As of today, there has been 1170 data breaches reported to Department of Health and Human Services, which have impacted over 40 million individuals. The numbers continue to increase at a rapid pace with a clear concern for data breaches in 2015. The final breach notification rule requires that healthcare organizations conduct a data breach investigation on each and every unauthorized use and disclosure of protected health information to determine if there is a “low probability that the information is compromised.” Four objective questions must be asked and answered EVERYTIME an investigation is completed:
- The nature and extent of the PHI involved in the data breach, including the types of identifiers and likelihood of the re-identification
- The unauthorized person (people) who used the PHI or whom it was disclosed to
- Whether the PHI was viewed, acquired, or re-disclosed
- The extent to which the risk to the PHI has been mitigated
With the answers to these questions complete, healthcare organizations can feel confident they have the documentation and burden of proof in place to submit a data breach to the Secretary of the Department of Health and Human Services (DHHS) – WRONG!!! Many more data elements must be collected during the investigation in the event that a data breach needs to be reported to DHHS. The notification submission method for a data breach from the Secretary of DHHS has recently been updated – which has more clear data elements and requirements for reporting. Understanding the data elements that must be reported is the foundation of creating a proper method for investigating and documenting a data breach. With the updated reporting form, covered entities and business associates must be ready to report all these data elements:
- Breach Start Date
- Breach End Date
- Discovery Start Date
- Discovery End Date
- Approximate Number of People Impacted
- Type of Breach (Hacking/IT Incident, Improper Disposal, Loss, Theft, Unauthorized Access/Disclosure)
- Location of Breach (Desktop Computer, Electronic Medical Record, Email, Laptop, Network Server, Other Portable Electronic Device, Paper/Films, Other-Must enter a location)
- Type of Protected Health Information Involved (Clinical, Demographic, Financial, Other-Must enter a details)
- Brief Description of the Breach
- Safeguards in Place Prior to Breach (None, Privacy Rule Safeguards, Security Rule Administrative Safeguards, Security Rule Technical Safeguards, Security Rule Physical Safeguards)
- Individual Notice Provided Start Date
- Individual Notice Provided End Date
- If Substitute Notice was required
- If Media was notified
- Actions taken in response to breach
If you are not collecting all these data points each time you are completing an investigation, you run the risk of not having all the accurate data and potentially have to repeat the investigation. Create a process that assures collection of all required data elements needed for a breach reporting up front so you don’t have to repeat work and run the risk of extending past the 60 day investigation and notification timeline! Don’t get in the habit of doing duplicate work – collect all the data elements up front. If you need a tool – contact TriPoint!
And don’t forget to check out the new and improved Data Breaches Impacting Greater than 500 Individuals website – https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf
Data Breach Fun Facts – Since September 1, 2009!
- The Make Up of the Data Breach Organizations
- 733 from Healthcare Providers
- 328 from Business Associates
- 104 from Health Plans
- 5 from Healthcare Clearing Houses
- Theft and Loss account for 63.5% of Data Breaches
- Paper is the top media source for data breaches making up 22.3%
- Laptops are the second top medium source making up 21.7%
- Largest data breach was in 2011 – 4.9 Million Individuals Impacted
Prepare, Document, and Take Action!
Danika