New FDA commissioner lays out bold new plan for mobile app regulation

Back in March, when President Donald Trump chose Dr. Scott Gottlieb to head up the FDA under his administration, MobiHealthNews noted that he had a history of advocating for a hands-off approach to mobile health regulation. Now, just three months later (and a little over a month after his confirmation to the post), Gottlieb has articulated his new — and somewhat radical — approach to mobile health app regulation.

In a blog post published this morning, Gottlieb laid out a plan that includes clearer articulation on which devices require FDA clearance, as well as a potential firm-based approach to FDA clearance and a proposal to use postmarket data in the regulation of health apps.

“For these … digital technologies to take hold and reach their fullest potential, it is critical that FDA be forward-leaning in making sure that we have implemented the right policies and regulatory tools, and communicated them clearly, to encourage safe and effective innovation,” Gottlieb wrote. “In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures. To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.”

Gottlieb reminded readers that the recently passed 21st Century Cures Act takes some categories of mobile medical app outside the FDA’s purview, such as clinical administrative support software and wellness and lifestyle apps. He said the FDA will publish guidelines that clarify the exact boundaries of this low-risk category, and, furthermore, intends to add some classes of apps not mentioned in the bill to the sphere of nonregulated devices.

He also laid out plans for a third-party certification program that would function sort of like TSA pre-check for FDA clearance.

“While the pilot program is still being developed, we are considering whether and how, under current authorities, we can create a third party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review,” he wrote. “Certification could be used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.”

Finally, Gottlieb said the FDA would work with Medical Device Innovation Consortium (MDIC), a public-private partnership, to investigate using MDIC’s National Evaluation System for health Technology (NEST) to streamline clearance for new devices and device updates.

FDA expert and Epstein Becker Green partner Bradley Merrill Thompson told MobiHealthNews in an email that this new direction is welcome news for him and many others in the industry who have long been frustrated by a lack of clarity from the agency.

“Since 2011, the CDS Coalition has been asking – indeed begging at times – for FDA to publish guidance that clarifies the scope of the agency’s regulation of clinical decision support software,” he wrote. “During the winter, after 21st Century Cures was signed into law, but before Dr. Gottlieb took over, FDA seemed still unsure what to do. Now FDA seems to be committing to publishing guidance in the coming months to clarify, beyond the legislation, what FDA will regulate in the area of clinical decision support and other such software. That is music to my ears.”

Thompson noted that Clinical Decision Support Coalition, an organization he is involved in the leadership of, has gone as far as to submit a citizen’s petition requesting this clarity. That petition includes a wish list of topics for FDA to address, including software associated with pharmaceuticals and, eventually, artificial intelligence. He’s also supportive of the new clearance pathway.

“In the blog post, Commissioner Gottlieb also seems to reference the discussions that industry has been having lately with FDA regarding adoption of the TSA pre-check idea as a better way of bringing new software to market,” Thompson wrote. “The blog post suggests that the agency is committed to this approach, which obviously we are delighted to hear. There is much good that can be done, although there is much work left to be done. It will be very important to get the details right.”

FDA has been talking lately about the creation of a new office of digital health funded by medical device user fees. Gottlieb didn’t mention that office in the blog post, but the two ideas are certainly compatible, since the development of a novel clearance pathway will require considerable staffing power.

Late last week we did a pre-conference roundup of news from the 77th Scientific Sessions of the American Diabetes Association. Now that the show has concluded, here’s a few more notable stories from the show:

Care4Life texting lowers A1C, but not as consistently as personal intervention

One study presented at the conference looked at 166 Medicaid patients with Type 2 diabetes and an average HbA1c levels of 10.5 percent. The cohort was split into three arms. One group used Wellpass’s (formerly Voxiva’s) Care4Life mobile app to keep track of blood sugar and blood pressure, get reminders about medications and doctor’s visits, and to get tips about nutrition and exercise. A second group had community health workers (CHWs) assigned to them to help coordinate access to food, medical visits, and medications. The third group had both the app and the community health worker. The study ran for a year.

Across all groups, patients decreased their A1C levels by an average of 1.3 percent and 30 percent of the group achieved the goal of A1C levels below 8 percent. By that metric, the group that did best was the group that had both interventions; 43 percent had A1Cs below 8 percent, compared to 29 percent of the community health worker group and 17 percent of the app-only group.

“When we provided the support of a CHW or a mobile health application, patients with type 2 diabetes experiencing challenges with their self-care were able to achieve important improvement in health measures and a reduction in distress secondary to living with this chronic condition,” Dr. Michelle Magee, associate professor of medicine at Georgetown University, and the Director of the MedStar Diabetes Institute, said in a statement. “Evidence to show both the potential impact of CHWs and the potential use of mobile health applications to improve health outcomes, as detailed in this study, are needed in order for health care systems to comfortably invest dollars to these new patient support approaches. Our study shows that these two strategies can significantly improve patient health. In fact, the reduction in A1C levels in our study was as positive a change as what we typically see with the addition of another antihyperglycemic medication to patients’ treatment regimens.”

Medtronic gives us an update on Sugar IQ

Medical device company Medtronic has been working on an IBM Watson-powered AI agent called Sugar IQ that can deliver insights to people with diabetes based on the history of their insulin doses, blood sugar readings, and behaviors like eating, sleeping, and exercise. The app was announced at CES in 2016 and shown off in more detail at last year’s Health 2.0.

At ADA, Medtronic head of innovation Huzefa Neemuchwala shared some preliminary data from the app as well as some anecdotes and case studies.

In a set of deidentified data from 97 beta testers who used the app between March 1st and May 25th. Users’ average time in their ideal blood glucose range per day increased by 37 minutes, average lows per year down were down 11.4 percent, and average highs per year were down 8.4 percent. Overall, 65 percent of users had fewer lows and 55 percent had fewer highs. Seventy-eight percent of users used the app to log their food.

In the case studies, the app only took a couple of days to detect trends, and gently nudging tips from the app were able to successfully modify that behavior.

Hygieia, iSageRx partner on titration

Hygieia, a company dedicated to making insulin management easier, and iSage, an AmalgamRx subsidiary that has an FDA-cleared app for automated titration of all basal insulin brands, are working together to integrate their two technologies, the iSage Rx provider- and patient-dosing platform and Hygieia’s proven d-Nav Insulin Guidance Service. The iSage technology will be incorporated into an ongoing pilot in Michigan with Hygieia, which has a network of specialty care clinics.

“Hygieia was first to recognize that there must be a better way to use insulin, and we’ve demonstrated that our d-Nav approach works. We are excited to be bringing this concept to the U.S. through a network of specialty-care clinics designed to simplify the process by which healthcare providers manage insulin,” Hygieia CEO Eran Bashansaid in a statement. “Healthcare providers can refer their patients to us and we’ll take on the burden of managing their patients’ insulin therapy. The game-changing combination of Hygieia and iSage Rx technology will provide patients on insulin proven success, peace of mind, and best-in-class technology.”

“We’re thrilled to support Hygieia’s rapidly expanding network of specialty-care clinics. This collaboration exemplifies our approach of enabling other companies and technologies to integrate and offer insulin titration solutions; we’re committed to creating the best insulin titration engine for patients with diabetes,” iSage CEO Ryan Sysko added. “Our goal is to further support Hygieia by incorporating the capability to titrate all types of insulin including premix, bolus, basal plus GLP1, and U500 by the end of the year.”

Greenville, South Carolina-based ChartSpan Medical Technologies, which makes digital care coordination tools, has raised $16 million in new capital led by Cypress Growth Capital.

ChartSpan’s platform runs the gamut of practice management software, mobile patient engagement and records management tools. The turn-key service is available to health systems and ambulatory practices throughout the country, enabling them to provide out-of-office healthcare services to their patients.

While the company’s headquarters are in South Carolina, ChartSpan’s main presence is in the Appalachian region. The latest funding will be used to expand out of their current stomping grounds, and the company is particularly focused on the job stimulus their growth will drive in South Carolina. On the heels of a 15-month period during which ChartSpan added 200 jobs, the company now expects to create another 300 in the next year and a half.

“This capital round helps us grow our national footprint,” ChartSpan CEO and cofounder, Jon-Michial Carter, said in a statement. “We currently have a stronghold throughout the Appalachian region. We plan to use these funds to deploy a national sales force and create hundreds of new clinical and technology jobs at our headquarters in Greenville.”

The company focused their last funding round on robust hiring as well, taking their $3.2 million round to create hundreds of nursing and certified healthcare clinician positions. Nationwide, the healthcare industry has been a major job generator for the last decade, and ChartScan is a tech-enabled example of that phenomenon. ChartSpan was part of the Mayo Clinic-sponsored Iron Yard Ventures Healthcare Accelerator Program in 2013 and has steadily worked to establish its footprint as a digital health leader in South Carolina, working with Greenville Chamber’s entrepreneur support program called NEXT and the Greenville Area Development Corporation.

“ChartSpan represents what can happen when public-private investments are made in South Carolina’s technology start-up ecosystem,” Peter Barth, NEXT Board Chair and The Iron Yard founder and CEO said in a statement. “The major capital investment announced today indicates the momentum the company has in the healthcare marketplace and the impact they are making in South Carolina as they move toward 500 jobs in downtown Greenville.”

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