Post #2422907
2026-03-17 22:19 UTC
@marz@caw.corbode.com @twistylittlepassages@weirder.earth it's in the PDF right here
https://downloads.regulations.gov/FDA-2025-P-7321-0001/attachment_2.pdf
“Develop Communications for Medical Providers: Such communications would include the following:
○ Mandatory documentation of informed consent and capacity assessment prior to initiating treatment in adolescents and vulnerable adults.”
Replies (2)
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@akesi_Anima@mastodon.art 2026-03-17 22:22
@marz@caw.corbode.com @twistylittlepassages@weirder.earth combined with the other bullet points, it effectively **removes informed-consent treatment entirely** and mandates heavy-handed gatekeeping
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@marz@caw.corbode.com 2026-03-17 22:23
@akesi_Anima@mastodon.art @twistylittlepassages@weirder.earth I read that the PDF and that part. I guess what I'm confused about is there's already mandatory documentation of informed consent in states that allow for it. The documentation is help onsite in compliance with PHI laws. So my guess is that people are thinking this implies submitting that PHI to a registry of some kind?