If you are planning to launch your healthcare mobile application in the USA, then yes, your app must comply with FDA and HIPAA regulations. If you are planning to integrate functionalities that monitor your patient's health or wish to sell prescription drugs on your healthcare app, then do note that having FDA registration is a must for you. HIPAA compliance is essential for healthcare applications that record and store patient data. Meeting this requirement means that your application is capable of maintaining data integrity and can be trusted with sensitive patient information. As a result, if you plan to launch your healthcare app in the US market, then you must ensure that your product complies with both of these requirements. It is in your best interest to avail healthcare app development services from a development partner with experience in developing such legally compliant mobile apps.