I.T. Thin in HHS Regulatory Plans

December 10, 2007

The Department of Health and Human Services has published its semi-annual regulatory agenda, identifying actions it intends to take. The menu of actions covering health information technology is decidedly light compared with previous regulatory agendas.

Deadlines for anticipated actions are not always accurate. The regulatory agenda, however, gives a look at what issues are getting attention in the department.

Missing in this agenda is the expectation of a proposed rule--announced in last April’s regulatory agenda--to tighten the HIPAA security rule in the wake of several incidents of compromised patient data involving laptops and other mobile computing devices.

Further, despite two recommendations in the past two years from the National Committee on Vital and Health Statistics that HHS quickly expand the scope of entities covered under the HIPAA privacy rule, the new regulatory agenda does not include such measures.

The last regulatory agenda published in April had at least a dozen actions relevant to information technology; only a small handful are in this latest agenda. They include:

* A proposed rule expected in September 2008 from the Food and Drug Administration to require submission of clinical trial data in a standardized electronic format. “Electronic submission of study data would improve patient safety and enhance health care delivery by enabling FDA to process, review and archive data more efficiently,” according to the agenda, published Dec. 10 in the Federal Register.

* A proposed rule expected in January 2008 making periodic revisions to the HIPAA transactions and code set standards.

* A final FDA rule expected in July 2008 to change safety reporting requirements for human drug and biological products. The rule would revise certain definitions and reporting formats as recommended by the International Conference on Harmonization. If published in July, the final rule would come more than five years after the proposed rule was published.

Other potential actions that are not necessarily related to information technology include:

* A final FDA rule expected in January 2008 to require labeling of human drugs to include a toll-free telephone number for reporting adverse events. The proposed rule was published in 2004.

* Updates to prospective payment systems and other fee schedules for numerous types of care settings.

* Updates on FDA reviews of the safety and effectiveness of multiple over-the-counter products.

Full text of the HHS semi-annual regulatory agenda is available at gpoaccess.gov/fr/index.html.

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