The House Committee on Energy and Commerce’s Subcommittee on Health hearing titled “Examining Federal Regulation of Mobile Medical Apps and Other Health Software” was held on November 19th on Capitol Hill. The hearing focused on FDA’s final medical app guidance published September 2013.
Jeffrey E. Shuren M.D. J.D., Director for FDA’s Center for Devices and Radiological Health discussed FDA’s recently published final guidance and emphasized that mobile health app developers and manufacturers need a clear, predictable, and reasonable understanding of FDA’s expectations.
He said, ‘As the final guidance demonstrates, FDA has adopted a balanced approach to mobile apps that supports continued innovation while ensuring appropriate patient protections. The Agency intends to exercise enforcement discretion for the majority of mobile apps since they pose minimal risk to consumers. However, FDA intends to focus its regulatory oversight on a subset of mobile apps that present a greater risk to patients if they do not work as intended.
The hearing was held to also discuss the legislation “Sensible Oversight for Technology Which Advances Regulatory Efficiency” or called the “SOFTWARE Act of 2013”. In the opening statement, Representative Joe Pitts, Chairman of the Subcommittee on Health said, “The SOFTWARE Act (H.R. 3303) is a starting place and an opportunity to begin a dialogue with the FDA.”
Energy and Commerce Committee Vice Chairman Marsha Blackburn (R-TN) and five of her colleagues both democrats and republicans recently introduced the SOFTWARE Act to modernize the FDA to meet the challenges the agency needs to meet.
The Act would provide for regulatory clarity regarding mobile medical applications, clinical decision support, EHRs, and other healthcare related software. By building on the guidance recently released by the FDA and codifying their risk-based regulatory approach, the Act would provide the regulatory certainty that technology companies need in order to continue to drive innovation and ensure patient safety.
As Michael Marchlik, Vice President for Quality Assurance and Regulatory Affairs at McKesson Technology Solutions said, “This bipartisan legislation is an important and necessary step toward establishing a new regulatory framework for health IT that recognizes the different categories of health IT as medical software, clinical software, and health software. The Act also would enable FDA to focus oversight on the technology that poses a potential risk to patient safety.”
He added, “The existing FDA regulatory framework is not well suited for regulating clinical software as medical devices or the software that operates these devices acting directly on a patient. As a result, potential harm can stem from how the device or software is designed and manufactured. Clinical software requires a new risk-based regulatory framework that will share responsibility among health IT developers and providers.”
Zachary J. Lemnois, Vice President for Research Strategy at IBM Research said, “This bill will refocus the government’s regulatory energies towards software and devices that directly affect patients, without interfering with their doctor’s ability to draw on as much information as possible. This enables consumers to have access to the most innovative healthcare IT without being burdened by regulatory requirements that will not improve the safety of the products.