PROJECT SUMMARY/ABSTRACT With the increased use of mobile health (mHealth) apps to improve health outcomes, protecting private health data is becoming increasingly important. These mHealth apps are offered by healthcare providers and used by patients for various reasons such as paying bills, scheduling appointments, sending messages to providers, accessing lab results, and viewing prescriptions and medical records. With patients’ increasing desire for data accessibility and app data sharing, it is critical to ensure that patients transmit their Protected Health Information (PHI) to apps that comply with HIPAA privacy and security regulations. Unfortunately, about 25% of healthcare providers suffer from data breaches violating HIPAA policies caused by using mobile devices that come with mHealth apps. These breaches result in lawsuits and loss of confidence among health providers and patients. Earlier research has focused on mobile device security but has not checked further how apps store or transfer data securely before being used by remote healthcare providers or users. A total of 303,867 complaints have been received in the HHS.gov until July 2022 [95], which indicates that most developers, including mHealth apps developers, are unaware of HIPAA security and privacy regulations. This creates the market opportunity to develop static and dynamic code analysis tools for mHealth app developers, so their developed products meet HIPAA security and privacy guidelines. Currently, there is a lack of an analysis framework to check mHealth apps’ security and privacy risks following the applicable HIPAA technical security and privacy guidelines. We have developed a framework to analyze mHealth apps for HIPAA security and privacy compliance for Android. The tool is available both as a web-based interface for users without knowledge of HIPAA or app security and as a plugin with Android Studio to enable health app developers to test source code for potential data security breaches related to HIPAA before posting to the marketplace. In addition, the tool addresses API level checking for secure data communication mandated by recent Centers for Medicare & Medicaid Services (CMS) guidelines between third-party mobile health apps and EHR systems. The analysis framework also addresses heterogeneous health data and enables providers to comply with HIPAA administrative and operational guidelines. We have performed two acceptance tests on the prototype based on partnering with HIPAA experts, medical doctors, and for-profit EHR vendors along with the effectiveness of tools for detecting health data security breaches. In Phase II, we propose a commercial product mSPAiOS as a mHealth HIPAA checker by extending the framework for iOS mHealth apps security and privacy assessment, plugin support for xCode environment, and performance evaluation of the product by at least 3 for-profit organizations/EHR vendors. The proposed tool has the potential to capture the market of the HIPAA-compliant assessment as a unique product that is not provided by any existing tools.

PROJECT NARRATIVE In this project, we aim to develop a Framework for mHealth App Security and Privacy Analysis called mSPAiOS intended to check the security and privacy of Android and iOS applications. The project is a further extension of our preliminary prototype developed from the STTR Phase I project, where android-based mHealth apps are checked for HIPAA-related technical security and privacy rules at the source code level for app users and developers. The Phase II commercial product aims to further extend the Phase I product by increasing language support for security and privacy checking, providing plugins support for developers in an integrated developed environment for Android and iOS, and testing more production-grade applications that are developed and maintained by at least 3 USA-based health IT companies/vendors. Moreover, this project will advance the secure EHR/EMR vendor integration via API with mHealth apps. The project has further implications of preventing several emerging and existing cyber-attacks that can potentially lead to massive healthcare data breaches, such as ransomware, and supply chain attacks, by detecting and preventing the vulnerabilities early.