Digital health is the broadest umbrella in the field — the FDA uses it to cover essentially any technology that touches health: mobile health (mHealth) apps, health information technology, wearables, telehealth and telemedicine, and personalized medicine. Because it is so wide, the term itself is descriptive rather than legal. Calling a product "digital health" creates no obligations on its own; it is a category, not a trigger.
What actually creates obligations are three concrete questions hiding underneath the label. First, does the software handle Protected Health Information (PHI) inside a relationship covered by HIPAA? If so, the Privacy and Security Rules apply. Second, does it bill a payer such as Medicare? Then the Centers for Medicare & Medicaid Services (CMS) reimbursement rules apply. Third, does it claim to diagnose, treat, cure, or prevent disease? Then it may be a medical device under FDA authority, potentially Software as a Medical Device (SaMD). A single "digital health" product can hit none, one, or all three.
For a product team the practical move is to translate the marketing umbrella into those specific regulatory triggers, function by function, early in design. Investors and press use "digital health" loosely; regulators use it as a bucket; builders should decompose it. The common pitfall is letting the broad, comfortable label paper over a feature that quietly crosses into device territory or into PHI handling without the BAAs, consent, and safeguards those paths demand — discovering the gap during diligence or an audit rather than in design review.
The handbook · 7 volumes
Fora Soft Video Engineering Handbook
Digital health covers everything from wearables to AI, so the first product decision is which part of that stack you actually need to build. Our seven-volume handbook covers the whole video stack, and for digital health products start with Volume 7: real-time AI, agents, serving, cost, regulation and vertical playbooks. Volume 3 covers video calls and Volume 6 models. Written by Nikolay Sapunov, CEO at Fora Soft.
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