'Software is Not a Medical Device': House Holds Hearing on SOFTWARE Act

The House Energy and Commerce Health Subcommittee held a hearing today on the bipartisan Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act. The act, H.R. 3303, would amend the Federal Food, Drug, and Cosmetic Act to allow for regulation of medical software. It would add a new “medical software” category to the FDA regulatory framework. Regulated software would not be medical devices in the strict sense, but would require FDA regulation as though they were. The bill would also take away FDA's jurisdiction over two new categories defined as “clinical software” and “health software.”

The bill defines medical software as:

“Clinical software” is defined as:

“Health software” means:

Representatives Marsha Blackburn (R-TN) and Diana DeGette (D-CO) introduced the legislation only a short time after FDA issued its final guidance on mobile medical apps with the hopes of codifying the provisions made in the guidance. “Unfortunately FDA is stuck using a 1970s definition of a medical device to regulate mobile medical apps and other healthcare-related software,” Blackburn said, speaking before the subcommittee. “The SOFTWARE Act would give the agency a needed tool for emerging technologies where necessary while allowing moderate- to low- risk developers the certainty necessary to proceed with development, knowing full well what the regulatory playing field is going to be.”

Subcommittee vice chairman Michael Burgess (R-TX) echoed Blackburn's comments, adding that creating clarity in the regulatory environment for software engineers is crucial. “We want predictability for our providers,” Burgess said, noting that software advancements like clinical decision support, for example, have the potential to transform how medicine is practiced. However, “the lack of careful regulation could end many of these programs before they begin.” Indeed many on the committee applauded FDA for restricting its reach with regards to medical software. Many will remember before the guidance was released there were fears that FDA would overreach and stifle innovation by attempting to regulate all types of health-related software and even smartphones and tablets.

Dr. Jeffrey Shuren, director of CDRH, was on hand to testify to the committee with regards to FDA's development of its mobile apps guidance and the agency's plans moving forward. Shuren said the mobile medical landscape reaches beyond FDA and is an interconnected framework that many government agencies will need to work together to properly regulate. “Mobile medical apps represent just one component in an increasingly connected healthcare environment. Three Federal Agencies—FDA, ONC, and FCC—have unique and complementary responsibilities in the health IT arena.” Shuren cited Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA) which requires the agencies to coordinate on a report, to be prepared by January 2014, that will contain “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.” 

In his own statements, Zachary Lemnios, VP of research strategy at IBM Research, agreed with Shuren. “The current approach is not a good fit for new technologies that operate within interconnected systems,” Lemnios said. “The field of medical information technology is populated with multiple players, whose technology can be rapidly and iteratively improved through deep collaboration between IT providers and the clinical end-users. The resulting technologies are intended to aid clinical decision making rather than directly diagnose or treat patients.” Lemnios went on to urge Congress to realize that all software is not the same and there should be a one-size-fits-all approach to regulating it. “Using the current medical device regulatory framework to determine if and how to regulate the diversity of potential healthcare IT software would be the proverbial case of trying to fit a square peg in a round hole.”

Shuren went on to conclude, “FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile apps that present risks to patients if they do not work as intended.”

There were, however, concerns that the attempt to legislate medical software may be moving too presumptively. Rep. Henry Waxman (D-CA) asked if perhaps the SOFTWARE act was coming too soon, especially since Congress and the medical device industry have not yet seen the full ramifications of FDA's mobile medical apps guidance. “We have barely had an opportunity to see how [the guidance is] working out and whether there are any instances of burdensome requirements stifling innovation in this area,” Waxman said in his opening remarks. “It is not appropriate to legislate based on unfounded fears of what 'might' happen in the future.”

He continued, “Second, by almost all of the accounts I have heard, the guidance has been very favorably received by most of the industry. It is written in a clear and concise manner, including a litany of specific examples that provide the regulatory certainty so many in the industry were seeking.”

He also questioned whether the SOFTWARE Act, in its current form, is able to strike the balance between patient safety and promoting innovation that the FDA guidance does. “As I think we will hear today, the current draft of the SOFTWARE Act does not strike that balance. This bill upsets this balance...As we all know, once a law is in place, it is very difficult to change it. And it is exceedingly difficult to craft the perfect legislative language that will preserve FDA’s ability to oversee an appropriate subset of these changing technologies now and years into the future.”

Dr. J. Leonard Lichtenfeld, deputy chief medical officer at the American Cancer Society, applauded the growing role of health information technology (HIT), software, and mobile apps in patient care, but also stressed some of the same concerns as Waxman and recommended some important considerations for the new model. He urged, whatever the final draft of the legislation be, it should make patient safety and privacy of paramount importance and create a fluid system capable of quickly adapting to changing technologies. He also asked that Congress be aware of details in definitions. “If changes are enacted to create new categories of medical software applications with differing levels of oversight, then the definitions of those categories must be very clear and not create loopholes, ambiguities, or unintended consequences.” He also asked Congress to ensure that solutions are focused on the actual problem. “Innovation in software and mobile apps can be promoted through regulatory certainty and the relief of regulatory burden on software sectors where it is not appropriate,” Lichtenfeld says. “This may be possible with narrower policy changes aimed at targeted sets of software rather than an entirely new paradigm for the full spectrum of software and mobile apps.”

Moving forward, the key takeaway for legislators will be that developers should hold patient safety and clinical outcomes at the highest regard but Congress should also be conscious of making sure that innovation and even simple software patches and updates can be implemented at a rate developers are accustomed to and will also help patients.

 -Chris Wiltz, Associate Editor, MD+DI

[email protected]

View the entire House subcommittee hearing below: