Continuous, Stringent, Full FDA Approval on All Ends
Ask yourself if the U.S. Food & Drug Administration, or the USFDA (FDA), holds a high possibility to consider your app as a “medical device”. If not, then it must comply with extra regulation from the FDA. In addition, please review these steps you can take to maximize your chances of gaining both HIPAA and FDA approval in this regard.
Mobile Security
“We recommend to first make sure and aim to develop a highly secure mobile app with the best security measures in the industry. This way, many of the HIPAA aspects would already be achieved and compliance would follow naturally. Developing a HIPAA compliance for your app would become a much simpler task if developers build the app according to the industry standards and frameworks.”
Proper security can often lead to approved compliance. It’s as simple as that. The U.S. government, with its highly stringent measures and high-security procedures overall, would have it no other way. So, your best option is to enforce security to ensure compliance.
Consultation
App developers and their agencies will rarely go wrong when they employ professionals to assist in this matter, especially when dealing with government compliance and proper legal standing. You should primarily consult a legal attorney or business with plenty of prior experience in the arena of mHealth. While doing so, it would not hurt to additionally seek out professionals in-app scrutiny, ones who hold a strong standing for in-depth analysis and action-plan implementation — the more well-versed and well-rated, the better. Remember: You can never “over-invest” in-app quality with compliance.
Key Conclusions – Final Thoughts to Take Home
The U.S. HIPAA is the ultimate authority in all things “healthcare”, and that no less includes the intrinsic, delicate realm of healthcare app development. There are many ways to develop such an app, not all of which end up in compliance, or ready for long-term market success. Keep in mind that, in this very time-consuming endeavor, one or all of seven unique challenges will present themselves: the line of action, HIPAA rules, and regulations push notifications, text messaging, FDA approval, overall mobile security, and consultation. Are you, as a developer, prepared to meet these challenges head-on?