For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/software-as-a-medical-device/release/3 Software, such as mobile device apps or telemedicine, creates exciting new opportunities for patient engagement and for improving healthcare. There are three main types of mobile apps: native, web, and hybrid. The wireless technologies in smartphones and wearable sensors, such as smartwatches, offer the potential for additional biometric data collection. HIPAA compliance requires multiple levels of oversight and auditing. The software development costs for healthcare are considerably higher than for consumer-oriented products due to FDA regulatory requirements; testing out proof-of-concept through low-cost alternatives is an important development strategy.