On October 22, Rep. Marsha Blackburn (R-TN) introduced a bill serving to “provide for regulating medical software, and for other purposes” in the House of Representatives. The bill, entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (“SOFTWARE”) Act (“the bill”), was co-sponsored by a bi-partisan group of lawmakers.
The bill creates a regulatory scheme based on three newly defined categories of software—“medical software,” “clinical software,” and “health software.” Although the bill proposes to carve out “medical software” from the definition of “device” in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321) (“the Act”), medical software would be subject to the same regulatory requirements as medical devices under the Act. In contrast, “clinical software” and “health software” would not be subject to regulation under the Act.
The bill defines medical software as software intended for human or animal use that is intended to be marketed (1) “to directly change the structure or any function of the body of man or other animals;” or (2) for “use by consumers and makes recommendations for clinical action that (i) includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider; and (ii) if followed, would change the structure or any function of the body of man or other animals. . . .” Medical software does not include software “whose primary purpose is integral to the functioning of a drug or device” or software that is a “component of a device;” such software presumably would continue to be regulated as part of the “parent” device or drug product.
The bill states clinical software is “clinical decision support software or other software” that “captures, analyzes, changes, or presents patient or population data or information and may recommend courses of clinical action, but does not directly change the structure or any function of the body of man or other animals” and is “intended to be marketed for use only by a health care provider in a health care setting.” The bill defines “health software” as software that “(A) captures, analyzes, changes, or presents patient or population clinical data or information; (B) that supports administrative or operational aspects of health care and is not used in the direct delivery of patient care; or (C) whose primary purpose is to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.”
As discussed in a prior post on InsideMedicalDevices, FDA issued final guidance on mobile medical software in September 2013. FDA’s final guidance appeared to narrow the scope of mobile apps that FDA intends to regulate as medical devices, but did not fully clarify several questions, including how FDA intends to regulate certain types of software that perform patient-specific analysis to aid or support clinical decision-making. A press release on Congresswoman Blackburn’s site states that the current statutory structure would allow FDA “to assert broad regulatory authority over a wide array of software,” and thus the purpose of the bill is to “tailor. . . [FDA’s]. . . authority to the realities of the 21st century by focusing [its] authority onto the products that pose a potential risk to human health.”