Regulation
Epstein Becker & Green's Bradley Merrill Thompson describes the agency's current trajectory for regulation of patient-facing and provider-facing telehealth products that incorporate AI.
Using a designated kit ordered by a doctor, patients will be able to self-swab and mail their samples to LabCorp testing facilities. The self-collection kits will be available in "most states" in the coming weeks.
Seven witnesses submitted statements and answered questions, leaving Senators with promising tech ideas, legislative priorities and words of caution.
A new guidance from the U.S. regulator relaxes a handful of requirements for these digital health devices, and clarifies the agency's long-term enforcement policy for low-risk wellness products.
A common toolbox has been compiled to help EU member states take a coordinated and standards-based approach to support exit strategies from their coronavirus containment measures, enabling them to stay complaint with data protection and privacy regulations.
Health
Innovators are eager to help but struggle to make the right connections.
Bodysphere's announcement was spread across a number of mainstream news and social media channels before the company released a statement that explained its misunderstanding.
Also Cue Health scores $13 million from the department of Health and Human Services Biomedical Advanced Research and Development authority in order to fund its portable COVID-19 diagnostic test.
The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.
Dr. Yuri Maricich, chief medical officer at Pear Therapeutics, speaks on his company's experience bringing a digital therapeutic product through the regulator's experimental program for health software.