The road ahead for FDA’s Pre-Cert program
FDA has taken important steps to develop the Pre-Cert program collaboratively with the software industry through a pilot but it has revealed areas where the program needs refinement.
FDA has taken important steps to develop the Pre-Cert program collaboratively with the software industry through a pilot but it has revealed areas where the program needs refinement.
When is the government going to reimburse new software and digital health products? Shouldn’t we also look at reimbursements to physicians that extend their reach to patients through digital innovations?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.