Loyola University Chicago School of Law JD 2017
Loyola University School of Law JD 2018
Apple has had a longstanding interest in breaking into the healthcare industry. Recently, Apple has hired a Toronto physician to work on expanding its health apps and Aetna will now provide subsidized Apple watches for certain employers. The potential for rapid expansion into the healthcare industry is primarily hindered by FDA requirements for gadgets or apps that act as medical devices. To progress Apple will need to decide whether to stay outside of FDA reach or to build a robust compliance plan encompassing the numerous medical device regulations.
Health Apps vs. Medical Apps
Apple has made a small foray into the health app market through the Apple Health App. The app is more equivalent to a data storage and tracking app than a true medical app, which is driving Apple to dive further into the industry. Apple recently hired Dr. Mike Evans to work on a potential Apple Medical App. Dr. Evans stated “[i]n the future, I’ll prescribe you an app. One of our whiteboards will drop in and explain what high blood pressure is. The phone will be Bluetoothed to the cap of your pills. I’ll nudge you towards a low salt diet. All of these things will all happen in your phone. I see you two or three days a year. The phone sees you everyday.” With Apple attempting to not only break into the medical app market but also revolutionize access to healthcare, there are concerns over how these apps will be regulated.
The FDA stated it will not regulate health apps, but will enforce stringent regulations on apps that function like medical devices. The FDA designates these unregulated health apps as “those that aim to improve overall health but don’t make any references to specific diseases or conditions — such as an app that plays soothing music for stress management — and those that do reference diseases or conditions but that can be controlled by a healthy lifestyle such as skin cancer from UV exposure.” An app would be regulated like a medical device if it’s intended to be used as an accessory to a regulated medical device or will transform a mobile platform into a regulated medical device. This is because the FDA deemed medical app devices can pose a high risk to consumers and as such, require regulation. On the other hand, the FDA deemed health apps do not pose a very high risk and thus, do not need regulation.
If Apple were to continue creating health apps and try to gain more market share, it’s likely to be a good choice as health apps are a lucrative business. Businessinsider.com predicts the market for health apps will grow 33.4% over the next four years to $59.2 billion. If Apple wants a cut of the market share but doesn’t want its devices to be heavily regulated by the FDA, health apps are the way to go.
The Apple Watch vs. Medical Devices
Beyond apps, the Apple Watch has started pushing into the medical device field. On September 27th, Aetna announced it would subsidize the Apple Watch to a few large employers. Though the announcement focused on apps, this could be an opening for the Apple Watch to become a widely accepted medical device. Using the watch as more than a fitness tracker has already been shown in several news stories. This past March Forbes wrote about a man whose life was saved after he checked his Apple Watch and realized his pulse was twice its normal rate. He immediately went to the hospital where the staff determined he was having a heart attack.
Similar to its health apps, Apple has stayed outside of FDA regulations since the watch is intended for general wellness purposes. Apple executive Tim Cook has stated the long approval processes for medical devices are to blame for the company’s slow approach to the industry. However, the watch and medical apps could bring competition to a viable long-term market while creating widely accepted user-friendly resources. If the watch could gather information about hydration, glucose and oxygen levels, or, as Dr. Evans theorized, blood pressure, it could be combined with an app to improve health outcomes. With these capabilities the watch and app would then be classified as a regulated medical device because of their use in the diagnosis, treatment, mitigation, or prevention of a disease.
Compliance for Apps and Medical Devices
Apple and any other hopeful businesses have two ways of complying with FDA regulations. They can either stay out of FDA regulations by only creating general wellness apps and devices or create/overhaul their existing policies and procedures, training and education protocols, and apply their auditing in a new way. A medical device manufacturer will need to create polices and procedures for proper labeling, marketing, registering with the FDA, verifying registration annually each fall, creating approved listing requirements, submitting 510(k) premarket notifications or determining if an exemption exists, and more.
Two requirements of note are Good Manufacturing Practices (GMP) and Medical Device Reporting. Even if a device is 510(k) exempt it must continue to comply with GMP records and complaint file requirements. GMP regulations are a key area for training and education, as well as internal auditing and monitoring. While GMP regulations do not establish specific instructions on how to produce a device, the FDA does demand that policies be established to ensure devices are safe and effective. In conjunction with GMP are reporting policies. Reporting for manufacturers falls under two main categories: if their device may have caused or contributed to a serious death or injury, or if they become aware of the device malfunctioning which may cause or contribute to a death or injury. As with any reporting requirement, communication policies and a hotline would further FDA compliance and notify the manufacturer of any incidents that should be reported. Breaking into a heavily regulated field is a challenge, but strong business predictions and the potential for increased health outcomes would benefit both the healthcare industry and Apple.