The Department of Health and Human Services (HHS) has published its semi-annual regulatory agenda, identifying 62 actions it intends to take across the department, in the final year of President George W. Bush’s administration.
A year ago, HHS had about a dozen actions relevant to health IT. In late 2007, the department only had three IT actions, and those remain on the agenda with slightly extended expected deadlines. The deadlines for anticipated actions are not always steadfast, but the agenda examines issues getting attention from HHS.
The health IT actions in the agenda published May 5 in the Federal Register, include:
- A proposed rule, extended one month to October, to require electronic submission to the FDA of clinical trial data in a standardized format, which would include new drug applications, biological license applications and abbreviated new drug applications;
- A proposed rule making revisions to the HIPAA transactions and code sets standards, which was initially expected in January, and has now been pushed to June; and
- An FDA rule to change safety reporting requirements for human drug and biological products was anticipated in July 2008, but is now pushed to April 2009, more than 5.5 years after the proposed rule was published. The final rule would revise certain definitions and reporting formats as recommended by the International Conference on Harmonization.
The HHS semi-annual regulatory agenda also includes anticipated updates to payment systems and other fee schedules for numerous types of care settings.