Crucial to healthcare transformation
Without a coordinated, systematic approach to digital medicine, healthcare executives risk overwhelming their technology and staff.
While several vendors offer solutions to address specific conditions and care challenges, trying to integrate too many of them can strain a health system’s data infrastructure. Vendor-specific sensor data can cause a host of issues if they need unique interfaces, data containers or other one-off technical requirements.
“One of the most important things, especially when it comes to clinical digital endpoints, is to avoid creating a complex and confusing mosaic of 500 individual point solutions that don’t speak to one another,” Goldsack said.
Clinically validated digital endpoints could help providers re-imagine their infrastructure and clinical workflows by allowing them to use a common set of proven data across therapeutic areas, reducing complexity and enabling providers to focus on what matters most. Clinical validity could also help curb the impact of labor shortages since wearables allow for remote and consistent monitoring.
Payers might also start to require validation to achieve quality goals for value-based payment, said Joe Lynch, a validation expert at Avalere Health.
Third-party accreditation for digital health tools might be a viable pathway for establishing a minimal level of clinical validity without the need to go through an established FDA pathway, according to experts. But no such accreditation exists.
“The bar will be lower, but it won’t be zero,” Safavi said.
New interoperability standards like the Fast Healthcare Interoperability Resources standard and open application programming interfaces could speed adoption of validated endpoints by accelerating the separation of data and applications in healthcare. “You want data that are generated in one place to be available for use in another place,” Safavi said.
Though clinical validation won’t guarantee the success of digital medicine in the long run, it’s hard for experts to see how digital tools will reach their potential if clinicians don’t understand and trust the data they provide. “If a digital endpoint is fully, clinically validated, you know what it means. You know what that data point is telling you,” Goldsack said. “That is a gift.”