3 ms·

> Open source is orthogonal to quality at that level. "Quality" has many meanings. The article gives the example of Sandler, who was unable to read data from h

> Open source is orthogonal to quality at that level. "Quality" has many meanings. The article gives the example of Sandler, who was unable to read data from her pacemaker, because the correctly functioning, quality, high-assurance software was kept secret from her, and only the manufacturer could decipher it. Regardless, quality is a red herring - the real issue is sovereignty over our own bodies. Which is impossible if we have devices with secret functionality embedded in us. We have a right to know how they work, the same as we have a right to know what medicine doctors administer to us.

Veserv 3y ago
You do not receive a full chemical makeup, structure, and formulation of the medicine you are ingesting. You do not receive the entire production process of the medicine you are ingesting. You do not receive the full quality control process needed to verify the structure of the medicine you are ingesting. For that matter, even if you received those only a vanishingly small number of individuals would even be qualified to evaluate that information. No, what we as a society do is rely on a certification, verification, and validation process done by third party experts that guarantees the medicine fits a specification and is fit for purpose. This does not always get it right, but it is pretty good and works in literally every other industry. Competent unbiased third party verification is sufficient for safety-critical deployments. Openness is neither sufficient, nor necessary. A closed device with no safety defects is usable, a open device with safety defects is unacceptable. Openness may constitute other goods, such as freedom, agency, and such, but it does not provide safety, efficacy, and fitness for purpose which are the most important elements of medical devices (i.e it is orthogonal to effective operation).
- transpute 3y ago
  > You do not receive a full chemical makeup, structure, and formulation of the medicine you are ingesting. Individual humans and their medical advisors choose what to ingest, from a marketplace of substances on a spectrum of transparency in content and consequences.
  - Veserv 3y ago
    Hardly any that are frequently ingested are anywhere in the vicinity of the openness normally expected from open source. Openness is not and has not been sufficient, necessary, or even expected for useful medicine or basically anything else. Openness is orthogonal to efficacy and safety. It just looks correlated in software because software is totally unverified as a general rule, so “unverified, but ability to verify” is much better safety and efficacy wise than “unverified, no ability to verify”. But “unverified” of any form is worthless garbage and unfit for critical purposes. What you need is “verified” at a bare minimum, anything less is unacceptable.
    - transpute 3y ago
      > What you need is “verified” at a bare minimum, anything less is unacceptable. Yes, most countries currently rely on centralized regulation and testing. Hopefully, decentralized verification will continue to improve with science education and sensor technology, as humans learn that "supply chain security" applies to all inputs to human bodies.
- jevoten 3y ago
  > You do not receive a full chemical makeup, structure, and formulation of the medicine you are ingesting I was not aware of this. Predictably, this causes problems [1], just as the closed nature of the pacemaker in the article caused problems. Something which you ignored, and continued claiming, counterfactually, that closed-source doesn't hamper patient safety. [1] https://theconversation.com/whats-in-your-medicine-may-surprise-you-a-call-for-greater-transparency-about-inactive-ingredients-143803 https://theconversation.com/whats-in-your-medicine-may-surpr...
  - Veserv 3y ago
    Verification is significantly more important for patient safety than openness. Just look at your local homeopathic remedy section for evidence of that; plenty of openness, but not a lick of verification. As to the formulation of your medicine, your average person is unqualified to evaluate it for efficacy. They would generally rely on a competent trusted third-party (their doctor) to evaluate it for them. The evaluator needs openness, but general openness is not really required even if it may be desirable for other reasons. A common benefit to openness is not restricting it to the designated evaluator allowing more freeform evaluation. This can have benefits in medicine if you are able to navigate medical analysis and do your own research. However, this still has limits as even a highly skilled layperson is unlikely to understand the specific pharmacokinetics so general openness at that level of detail is unlikely to be particularly useful. You will almost certainly rely on a competent, trusted third party to confirm and verify conformance for you. To sum up, what matters is verification by trusted, competent parties. Verification demands openness to the evaluator, but does not need to extend further than that to see significant benefits. There may be additional benefits to openness, but efficacy and safety are more effectively achieved in other well-known, tried and true ways.
- reedciccio 3y ago
  > You do not receive a full chemical makeup, structure, and formulation of the medicine you are ingesting. ? Don't you get close enough by reading the relevant FDA approval documents, the list of patents of the active ingredients of the medicine you ingest? Nobody needs to be a biologist but many independent experts can verify what's in a pill. When it comes to software in our bodies, it's supposed to be secret?

Veserv 3y ago

You do not receive a full chemical makeup, structure, and formulation of the medicine you are ingesting. You do not receive the entire production process of the medicine you are ingesting. You do not receive the full quality control process needed to verify the structure of the medicine you are ingesting. For that matter, even if you received those only a vanishingly small number of individuals would even be qualified to evaluate that information. No, what we as a society do is rely on a certification, verification, and validation process done by third party experts that guarantees the medicine fits a specification and is fit for purpose. This does not always get it right, but it is pretty good and works in literally every other industry. Competent unbiased third party verification is sufficient for safety-critical deployments. Openness is neither sufficient, nor necessary. A closed device with no safety defects is usable, a open device with safety defects is unacceptable. Openness may constitute other goods, such as freedom, agency, and such, but it does not provide safety, efficacy, and fitness for purpose which are the most important elements of medical devices (i.e it is orthogonal to effective operation).

transpute 3y ago
> You do not receive a full chemical makeup, structure, and formulation of the medicine you are ingesting. Individual humans and their medical advisors choose what to ingest, from a marketplace of substances on a spectrum of transparency in content and consequences.
- Veserv 3y ago
  Hardly any that are frequently ingested are anywhere in the vicinity of the openness normally expected from open source. Openness is not and has not been sufficient, necessary, or even expected for useful medicine or basically anything else. Openness is orthogonal to efficacy and safety. It just looks correlated in software because software is totally unverified as a general rule, so “unverified, but ability to verify” is much better safety and efficacy wise than “unverified, no ability to verify”. But “unverified” of any form is worthless garbage and unfit for critical purposes. What you need is “verified” at a bare minimum, anything less is unacceptable.
  - transpute 3y ago
    > What you need is “verified” at a bare minimum, anything less is unacceptable. Yes, most countries currently rely on centralized regulation and testing. Hopefully, decentralized verification will continue to improve with science education and sensor technology, as humans learn that "supply chain security" applies to all inputs to human bodies.
jevoten 3y ago
> You do not receive a full chemical makeup, structure, and formulation of the medicine you are ingesting I was not aware of this. Predictably, this causes problems [1], just as the closed nature of the pacemaker in the article caused problems. Something which you ignored, and continued claiming, counterfactually, that closed-source doesn't hamper patient safety. [1] https://theconversation.com/whats-in-your-medicine-may-surprise-you-a-call-for-greater-transparency-about-inactive-ingredients-143803 https://theconversation.com/whats-in-your-medicine-may-surpr...
- Veserv 3y ago
  Verification is significantly more important for patient safety than openness. Just look at your local homeopathic remedy section for evidence of that; plenty of openness, but not a lick of verification. As to the formulation of your medicine, your average person is unqualified to evaluate it for efficacy. They would generally rely on a competent trusted third-party (their doctor) to evaluate it for them. The evaluator needs openness, but general openness is not really required even if it may be desirable for other reasons. A common benefit to openness is not restricting it to the designated evaluator allowing more freeform evaluation. This can have benefits in medicine if you are able to navigate medical analysis and do your own research. However, this still has limits as even a highly skilled layperson is unlikely to understand the specific pharmacokinetics so general openness at that level of detail is unlikely to be particularly useful. You will almost certainly rely on a competent, trusted third party to confirm and verify conformance for you. To sum up, what matters is verification by trusted, competent parties. Verification demands openness to the evaluator, but does not need to extend further than that to see significant benefits. There may be additional benefits to openness, but efficacy and safety are more effectively achieved in other well-known, tried and true ways.
reedciccio 3y ago
> You do not receive a full chemical makeup, structure, and formulation of the medicine you are ingesting. ? Don't you get close enough by reading the relevant FDA approval documents, the list of patents of the active ingredients of the medicine you ingest? Nobody needs to be a biologist but many independent experts can verify what's in a pill. When it comes to software in our bodies, it's supposed to be secret?