The long-awaited final modifications to the HIPAA Privacy, Security, Enforcement and Breach Rules were introduced Thursday. The 563-word document outlines the changes that were initially slated for implementation last summer (remember the omnibus rule?). So how do these modifications affect HIPAA cloud providers?

While cloud providers have generally been considered and treated as business associates in the industry, the modifications make it even clearer that data center operators are officially considered business associates and are also directly liable for being compliant with the HIPAA standards that apply to business associates. The federal document states:

A data storage company that has access to protected health information (whether digital or hard copy) qualifies as a business associate, even if the entity does not view the information or only does so on a random or infrequent basis. Thus, document storage companies maintaining 26 protected health information on behalf of covered entities are considered business associates, regardless of whether they actually view the information they hold.  To help clarify this point, we have modified the definition of “business associate” to generally provide that a business associate includes a person who “creates, receives, maintains, or transmits” (emphasis added) protected health information on behalf of a covered entity.

As I wrote about in Healthcare Organizations: Seeking a Cloud Provider? BAAs Required, healthcare organizations need to be cautious about signing with ‘HIPAA-ready’ or ‘HIPAA certified’ cloud hosting providers. Being ‘HIPAA compliant’ or ‘HIPAA audited’ means they have undergone an independent audit, preferably measured against the latest OCR HIPAA Audit Protocol that outlines each requirement and auditor testing criteria.

If you use a cloud service, it should be your business associate. If they refuse to sign a business associate agreement, don’t use the cloud service. – David S. Holtzman of the Health Information Privacy Division of OCR during a speech at the Health Care Compliance Association’s 16th Annual Compliance Institute.

Another point they make is that business associates must also adhere to the Breach Notification Rule – including the subcontractors of business associates. For an example of what a breach notification clause might look like in a business associate agreement (BAA), read our BAA Breach Notification Clause.

Covered entities and business associates should take note – the document also states that “these proposed changes would make covered entities and business associates liable under § 160.402(c) for the acts of their business associate agents, in accordance 61 with the Federal common law of agency, regardless of whether the covered entity has a compliant business associate agreement in place.

While business associates and agents are directly liable under HIPAA, covered entities are also directly held responsible for any actions of their business associates and other contractors down the chain of command; making a great case for why it’s important to carefully choose your HIPAA cloud hosting provider. Healthcare Software as a Service (SaaS) companies, EHR providers and other supporting healthcare vendors need to ensure their cloud Infrastructure as a Service (IaaS) providers undergo annual HIPAA audits, train their staff in security, and have the policies and procedures in place that adhere to security guidelines.

 

References:
HHS: Modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules (PDF)

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