FDA regulation

Dr. Doug Fridsma, former ONC chief science officer and current chief medical informatics officer at Health Universe, discusses GPT-5, including HIPAA compliance, FDA oversight and potential risks for patients uploading healthcare data.

Ben Wolf, partner in Alston & Bird's Health Care Group, told MobiHealthNews how FDA staffing cuts could slow device approvals and what companies can do to stay ahead.

The judge ruled that the FDA overstepped its authority by regulating LDTs as medical devices, overturning the rule and remanding it to the HHS Secretary for review.

Nurx, Carbon Health and Everlywell have officially halted their mail-order testing-kit services. But at least one startup is still moving to secure an Emergency Use Authorization for its at-home rapid serology diagnostic.

The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.