Earlier this month, the Office for Civil Rights (OCR) issued guidance on an individual’s right to access the individual’s health information. That an individual has a broad right to access has been recognized in the HIPAA privacy regulations since they became effective in 2003. OCR has found, however, that individuals are facing obstacles to accessing their health information, and believes this needs to change. To help covered providers, plans and business associates better understand the right to access, the agency issued a comprehensive set of frequently asked questions (FAQ). These FAQs address a number of access issues, but they also provide practical insight on some key points, one of which is summarized below.
In general, the FAQs address the scope of information covered by HIPAA’s access right, the very limited exceptions to this right, the form and format in which information is provided to individuals, the requirement to provide timely access to individuals, and the intersection of HIPAA’s right of access with the requirements for patient access under the HITECH Act’s Electronic Health Record (EHR) Incentive Program. In some cases, the guidance in the FAQs goes beyond just accessing health information. Consider the following FAQ:
What is a covered entity’s obligation under the Breach Notification Rule if it transmits an individual’s PHI to a third party designated by the individual in an access request, and the entity discovers the information was breached in transit?
If a covered entity discovers that the PHI was breached in transit to the designated third party, and the PHI was “unsecured PHI” as defined at 45 CFR 164.402, the covered entity generally is obligated to notify the individual and HHS of the breach and otherwise comply with the HIPAA Breach Notification Rule at 45 CFR 164, Subpart D. However, if the individual requested that the covered entity transmit the PHI in an unsecure manner (e.g., unencrypted), and, after being warned of the security risks to the PHI associated with the unsecure transmission, maintained her preference to have the PHI sent in that manner, the covered entity is not responsible for a disclosure of PHI while in transmission to the designated third party, including any breach notification obligations that would otherwise be required. Further, a covered entity is not liable for what happens to the PHI once the designated third party receives the information as directed by the individual in the access request.
A couple of interesting points are made and clarified with this FAQ. One is that if an individual is warned about the risks of unsecured transmissions of PHI, but decides to proceed with the communication despite the warning, the covered entity is not responsible if there is a breach of the information while it is in transit. That is, no breach of unsecured PHI (but the covered entity still would have to consider state law). Second, after the covered entity fulfills the request of the individual and provides the PHI to a third party, the covered entity is no longer responsible.
So, as covered entities and business associates read though the new access guidance, they should be on the lookout for points like this which can reduce costs and better manage risk.
The named plaintiff, Alu Banarji, filed suit after receiving numerous telephone calls on her cell phone. According to the Court, Ms. Banarji’s father, Sami, took out a loan with WCC and on the loan application he listed his daughter’s cell phone number as his own. Ms. Banarji is the primary caregiver for her father. When Mr. Banarji failed to make payment, WCC began calling the cell phone number he had listed on his loan application to inquire about the debt. Ms. Banarji claims she had no involvement with her father’s loan and she repeatedly asked WCC to stop calling her cell phone.
The Report details that nearly 50 million records of Californians have been breached and the majority of these breaches resulted from security failures. In fact, the Report explains that nearly all of the exploited vulnerabilities, which enabled the breaches, were compromised more than a year after the solution to address the vulnerability was publicly available. According to Ms. Harris, “It is clear that many organizations need to sharpen their security skills, trainings, practices, and procedures to properly protect consumers.”
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For those unfamiliar with the term, “interoperability” generally refers to the interconnectivity of various products or systems. For purposes of the FDA’s guidance, interoperability means the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged. The exchange of information includes transmission, reception or both, that may be accomplished by means of wires or wireless methods which on a local network, or through the internet. The use of exchanged information can include various purposes such as displaying, storing, interpreting, analyzing and automatically acting or controlling another product.
What do we know so far? The European Commission announced the EU-U.S. Privacy Shield agreement on February 2, 2016. In announcing the agreement, the European Commission said: