Last fall, the provisions governing Business Associate Agreements under the HITECH law went into effect. Many covered entities used templates and models offered by professional societies and the Department of Health and Human Services, but it’s becoming increasingly clear that the “model” agreements were simply a stopgap measure, and that organizations that use BAAs need to conduct ongoing reviews of the documents and customize the language to meet the individual needs of their company.
The need for ongoing reviews to business associate agreements stems from an increased focus on compliance, and audits from the Office of Civil Rights (OCR) in DHHS. In the past, HIPAA compliance audits were limited to specifically covered entities, such as doctors’ offices and hospitals. Using HIPPA-compliant providers like healthcare fax companies to transmit protected data on their encrypted servers has been the best way for health care professionals to avoid audit issues.
However, the provisions of HITECH allow for audits of subcontractors as well, ensuring that they too are complying with the privacy and security policies of the act. Essentially, then, a business associate agreement serves as an agreement by the subcontractor that it will adhere to the rules and standards of HIPAA — and they understand the consequences of noncompliance.
Some argue that the notion of business associate agreements is outdated, given that HITECH holds all subcontractors who have access to HIPAA-protected data to the same privacy and security standards as the covered entity itself, even without the written agreement. The law still states, though, that covered entities must negotiate and maintain compliant BAAs with the companies that have access to their data — even those that may not directly have access to the data.
The simple fact that the OCR is conducting audits of business associate agreements and the companies covered by the agreements, highlights the importance of maintaining up-to-date and comprehensive agreements — meaning that the “boilerplate” agreement that you signed to meet the basic compliance standards may not be enough at this point.
Considerations for Review
Since it’s been a year since the new provisions went into effect, it’s very likely that your BAAs are reasonably up-to-date, and in compliance with the laws. That being said, if you used a template, or you only made minor changes to existing agreements, it’s best to review the agreements you have on file to ensure they comply with current law.
Many experts agree that BAAs should be reviewed at least once a year or more often if they expire, or if there are significant changes to the business relationship.
When reviewing your business associate agreements, there are a few key points to pay close attention to:
Guest post by Travis Good, M.D., CEO and co-founder of Catalyze, Inc.
Even if a bit delayed, the power and value of cloud-based technologies is starting to seep into healthcare. With each new cloud-based technology piloted or taken to scale by a healthcare organization, other institutions and corporations become more willing to roll the dice on deploying cloud-based technology. While still slow, it is happening, but not where you may think. Instead of found in the typical core applications of EHR or practice management systems, we find cloud-based technologies being introduced into the innovative health technology areas of virtual care delivery and patient self-reporting. Those areas are breaking down the barriers to cloud adoption in healthcare and that pace is increasing.
Cloud-based technology acceptance, along with everything else in the healthcare industry is moving faster than ever before. Accountable care, bundled payments, patient satisfaction, continuous care and the consumerization of healthcare are catalyzing changes to a very large, slow moving, highly regulated and risk averse industry. Technology and technology enabled services are essential for riding out these waves of change.
Every healthcare segment has seen these paradigm shifts and is trying to carve out a piece of the new pie. Large medical centers and health systems want to commercialize tools created in-house. Payers are building technology geared toward new forms of care delivery and price transparency, while biopharma is building technology to deliver continuous care powered by data from its core products – devices and medicines. All three of these healthcare segments can build technologies that utilize cloud computing and thus reap the following benefits:
A more nimble organization
Consumption of only the resources needed
Access to technology and apps across geographic barriers
Compliance and Cloud Computing
With recent changes to HIPAA that went into affect as part of the HITECH and HIPAA Omnibus Rule in 2013, a surge in compliance interest has developed, especially with compliance as it relates to cloud computing. The HIPAA Omnibus Rule created a new segment within the string of compliance leading back to covered entities. The new “subcontractor” segment is something of which every healthcare compliance officer must be aware. In much the same way as a business associate processes, transmits or stores ePHI for a “covered entity,” a subcontractor will also process, transmit, or store ePHI for “business associates.” And, subcontractors, like business associates, are required to sign business associate agreements (BAAs). These agreements outline the obligations of each party in meeting different aspects of HIPAA compliance rules, and delegate the risk based on different types of possible ePHI breaches.
In creating this new “subcontractor” entity, the Omnibus Rule accounted for the paradigm shift in technology development and cloud computing. The most commonly used example of a subcontractor is found in a cloud hosting provider like Amazon (AWS) or Rackspace; yet, many other types of services exist that could be considered subcontractors.
As data and services are being accessed via Web services (typically APIs), a huge number of BLANK-as-a-Service offerings have emerged. Many modern applications utilize third-party APIs for features and functionality to speed time-to-market, while adding value to users. Using simple to consume APIs, modern applications can tap into databases, messaging (SMS, Push, email or voice), usage metrics, logging, customer support, data sources, backup and so forth.