President Donald Trump's freeze on Obama administration rules raises doubts over the future of recently issued revisions to patient consent rules on clinical research and sharing of drug and alcohol treatment records.
Trump issued a 60-day hold on rules that have been published in the Federal Register but have yet to reach their effective date.
The ones related to privacy issues include revisions to the Common Rule for human research subjects and 42 CFR Part 2 covering drug and alcohol treatment records. But even if they successfully make it through the freeze, there are no guarantees those rules will survive a congressional committee process that may revise them.
On Jan. 19, HHS and 15 other federal agencies published a final rule on the Common Rule, with effective dates of Jan. 19, 2018, and Jan. 20, 2020.
The 42 CFR Part 2 rule published by the HHS in the Federal Register on Jan. 18 carries an effective date of Feb. 17, 2017.
“What I caution against is seeing either of these rules in a vacuum,” said Jennifer Geetter, a partner in the healthcare legal practice of McDermott, Will & Emery.
“They're pieces of a complicated regulatory landscape,” Geetter said. “Everyone is going to have to stay nimble.”
The 21st Century Cures Act, passed with bipartisan support and signed into law by President Barack Obama in December, calls for the formation of work groups to study both the Common Rule and 42 CFR Part 2.
“I would assume the working groups will go forward,” Geetter said. “This is a new administration with all sorts of priorities in healthcare. Whether this will be their focus, I really don't know.”
Both rule revisions envisioned “streamlining things and reducing administrative burdens,” which match the stated goals of the Trump administration, said Kirk Nahra, a law partner at Wiley Rein.
“Other than taking the position they don't want anything that came out of the other administration,” Nahra said, “you could definitely look at them and say they didn't go far enough in simplifying things, and I'm sympathetic to that view. But I don't know that they're going to say: Let's start over and simplify more.”
Given all the other healthcare issues the new administration has on it's plate, “I doubt they are even a third-tier issue,” Nahra said.