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FDA regulates many health care apps
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With most of the U.S. population having access to the Internet via smartphones, it is difficult to escape the utilization of those ever-present “apps.”
As providers of medical care bound by the regulations requiring all health workers to be mindful of patient confidentiality, it is important to realize that the apps you are using just might be subject to some regulatory oversight. The U.S. Food and Drug Administration has become involved in regulating health care apps, with optometry apps being no exception.
In September 2013, and roughly 2 years after initial usage guidelines for apps were released, the FDA published a comprehensive guide titled, “Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff.” This publication issues basic regulations and recommendations on the use and development of health care apps.
Agustin L.
Gonzalez
Apps that transform a mobile communication device or smartphone into a regulated medical device and the use of mobile communication devices to control a medical device are all subject to the regulatory guidelines.
Those apps that are excluded or not explicitly covered by the guidelines include the use of reference materials, textbooks or teaching aids, apps used for tracking health or making general recommendations on health and wellness, and apps developed to assist with clerical office functions such as billing and appointments.
The vast majority of mobile apps do not meet the definition of a “medical device” under section 201(h) of the Federal Food, Drug and Cosmetic Act, which means the FDA does not regulate them. However, some mobile apps may meet the definition of a medical device if they could pose a risk to the public. In such cases, the FDA intends to monitor and supervise the use of these devices.
The best place to find out if the app you are using is subject to the FDA’s oversight is appendix C of the guide, or the FDA’s Products and Medical Procedures website: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/.
It is also important for optometrists using or developing apps for the eye care practice to consider other regulatory requirements such as the Health Insurance Portability and Accountability Act, or HIPAA, and the Health Information Technology for Economic and Clinical Health Act, or HITECH Act. Be aware that failure to observe these guidelines could result in penalties.