How Have Large HIPAA Breaches Happened?
Since 2009, some 21 million health records have been compromised in major HIPAA security breaches reported to the US government. Loss or theft of electronic equipment or storage media has been the source of more than 66% of all large HIPAA breaches during this period. The individuals affected by these breaches amount to nearly 73% of all individuals affected by large HIPAA breaches reported to HHS during the same time period. In most cases the theft or loss involved a laptop or electronic media, such as a flash drive, containing unencrypted PHI. In contrast, large breaches attributed to hacking amounted to 8% of the total incidents and affected 6% of the individuals whose PHI was disclosed.
These data suggest that the implementation of IT systems that enable secure sharing of information without the need to transport it on a computer or storage media will go a long way toward eliminating the majority of large HIPAA breaches.
Use the Cloud to Reduce HIPAA Risk
The first, and perhaps the most important, step one can take in reducing the risk of HIPAA breaches is to make sure that users of PHI are not transporting unencrypted data on portable equipment (like laptops) or media (like flash drives). New genomic data management systems enable this goal by keeping data in the cloud, and providing access to users via a web browser. In this architecture, only the PHI that the user is viewing in his or her web browser is resident on the user’s computer; all other data remains on secure servers.
The use of the cloud can also facilitate enforcement of encryption requirements. For example, many of the new commercial systems encrypt all data while in transit and while at rest. This means that even if data somehow become accessible to an unauthorized person, they would be secured and could not be read unless the hacker also obtains the encryption key. While this is also possible using an on-premises data center, it is much harder to enforce where users download and store data.
Further, the significant costs of security audits, certifications, and assessments to demonstrate best efforts to comply with HIPAA security requirements are more easily borne by cloud providers than by private data centers. Such certifications could provide meaningful defense against civil or criminal prosecution, even if there is an unavoidable breach.
The use of an appropriately designed and developed cloud-based system for managing genomic PHI can also facilitate compliance with the physical and technical safeguards required by the HIPAA Security Rule. Most cloud service providers implement physical security measures that exceed those that are practical for all but the largest of single-institution data centers. In addition, systems designed to manage genomic data automatically implement technical and other safeguards to ensure data confidentiality and integrity, including encryption, multi-factor authentication, automatic session timeouts, and logging for auditability.
While it may not be intuitively obvious, in most cases a user of genomic PHI can dramatically reduce its compliance risk by using a cloud-based solution consistent with the standards described in this article.
 Rodriguez, L. et. al, “The Complexities of Genomic Identifiability”, Science, vol. 339, no. 6117, p.275 (January 18, 2013).