Health Law Advisor

Interoperability and patient access to data has been pushed to the forefront as a primary concern for the health industry. This is largely due to proposed rules published this spring by the Office of the National Coordinator for Health Information Technology (ONC) and the Center for Medicare and Medicaid Services (CMS) that seek to advance interoperability and support the access, exchange, and use of electronic health information. In August 2019, the ONC held its third annual National Coordinator for Health IT Interoperability Forum in Washington DC. The event brings together the ...

On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco products on the market as of the August 8, 2016 deeming rule that extended FDA’s regulatory jurisdiction to include all tobacco products. Accordingly, manufacturers of e-cigarettes now have until May 2020 to submit ...