Great post, Sophie. Regarding requiring embedded screening software in benchtop equipment, the Bill might already require it, if I've read it correctly (i.e. Sec 4(a)(1)). Though, at the very least the Bill should make it more explicit that embedded screening software is required, which your second recommendation correctly notes.
Hi Andy!! Thank you so much for pointing this out— I think you may be right that a reasonable reading of 4(a)(1) could support embedded screening. The top-level requirement is for covered providers to "implement screening protocols for all sequences of concern," and since benchtop synthesizer sellers are covered providers, that requirement does technically apply to them.
That said, "implement screening protocols" isn't defined, and I think a manufacturer's legal team could plausibly argue it only means screening at point of sale rather than embedding ongoing screening in the hardware. The bill's operative language throughout Section 4 is oriented around orders and customers rather than ongoing requirements/anything specific re: embedded software/hardware (e.g. see Sec 4(a)(1)(A)).
So I think we agree: even if the bill can be read to require it, an explicit amendment removing the ambiguity would be much stronger than relying on interpretation. Thanks for the close read!!
Absolutely. That's something that we (New Zealand) made sure to include explicitly in section 157 of our gene technology bill and the UK included it in their guidance as well. Hopefully that gets amended in the US Bill.
Great post, Sophie. Regarding requiring embedded screening software in benchtop equipment, the Bill might already require it, if I've read it correctly (i.e. Sec 4(a)(1)). Though, at the very least the Bill should make it more explicit that embedded screening software is required, which your second recommendation correctly notes.
Hi Andy!! Thank you so much for pointing this out— I think you may be right that a reasonable reading of 4(a)(1) could support embedded screening. The top-level requirement is for covered providers to "implement screening protocols for all sequences of concern," and since benchtop synthesizer sellers are covered providers, that requirement does technically apply to them.
That said, "implement screening protocols" isn't defined, and I think a manufacturer's legal team could plausibly argue it only means screening at point of sale rather than embedding ongoing screening in the hardware. The bill's operative language throughout Section 4 is oriented around orders and customers rather than ongoing requirements/anything specific re: embedded software/hardware (e.g. see Sec 4(a)(1)(A)).
So I think we agree: even if the bill can be read to require it, an explicit amendment removing the ambiguity would be much stronger than relying on interpretation. Thanks for the close read!!
Absolutely. That's something that we (New Zealand) made sure to include explicitly in section 157 of our gene technology bill and the UK included it in their guidance as well. Hopefully that gets amended in the US Bill.