In April of this year, the US Food and Drug Administration (FDA), along with the Office of the National Coordinator for Health Information Technology (ONC), issued a new proposed framework indicating their desire to more consistently regulate health technology, including health software.
Now members of Congress have written to the ONC regarding that proposal, saying parts of it go above and beyond its authority under the law.
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed into law, and with it a requirement that FDA, ONC and Federal Communication Commission all work together to develop a cohesive approach toward health IT.
Section 618 of FDASIA called for the group to specifically consider mobile medical applications, how to best promote innovation in health IT, patient safety and regulatory simplicity.
The overarching goal of the initiative was to simplify health IT regulations such that companies understand which agency's-FDA or FCC-requirements they will be expected to meet and how they can expect to meet them when they want to bring a new product to market.
FDA, FCC and ONC all said they were looking to consider three things:
- types of risk that may be posed by health IT that impact patient safety, the likelihood that these risks will be realized, and the impact of these considerations on a risk-based approach
- factors or approaches that could be included in a risk-based regulatory approach for health IT that also promote innovation and protect patient safety
- approaches to avoid duplicative or overlapping regulatory requirements
The group released a set of draft recommendations in September 2013, which called for FDA, ONC and FCC to work together to coordinate their actions. The draft report similarly called for the creation of new frameworks of regulation and reporting.
Those recommendations were borne out in fuller detail in April 2014, when ONC, FDA and the FCC released their final report, Proposed Strategy and Recommendations for a Risk-Based Framework.
As Regulatory Focus explained in our write-up on the final report, the group called for the creation of a so-called "Health IT Safety Center," which would be run by ONC as a public-private entity with input from FDA, FCC and the Agency for Healthcare Research and Quality (AHRQ). The center would be charged with promoting patient safety, as well as "assisting in the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts," the group wrote.
A Skeptical Congress
But after reading the proposal, legislators are now pressing ONC to explain its authority to establish the Health IT Safety Center at all, saying it seems unlikely that it can.
The legislators, with the House Energy and Commerce Committee, wrote that the report "suggests that the ONC would, among other things, create a Health IT Safety Center for the purposes of regulating software and other Health IT products. In addition, the ONC 2014 budget suggests it will impose a new user fee on Health IT vendors and developers to support ONC's certification and standardization activities."
"However, it is not clear to us under what statutory authority ONC is now pursuing these enhanced regulatory activities, including the levying of new user fees, on Health IT," the legislators wrote in a letter to Karen DeSalvo, national coordinator for HIT at ONC.
The legislators, including Committee Chairman Fred Upton, Committee Vice Chairman Marsha Blackburn and subcommittee chairmen Joseph Pitts and Greg Walden—all Republicans—asked ONC to provide more details about its intentions going forward, including how it plans to interface with FDA.
"FDA is provided with the authority to regulate medical devices by the Federal Food, Drug and Cosmetic Act," they wrote. "What similar authority does ONC point to, going forward, to participate in regulatory activities in coordination with the FDA and the FCC," they asked.
In a separate statement, the legislators said they feared that the efforts amounted to "another layer of bureaucracy" that could "hamper" efforts to bring cutting-edge technology-based treatments to consumers in a timely fashion.
FDA has already clarified that it is not seeking any "new areas of oversight."