September 01, 2018

Advising Mobile Medical App Developers: Untangling the Regulatory Web

Amy Fehn, Health Law Office of Amy Fehn, Southfield, Michigan

As mobile app developers continue to address the needs of patients and healthcare providers in the management of health and wellness, it is important for developers and the attorneys advising them to be aware of the many statutes, regulations and guidance documents that should be considered.  The Federal Trade Commission’s (FTC) website is a good place to start, as it includes an interactive tool developed by the FTC in cooperation with the following Department of Health and Human Services (HHS) agencies:  the Office of the National Coordinator for Health Information Technology (ONC), the Office for Civil Rights (OCR) and the Food and Drug Administration (FDA).1   The interactive tool helps developers determine whether their app is subject to the Federal Food, Drug and Cosmetic Act (FD&C Act), the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Federal Trade Commission Act (FTC Act) or the FTC’s Breach Notification Rule.2  In addition to these laws and depending on the expected geographic locations of the apps users, mobile app developers may need to consider the requirements of the General Data Protection Regulation (GDPR)3 and similar state laws, such as the California Consumer Privacy Act (CCPA) of 2018.4

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