HHS Withdraws Breach Notification Rule

Health data privacy groups are applauding the fact that the Department of Health and Human Services has withdrawn the Final Rule for Breach Notification for Unsecured Protected Health Information for further study.

HHS received lots of public comment about the “harm standard” in its proposed rule, yet the final rule did not reflect those concerns. The harm standard stated that a breach does not occur unless the access, use or disclosure poses “a significant risk of financial, reputational, or other harm to an individual.”

In the event of a breach, the rule required HIPAA-covered entities to perform a risk assessment to determine if the harm standard is met. If they decided that the risk of harm to the individual is not significant, the health providers were not required to tell patients that their health information was breached.

Privacy groups likened that setup to the fox guarding the henhouse.

In announcing it would withdraw the final breach rule to allow for further consideration, HHS said, “This is a complex issue and the Administration is committed to ensuring that individuals’ health information is secured to the extent possible to avoid unauthorized uses and disclosures, and that individuals are appropriately notified when incidents do occur.”

A group called the Coalition for Patient Privacy put out a release congratulating HHS for seeing the flaws in the rule.

“This is a huge step in the right direction,” it said. “Congress, the Coalition for Patient Privacy, and patients everywhere spoke out against the blatant disregard for patients' rights to be notified of all breaches.”

In a reminder of what is at stake, the Philadelphia Inquirer reported July 30 that Thomas Jefferson University Hospital in Philadelphia told 21,000 of its patients that a laptop computer with unencrypted health and personal information was stolen in June. More than 120 breaches have been reported to HHS since last September. Scot Silverstein, M.D., a medical informatics professor at Drexel University, told the Inquirer that “there is almost no excuse for unencrypted data to be sitting on any computer at a hospital or any organization.”