Digital Health: Still a brave new world
At this year's BIO-Europe Spring® panel on "The Convergence of Therapeutics and Digital Health," two panelists from big pharma joined two from Scandinavian digital health companies, agreeing that while the platform for digital health technologies is strong in Europe, much trailblazing remains to be done to clarify the complexities in regulation and adoption of new roles within the digital health sphere.
“Digital is coming to all industries. And even the most regulated, like banking, have been revolutionized by it,” said panel moderator Erika Rask of MedUniverse, a patient case software and web service for healthcare professionals. Indeed there is no doubt that as patients demand more direct treatment information and healthcare providers call for lower drug costs, business models must adapt. In the words of Nima Jokilaakso, Executive Partner at digital health consultancy D Health Scandinavia, “The healthcare ecosystem is being completely reshaped around pharma, technology developers and new players.”
This reshaping of a longstanding ecosystem comes as the result of a paradigm shift in how medicine is viewed. When asked by an audience member about Merck’s approach to digital health, panelist Mats Berggren, head of Health Policy and Market Access, answered that digital is “embedded” in the company. “Digital health is about bringing together advanced therapeutics, advanced monitoring and advanced devices into one treatment concept for enhanced results,” he said.
With this new multi-part definition of treatment comes challenges in execution. The formula of traditional partnerships and mechanics of existing research collaborations no longer apply. Theresia Bredenwell, external affairs director at AbbVie, summed up the difficulties facing pharma companies and likely all parts of the ecosystem: “AbbVie’s strategy is to drive sustainable healthcare solutions that improve the lives of people affected by disease. This often involves digital solutions but this is new ground for both traditional and non-traditional players in the market and each new project has no predefined standard for how to do it and what the business model should look like. It is unknown territory and with no common standard, either technical or process-wise, taking a pilot to national implementation is a challenge.”
On the technology startup side, digital health is already rapidly becoming a crowded space. A plethora of digital health apps and startups have cropped up in the last half decade, seizing every opportunity to satisfy consumer desires and flooding the market with health-related apps ranging from those that track exercise and weight loss to those that help users give up smoking and even suggest diagnoses. Jokilaakso delivered some blunt criticism for adopters of this direct-to-consumer approach: “[As a digital health consultancy], we can’t work with you if what you’re attracted to is the early revenue of going direct-to-consumer.”
Companies that have circumvented regulatory processes and paid scant regard to patient safety show a dramatic departure from the meticulous, rule-bound path that traditional therapeutics have taken to market. This new wave of health apps has made product claims that are often unsubstantiated by clinical evidence and bring little to the table in real-world healthcare settings. Without high-quality outcomes data, not only do they raise unprecedented safety concerns, it can be difficult for payers, providers and other healthcare purchasers to identify therapeutic or economic value for use in patient care. "The main hindrance of startups sustainably entering the sphere of digital health is the regulatory aspect," Jokilaakso stated.
That said, the regulatory landscape remains quite undefined and return on investment is difficult to measure. Even with pharma’s extensive know-how about therapeutics and disease treatment, and technology developers’ breakthrough understanding of human behavior and information processing, the reshaping of medicine seems incomplete without a third emerging player—a regulatory body—that completes the polygon of digital health with its ability to weigh the unique contributions of both.
Some organizations have stepped forward to cautiously embrace the role but a clear description of the process remains unformed. With a quickly rising demand for solutions that deliver on convenience and affordability without compromising pharma’s rigorous standard of proven outcomes, it is indisputable that digital has taken the reigns and will leave behind any entity that can’t hold on.
Taking place September 15 in Boston at BioPharm America™, Digital Medicine Connect will address the need for evidence-driven validation of digital medicine products, highlight unique business models emerging within the space and assess the regulatory considerations and differing roles of pharma, researchers, tech developers and other stakeholders.