The HIPAA Breach Notification Rule, 45 CFR §§ 164.400-414, originally published in August 2009, is an extremely important but often overlooked provision of the Health Insurance Portability and Accountability Act (“HIPAA”), and healthcare providers should take note of what it is for.
A breach (or compromise) to the security or privacy of protected health information (“PHI”) is defined by the U.S. Department of Health & Human Services (“HHS”) as acquisition, access, use or disclosure that “poses a significant risk of financial, reputational, or other harm to the individual.”
Among other things, the Breach Notification Rule requires healthcare providers (“Providers”) to demonstrate to HHS that the Provider has taken appropriate remedial measures following the discovery of breach or disclosure of unsecured PHI.
Providers who can demonstrate this may avoid or limit their liability related to the alleged breach. Remedial measures include notice to patients and others of the impermissible use or disclosure that compromised the security or privacy of the PHI.
For licensed health care professionals and providers already familiar with the HIPAA Breach Notification Rule, it is important to recognize that the rule recently underwent significant changes.
In January 2013, HHS published a final rule that included modifications to HIPAA’s Privacy and Security Rules. A main area affected by this update is the addition of obligations on providers and their business associates to identify and report breaches of PHI.
Under the previous “harm standard,” providers had discretion as to whether a breach was reportable, based on whether that breach would result in a significant risk of financial or reputational harm. The HHS decision to change the “harm standard” was due to its inconsistent application by providers.
The new standard, as announced in the final rule, presumes that any unauthorized use or disclosure of unsecured PHI is a reportable breach. Providers can refute that presumption only by determining there is a low probability that the PHI has been compromised.
There are many nuances to the HIPAA Breach Notification Rule, and providers must know whether they are required to notify:
In addition, providers must know when their business associates are required to notify them if a breach occurs at or by the business associate.
If you believe that a breach of PHI may have occurred, contact us at Chapman Law Group as soon as possible.
As seasoned professionals in compliance laws for health care who handle HIPAA compliance matters for clients and practices nationally, our healthcare compliance and HIPAA attorneys are always keeping with the newest developments and rules for HIPAA, so that we can advise and assist your healthcare practice on what to do next.
The health care compliance attorneys at Chapman Law Group have vast experience in state and federal health care regulations and best practices across the U.S. One of our lawyers is a former Medicare attorney, another is a former Medicaid fraud prosecutor, and each of us holds an LL.M. in Health Law from Loyola University Chicago School of Law — the top school in the U.S. for healthcare law.
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Instead of potentially facing charges under the False Claims Act, the provider was paid the governmental incentive for properly achieving meaningful use or the exclusions thereunder.
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