Prescription digital therapeutic products can improve health for the underserved, especially in the area of mental health. Apart from addressing the severe shortage of mental health professionals by increasing access to care, recent science would suggest the digital therapeutic modality can be particularly effective at treating widespread conditions, including those made worse by the pandemic....
It’s been quite a year: COVID-19, a change in administration and a year of transition for FDA digital health policy. In light of all the change and uncertainty, many digital health companies are struggling to decide upon a regulatory strategy for 2021.
My advice? If at all possible, stay away from FDA. They have enough to do right now. The people I know at FDA have been working 12- and 15-hour...
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.
Many appreciate that telemedicine...
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.
Let’s say I could show you,...
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.
As a pro bono project, together...
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
In January, FDA released version 1.0 of its Working Model for the agency’s Precertification Program for Software as a Medical Device (SaMD) (i....
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.
FDA’s concept of a...
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
Since the Medical Device Amendments of 1976, a hallmark of FDA’s regulation of medical devices has been the agency’s risk-based approach....
There seems to be a modern day gold rush as companies explore how to use machine learning in clinical decision support software. Unfortunately for libertarians, FDA will regulate some of that software because of its risk profile. While the 21st Century Cures Act that passed last December exempted certain CDS from regulation and indeed FDA intends to exempt even more, FDA will continue to regulate...
