With the Theranos scandal now fading into Silicon Valley lore, the reality of digital biomarkers and the data derived from devices is teeming with information, opportunity and the need for clarity. Clinically we rely on biomarkers daily to track states of health and illness, such as cholesterol, blood sugar, and body temperature. With the advent of digitally derived data, the scope seems endless and moves well beyond blood based metrics, but how do we determine the hype from what’s helpful.
A new paper by Lmar Babrak and colleagues from the University of Applied Sciences Northern Sweden published in Digit Biomark illuminates the opportunities and pitfalls of this new era of digital biomarkers. Internationally, many groups are working on terminology to describe the digital biomarker space; these include the National Institute of Health (NIH) and the Federal Drug Administration (FDA) in the USA and European Medicines Agency in the European Union.
Digital biomarkers are subject to the multiple definitions for the same marker if the marker derives from the field of engineering versus the field of medicine. This paper outlines key considerations for the future of digital biomarkers and their potential to support or enhance health, be it the consumer who wants to track their metrics, a fitness professional who is working with an athlete to improve performance, or a doctor that wants to glean more insights from the continuous data monitoring digital offers. The diagram below maps traditional and digital biomarkers on critical dimensions, which include monitoring, prognostic, predictive aspects of biomarkers to diagnostic and real-time responses to pharmacology.
The definition of a biomarker is provided by the NIH-FDA, “a characteristic that is measured as an indicator of normal biological or pathogenic processes or responses to an exposure or intervention.” The authors call for standardization of definitions of biomarkers, so there is clarity on measurement. The depth and breadth of the field also needs to be thoroughly mapped. At this point in development, it might be premature to narrow the area since it is still developing. Will biomarkers behave the same way in diverse populations? Many questions are still unanswered. It would be unfortunate if this field were to develop in the narrow way traditional medicine has evolved based mostly on the literature of white populations. Additional studies need to be undertaken to explore the predictive elements of a continuous real-time data set versus traditional point-in-time data monitoring. Data use, transparecy, privacy, and security also loom large in this area. A spectrum of risk exists from consumer’s tracking of their data to their doctor monitoring their data to manage or prevent illness. All too few protections exist for consumer data, and data use is often buried in terms and conditions that aren’t transparent.
Digital biomarkers are also a new space for regulatory agencies, the FDA’s PRE CERT program, and Software as a medical device (SaMD) are adding clarity on how to get approval in the USA- this is a welcome development for tech companies and health care systems alike to develop standards for quality assurance.
The new field of digital biomarkers holds great promise for areas like Parkinsons and Alzheimers and other applications are emerging. It is still unclear whether these new data sources will augment current care models or if new models of care will arise. I will be following these developments with great interest.
Thanks for reading – Trina
(Opinions are my own)
Traditional and Digital Biomarkers: Two Worlds Apart?