Harvard Business School highlights Digital Diagnostics, our Founder and Executive Chairman, Michael D. Abramoff, MD, PhD, and the development of LumineticsCore®.
Harvard Business School has published a case study detailing the growth pathway of Digital Diagnostics, including our Founder and Executive Chairman, Michael D. Abramoff, MD, PhD’s journey to identify a critical patient need that could be addressed using AI and the launch of the company. The case dives deeply into the development of LumineticsCore® and each of the many hurdles Digital Diagnostics overcame to bring an idea through creating a new industry in healthcare. We are honored that our approach to building AI the Right Way is now being taught as the model for thoughtful AI deployment in healthcare. With the recent publication, it seemed like a fitting time to reflect on the journey that took LumineticsCore from concept to a foundational framework for how autonomous AI can be thoughtfully deployed in healthcare.
Addressing the Unmet Needs of Patients
Like many healthcare innovations, LumineticsCore began with identifying and addressing an unmet patient need. While training to become an ophthalmologist and retina specialist, Digital Diagnostics’ founder, Dr. Abramoff, saw that many patients suffering from diabetic retinopathy (DR) were coming to see him when the disease was already too advanced for them to receive optimal treatment. Recognizing a longstanding gap in patient care, he theorized that a computer could mimic the way physicians think – an approach he believed could lead to earlier diagnoses for patients with DR and help prevent blindness. And so, the concept of LumineticsCore was born.
From Concept to Reality
To put his theory to the test, Dr. Abramoff drew on his background in machine learning, neuroscience, and software development and spent years creating algorithms that could mimic how clinicians make diagnoses. Throughout the process, he remained focused on patient safety, AI efficacy, and patient outcomes, understanding that trusting a computer to make medical decisions would require careful ethical consideration.
A Collaborative Effort
In 2018, LumineticsCore (as IDx-DR) received FDA De Novo clearance as the first autonomous AI diagnostic system in healthcare. Through a long, thoughtful process, Dr. Abramoff spent years collaborating with the FDA prior to gaining clearance. Extensive collaborations with ethicists, policymakers, and patient and physician advocacy groups were also vital in the development and deployment of LumineticsCore, helping ensure the technology was not only clinically sound but also ethically and socially responsible, ultimately improving patient outcomes and reducing administrative burden as the focus.
Paving the Way for Ethical AI
In 2019, LumineticsCore reached another milestone when the National Committee for Quality Assurance (NCQA) clarified its Healthcare Effectiveness Data and Information Set (HEDIS) measures to confirm that autonomous AI could be used to diagnose DR and close the eye exam for diabetes care gap in a primary care setting. The following year, Dr. Abramoff published an ethical framework for autonomous AI, marking the culmination of decades of research and laying the foundation for responsible AI development.
Securing Reimbursement
Gaining FDA clearance was a critical achievement, but it marked only the beginning of the next phase for LumineticsCore: achieving national reimbursement and coverage. Without reimbursement, it is difficult to drive provider adoption and patient access. In 2021, after several more years of collaborative efforts, the Centers for Medicare and Medicaid Services (CMS) established CPT code 92229, allowing, for the first time, the use of autonomous AI in a reimbursable primary care setting. Reimbursement codes like this are essential for clinical adoption. Without a code, innovative technologies often struggle to reach the patients they’re designed to help.
Widespread Use and Ongoing Adoption
FDA clearance marked the entry for utilization and access to LumineticsCore. However, when the CPT code and national payment were implemented in the subsequent years, adoption surged. In fact, researchers at Stanford University identified AI solutions for DR as one of the fastest growing sectors in healthcare, citing LumineticsCore as the first solution to gain FDA clearance in this field.
Thank you to Harvard Business School for sharing our story. We’re especially proud that our approach is being recognized as the leading example of how autonomous AI can be responsibly developed and successfully integrated into the healthcare system.
Purchase the full Harvard Business School case study to further explore Digital Diagnostics’ journey.