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 "Pending Mobile Medical Apps Guidance Provokes Heated Controversy."
Following is an excerpt:
An impassioned debate brewing about FDA's planned timing for finalizing mobile medical apps guidance bubbled to the surface at a recent meeting of the HHS workgroup tasked with recommending a health IT regulatory framework. Despite pressure to delay the guidance, FDA says it is still pushing ahead.
An HHS-sponsored workgroup convened a conference call last week to discuss its recently released draft recommendations for a comprehensive regulatory structure for health information technology. They ended up spending more time than expected on one very specific point: the timing of FDA's release of a final guidance on regulating mobile medical apps.
Bradley Thompson, a lawyer who heads the mHealth Regulatory Coalition, which also represents a diverse set of health care groups including app makers, device firms, software companies and health care provider organizations that support accelerated release of FDA guidance, argued that controversy was not a reason to avoid issuing guidance.
"We're free to make our recommendations, even in controversial areas," Thompson said. "[I'm] not sure why we would change our recommendation because of outside controversy."
Brad Thompson, too, thinks he has the motives of the comprehensive faction sussed out.
"My concern is that we have a bunch of special interest[s] trying to stir up controversy, and I'm not even sure they've read the draft guidance document," he wrote in an email to "The Gray Sheet."
"In the draft guidance document ?... FDA says that they want to use enforcement discretion not to regulate certain categories, including apps that 'allow individuals to self-manage their disease or condition.' That is huge. If we can get FDA to publish the guidance with something like that in it, that would let a tremendous number of mobile apps off the regulatory hook."
"But instead, through a campaign of misinformation, we have some groups playing politics, trying to get FDA to do nothing while they go after whatever their macro agenda is, [which] includes avoiding the medical device tax. In the meantime, they're killing the innovators."
