HHS Finalizes Rule on Health IT Interoperability

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The HTI-1 Rule establishes algorithm transparency requirements, adopts interoperability standards and enhances information blocking requirements

Jan. 12, 2024 (ACP) -- As part of its bid to improve data sharing in medicine, the U.S. Department of Health and Human Services (HHS) has finalized a new health information technology regulation.

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule, finalized in December, implements key provisions of the 21st Century Cures Act, with a specific emphasis on algorithm transparency, health IT certification, and information blocking.

“Physicians are now expected to take steps to ensure that their patients' electronic health information is accessible and usable per new regulations,” said Dr. Deepti Pandita, chair of the ACP Medical Informatics Committee. “Information blocking is defined as practices that interfere with, prevent or otherwise restrict the exchange or use of electronic health information. The key is for physicians to be aware of what constitutes information blocking and make sure their electronic medical records allow for information sharing.”

As Pandita explained, the new rule is related to the larger issue of “interoperability” in electronic health records. “One of the biggest interoperability challenges is managing inconsistent data from multiple sources,” she said. “Information stored in different databases can have a variety of formats and data types that are not easily compatible with one another. This leads to a lot of waste in the ecosystem of health care, with duplication of tests and orders.”

In addition, errors can occur when physicians are unable to fully understand what has transpired in terms of a patient's care. “The problem is somewhat mitigated if physicians are on the same electronic medical record system,” Pandita said, “but it is a bigger problem if patients receive care in different systems or if the physicians are using disparate systems.”

“There are also safety concerns,” she explained, “as patients don't have unique identifiers across the country. Often, patients are misidentified or may not be identified at all depending on how they were registered in any unique practice. Some other unique challenges are the lack of payer participation in data sharing and the high cost of integration.”

Under the new rule, according to Pandita, it is especially important for physicians who practice in more than one location or provide care in multiple states to keep in mind that each electronic medical record system needs to be set up in accordance with federal rules while also respecting state laws. “Physicians also need to be aware that physicians who engage in information blocking could be subject to disincentives,” she noted.

The HTI-1 final rule will “make updates to the ONC (Office of the National Coordinator for Health Information Technology) Health IT Certification Program -- a certification program that includes various standards, implementation specifications and certification criteria for electronic health record software companies and health IT developers,” Pandita said.

The rule also aims to increase transparency of predictive decision support interventions. “Transparency can empower users to make informed choices about how they use an algorithmic decision-making system and judge its potential consequences,” Pandita said. “However, transparency is often conceptualized by the outcomes it is intended to bring about, not the specifics of mechanisms to achieve those outcomes. The hope -- as mentioned in an HHS press release -- is that this regulatory approach will make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision-making and to assess such algorithms for fairness, appropriateness, validity, effectiveness and safety.”

Moving ahead, she said, “more research is needed to validate if this indeed bears fruition. Developers will have to comply with the decision-support intervention requirements by the end of 2024.”

Meanwhile, a proposed rule, released in October 2023, sets disincentives for information blocking by clinicians and physicians. The enforcement mechanisms will go into effect when the regulation is finalized.

“While ACP applauds the development of disincentives that apply to physicians and other clinicians who knowingly engage in practices that are likely to interfere with the access, exchange or use of health information, the College has some concerns about the proposed regulatory approaches as laid out throughout the proposed rule,” Pandita said.

ACP has encouraged the regulatory agencies to develop clear guidance materials to provide physicians with a baseline for the requirements to comply with health data requests and ensure physicians are not inadvertently blocking information. In addition, this guidance and/or educational resources should include examples of the types of documentation needed if physicians are subject to an information-blocking claim or investigation. The guidance should also inform physicians on how the knowledge requirement for information blocking by clinicians and physicians would be evaluated.

For now, Pandita encouraged ACP members to look at the wider picture. “Physicians might feel that this rule adds to all the regulatory burden they already face in taking care of patients. However, this rule is based on the premise that it will improve patient care and patient outcomes,” she said. “Encouraging the flow of health information, sharing health information in a timely manner and making information and data visible in a seamless manner reduces the cost of care and reduces adverse outcomes. The rules will help to improve population health by making information about health trends more readily available.”

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