Health Care Law News and Insights

In 2018, Apple made headlines when it released a new version of its smartwatch that included an FDA-cleared electrocardiogram feature. Conor Hale, New Apple Watch receives FDA clearance for built-in ECG, Fierce Biotech (Sept. 12, 2018). This feature cemented the smartwatch's classification as a medical device. With the popularity of wearable health...

Read More

Several cases of monkeypox has now been found in the United States. We do not yet know whether employers will need to worry about monkeypox in the context of their workforces and workplace, but it may be wise to be informed. Monkeypox is a viral illness that has symptoms including...

Read More

The FDA recently released a draft guidance for what documentation sponsors should include in premarket submissions for software-based products. The new guidance is an update to the current guidance, which is from 2005, and it has important information for anyone operating in the digital health space. In addition to BrightInsight's...

Read More