The U.S. Department of Health and Human Services (HHS) today issued for public comment draft two of the Trusted Exchange Framework and Common Agreement (TEFCA) that will support the full, network-to-network exchange of health information nationally. HHS also released a notice of funding opportunity to engage a non-profit, industry-based organization that will advance nationwide interoperability.
Specifically, the documents being released for comment are: (1) a second draft of the Trusted Exchange Framework (TEF), (2) a second draft of the Minimum Required Terms and Conditions (MRTCs) for trusted exchange, and (3) a first draft of a Qualified Health Information Network (QHIN) Technical Framework. These documents will form the basis of a single Common Agreement that QHINs and their participants may adopt. This Common Agreement will create baseline technical and legal requirements for sharing electronic health information on a nationwide scale across disparate networks.
“The seamless, interoperable exchange of health information is a key piece of building a health system that empowers patients and providers and delivers better care at a lower cost,” said HHS Secretary Alex Azar. “The 21st Century Cures Act took an important step toward this goal by promoting a national framework and common agreement for the trusted exchange of health information. We appreciate the comments and input from stakeholders so far and look forward to continued engagement.”
In developing a TEFCA that meets industry’s needs, HHS’ Office of the National Coordinator for Health Information Technology (ONC) has focused on three high-level goals:
Provide a single “on-ramp” to nationwide connectivity;
Ensure electronic information securely follows you when and where it is needed; and
Support nationwide scalability for network connectivity.
ONC will maintain the TEF, while a non-profit, industry-based organization, known as the Recognized Coordinating Entity (RCE), will be awarded funds to develop, update, implement, and maintain the Common Agreement. Through this effort, ONC will define the minimum required terms and conditions needed to bridge the current differences among data sharing agreements that are preventing the flow of electronic health information. The industry-based RCE will be tasked with developing additional required terms and conditions necessary to operationalize the Common Agreement and meet the interoperability requirements of the 21st Century Cures Act.
DirectTrust announces that it has received accreditation by the American National Standards Institute (ANSI) to develop DirectTrust Standards to enhance healthcare interoperability and identity using Direct exchange and trust frameworks. DirectTrust also issued a call for industry stakeholders to participate in the development of DirectTrust Standards.
DirectTrust is a non-profit health care industry alliance created to advance the electronic sharing of protected health information (PHI) between provider organizations, and between providers and patients, for the purpose of improved transitions of care, care efficiency and coordination, patient satisfaction and reducing healthcare cost. ANSI coordinates, facilitates and promotes the development of voluntary consensus standards that are relied upon by the industry, government agencies and consumers across the United States and around the world. DirectTrust began the ANSI application process in 2018 and received notice of accreditation on March 26, 2019.
Scott Stuewe, DirectTrust president and CEO said, “DirectTrust and the Direct Project have always had a consensus approach to standards development. We’re thrilled to achieve this milestone of ANSI accreditation to ensure standards we establish to foster interoperability are consistent with the ANSI goals of transparency and balance.”
National Coordinator for Health Information Technology, Don Rucker, M.D., added, “In 2010 the Office of the National Coordinator for Health IT initiated the Direct Project as a new option for the secure exchange of electronic health information. DirectTrust’s accreditation by ANSI is an important step forward for this decade-long public-private effort to advance interoperability nationwide.”
The DirectTrust Standards mission – to develop standards and specifications that enable and promote healthcare interoperability using Direct exchange and trust frameworks – grew from voluntary discussions and workgroup meetings that began in 2011 among stakeholders eager to develop standards suitable for the growth such an exchange approach. From its inception, the Direct Project was structured as a consensus-based standards development organization with participation from and the sanction of the Health and Human Service Office of the National Coordinator but with no affiliation with an accrediting authority. More information about DirectTrust Standards can be found at www.DirectTrust.org through selection of the Standards menu.
Call for Participation
DirectTrust also issued a “call for participation” for the Direct Standard Consensus Body, a group of industry stakeholders that will be created to develop standards while conducting discussions in according with ANSI requirements. Participation in DirectTrust Standards is open to any person or company that has a direct and material interest within the respective scope of the work of Standards development. DirectTrust membership includes eligibility for participation in Standards activities. Non-members interested in participation can visit bit.ly/DTParticipateStandards to complete an application.
Following the release of its proposed new rules designed to improve the interoperability of electronic health information, members of leadership from the Centers for Medicare & Medicaid Services (CMS) hosted a call to provide additional detail about the proposed rule, and to answer questions from the media. The following includes the key takeaways from the officials hosting the call.
Seema Verma, Administrator, CMS
CMS shares a commitment with patients to obtain and share their health data.
The proposed rules ensure patients have access to their records in digital format.
We are “unleashing” data for research and innovation while tackling what might be the greatest healthcare challenge in our history, including the potential upcoming healthcare cost crisis that could destroy the US economy.
MyHealthEData unleashes innovation and focuses on results.
CMS is doubling down by requiring health plans to release claims data. All health plans in Medicare, Medicaid and that have plans within the federal exchange must allow for information be shared so patients can take their records with them when they move on.
Through these efforts, more than 125 million patients will have access to health information and be able to take information with them.
We are putting an end to information blocking and will publically identify doctors, hospitals and others who engage in information blocking.
Patient data doesn’t belong to doctor, but to the patient.
We’re putting the patient at the center of healthcare data. The time of keeping patients in the dark to trap them in systems so that they can never leave are over.
We are empowering patients to understand their healthcare information.
This rule allows patients to aggregate their data in one place through APIs/apps – putting the data in one place to help them understand it. They can organize the information, create care reminders, take data for the next provider when they go to a new provider.
This allows for aggregation of data in one place; physicians no long need to duplicate tests, for example.
Patients can donate their data for research, if they so desire, possibly opening up new wave of innovation of development.
Don Rucker, MD, National Coordinator for Health Information Technology (ONC)