Digital health companies are quickly embracing changes by the Food and Drug Administration that would make it easier for consumers and hospitals to use their technologies. Last week, the FDA approved an emergency use authorization for Livongo, allowing at-home glucose monitors to be used in hospitals. It also loosened regulations around the use of software tools for mental health.
Though companies are still processing the new regulations, most were enthusiastic about the temporary changes.
“I think this is a really good step in the right direction for both access to digital therapeutics and quality standards for digital therapeutics. We’re quite excited about this announcement,” said Corey McCann, CEO of Pear Therapeutics, a startup that has three approved digital therapeutics for behavioral health. “I think there’s a tremendous opportunity to continue to make digital therapeutics the standard of care.”
Seeing a growing need for mental health services during the pandemic, the FDA moved last week to temporarily waive requirements around low-risk software tools for mental health.
“In the context of the COVID-19 public health emergency, the use of digital health technologies … may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine,” the FDA wrote in its guidance.
For example, the agency waived its requirement for companies to submit a 510(k) premarket notification before distributing a digital health solution to the public. The FDA also waived requirements on reporting corrections and removals, as well as registration and listing requirements.
The new guidance would apply to software that provides wellness recommendations for patients with anxiety, depression, OCD and other mental health conditions. Some examples include digital health tools that provide activity reminders, and mindfulness or meditation activities. Digital therapeutics prescribed to treat a specific condition, such as substance abuse, would not be exempted under these waivers.
Of course, low-risk digital health products will still be subject to some quality measures, including software verification and ensuring needed cybersecurity protections are in place.
The FDA also added labeling recommendations to more clearly distinguish between products that have received clearance and those that have not. Companies are asked to describe the intended patient group and age range for their product, a summary of clinical testing, and to identify any functions that are not FDA cleared.
“I think the FDA really took the opportunity to clarify quality standards for both cleared and non-cleared therapeutics,” McCann said. “I see this evolving in a drugs versus supplements dichotomy. I think product labeling is important to educate patients and clinicians in that context.”
The new guidance wouldn’t affect Pear’s three approved digital therapeutics, which can be prescribed to treat substance abuse and insomnia. But the company has more than 10 additional products in its pipeline, many of which have a mental health component.
When asked if Pear would seek an emergency use authorization for any of its products, McCann said he didn’t yet have a clear answer, as the guidance was just a few days old.
“It’s something we’re really doing the work around,” he said.
Livongo gets emergency approval
Livongo, a publicly traded company that makes products for patients with type 2 diabetes, hypertension and other chronic conditions, applied for an emergency use authorization for its glucose monitors to be used in a hospital setting.
The FDA approved Livongo’s EUA last week, and also updated its guidance to allow hospitals to use at-home glucose monitors to remotely monitor Covid-19 patients’ blood glucose levels.
The goal is to reduce the amount of personal protective equipment healthcare workers need to use, and provide better care to patients hospitalized for Covid-19. Patients would be able to check their blood sugar levels, with the results transmitted to their physician, allowing them to remotely monitor their health.
“At Livongo, over the past weeks we’ve fielded request after request from hospitals in pandemic hot zones asking if our diabetes meter could be used for people with diabetes who are hospitalized with the virus,” Livongo CMO Dr. Bimal Shah wrote in a Wednesday blog post. “Yesterday’s welcome news that the FDA has granted an emergency-period waiver to allow any inpatient facility in the country to use Livongo’s cellular enabled diabetes meter couldn’t have come soon enough.”
It’s especially important for diabetic patients to pay attention to their blood glucose levels while hospitalized, as they can fluctuate dramatically. That can, in turn, have a significant effect on health outcomes.
“People with diabetes admitted to the hospital under even non-pandemic conditions are typically stressed, not eating normally, and as a result likely to experience higher than usual fluctuation in their blood glucose levels – placing demands on hospital staff for regular checking and monitoring,” Shah wrote.
DarioHealth, a digital health company that makes glucose monitors that can plug directly into a patient’s smartphone, said it had seen significantly increased demand from health systems in the last two months. They could use its technology to remotely monitor patients with diabetes and hypertension.
“The surge in demand for remote provider-patient access has provided us the opportunity to adapt our platform to a number of new settings,” DarioHealth President and General Manager Rick Anderson said in an emailed statement. “In addition to our current digital health capabilities we are responding with the addition of features to meet patient and provider demand in the new remote healthcare dynamic.”
Other companies, such as Dexcom and Abbott, are also supplying their continuous glucose monitoring systems (CGMs) to hospitals during this time. According to the Wall Street Journal, 86 hospitals had requested DexCom’s CGMs.
Photo credit: photo_chaz, Getty Images