The Electronic Health Record Association (EHRA) has written letters to the ONC (the Office of the National Coordinator for Health IT) and CMS (the Centers for Medicare & Medicaid Services), requesting that the agencies give public stakeholders 30 more days to respond to its two proposed rules on interoperability and patient access.
The ONC rule, titled “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT," is 724 pages in length, and was released on Feb. 11. Key elements of the proposed regulation include a provision requiring that patients can electronically access all of their digital health data (structured and/or unstructured) at no cost. What’s more, the rule implements the information blocking provisions of the 21st Century Cures Act.
Stakeholders are likely to find that the proposed rule contains many complex parts. For instance, information blocking in of itself can be quite subjective, so ONC also proposed several exceptions to it. But still, the devil is in the details when determining if a specific situation qualifies as an exception or not, and there is a considerable amount of grey area, even with the proposed exceptions laid out in the rule.
What’s more, the proposal calls for health IT developers to publish APIs (application programming interfaces) and allow health information from such technology to be accessed, exchanged, and used without special effort. The rule also proposes to require the use of the FHIR (Fast Healthcare Interoperability Resources) standard for APIs.
As such, the EHR Association wrote to National Coordinator for Health IT Don Rucker, M.D., to request a 30-day extension of the comment period to June 3, 2019.
“The proposed rule from ONC is a substantive one. It suggests complicated, significant adjustments to the regulations already governing the health information and technology industry, and stakeholders deserve adequate time to provide thoughtful, detailed comments on the impacts of the proposals,” the group wrote in its letter.
The EHRA added, “If additional time is allowed, it would enable EHR developers to survey EHR Association members in order to provide ONC with actual development timelines for the measures being proposed. While some measures may be straightforward to achieve in a short timeline, others are likely to require more complex coding and implementation, thus calling into question the feasibility of the proposed 24-month development, testing and implementation timeline.”
Separately, the association also asked CMS, which released its own proposed rule on Feb. 11, titled Interoperability and Patient Access Proposed Rule,” to give stakeholders 30 more days to comment on the proposals. “Between CMS and ONC’s two proposed rules, developers and other healthcare stakeholders have a lot of work ahead of us for this comment period,” the EHRA wrote.
The group added in its comments, “As we’ve begun to delve more deeply into the proposed rule, we have already identified several areas that would indirectly require developer action, which appears unanticipated by the authors of the proposed regulations. We recognize the desire to roll out these rules quickly; but, with an ultimate goal of enhanced usability and widespread data sharing, it’s important that adequate time be allowed for commenters.”
