Omen Safavi

Meet the HIPPO HIPAA Expert

Omen Safavi, J.D.

Omen Safavi  is licensed attorney, who is admitted to the Tennessee Bar. Omen manages the operations of a Maternal Fetal Medicine practice in Austin, Texas.

He is a graduate of the Saint Louis University School of Law, which has been the number one Health Law program in the United States, as ranked by U.S. News and World Report, from 1990-2014. Omen serves as the Director of Compliance for HIPPO Data Storage.

The Blindfolded Business Associate: New HHS Guidance on HIPAA & Cloud Computing


According to the latest HIPAA-related guidance (Guidance) published by the U.S. Department of Health and Human Services (HHS), a cloud service provider (CSP) maintaining a client’s protected health information (PHI) is a business associate even when the CSP can’t access or view the PHI. In other words, even where the PHI is encrypted and the CSP lacks the decryption key, the CSP is a business associate because it maintains the PHI and, therefore, has HIPAA-related obligations with respect to the PHI.

HHS explains:

While encryption protects ePHI by significantly reducing the risk of the information being viewed by unauthorized persons, such protections alone cannot adequately safeguard the confidentiality, integrity and availability of the ePHI, such as ensuring that the information is not corrupted by malware, or ensuring through contingency planning that the data remains available to authorized persons even during emergency or disaster situations. Further, encryption does not address other safeguards that are also important to maintaining confidentiality, such as administrative safeguards to analyze the risks to the ePHI or physical safeguards for systems and services that may house the ePHI.”

It makes sense to treat a CSP as a business associate if it holds PHI, even if it cannot view or access that PHI. After all, a business associate is a person or entity that performs a function or service on behalf of a covered entity (or another business associate) that requires it to create, receive, maintain, or transmit PHI.

Still, HHS’s explanation is less than satisfying, perhaps because it rather crudely mixes together very distinct HIPAA obligations:  protecting the confidentiality of PHI, on one hand, and protecting the integrity and availability of PHI, on the other.

Under the HIPAA regulations, a business associate is only required to provide notice to the covered entity following the discovery of a breach of unsecured PHI. “Unsecured” PHI is defined as PHI that is “not rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the Secretary [of HHS]…” – in other words, PHI that is not encrypted at a level that meets HHS’s standards. The HIPAA regulations also say that a breach excludes a “disclosure of PHI where a covered entity or business associate has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.” Obviously, a disclosure of PHI that cannot be viewed will also not be able to be retained.

HHS contends that encryption “alone cannot adequately safeguard the confidentiality” of the PHI, but, later in the Guidance, concedes that if the PHI is encrypted at a level that meets HHS’s standards, an unauthorized incident would fall within the breach “safe harbor” and would not need to be reported to the CSP’s customer. In such a case, the confidentiality of the PHI would be adequately safeguarded by encryption alone and the CSP arguably would not have an obligation to do anything else under HIPAA to protect the confidentiality of the PHI.  The CSP would have an ongoing obligations, however, to protect the integrity and accessibility of the encrypted PHI under HIPAA. The encryption “blindfold” will simplify the CSP’s obligations under HIPAA.

A CSP is in a tricky position if it holds encrypted PHI for a customer, but does not know that it holds it. The Guidance emphasizes that if a CSP maintains PHI for a customer that is a covered entity or business associate, it must execute a business associate agreement with the customer, and risks enforcement action (such as reported here) by the Office of Civil Rights (OCR) within HHS if it doesn’t have one.

“OCR recognizes that there may, however, be circumstances where a CSP may not have actual or constructive knowledge that a covered entity or another business associate is using its services to create, receive, maintain, or transmit ePHI.  The HIPAA Rules provide an affirmative defense in cases where a CSP takes action to correct any non-compliance within 30 days … of the time that it knew or should have known of the violation… This affirmative defense does not, however, apply in cases where the CSP was not aware of the violation due to its own willful neglect.”

Two key take-aways from the Guidance for CSPs? If you are blindfolded from viewing the data you maintain or transmit on behalf of your customers, or otherwise do not know whether the data might bring HIPAA obligations along with it, take reasonable steps to find out if the customer is a covered entity or business associate and whether the data includes PHI.  If so, execute a business associate agreement. Then, make sure the blindfold (i.e., encryption level) meets HHS’s standards and do NOT accept or have access to the decryption key.  This way, you can focus your HIPAA compliance efforts on protecting the integrity and accessibility of the data, not on its confidentiality.





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Six Tips for a Small Business to Avoid HIPAA Security Breach Headaches


Last week, I blogged about a recent U.S. Department of Health and Human Services Office of Civil Rights (OCR) announcement on its push to investigate smaller breaches (those involving fewer than 500 individuals).   The week before that, my partner and fellow blogger Michael Kline wrote about OCR’s guidance on responding to cybersecurity incidents.  Today, TechRepublic Staff Writer Alison DeNisco addresses how a small or medium sized business (MSB) can deal with the heightened threat of OCR investigations or lawsuits emanating from a security breach.  Alison’s piece, “Security breaches:  How small businesses can avoid a HIPAA lawsuit”, is must-read for MSBs struggling to understand and prioritize their cybersecurity needs.

Michael and I spoke with Alison about the recent OCR pronouncements, and she pulled several of our comments together to create a list of tips for an SMB to consider to minimize HIPAA security breach headaches. The following 6 tips are excerpted from the full article:

Hire a credible consultant to help you approach the issue, and how you would respond in the event of a breach. [In other words, perform your own security risk assessment, or, if impractical, hire an expert to perform one.]
Document that you have policies and procedures in place to fight cyber crime. “If you didn’t document it, it didn’t happen,” Kline said.
Stay informed of cybersecurity news in your industry, or join an association. Be aware of what other companies in your space are doing to protect themselves.
Update your security settings on a regular basis, perhaps every time you add new employees or change systems, or on an annual basis.
Present annually to your company board on where the company is in terms of cybersecurity protection, and where it needs to be to remain as safe as possible in the future.
If you’re an IT consultant working with a healthcare organization, be clear with your client what you need to access and when, Litten said. “A client that has protected health information in its software should carefully delineate who has access to that software,” she added.

The article also quotes Ebba Blitz, CEO of Alertsec, who offers an equally important tip for the SMB dealing with employees’ use of mobile devices that contain or are used to transmit PHI:

You need a good plan for mitigating BYOD,” Blitz said. She further recommends asking employees to document their devices, so businesses can keep track of them and install security tools.

In summary, confronting ever-growing and evolving challenges of cybersecurity for SMBs is dependent upon serious planning, development and implementation of current policies and procedures, documentation of cybersecurity measures taken and entity-wide commitment to the efforts.





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Small HIPAA Breaches, Big HIPAA Headaches


What you might have thought was not a big breach (or a big deal in terms of HIPAA compliance), might end up being a big headache for covered entities and business associates. In fact, it’s probably a good idea to try to find out what “smaller” breaches your competitors are reporting (admittedly not an easy task, since the “Wall of Shame” only details breaches affecting the protected health information (PHI) of 500 or more individuals).

Subscribers to the U.S. Department of Health and Human Services Office of Civil Rights (OCR) listserv received an announcement a couple of weeks ago that OCR would begin to “More Widely Investigate Breaches Affecting Fewer than 500 Individuals”. The announcement states that the OCR Regional Offices investigate all reported breaches involving PHI of 500 or more individuals and, “as resources permit”, investigate breaches involving fewer than 500.  Then the announcement warns that Regional Offices will increase efforts “to identify and obtain corrective action to address entity and systemic noncompliance” related to these “under-500” breaches.

Regional Offices will still focus these investigations on the size of the breach (so perhaps an isolated breach affecting only one or two individuals will not raise red flags), but now they will also focus on small breaches that involve the following factors:

*          Theft or improper disposal of unencrypted PHI;

*          Breaches that involve unwanted intrusions to IT systems (for example, by hacking);

*          The amount, nature and sensitivity of the PHI involved; and

*          Instances where numerous breach reports from a particular covered entity or business associate raise similar concerns

If any of these factors are involved in the breach, the reporting entity should not assume that, because the PHI of fewer than 500 individuals was compromised in a single incident, OCR is not going to pay attention. Instead, whenever any of these factors relate to the breach being reported, the covered entity (or business associate involved with the breach) should double or triple its efforts to understand how the breach occurred and to prevent its recurrence.  In other words, don’t wait for the OCR to contact you – promptly take action to address the incident and to try to prevent it from happening again.

So if an employee’s smart phone is stolen and it includes the PHI of a handful of individuals, that’s one thing. But if you don’t have or quickly adopt a mobile device policy following the incident and, worse yet, another employee’s smart phone or laptop is lost or stolen (and contains unencrypted PHI, even if it only contains that of a small handful of individuals), you may be more likely to be prioritized for investigation and face potential monetary penalties, in addition to costly reporting and compliance requirements.

This list of factors really should come as no surprise to covered entities and business associates, given the links included in the announcement to recent, well-publicized OCR settlements of cases involving smaller breaches.  But OCR’s comment near the very end of the announcement, seemingly made almost in passing, is enough to send chills down the spines of HIPAA compliance officers, if not induce full-blown headaches:

Regions may also consider the lack of breach reports affecting fewer than 500 individuals when comparing a specific covered entity or business associate to like-situated covered entities and business associates.”

In other words, if the hospital across town is regularly reporting hacking incidents involving fewer than 500 individuals, but your hospital only reported one or two such incidents in the past reporting period, your “small breach” may be the next Regional Office target for investigation. It will be the covered entity’s (or business associate’s) problem to figure out what their competitors and colleagues are reporting to OCR by way of the “fewer than 500” notice link.





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