While the EHR Association supports the Office of the National Coordinator for Health IT’s efforts to improve interoperability, the group contends that an ONC proposed rule exceeds the mandate of the 21st Century Cures Act and goes far beyond the intent of Congress.
“We worked throughout the drafting of the 21st Century Cures Act with Congress and are supportive of its goal to remove obstacles to information exchange, but we have found that the tremendously broad reach of the proposed rule goes far beyond Congressional intent,” states EHRA in a blog posted this week. “In particular, we have significant concerns regarding timelines, ambiguous language, disincentives for innovation and definitions related to information blocking.”
When it comes to the latter, EHRA notes that ONC’s proposed rule seeks to implement the information blocking provisions of the Cures Act and includes seven exceptions to the definition of information blocking—the act of intentionally interfering with the sharing of electronic health information.
However, the vendor group makes the case that the “exceptions section as proposed do not seem enforceable” and that ONC has “gone well beyond what was intended, such as in the definitions of ‘interoperability elements’ and ‘electronic health information’ ”—both of which EHRA says are “written so broadly as to pull in technologies and stakeholders well outside of what is reasonable, and we strongly encourage that those definitions be revisited to narrow them significantly.”
EHRA also takes exception to ONC’s use of other “ambiguous language” in the proposed rule, which it believes is problematic for “affected stakeholders,” who potentially face penalties of as much as $ 1 million per infraction.
“While the language was well-crafted in many instances, some sections of the proposed rule offer room for interpretation, with words and phrases like ‘reasonable’ and ‘as soon as possible,’ ” according to the group. “These vagaries inherently conflict with ONC’s intent to propagate a rule that is clear, predictable and administrable. For example, the phrase ‘near real-time’ requires clarification.”
As a result, EHRA wants to see “additional clarifications and examples be made before finalization of the rule, possibly through issuance of an Interim Final Rule rather than a Final Rule this fall, to allow continuation of the clarification and feedback process.”
The vendor group also charges that ONC’s proposed rule, as written, “would discourage innovation by imposing limitations on profit as well as compulsory licensing terms for new intellectual property, created through extensive investment in development.”
Specifically, EHRA complains that the proposed rule “requires EHR developers and others to share their intellectual property with anyone who asks under Fair, Reasonable and Non-Discriminatory,” or FRAND, terms.” Under this compulsory licensing model, the group contends that “anyone could ask for our intellectual property, and for a ‘reasonable’ price-capped fee, they’d be able to layer their own work over ours or otherwise repurpose it,” which “would have a chilling effect on innovation, by removing incentives for new or established companies to invest in emerging technologies or any significant effort to update existing ones.”
EHRA also objects to the ONC’s proposed rule for appearing to “imply that established EHR developers are incapable of innovation,” which it describes as “an inaccurate characterization that trivializes the work that companies in our association do every day to improve clinician experience and bring new emerging technologies to the market.”
Earlier this year, ONC issued a proposed rule—along with a companion rule from the Centers for Medicare and Medicaid Services—intended to make electronic health information accessible to patients and providers. However, stakeholders have questioned whether the aims are achievable as the rules are currently written and within the proposed timelines.
For its part, EHRA contends that the ONC rule’s “proposed 24-month timeline for development, testing, training and implementation across all our clients is not feasible for the more challenging proposals, which require complex coding and implementation processes.”
The vendor group comments that the “short timeframe also raises other questions, such as, how will potential conflicts between the timelines in the proposed rule and requirements of other CMS and ONC programs be resolved?” while noting that “developers and providers already juggle dozens of other regulations and reporting requirements, so it will be important to identify where and how measures in this proposal intersect with timeframes for existing rules or programs.”
EHRA has yet to submit all of these comments on the proposed rule to ONC. Before making its submission to the agency, the group says the comments must still go through final rounds of review by EHRA’s executive committee.
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