Regulation

By  Bradley Merrill Thompson 03:46 pm April 24, 2020
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...
By  Dave Muoio 01:07 pm April 21, 2020
Thanks to an updated emergency use authorization (EUA) from the FDA, LabCorp's COVID-19 RT-PCR test is now the first diagnostic test for COVID-19 that permits at-home sample collection. Now, patients may use Q-tip-style nasal cotton swabs and saline included in LabCorp's designated self-collection kit – which the company is branding as the "Pixel by LabCorp COVID-19 Test." These samples are...
By  Jonah Comstock 04:38 pm April 17, 2020
With the COVID-19 pandemic preventing large gatherings of any kind, the Senate Committee on Commerce, Science and Transportation last week was forced to hold its hearing on big data and privacy protections in response to the pandemic as a “paper hearing.” Participants submitted written testimony only. Lawmakers sent those experts questions, and the panel responded with written answers. Despite...
By  Dave Muoio 02:38 pm April 16, 2020
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to submit a 510(k) premarket notification – for the duration of the COVID-19 emergency. "Device availability may increase patient access to digital therapeutics while individuals are following 'stay at home' orders or practicing social distancing,...
By  Piers Ford 08:21 am April 15, 2020
The European Commission has adopted a recommendation to support exit strategies with a standardised approach to mobile data usage and apps development as some member states begin a slow relaxation of measures implemented in an effort to contain the coronavirus pandemic. Digital tools are central to the recommendation, which is based on the adoption of a toolbox currently on schedule to be...

Credit - Markus Spiske

By  Piers Ford 08:40 am April 3, 2020
The lack of a co-ordinated approach to procurement is hampering the efforts of healthcare tech companies and innovators to meet the growing demand from healthcare delivery organisations for equipment and digitally-enabled remote services across Europe sparked by COVID-19. The European Commission’s widely welcomed adoption of decisions on harmonised standards for medical devices that will enable a...
By  Dave Muoio 03:13 pm April 2, 2020
Editor's note: On the same day this story was published, the FDA publicized the first Emergency Use Authorization of a serology test, Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test. This story has been updated to reflect that development. On Tuesday morning, Los Angeles-based Bodysphere announced that it had received an Emergency Use Authorization (EUA) for a rapid COVID-19 serology test able to...
By  Laura Lovett 04:34 pm April 1, 2020
Testing for COVID-19 has been somewhat of a roller coaster in the last few weeks. With each day, the FDA pushes forward in its efforts to expedite the review and rollout of sorely need COVID-19 diagnostic testing. It has enabled the Emergency Use Act, which relaxes standards during a time of crisis.  On March 30 the agency revealed that, since January, it has worked with more than 230 test...
By  HIMSS Media 04:31 pm March 30, 2020
These have been turbulent times for the FDA. On the one hand, the U.S. regulator has found itself carefully unravelling guidances to bolster COVID-19 testing and treatment – sometimes leading to confusion for companies searching for new ways to combat the global epidemic. On the other, the agency continues to push forward with broader initiatives to remap its processes so that novel software...
By  Dave Muoio 01:55 pm March 27, 2020
Yesterday, Pear Therapeutics announced the regulatory clearance of Somryst, its prescription digital therapeutic for chronic insomnia. And while the product is noteworthy for these patients and Pear's broader business, it also stands as a major milestone for the digital health industry – the first product to be evaluated throught the FDA's Digital Health Software Precertification Program. Now...