HITECH FINAL RULE BREACH NOTIFICATION. Leslie J. Pfeffer, BS, CHP Interim University HIPAA Privacy Officer Indiana University

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1 HITECH FINAL RULE BREACH NOTIFICATION Leslie J. Pfeffer, BS, CHP Interim University HIPAA Privacy Officer Indiana University

2 HIPAA HITECH Final Rule Modifies the Breach Notification Rule replacing the interim rule published in 2009) Clarifies Definition of Breach Removes Harm Threshold Adds Risk Assessment Notice IU s Policy Information and Information System Incident Reporting, Management and Breach Notification

3 Breach Notification Clarifies definition of a Breach: Any impermissible use or disclosure is presumed to be a breach, and the standard to determine the likelihood that the PHI has been or would be compromised has changed Removed the ambiguous harm threshold, allows instead for a more objective standard CE must provide notification unless an exception applies or demonstrates through a risk assessment there is a low probability the PHI has been or will be compromised Violation of Minimum Necessary could trigger a breach notification

4 Breach Notification Risk Assessment Nature and extent of the PHI involved Types of identifiers Likelihood of re identification Could info be used for identity theft? The unauthorized person who used the PHI or to whom the disclosure was made A Covered Entity or part of a CE PHI Was actually acquired or view or whether opportunity existed or acquisition did not occur The extent to which the risk has been mitigated Signed confidentiality agreement not to use information

5 Breach Notification Notification Requirements CE must notify affected individuals following discovery of breach of unsecured PHI Notification in written form First class mail if affected individuals have agreed to receive such notices electronically If CE has insufficient or out of date information > 10 individuals must provide an alternative notification via Major Print Media and/or Major Broadcast Media

6 Breach Notification Notification Requirements Individuals Notification (cont) Notification must be provided without unreasonable delay A description of the breach Steps affected individuals should take to protect themselves from potential harm Brief description of what CE is doing to investigate, mitigate harm and prevent further breaches Contact information for someone within CE to obtain additional information about the breach

7 Breach Notification Notification Requirements Media Notice Covered Entities that experience a breach affecting more than 500 individuals (residents of a State or jurisdiction) in addition to individual Notification must provide notification to prominent media outlets serving the area. Typically in the form of a Press release Must contain same information provided in individual notice Without unreasonable delay

8 Breach Notification Notification Requirements Notice to the Secretary In addition, must notify the Secretary of the Department of Health and Human Services of all breaches If 500 or more Must notify without unreasonable delay In no case more than 60 days If less than 500 Must report annually to the Secretary Due no later than 60 days after the end of the calendar year in which the breach occurred

9 Breach Notification Notification Requirements Notification by Business Associate Business Associates must notify the Covered Entity following the discovery of the breach Must notify without unreasonable delay In no case more than 60 days To the extent possible must provide Identification of each individual affected Information required to be provided by Covered Entity

10 Breach Notification Burden of Proof Covered Entities & Business Associates Have the burden of proof to demonstrate all required notifications have been provided or that a use or disclosure of unsecured protected health information did not constitute a breach Must notify without unreasonable delay In no case more than 60 days To the extent possible must provide Identification of each individual affected Information required to be provided by Covered Entity

11 IU Breach Notification Policy ISPP 26 Information and Information System Incident Reporting, Management and Breach Notification rmation it/ispp/ispp 26.shtml

12 IU Breach Notification Policy Scope This policy applies to all: information whether in printed, verbal, or electronic form created, collected, stored, manipulated, transmitted or otherwise used in the pursuit of Indiana University's mission, regardless of the ownership, location, or format of the information information systems used in the pursuit of Indiana University's mission irrespective of where those systems are located individuals encountering such information or information systems regardless of affiliation

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