The HIPAA Omnibus Regulation was publicly distributed by HHS last week with today, January 25, being the official publication date. The requirements are effective as of March 26, 2013 with a compliance deadline for almost all matters of September 23, 2013. For those persons who are currently involved in pre-existing Business Associate (BA) Contracts an additional extension of time has been granted until either the Business Associate Contract is in the process of renewal or September 22, 2014, whichever date occurs first.
The Omnibus Rule requires a significant amount of reevaluation and new structuring of policies and practices within your entity. Newly-covered Business Associates have even greater compliance efforts in store. It will require at a minimum, new Business Associate Agreements, new policies on reporting breaches, new policies on marketing and an entirely new and revised Notice of Privacy Practices. Business Associates may also find themselves assessing the addressable security standards for the first time.
As part of its attempt to assist covered entities, Business Associates and others in beginning the compliance process, HHS posted a proposed sample Business Associate Agreement on its website today.
However the Business Associate provisions tend to be the most clear cut of the requirements of HHS/OCR in relationship to HIPAA and other areas of the law and regulations remain more opaque. As noted, there are new requirements in regard to reporting of breaches, specifically the requirements relating to what constitutes a breach. The prior assessment of what created a breach was whether or not a significant risk of financial, reputational or other harm existed to the patient. That standard no longer exists. The new standard for assessing whether or not a reportable breach has occurred shifts the burden of proof to the covered entities or BA to show that there is a “low probability of risk” that the information has been “compromised.” But what exactly is compromised information?
The definition of compromised information is not clear from the regulations. The regulations provide guidance on risk analysis information which include an assessment of 1) the type of information, including identifiers, which is contained within the data as well as how much data may have been subject to breach; 2) The nature and type of unauthorized person or entity received the information with a lower risk being assessed to another physician who may have accidentally receiving information verses a stranger; 3) a factual assessment as to whether or not the information was actually acquired or reviewed. One example would be a provider’s ability to prove that the envelope had been misdelivered but never opened; and 4) whether or not the risk of “compromise” has been mitigated and in what manner.
This still doesn’t define what constitutes compromise and little other guidance has been given on this matter. Sue McAndrew, Deputy Director of HHS, in speaking today as part of an American Bar Association educational program did not fully articulate a definition of “compromised information” but indicated that the office of HHS/OCR did anticipate the need for guidance on the area of breach assessments and would be posting on the website additional information and materials.
Another area which has drawn significant questions from providers and Business Associates is the exact definition of “conduit” in regard to persons who maintain or transfer data but do not create or manipulate PHI. HHS/OCR presumably will also be posting guidance regarding these matters.