Archive for HHS
Editor’s note: This is the third in a three-part series about breach notifications. Part one focused on how to prevent breaches. Part two tackled how to handle breaches. This installment offers some final tips if a breach occurs. focused on how to prevent breaches.
Now that you’ve followed protocol—the government’s and your facility’s—consider these final checklist items for after you respond accordingly to a breach.
They are offered by Andrew E. Blustein, Esq., partner and cochair of Garfunkel, Wild & Travis’ Health Information and Technology Group in Great Neck, NY; Hackensack, NJ; and Stamford, CT:
- Incorporate lessons learned into existing procedures (were internal reporting and investigation fast and efficient?)
- Include the breach on the annual log reported to HHS
- Modify policies as necessary
- Reeducate staff members regarding lessons learned
- Look for repeating patterns (e.g., one patient area that has multiple incidents)
- Include the unauthorized disclosure on the accounting of disclosures
- Include any sanctions on the HIPAA sanctions log
- Ensure that investigation notes and reports were appropriately detailed and that they are maintained
HHS has said it will not enforce breach notification provisions until February 2010—or 180 days from the publication of the interim final rule—but HITECH states that covered entities (CE) are subject now to penalties for noncompliance.
CEs should have breach response systems in place already, says Chris Simons, RHIA, director of UM and HIM and the privacy officer at Spring Harbor Hospital in Westbrook, ME.
However, if CEs still need to work on their policies, they should focus their energies on making sure staff members understand the process for and importance of prompt reporting.
“If your staff doesn’t know who their privacy officer is, that’s a problem,” Simons says. “That’s a good starting place. Make sure staff knows what a breach is and who to report it to. They should be encouraged to immediately report even the suspicion of an issue.”
Document everything your organization does in response to a suspected breach, Simons adds. Conduct a risk analysis to expose your internal weaknesses. It could help you prevent a breach in the first place, which, after all, is the goal.
“What are your serious risks, and what are your minor risks?” Simons says. “How are you educating people, and are your policies and procedures in place? Get out there and do your rounds to see what’s going on and see if you hear things.”
This series contained excerpts from the HCPro, Inc., white paper, “HHS Breach Notification Interim Final Rule. Form Your Incident Response Team, Set Policies and Procedures to Comply with New Federal HIPAA Regulations.”
Dom Nicastro is a senior managing editor at HCPro, Inc. in Marblehead, MA. He edits the Briefings on HIPAA and Health Information Compliance Insider newsletters. E-mail him at dnicastro@hcpro.com.
Editor’s note: This is the second in a three-part series about breach notifications. This installment focuses on handling breaches.
Your facility has a breach of unsecure PHI. What do you do?
In addition to following requirements spelled out in HHS’ interim final rule on breach notification, consider these tips for handling the breach:
- Initiate an investigation immediately. The team leader, or point person, must be ready for action, says Andrew E. Blustein, Esq., partner and cochair of Garfunkel, Wild & Travis’ Health Information and Technology Group in Great Neck, NY; Hackensack, NJ; and Stamford, CT. Immediately consider whether the organization needs to make a report to authorities. Ask the following questions: What information was potentially disclosed?; What technical safeguards were in place? How many people were affected? Could the information be used adversely against such individuals?
- Determine whether an exception to the notification requirement applies. Was the breach such that the person receiving the information would not be able to retain and use it? Was it an unintentional disclosure in good faith or an inadvertent disclosure to another individual at the same facility?
- Determine the need to notify the individual. Check the regulations contained in the HHS interim final rule and state breach notification laws. Consider whether notification could mitigate any harmful effects on the individual. If a patient’s credit card or Social Security information was stolen, it may be appropriate to offer him or her credit monitoring services, Blustein says.
- Determine appropriate sanctions. Following through on appropriate internal sanctions can send a chilling message throughout your organization, Blustein says. “Also, if [the Office for Civil Rights] comes in, and something egregious occurred and you’ve done nothing about it, what are you doing about mitigating the problem in the future?” he says. Depending on the employee involved and the type of violation, consider offering additional HIPAA training, issuing a warning, putting the employee on probation or suspension, or, in extreme situations, terminating the employee.
Tomorrow, we will conclude the series with tips for how to proceed after a breach. All material comes from excerpts from the HCPro, Inc., white paper, “HHS Breach Notification Interim Final Rule. Form Your Incident Response Team, Set Policies and Procedures to Comply with New Federal HIPAA Regulations.”
Check out our new white HIPAA whitepaper, “HHS breach notification interim final rule: Form your incident response team, set policies and procedures to comply with new federal HIPAA Regulations. November, 2009.”
HHS published in the Federal Register today the HIPAA enforcement interim final rule as part of the provisions in the HITECH Act, according to an OCR press release.
No major changes to HITECH enforcement. Just some slight language changes.
The interim final rule becomes effective November 30. HHS has invited public comments on the interim final rule, which will be considered if received by December 29.
Throw in some more rhetoric in support of HHS eliminating its “harm threshold” from its interim final rule on breach notification. This time, it’s the consumer advocacy group Consumer Watchdog, which says in a letter to HHS:
Inexplicably, and flouting Congressional intent, the Department of Health and Human Services has introduced a “harm” standard before breach notification is required. You have decided to interpret “compromises the security” of data to include a substantial harm standard. Under the HHS interpretation, if the breaching entity decides there is no significant risk of financial, reputation or other harm to the individual, the provider or health insurer never has to disclose that the sensitive information was used or disclosed in violation of the federal privacy rule.
In other words, the company responsible for protecting the sensitive data gets to decide if it needs to bother to tell anyone that sensitive health data was breached. This is simply outrageous.
It is even more troublesome when one recalls that the House Committee on Energy and Commerce considered a similar “harm” standard during discussions of health and information technology legislation in May 2008. Committee members considered public comments and practices of various states; they explicitly rejected a “harm” standard.
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