In recent years, a wave of smart phone applications are being proposed that monitor human health, control medical device operations, and provide feedback to promote healthy activities. These advances have led regulatory agencies such as the Food and Drug Administration to consider the smartphone as a medical device. Thus, smartphone applications for health care are critical pieces of software that have strict requirements on patient safety, data security, and efficacy. Healthcare applications (Health apps) involve several unique features such as interfacing with physiological sensors, data sharing among applications, communicating and storing personalized data in cloud servers, maintaining privacy of health data, controlling mission critical medical devices (infusion pumps, ventilators), and displaying physiological data in a way intuitive to the user and time saving for the doctor. These features introduce several key software development issues which when not addressed adequately can cause harm to the users. Current methods for application approval do not consider safety, security and efficacy. This workshop is a platform to discuss the smartphone based healthcare application software development with special focus on their unique characteristics and regulatory requirements.