On January 18, 2018, the newly formed Health Information Technology Advisory Committee (“HITAC”) held its first meeting to discuss health IT goals for 2018 and beyond. HITAC’s purpose is to advise the country on key, modern questions as the healthcare industry moves beyond the initial phases of the adoption of electronic health records. Representatives from the Office of the National Coordinator for Health Information Technology (“ONC”) discussed timelines for the issuance of new regulations and provided updates on several key ONC initiatives. Speakers included Eric Hargan, Acting Secretary for the Department of Health and Human Services, Don Rucker, the National Coordinator for Health Information Technology, and several ONC representatives. HITAC is next scheduled to meet on February 21, 2018.
HITAC Background & Primary Purposes
HITAC was formed by the 21st Century Cures Act (P.L. 114-255). Foundational purposes of HITAC include furthering the goals of increasing interoperability and making personal medical data available to patients, while balancing the security and privacy of that information. Members of HITAC include representatives from providers (e.g., Sutter Health, Baptist Health, Mayo Clinic, and the University of Mississippi Medical Center), payers (e.g., Anthem), vendors (e.g., Epic, IBM, and Watson Health), and government agencies (e.g., Kate Goodrich of the Centers for Medicare and Medicaid Services (“CMS”)).
Acting Secretary Hargan delivered opening remarks and spoke on the importance of HITAC and its primary charges. Specifically, he outlined the expectation that HITAC will have a key role in improving interoperability and usability for health IT. With an eye to the future, he looked ahead to other aspirational IT goals as well, including harnessing machine learning to assist in clinical decision-making and making data more available via smartphones in response to anticipated public demand. He encouraged HITAC to be forward-thinking as it develops its recommendations to ONC.
A key takeaway from this initial HITAC meeting is that ONC is working to issue regulations addressing several provisions of the 21st Century Cures Act. While the Health Information Technology for Economic and Clinical Health (“HITECH”) Act pushed for the adoption and meaningful use of electronic health records, the 21st Century Cures Act pushes for the exchange and interoperability of electronic health data. Representatives of ONC confirmed at the HITAC meeting that they anticipate issuing a proposed rule in April 2018 which will address, among other things:
- Conditions of certification and maintenance of certification for health IT developers.
- A process by which health information networks will voluntarily attest to their adoption of a trusted exchange framework and common agreement in support of network-to-network exchange.
- Classes of data to be included in the Trusted Exchange (e.g., what classes of data should be included and which should be considered “emerging” data classes).
- Exceptions to what constitutes “information blocking” (e.g., whether blocking patient access constitutes information blocking).
ONC stressed that it seeks comments and feedback from stakeholders across the healthcare spectrum, including clinicians, patients, and state agencies, as well as IT developers.
Trusted Exchange Framework Updates
ONC representatives also provided an update on the work completed by the Trusted Exchange Framework Task Force to date. The Task Force was formed to develop recommendations on the Trusted Exchange Framework and Common Agreement (“TEFCA”). The creation of TEFCA is mandated by Section 4003 of the 21st Century Cures Act, in support of the overarching goal of nationwide interoperability among health information networks.
Currently, many health information networks do not directly exchange health information. Multiple factors contribute to this lack of interoperability, but the result is limitations on the access and use of health information by individuals, providers, health systems, and public agencies. This, in turn, impacts the ability to improve patient care and outcomes. The overarching goal of the Trusted Exchange Framework is to help build and maintain trust across and among these health information networks to encourage nationwide interoperability. Representatives from ONC discussed their vision of health interoperability to function like the telecom industry, whereby individuals utilizing different carriers are able to connect regardless of the carrier they have chosen. The “Common Agreement” refers to an agreement with a minimum set of terms and conditions for information exchange between health information networks for the purpose of ensuring that common practices are in place and required of all participants in the Trusted Exchange Framework.
To date, ONC has issued a Draft Trusted Exchange Framework (accessible here: https://www.healthit.gov/sites/default/files/draft-trusted-exchange-framework.pdf). ONC seeks public comment on several areas of the TEFCA, including:
- Uses of the data in the Exchange Framework (which is currently limited to HIPAA-permitted uses and disclosures);
- How to allow machine learning with all of the available data;
- How to ensure security of the data; and
- Solutions to ease the administrative burden of verifying that requestors are authorized to receive the data requested.
Also of note was the discussion of the search for a Recognized Coordinating Entity (“RCE”) to administer and monitor compliance with the TEFCA. ONC is seeking an RCE with which to partner for multiple years, with a goal of having the RCE in place by August of 2018. ONC expects that there will be a bid opportunity in the Spring of 2018 (likely in April or May). Once the bid opportunity is announced, interested organizations will have 30 days to apply.
Finally, ONC representatives also shared an anticipated timeline for several key components in the development of the TEFCA:
- January 5, 2018: Release Draft Trusted Exchange Framework
- January 18, 2018: First official meeting of HITAC
- February 20, 2018: Public Comments Due
- March 19, 2018: Present Trusted Exchange Framework Taskforce Comments
- April 18, 2018: Present USCDI Taskforce Comments
- December 2018: HITAC Final Report
- December 2018: Release Final TEFCA
ONC Initiatives Updates
Elise Sweeney Anthony, the Director of Policy at ONC, updated HITAC on recent initiatives, including:
- Creation of the 2018 version of the Model Privacy Notice. The Model Privacy Notice provides a quick resource for IT developers, but, as discussed by Ms. Anthony, is not meant to be a replacement for an in-depth look by developers into their privacy practices.
- Creation of new resources that are more accessible to healthcare providers. For example, ONC has a behavioral health module and a long-term care module that identify how technology can be useful to these providers. A copy of the guidance, “Highlights for the Provider Community” is accessible here: https://www.healthit.gov/sites/default/files/tefca-provider.pdf
- Publication of a report on patient ability to access health records, accessible here: https://www.healthit.gov/sites/default/files/onc_records-request-research-report_2017-06-01.pdf.
EHR Standards and Certification Updates
Steve Posnack, Director of the Office of Standards and Technology at ONC, provided updates on EHR standards. Of particular note was his discussion of the 2018/2019 Edition of the Health IT Certification Program standards and its focus on compliance. Per Mr. Posnack, ONC is ready to push providers who are lagging behind on EHR adoption. Additionally, there are a variety of new requirements in the 2018/2019 Edition, including that EHR vendors must include “batteries not included” provisions. In other words, disclosures that better inform consumers about what is not included in the products. ONC is also working with CMS to generate a single EHR number so healthcare providers can use a single number to report meaningful use, even with multiple EHR vendors. Mr. Posnack also discussed new tools for providers to test their EHRs, including an option for providers to send test encrypted emails or messages to ONC and receive feedback on whether the message came through. Finally, Mr. Posnack outlined some priorities for his office for 2018 and beyond, including:
- Investment in FHIR (the standard for exchanging healthcare information electronically); and
- Population health services and how to connect systems like the Prescription Drug Monitoring Database (PDMP) with EHRs so physicians and providers are not required to utilize separate networks.
The inaugural meeting of HITAC provided a helpful orientation to the important work the Committee will undertake in 2018. Interoperability and usability will be key concerns for Committee members as they develop their recommendations to ONC, as will navigating the complexity of varying state requirements and public expectations for data security. As the Committee works to develop the framework for interoperability, now is the time for health care systems, facilities, and clinicians to follow the developments and weigh in through comments, participation, or otherwise, to shape the future of health IT.