On January 5, 2018, the United States Department of Health and Human Services released for public comment a draft Trusted Exchange Framework, which seeks to accomplish interoperability with respect to patients’ Electronic Health Information (“EHI”) through the creation of Health Information Networks (“HINs”). The 21st Century Cures Act, which Congress enacted in 2016, has the goal of creating a trusted exchange focusing on streamlining patient EHI and establishing a network designed to “achieve a system where individuals are at the center of their care and where providers have the ability to securely access and use health information from different sources.” The Trusted Exchange Framework is the federal government’s attempt to achieve that goal.
The draft Trusted Exchange Framework is broken down into two parts:
Part A—Principles for Trusted Exchange
Part B—Minimum Required Terms and Conditions for Trusted Exchange
Part A sets forth and relies on six principles:
(1) Standardization (adherence to industry standards and best practices);
(2) Transparency (an open free flowing exchange);
(3) Cooperation and Non-Discrimination (collaboration from all stakeholders);
(4) Privacy, Security, and Patient Safety (data protection and integrity);
(5) Access (conveniently obtain EHI); and
(6) Data-driven Accountability (streamlined process for a cohort of patients to help lower cost of care).
These principles are guidelines qualified HINs need to follow to help build a trusting relationship between participants and patients and, without adherence to this foundation, a new modernized system cannot properly flourish.
Part B sets forth the minimum required terms and conditions participants must adopt and follow to ensure a trusted exchange of EHI. This is accomplished through a trusted exchange framework and common agreement (“TEFCA”). The TEFCA seeks to ensure, among other things, that there is “[c]ommon authentication processes of trusted health information network participants, [a] common set of rules for trusted exchange, and [a] minimum core of organizational and operational policies to enable the exchange of EHI among networks.” A sample TEFCA can be found in the draft Trusted Exchange Framework.
In sum, it is clear that the federal government is finally taking a serious look at how our healthcare system can become more efficient and modernized in our ever-changing society. Putting into place a final Trusted Exchange Framework, with input from all stakeholders, is a great step towards reaching that goal.
The deadline for public comment is February 18, 2018.