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01.27.2016 Legal News

2016 HIPAA Audits to Begin: Are you Confident in Your HIPAA Compliance?

Although the Health Insurance Portability and Accountability Act, or “HIPAA,” has been around since 1996, with its implementing regulations first published in the early 2000s, it is definitely not “old news.”  In light of recent heightened awareness of data privacy and security and the potential for damaging data breaches, particularly with respect to health records, HIPAA is once again at the forefront of regulators’ minds, and should be at the forefront of providers’ minds as well.

Beginning early this year, the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”) will begin performing random desk and on-site audits of not only covered entities (e.g., physicians, hospitals, laboratories, etc.) but also of business associates (e.g., persons or organizations that perform functions on behalf of covered entities, such as data hosting companies, law firms, etc.). These audits are expected to focus on areas of noncompliance that OCR has witnessed in its previous audits and enforcement actions, such as risk analyses and use of encryption technology.

HIPAA imposes a long list of privacy, security, and breach notification requirements.[i] For example, covered entities and business associates must ensure documentation of and compliance with privacy and security policies and procedures, performance of security risk analyses of electronic protected health information, appropriate use of Business Associate Agreements, and, for covered entities, appropriate dissemination of a Notice of Privacy Practices.  Any entity that has experienced a breach should ensure that it has appropriately evaluated, responded to, and documented the breach in accordance with HIPAA.  All entities should have systems and protocols in place to properly address a breach should one occur.

HIPAA violations can carry stiff penalties, with a range per violation of $100 to $50,000.[ii]  Further, the regulations set an annual maximum penalty of $1.5 million for multiple violations of the same provision, meaning penalties can be even higher if multiple violations of multiple provisions occur.[iii]  A HIPAA violator may also face criminal penalties or exclusion from federal health care programs.  In some states, including Virginia, a private right of action related to a breach of privacy or medical confidentiality may be afforded to individuals whose health information is mishandled.[iv]

With HIPAA audits right around the corner, health care practitioners, providers and their business associates need to place additional focus on carefully evaluating their past and current HIPAA compliance to identify and strengthen any areas of potential noncompliance.


[i] See generally 45 C.F.R. Parts 160 and 164, Subparts A, C, and E; 45 C.F.R. §§ 164.400 et seq.
[ii] 45 C.F.R. § 160.404.
[iii] Id.
[iv] See e.g., Fairfax Hosp. By and Through INOVA Health Sys. Hosps., Inc. v. Curtis, 254 Va. 437, 492 S.E.2d 642, (1997).