Hoping to increase the transparency of its decision-making processes, the Canadian FDA is developing guidance to clarify what factors it takes into account when determining whether a regulated medical product is to be considered a device rather than a drug, and vice versa.

The Centers for Medicare & Medicaid Services (CMS) Innovation Center has announced agreements with 45 commercial, federal and state insurers in seven markets across the U.S. to participate in the Comprehensive Primary Care initiative, a multi-payor model.

The Office of the National Coordinator for Health IT (ONC) launched its new standards and interoperability framework, Health eDecisions, last week.

The U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) is steering the FDA toward clearer policies for settling spats when review staffersmanagers as well as scientistsdisagree over device-clearance decisions. For its part, the FDA has agreed to act on the advice.

Responses from the first large, multicenter survey of patient attitudes toward CT colonography (CTC) in clinical practice demonstrate the procedure is preferred over traditional optical colonoscopy. The results showcase CTCs potential for increasing colorectal cancer (CRC) screening adherence, according to a study published in the June issue of the American Journal of Roentgenology.

The California Department of Public Health is fining 13 hospitals a total of $825,000 over licensing irregularities that either caused or were likely to cause serious injury or death to patients.

A group of high-profile organizations representing hospitals, physicians, nurses, medical researchers and patient advocacy is imploring two Congressional committees to set deadlines that would help bring to fruition the unique medical device identifier (UDI) system that has been in the making for several years now.

Several announcements made by the U.S. Department of Health and Human Services (HHS) indicate the degree to which a better handle of data is impacting the healthcare landscape.