Government oversight of software used in the health care industry must be flexible in an era of rapid technological advancements, a representative of the American Cancer Society testified on Nov. 19 before the House Energy and Commerce Committee subcommittee on health.
“Any oversight system should be fluid,” said J. Leonard Lichtenfeld, M.D., deputy chief medical officer at the cancer society. “Technology is advancing at a speed that challenges our ability to provide effective oversight. Some of the technology used today was almost unheard of five years ago, so any new oversight structure should not be so rigid that it cannot quickly adapt to new realities.
The subcommittee is considering H.R. 3303, “The Software Act,” which is bi-partisan legislation introduced in October to specify types of health software that would not be subject to regulation under the Food and Drug Administration
Lichtenfeld acknowledged the task ahead of FDA, along with other government agencies in creating a risk-based regulatory framework for health care software. “You will find nearly universal agreement that scheduling and billing software does not merit Food and Drug Administration clearance and that diagnostic imaging software does merit FDA oversight. The real challenge lies in creating the risk-based paradigm to calibrate oversight for everything in between.”
Details matter, he asserted. If new categories of medical software applications are created with different levels of oversight, the definitions “must be very clear and not create loopholes, ambiguities or unintended consequences.”
Lichtenfeld urged lawmakers to focus their solution on the actual problem: “Innovation in software and mobile apps can be promoted through regulatory certainty and the relief of regulatory burden on software sectors where it is not appropriate. This may be possible with narrower policy changes aimed at targeted sets of software rather than an entirely new paradigm for the full spectrum of software and mobile apps.”
Testimony from Lichtenfeld and other witnesses at the hearing is available here.
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