HIA Calls ONC to Reconsider Health IT Requirements of Proposed Rule

The Health Innovation Alliance (HIA) has submitted comments on the ONC proposed rule, Health Data, Technology, and Interoperability (HTI-1), which aims to implement provisions of the 21st Century Cures Act and make several enhancements to the ONC Health IT Certification Program.

While HIA supports the proposed rule, the alliance outlined several steps ONC should take before finalizing the law.

The proposed rule would require the adoption of the United States Core Data for Interoperability (USCDI) Version 3 as a standard within the ONC Health IT Certification Program. USCDI v3 expands upon several existing data classes and adds 24 new data elements to USCDI v2.

HTI-1 would also establish an expiration date for USCDI Version 1 as an adopted data standard in the Certification Program.

“HIA agrees with the proposed expansion of USCDI to increase the availability of standardized data in the healthcare system, but we caution ONC to carefully consider, now and in the future, the timelines for transitions and implementation as well as the need for clarity on the specific data elements, the standards, and implementation guides to be used,” Brett Meeks, executive director of HIA, wrote in the letter to ONC.

Another statute of the proposed rule would require developers to implement capabilities to execute the HIPAA requirement that patients can request restrictions on disclosing their protected health information.

While HIA appreciates this proposal, the letter noted that implementing such a requirement may be difficult or impossible.

“HIA urges ONC to work with developers to achieve the policy goals of patient privacy with the practical implications of delivering patient care and coordinating care between providers,” Meeks wrote. “Congress and HHS have gone to great lengths to improve interoperability and the availability of health information to those who need it, as ONC is acutely aware.”

“Segmenting some patient information from records will lead to incomplete information to provide care and could lead to patient harm,” he added.

The letter noted that HHS is implementing a change to the 42 CFR Part 2 privacy protections following an act of Congress and the pleading of the healthcare community for decades. The changes aim to prevent opioid deaths due to incomplete data at the point of care.

“HIA urges ONC to balance the need for an accurate and complete record to deliver patient care with the need to maintain patient privacy and honor the patient’s wishes,” Meeks wrote.

HIA also called ONC to defer regulation of technologies like artificial intelligence (AI) to the FDA and ensure that EHR certification criteria do not subject developers to unnecessary regulation as medical device manufacturers.

“Interoperability within the healthcare system will create expanded access and efficiency, better patient safety, and lower costs,” Meeks wrote in a statement emailed to journalists. “But the system cannot work unless the laws and regulations are specific and nimble enough to allow for innovation.”

“Government regulation of health technology must enable innovation while balancing the need to ensure safety, reliability, and accountability. If the balance tilts too far in one direction or the other, patients pay the ultimate cost,” he added.