Seth Frank coined the term digital health in 2000; the early framing included internet-based content to improve health and chronic condition management and has more recently been expanded to include genomics, apps, wearables, and telemedicine. We have reached an inflection point in digital health with the emergence of digital therapeutics, tools that deliver evidence-based outcomes for standard clinical metrics, while nascent the promise and potential these tools bring is a game changer for healthcare. The value of continuous data monitoring can shed new light on how daily habits and actions can contribute to optimal management of a chronic disease or support healthier lifestyles to prevent disease.
A new paper in Nature Digital Medicine by Simon Matthews from the Amstrong Institute of Patient Safety in Baltimore proposed a path toward validation in the digital health space. The journey of validation has several components that have been developed in varying degrees, but none yet address the totality of product development. Many groups like the Digital Therapeutic Alliance, the Personal Connected Health Alliance and the National Health Service (NHS) in the UK have developed frameworks for evaluating digital health that form useful starting places, but they often lack transparency in how apps are scored and assessed.
The authors call for a broader and deeper framework where the tech mantra of “fail fast, fail often” meets the healthcare mantra of “first do no harm” provides the cultural journey that needs to be made to truly embed these tools into systems where they are most likely to be leveraged and deployed.
Matthews and colleagues propose a digital health scorecard which would enable health systems and customer to determine if digital therapeutic met the standards for validation and would include the domains of: technical, clinical, usability and cost to form a more complete picture of the solution being assessed.
If all the dimensions listed in the figure above form a scorecard this would be a significant improvement on the current fragmented process, which often feels like a black box and makes customers and health systems more wary of how well the product can help prevent or manage the disease. Having standards to do conduct side by side comparisons will also be new for app companies as they have worked hard to create their niche market and differentiate themselves, a robust evaluation framework makes it much easier to separate the marketing hype claims from the reality of product market fit.
I for one and delighted to see this dialogue about validation frameworks enter the digital health era- if we are to leverage the many great tools that exist that can scale solutions and positively impact the health of populations we will have entered a new era in healthcare.
Thanks for reading – Trina
(Opinions are my own)
Digital Health – a path to validation