AMIA wants a decision on Common Rule updates

Tom Price speaking
In a letter to HHS Secretary Tom Price and OMB Director Mick Mulvaney, AMIA requested clarification on the Common Rule update.

A national healthcare informatics organization is getting impatient with the Trump administration’s indecisiveness over updates to the Common Rule that have health IT implications.

In a letter released to the public on Tuesday, the American Medical Informatics Association (AMIA) urged Department of Health and Human Services (HHS) Secretary Tom Price and Office of Management and Budget Director John Mulvaney to finalize updates to the Common Rule that would provide researchers better access to healthcare data.

Clarifying the fate of the regulation would “provide much-needed certainty to stakeholders,” AMIA wrote.

“We live in an age of ubiquitous data,” AMIA President and CEO Douglas B. Fridsma, M.D., Ph.D., said in a statement. “Patients expect researchers to leverage their data for improved care in responsible ways. The updated Common Rule enables and encourages better transparency so that new discoveries are possible.”

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The Obama administration finalized an update to the Common Rule the day before the administration changed hands, modernizing a regulation that had been in place since 1991 by improving protections for research participants and providing access to EHR and patient-reported data. The updates were scheduled to take effect January 19, 2018.

But Trump’s regulatory freeze left the update hanging in the balance. Five months later, AMIA requested the administration release a public statement reinstating the regulation’s effective date and extending compliance dates by six months.

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AMIA wrote that the updates are particularly important to new large-scale research efforts like the All of Us program and the Cancer Moonshot Initiative. The organization also believes the rule will allow clinicians to leverage clinical data to comply with MACRA and improve population health initiatives that rely on genomic sequencing, information technology and patient data.

“The absence of such a signal will delay the revised Common Rule’s new benefits, and leave in place a legacy rule that neither serves research participants, nor the research community,” the letter stated.