There is now unanimous agreement that Artificial Intelligence will play an essential role in healthcare delivery. Innovation of new AI-powered devices and approaches in medicine require exquisite regulatory guidance. And both the regulatory and reimbursement landscapes can be complex, nuanced, and evolving. As a result, multidisciplinary physicians such as Dr. Domnitz who have additional expertise in accountability, regulations, compliance, and business will play an increasingly strategic role in both the design and implementation of ethical, effective, and timely innovations for our patients.
A few days ago, the Food and Drug Administration (FDA) opened a Digital Health Center of Excellence, and also has an ongoing pilot of its Digital Health Certification (“pre-cert”) program. RETINA-AI Health, Inc. is keeping a close watch on these developments and is planning to be fully ready to participate once the pre-cert program opens. Dr. Domnitz’ 10 years of experience in international audit, including Sarbanes-Oxley, plus her