 10PM, announcing that the temporary basal (which can't kill me at maximum setting) expired and a new one was chosen. It's best choice is actually to suspend basal entirely when it knows I've dosed too much, which makes it a very legit safety improvement.

Oh, and a company created the example, which waters down your point - what convinced you that the very capable hands of people affected by the disease directly with a strong desire for data to back every thing up is anything like an accident waiting to happen? There's no profit motive here! (PS: it runs a direct test suite on install, and has cloud CI)

I have to add: Thalidomide is still prescribed today as it is a very effective drug. Also, as a response, the US has a much stronger system for evaluating drug safety.

US regulators did not approve thalomide until after the risks were known. Their system for evaluating drug safety is the strongest in the world and that is why there were no thalomide induced birth defects in the US. Those problems, subtleties and failures of regulation were in European markets where thalomide was approved more quickly (and new manufacturing processes were less closely regulated than the drug itself). EU has stronger regulatory practices in place as a result.

The narrative is more complicated than that, see https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey and https://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-af.... In particular: athough Kelsey did correctly identify issues, there wasn't legal support for that kind of regulation until her work led to https://en.wikipedia.org/wiki/Kefauver_Harris_Amendment which was necessary legal support for the FDA regulation process.

True, but the point is more about that the government (and the people) went after the producer of the drug, despite that producer not really having screwed up, and left the ones that had screwed up (state, mothers and doctors) alone.

Furthermore, the law did not really support these cases. But when you cripple 10.000 babies, law does not matter. Plus we all know they went after the company, not because it was at fault, but because they could band together against it.

If that were to happen to an open source project (and that seems a reasonable guess for open source "biohacks"/medicine when they screw up) ... the authors will go to jail for life and die bankrupt. It doesn't matter what license, it doesn't matter what contracts say, it wouldn't even matter if you have personal videos of every user saying they will never hold you responsible with a paper around it signed in blood by both the user and a public notary.

THAT's why we have the pharmaceutical industry we have.

That's not the endorsement. The endorsement is that it's okay for a single product to be suboptimal as long as the system is optimal. It's more optimal to prevent or slow down a number of innovations in order to protect the vast majority of people from the sort of mistakes and scams that other industries accept as standard.

Wow.

That's pretty amazing. You're accusing me of active malice for explaining the (entirely reasonable) thought process behind the government's legal system for regulation that pharma must comply with to operate.

I think when you move from the realm of anecdote to dealing with statistics, products with 100 million users, and historical cases (Therac-25), you gain a perspective that regulation is probably the simplest and most effective mechanism for keeping deaths at a minimum while allowing new products to reach the market.

You're actively ignoring the point and just being offended which is natural because it was put extremely bluntly. But you've just restated that the current state of affairs is "entirely reasonable" when the comment you are replying to explains why it's actively harmful. You've provided no argument for why it's reasonable, just taken offense and waved around cases of catastrophic failure.

I don't understand what's unreasonble about:

1) companies have a profit motive and they want to design and sell products

2) historically, we have seen that companies acting with profit motives often have incentives to ignore problems with their products and even actively suppress them

3) the government wants to incentivize companies to make new products that help people

4) but they also don't want large numbers of people to die, or even small numbers of people, due to errors of any kind.

5) we have ample evidence that when unregulated, errors occur and people die. Statistically across large numbers of drugs and medical treatments, we have enough data to make strong, but not perfect statements about which processes minimize negative problems while maximizing availability of product to sick people. In some cases, people die because executives explicitly chose to cut corners. With regulation, we can catch those executives and put them in jail.

6) in general, the one thing that comes out of all of this is that extensive record keeping is required for investigators to deal with problems when they occur. Most of regulation is just record keeping- what did we do, what happened when we did it- and change control. Literally, my job was to ensure that firmware updates didn't change the observable properties of a system that was making a drug that saved people. Yes, when a firmware of a machine that makes drugs is updated, and it has a bug, people can die.

7) given about a hundred years of experience in this area, enough people who work on "reliability" (like SRE in tech) people have developed a set of techniques, called regulation, which attempts to minimize the number of deaths, while still allowing products to reach the market. Like SRE, it's a combination of hard-won experience and a lot of intelligence, along with not enough monitoring data.

8) I also feel pain and unhappiness that pharma doesn't move faster. It wasn't until I worked daily on product development and implementing regulation that I began to appreciate that this is a truly complicated problem with a lot of variables, incentives and players.

9) Even giving my best good faith effort, I simply cannot credit people who give anecdotal evidence about friends with diabetes. There are a number of reasons for this, but basically, if you do enough large-scale decision making, you'll find that anecdotes introduce bias that can lead to poor decision making. I see problems, also, in the DIY community where people sort of assume the best possible results; in science, after you run enough experiments, you get to see: it's easy to fool yourself and think what you've done is good, but it really has to percolate through the system and get evaluated and reproduced by many people before you can trust it.

If you don't think the above logic chain is reasonable, that's OK. Many people aren't happy with how slowly pharma and medical DX industries and FDA work. But, you should basically understand that the entire goal here is to ensure good products make it to the market without "too many unnecessary deaths".

The worst part of all of this is that I dedicated many years of my life to improving the speed at which drugs could be discovered and brought to patients, only to learn that the primary reasons we can't, are political, structural, systemic, and incentivized. If somebody had a better solution than what the current market has, I can point funding at them.

In some ways, I think the FDA is a victim of its own success. If I'm not mistaken, it was created in part because of the 100+ deaths around Elixir sulfanilamide. But since the FDA has helped prevent things like that from recurring, we underestimate the potential dangers of under-regulating.

Not that the FDA couldn't be more efficient (possibly considerably more so), but it's clear that most products that go into production work, and that can't be discounted.

https://en.wikipedia.org/wiki/Elixir_sulfanilamide

Context: I am a type 1 diabetic.

As far as doctors are concerned I am an exemplary patient who has shown blood glucose controls as good as they come (A1C of less than 6.5 for more than a decade now for those that know what it means).

I regularly hear from "concerned" people how they know someone else who's blood control isn't as good and they should do better, etc..., etc...

I have personally used some of these DIY products and so I want to be very clear; the difference between "somewhat poorly controlled blood sugar" and just one really bad mistake in "tightly/ best-controlled blood sugar" is this

1) Poorly controlled - in a decade I will start to have some additional health problems (vision impairment/neuropathy/etc)

2) Tightly controlled w/dosing mistake - Coma/Brain Dead/Dead

There is a good reason to test this equipment and take a conservative approach.

Physical activity level and how much active or "on board" insulin you need when you are being active vs inactive can vary by 10x. As an example of this; before I do cardio workouts I intentionally do a carb load and let my blood sugar raise before starting to counter the effect the exercise will have on my blood sugar. Despite this on two occasions during running I have experienced double drops (super fast blood sugar drop to unsafe levels) to levels so low I started to black out.

Nightscout/OpenAps/Dexcom/Medtronic, it doesn't matter open source or closed source none of these devices can handle these scenarios so at the end of the day it is still on me to intervene and make decisions based on what I am going to do. Until something better than pump systems come along (and these "artificial pancreas" systems as they are calling them to day are still just pump systems; I will have to intervene no matter how sophisticated the algorithms.

In summary; just because you care about someone with diabetes, do not presume you know what is best for us.

OpenAPS doesn't mean you never have to intervene, nor does it claim to. It does mean that the interventions needed are less frequent and more predictable. Ie, in the case of exercise--if it's only a small drop, shutting off basal is enough to counteract it, so it'll do that, and you don't have to do anything. If it's a larger drop, you need to eat carbs to counter it--and it'll send you a notification telling you how many carbs you need to eat, and this notification will typically come quite a bit earlier than the low-glucose alarm the CGMS will eventually send.

Yep; I'm aware of all of that.

I'm glad that the open source community is getting involved and I want to see these things help move the industry forward.

My comments were to the parent who presumes

1. To know what is best for diabetics 2. The device is inherently less risky than current options

Nightscout absolutely would not get through FDA approvals today if for nothing other than catastrophic failures. I love the features and think it's way more robust than what is provided by Dexcom, but at the end of the day, I switched back to Dexcom's receiver and app because it doesn't crash.

OpenAPS is great, but requires a level of research and effort than many patients aren't capable of. Then on top of this OpenAPS has this nice disclaimer as an opener, "By proceeding to use these tools or any openaps repositories, you agree to abide by the copyright agreement and release any contributors from any liability."

Now I understand why that statement is there, but when someone dies using this "product" that hasn't been approved by the FDA; well let's just say I hope all parties involved have really good umbrella policies, because I'm not too sure that's going to hold up in a court of law.