When mobile tech becomes medical device
This article was first featured on MedCityNews. Click here to read the original.
Healthcare, clinical trials, and technology are advancing at a record pace, and nowhere is it more evident than in the development and use of mobile health (mHealth) technologies. This is not lost on the media, with the amount of time and attention being put into the assessment and reporting on availability and accuracy of some devices. Fitness trackers like Fitbit are being constantly debated in regard to their merits and accuracy.
At the same time, regulators are trying to keep pace with the innovation and use of mHealth devices. The FDA has issued a number of guidance documents in the past two years clarifying its position on medical devices, software, mobile technology, and what the agency will pursue with regards to enforcement. Other international regulatory agencies are monitoring the release and use of medical devices and communicating their expectations as well.
Mobile health technology is now being developed and deployed on a wide variety of platforms, including smartphones, watches, tablets, and wearable fitness devices. Body Mass Index (BMI) calculators, diet and exercise trackers, smartphone-based blood glucose meters, and other products are widely available, with varying bits of understanding of the accuracy and purpose of these products.
So when does mobile technology become a medical device? In the simplest terms, it’s about intended use and what the product manufacturer is representing as intended use. According to Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act, medical devices are defined as:
“intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body.”
Evaluation of the product categorization as a medical device really focuses on the representation of what the device is supposed to be used for. Still, confusion persists about whether the device is software, hardware, or combined with a commercially-available gadget—like a smartphone. These attributes influence some decision making and testing, but they don’t impact the basic categorization of medical device vs. mobile tech.
To provide further clarity, here are some examples of medical devices and mobile tech:
Fitbits, other fitness trackers, and watches – in spite of their growing use in health care and clinical trials, these are not medical devices; they are mobile technology. They are used to gather data which is advisory to clinicians and researchers, similar to surveys and questions to a patient. They are not represented as accurate enough or intended to be relied on for clinical decision making. Although accuracy may be a focus of development and expected by the public and certain critics of the technology, their current use and representation is that of a “wellness product.”
Smartphone-based blood glucose meters and ECGs – these are medical devices. They are represented as providing clinical information that can be used by a patient and shared with a health care professional to assist in treatment. These products may be available in over-the-counter versions, but as claims are made about their accuracy and ability to help make health decisions, they are regulated as medical devices.
Virtual health care aids – smartphone, tablet, or PC-based systems that help providers speak with patients or review information to provide consultative care are not medical devices. These products help access information, but they don’t gather or modify clinical information. They are merely tools to access important data in the health care setting.
Aside from FDA and international clinical regulations, many of these tools fall under the domain of other laws and compliance requirements, like the Federal Trade Commission here in the U.S. or HIPAA compliance expectations for data privacy. These laws and regulations are very important and need to be understood with regard to the product. Regulations vary by jurisdiction and navigating through them takes time and experience.
Finally, the platform itself should not be the focus.
Apple, Samsung, Google, and other mobile technology providers have presented innovative platforms which are stimulating rapid and exciting advances in end-user technology and portability. However, each of these vendors and others has made their platforms available to developers as just that—a platform. It is the software or health care technology company who is responsible for the development, testing, and compliance of their technology as a medical device. Otherwise, it remains a piece of mobile tech.