Bradley Merrill Thompson a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "IT Developers Differ Over How Federal Government Should Oversee Health Software."
Following is an excerpt:
Health information technology developers are split over how they would like to see the federal government oversee their software products, with some saying regulatory guidance alone is sufficient and others calling for an overhaul of the decades-old law that was written before their products ever were contemplated. ...
Rep. Marsha Blackburn (R-Tenn.) introduced in October the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act (H.R. 3303) that would carve out a single category of software products that the FDA could regulate, putting most health IT software products—including clinical decision software—into one of two other categories of products that would be outside the FDA's regulatory purview. ...
Thompson, who is general counsel for two industry groups representing IT firms, the Clinical Decision Support Coalition and the mHealth Regulatory Coalition, said legislation that locks in an approach for overseeing health software could have the unintended effect of being too rigid for future technologies and could allow some products that should be scrutinized by the FDA to slip through the regulatory cracks.
Thompson acknowledged that existing law does not address current and emerging technologies directly, but also said that the law isn't "so broken" that oversight couldn't be modernized through the regulatory process.
He also reiterated comments from the FDA's Shuren at the Nov. 19 hearing that while statutory changes might be necessary, now might not be the right time for those changes.
Instead, Thompson, like Shuren, said changes to the law should be held until after the FDASIA recommendations are made next year. ...
Thompson explained that in the current health-care marketplace, software is part of systems, not acting on a stand-alone basis. And, while some industry representatives argued that was the very reason the SOFTWARE Act was necessary, Thompson said the bill was too narrow in trying to categorize all manner of health software into three buckets—medical software, clinical software or health software.
He said the coalitions he is working with are considering the benefit of a more nuanced classification system for software.
For example, he said, CDS software can be as simple as a body mass index (BMI) calculator or as sophisticated as a program that provides computer-aided diagnoses and radiation therapy doses.
On the one end of the spectrum, he said, BMI calculators don't deserve oversight scrutiny, but other products that help physicians make treatment decisions for complex patient situations should be looked at differently by regulators.
"Technology can be complex. Unfortunately, that means that policy, if it is going to be sensitive to the technology drivers, needs to be nuanced," the mHealth Regulatory Coalition wrote in a Nov. 18 letter to House Energy and Commerce leaders.
"Three categories will not capture the broad spectrum, graduated differentiation and networked complexity of today's health information technology."
The coalition went on to suggest the committee "move slowly here, and carefully map out the technology that exists today and where it is likely to go tomorrow, before developing its policy solutions."
Thompson also warned that even with changes to the law, the FDA would have to weigh in with guidance on how software would be categorized under the SOFTWARE Act.
"The language isn't self-executing," he said. "Guidance is still needed."
