Public Policy

Woman puts at-home COVID-19 test into sample bag.
FDA streamlines pathway to at-home asymptomatic COVID-19 test approval
By Mallory Hackett | 01:54 pm | March 18, 2021
The agency will allow some COVID-19 tests to be used at home for regular asymptomatic testing.
FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing
By Dave Muoio | 05:36 pm | March 05, 2021
The system delivers its results to a companion app in about 20 minutes, according to the agency.
Media reports indicate that One Medical has allowed people connected with company executives and other ineligible individuals to skip the vaccination line.
House panel launches investigation into One Medical’s vaccination practices
By Mallory Hackett | 12:32 pm | March 03, 2021
  Media reports indicate that One Medical has allowed people connected with company executives and other ineligible individuals to skip the vaccination line.   
The Analytic for Hemodynamic Instability tool can identify hemodynamic instability with 96% sensitivity and detects stable patients with 85% specificity.
FDA grants De Novo classification to Fifth Eye's continuous hemodynamic status monitoring tool
By Mallory Hackett | 01:26 pm | March 02, 2021
The Analytic for Hemodynamic Instability tool can identify hemodynamic instability with 96% sensitivity and detects stable patients with 85% specificity.   
FDA's enforcement discretion for digital health is more ambiguous than ever in 2021
By Dave Muoio | 03:06 pm | February 25, 2021
Industry regulatory leaders outline the best approaches for digital health companies looking to make sense of FDA's long-in-the-tooth enforcement discretion guidelines.
HIMSSCast: Is the FDA taking digital health regulation in the right direction?
By MobiHealthNews | 12:42 pm | October 09, 2020
Bradley Merrill Thompson, an FDA-watcher, lawyer and occasional MobiHealthNews guest contributor, joins the MobiHealthNews team for a closer look at what the FDA has been up to around digital health and AI.
HIMSSCast: FDA grapples with home COVID-19 testing, moves forward with Pre-Cert Program
By HIMSS Media | 05:31 pm | March 30, 2020
The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.