As digital health companies get record funding for novel but as-yet unproven technology, there are individual efforts underway to obtain validation for health tech.
One of them is One Drop, a New York City-based digital chronic condition management solution with advanced predictive capabilities. Recent studies found that use of One Drop helped members with stage 2 hypertension decrease blood pressure on average -21/-12 mmHg; lowered A1C of members with diabetes by -1.25%; decreased risk of depression by almost 5 times compared to control group. Employers are offering One Drop as a benefit to their employees with chronic conditions.
Lindsay Sears, vice president of evidence generation at One Drop, recently responded in an email about the significance of evidence generation and validation for digital health companies.
MedCity News: Why do you see clinical evidence and third-party validation as no longer an option but a requirement?
Lindsay Sears: It’s critical to show clinical evidence of effectiveness when it comes to health and well-being programs. There are a lot of ways numbers can be presented to make a program look better than it actually is, and so it really is essential to adopt robust, published methodologies and have those results vetted and approved through third-party validation organizations as well as submitted for publication in peer-reviewed journals and presentation at scientific meetings.
MedCity News: Can you discuss the importance of validity and evidence generation among digital health companies?
Sears: Drawing robust insights and evidence from real-world data can be really challenging. Small, incomplete, or inaccurate data collection can limit a company’s ability to demonstrate outcomes or dive deeper into understanding the how’s and why’s of their program’s effectiveness. To avoid common pitfalls and errors associated with real-world data collection, companies should rely on reliable, accurate, remote sensing devices to gather clinical evidence and follow guidelines from organizations like American Diabetes Association and American Heart Association in how to appropriately clean and analyze clinical data.
MedCity News: Why is this evidence the only way to gain trust and interest among providers, payers, and consumers?
Sears: Full transparency into the timing, population, and nature of the data collected is a central part of 3rd party validation and the scientific publication process. Experts who understand some of the nuances involved with evaluation will review evidence with this context in mind to assure its validity to the public, providers, and payers. This provides a level of assurance and trustworthiness to broader consumers and decision-makers who may not have that training or technical background.
MedCity News: How can companies advance equitable access to digital health solutions through evidence generation?
Sears: We’ve developed a position on how our evidence generation efforts will be used to support health equity and access in our industry. First, efforts should be taken to recruit from diverse populations to ensure fair representation in the data. Second, evidence groups should seek out opportunities to gather member data on social determinants of health, race, ethnicity, and other socioeconomic status variables when conducting research. Third, the effectiveness of health programs should always be investigated within subgroups who are at higher risk for health inequity and discrimination. Lastly, there needs to be a feedback loop connecting insights from data on access, adoption, and effectiveness back into the health program.
MedCity News: What pain point does your technology at One Drop address?
Sears: Traditional healthcare cannot properly support people with chronic conditions. Every human is unique, yet the current system continues offering generic treatment plans designed for the average person and taking a reactive approach to care. Adverse events trigger diagnostics, and individuals receive insights based on retrospective data. Doctors offer prescriptions and treatment plans to manage the symptoms of sickness without investing in the prevention required to keep people healthy. As a result, chronic and preventable health conditions are the leading cause of death and disability in the United States. One Drop disrupts the reactive and retrospective system with a continuous, predictive, and personalized care experience—delivered digitally for 24/7 accessibility.
MedCity News:What is the gap you are trying to address?
Sears: The digital chronic health management market is crowded. Most emerging solutions replicate the symptom-focused healthcare system by offering reactive assistance through remote monitoring, insights based on retrospective data, and virtual care that is provider-dependent and episodic. Prior solutions have also been condition-specific, meaning someone with multiple chronic conditions would have to use one platform for their diabetes needs (e.g., blood glucose monitoring) and another for heart health.
One Drop offers a centralized solution for managing one or more chronic conditions, personalized to meet an individual’s dynamic health needs and preferences. What started as a diabetes app and smart meter has since transformed into a precision health platform used by approximately 1.5 million members living with diabetes, prediabetes, hypertension, or a combination of these conditions, now available in all 195 countries. Members receive connected medical devices and access to the award-winning One Drop app (iOS and Android)—used to access data tracking, one-on-one coaching, educational content, and AI-powered health predictions to support meaningful behavior change.
MedCity News: Can you explain how One Drop works?
Sears: At One Drop, we call our approach precision health. Precision health combines real-time data, predictive insights, and on-demand clinical health coaching to deliver a continuous, dynamic, hyper-personalized care experience. Our platform simplifies decision-making and makes it easier for people with or at risk for chronic conditions to practice self-care behaviors that benefit their physical, mental, and emotional well-being.
MedCity News: What is wrong with third-party validation/clinical evidence? How is One Drop doing it better?
Sears: Third-party validated evidence is always a good thing when there is a balance of clinical and real-world evidence. It does become problematic when a given program only has demonstrated evidence in clinical trial settings and lacks demonstrated outcomes in the real world. Clinical trial settings often involve compensation to research participants and heavy oversight and monitoring by clinical staff, which may not be reflective of what happens in the real world. Real-world evidence of effectiveness is really important to understand how programs work in practice when delivered as intended.
Photo: Anastasia Usenko, Getty Images
