In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said, does not ensure they are properly designed, consistently assembled or clinically valid.
She called for a “critical baseline” of these sorts of in vitro diagnostics, which previously had been more “simple.”
“As a result we are considering a risk-based framework,” Hamburg said.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
In a panel following the speech, WSJ columnist and American Enterprise Institute Resident Fellow Dr. Scott Gottlieb disagreed with FDA’s movement into this area.
“A lot of these issues around laboratory development tests can be addressed through CLIA properly,” he said. “I think we have to ask hard questions about whether CLIA–or the FDA for that matter–should be judging clinical utility.”
He said they should be tested for accuracy, but that it would be a broad definition of medical devices to include LDTs.
“Mobile apps probably isn’t an area of high risk,” Gottlieb added.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
