If there is one aspect of the HITECH Act amendments to the HIPAA privacy rule that has had a major impact on the health care provider community and its business associates, it is the so called “Breach Notification Rule.” The rule requires that covered entities (and their business associates) report breaches of unsecured protected health information to both the subject individuals and to the Secretary of Health and Human Services, unless the breach falls within a narrow statutory exception or, at least at present, the breach fails to reach a controversial “harm threshold.” (For a more detailed discussion of the Breach Notification Rule, and its detailed reporting requirements, see Jim and Josh’s article, “HITECH Act Breach Notification Rule Now in Effect, But No Sanctions Apply Until 2010.”) While this rule caused quite a stir in the HIPAA community, it is also important to remember that it represents only half of the puzzle – in many states, local data breach notification laws impose even stricter requirements and shorter time lines.
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