I.T. Light in HHS Rules Agenda

May 5, 2008

The Department of Health and Human Services has published its semi-annual regulatory agenda, identifying actions it intends to take. The menu is light in the final year of the Bush administration, with about 62 items across the department.

A year ago, the department had at least a dozen actions relevant to information technology. In late 2007 the department only had three I.T. actions, and those three remain on the agenda with slightly extended expected deadlines. Such deadlines for anticipated actions are not always accurate, but the regulatory agenda gives a look at issues getting attention in HHS.

The I.T. actions in the semi-annual regulatory agenda published May 5 in the Federal Register include:

* A proposed rule, pushed back one month to October, to require electronic submission to the Food and Drug Administration of clinical trial data in a standardized format. This would include new drug applications, biological license applications and abbreviated new drug applications.

* A proposed rule making periodic revisions to the HIPAA transactions and code set standards. Expected in January, the date now is pushed to June.

* A final FDA rule to change safety reporting requirements for human drug and biological products was anticipated in July 2008. Now, it is 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, and updates on FDA reviews of the safety and effectiveness of over-the-counter drugs. It is available at gpoaccess.gov/fr/index.html.

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