Industry: New SOFTWARE Act Provides Certainty

Rep. Blackburn’s SOFTWARE Act has changed substantially since it was first introduced and is being praised by device manufacturers for providing much needed clarity on how far FDA can go to regulate Medical and Health software.

Industry groups say the updated language in the new 21^st Century Cures document covering medical software such as mobile health applications and clinical administrative software gives software developers much needed certainty.

After a year of roundtable discussions and committee hearings, the House Energy and Commerce Committee released a discussion document based on their 21^st Century Cures Initiative which includes legislation proposed by Reps. Marsha Blackburn, R-Tenn., called the Sensible Oversight For Technology Which Advances Regulatory Efficiency (SOFTWARE) Act. (See (Also see "Device Industry Grab-Bag Of Provisions In 21st Century Cures Draft" - Medtech Insight, 27 Jan, 2015.).)

However, the language proposed in the discussion document is significantly different than what was initially floated in October 2013. (See (Also see "Bipartisan House Bill Introduced To Curb FDA Health IT Oversight" - Medtech Insight, 23 Oct, 2013.).) It more closely resembles the Senate version of the bill introduced by Sens. Orin Hatch, R-Utah, and Michael Bennett, D-Colo. (See (Also see "Senate Bill Would Exempt Low-Risk Apps From FDA Oversight" - Medtech Insight, 5 Dec, 2014.).)

In the past, Bradley Thompson, with the recently shuttered mHealth Regulatory Coalition, suggested that trying to legislate the rules on mobile health applications would create too many restrictions and preferred to give FDA more leeway to develop guidance that would respond to how the industry and technology evolved. However, he says they support the new broader language which strikes a balance between legislative direction and allowing FDA flexibility to develop guidance. (See (Also see "Active Months Ahead For mHealth Regulatory Policymaking" - Medtech Insight, 1 Oct, 2014.).)

“Originally, the authors of the bill were addressing all health information technology and trying to divide it into three different buckets…But over the last year, the sponsors of the bill apparently changed their mind and instead are much more focused on drawing a sharper line around FDA regulation,” said Thompson. “So that's a much different exercise than was originally envisioned. Thus, the bill has the more modest goal of simply trying to put ambiguous software on either one side of the line.”

Stephanie Zaremba, a senior manager for government affairs at AthenaHealth, praised the bill and said it represents a rare moment when lawmakers come across party lines and chambers to stand behind legislation that can improve patient safety while also giving industry the certainty it needs to move forward with their business plans.

“I think it's a really great thing for patient safety because we're now going to have a framework for these health [information technology] products that makes them safer and it's also going to be a great thing for innovation because you're going to have entrepreneurs knowing where they stand,” she said.

Even though FDA has been simultaneously developing guidance for mobile health, Zaremba says from a legal perspective they don’t offer the kind of certainty that legislation does.

“There have been a lot of groups in the past year that have been pretty opposed to this legislation…[with the new changes] we think we’re seeing those groups changing their position,” she said.

New SOFTWARE Act

Even before the SOFTWARE Act was proposed, FDA, the Office of the National Coordinator for Health IT and other agencies outlined their thinking of health software in its FDASIA Health IT report and said it would take a risk-based approach and refrain from regulating most mHealth technology. (See (Also see "ONC Outlines Plan To Expand Telehealth, Mobile Health" - Medtech Insight, 11 Dec, 2014.).)

“The administration was moving forward along the same lines as what’s in [the SOFTWARE Act] and we think that’s good…it was very similar to our framework actually,” said Janet Marchibroda, director of health innovation at the Bipartisan Policy Center which has been heavily involved with helping draft the new legislation. “But many companies developing products in this area [felt] just having a draft plan out there wasn’t law and they couldn’t hang their hats on it which is why legislation was needed.”

While the previous version of the legislation proposed a three-tier system that would put health software into categories based on their level of risk, the new proposal lines up more with the Senate version to break them into two categories. In the previous version, software prescribed and monitored by physicians would not be regulated by FDA but the new version seems to have pulled that language and instead replaced it with a timeline for FDA to develop regulations categorizing various medical software within two years of enacting the law.

The proposed language states that medical software would not be required to have a premarket approval or clearance unless superseded by other provisions of the act.

According to the proposed language, health software that is not considered medical software, a component and is intended to provide healthcare support should not be regulated by FDA. Such software could include programs for administration, aggregating medical data, platforms for other software, and or applications to help patients monitor their health.

Keeping this software outside of FDA’s regulatory authority is part of the “the learned intermediary” approach, according to Zaremba. She says the idea is that health software alone would not be used to make clinical decisions, but rather physicians who have medical training would use the information from the software to make decisions. Therefore, the software itself can be regarded as “low-risk.”

The committee does however ask: “How do we ensure that products that have features that should be regulated as medical software or medical devices or components thereof are not exempted from regulation as such products?”

According to the bill, within the 24 month period after enactment FDA would be required to develop regulations to classify medical software, standards for development of medical software, develop validation and verification standards for such software, timelines for reviewing the software, oversight of software modifications, software manufacturing standards, oversight of medical software quality systems, labeling requirements and postmarketing requirements.

The bill also states FDA should convene with industry and other stakeholders within six months of the act being made into law to discuss it and hold a follow-up workshop six months thereafter. Within 18 months of the law being passed, FDA is required to issue draft guidance based on the regulatory oversight proposed in the bill.

Another addition to the SOFTWARE Act is clarification of what should be considered a medical accessory. Incidentally, FDA recently issued a draft guidance outlining its definition and regulatory oversight of medical accessories.

“The legislation takes a somewhat similar approach to the guidance in terms of defining what an accessory is, but then specifies that FDA needs to classify accessories independently of the parent medical devices they accessorize,” said Thompson. “In contrast, the FDA guidance just tells companies to come in on a case-by-case basis and request down classification.”

What’s Next?

The mHealth Regulatory Coalition closed shop in January after completing their objectives of getting FDA to release a mobile medical app guidance, a wellness guidance and an accessory guidance.

“The group was only supposed to be in existence for about a year back in 2010, but it took as it turns out longer than that – indeed four years – to achieve the objectives the group set for itself,” said Thompson. He says the group is “fundamentally” satisfied with the direction of the mobile medical app and general wellness guidance, and doesn’t think there needs to be any legislation regarding FDA oversight in those areas.

However, Thompson also represents the Clinical Decision Support (CDS) Coalition which has spent the last three years working with FDA and other stakeholders on how far the agency’s oversight of CDS software should be. The coalition is recommending FDA have jurisdiction over high-risk software where users are substantially dependent on them for a diagnosis or treatment decision and would like to see it cemented through the proposed legislation.

“In effect, this idea of substantial dependence is a way to distinguish between software that is used simply within the practice of medicine, and software that functions as a regulated medical device,” said Thompson. “The Hatch and Bennet legislation addresses this criterion of transparency, and we'd love to see that embraced in the house bill as well. We believe there is broad support for using this concept of transparency to draw the line around FDA jurisdiction of CDS.”

He also says he does not think risk should be the only criterion determining what FDA regulates. In general he says FDA should not regulate the practice of medicine and says medical software can often take on elements of the practice of medicine when physicians use them to gather information in their decision-making.

“Even if the physician's decision involves a risky therapy, fundamentally physician decision-making is part of the practice of medicine and should be regulated by the state boards of medicine, not FDA,” said Thompson. “So it is this additional principle, beyond risk, which needs to be spelled out more specifically in the statute.”

For Marchibroda the next step is to work with FDA to develop regulatory oversight of high-risk medical software.

“We think it [should be] through a public-private partnership that there is voluntary consensus standards and independent testing, just like we have for other parts of healthcare,” she said. “This bill was silent as to what types of oversight that should be applied to health software and we’re okay with that.”

Overall Zaremba says AthenaHealth is very happy with how the bill has turned out and plans to submit “single-word” tweaks to help clarify certain parts.

[Editor's note: Each week, "The Pink Sheet" DAILY features a story from “The Gray Sheet,” highlighting a current topic in the medical device or diagnostics sectors.]