Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."

While the U.S. House and Senate push forward with controversial legislative packages aimed at making prescription drugs more affordable for Americans, other bills that would impact the biopharma sector are making their own way through Congress, being absorbed into the larger pricing packages or getting tacked on to unrelated legislation.

SUZHOU, China – Under the "Healthy China" campaign, China has introduced a three-year action plan for preventing and treating cancer. The plan vows to speed up the marketing of cancer drugs in the country, even aiming for simultaneous marketing with other countries.

The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward.

BOSTON – The 2019 Medtech Conference included the annual FDA town hall session, and Jeff Shuren, director of the agency's device center, said the pace of scientific change is outstripping the agency's ability to keep up. Shuren said the solution might be "regulatory Legos," an approach that might eliminate the need to go to Congress for new statutory authorities every time device makers carve open a new technological frontier.