Before Congress left for the annual Easter Recess, the House Energy and Commerce Committee devoted most of its week to focusing on mobile health innovation with three separate hearings on the topic. Two of the three hearings included witnesses from San Diego’s innovation community represented by Qualcomm and the West Health Institute.
The first hearing was in the Subcommittee on Communications and Technology and was titled “Health Information Technologies: Harnessing Wireless Innovation.” Subcommittee Chairman Greg Walden (Oregon) started the hearing by noting that the Subcommittee does not often hold hearings on FDA issues as other Subcommittees have jurisdiction over FDA but because the mobile health sector is innovating so rapidly through wireless devices, and because of the concern that if the FDA regulates in a heavy-handed way, wireless health innovation could be stifled, it was necessary for the Subcommittee to review the issues in greater depth.
“Investors, wireless device manufacturers and application developers all face the uncertainty of an FDA regulatory regime that may or may not apply to them and the possibility of an additional excise taxj[Obamacare medical device tax] that cuts into already thin margins. The collision of worlds in the mobile health – or mHealth – market is a study in contrasts,” stated Walden. Walden continued, “The app economy is characterized by low barriers to entry, quick time to market, and the ability to adapt to quickly changing user needs. Medical devices, on the other hand, face a long and costly pre-market approval process at the FDA. We all want to ensure patient safety, but why would we treat mobile applications the same as a dialysis machine? While the IRS and the FDA have provided some draft guidance on how they will apply the medical device definition and the medical device tax, their analysis is not a poster child of clarity and leaves large parts of the economy wondering if they will be on the hook for what is essentially a tax on innovation.”
Robert Jarrin, Senior Director of Government Affairs for Qualcomm, discussed the revolutionary impact of mobile technology and its global reach as 3.2 billion of the world’s 7 billion people are connected to mobile technology, many of them with multiple mobile connections. Those connections garner much of the user’s attention as users tend to check their phones about 150 times per day—an average of once every six and-a-half minutes. Today’s handheld smartphone has more computing power than Apollo 11 did when it landed on the moon. Noting that just as many Americans have ubiquitous access to smartphones, many Americans also struggle with chronic disease, Jarrin surmised, “Hence it was only a matter of time before healthcare technology innovators would take notice of the potential to personalize and take advantage of the mobile platform to facilitate and improve the delivery of affordable healthcare. Nowhere is this growth more obvious than in the mobile health applications landscape, which has, quite simply, skyrocketed.” The concern among wireless health innovators like Qualcomm is that nearly two years has passed since the FDA issued a Draft Guidance on Mobile Medical Applications (MMA). That failure to release final MMA guidance “has created uncertainty among countless budding entrepreneurs and large corporations that fear the prospect of facing FDA regulation.” To give the FDA some guideposts as to what innovators might find helpful in a Final Guidance, Qualcomm has proposed seven recommendations including:
- FDA should promptly finalize the MMA draft guidance document.
- The final MMA guidance should offer specific examples of low-risk, regulated mobile medical devices that FDA, through enforcement discretion, would not regulate.
- There should be clarity on “Intended Use” in light of ambiguous and general health claims and terms that are popularly used by the health IT industries.
- For those apps that warrant listing as low-risk Class I devices, the Agency should consider how it will assess exemption from Good Manufacturing Practices (GMP).
- Accessories should be classified according to their individual level of risk and not according to the device with the highest classification level.
- FDA should continue its commitment to consistency, predictability and transparency by coordinating internal and external efforts through a single dedicated office of mobile health within FDA.
- The agency would benefit to utilize external facing resources such “CDRH Learn”, “Device Advice” and the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) to work with app developers and their communities.
The second hearing was in the Subcommittee on Health and was titled “Health Information Technologies: How Innovation Benefits Patients.” Subcommittee Chairman Joe Pitts (Pennsylvania) laid out the Subcommittees desire to review the appropriate intersection between innovation and regulation in healthcare innovation, “Therefore, it goes without saying that these technologies hold great potential for patients and providers. However, with the proliferation of these technologies have come concerns about how their use may negatively impact patients…While FDA’s attention to the needs of patients is commendable, its action requires very close scrutiny. This subcommittee has examined in the past the negative impacts that FDA regulation – with its uncertainty, high costs, and long approval times – has had on the medical device industry. If we allow the same to happen in this space, such negative impacts could cripple a still evolving and promising industry, where the average developer is small and the cost of these apps are relatively inexpensive.”
Dr. Joe Smith, Chief Medical and Science Officer of the West Health Institute, stressed the need for America’s healthcare system to have to change, “Our nation’s health care system is in dire need of dramatic change. The subtitle of the Institute of Medicine’s (IOM) recent publication on U.S. health says it all ‘Shorter Lives, Poorer Health.’ The report illustrates that Americans are living sicker and dying quicker than citizens of peer nations that spend far less for higher quality outcomes. The economics are unsustainable. As we approach spending nearly 20 percent of our gross domestic product [GDP] and our family budgets on health care, we risk foreclosing on the American Dream, hindering our international competitiveness, and potentially compromising our national security. The logistical challenges of extending our current model of care delivery to an aging population, with a growing shortage of physicians, only make the need for change more clear.”
Dr. Smith continued, “We see an enormous opportunity to use information technology, device innovation, and smart/learning systems to transform health care delivery and create empowered, informed consumers of health care. Health care must be allowed and encouraged to rapidly evolve using the same innovations that have already revolutionized other industries. Banking, education, retail, computing, photography, and communication have all been transformed in our lifetimes, lowering their complexity and cost while improving efficiency and ease of use. Health care has avoided this modernization, persisting in a model of delivery that to our grandparents is as recognizable as it is complex and unaffordable.” The West Health Institute’s goal is to help advance such a transformation and is hopeful that some ingredients for evolution already exist, “Importantly, the technological elements required to realize this transformation in health care delivery are close at hand, but our regulatory and reimbursement systems frustrate the innovation, development, and adoption required to realize the full vision.” To spur the discussion, Dr. Smith discussed three enablers WHI has identified as necessary for transformation:
- Streamlined, predictable, transparent, risk-based regulation that fosters innovation and investment for the benefit of patients, as well as our ailing health care system;
- A proactive regulatory and reimbursement stance on true functional interoperability, not just the semantic interoperability of our electronic health records, but also medical device interoperability — to take full advantage of the medical technology that we have to create an integrated, coordinated health care system; and
- Reimbursement policy that aligns stakeholder incentives and drives adoption of appropriate technology to improve the safety, efficiency, and cost of health care delivery.
Related to interoperability, Dr. Smith released a new WHI study that found that “functional medical device interoperability improves patient care, increases efficiency, and results in more than $30 billion a year in health care savings.”
After the busy week, Timothy Tardibono, CONNECT’s Washington D.C. Office director reflected, “It was a good week for San Diego’s health innovation community. The House is really focused on innovation related issues and it was encouraging that the powerful Energy & Commerce Committee is exposed to San Diego’s innovation story. Both Mr. Jarrin and Dr. Smith did excellent jobs, not only raising important concerns, but also providing thought-provoking policy solutions. San Diego is blessed to have these kinds of innovation policy leaders helping to advance America’s competitiveness and to shepherd the growth of the health innovation ecosystem.”
To learn more about, or watch the “Harnessing Wireless Innovation” hearing, click here.
To learn more about, or watch the “How Innovation Benefits Patients” hearing, click here.
To learn more about West Health Institute’s study on Interoperability, click here.