Avoiding Pitfalls with Smartphone Medical Devices

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Author: Jeff Chininis | Date: September 26, 2023

Smartphones are everywhere. They help us pay our bills, keep our calendars, connect us to our colleagues and loved ones, save our most precious memories, and more. But did you know the value of smartphones in health care? In addition to their convenience and availability, smartphone medical devices offer a wide range of capabilities that can revolutionize health care delivery and outcomes for patients. But, to succeed in this emerging market, developers should be aware of and avoid some substantial pitfalls.  

A smartphone medical device is a bit of a misnomer because the smartphone usually serves as an accessory or intermediary to connect with an interface of a physical device, implantable device, or other embedded system. But there are a lot of advantages to utilizing a smartphone with a medical device. The first is accessibility – medical professionals are often glued to their mobile devices just like the rest of us. Medical devices for Android phones or iOS operating systems offer physicians portable smartphone medical diagnostics wherever they are. iOS- or Android-based medical devices can collect and communicate critical information on a patient’s health. For example, a smartphone can help screen a patient for a concussion, its microphone can monitor for sleep apnea, or its camera can measure a patient’s heart rate. Smartphone applications also commonly serve as a landing space for wearable medical devices tracking critical patient information. The wearable device sends smartphone data that informs a patient or doctor to help make critical treatment decisions. Using a smartphone with a medical device also allows you to control the product, improve it, and make needed software or firmware updates using Wi-Fi, cellular, or Bluetooth Low Energy (BLE) connections. It’s also simple to do – even if you are designing a product that does not initially include mobile device diagnostics, incorporating a BLE chip to add the capability later is generally unobtrusive and won’t derail your project.

With all the promise the proliferation of smartphones and mobile medical devices holds, there are also some significant potential challenges developers could face if they are not prepared. Here are some tips to help you avoid them and bring an effective and profitable device to market.

Know if your product is a medical device. In recent years, there has been an influx of wellness devices aiming to provide consumers with information on their health, but technically many are not medical devices. It is an important distinction because medical devices are regulated by the U.S. Food and Drug Administration (FDA) in the United States, and they must undergo the FDA’s approval process, often thorough and lengthy, to legally be sold in the U.S. Wellness devices do not. The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article (…) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease (…) intended to affect the structure or any function of the body.” (1) The challenge is that sometimes a device diagnostic tool uses Android or iOS platforms and toes a very thin line on FDA regulation. For example, one company recently received a warning letter from the FDA regarding the sale of their product that monitored heart rate and blood oxygen levels in infants. The company believed its product fell under the wellness category, but it caught the attention of the FDA which flagged it as a potential smartphone medical device. The manufacturer had to develop a separate product that does not gather the same information while removing its original product from the market as the company navigated the FDA’s regulatory approval process.

Understand your HIPAA responsibilities. The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) was passed to protect sensitive patient health information.  As your smartphone medical device gathers data, it is important to know if you are required to adhere to HIPAA regulations, or your company and reputation could face serious consequences.

Incorporate cybersecurity. Adding robust cybersecurity to your product is essential, not only to protect patient health information and avoid potential HIPAA violations but also to protect other identifying information like social security numbers and credit card information, as well as protect the device’s ability to do what it is supposed to.

The best way to avoid these pitfalls is to work with experienced partners who know how to connect smartphones to medical devices, build the devices integrating the technology, and support your regulatory body submission. Vantage MedTech can be that partner for you, whether you are developing mobile phone diagnostic equipment or utilizing smartphone technology in another way. Our medical device design and development experts can help.

(1) https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

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