U.S. National “Density” Reporting Standard
As you may recall, 2019 saw progress on both the federal legislative and regulatory fronts for a national breast density reporting standard for patients and referring providers (learn more HERE). The federal law directs the FDA, through the regulatory process, to develop reporting language and ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density – though no timeline was included.
So, where are we now? Next steps would be the publication of the FDA/MQSA Final Rule and implementation period. While that was originally anticipated in Sept/Oct of 2020, updated timing has not yet been announced. In the meantime, individual state “inform” laws remain in effect and guide reporting requirements.