Laboratorians have become accustomed to watching over the security and integrity of patient data developed and stored within their own walls. But increasingly they may also have to watch out for data originating from a variety of sources not initially under their control—including new generations of smartphone applications and remote monitoring devices.

At the beginning of August, DarioHealth, Caesarea, Israel, announced that it would be presenting the results of a user study of its new MyDario glucose monitoring smartphone application at the annual meeting of the American Association of Diabetes Educators later in the month. The study included 162 app users who participated in the coaching program that the company offers through its digital blood glucose and blood pressure monitoring app.

The study demonstrated that the company’s solution helps to improve the blood glucose levels and overall health of users managing type 2 diabetes, and underscored the importance of personalized interventions for helping users to achieve in-range glucose levels. Use of the app was shown to be an effective way for a user to measure how his or her body reacts to various foods, exercise, and other stimuli.

“The results show that well-designed digital therapies can have a meaningful and substantial positive impact on the health of digital app users, which is a central goal of ours,” said Olivier Jarry, DarioHealth president and chief operating officer. “Digital therapeutic interventions can be an indispensable tool for individual users, employers, healthcare providers, insurance companies, and clinics to create user engagement and improve the health outcomes of individuals with chronic illness.”

But after 45 million medical devices were recalled in 2018 due to software and security issues, health officials, clinicians, and patients have expressed concerns about the data security of similarly positioned remote cardiac monitoring devices. FDA has warned that some cardiac implants can be hacked from as far away as 20 feet, and that data integrity should be a top priority for all medical device manufacturers.

According to Stuart Long, CEO of digital health company Infobionic, Waltham, Mass, remote patient monitoring has improved patient outcomes over the past 10 years. But devices that use wireless radiofrequency or Bluetooth connectivity are still subject to cybersecurity risks. The radio frequencies of monitors vary by patient and clinic, making it difficult for a hacker to be both within range and able to tap into the device at the same time. Nevertheless, if successful, hackers can modify or reprogram the device and access or alter sensitive patient data.

“New technology, improved consumer awareness, and precautionary steps will reduce the risk of hackers accessing remote monitors and patients’ personal identifying information,” says Long. He recommends that patients take precautions when using remote and implantable devices, including:

  • Use only devices that are directly from the manufacturer.
  • Take advantage of the latest software upgrades and other device improvements.

New technologies are certainly poised to make important contributions in monitoring the health of patients. But laboratorians should be aware of issues that may affect the data they see in patient records, especially when discordant values could influence clinical decisionmaking.

Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199

Featured image: Smartphone health app. Image © George J McLittle courtesy Dreamstime (ID 105051768).