Members of the U.S. House of Representative submitted an October 1, 2009 letter of concern to Secretary Sebelius and the Department of Health and Human Services (HHS) concerning inclusion of a “harm standard” in the recently released(August 24, 2009) Interim Final Rule – Breach Notification for Unsecured Protected Health Information (45 CFR Part 160 and 164) 74 Fed. Reg. 42740.
HHS in developing the Interim Final Rule interpreted the term “compromises” as meaning that a threshold substantial harm standard should be included when determining whether a breach of data has occurred. However, the Members indicate in their letter that they considered whether a “harm standard” should be a part of the legislation and decided not to include such a standard. The letter urges HHS to revise and repeal the harm standard provisions included in the Interim Final Rule.
The letter was submitted by Rep. Henry Waxman, Rep. Charles Rangel, Rep. John Dingell, Rep. Frank Pallone, Jr., Rep. Pete Stark and Rep. Joe Barton.