July 14, 2020

Volume X, Number 196

July 13, 2020

Subscribe to Latest Legal News and Analysis

FTC Creates Interactive Tool for Developers of Mobile Health Applications

The Federal Trade Commission (FTC) recently created a new interactive tool for mobile health application developers to utilize in determining which federal laws and regulations might apply to them. A Mobile Health Application is any application on a mobile device which delivers health care services. This could include applications which keep track of health information, monitor chronic illnesses, or allow a patient to directly communicate or share information with his/her health care provider.

The FTC, together with the Office of Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA), has designed a web-based tool that takes mobile health application developers through a series of questions about the nature of their applications, including the function, the data collected, and the services provided to users. Based on the answers to the questions, the tool helps mobile health application developers to figure out whether or not certain federal statutes and regulations might apply to them, including:

  • Health Insurance Portability and Accountability Act (HIPAA) Rules

  • Federal Food, Drug, and Cosmetic Act (FD&C Act)

  • Federal Trade Commission Act (FTC Act)

  • Federal Trade Commission’s Health Breach Notification Rule.

The tool, which is maintained on the FTC’s website, links to each agency’s (OCR, ONC, FDA) website for more information about the laws and regulations for which they have compliance and enforcement responsibility.

The Director of the FTC’s Bureau of Consumer Protection stated, “Mobile app developers need clear information about the laws that apply to their health-related products”, and “by working with our partner agencies, we’re helping these businesses build apps that comply with the law and provide more protection for consumers.” More and more, individuals are becoming increasingly reliant on managing their health care through mobile health applications. Studies project that by 2020, the worldwide mobile health market is expected to grow to $49 billion.1 The worldwide mobile health market was valued at just $4.75 billion in 2014.

The FTC’s Mobile Health Apps Interactive Tool can be found here.


1 “mHealth is Expected to Reach $49.12 Billion by 2020”, Grand View Research, August 2015, http://www.grandviewresearch.com/press-release/global-mHealth-market

© 2020 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume VI, Number 113

TRENDING LEGAL ANALYSIS


About this Author

Jenna Moran, Corporate Attorney, Dinsmore Law Firm
Associate

Jenna is a member of the Corporate Department, focusing her practice on health care law. Prior to joining Dinsmore, she served as a judicial extern for Judge Raymond Mitchell in the Circuit Court of Cook County in Chicago. She also worked as a law clerk for Krieg DeVault, LLP in Chicago where she gained experience in regulatory compliance, pharmacy law, Medicare/Medicaid appeals and reimbursement, and health law litigation. Jenna also served as the Symposium Editor for the DePaul Law Review, where she organized the 24th annual DePaul Law Review Symposium bringing...

513-977-8269
Jennifer Mitchell, health care practice group partner, Dinsmore Shohl, law firm,
Partner

Jennifer is a Partner in the Health Care Practice Group and leads the firm’s HIPAA Privacy and Security practice and initiatives. In her HIPAA practice, she works with clients to minimize the risk of privacy and data security issues, assisting with all aspects of HIPAA privacy and security compliance, governance, audits/investigations, breach analyses, training and strategic planning. She has a thorough understanding of federal and state privacy and confidentiality laws and has served as a health care privacy expert witness. 

Within the constantly evolving health care legal landscape, in addition to HIPAA, Jen provides health care regulatory and compliance guidance to her clients in areas such as the federal and state anti-kickback laws, Stark law, PPACA (health reform), Sunshine Act, Medicare Secondary Payer laws, pharmaceutical marketing rules, ADA standards, and other laws and regulations impacting her health care clients. 

513-977-8364