The so-called "harm threshold" provision was included in an interim final rule published late last month by the U.S. Department of Health and Human Services (HHS) in a bill requiring breach notification for unsecured health information. Under the provision, health-care entities would have to publicly disclose data compromises only if they think the breach will cause financial harm to those whose data was compromised or hurt their reputation.
In a letter dated Oct. 1, members of the House committee asked HHS Secretary Kathleen Sebelius to revise or repeal the new provision at the "soonest appropriate opportunity."
The letter, signed by the chairman of the committee, Rep. Henry Waxman (D-Calif.) and others, noted that the new harm threshold provision runs counter to Congress' intent in passing the breach notification bill. The bill's statutory language does not imply a harm standard, Waxman wrote. In fact, in drafting the bill, Congress had explicitly rejected the idea of including such a provision because of the "breadth of discretion" it would have given a breached entity, the letter said.
The health-care breach notification law is part of the $20 billion Health Information Technology for Economic and Clinical Health Act (HITECH) that was passed by Congress earlier this year as part of President Obama's economic stimulus plan. The law, which went into effect last week, requires any organization covered under the Health Insurance Portability and Accountability Act (HIPAA) to notify patients of a data breach involving their personal health information. Companies that use encryption and data destruction methodologies to render sensitive health information unusable and unreadable to unauthorized individuals are exempt.
Privacy and civil rights groups claimed that the HHS had essentially neutered the breach notification bill with its harm threshold requirement. They also accused the department of caving in to industry pressure. Groups such as Patient Privacy Rights, a watchdog group in Texas, and the Washington-based Center for Democracy and Technology said the provision completely undermined the intent of the bill and removed any incentive for breached entities to disclose a data compromise.