MRC urges hold on further health IT regulation until FDASIA report
The mHealth Regulatory Coalition (MRC) is urging Congress to hold off on passing legislation further regulating health IT until the Food and Drug Administration Safety and Innovation Act (FDASIA) workgroup releases its report.
The workgroup is set to present its report on a risk-based regulatory framework for health IT, which includes mobile health, sometime early this year.
In its approved policy proposal, MRC said premature legislation could thwart opportunities in the future to balance both public health protections and innovation.
“Protecting patients is of paramount importance here just as it is anywhere in healthcare. Patients come first. But we frankly see potential opportunities down the road, after these issues have percolated a bit, to both increase patient protections while simultaneously decreasing the regulatory burdens on those who innovate in this space, producing public health advancements,” according to the proposal.
MRC recommended several objectives that legislators should pursue when creating a new regulatory paradigm for health IT, including:
- Collection of “good data” on health IT risks
- Systems-level regulation that recognizes a future of health IT that is based on integrating technology
- A nuanced categorization scheme that takes into account different risk factors of the elements of health IT systems
- Utilization of private resources, such as notified bodies, to certify low risk medical technology
- Encouragement of collaboration between IT vendors, researchers and end users
The policy proposal also created new terms to identify various elements within a health IT system and various roles and responsibilities of the organizations that manage those elements.