A group of legislators has filed a bill seeking to further define what the FDA can and can't do with regard to regulating mobile medical apps.
The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act (H.R. 3303), filed on October 22 by six House members – three from each party – targets Section 201 of the Federal Food, Drug and Cosmetic Act.
"Estimates indicate that the number of consumers using medical apps on their smart phones will grow to 500 million by 2015. But today the FDA lacks the necessary tools to appropriately oversee these innovative products without overstepping their authority and stifling innovation," the House members said in a joint statement. "Under current law, the FDA could use its definition of a medical device to assert broad regulatory authority over a wide array of software. The SOFTWARE Act tailors their authority to the realities of the 21st Century by focusing their authority onto the products that pose a potential risk to human health."
The bill would classify software into three distinct categories – clinical, health and medical – and restrict the FDA's focus to medical software. It further mandates that the president and Congress "should work together to develop and enact legislation that establishes a risk-based regulatory framework for such clinical software and health software that reduces regulatory burdens, promotes patient safety and fosters innovation."
Writing on Practice Fusion's EHR Bloggers site, Lauren Fifield, senior health policy advisor for Practice Fusion, clarified those three categories.
"The primary delineating point between ‘medical software’ as opposed to ‘clinical software’ and ‘health software’ is that the former is marketed to and leads to changes in any bodily function of human beings or other animals," she wrote. "As proposed, ‘clinical software’ is intended and marketed for use in the healthcare setting by a healthcare provider, while ‘health software’ is not used in the direct delivery of patient care."
"The (bill's sponsors) emphasize that ‘clinical software’ and ‘health software’ are important to the advancement of national healthcare delivery goals, including improved patient safety and innovation, lower delivery costs, increased quality and efficacy of care provided, and improved health of individuals," she added. "The representatives suggest that the president and Congress should work together to enact legislation that would promote patient safety and innovation through the development of a reduced-burden, risk-based regulatory framework for ‘clinical software’ and ‘health software.'"
In an accompanying statement with the bill, each of the bill's six sponsors supported the need for legislation.
“Our legislation takes the necessary steps to protect technological innovation that is filtering into growth sectors like healthcare," said Rep. Marsha Blackburn (R-Tenn.) in the statement. "This bill would provide the FDA with the tools it needs to effectively protect consumers who use high-risk technologies, while allowing the innovation of low-risk technologies to continue without being caught up in the expensive and time-consuming FDA approval process all while protecting patient safety.”
“Every day, innovative pioneers in the mobile health sector are working on solutions that help patients while reducing healthcare costs," added Rep. Greg Walden (R-Ore.), another sponsor, in the statement. "The app economy is characterized by low barriers to entry, quick time to market and the ability to adapt to quickly changing user needs. Medical devices, on the other hand, face a long and costly pre-market approval process at the FDA. We all want to ensure patient safety, but why would we treat mobile applications the same as a dialysis machine? Our common-sense legislation gives regulatory clarity to this innovative industry while focusing efforts on potential risks to human health.”
Along with Blackburn and Walden, the bill's sponsors are Reps. Phil Gingrey, MD (R-Ga.), G.K. Butterfield (D-N.C.), Diana DeGette (D-Col.) and Gene Green (D-Texas).
“As new technologies emerge, it’s important that federal regulatory agencies like the FDA are properly equipped to provide a common sense level of oversight of medical software," Green said in the statement. "This bill builds on the steps forward made by the FDA in their recently released guidance and focuses federal resources on the medical software that pose a risk to patients and should be trusted to be safe and effective by patients and providers alike. This bill aims to encourage innovation in medical related software while providing the regulatory framework to keep us safe.”
The bill drew support from the Software and Industry Information Association.
“The SOFTWARE Act takes necessary steps to establish regulatory framework for medical software without compromising safety," SIAA President Ken Walsh said in an Oct. 23 statement. "Specifically, the SOFTWARE Act would create a bright line that delineates when the Food and Drug Administration (FDA) should regulate medical software, and when it should not, calling for FDA regulation of software only when it has the ability to change the end user’s current state of physiology with limited or no opportunity for informed human intervention."
Not everyone is on board with the legislation, however. Bradley Merrill Thompson, a Washington D.C. attorney and general counsel for the mHealth Regulatory Coalition questioned whether the bill would do more harm than good. In an interview with FierceMobileHealthcare, he said "the act of separating the software (into three categories) is fraught with challenges" and might "produce some unexpected outcomes."
The bill follows on the heels of the FDA's release last month of a final guidance document identifying which categories of mobile medical apps it would regulate. The long-awaited document was met with praise from most mHealth advocates.
While the SOFTWARE Act seeks to give the FDA a clear path to regulating mHealth apps, others have questioned whether the agency should even have that authority. In 2011, the Institute of Medicine issued a report – after being directed to do so by the Office of the National Coordinator for Health IT – advising that the FDA isn't the right agency to regulate HIT. The report indicated the FDA would likely hinder market innovation, which could also jeopardize patient safety, and has neither the manpower nor the investigative capabilities to regulate medical devices.
More recently, a coalition of roughly 120 health IT stakeholders had asked the government to delay the FDA's final guidance due to concerns about competing interests between the FDA, the ONC and other agencies caught up in HIT regulation. That group urged officials to wait until a workgroup created by the FDA Safety Innovation Act of 2012 finishes its review of the HIT regulatory framework.
That FDASIA workgroup completed its review, also in September, and recommended that the FDA move forward with its guidance. The FDA did so just a few weeks later.
