Before a drug is approved by the U.S. Food and Drug Administration (FDA), it must demonstrate both safety and efficacy.
However, the #FDA does not require an understanding a drug’s mechanism of action for approval.
This acceptance of results without explanation raises the question of whether the "#blackbox" decision-making process of a safe and effective #artificial#intelligence model must be fully explained in order to secure FDA approval.
This topic was one of many discussion points addressed on Monday, Dec. 4 during the 🔸"MIT Abdul Latif Jameel Clinic for Machine Learning in Health AI and Health Regulatory Policy Conference", 🔸which ignited a series of discussions and debates amongst faculty; regulators from the United States, EU, and Nigeria; and industry experts concerning the regulation of AI in health.
As #machine#learning continues to evolve rapidly, uncertainty persists as to whether regulators can keep up and still reduce the likelihood of harmful impact while ensuring that their respective countries remain competitive in innovation.
To promote an environment of frank and open discussion, the Jameel Clinic event’s attendance was highly curated for an audience of 100 attendees debating through the enforcement of the Chatham House Rule, to allow speakers anonymity for discussing controversial opinions and arguments without being identified as the source.
Rather than hosting an event to generate buzz around AI in health, the Jameel Clinic's goal was to create a space to keep regulators apprised of the most cutting-edge advancements in #AI, while allowing faculty and industry experts to propose new or different approaches to #regulatory frameworks for AI in #health, especially for AI use in #clinical settings and in #drug#development.
AI’s role in medicine is more relevant than ever, as the industry struggles with a post-pandemic labor shortage, increased costs (“Not a salary issue, despite common belief,” said one speaker), as well as high rates of burnout and resignations among health care professionals.
One speaker suggested that priorities for clinical AI deployment should be focused more on operational #tooling rather than patient diagnosis and treatment.
One attendee pointed out a “clear lack of #education across all constituents — not just amongst developer communities and health care systems, but with patients and regulators as well.”
Given that medical doctors are often the primary users of clinical AI tools, a number of the medical doctors present pleaded with regulators to consult them before taking action.
#Data#availability was a key issue for the majority of AI researchers in attendance.
They lamented the lack of data to make their AI tools work effectively.
Many faced barriers such as intellectual property barring access or simply a dearth of large, high-quality datasets.
“Developers can’t spend billions creating data, but the FDA can,” a speaker pointed out during the event.
“There’s a price uncertainty that could lead to underinvestment in AI.”
Speakers from the EU touted the development of a system obligating governments to make health data available for AI researchers.
Let's pretend we're proponents of free and open source software, enlist an army of week intentioned FOSS developers to contribute to our project, and once successfully deployed in many enterprises across the industry...
Pull the rug out and convert it into a proprietary product with a bunch of undisclosed, hidden code that we won't ever show you - Muahahaha...
Yeah. I see this happening right now in several prominent and celebrated open source projects that you're probably completely oblivious to those sinister objectives.
This is why the most ubiquitous desktop operating system in the world is Minix.
What's that you say?
Yup, Minix. But that's no secret, the cat was out of the bag on that one a few years back (after being secretly so for many years).
Before you contribute any more code, translations, or documentation to a software project, consider this:
Now, there's another point to be made here, without specifically naming any projects currently abusing user contributions. Let's call this hypothetical project "hammer&anvil", itself a fork of a popular software project - but claims it's all about being free and transparent, wanting to distinguish itself from the project it's forked from by adopting GPL3 instead of a permissive license.
Sure, the project's BDFL (let's call her "Strawberry Daiquiri"), says one day, "were forming a fork of project X because they've formed a company and I'm afraid what they are going to do with X because it's under a permissive license. This girl will be brutally transparent and completely run by the community under the philosophy of anarchy, but we're going to call it a sociocracy so you don't know that it's really just me making a proprietary product for my own ambitions".
Well, Miss Daquiri decides to capture by capitalizing upon the sentiment that folks have for Copyleft - it's supposed to protect free software, right?
Well, this fork (hammer& anvil) is a hosted solution - meaning SaaS, meaning, it runs elsewhere (other than in your computer) in the cloud as a publicly accessible service. Hmmmm.
That means that the most appropriate Copyleft license is likely the AGPL, and not the GPL as one would expect fur a desktop or other local program that you actually download and install in your laptop or server.
The GPL requires that when you distribute (give away or sell) your program, either by letting someone download or handing it to them on a USB stick, Etc., You must also make available ALL of the source code, including any changes you've made to the program.
But if you run a modified GPL program as a service in the cloud you don't have to provide ANY off the changes you've made to the code.
Hmmm.
With AGPL you do have to supply your users with ANY code modifications you've made to the running service to which they have accounts...
So let's just say that you fork Mastodon, and call it Glitch-Soc, modify it, and run it in the cloud for people to create accounts on and use (for free or for monthly subscription fees - it doesn't matter). ANY and ALL changes to the code base that you make MUST be made available anytime a user asks for the source code, because it's an #AGPL licensed product.
And in reality, such is actually the case with this exceedingly popular and capable #fork. It's a fine product in it's own right.
But had you changed the license to all contributions moving forward to #GPL, you wouldn't have to provide any modifications you made (unless you give or sell the software product itself on say, a USB stick or via download).
Why? Because you're just allowing them to access and use your service, your not actually giving them the program to use for themselves elsewhere - so any modifications you made since forking under a different license (GPL instead of AGPL) isn't something you have to show them.
You've essentially created a #proprietary product (if you're so nefarious as to hide your code changes by butt disclosing them), the only code of which you must supply being that which existed under the AGPL before you forked it.
Both #Copyleft and permissive open source #licenses like #BSD and #MIT can be a good thing, or they can be abused beyond the intentions of the #FOSS inclined project contributors. Just make sure that you understand what can and cannot be changed where your intended purpose for the #distribution and #availability of source code is concerned....
There are BIG differences between the ramifications of each #license and how they can affect transparency and distribution of your free gifts to the world.
In our hypothetical scenario with hammer&anvil, the #BDFL, #Strawberry Daiquiri, has decided that she's going to launch a hosted service, and she's going to include things that you don't see and can't be aware of behind the scenes which, if disclosed, you would have nothing to do with - but you'll never know what kinds of scary things she's done with the product that only resembles the original on the surface, because Miss Daquiri will never have to show you the code she has added behind the scenes.
"Beautiful Victor, Beautiful."
-The Monster, speaking to his creator in the film, 'Frankenstein, The True Story'.
We've seen the requests, and now the Vivaldi Browser is available on the #MicrosoftStore. We're happy to see the increased #Availability for our users.