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 "Stakeholders Divided on House Draft Clarifying FDA's mHealth Authority."
Following is an excerpt:
A draft bill proposing to separate mobile health from FDA's definition for medical devices could deepen a split among industry, medical and patient groups over how Congress and federal agencies should move forward with implementation of mHealth regulations. A key mobile health stakeholder group raised concern that the new language would cause further confusion and work in opposition to a congressional mandate directing FDA and other agencies to develop recommendations on a regulatory strategy.
The mHealth Regulatory Coalition has pushed against Congress taking any action that could delay FDA's issuance of final guidance for mHealth. The coalition told lawmakers that the draft bill was inconsistent with the FDASIA mandate for the tri-agency report and could delay implementation of a regulatory framework. The changes proposed in the bill could also create fissures between the United States and other countries working to harmonize policies on health technology, the coalition said.
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said it is unclear whether the bill would do anything more than exempt mHealth from the Affordable Care Act's device tax.
House Republicans have said they are concerned that if FDA regulates mHealth technologies as medical devices they will be subject to the 2.3 percent excise tax for devices under ACA. Thompson said the bill appears to be an attempt to ensure that does not happen.
"The bill just creates a new category at FDA, but it doesn't change one iota how it would be regulated," he said, noting it would be more beneficial if lawmakers simply repealed the device tax.
