Capitol Hill: Call for new reg framework for apps

On day two of three scheduled days of hearings regarding health IT, specifically the growth of medical apps and whether they warrant FDA oversight, the House Committee on Energy & Commerce debated innovation, device tax and more.

Chairman Joe Pitts (R-Pa.) said that the proliferation of medical apps holds great potential for patients and providers but also bring concerns about how their use could negatively impact patients.

One of the five witnesses participating in the hearing was Joseph M. Smith, MD, PhD, chief medical and chief science officer at the West Health Institute in San Diego. Smith called for three key enablers for the transformation of the U.S. healthcare system:

  1. Streamlined, predictable, transparent, risk-based regulation that fosters innovation and investment for the benefit of patients, as well as our ailing healthcare system;
  2.  A proactive regulatory and reimbursement stance on true functional interoperability, not just the semantic interoperability of our EHRs, but also medical device interoperability -- to take full advantage of the medical technology that we have to create an integrated, coordinated healthcare system; and
  3. Reimbursement policy that aligns stakeholder incentives and drives adoption of appropriate technology to improve the safety, efficiency and cost of healthcare delivery.

“It’s difficult to overstate our challenges,” Smith said. “Our healthcare delivery system is exceeding our nation’s budget and our providers’ bandwidth without yet meeting our patients’ needs. Healthcare must be allowed and encouraged to rapidly evolve. We must drive regulation at the pace of innovation and not vice versa.”

Jim Bialick, executive director of the Newborn Coalition which works to screen newborns for congenital heart defects, called for a new patient-centric, flexible framework for medical app oversight. He said that FDA’s 2011 draft guidance to regulate mHealth apps as medical devices was surprising but also already outdated at the time. “A new regulatory process is daunting. Reform will not be without controversy.”

Mobile apps can no longer be considered discreet pieces of software that reside on a specific device, Bialick said, thanks to cloud technology. “Congress should be concerned that the creativity and innovation that is helping patients and parents may evaporate under well-intentioned, but ill-conceived regulations. What we need is a new framework for evaluating health technologies that can scale to effectively regulate what we are using today, and anticipate technologies yet to be conceived.”

Another witness, Jacqueline Mitus, MD, senior VP of clinical development and strategy for McKesson Health Solutions, also called for a new regulatory framework that is risk-based and specific to health IT. Mitus also expressed concern for the broad definition of medical devices. “It can be interpreted to include all health IT including medical software.”

The safety of a medical device “is almost entirely dependent on how it is manufactured. The safety of health IT, on the other hand, hinges on how it is developed and, more important, how it is implemented,” she said. Moreover, medical devices are directly involved in the care of a patient with little opportunity for a clinician to intervene. The majority of health IT, however, provides data and guidance. The ability of a learned intermediary distinguishes this technology from other devices, Mitus said.

“Safety considerations need to be embedded throughout the whole process” of health IT, said David Classen, MD, MS, CMIO of University of Utah Health Science Center. He called for shared responsibility between vendors and users because “it’s important to recognize that health IT products generally cannot be installed out of the box. Health IT in operation can look different than it did on the shelf.”

When asked whether data should be classified as a medical device, all the witnesses said no.

When asked whether he believed FDA has the expertise to regulate medical app technology, Smith said, “it’s quite challenging for the FDA for many reasons to stay as current as possible on those things that are just emerging. The opportunity for external expertise needs to be exploited much more thoroughly.”

“Health IT requires a different paradigm not well-suited to the current process,” said Mitus. Classen said that if FDA is further involved then a framework should be created.

“Until we focus entirely on the outcome, we will facilitate the system we’ve had which is one of emergency rescue as opposed to healthcare,” said Smith. “There’s a huge difference between a one-to-one patient encounter vs. information you can get on the web.”

“A medical device, in our minds, sits directly tied to a patient replacing human judgment,” said Mitus. “A physician who receives an alert or accesses guidelines and is allowed to use his or her own common sense is fundamentally different than a device.”

“That’s a distinction that has to be made,” said Henry Waxman, (D-Calif.).

Another committee member noted that if a burdensome regulatory process inhibits innovation and financial success, “investors are more likely to look for the next Angry Bird rather than the next angry mole.”

Bialick pointed out that any additional cost to the development process—most likely in the form of taxes—would change the app market. “If we increase startup costs, vendors are likely going to have to stop offering their apps for free to require that end-users pay for additional functionality within the app.”

Phil Gingrey (R-Ga.) said some have suggested the mobile health apps may be a game changer. Smith responded that “it would be sad if where we are is where we’re going.” We’re on the cusp of more engaged consumers and ambient healthcare.