Digital Health Solutions

Digital Health Solutions

Applying clinical insights to digital health innovation

Our Thinking

New wearables, mobile health apps, and other digital health technologies come to market every day, with many companies making claims about the health benefits their products provide. In an effort to distinguish themselves from competitors and build trust with patients, some digital health innovators are now seeking clinical evidence that can validate the value of their offerings.

At the DCRI, we partner with these innovators to bring clinical insights to groundbreaking applications that improve health outcomes. Our capabilities include:

  • Thought leadership on clinical utility and potential of digital health solutions, guidance, and strategy
  • Regulatory planning
  • Comparative effectiveness studies
  • Study design
  • Protocol development
  • Feasibility studies
  • Data analysis
  • Registries
  • Real-world data studies
  • Randomized clinical trials

  • Patient-generated data come with opportunities, challenges
  • Studying a Digital Treatment for ADHD

In the videos above, DCRI Digital Health Solutions experts Satasuk Joy Bhosai, MD, MPH, and Scott Kollins, PhD, MS, discuss the challenges and opportunities brought to clinical research by digital health solutions such as wearable devices and apps.

Addressing Solutions


Translating ideas into action

  • Applying independent, insightful perspectives to help companies determine scope of evidence generation
  • Designing studies that generate fit-for-purpose evidence

Evaluating and validating products and services

  • Evaluating, and potentially validating, digital health innovations
  • Conducting studies of all sizes, from small feasibility studies to large randomized clinical trials

Identifying the right pathway to adoption

  • Forming strategic academic partnerships and connections to help advance adoption and scale applications
  • Providing guidance to companies on navigating regulatory pathways

We Partner With

Emerging and small life sciences companies to advance innovative digital applications.

Large pharma companies and payers to validate applications in conjunction with commercialization.

Tech start-ups to determine the best path to evidence, dependent upon their business goals.


Clinical research organizations to offer deep expertise in digital application evaluation and validation.

Federal agencies to assist in advancing ideas into the digital market.

Investors to help evaluate the potential of digital health innovations for the health care market.


Providing a Path to Proof for an ADHD Digital Therapy

Research from the DCRI shows that children who used a video-game based app experienced an improvement in their ADHD symptoms. The game, developed by Akili Interactive Labs, Inc., was submitted to the FDA and could become the first digital therapeutic for ADHD to receive FDA clearance.

Virtual Assistant as Effective as Traditional Physical Therapy

DCRI researchers found that remote physical therapy administered by Reflexion Health’s FDA-cleared Virtual Exercise Rehabilitation Assistant, VERA™, resulted in lower costs and fewer rehospitalizations than traditional physical therapy after knee replacement surgery.

A New Era for Personal Health Engagement

DCRI’s Christopher Granger, MD, talks about how the Apple Watch can be used in health care applications. The Apple Heart Study, for which he was a member of the steering committee, used Apple Watch data to identify irregular heart rhythms, including atrial fibrillation.

Digital Solutions in Action

Project Baseline logo

Utilizing Google Cloud Platform to Move Toward Disease Prevention

The Project Baseline study is a longitudinal study collecting broad phenotypic health data from approximately 10,000 participants. The study is designed to develop a well-defined baseline of health as a reference point, as well as a rich data platform that may be used to better understand the transition from health to disease. Data will be collected through clinical visits, daily use of a wearable device and other sensors, and participation in interactive surveys and polls. The Project Baseline data repository is built on the Google computing infrastructure and hosted on the Google Cloud Platform.

Leveraging Clinical and Regulatory Expertise to Design a Way Forward

DCRI Think Tanks tackle the biggest challenges in health care by bringing together patients, academic investigators, site investigators, regulatory agencies, pharmaceutical, and device industry leaders, payers, technology companies, and more. DCRI Think Tanks published a white paper from an October 2018 Think Tank that explored how to implement technology to improve clinical trials.

Bringing clinical expertise to the Digital Therapeutics Alliance

In May 2019, the DCRI became the first academic organization to become a member of the Digital Therapeutics Alliance. The group works to improve access to digital therapeutics for patients, providers, and payers in an effort to reduce costs and enhance individualized health care. The DCRI brings value to the partnership by sharing expertise on how companies can clinically evaluate their heath innovations in a quickly growing space that can be difficult to regulate.

Digital Health Solutions Leadership at the DCRI

Satasuk Joy Bhosai, MD, MPH

Satasuk Joy Bhosai, MD, MPH

Chief of Digital Health & Strategy, Duke Clinical Research Institute

Associate Director, Duke Global Health Innovation Center

Associate Director, Duke Innovations in Healthcare

Scott Kollins, PhD

Scott Kollins, PhD, MS

Professor, Department of Psychiatry & Behavioral Sciences and Department of Psychology & Neuroscience

Director, Duke ADHD Program