The rise of cloud service providers as business associates
As more healthcare providers start to utilize cloud services, the issue of cloud service providers (CSP) as business associates is becoming more complex. Both covered entities and business associates need to understand how they can take advantage of cloud options while still maintaining HIPAA compliance.
HHS released more detailed guidance on cloud computing, CSPs, and business associates in 2016 to help clarify potential confusion.
“When a covered entity engages the services of a CSP to create, receive, maintain, or transmit ePHI (such as to process and/or store ePHI), on its behalf, the CSP is a business associate under HIPAA,” the guidance states. “Further, when a business associate subcontracts with a CSP to create, receive, maintain, or transmit ePHI on its behalf, the CSP subcontractor itself is a business associate.”
HHS also suggested a service level agreement (SLA) to address more specific business expectations between the CSP and its customer. The provisions could potentially cover the following areas:
- System availability and reliability;
- Back-up and data recovery (e.g., as necessary to be able to respond to a ransomware attack or other emergency situation);
- Manner in which data will be returned to the customer after service use termination;
- Security responsibility; and
- Use, retention and disclosure limitations.
However, HHS noted that a CSP is considered a HIPAA business associate even if it only stores encrypted ePHI and does not have a decryption key. HIPAA regulations still define an entity as a business associate even if that organization cannot actually view the ePHI it is maintaining for a covered entity or other business associate.
Encrypting ePHI reduces the risk of potential exposure, but it cannot on its own “safeguard the confidentiality, integrity, and availability of ePHI as required by the Security Rule.”
“Encryption does not maintain the 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,” HHS maintains.
Providers will need to seek out secure and compliant cloud service providers on their own. OCR will also not assist healthcare organizations that are trying to find cloud services that are reportedly HIPAA compliant.
“OCR does not endorse, certify, or recommend specific technology or products,” the guidance says.
While HHS and OCR offer guidance on how covered entities and business associates can utilize cloud computing, those healthcare organizations should still perform their due diligence when seeking out secure options. From there, crafting an applicable business associate contract, BAA, or SLA will be necessary to guarantee that all parties understand what is expected in terms of PHI security.
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What happens when BAs violate HIPAA regulations?
Business associates can be held liable for PHI exposure. Whether the partners involved lack a business associate agreement or a business associate simply falls victim to a ransomware attack, these organizations must also ensure they stay HIPAA compliant.
In April 2017, the Center for Children’s Digestive Health (CCDH) agreed to a $31,000 OCR HIPAA settlement after it was found that CCDH did not have a BAA with FileFax, Inc., a patient information storage provider.
An August 2015 compliance review was instigated after FileFax had been investigated.
“While CCDH began disclosing PHI to Filefax in 2003, neither party could produce a signed Business Associate Agreement (BAA) prior to Oct. 12, 2015,” according to OCR.
Furthermore, OCR found that the PHI of at least 10,728 individuals was disclosed to FileFax “when CCDH transferred the PHI to Filefax without obtaining Filefax’s satisfactory assurance.”
Minnesota-based North Memorial Health Care also learned the hard way why it is essential to properly identify business associates.
The hospital failed to identify Accretive Health, Inc. as a business associate, and agreed to a $1.55 million OCR HIPAA settlement in 2016.
North Memorial filed a breach report in September 2011 when an unencrypted, password-protected laptop was stolen from an Accretive member’s locked vehicle. The report stated that the ePHI of 9,497 individuals was possibly impacted.
OCR also found that North Memorial did not “complete a risk analysis to address all of the potential risks and vulnerabilities to the ePHI that it maintained, accessed, or transmitted across its entire IT infrastructure.”
Not having a BAA also led to an OCR HIPAA settlement for Care New England Health System (CNE).
OCR determined that Woman & Infants Hospital of Rhode Island (WIH) was a CNE covered entity, and had lost unencrypted backup tapes that held the ultrasound studies of approximately 14,000 individuals.
This led to a $400,000 settlement, along with the requirement that CNE adhere to an OCR corrective action plan.
CNE was also allowed “to create, receive, maintain, or transmit PHI on its behalf, without obtaining satisfactory assurances as required under HIPAA.”
“From September 23, 2014, until August 28, 2015, WIH impermissibly disclosed the PHI of at least 14,004 individuals to its business associate when WIH provided CNE with access to PHI without obtaining satisfactory assurances, in the form of a written business associate agreement, that CNE would appropriately safeguard the PHI,” OCR explained.
Both covered entities and business associates will benefit from having a current and comprehensive BAA in place. This way all parties understand how they are expected to store, transfer, and handle PHI and other sensitive information.
Additionally, BAAs will help ensure HIPAA compliance and prove to OCR that necessary steps were taken to keep data secure should an investigation ever need to take place.
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Identifying BAAs and reviewing the business associate relationship
Healthcare providers should not hesitate in reaching out to a third-party knowledgeable on business associate agreements to ensure that a thorough business associate agreement has been established.
For example, a lawyer who practices in the healthcare IT privacy and security space should understand the intricacies of HIPAA and understand what needs to be in place in a proper business associate agreement.
HHS also suggests the following resources for healthcare providers that want to know more about the HIPAA Privacy and Security Rules in general, beyond just business associate agreements:
- ONC’s Guide to Privacy and Security of Electronic Health Information
- State Attorneys General offices
- Medscape members’ Patient Privacy: A Guide for Providers
A thorough knowledge of HIPAA regulations will help providers understand the business associate relationship. Utilizing available tools and resources can also help organizations create applicable business associate agreements that will work toward PHI security.