In past editorials, Trump’s FDA pick advocated hands-off approach for health apps

With previous rumored Trump picks to lead the FDA, we’ve had to rely on speculation to gauge their approach to mobile and digital health. Not so with former FDA deputy commissioner Dr. Scott Gottlieb, Trump’s final pick as of Friday.

Gottlieb, who will still have to be confirmed by the Senate, has made his feelings about mobile health regulation very clear. In 2014, he co-authored a piece for the Wall Street Journal about the FDA’s approach to mobile health and in 2015 he wrote a piece for Forbes. In both, he argued that FDA regulation of mobile health stifles innovation for little benefit.

“The ambiguity created by the guidance and the agency’s premarket review processes forces innovators to seek the FDA’s nod for every new launch and every small advance,” Gottlieb and co-author Colleen Klasmeier wrote for the Journal. “This slows progress to a crawl. Worse, the lag may be almost entirely unnecessary, as most of these products are not properly regarded as a medical device in the first place.”

Gottlieb argues that regulation for mobile health should be the exception, not the rule.

“Most of these products pose very low risk to consumers,” Gottlieb wrote in the Forbes piece. “They’re meant to help people track and interpret their own health information. In that respect, they often do little more than help consumers organize information that they could glean for themselves – albeit far less reliably – using the Internet. But since many of the more sophisticated offerings help people diagnose their own illness, FDA says they meet the definition of being a medical device. That makes them subject to a regulatory scheme that was crafted more than 40 years ago, before these technologies were ever imagined.”

Specifically, Gottlieb argues that the point at which a digital health device or app requires regulation is exactly the point at which it becomes innovative, and as a result large companies like Apple are “dumbing down” consumer products, excluding health features they technically could build to elude the FDA.

“FDA has said it doesn’t intend to regulate ‘general wellness’ apps and mobile tech, like fitness and calorie trackers,” Gottlieb wrote in 2015. “But if these platforms make disease-specific claims, FDA wants to review them. When does an app cross that line? Any time it does something smart. Envision a nutrition app that counts your calories and tracks how your diet might raise or lower your risk for diabetes, or cause blood sugar surges. Or an app that helps correlate your symptoms with a list of probable causes.”

As to a solution, Gottlieb has advocated passing responsibility for digital health tools away from the FDA entirely, either to a newly created government group or to the industry to self-regulate. This is a solution that can sometimes evoke eyerolls, but Gottlieb contends that it’s exactly what was done with EHRs at a time when they were a political priority and those in power at HHS didn’t want their adoption to be stymied by FDA regulation.

As FDA commissioner, Gottlieb would have the opportunity to put these ideas into action, assuming his stance hasn’t changed over the last few years. If he does, and he’s right that companies are currently holding back innovations, Gottlieb’s tenure could turn out to be a very interesting one for the digital health space.

Mount Sinai Apple ResearchKit study on asthma shows feasibility of smartphone-only studies

A new study demonstrates that conducting some studies entirely via smartphones is feasible, fruitful and scalable: it stands up to scientific rigor, allows for large-scale participant enrollment,and captures unique environmental data not available through traditional methods, as researchers at the Icahn School of Medicine at Mount Sinai have learned.

In a new article published today in the journal Nature Biotechnology, researchers show how they used the Apple ResearchKit framework to develop an iOS app to study how asthma affects the every day life of different people, as well as how they are managing their condition over time. They launched the Asthma Mobile Health Study in March 2015, and interest was immediately evident: within six months, 50,000 iPhone users had downloaded the app, which featured surveys to assess symptoms, medication adherence and other factors about the condition.

The total sample size capped at 7,593 people who completed the electronic informed consent process and enrolled in the study, and 85 percent of this group completed as least one survey. During the six-month study, 2,317 people ended up being “robust users,” filling out multiple surveys, and the results were compared to existing asthma patient studies and controlled for external factors like the reliability of patient-reported data.

“We critically assessed the feasibility, strengths, and limitations of a smartphone-based study and found that this methodology is particularly suitable for studies of short duration that require rapid enrollment across diverse geographical locations, frequent data collection and real-time feedback to participants,” Dr. Yvonne Chan, principal investigator of the study and the director of Digital Health and Personalized Medicine at the Icahn Institute for Genomics and Multiscale Biology, said in a statement. “Our study demonstrates the power of mobile health tools to scale and accelerate clinical research so that we can derive the evidence needed to inform clinical practice and improve patient care.”

The added advantage of the smartphone was the ability to collect other useful data such as geolocation and air quality, helping researchers to correlate daily asthma symptoms to environmental factors (for example, wildfires in Washington state that led to increased symptoms in some participants). Other factors that could be corroborated include pollen and heat.

“The Asthma Mobile Health study represents the coming together of academia and industry to benefit from the ubiquity of smartphones and harness the power of citizen-science to modernize the clinical research process,” Dr. Eric Schadt, senior author on the paper, said in a statement. Schadt is also a genomics professor and the founding director of the Icahn Institute for Genomics and Multiscale Biology at Mount Sinai.

At the time of the study, there were some three billion smartphones in use around the world, a figure that is expected to double by 2020. This has Mount Sinai thinking seriously about the future impact of mobile health studies in terms of reaching huge numbers of participants, which could be accomplished through actions like enterprise-level electronic informed consent.

“We now have the ability to capture rich research data from thousands of individuals, to better characterize ‘real world’ patterns of disease, wellness, and behavior,” Schadt said in a statement. “This approach provides a more comprehensive and accurate view of our patients that was not feasible in the past due to logistical limitations and prohibitive costs.”

Data show gamified, personal coaching program SidekickHealth a good complement to in-person DPPs

Digital coaching and a gamified approach to healthy lifestyle choices may be a powerful tool in managing chronic conditions, according to new data from health engagement platform provider GoodlifeMe, which makes SidekickHealth.

SidekickHealth is a suite of online, customizable wellness and disease prevention programs for providers and employers. The web or-mobile-based programs offer personalized coaching, games and diet and exercise tracking based on each individual’s specific health needs, and are used as part of many CDC-recognized diabetes prevention programs. It is based on brain research and gamification technology developed in collaboration with experts from Harvard and MIT, and is accessible either online or through a mobile app.

“Our brains don’t always work to make logical choices. So we developed SidekickHealth to activate the emotional triggers as well as the logic of decision-making,” SidekickHealth CEO and cofounder Dr. Tryggvi Thorgeirsson said in a statement.  “It’s a new approach that is getting results far beyond those achieved with coaching alone. While our initial focus has been in the area of diabetes prevention, the same principles apply to improving the management of chronic illnesses that are lifestyle related, like obesity and hypertension.”

Over the past year, SidekickHealth was deployed across many in-person, community-based diabetes prevention programs across the country including several for populations with added challenges such as language barriers or old age. When using SidekickHealth, DPPs saw improved treatment compliance and reduction of diabetes compared to those who did not use the game, with Sidekick users up to three times more likely to reach their five percent weight loss goals within 16 weeks. They were also 30 percent less likely to drop out of their DPP.

“We are seeing that a program like SidekickHealth combined with personal coaching is the key to motivating people to make significant changes in their behavior, even those groups who have been challenged by genetic pre-disposition, social or economic disparities,” Thorgeirsson said in a statement.

SidekickHealth’s programs allow users to make commitment contracts for certain behaviors like skipping soda or increasing vegetable consumption, and also offers mindfulness exercises that are powered by artificial intelligence and evidence-based guidelines from the CDC. On average, people have six to eight interactions with the program per day, seven days per week.

Along with providing a way for employers to offer wellness and disease prevention programs to their employees, SidekickHealth is also intended to complement in-person DPP programs. Those who partnered with SideKickHealth did so to make their programs more scalable by reaching populations where access to healthcare or transportation may be poor, but smartphone use is high. Additionally, the use of images and games cut through many cultural differences or social disparities that could act as barriers to patient engagement.

“With SidekickHealth, we can maintain the high-touch relationships that are especially important to low-income participants,” Marlayna Bollinger, founder and executive director of San Diego-based DPP Skinny Gene Project, said in a statement. “We can modify the program to make it culturally relevant and ensure information is not just received; it’s understood. In groups that are at high risk for diabetes, like Hispanics and Native Americans, SidekickHealth has been especially effective in helping people lower their risk for diabetes.”

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