HHS publishes sked of upcoming policy season

By Mary Mosquera
Monday, December 07, 2009

The government health IT community is on schedule to release a raft of health IT policies over the next few months that aim to substantially remake the healthcare delivery system, according to a summary of impending business published by the Department of Health and Human Services today.

HHS outlined a timetable for the regulations, ranging from milestones for standards and certification to rules governing electronic inserts for drug products, in the Federal Register. The schedule also explains the actions that the department plans to take under the regulations.

According to the agenda, the Centers for Medicare and Medicaid Services may start making Medicare incentive payments to hospitals under the federal health IT stimulus plan on Oct. 1, 2010, the first day of the 2011 federal fiscal year; physicians who qualify will have to wait until Jan. 1, 2011.

In addition to some of the more well-known health IT rules promised under the HITECH Act, including a proposed rule defining meaningful use of health IT expected this month, the agenda noted some other more obscure red letter dates on the policy calendar including:

-- The Office of Civil Rights (OCR) this month will also propose how healthcare providers and plans and their business associates must account for the use and disclosure of personal health information in a revision of the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.

-- Also this month, the Health Resources and Services Administration will take final action on a plan for states to create reporting systems for disciplinary actions relating to licensing of physicians and hospitals;

-- In February, 2010, the OCR will release a final rule for how business associates notify consumers in the event of breach of health information;

-- By March 2010, a Food and Drug Administration (FDA) rule for electronic package inserts for human drug and biological prescription products instead of paper so that safety data can be updated;

-- In June 2010, an FDA rule is expected on submitting data and reports electronically about human drugs and biologics through the use of standards to improve patient safety and efficiency;

-- September 2010, an FDA rule that medical device makers submit their registration and listing data electronically.



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