Comment by doctoring | Hacker News Reader

Comment by doctoring | Hacker News Reader

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I'm an MD, practicing in the US.

I don't know the actual legality. But here's what I do know from attempting to implement multiple projects within the US for clinical care and for clinical research: most providers, hospitals, and pharmaceutical companies we have worked with have balked at the ability to have high resolution data fed into their medical record or research data systems. In most cases, they are worried that if they had the data, they would have to act on it were something to be concerning. And they do not want that responsibility.

Example: we were in talks to feed in near-realtime blood glucose, activity, and blood pressure measurements from patients on a clinical trial. Surely that would be useful for better sussing out the effects of a research drug than the current process (patient comes in every few months to get measured or have their log data entered or meter data downloaded)? Nope, multiple top 5 pharma companies didn't want the responsibility and liability of seeing their data that often, because what if a patient had super low or super high glucose and they later died? You had the ability to act on it but didn't.

They'd rather just not have it at all. It sounds ridiculous. And again, I don't know the actual legal/liability issues, but based on my experience with malpractice cases, I could see a viable case to be made. And there are certainly institutions out there who believe the benefit is worth the cost of that responsibility for certain use cases. But my experiences have definitely made me reconsider some of these things.

All that said, I am definitely in favor of collecting more health data (somehow), because until we have more data we won't know its utility. So far, in general it has been shown that more testing and more information often doesn't lead to better outcomes, but the cost of data is getting lower -- aside from aforementioned liability cost/fear.

From the situation as you describe it, it'll likely require a government mandate or "Good Samaritan" type of law to resolve the issue since it derives from fear of litigation. Unfortunate.

I imagine getting something like this implemented at a state level in one or two key states could enable collection of large scale medical data for analysis on behalf of the public.

Edit: Question for you, given your experience do you think it might be possible to convince big pharmaceuticals to collect high fidelity data if said data was collected into wearable devices and only processed after the fact? As analogy to use a "black box" recorder approach rather than flight control systems. Though not sure how far to take that "black box" analogy.

@doctoring Do you think that those 5 pharma companies would be interested in the service that would take care of data collection and alerting patient/911? If it is possible I would like to talk to you about this and other ideas. Could you contact me at redant409[at}gmail.com?

Sounds like a bit of a catch-22: you don't want to collect the data until you've collected enough data to know that you're not causing harm.

Not really. We have a system for this: clinical trials. I, as a lone doc, am not equipped to make heads or tails of un-randomized un-controlled piles of data. A clinical trial -is-.

That’s why we use them.

> I, as a lone doc, am not equipped to make heads or tails of un-randomized un-controlled piles of data.

Isn't that a description of literally what every practicing doctors, that isn't involved in research, actually does?

And clinical trials are extremely expensive. Surely there's some utility in gathering data between the extremes of doctor-patient and clinical trial.

No, it’s not.

We use properly conducted clinical science to give us a framework for interpreting the data we see, comparing data we have to studies with appropriate external validity to allow that comparison.

And no, there isn’t, if an RCT is at all feasible. There was a great paper a few years back that reviewed various case-control studies for conditions that were ultimately explored using RCTs (eg, knee arthroscopy, internal mammary artery ligation). What they found was that the retrospective study consensus was basically a coin-flip with respect to the RCT consensus. They just don’t provide useful data - too many confounders, known and unknown, go unaddressed.

This sounds like a really interesting paper -- do you happen to have a link to the reference?

I’m not ignoring your request; in trying to dig up the paper, I came across a couple papers with data claiming to show the opposite. I’m trying to digest it all before returning to this topic, so I can give a more useful response. And I haven’t found that paper yet.

> We use properly conducted clinical science to give us a framework for interpreting the data we see, comparing data we have to studies with appropriate external validity to allow that comparison.

I am extremely skeptical that this is in fact an even approximate description of how medicine actually works. Maybe not what you're doing! But what almost all of the doctors I've ever seen? They're not keeping up with all of clinical science. And even if they were, lots of clinical science is not being properly conducted. Just listen to or read the gripes that the statisticians have!

My previous claim still stands; you wrote:

> I, as a lone doc, am not equipped to make heads or tails of un-randomized un-controlled piles of data.

An individual patient, provides "un-randomized un-controlled piles of data" to their doctor – or, rather, not even piles of data. There's the visual evidence available from looking at and watching a patient when they're visiting your office (or whatever). There are sounds, smells, touch too. Then there's the verbal evidence. Then there's the results of whatever tests it is you order. If that's not un-randomized and un-controlled data, I don't know what is.

There's no framework for interpreting all possible medical evidence, even for the smallest professional specialties. There are no RCT for medical expert systems; none that anyone could legally use instead of a licensed doctor.

And there are lots and lots of interventions that doctors perform that have never been adequately studied in the form of RCTs. Doctors, in the real world, exercise an incredible degree of latitude with regard to what interventions they can perform based on their own personal judgement.

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