With many regulatory barriers clear, remaining roadblocks for digital therapeutics are cultural, logistical

While some of the more obvious barriers to digital therapeutics adoption in Europe have come crashing down recently, adoption is still hampered by cultural momentum. That was the conclusion of a group of digital therapeutics stakeholders who presented at HIMSS & Health 2.0 Europe Digital Event today, in a session moderated by YourCoach Health chairman and COO Eugene Borukhovich.

“Once a product is CE Marked, has all the clinical evidence, has gone through even an HCA process, that even isn’t enough,” said Jessica Shull, European lead at the Digital Therapeutics Alliance. “So what we’re looking at is countries where there are these frameworks, products have been approved, they’ve been shown to be effective, they’ve even been shown to have healthy economic data, but physicians still aren’t prescribing at the rates that we would hope.”

A number of European governments have rolled-out the red carpet for digital therapeutics, including Germany, which has announced broad reimbursement for digital therapeutics.

“All eyes are on Germany,” Borukhovich said. “There’s a lot of entrepreneurs and large companies that are saying ‘Cool, we’re going to get reimbursed, let’s hop on over to Germany.’ But I know the picture’s not that simple.”

“That’s what we wanted,” Julia Hagen, director, regulatory and politics, at Health Innovation Hub. “We want to attract great digital solutions to the German healthcare system. So yes, welcome. Come on over.”

The rest of the panelists represented people who either used or made digital therapeutics: Ken Cahill, CEO of digital mental health company SilverCloud, Alejandro Suero, whose company ReHand offers a digital therapeutic for physical rehab for hand injuries, and Dr César Morcillo Serra, medical director of internal medicine at Sanitas Digital Hospital.

Panelists agreed on two major takeaways for how to improve adoption of digital therapeutics: the importance of working with providers and the need to integrate these new devices into old workflows and processes.

“Digital transformation must focus on the patient and the healthcare professionals, because as you know people and culture are the main barrier for this kind of transformation,” Serra said. “We must focus on how to prescribe these digital tools to help our patients. Everything must help with these workflows — not giving us more work, but trying to help us.”

As such, Serra encouraged digital therapeutics innovators to focus on chronic conditions, which take up so much of the time of physicians like him.

Suero’s chosen focus — hand injuries, are a $5.8 billion per year problem, he said, and one that doesn’t lend itself well to the intermittent contact of traditional medicine.

To bring providers on board, Cahill shared, SilverCloud has found success by getting them invested first as patients.

“One of the most powerful workstreams is to deploy the programme within the health system’s own staff,” he said. “They’re one of the most heavily challenged workforces that are out there in terms of stigma for mental healthcare, in terms of actually being able to take time away and go and do it. So them almost taking their own medicine has been a huge way of creating champions within these organisations.”

Panelists warned that there are other challenges still awaiting digital therapeutics beyond adoption. Interoperability, for instance, is a huge challenge, Shull said, because of the influx of data digital therapeutics will produce. And building a clinical evidence base is no small thing, Suero and Cahill said.

“The challenge in terms of building that evidence base is to build it in the right way,” Cahill said. If you are building an evidence-base, it has to mirror what the protocol design was, what the research design was. It may seem simple, but in fact it’s reasonably complicated. … We’ve got five active randomised control trials today even though we’re 10 years out [of launch]. That will be one of the biggest challenges for us to show that proof.”

But one thing is for sure: It’s time to move beyond the rudimentary conversations about digital therapeutics and get into the nitty-gritty.

“I want to see real discussion, not about the broad ‘Should we have a data privacy discussion?’, but I want to get the discussion to the level where it’s about the medical application and its effects and not this general digital health blah blah is it great or not and can we stop it?” Hagen said. “No, we can’t.”

Register now to attend the HIMSS & Health 2.0 European Digital Conference and keep up with the latest news and deveopments from the event here.

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