Whenever there is an unauthorized acquisition, access, use, or disclosure of Protected Health Information in violation of the HIPAA Privacy Rule, there may be a breach to report to the individual affected and to HHS. The requirements to review such incidents and report them as necessary are significant. Failure to make a timely notification can result in penalties. Given that research shows that more than 95% of all healthcare entities experience some kind of a breach at least every two years, being prepared is essential to minimizing the compliance risks to your organization.
Breaches of Protected Health Information are becoming more and more common, and can be a result of a variety of circumstances, from words spoken too loudly in a public setting, to a lost thumb drive full of medical records, to files being held for ransom by hackers.
Any violation of the HIPAA Privacy Rule may be a reportable breach under the HIPAA Breach Notification rules, requiring notification of individuals and HHS when information security is breached. Any incident involving a HIPAA issue must be evaluated to see if it is reportable, and any decisions or actions must be fully documented.
There is a number of steps that must be taken to determine if an incident is a breach, and whether or not that breach is reportable. Determining whether to report or not is not necessarily straightforward, but there are guidelines to follow to help at every step of the way. Even Ransomware attacks by hackers may be reportable, if you lose control of your data and don’t know exactly what happened.
If the evaluation of necessity to report is not done correctly, you may not make the right decisions about reporting and be subject to penalties for non-compliance upon an investigation of a breach by HHS. Breach investigations, even for small breaches, are a new priority at HHS, and the HHS regional offices are taking on the job of looking into small breaches (affecting under 500 individuals), especially when there have been multiple breaches or repeated similar breaches.
Penalties for non-compliance can be up to $50,000 per day in cases of willful negligence, so it is essential to evaluate incidents to see if they are reportable breaches, and act properly on the evaluation.
We will examine how to determine if a privacy violation is potentially a breach according to the definition, and then describe the subsequent steps in the evaluation, if it is determined that the definition has been met. We will discuss the exceptions to the breach definition for inadvertent internal uses, or when it can be determined that the information could not be retained in any way by the receiving party.
Entities can avoid notification if information has been encrypted according to Federal standards. We will cover the guidance from the US Department of Health and Human Services that shows how to encrypt so as to prevent the need for notification in the event of lost data. Failing that, a risk analysis can be conducted to determine the probability of compromise of the information, considering four factors: what the data is and how well identified it is, to whom was it released and do they have obligations to protect the information, whether or not the information actually exposed, and whether or not the incident has been mitigated properly.
We will discuss how to create the right breach notification policy for your organization and how to follow through when an incident occurs. In addition, a policy framework to help establish good security practices is presented.
We will explain, based on historical analysis of reported breaches, what measures must be taken today to protect information from the most common threats, as well as discuss information security trends and explain what kinds of efforts will need to be undertaken in the future to protect the security of PHI.
Areas Covered in the Session:
- The definition of a Breach under HIPAA
- Evaluating the Privacy violation
- Reviewing the exceptions to the definition of a breach
- What is good enough encryption according to the rules
- Performing the Risk Analysis to determine the necessity to report
- Ransomware and Breaches - When to Report
- Avoiding Breaches
- The most common causes of breaches
- Reporting breaches to HHS and the individuals
- Reporting breaches to the press and other agencies
- Documenting your analysis and decisions
Jim Sheldon Dean,
Director of Compliance Services ,
Lewis Creek Systems, LLC
Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of health care entities.
Sheldon-Dean serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the WEDI 2011 Award of Merit. He is a frequent speaker regarding HIPAA and information privacy and security compliance issues at seminars and conferences, including speaking engagements at numerous regional and national healthcare association conferences and conventions and the annual NIST/OCR HIPAA Security Conference in Washington, D.C.
Sheldon-Dean has more than 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development. His experience includes leading the development of health care related Web sites; award-winning, best-selling commercial utility software; and mission-critical, fault-tolerant communications satellite control systems. In addition, he has eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master's degree from the Massachusetts Institute of Technology.
Attendees should include Compliance Officers, Privacy and Security Officers, and leadership and staff in health information management, information security, and patient relations, as well as staff in patient intake and front-line patient relations and any others that are involved in, interested in, or responsible for, patient communications, information management, and privacy and security of Protected Health Information under HIPAA, including:
- Compliance director
- Privacy Officer
- Security Officer
- Information Systems Manager
- HIPAA Officer
- Chief Information Officer
- Health Information Manager
- Healthcare Counsel/lawyer
- Office Manager
- Contracts Manager