AMIA blasts Trump administration’s ‘history of delay’ with Common Rule implementation

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AMIA said the Trump administrations history of delays to the Common Rule hangs over it "like an ominous cloud." (Sarah Stierch/CC BY 4.0)

The Trump administration proposed another delay to updates to the Common Rule, a research regulation with several key health IT provisions that has been repeatedly postponed since Trump took office.

In a proposed rule (PDF) issued by the Department of Health and Human Services (HHS) along with 15 other federal agencies last week, the administration planned to delay all but three provisions of the Federal Policy for the Protection of Human Subjects, known as the Common Rule, for another six months.

Although the American Medical Informatics Association has previously advocated for a January 2019 implementation date, the organization expressed concern that regulators would continue delaying the rule without a July effective date.

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“This Administration’s history of delay hangs over this NPRM like an ominous cloud,” Jeff Smith, vice president of public policy said in a statement.

RELATED: HHS issues 6-month delay to Common Rule implementation

The Obama-era updates, finalized just one day before President Trump took office, were stymied by an immediate regulatory freeze. A January 2018 implementation date was later delayed six months to July 19. Under the proposed rule, researchers could take advantage of three “burden-reducing provisions” beginning this July, but implementation of the remainder of the rule would be delayed.

The health IT updates to the regulation, ones that would allow researchers to obtain broad consent from patients for data generated by wearable devices to give researchers access to EHR data for low-risk studies on quality care, were not among the three provisions with an earlier start date. 

Smith argued that proceeding with a July 19 effective date would allow prepared researchers to move forward with provisions “meant to enable a learning health system through the supplemental use of EHR data.”

“AMIA strongly opposes the NPRM’s alternative proposals to delay both the general effective and compliance date to January 2019 and we reject any notion that further delay beyond January 2019 is necessary,” he added.

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