With 65,000+ healthcare apps in app stores, the regulatory landscape has become a bewildering maze. FDA classifications, HIPAA compliance, GDPR requirements, and ISO standards all intersect—but few developers understand which rules apply to their app. This guide cuts through the confusion with clarity.
Understand the difference between wellness apps, low-risk clinical tools, and Software as a Medical Device. Learn which features trigger regulatory oversight and how intended use statements determine your approval pathway.
Master the criteria for FDA exemptions, 510(k) clearance, de novo classification, and full premarket approval. Discover why functionally similar apps can qualify for vastly different regulatory tracks based on claims and risk levels.
Learn what the Privacy Rule, Security Rule, and Enforcement Rule actually require. Understand how to design authentication, encryption, and access controls that protect electronic health information throughout its lifecycle.
Discover why healthcare data falls into GDPR’s “special category” requiring heightened protection. Learn how to implement user consent, data portability, deletion rights, and breach notification that satisfy European regulators.
Understand how Health Level Seven International standards enable seamless data exchange between systems. Learn which HL7 versions and implementation guides apply to your integration needs and why standardization matters.
Get early insight into how FDA’s evolving approach to software regulation will streamline reviews for qualified developers. Understand what organizational maturity and process rigor the precertification program will require.
