ARLINGTON, Va., Oct. 30 -- The Association for the Advancement of Medical Instrumentation issued the following news release:
A new bill in Congress seeks to further define the U.S. Food and Drug Administration's (FDA) regulatory authority over mobile medical applications, clinical decision support, electronic health records, and other healthcare-related software.
Rep. Marsha Blackburn, R-TN, introduced HR 3303, the "Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act," which she said builds upon the recent FDA guidance governing mobile medical apps. The bill has five cosponsors from both sides of the aisle: Reps. Gene Green, D-TX, Phil Gingrey, MD, R-GA, Diana DeGette, D-CO, Greg Walden, R-OR, and G. K. Butterfield, D-NC.
According to a statement from Blackburn's office, under current law, the FDA could use its definition of a medical device to regulate many types of software--potentially stifling innovation. In the statement, Blackburn's office said her bill would focus regulatory authority on products that pose the greatest risks to human health.
If enacted as written, the SOFTWARE Act would establish three kinds of software--medical, clinical, and health--the latter two of which would not be subject to regulation under the Federal Food, Drug, and Cosmetic Act. The bill designated the FDA'sCenter for Devices and Radiological Health as having regulatory responsibility over medical software, which can "directly change the structure or any function of the body of man or other animals," according to the proposed legislation.
Clinical software, as defined by the bill, can capture and analyze patient data and serve as a support tool for clinicians in the healthcare setting. Health software would not be used in the direct delivery of patient care and has its primary purpose "to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data," according to the proposed bill.
The bill's introduction came about a month after the FDA released its final guidance on mobile medical apps. According to the document, the agency will focus on apps that either are intended to be used as an accessory to a regulated medical device, or can transform a mobile platform into a regulated medical device.
Blackburn said her bill would benefit both industry and the FDA. "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," she said in the statement released by her office.
Butterfield noted that mobile medical apps can improve the health of patients living in remote locations. "In rural areas like many I represent, access to care can be a challenge. Smartphone apps can help individuals better monitor their health and improve health outcomes when used in conjunction with the tools available to healthcare providers," he said.
The proposed bill has received praise in some circles, including from the Information Technology and Innovation Foundation (ITIF). "As long as there is regulatory uncertainty about medical software, many companies will avoid developing new technology for this market," said Daniel Castro, a senior analyst with ITIF, in a prepared statement. "The SOFTWARE Act would have the FDA focus its regulatory oversight on those technologies that pose the greatest risk to human health, while allowing lower risk products into the marketplace more rapidly."
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