In the fall of 2015, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) released an online resource to assist mobile health application developers in determining whether they need to comply with the Health Insurance Portability and Accountability Act (“HIPAA”). This week, the Federal Trade Commission (“FTC”) announced a new web-based tool to assist these same innovators to figure out where they fit within a broad range of laws related to the development of new technology in the health care realm, including the FTC Act, the FTC’s Health Breach Notification Rule, HIPAA, and the Federal Food, Drug, and Cosmetics Act. This new guidance tool is interactive and asks users to respond to high-level questions about the features, data collection, and service goals of the developer’s app, then directs the developer to information on certain federal laws that may apply to their app, or notifies the developer that a specific law or group of laws is unlikely to be applicable to its app.
The FTC’s new tool, available here, aims to assist health product developers to navigate the complex framework of inter-related federal laws designed to ensure protection of patient safety, while encouraging innovation and continued investment in the area of digital health services. Collaboration between the FTC, OCR, the FDA, and HHS’ Office of National Coordinator for Health Information Technology, made it possible for the web-based resource to identify and guide developers toward a wide array of information for health technology developers to consider, rather than previous tools designed for compliance with specific laws.
This resource is an encouraging step forward for continued innovation and development of mobile healthcare services nationwide.