Kim Tyrrell-Knott Quoted in Article, “House Republicans Question FDA on Mobile Medical Software: Taxes”Bloomberg Businessweek March 15, 2013
Kim Tyrrell-Knott, a Member of the Firm in the Health Care and Life Sciences practice, based in San Diego, CA, and Washington, DC, offices, was quoted in an article titled "House Republicans Question FDA on Mobile Medical Software: Taxes."
Following is an excerpt:
Republicans in Congress are probing whether the president's health-care overhaul will mean higher taxes for companies that sell mobile medical applications. ?...
Companies and lawmakers say questions about how the FDA would regulate apps may hold back growth in the market at a time when software developers are writing code to track sugar levels for diabetics on the fly or to transmit data from a patient's heart monitor to a doctor. They expressed concern about whether mobile devices like smartphones with regulated apps on them would be regulated as medical devices, and if so, whether they would be subject to a tax under the Affordable Care Act. ?...
Software developers and mobile health product vendors are uncertain how future regulations would affect their industry, said Kim Tyrrell-Knott.
For example, developers and vendors don't know if phones or other mobile devices using these applications will be considered "accessories" to medical devices and therefore subject to FDA regulation, she said.
"From an industry perspective, we're definitely eager to know when the final guidance will come out," Tyrrell-Knott said. "Folks need that predictability."