Mobile health application developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration published its long-awaited final guidance on mobile medical applications under the Federal Food, Drug, and Cosmetic Act. It is vital for any app developer to understand whether the guidance applies to their product from the initial design stage. Those who are already marketing software and apps that involve healthcare should also review the guidance with care to try to determine how FDA’s new regime impacts both business plans and continuing operations.
Mobile health (“mHealth”, “telehealth” or any other terms for health care delivered wirelessly) is revolutionizing the health care industry. That message resounded at last week’s mHealth Summit, which gathered roughly 4,000 investors and angel-funders, telecom and software companies, and entrepreneurs and developers to share ideas and display new mHealth products. Hot mHealth areas include data analytics, texting and medical records. Home health and medical homes also stand to benefit with the introduction of products designed to submit protected health information (“PHI”) and other data between patient and provider. Continue reading mHealth/Telehealth Investors and Entrepreneurs: The Generational Divide