Health IT

Digital biomarkers: Lots of potential, but where’s the validation?

There’s still a gap between potential and validation when it comes to digital biomarkers.

rock healthDigital biomarkers are showing great potential as powerful and cost-efficient tools to track health and predict outcomes, as outlined in a new Rock Health report.

“Digital biomarkers offer a cost-effective opportunity to extend the collection of population level health data over time and introduce longitudinal data for individual consumers,” the report says.

Furthermore, they can supplement existing biomarkers, particularly in fields like psychiatry and neurology where diseases monitoring tends to be subjective. Digital biomarkers could lend a level of subjectivity, if wielded accurately.

However, the question of validating the use of these data points still looms – and we’re still not at a point of confirming whether the collection, analysis and utilization will yield fruitful outcomes, as a new study from PeerJ is showing.

There are three tiers in which digital health could show use: Payers, providers and biopharma. Specifically:

Payers could use digital biomarkers to incentivize medical policy plans – informing insurers on the best coverage for their customers. Furthermore, insurers could use this data to design reimbursement policies – both for drugmakers and for providers.

Providers could theoretically use digital biomarker data to stratify patient populations, identifying high-risk, high-cost individuals – and predict readmission. Digital tools could monitor disease progression, and provide appropriate interventions – as well as improve the objectivity of diagnoses and treatment selection, Rock Health says.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

And for biopharma, the best utility of digital biomarkers could be in clinical trial recruitment – targeting patient populations to trigger faster trials with smaller, more specified sample sizes. Disease progression in control as well as test populations could be studied more accurately, and the industry could develop lower cost and more robust diagnostics to improve personalized medicine pathways.

However, it’s important to point out that it’s still early days for both digital biomarkers and digital interventions – with a lot of work to be done in terms of validation. An Eric Topol-led study published in PeerJ last month studied health care utilization in individuals using smartphone-enabled biosensors.

That is, it gave several patients that had submitted insurance claims for hypertension, diabetes, or arrhythmia a number of mobile-enabled devices that monitored their conditions – and tracked a range of digital biomarkers over the course of six months. The idea was to use these constantly tracked data points to allow for timely interventions and ultimately reduce costs. However:

“There was little evidence evidence of differences in health care costs or utilization as a result of the intervention,” the study concluded. Control and intervention groups performed just about the same, despite the steady surveillance of these digital biomarkers. There was a bit of an improvement in terms of self-management, but by and large patients didn’t appear to benefit from the additional monitoring.

“This result suggests there are not large short-term increases or decreases in health care costs or utilization associated with monitoring chronic health conditions using mobile health or digital medicine technologies,” the paper says.