HIPAA Omnibus Rule Compliance Deadline

September 23, 2013

September 23, 2013, the deadline for compliance with the new Health Insurance Portability and Accountability Act (HIPAA) regulations, is here. Although there has been much discussion about the new regulations since they were originally presented in the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, some requirements may have received less attention than others.

Common considerations under review by many covered entities (including self-insured health plans), business associates, and subcontractors, include:

  • Are you a "business associate" or a "subcontractor" of a business associate? The rules have changed, and many companies now have new privacy and security obligations. If you maintain protected health information on behalf of another, even if you do not use or disclose that protected health information, you may be a business associate.1
  • Do you have a procedure for handling incidents involving the security of protected health information? The rules now require covered entities and business associates to respond to the discovery of a breach of unsecured protected health information by assessing specific factors regarding risk and, where necessary, notifying affected individuals and government agencies.
  • Do you have all of the required contracts in place? Covered entities need to have business associate contracts with the entities that provide services touching on protected health information, even those that merely maintain that information on the covered entity's behalf. The rules also require business associates to have similar contracts with any entities that provide such services on their behalf.
  • Are your contracts up to date? The new rules around breaches of unsecured protected health information require assessment and remediation that could be costly. Do your contracts allocate the cost of compliance with these new assessment and remediation rules in a manner that matches your business goals (e.g. put the cost of compliance on the party responsible for the breach)?
  • Have you conducted and documented an assessment of your security practices? Covered entities and business associates must also conduct and document a risk assessment of their security practices, including each of the addressable and required specifications of the Security Rule.

Potential gaps in preparation for the effective date of the rules are significant given that all covered entities and business associates are directly responsible for complying with HIPAA requirements, and may be held liable if they do not. That liability is a considerable risk, including potential penalties in the millions of dollars and state attorneys general actions for damages. Many service providers continue to struggle with the rules and whether or not they apply to unique circumstances of their business. Entities that proactively attempt to address the new requirements will be better positioned to protect themselves in the face of uncertainty under the regulations.

Wilson Sonsini Goodrich & Rosati attorneys regularly assist clients with all aspects of their privacy and information governance needs, including HIPAA compliance evaluations, security incident response, and incident avoidance. For additional information about HIPAA compliance and related questions, please contact Gerry Stegmaier at or (202) 973-8809 or Wendy Devine at or (858) 350-2321.

1 See, e.g.