Regulation

Eko's ECG low ejection fraction tool will now be able to help clinicians spot cardiac complications associated with the novel coronavirus. 

This news means that the Australian company will be able to expand to the United States. 

The continuous remote monitor can help prevent complications driven by experimental COVID-19 treatments such as hydroxychloroquine or chloroquine, according to the agency.

Dr. Don Rucker, National Coordinator for Health Information Technology Office of the National Coordinator for Health IT, discusses his work with the Global Digital Health Partnership initative. 

Data privacy will be a key focus as development of the government’s NHS tracing app heads toward testing and review. But with release still unlikely for several weeks, one member of the development team suggests that lost time has already cost lives.

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.