The Trump Administration has in the last two weeks issued executive orders that directly impact current health IT legislation and the implementation of recent regulations.
CFR Part 2
Last week the Administration issued a 60-day freeze on final rules that had been published in the Federal Register but had not yet met their effective date, according to a memo released by the White House. The freeze is intended to give the new administration and new department secretaries time to review new rules. This could impact the CFR Part 2 final rule—which was published in the Federal Register on January 8—and which finalizes changes to Confidentiality of Alcohol and Drug Abuse Patient Records regulations. That rule, however, is set to be effective on February 17, making it subject to the freeze.
It’s currently unclear what might happen with CFR Part 2 when the new Department of Health and Human Services Department Secretary reviews it, AHIMA’s Lauren Riplinger, JD, senior director, federal relations, says it’s likely to be implemented on March 20.
21st Century Cures
What’s less clear, however, is how a new executive order (EO) released by the White House on Monday will impact the 21st Century Cures Act passed at the end of the Obama Administration. The newest EO, called the “one-in, two-out” rule, requires all federal agencies to kill two regulations for every new one proposed.
Riplinger says AHIMA is waiting on the Office of Management and Budget to issue more specific guidance to the agencies as to how this EO is going to be implemented.
“There are a couple of challenges we are seeing here—the first is that there are various aspects of Cures that require the agencies to perform a specific action so how this EO will be enforced when the agencies are required by law to act (in some cases within a certain timeframe as the Cures Act does in a couple of places) is very problematic,” Riplinger said. “The other challenge is that we don’t know yet if the EO will cover guidance documents issued by the agencies which were also required by Cures.”
Kelly McLendon, RHIA, CHPS, managing director of CompliancePro Solutions, says that in response to possible changes in privacy regulations impacted by this EO, he’s advising his clients to “hold tight and see what happens with implementation of The Cures Act, which certainly needs much rule-making to be implemented.”
The Cures Act was largely devoted to regulations surrounding medical device and prescription drug approval, but has numerous implications for health information management (HIM) and health IT professionals. Among the provisions related to HIM is the law’s Title XI: Compassionate Communication of HIPAA, which calls upon the HHS Office for Civil Rights to issue additional guidance that would further clarify permitted uses and disclosures of protected health information of patients seeking or undergoing mental or substance use disorder treatment.
McLendon is telling his clients to keep doing what they’re already doing with regard to privacy and security. Any changes will be well covered by the media and guidance will follow.
“Chaos and disarray are certainly on the horizon from a compliance perspective with all federal rules. But if we as professionals stay on top of the changes, HIM professionals (among others) will be seen as valuable to their organizations as they provide stewardship through the changes,” McLendon adds.