Draft legislation released by the Senate health committee for public comment would not only reduce healthcare costs but is also meant to improve patient access to data. Section 501 of the Lower Health Care Costs Act of 2019 includes a requirement to provide patients with health claims, network and cost information to help them make… Read More »
The Food and Drug Administration is proposing recommendations on how to better design studies to assess pregnancy outcomes in women exposed to FDA-regulated drugs and biological products. The new guidance includes sections on obtaining information from databases and electronic health records systems. According to the agency, its recommendations replace 2002 guidance issued to industry—which has… Read More »
The Department of Health and Human Services continued its push to improve interoperability and increase access to health information with new rule-making efforts. On Friday morning, HHS through the Office of the National Coordinator for Health IT issued a second draft of the Trusted Exchange Framework and Common Agreement (TEFCA), among other steps to promote… Read More »